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PROMETHAZINE HYDROCHLORIDE

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Overview

What is PROMETHAZINE HYDROCHLORIDE?

Each tablet for oral administration contains 12.5 mg, 25 mg, or 50 mg promethazine HCl. The inactive ingredients present are colloidal silicon dioxide, disodium EDTA, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, saccharin sodium, and sodium starch glycolate. 12.5 mg also contains - FD&C Yellow No. 5 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake; 50 mg also contains - FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake.

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

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

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 does PROMETHAZINE HYDROCHLORIDE look like?



What are the available doses of PROMETHAZINE HYDROCHLORIDE?

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What should I talk to my health care provider before I take PROMETHAZINE HYDROCHLORIDE?

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How should I use PROMETHAZINE HYDROCHLORIDE?

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.

Promethazine hydrochloride tablets are contraindicated for children under 2 years of age


What interacts with PROMETHAZINE HYDROCHLORIDE?

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


Promethazine hydrochloride tablets 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.



What are the warnings of PROMETHAZINE HYDROCHLORIDE?

PROMETHAZINE HYDROCHLORIDE TABLETS 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 PROMETHAZINE HYDROCHLORIDE TABLETS IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE TABLETS HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TABLETS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE TABLETS 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 a reduced dosage in the presence of promethazine HCl (see and).

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 tablets have 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

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 DISEASE.

Excessively large dosages of antihistamines, including promethazine hydrochloride tablets, in pediatric patients may cause sudden death (see ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride tablets 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.


What are the precautions of PROMETHAZINE HYDROCHLORIDE?

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 hydrochloride tablets should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

Promethazine hydrochloride tablets 12.5 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Information for Patients

Promethazine hydrochloride 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 and ). 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

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 HCl. 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 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.

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

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

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 HCl:

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

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

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 HCl was nonmutagenic in the  test system of Ames.

Pregnancy

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 promethazine hydrochloride tablets in pregnant women.

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

Promethazine hydrochloride tablets 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 ). Limited data suggest that use of promethazine hydrochloride tablets 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 .)

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 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 HCl TABLETS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE

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

Geriatric Use

Clinical studies of promethazine HCl 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 HCl tablets and observed closely.


What are the side effects of PROMETHAZINE HYDROCHLORIDE?

Central Nervous System –

Cardiovascular –

Dermatologic –

Hematologic –

Gastrointestinal –

Respiratory –

Other –

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.


What should I look out for while using PROMETHAZINE HYDROCHLORIDE?

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

Promethazine hydrochloride tablets 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.


What might happen if I take too much PROMETHAZINE HYDROCHLORIDE?

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.


How should I store and handle PROMETHAZINE HYDROCHLORIDE?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Promethazine Hydrochloride Tablets, USP are available as follows:12.5 mg: orange, round, scored tablet debossed "5138" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.25 mg: white, round, scored, flat-faced beveled edge tablet debossed "5137" on one side and debossed "V" on the reverse side, in bottles of 10, 100, 1000 and 2500.50 mg: pink, round tablet debossed "5136" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.Promethazine Hydrochloride Tablets, USP are available as follows:12.5 mg: orange, round, scored tablet debossed "5138" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.25 mg: white, round, scored, flat-faced beveled edge tablet debossed "5137" on one side and debossed "V" on the reverse side, in bottles of 10, 100, 1000 and 2500.50 mg: pink, round tablet debossed "5136" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.Promethazine Hydrochloride Tablets, USP are available as follows:12.5 mg: orange, round, scored tablet debossed "5138" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.25 mg: white, round, scored, flat-faced beveled edge tablet debossed "5137" on one side and debossed "V" on the reverse side, in bottles of 10, 100, 1000 and 2500.50 mg: pink, round tablet debossed "5136" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.Promethazine Hydrochloride Tablets, USP are available as follows:12.5 mg: orange, round, scored tablet debossed "5138" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.25 mg: white, round, scored, flat-faced beveled edge tablet debossed "5137" on one side and debossed "V" on the reverse side, in bottles of 10, 100, 1000 and 2500.50 mg: pink, round tablet debossed "5136" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.


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Clinical Information

Chemical Structure

No Image found
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 H 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.

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

Promethazine hydrochloride tablets 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.

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 hydrochloride tablets should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

Promethazine hydrochloride tablets 12.5 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Central Nervous System –

Cardiovascular –

Dermatologic –

Hematologic –

Gastrointestinal –

Respiratory –

Other –

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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