Primaxin IM

Generic Name: imipenem and cilastatin (IM i PEN em and SYE la STAT in)

Brand Names: Primaxin IM, Primaxin IV

What is Primaxin IM (imipenem and cilastatin)?

Imipenem is an antibiotic that fights serious infections caused by bacteria.

Cilastatin helps imipenem work more effectively by preventing the breakdown of the antibiotic in the kidneys.

Imipenem and cilastatin is used to treat severe infections of the lower respiratory tract, skin, stomach, female reproductive organs, and other body systems.

Imipenem and cilastatin may also be used for other purposes not listed here.

What is the most important information I should know about Primaxin IM (imipenem and cilastatin)?

Do not use imipenem and cilastatin if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

Before using imipenem and cilastatin, tell your doctor if you have kidney disease (or if you are on dialysis), or a seizure disorder.

Also tell your doctor if you are either allergic to or are currently taking a penicillin or cephalosporin antibiotic such as Amoxil, Augmentin, Bactocill, Beepen-VK, Ceclor, Ceftin, Duricef, Dycill, Dynapen, Keflex, Ledercillin VK, Omnipen, Pen-V, Pfizerpen, Principen, Veetids, and others.

Primaxin IM (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Primaxin IM into a vein and do not inject Primaxin IV into a muscle.

Call your doctor at once if you have serious side effects such as pounding heartbeats, confusion, hallucinations, seizure (convulsions), feeling light-headed, fainting, flu symptoms, nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), or a severe blistering, peeling, and red skin rash.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What should I discuss with my healthcare provider before use Primaxin IM (imipenem and cilastatin)?

Do not use imipenem and cilastatin if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

If you have any of these other conditions, you may need a dose adjustment or special tests:

• kidney disease (or if you are on dialysis);


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  epilepsy or other seizure disorder;

  
  


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  a history of allergy to penicillin antibiotics such as Amoxil, Augmentin, Omnipen, Principen, Dycill, Dynapen, Bactocill, Beepen-VK, Ledercillin VK, Pen-V, Pfizerpen, Veetids, and others; or

  
  


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  a history of allergy to cephalosporin antibiotics such as Ceclor, Ceftin, Duricef, Keflex, and others.

  
  

FDA pregnancy category C. It is not known whether imipenem and cilastatin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether imipenem and cilastatin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Primaxin IM (imipenem and cilastatin)?

Imipenem and cilastatin is injected into a vein (IV) or into a muscle (IM).

Imipenem and cilastatin is usually given in a clinic or hospital setting. The IV medicine must be given as a slow infusion and can take up to an hour to complete. Tell your caregiver if you feel nauseated during the infusion. You may need to receive the medicine at a slower rate.

The IM form of imipenem and cilastatin is given as a rapid injection into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Primaxin IM (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Primaxin IM into a vein and do not inject Primaxin IV into a muscle.

Imipenem and cilastatin is usually given as long as needed until your infection has cleared or you have been symptom-free for at least 48 hours.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Imipenem and cilastatin will not treat a viral infection such as the common cold or flu.

Do not give this medication to another person, even if they have the same symptoms you do.

Imipenem and cilastatin is a powder that must be mixed with a liquid (diluent). Primaxin IM and Primaxin IV are each mixed with different types of diluent.

Prepare your dose in a syringe only when you are ready to give yourself an injection.

After mixing Primaxin IV, you may keep it in a refrigerator and use it within 24 hours. You may also store the mixed IV medicine at room temperature if you use it within 4 hours. Store unmixed imipenem and cilastatin powder at room temperature away from moisture and heat.

What happens if I miss a dose?

If imipenem and cilastatin is given in a hospital setting, it is not likely that you will miss a dose. If you are using the medication at home and you miss a dose, give the injection as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include weakness, drooping eyelid, tremors, trouble breathing, or seizure (black-out or convulsions).

What should I avoid while using Primaxin IM (imipenem and cilastatin)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Primaxin IM (imipenem and cilastatin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

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  fast or pounding heartbeats;

  
  


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  diarrhea that is watery or bloody;

  
  


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  confusion, tremors, hallucinations, seizure (convulsions);

  
  


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  feeling light-headed, fainting;

  
  


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  fever, chills, body aches, flu symptoms;

  
  


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  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  
  


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  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

  
  

Less serious side effects may include:

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  pain, swelling, or redness where the medicine was injected;

  
  


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  mild nausea, vomiting, heartburn, or stomach pain;

  
  


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  sore throat;

  
  


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  vaginal itching or discharge;

  
  


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  mild skin rash or itching;

  
  


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  dizziness or tired feeling;

  
  


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  numbness or tingling; or

  
  


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  ringing in your ears.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Primaxin IM (imipenem and cilastatin)?

Tell your doctor about all other medications you use, especially:

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  valproic acid (Depakene, Stavzor);

  
  


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  ganciclovir (Cytovene);

  
  


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  probenecid (Benemid);

  
  


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  a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin), ampicillin (Omnipen, Principen), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others); or

  
  


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  a cephalosporin antibiotic such as cefaclor (Ceclor), cefuroxime (Ceftin), cefadroxil (Duricef), cephalexin (Keflex), and others.

  
  

This list is not complete and other drugs may interact with imipenem and cilastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Primaxin IM resources

• Primaxin IM Side Effects (in more detail)
• Primaxin IM Use in Pregnancy & Breastfeeding
• Primaxin IM Drug Interactions
• Primaxin IM Support Group
• 0 Reviews for Primaxin IM - Add your own review/rating

• Primaxin IM Prescribing Information (FDA)


• Primaxin IM MedFacts Consumer Leaflet (Wolters Kluwer)


• Primaxin IM Advanced Consumer (Micromedex) - Includes Dosage Information


• Imipenem-Cilastatin Professional Patient Advice (Wolters Kluwer)


• Primaxin IV Prescribing Information (FDA)


• Primaxin IV MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Primaxin IM with other medications

• Aspiration Pneumonia
• Bacteremia
• Bacterial Infection
• Bone infection
• Bronchitis
• Deep Neck Infection
• Endocarditis
• Endometritis
• Febrile Neutropenia
• Intraabdominal Infection
• Joint Infection
• Kidney Infections
• Meningitis
• Nosocomial Pneumonia
• Pelvic Infections
• Peritonitis
• Pneumonia
• Pneumonia with Cystic Fibrosis
• Septicemia
• Skin and Structure Infection
• Skin Infection
• Urinary Tract Infection

Where can I get more information?

• Your doctor or pharmacist can provide more information about imipenem and cilastatin.

See also: Primaxin IM side effects (in more detail)

Promethazine Tablets

Dosage Form: tablet
Promethazine Hydrochloride Tablets, USP

Promethazine Tablets Description

Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as (±)-10-[2-(Dimethylamino)propyl]phenothiazine monohydrochloride and has the following structural formula:

Promethazine hydrochloride is a racemic compound; the empirical formula is C17H20N2S • HCl and its molecular weight is 320.88.

Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.

Each tablet for oral administration contains 25 mg or 50 mg of promethazine hydrochloride, USP. The inactive ingredients include: lactose (monohydrate), magnesium stearate and microcrystalline cellulose. The 50 mg also contains D & C Red Lake Blend (D & C Red #27 and D & C Red #30).

Promethazine Tablets - Clinical Pharmacology

Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties.

Promethazine is an H1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last 4 to 6 hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

Indications and Usage for Promethazine Tablets

Promethazine hydrochloride tablets are useful for:

Perennial and seasonal allergic rhinitis.

Vasomotor rhinitis.

Allergic conjunctivitis due to inhalant allergens and foods.

Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.

Amelioration of allergic reactions to blood or plasma.

Dermographism.

Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled.

Preoperative, postoperative or obstetric sedation.

Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.

Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.

Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.

Active and prophylactic treatment of motion sickness.

Antiemetic therapy in postoperative patients.

Contraindications

Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age.

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.

Warnings

PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.

POST-MARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

CNS Depression

Promethazine hydrochloride tablets may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central nervous system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence of promethazine hydrochloride (see PRECAUTIONS: Information for Patients and Drug Interactions).

Respiratory Depression

Promethazine hydrochloride tablets may lead to potentially fatal respiratory depression.

Use of promethazine hydrochloride tablets in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.

Lower Seizure Threshold

Promethazine hydrochloride tablets may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.

Bone-Marrow Depression

Promethazine hydrochloride tablets should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine hydrochloride has been used in association with other known marrow-toxic agents.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine hydrochloride alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of promethazine hydrochloride, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered.

Use in Pediatric Patients:

PROMETHAZINE HYDROCHLORIDE TABLETS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TABLETS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.

ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HYDROCHLORIDE TABLETS ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE’S SYNDROME. THE USE OF PROMETHAZINE HYDROCHLORIDE TABLETS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE’S SYNDROME OR OTHER HEPATIC DISEASES.

Excessively large dosages of antihistamines, including Promethazine HCl Tablets in pediatric patients may cause sudden death (see OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine HCl in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.

Other Considerations

Administration of promethazine HCl has been associated with reported cholestatic jaundice.

Precautions

General

Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.

Promethazine HCl Tablets should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

Information for Patients

Promethazine HCl Tablets may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The use of alcohol or other central nervous system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment (see WARNINGS: CNS Depression and PRECAUTIONS: Drug Interactions). Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.

Patients should be advised to report any involuntary muscle movements.

Avoid prolonged exposure to the sun.

Drug Interactions

CNS Depressants

Promethazine hydrochloride tablets may increase, prolong, or intensify the sedative action of other central nervous system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine hydrochloride. When given concomitantly with promethazine hydrochloride tablets, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine hydrochloride relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.

Epinephrine

Because of the potential for promethazine hydrochloride to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine hydrochloride tablets overdose.

Anticholinergics

Concomitant use of other agents with anticholinergic properties should be undertaken with caution.

Monoamine Oxidase Inhibitors (MAOI)

Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with promethazine hydrochloride tablets.

Drug/Laboratory Test Interactions

The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride:

Pregnancy Tests

Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.

Glucose Tolerance Test

An increase in blood glucose has been reported in patients receiving promethazine hydrochloride.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. Promethazine was nonmutagenic in the Salmonella test system of Ames.

Pregnancy

Teratogenic Effects. Pregnancy Category C

Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine hydrochloride. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50 kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.

Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well controlled studies of promethazine in pregnant women.

Promethazine hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Promethazine administered to a pregnant woman within 2 weeks of delivery may inhibit platelet aggregation in the newborn.

Labor and Delivery

Promethazine hydrochloride may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown. (See also Nonteratogenic Effects.)

Nursing Mothers

It is not known whether promethazine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from promethazine hydrochloride tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

PROMETHAZINE HYDROCHLORIDE TABLETS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (See WARNINGS: Black Box Warning and Use in Pediatric Patients).

Promethazine hydrochloride tablets should be used with caution in pediatric patients 2 years of age and older (see WARNINGS: Use in Pediatric Patients).

Geriatric Use

Clinical studies of promethazine hydrochloride formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of promethazine hydrochloride tablets and observed closely.

Adverse Reactions

Central Nervous System: Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.

Cardiovascular: Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic: Dermatitis, photosensitivity, urticaria.

Hematologic: Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal: Dry mouth, nausea, vomiting, jaundice.

Respiratory: Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS: Respiratory Depression.)

Other: Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS: Neuroleptic Malignant Syndrome.)

Paradoxical Reactions: Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine hydrochloride. Consideration should be given to the discontinuation of promethazine hydrochloride and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.

Overdosage

Signs and symptoms of overdosage with promethazine hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex).

Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine like signs and symptoms – dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms – may occur.

Treatment

Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine hydrochloride are not reversed by naloxone. Avoid analeptics which may cause convulsions.

The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. Oxygen may also be administered.

Limited experience with dialysis indicates that it is not helpful.

Promethazine Tablets Dosage and Administration

Promethazine hydrochloride tablets are contraindicated for children under 2 years of age (see WARNINGS: Black Box Warning and Use in Pediatric Patients).

Allergy

The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25 mg doses at bedtime or 6.25 mg to 12.5 mg taken 3 times daily will usually suffice. After initiation of treatment, in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25 mg doses will control minor transfusion reactions of an allergic nature.

Motion Sickness

The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, promethazine hydrochloride tablets, syrup, or rectal suppositories, 12.5 mg to 25 mg, twice daily, may be administered.

Nausea and Vomiting

Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients).

The average effective dose of promethazine hydrochloride tablets for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally or by rectal suppository. 12.5 mg to 25 mg doses may be repeated, as necessary, at 4 to 6 hour intervals.

For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.

For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4 to 6 hour intervals, as necessary.

Sedation

This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 mg to 25 mg promethazine HCl by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 mg to 50 mg for nighttime, presurgical, or obstetrical sedation.

Pre- and Postoperative Use

Promethazine HCl in 12.5 mg to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.

For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine like drug.

Usual adult dosage is a 50 mg promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.

Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 mg to 25 mg in children and 25 mg to 50 mg doses in adults. Promethazine hydrochloride tablets are contraindicated for children under 2 years of age.

How is Promethazine Tablets Supplied

Promethazine hydrochloride tablets, USP for oral administration are available as:

25 mg: Round, white, scored tablets, debossed GG 225 on one side and plain on the reverse side and are supplied as:

NDC 0781-1830-01 bottles of 100

NDC 0781-1830-10 bottles of 1000

50 mg: Round, pink, unscored tablets, debossed GG 235 on one side and plain on the reverse side and are supplied as:

NDC 0781-1832-01 bottles of 100

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Dispense in a tight, light-resistant container.

Rev. 05-2006M

7299

Sandoz Inc.

Princeton, NJ 08540

mg Label

Promethazine HCl

Tablets, USP

25 mg

Rx only

100 Tablets

SANDOZ

mg Label

Promethazine HCl

Tablets, USP

50 mg

Rx only

100 Tablets

SANDOZ

PROMETHAZINE HYDROCHLORIDE  promethazine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0781-1830 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE   CELLULOSE, MICROCRYSTALLINE   MAGNESIUM STEARATE   D&C RED NO. 27   D&C RED NO. 30   XANTHAN GUM

Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code GG;225 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0781-1830-01 100 TABLET In 1 BOTTLE None 2 0781-1830-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA084234	12/19/1975

PROMETHAZINE HYDROCHLORIDE  promethazine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0781-1832 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE   CELLULOSE, MICROCRYSTALLINE   MAGNESIUM STEARATE   D&C RED NO. 27   D&C RED NO. 30   XANTHAN GUM

Product Characteristics Color PINK Score no score Shape ROUND Size 10mm Flavor Imprint Code GG;235 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0781-1832-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA084176	02/18/1975

Labeler - Sandoz Inc (110342024)

Revised: 01/2012Sandoz Inc

Promethazine Suppositories

Pronunciation: proe-METH-a-zeen
Generic Name: Promethazine
Brand Name: Phenergan

Promethazine Suppositories should not be used in children younger than 2 years old. Potentially fatal side effects (eg, difficult or slowed breathing, drowsiness leading to coma) may occur in this age group when taking Promethazine Suppositories.

Caution should be used when using Promethazine Suppositories in children 2 years old and older. The lowest possible dose should be used in this age group, and Promethazine Suppositories should not be used with other medicines that cause slowed breathing.

Promethazine Suppositories are used for:

Relieving allergy symptoms, including hives or runny nose. It is used to prevent and control nausea and vomiting during and after surgery. It is also used to help produce light sleep; prevent and treat motion sickness; or treat pain after surgery, in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Promethazine Suppositories are a phenothiazine. It works by blocking the action of various chemicals in the brain, preventing or reducing the symptoms these chemicals cause.

Do NOT use Promethazine Suppositories if:

• you are allergic to any ingredient in Promethazine Suppositories


• you have severe central nervous system depression or are in a coma


• you are taking astemizole, cisapride, terfenadine, or tramadol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Promethazine Suppositories:

Some medical conditions may interact with Promethazine Suppositories. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have nervous system problems, bone marrow depression, alcoholism, heart problems, a blood disease, glaucoma, increased eye pressure, low blood pressure, liver problems, prostate problems, Parkinson disease, seizures, or Reye syndrome, or if you have been in a coma

Some MEDICINES MAY INTERACT with Promethazine Suppositories. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Charcoal or lithium because they may decrease Promethazine Suppositories's effectiveness


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), astemizole, cisapride, general anesthetics (eg, thiopental), methyldopa, terfenadine, or tramadol because side effects, such as low blood pressure and seizures, may occur


• ACE inhibitors (eg, enalapril), haloperidol, lithium, meperidine, metrizamide, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), naltrexone, polypeptide antibiotics (eg, actinomycin), or trazodone because the risk of their side effects may be increased by Promethazine Suppositories


• Bromocriptine, epinephrine, levodopa, or pergolide because their effectiveness may be decreased by Promethazine Suppositories

This may not be a complete list of all interactions that may occur. Ask your health care provider if Promethazine Suppositories may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Promethazine Suppositories:

Use Promethazine Suppositories as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands before and after using Promethazine Suppositories. If the suppository is too soft to use, put it in the refrigerator for about 15 minutes. You may also run cold water over it. Remove the wrapper. Moisten the suppository with cool water. Lie down on your side. Insert the pointed end of the suppository into the rectum. Use your finger to push it in completely.


• If you are using Promethazine Suppositories for motion sickness, take a dose at least 30 to 60 minutes before you begin traveling.


• If you miss a dose of Promethazine Suppositories and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Promethazine Suppositories.

Important safety information:

• Promethazine Suppositories may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Promethazine Suppositories with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Promethazine Suppositories; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Promethazine Suppositories. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.


• Promethazine Suppositories may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Promethazine Suppositories. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Use Promethazine Suppositories with extreme caution in the ELDERLY; they may be more sensitive to its effects.


• Promethazine Suppositories should not be used in CHILDREN younger than 2 years old. Serious, and sometimes fatal, side effects (difficult or slowed breathing, drowsiness leading to coma) have occurred when Promethazine Suppositories has been used in children in this age group.


• Promethazine Suppositories should be used with extreme caution in CHILDREN 2 years old or older. The lowest effective dose should be used in children 2 years old and older.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Promethazine Suppositories while you are pregnant. If you are or will be breast-feeding while you use Promethazine Suppositories, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Promethazine Suppositories:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; dizziness; drowsiness; dry mouth; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; excessive sweating; fainting; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, delirium, exaggerated sense of well-being, excitability, hysteria, nervousness); seizures; severe of persistent dizziness; shortness of breath or trouble breathing; slow or fast heartbeat; tremor; trouble sleeping; uncontrolled muscle movements; unusual brusing or bleeding; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Promethazine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include convulsions; dry mouth; flushing; hallucinations; loss of consciousness; nightmares; seizures; shortness of breath; trouble breathing; unusual drowsiness or restlessness.

Proper storage of Promethazine Suppositories:

Store Promethazine Suppositories in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Promethazine Suppositories out of the reach of children and away from pets.

General information:

• If you have any questions about Promethazine Suppositories, please talk with your doctor, pharmacist, or other health care provider.


• Promethazine Suppositories are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Promethazine Suppositories. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Promethazine resources

• Promethazine Side Effects (in more detail)
• Promethazine Use in Pregnancy & Breastfeeding
• Drug Images
• Promethazine Drug Interactions
• Promethazine Support Group
• 67 Reviews for Promethazine - Add your own review/rating

Compare Promethazine with other medications

• Allergic Reactions
• Anaphylaxis
• Hay Fever
• Light Sedation
• Motion Sickness
• Nausea/Vomiting
• Opiate Adjunct
• Sedation
• Urticaria
• Vertigo

Pamelor

Generic Name: nortriptyline (nor TRIP ti leen)

Brand Names: Pamelor

What is Pamelor (nortriptyline)?

Nortriptyline is in a group of drugs called tricyclic antidepressants. Nortriptyline affects chemicals in the brain that may become unbalanced.

Nortriptyline is used to treat symptoms of depression.

Nortriptyline may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Pamelor (nortriptyline)?

Do not use nortriptyline if you have recently had a heart attack, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking Pamelor (nortriptyline)?

Do not use this medication if you are allergic to nortriptyline, or if you have recently had a heart attack. Do not use nortriptyline if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take nortriptyline before the MAO inhibitor has cleared from your body.

Before taking nortriptyline, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  heart disease;

  
  


• 
  

  a history of heart attack, stroke, or seizures;

  
  


• 
  

  bipolar disorder (manic-depression);

  
  


• 
  

  schizophrenia or other mental illness;

  
  


• 
  

  diabetes (nortriptyline may raise or lower blood sugar);

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  glaucoma; or

  
  


• 
  

  problems with urination.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take nortriptyline.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether nortriptyline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medication.

Do not give this medication to anyone under 18 years old without the advice of a doctor.

How should I take Pamelor (nortriptyline)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking nortriptyline. You may need to stop using the medicine for a short time.

Do not stop using nortriptyline without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take a few weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve during treatment with nortriptyline. Store nortriptyline at room temperature away from moisture and heat.

See also: Pamelor dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of nortriptyline can be fatal.

Overdose symptoms may include extreme drowsiness, confusion, agitation, hallucinations, blurred vision, vomiting, muscle stiffness, feeling hot or cold, fainting, seizure (convulsions), or coma.

What should I avoid while taking Pamelor (nortriptyline)?

Avoid drinking alcohol. It can cause dangerous side effects when taken together with nortriptyline.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants). They can add to sleepiness caused by nortriptyline.

Grapefruit and grapefruit juice may interact with nortriptyline. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

Nortriptyline can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Nortriptyline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Pamelor (nortriptyline) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heart rate;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  confusion, hallucinations, or seizure (convulsions);

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  restless muscle movements in your eyes, tongue, jaw, or neck;

  
  


• 
  

  tremors;

  
  


• 
  

  extreme thirst with headache, nausea, vomiting, and weakness;

  
  


• 
  

  feeling light-headed or fainting; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, stomach pain, loss of appetite;

  
  


• 
  

  constipation or diarrhea;

  
  


• 
  

  weight changes;

  
  


• 
  

  dry mouth, unpleasant taste;

  
  


• 
  

  weakness, lack of coordination;

  
  


• 
  

  numbness or tingly feeling;

  
  


• 
  

  blurred vision, headache, ringing in your ears;

  
  


• 
  

  mild skin rash;

  
  


• 
  

  breast swelling (in men or women); or

  
  


• 
  

  increased sweating.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Pamelor (nortriptyline)?

Before taking nortriptyline, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Before taking nortriptyline, tell your doctor if you are currently using any of the following drugs:

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  guanethidine (Ismelin);

  
  


• 
  

  reserpine; or

  
  


• 
  

  heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

  
  

This list is not complete and there are many other medicines that can interact with nortriptyline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Pamelor resources

• Pamelor Side Effects (in more detail)
• Pamelor Dosage
• Pamelor Use in Pregnancy & Breastfeeding
• Drug Images
• Pamelor Drug Interactions
• Pamelor Support Group
• 17 Reviews for Pamelor - Add your own review/rating

• Pamelor Prescribing Information (FDA)


• Pamelor MedFacts Consumer Leaflet (Wolters Kluwer)


• Pamelor Monograph (AHFS DI)


• Pamelor Advanced Consumer (Micromedex) - Includes Dosage Information


• Nortriptyline Prescribing Information (FDA)

Compare Pamelor with other medications

• Burning Mouth Syndrome
• Cyclic Vomiting Syndrome
• Depression
• Diabetic Nerve Damage
• Dysautonomia
• Migraine Prevention
• Neuralgia
• Neurosis
• Pain
• Panic Disorder
• Persisting Pain, Shingles
• Primary Nocturnal Enuresis
• Reflex Sympathetic Dystrophy Syndrome
• Smoking Cessation
• Tinnitus
• Vulvodynia

Where can I get more information?

• Your pharmacist can provide more information about nortriptyline.

See also: Pamelor side effects (in more detail)

Paxil

Generic Name: paroxetine (Oral route)

par-OX-e-teen

Oral route(Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Oral route(Tablet;Tablet, Extended Release;Suspension)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

• Paxil


• Paxil CR


• Pexeva

Available Dosage Forms:

• Tablet


• Tablet, Extended Release


• Suspension

Therapeutic Class: Antidepressant

Pharmacologic Class: Serotonin Reuptake Inhibitor

Uses For Paxil

Paroxetine is used to treat mental depression, obsessive-compulsive disorder (OCD), panic disorder, generalized anxiety disorder (GAD), social anxiety disorder (also known as social phobia), premenstrual dysphoric disorder (PMDD), and posttraumatic stress disorder (PTSD).

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of the chemical called serotonin in the brain.

This medicine is available only with your doctor's prescription.

Before Using Paxil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of paroxetine in the pediatric population. Safety and efficacy have not been established.

Studies have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking the medicine. Talk with your doctor if you have concerns about this.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paroxetine in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have hyponatremia (low sodium in the blood) which may require caution and an adjustment in the dose for patients receiving paroxetine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Linezolid


• Methylene Blue


• Metoclopramide


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Pimozide


• Procarbazine


• Rasagiline


• Selegiline


• Thioridazine


• Toloxatone


• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Aceclofenac


• Acemetacin


• Acenocoumarol


• Alclofenac


• Almotriptan


• Ancrod


• Anisindione


• Antithrombin III Human


• Apazone


• Ardeparin


• Aspirin


• Benoxaprofen


• Bivalirudin


• Bromfenac


• Bufexamac


• Carprofen


• Certoparin


• Cilostazol


• Citalopram


• Clometacin


• Clonixin


• Clopidogrel


• Dalteparin


• Danaparoid


• Defibrotide


• Dermatan Sulfate


• Desirudin


• Desvenlafaxine


• Dexfenfluramine


• Dexketoprofen


• Dextromethorphan


• Diclofenac


• Dicumarol


• Diflunisal


• Dipyridamole


• Dipyrone


• Droperidol


• Droxicam


• Duloxetine


• Eletriptan


• Enoxaparin


• Eptifibatide


• Escitalopram


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenfluramine


• Fenoprofen


• Fentanyl


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Fluoxetine


• Flurbiprofen


• Fluvoxamine


• Fondaparinux


• Frovatriptan


• Haloperidol


• Heparin


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Lornoxicam


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Milnacipran


• Nabumetone


• Nadroparin


• Naproxen


• Naratriptan


• Nefazodone


• Nepafenac


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Parnaparin


• Paroxetine


• Pentosan Polysulfate Sodium


• Phenindione


• Phenprocoumon


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Prasugrel


• Propyphenazone


• Proquazone


• Reviparin


• Rizatriptan


• Salicylic Acid


• Salsalate


• Sertraline


• Sibutramine


• St John's Wort


• Sulindac


• Sumatriptan


• Suprofen


• Tamoxifen


• Tapentadol


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Ticlopidine


• Tinzaparin


• Tirofiban


• Tolmetin


• Tramadol


• Trazodone


• Tryptophan


• Vilazodone


• Warfarin


• Zolmitriptan


• Zomepirac

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline


• Amoxapine


• Aprepitant


• Asenapine


• Bupropion


• Cimetidine


• Clarithromycin


• Clomipramine


• Clozapine


• Cyproheptadine


• Darunavir


• Desipramine


• Dothiepin


• Doxepin


• Encainide


• Flecainide


• Fluoxetine


• Fluphenazine


• Fosamprenavir


• Fosphenytoin


• Galantamine


• Ginkgo


• Iloperidone


• Imipramine


• Lithium


• Lofepramine


• Metoprolol


• Nortriptyline


• Paliperidone


• Perhexiline


• Perphenazine


• Phenytoin


• Procyclidine


• Propafenone


• Protriptyline


• Quinidine


• Risperidone


• Ritonavir


• Tamsulosin


• Tetrabenazine


• Trimipramine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or


• Bleeding problems or


• Bone problems or


• Glaucoma, narrow angle or


• Hyponatremia (low sodium in the blood) or


• Mania, history of or


• Seizures, history of—Use with caution. May make these conditions worse.

• Diseases affecting metabolism or diseases involving blood circulation—Caution should be used in patients with these medical problems.

• Heart disease, unstable or


• Heart attack, recent history of—The effects of paroxetine in patients with these conditions are not known.

• Kidney disease or


• Liver disease—Use with caution. Higher blood levels of paroxetine may occur, increasing the chance of side effects.

Proper Use of paroxetine

This section provides information on the proper use of a number of products that contain paroxetine. It may not be specific to Paxil. Please read with care.

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Paroxetine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

You may have to take paroxetine for several weeks before you begin to feel better. Your doctor should check your progress at regular visits during this time. Also, if you are taking paroxetine for depression, you will probably need to continue taking it for at least 6 months to help prevent the depression from returning.

If you are taking the oral suspension, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.

Swallow the extended-release tablets or tablets whole. Do not break, crush, or chew it.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (suspension):
  
  • For depression:
    
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.
    
    
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For generalized anxiety disorder:
    
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.
    
    
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For obsessive-compulsive disorder:
    
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg (30 mL) per day.
    
    
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For panic disorder:
    
    • Adults—At first, 10 milligrams (mg) (5 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg (30 mL) per day.
    
    
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For posttraumatic stress disorder:
    
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.
    
    
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 40 mg (20 mL) per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For social anxiety disorder:
    
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning.
    
    
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 20 mg (10 mL) per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage form (tablets):
  
  • For depression:
    
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg per day.
    
    
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For generalized anxiety disorder:
    
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg per day.
    
    
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 40 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For obsessive-compulsive disorder:
    
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 60 mg per day.
    
    
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For panic disorder:
    
    • Adults—At first, 10 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
    
    
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For posttraumatic stress disorder:
    
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg per day.
    
    
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For social anxiety disorder:
    
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning.
    
    
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage form (extended-release tablets):
  
  • For depression:
    
    • Adults—At first, 25 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 62.5 mg per day.
    
    
    • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose is usually not more than 50 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For panic disorder:
    
    • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 75 mg per day.
    
    
    • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For social anxiety disorder:
    
    • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 37.5 mg per day.
    
    
    • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 37.5 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For premenstrual dysphoric disorder:
    
    • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 25 mg per day.
    
    
    • Older adults and children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Paxil

It is important that your doctor check your progress at regular visits to allow changes in your dose and help reduce any side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not take paroxetine within 2 weeks of taking an monoamine oxidase (MAO) inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]), linezolid (Zyvox®), or methylthioninium chloride (methylene blue). Do not take an MAO inhibitor for at least 2 weeks after taking paroxetine. If you do, you may develop extremely high blood pressure or seizures.

Do not take thioridazine (Mellaril®) while you are taking paroxetine. You should not use pimozide (Orap®) while you are taking this medicine. Using these medicines together can cause very serious heart problems.

Do not take Pexeva® tablets if you are also using Paxil® tablets. These medicines should not be taken together because both medicines contains paroxetine. Ask your doctor if you have any questions.

This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Tell your doctor right away if you develop any allergic reactions, such as skin rash or hives, while taking paroxetine.

Paroxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This is to decrease the chance of having discontinuation symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Make sure your doctor knows about all the other medicines you are using. Paroxetine may cause a serious condition called serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines such as lithium, tryptophan, St. John's wort, or some pain medicines (e.g., tramadol [Ultram®], rizatriptan [Maxalt®], sumatriptan [Imitrex®], or zolmitriptan [Zomig®]). Check with your doctor first before taking any other medicines.

Check with your doctor right away if you develop the following symptoms during the first few weeks of treatment with paroxetine: inability to sit still, need to keep moving, or restlessness.

Paroxetine has not been shown to add to the effects of alcohol. However, use of alcohol is not recommended in patients who are taking paroxetine.

Paroxetine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly.

Hyponatremia (low sodium in the blood) may occur with this medicine. Stop using the medicine and check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal anti-inflammatory agents also called NSAIDs (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or warfarin (Coumadin®).

This medicine may increase the risk of bone fractures. Tell your doctor if you have unexplained bone pain, tenderness, swelling, or bruising. Also, ask your doctor about ways to keep your bones strong to help prevent fractures.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Paxil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Agitation


• chest congestion


• chest pain


• chills


• cold sweats


• confusion


• difficulty with breathing


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position


• fast, pounding, or irregular heartbeat or pulse


• muscle pain or weakness


• skin rash

Rare

• Absence of or decrease in body movements


• bigger, dilated, or enlarged pupils (black part of the eye)


• difficulty with speaking


• inability to move the eyes


• incomplete, sudden, or unusual body or facial movements


• increased sensitivity of the eyes to light


• low blood sodium (confusion, convulsions [seizures], drowsiness, dryness of the mouth, increased thirst, or lack of energy)


• red or purple patches on the skin


• serotonin syndrome (confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking and acting with excitement you cannot control, trembling or shaking, or twitching)


• talking, feeling, and acting with excitement and activity you cannot control

Incidence not known

• Back, leg, or stomach pains


• bleeding gums


• blindness


• blistering, peeling, or loosening of the skin


• bloated, full feeling


• bloody or black, tarry stools


• bloody urine


• blue-yellow color blindness


• blurred vision


• coma


• constipation


• cough or hoarseness


• dark urine


• decreased frequency or amount of urine


• decreased vision


• depression


• difficulty opening the mouth


• difficulty with swallowing


• electric shock sensations


• epileptic seizure that will not stop


• excessive muscle tone


• eye pain


• fainting


• fixed position of the eye


• fluid-filled skin blisters


• general body swelling


• general feeling of tiredness or weakness


• headache


• high fever


• hives


• inability to move the arms and legs


• inability to sit still


• increased blood pressure


• increased sweating


• increased thirst


• incremental or ratchet-like movement of the muscle


• indigestion


• itching skin


• joint pain


• light-colored stools


• lockjaw


• loss of appetite


• loss of bladder control


• low blood pressure


• lower back or side pain


• muscle spasm, especially of the neck and back


• muscle tension or tightness


• nausea


• need to keep moving


• nosebleeds


• painful knees and ankles


• painful or difficult urination


• painful or prolonged erection of the penis


• pale skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• raised red swellings on the skin, the buttocks, legs, or ankles


• red, irritated eyes


• rigid muscles


• seizure or coma late in pregnancy


• sensitivity to the sun


• shortness of breath


• skin redness or soreness


• skin sores, welts, or blisters


• skin thinness


• slow heart rate


• slow movement


• slow reflexes


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• spasms of the throat


• stiff muscles


• stomach pain


• sudden numbness and weakness in the arms and legs


• swelling of the breasts


• swelling of the face, fingers, or lower legs


• swollen or painful glands


• tightness in the chest


• unexpected or excess milk flow from the breasts


• unusual bleeding or bruising


• unusual or decreased blood cell production


• unusual tiredness or weakness


• vomiting


• weight gain


• wheezing


• yellowing of the eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Dizziness


• drowsiness


• flushing of the face


• irritability


• large pupils


• racing heartbeat


• trembling or shaking

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• decreased appetite


• decreased sexual ability or desire


• excess air or gas in the stomach or intestines


• heartburn


• nervousness


• pain or tenderness around the eyes and cheekbones


• passing gas


• problems in urinating


• runny or stuffy nose


• sexual problems, especially ejaculatory disturbances


• sleepiness or unusual drowsiness


• stomach discomfort, upset, or pain


• sweating


• trauma


• trouble with sleeping

Less common

• Abnormal dreams


• anxiety


• bladder pain


• body aches or pain


• change in sense of taste


• changes in vision


• cloudy urine


• confusion


• congestion


• difficulty in focusing the eyes


• difficulty with moving


• discouragement, feeling sad, or empty


• drugged feeling


• dryness of the throat


• excessive muscle tone


• fainting or loss of consciousness


• fast or irregular breathing


• feeling of unreality


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• frequent urge to urinate


• headache, severe and throbbing


• heavy bleeding


• increase in body movements


• increased appetite


• irritability


• itching of the vagina or genital area


• itching, pain, redness, or swelling of the eye or eyelid


• lack of emotion


• loss of interest or pleasure


• loss of memory


• lump in the throat


• menstrual changes


• menstrual pain or cramps


• muscle twitching or jerking


• pain during sexual intercourse


• problems with memory


• problems with tooth


• rhythmic movement of the muscles


• sense of detachment from self or body


• severe sunburn


• slow heartbeat


• sneezing


• thick, white vaginal discharge with no odor or with a mild odor


• tightness in the throat


• tingling, burning, or prickling sensations


• trouble concentrating


• voice changes


• watering of the eyes


• weight loss


• yawn

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Actions that are out of control


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• crying


• depersonalization


• diarrhea


• dizziness or lightheadedness


• dysphoria


• electric shock sensations


• euphoria


• fear


• feeling unwell or unhappy


• increased sweating


• irritability


• muscle pain


• nervousness


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• talking, feeling, and acting with excitement


• unusual drowsiness, dullness, or feeling of sluggishness


• unusual tiredness or weakness


• vision changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Paxil side effects (in more detail)

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More Paxil resources

• Paxil Side Effects (in more detail)
• Paxil Use in Pregnancy & Breastfeeding
• Drug Images
• Paxil Drug Interactions
• Paxil Support Group
• 195 Reviews for Paxil - Add your own review/rating

• Paxil Prescribing Information (FDA)


• Paxil Consumer Overview


• Paxil Monograph (AHFS DI)


• Paxil MedFacts Consumer Leaflet (Wolters Kluwer)


• Paroxetine Professional Patient Advice (Wolters Kluwer)


• Paroxetine Prescribing Information (FDA)


• Paxil CR Prescribing Information (FDA)


• Paxil CR Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Pexeva Prescribing Information (FDA)


• Pexeva MedFacts Consumer Leaflet (Wolters Kluwer)

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