PROMETHEGAN 50 mg/1
promethazine hydrochloride · SUPPOSITORY · Cosette Pharmaceuticals, Inc.
PROMETHEGAN is a suppository containing promethazine hydrochloride at 50 mg/1, taken rectal. Manufactured by Cosette Pharmaceuticals, Inc..
Key Facts
- Brand Name
- PROMETHEGAN
- Generic Name
- promethazine hydrochloride
- NDC Code (Product)
0713-0132- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Strength
- 50 mg/1
- Dosage Form
- SUPPOSITORY
- Route
- RECTAL
- Marketing Status
- Application #
- ANDA087165
- Marketing Start
- 08/31/1987
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age ( see WARNINGS–Black Box Warning and Use in Pediatric Patients ). Promethazine HCl Suppositories are for rectal administration only. Allergy The average 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 hydrochloride 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 HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. Nausea and Vomiting Antiemetics should not be use…
Contraindications
CONTRAINDICATIONS 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.
Drug Interactions
Drug Interactions CNS Depressants – Promethazine HCl 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 Promethazine HCl 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 promethazine HCl to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine HCl Suppositories overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken wit…
Adverse Reactions
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 …
Frequently Asked Questions
What is PROMETHEGAN used for?
PROMETHEGAN contains promethazine hydrochloride. It is a suppository taken rectal. Consult your doctor for specific uses.
Is PROMETHEGAN a controlled substance?
PROMETHEGAN is not classified as a controlled substance by the DEA.
What is the generic name for PROMETHEGAN?
The generic name for PROMETHEGAN is promethazine hydrochloride. There are 11 other brand versions of promethazine hydrochloride.
What is the NDC code for PROMETHEGAN 50 mg/1?
The NDC (National Drug Code) for PROMETHEGAN 50 mg/1 is 0713-0132, listed by Cosette Pharmaceuticals, Inc..
Other PROMETHEGAN Dosages
Other Promethazine Brands
See all →- Promethazine Hydrochloride and Codeine Phosphate10 mg/5mL72162-2042
- Promethazine Hydrochloride25 mg/176420-679
- PROMETHAZINE HYDROCHLORIDE12.5 mg/110702-002
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution15 mg/5mL17856-0155
- PROMETHAZINE HYDROCHLORIDE25 mg/mL39822-5525
- PROMETHAZINE HYDROCHLORIDE25 mg/150090-4453
- PROMETHAZINE HYDROCHLORIDE25 mg/150090-4608
- Promethazine Hydrochloride25 mg/151655-140
- Promethazine Hydrochloride25 mg/153746-521
- Promethazine Hydrochloride12.5 mg/160687-660
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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