Drugs Details

Drugs Info of Pentazine, Phenergan
Drugs Details
  • Drugs Type  : FDA
  • Date : 27th Mar 2015 03:43 am
  • Brand Name : Pentazine, Phenergan
  • Generic Name : promethazine (oral) (Pronunciation: pro METH a zeen)
Descriptions

Each tablet of Phenergan contains 12.5 mg, 25 mg, or 50 mg promethazine HCl. The inactive ingredients present are lactose, magnesium stearate, and methylcellulose. Each dosage strength also contains the following:

12.5 mg-FD&C Yellow 6 and saccharin sodium;
25 mg-saccharin sodium;
50 mg-FD&C Red 40.

Each rectal suppository of Phenergan contains 12.5 mg, 25 mg, or 50 mg promethazine HCl with ascorbyl palmitate, silicon dioxide, white wax, and cocoa butter. Phenergan (promethazine) Suppositories are for rectal administration only.

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

Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,alpha;-trimethyl-, monohydrochloride, (±)- with the following structural formula:

Phenergan (promethazine HCI) structural formula illustration

Promethazine HCl 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.

What are the possible side effects of oral promethazine (Pentazine, Phenergan)?

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.

Stop using promethazine and call your doctor at once if you have any of these serious side effects:

  • twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • high fever, stiff muscles, confusion, sweating,...

Read All Potential Side Effects and See Pictures of Phenergan »

What are the precautions when taking promethazine (Phenergan)?

See also Warning section.

Before taking promethazine, tell your doctor or pharmacist if you are allergic to it; or to any other phenothiazines (such as prochlorperazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic obstructive pulmonary disease-COPD, sleep apnea), blood/immune system problems (such as bone marrow depression), high pressure in the eye (glaucoma), heart disease (such as irregular heartbeat), high blood pressure, liver disease, certain brain disorders (such as neuroleptic malignant...

Read All Potential Precautions of Phenergan »


This monograph has been modified to include the generic and brand name in many instances.

 

Indications

Phenergan (promethazine) , either orally or by suppository, is 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 post-operative 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.

Dosage Administration

Phenergan (promethazine) Tablets and Phenergan (promethazine) Rectal Suppositories are contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients).

Phenergan (promethazine) Suppositories are for rectal administration only.

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 to 12.5 mg taken three 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, Phenergan (promethazine) Tablets, Syrup, or Rectal Suppositories, 12.5 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 Phenergan (promethazine) 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 (cf. Phenergan (promethazine) Injection) or by rectal suppository. 12.5- 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 to 25 mg Phenergan (promethazine) by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.

Pre- and Postoperative Use

Phenergan (promethazine) in 12.5- 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 50 mg Phenergan (promethazine) 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 to 25 mg in children and 25- to 50-mg doses in adults.

Phenergan (promethazine) Tablets and Phenergan (promethazine) Rectal Suppositories are contraindicated for children under 2 years of age.

How Supplied

Phenergan® (promethazine HCl) Tablets are available as follows:

12.5 mg, orange tablet with "WYETH" on one side and "19" on the scored reverse side.

NDC 0008-0019-01, bottle of 100 tablets.

25 mg, white tablet with "WYETH" and "27" on one side and scored on the reverse side.

NDC 0008-0027-02, bottle of 100 tablets.
NDC 0008-0027-07, Redipak® carton of 100 tablets (10 blister strips of 10).

50 mg, pink tablet with "WYETH" on one side and "227" on the other side.

NDC 0008-0227-01, bottle of 100 tablets.

Keep tightly closed.

Store at controlled room temperature 20º to 25ºC (68º to 77ºF).

Protect from light.

Dispense in light-resistant, tight container.

Use carton to protect contents from light.

Phenergan® (promethazine HCl) Rectal Suppositories are available in boxes of 12 as follows:

12.5 mg, ivory, torpedo-shaped suppository wrapped in copper-colored foil, NDC 0008-0498-01.
25 mg, ivory, torpedo-shaped suppository wrapped in light-green foil, NDC 0008-0212-01.
50 mg, ivory, torpedo-shaped suppository wrapped in blue foil, NDC 0008-0229-01.

Store refrigerated between 2°-8°C (36°-46°F).
Dispense in well-closed container.

Wyeth Pharmaceuticals Inc.,Philadelphia, PA 19101
Rev 07/05
FDA rev date: 11/8/2004


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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 HCl. Consideration should be given to the discontinuation of promethazine HCl 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.

Read the Phenergan (promethazine) Side Effects Center for a complete guide to possible side effects

Learn More »
 

Interactions

CNS Depressants -

Phenergan (promethazine) Tablets and Suppositories 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 HCl. When given concomitantly with Phenergan (promethazine) Tablets and Suppositories, 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 HCl 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 Phenergan (promethazine) to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Phenergan (promethazine) Tablets and Suppositories 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 Phenergan (promethazine) Tablets and Suppositories.

Drug/Laboratory Test Interactions

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

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 HCl.

Read the Phenergan Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

PHENERGAN (promethazine) SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.

POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PHENERGAN (promethazine) IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PHENERGAN (promethazine) HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PHENERGAN (promethazine) TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PHENERGAN (promethazine) 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

Phenergan (promethazine) Tablets and Suppositories 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 HCl (see PRECAUTIONS-Information for Patients and DRUG INTERACTIONS).

Respiratory Depression

Phenergan (promethazine) Tablets and Suppositories may lead to potentially fatal respiratory depression.

Use of Phenergan (promethazine) Tablets and Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.

Lower Seizure Threshold

Phenergan (promethazine) Tablets and Suppositories 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

Phenergan (promethazine) Tablets and Suppositories should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when Phenergan (promethazine) 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 HCl 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 HCl, 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 HCl should be carefully considered.

Use in Pediatric Patients

PHENERGAN (promethazine) TABLETS AND SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PHENERGAN (promethazine) TABLETS AND SUPPOSITORIES 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 PHENERGAN (promethazine) TABLETS AND SUPPOSITORIES ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE'S SYNDROME. THE USE OF PHENERGAN (promethazine) TABLETS AND SUPPOSITORIES 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 Phenergan (promethazine) Tablets and Suppositories, in pediatric patients may cause sudden death (see OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of Phenergan (promethazine) 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.

Phenergan (promethazine) Tablets and Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

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 HCl. 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 Phenergan® (promethazine) Tablets and Suppositories in pregnant women.

Phenergan (promethazine) Tablets and Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Phenergan (promethazine) Tablets and Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.

Labor and Delivery

Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). Limited data suggest that use of Phenergan (promethazine) 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 HCl 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 Phenergan (promethazine) Tablets and Suppositories, 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

PHENERGAN TABLETS AND SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS- Black Box Warning and Use in Pediatric Patients).

Phenergan (promethazine) Tablets and Suppositories 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 Phenergan (promethazine) 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 Phenergan (promethazine) Tablets and Suppositories and observed closely.


This monograph has been modified to include the generic and brand name in many instances.

 

OverDose

Signs and symptoms of overdosage with promethazine HCl 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 HCl 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.

ContrainDications

Phenergan (promethazine) Tablets and Suppositories are contraindicated for use in pediatric patients less than two years of age.

Phenergan (promethazine) Tablets and Suppositories are 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.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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 four to six 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.


This monograph has been modified to include the generic and brand name in many instances.

 

Patient Information

Phenergan (promethazine) Tablets and Suppositories 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.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

PROMETHAZINE - ORAL

 

(proe-METH-a-zeen)

 

COMMON BRAND NAME(S): Phenergan

 

WARNING: Promethazine should not be used in children younger than 2 years because it may cause serious (possibly fatal) slow/shallow breathing. When using this medication in children 2 years and older, the lowest effective dosage should be used, and other drugs that affect breathing should be avoided. Get medical help right away if slow/shallow breathing occurs.

In children, drugs for nausea should only be used in cases of prolonged vomiting of a known cause. Avoid use of promethazine in children with liver disease (including possible Reye's syndrome).

 

USES: See also Warning section.

Promethazine is used to prevent and treat nausea and vomiting related to certain conditions (such as before/after surgery, motion sickness). It is also used to treat allergy symptoms such as rash, itching, and runny nose. It may be used to help you feel sleepy/relaxed before and after surgery or to help certain narcotic pain relievers (such as meperidine) work better. It may also be used for a short time to treat a runny nose due to the common cold.

Promethazine is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its other effects (such as anti-nausea, calming, pain relief) may work by affecting other natural substances (such as acetylcholine) and by acting directly on certain parts of the brain.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking promethazine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually 2 to 4 times daily. For motion sickness, the first dose of promethazine should be taken 30 to 60 minutes before beginning travel. For allergies, this medication may be taken once daily at bedtime to avoid being drowsy during the day. When used before surgery, promethazine may be taken the night before or just before the procedure and may be continued afterwards as directed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your age, medical condition, and response to treatment. In children, the dosage may also be based on weight. Do not increase your dose or take this medication more often than directed.

Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Drowsiness, dizziness, constipation, blurred vision, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting, slow heartbeat, mental/mood changes (such as hallucinations, nervousness, irritability, restlessness, confusion), unusual/uncontrolled movements (such as fixed upward stare, neck twisting, tongue movements), shaking (tremor), difficulty urinating, easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin.

Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, seizures.

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Phenergan (promethazine) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: See also Warning section.

Before taking promethazine, tell your doctor or pharmacist if you are allergic to it; or to any other phenothiazines (such as prochlorperazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic obstructive pulmonary disease-COPD, sleep apnea), blood/immune system problems (such as bone marrow depression), high pressure in the eye (glaucoma), heart disease (such as irregular heartbeat), high blood pressure, liver disease, certain brain disorders (such as neuroleptic malignant syndrome, Reye's syndrome, seizures), stomach/intestine problems (such as blockage, ulcer), overactive thyroid (hyperthyroidism), difficulty urinating (for example, due to enlarged prostate).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Promethazine may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication may decrease your ability to sweat, making you more likely to get heat stroke. Avoid activities that may cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). When the weather is hot, drink plenty of fluids and dress lightly. If you become overheated, promptly seek cooler shelter and stop exercising. Get medical help right away if you develop a fever, mental/mood changes, headache, or dizziness.

Liquid products may contain sugar and/or alcohol. Caution is advised if you have diabetes, liver disease, or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Children may be more sensitive to the side effects of this drug, especially slowed breathing (see Warning section). This drug can often cause excitement in young children instead of drowsiness. Special care should be taken when using this medication in children who have lost a lot of fluid (dehydration), those who have a family history of sudden infant death syndrome (SIDS), and those who are hard to wake up from sleep.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, constipation, or trouble urinating. Drowsiness and confusion can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if promethazine passes into breast milk. It may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), metoclopramide.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including some pregnancy tests, glucose tolerance test, allergy skin testing), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, fainting, slow/shallow breathing, seizures, muscle stiffness/twitching, widened pupils. In children, mental/mood changes (such as restlessness, irritability, hallucinations) may occur before drowsiness.

 

NOTES: Do not share this medication with others.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Pentazine, Phenergan

Generic Name: promethazine (oral) (Pronunciation: pro METH a zeen)

  • What is oral promethazine (Phenergan)?
  • What are the possible side effects of oral promethazine (Phenergan)?
  • What is the most important information I should know about oral promethazine (Phenergan)?
  • What should I discuss with my doctor before taking oral promethazine (Phenergan)?
  • How should I take oral promethazine (Phenergan)?
  • What happens if I miss a dose (Phenergan)?
  • What happens if I overdose (Phenergan)?
  • What should I avoid while taking oral promethazine (Phenergan)?
  • What other drugs will affect oral promethazine (Phenergan)?
  • Where can I get more information?

What is oral promethazine (Phenergan)?

Promethazine is in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain. Promethazine also acts as an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body.

Promethazine is used to treat allergy symptoms such as itching, runny nose, sneezing, itchy or watery eyes, hives, and itchy skin rashes.

Promethazine also prevents motion sickness, and treats nausea and vomiting or pain after surgery. It is also used as a sedative or sleep aid.

Promethazine is not for use in treating symptoms of asthma, pneumonia, or other lower respiratory tract infections.

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

Promethazine 12.5 mg-AMN

round, white, imprinted with AN 745

What are the possible side effects of oral promethazine (Phenergan)?

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.

Stop using promethazine and call your doctor at once if you have any of these serious side effects:

  • twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
  • feeling like you might pass out;
  • seizure (convulsions);
  • pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;
  • decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
  • hallucinations, agitation;
  • nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

  • dizziness, drowsiness, anxiety;
  • blurred vision, dry mouth, stuffy nose;
  • ringing in your ears;
  • weight gain, swelling in your hands or feet;
  • impotence, trouble having an orgasm; or
  • constipation.

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.

Read the Phenergan (promethazine) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about oral promethazine (Phenergan)?

Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.

Promethazine should not be given to a child younger than 2 years old. Promethazine can cause severe breathing problems or death in a child younger than 2. Carefully follow your doctor's instructions when giving this medicine to a child of any age.

Promethazine 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 drinking alcohol, which can increase some of the side effects of promethazine.

There are many other medicines that can interact with promethazine. 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.

Side Effects Centers
  • Phenergan

Patient Detailed How Take

What should I discuss with my doctor before taking oral promethazine (Phenergan)?

Promethazine should not be given to a child younger than 2 years old. Promethazine can cause severe breathing problems or death in a child younger than 2. Carefully follow your doctor's instructions when giving this medicine to a child of any age.

Do not use this medication if you have severe asthma, emphysema, or other breathing problem, or if you are allergic to promethazine or other phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), thioridazine (Mellaril), or trifluoperazine (Stelazine).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take promethazine, tell your doctor if you have:

  • a history of seizures;
  • heart disease or high blood pressure;
  • liver or kidney disease;
  • severe asthma, emphysema, chronic obstructive pulmonary disease (COPD) or other breathing problem;
  • sleep apnea (breathing stops during sleep);
  • glaucoma;
  • a stomach ulcer or digestive obstruction;
  • bone marrow depression;
  • adrenal gland tumor (pheochromocytoma);
  • enlarged prostate or problems with urination;
  • low levels of calcium in your blood (hypocalcemia); or
  • if you have ever had a serious side effect while using promethazine or any other phenothiazine.

FDA pregnancy category C. It is not known whether promethazine is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether promethazine 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.

How should I take oral promethazine (Phenergan)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Promethazine can be taken with or without food or milk.

Measure liquid medicine with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, or if they get worse while taking promethazine.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using promethazine.

Store this medication at room temperature away from moisture, heat, and light.

Side Effects Centers
  • Phenergan

Patient Detailed Avoid Taking

What happens if I miss a dose (Phenergan)?

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 (Phenergan)?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include severe drowsiness, dizziness, dry mouth, large pupils, flushing, nausea, vomiting, shallow breathing, and fainting.

What should I avoid while taking oral promethazine (Phenergan)?

Promethazine 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 getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase some of the side effects of promethazine.

Avoid exposure to sunlight or tanning beds. Promethazine can make your skin more sensitive to sunlight, and a sunburn may result. Wear sunscreen (SPF 15 or higher) and protective clothing if you must be outdoors.

What other drugs will affect oral promethazine (Phenergan)?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with promethazine and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines.

Also tell your doctor if you are using any of the following medicines:

  • lithium (Eskalith, Lithobid);
  • atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
  • blood pressure medication such as guanadrel (Hylorel), guanethidine (Ismelin), propranolol (Inderal), and others;
  • a blood thinner such as warfarin (Coumadin);
  • bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
  • bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), and others;
  • an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or
  • medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor (prolactinoma); or
  • medicine to treat stomach ulcer or irritable bowel syndrome, such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), mepenzolate (Cantil), or propantheline (Pro-Banthine).

This list is not complete and there are many other medicines that can interact with promethazine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start 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.

Where can I get more information?

Your pharmacist can provide more information about oral promethazine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 5.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Phenergan

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI