Promethazine Hydrochloride
Generic: PROMETHAZINE HYDROCHLORIDE
Basic Information
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
f4c23037-e415-7604-e053-2995a90a5bb6
Indications & Usage
Promethazine Hydrochloride, is useful orally 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 post-operative 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.
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 post-operative 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.
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 promethazine hydrochloride.
Consideration should be given to the discontinuation of promethazine hydrochloride 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.
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 promethazine hydrochloride.
Consideration should be given to the discontinuation of promethazine hydrochloride 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.