Promethazine Hydrochloride and Phenylephrine Hydrochloride 5 mg/5mL
Promethazine and Phenylephrine · SOLUTION · Amneal Pharmaceuticals LLC
Promethazine and Phenylephrine is an oral liquid medication that combines an antihistamine with a decongestant to relieve symptoms of allergies, colds, and upper respiratory conditions. This prescription medication helps reduce nasal congestion, sneezing, and other allergy-related symptoms.
Key Facts
- Brand Name
- Promethazine Hydrochloride and Phenylephrine Hydrochloride
- Generic Name
- Promethazine and Phenylephrine
- NDC Code (Product)
65162-679- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- 5 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040902
- Marketing Start
- 08/25/2009
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Promethazine hydrochloride and phenylephrine hydrochloride oral solution is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Dosage & Administration
DOSAGE AND ADMINISTRATION Promethazine hydrochloride and phenylephrine hydrochloride oral solution is contraindicated for children under 2 years of age ( see WARNINGS – Black Box Warning and Use In Pediatric Patients ). The recommended doses are given in the following table: Adults And Children 12 Years And Over 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours. Children 6 To Under 12 Years Of Age ½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours. Children 2 To Under 6 Years Of Age ¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours.
Warnings
WARNINGS WARNING PROMETHAZINE HYDROCHLORIDE 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 IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. Promethazine CNS Depression Promethazine 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 anal…
Contraindications
CONTRAINDICATIONS Promethazine is 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. Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (MAOI).
Drug Interactions
Drug Interactions Promethazine CNS Depressants Promethazine 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, 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 to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) Drug…
Adverse Reactions
ADVERSE REACTIONS Promethazine 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 – Promethazine; Respiratory Depression .) Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS – Promethazine; Neuroleptic Malignant Syndrome .) Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported…
Frequently Asked Questions
What is Promethazine Hydrochloride and Phenylephrine Hydrochloride used for?
Promethazine and Phenylephrine is an oral liquid medication that combines an antihistamine with a decongestant to relieve symptoms of allergies, colds, and upper respiratory conditions. This prescription medication helps reduce nasal congestion, sneezing, and other allergy-related symptoms.
Is Promethazine Hydrochloride and Phenylephrine Hydrochloride a controlled substance?
Promethazine Hydrochloride and Phenylephrine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Promethazine Hydrochloride and Phenylephrine Hydrochloride?
The generic name for Promethazine Hydrochloride and Phenylephrine Hydrochloride is Promethazine and Phenylephrine. There are no other listed brand versions of Promethazine and Phenylephrine.
What is the NDC code for Promethazine Hydrochloride and Phenylephrine Hydrochloride 5 mg/5mL?
The NDC (National Drug Code) for Promethazine Hydrochloride and Phenylephrine Hydrochloride 5 mg/5mL is 65162-679, listed by Amneal Pharmaceuticals LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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