Promethazine Hydrochloride 25 mg/1
Promethazine Hydrochloride · TABLET · Amneal Pharmaceuticals LLC
Promethazine Hydrochloride is a tablet containing promethazine hydrochloride at 25 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals LLC.
Key Facts
- Brand Name
- Promethazine Hydrochloride
- Generic Name
- Promethazine Hydrochloride
- NDC Code (Product)
65162-521- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- 25 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091179
- Marketing Start
- 03/03/2011
Recall History
Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Qualitest Pharmaceuticals
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Morton Grove Pharmaceuticals, Inc.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Actavis Mid Atlantic LLC
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Actavis Mid Atlantic LLC
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Morton Grove Pharmaceuticals, Inc.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Qualitest Pharmaceuticals
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Side 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 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 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…
Warnings
WARNINGS PROMETHAZINE HCl SUPPOSITORIES 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 HCl SUPPOSITORIES IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCl TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCl 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 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, g…
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 and 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 admini…
Frequently Asked Questions
What is Promethazine Hydrochloride used for?
Promethazine Hydrochloride contains Promethazine Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Promethazine Hydrochloride a controlled substance?
Promethazine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Promethazine Hydrochloride?
The generic name for Promethazine Hydrochloride is Promethazine Hydrochloride. There are 8 other brand versions of Promethazine Hydrochloride.
What is the NDC code for Promethazine Hydrochloride 25 mg/1?
The NDC (National Drug Code) for Promethazine Hydrochloride 25 mg/1 is 65162-521, listed by Amneal Pharmaceuticals LLC.
Other Promethazine Brands
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- PROMETHEGAN25 mg/10713-0526
- 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 HYDROCHLORIDE6.25 mg/5mL62135-774
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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