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PROMETHEGAN
Overview
What is PROMETHEGAN?
Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, white wax, hard fat, and glyceryl monostearate. Promethazine HCl Suppositories, USP are for rectal administration only.
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, -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 soluble in water and freely soluble in alcohol.
What does PROMETHEGAN look like?
What are the available doses of PROMETHEGAN?
Sorry No records found.
What should I talk to my health care provider before I take PROMETHEGAN?
Promethazine HCl 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 ).
How should I use PROMETHEGAN?
Promethazine HCl Suppositories, USP 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 HCl Rectal Suppositories are contraindicated for children under 2 years of age (
WARNINGS–Black Box Warning and Use in Pediatric Patients).
Allergy
Motion Sickness
Nausea and Vomiting
WARNINGS– Use in Pediatric Patients
Sedation
Pre- and Postoperative Use
What interacts with PROMETHEGAN?
Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine HCl 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.
What are the warnings of PROMETHEGAN?
Sorry No Records found
What are the precautions of PROMETHEGAN?
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 Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function.
What are the side effects of PROMETHEGAN?
Central Nervous System
Cardiovascular –
Dermatologic –
Hematologic –
Gastrointestinal –
Respiratory –
WARNINGS–Respiratory Depression
Other –
WARNINGS–Neuroleptic Malignant Syndrome
Paradoxical Reactions
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What should I look out for while using PROMETHEGAN?
Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age.
Promethazine HCl 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.
What might happen if I take too much PROMETHEGAN?
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, and 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 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 that 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.
How should I store and handle PROMETHEGAN?
Storage and HandlingStore at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC- 30ºC (59ºF -86ºF) [See USP Controlled Room Temperature].Storage and HandlingStore at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC- 30ºC (59ºF -86ºF) [See USP Controlled Room Temperature].Product: 50090-1569Product: 50090-1575NDC: 50090-1575-0 12 SUPPOSITORY in a BOXNDC: 50090-1575-1 4 SUPPOSITORY in a BOXNDC: 50090-1575-2 6 SUPPOSITORY in a BOXProduct: 50090-1569Product: 50090-1575NDC: 50090-1575-0 12 SUPPOSITORY in a BOXNDC: 50090-1575-1 4 SUPPOSITORY in a BOXNDC: 50090-1575-2 6 SUPPOSITORY in a BOXProduct: 50090-1569Product: 50090-1575NDC: 50090-1575-0 12 SUPPOSITORY in a BOXNDC: 50090-1575-1 4 SUPPOSITORY in a BOXNDC: 50090-1575-2 6 SUPPOSITORY in a BOXProduct: 50090-1569Product: 50090-1575NDC: 50090-1575-0 12 SUPPOSITORY in a BOXNDC: 50090-1575-1 4 SUPPOSITORY in a BOXNDC: 50090-1575-2 6 SUPPOSITORY in a BOXProduct: 50090-1569Product: 50090-1575NDC: 50090-1575-0 12 SUPPOSITORY in a BOXNDC: 50090-1575-1 4 SUPPOSITORY in a BOXNDC: 50090-1575-2 6 SUPPOSITORY in a BOX
Clinical Information
Chemical Structure
No Image foundClinical 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 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 HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine HCl 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.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 Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function.
Central Nervous System
Cardiovascular –
Dermatologic –
Hematologic –
Gastrointestinal –
Respiratory –
WARNINGS–Respiratory Depression
Other –
WARNINGS–Neuroleptic Malignant Syndrome
Paradoxical Reactions
Array
www.fda.gov/medwatch
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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