Promethazine Hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- PROMETHAZINE HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- PROMETHAZINE HYDROCHLORIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- PROMETHAZINE HYDROCHLORIDE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
PROMETHAZINE HYDROCHLORIDE DESCRIPTION
CLINICAL PHARMACOLOGY
INDICATIONS & USAGE
PROMETHAZINE HYDROCHLORIDE CONTRAINDICATIONS
WARNINGS
PROMETHAZINE HYDROCHLORIDE TABLETS USP 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.
CNS Depression
PRECAUTIONS-Information for PatientsandDrug Interactions).
Respiratory Depression
Lower Seizure Threshold
Bone-Marrow Depression
Neuroleptic Malignant Syndrome
Use in Pediatric Patients
PROMETHAZINE HYDROCHLORIDE TABLETS USP ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TABLETS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.
ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HYDROCHLORIDE TABLETS ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYESYNDROME. THE USE OF PROMETHAZINE HCL TABLETS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYESYNDROME OR OTHER HEPATIC DISEASES.
OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.
Other Considerations
PRECAUTIONS
GeneralInformation for Patients
WARNINGS-CNS DepressionandPRECAUTIONS-Drug Interactions). Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.
Drug Interactions
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Labor and Delivery
DOSAGE AND ADMINISTRATION). Limited data suggest that use of promethazine during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown. (See alsoNonteratogenic Effects.)
Nursing Mothers
Pediatric Use
PROMETHAZINE HYDROCHLORIDE TABLETS USP ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS-Black Box Warning and Use in Pediatric Patients).
WARNINGS-Use in Pediatric Patients).
Geriatric Use
PROMETHAZINE HYDROCHLORIDE ADVERSE REACTIONS
Central Nervous SystemCardiovascular- 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). (SeeWARNINGSRespiratory Depression.)
Other- Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (SeeWARNINGS-Neuroleptic Malignant Syndrome.)
Paradoxical Reactions
OVERDOSAGE
Treatment
DOSAGE & ADMINISTRATION
Promethazine Hydrochloride Tablets USP are contraindicated for children under 2 years of age (see 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
HOW SUPPLIED
DAN DAN and5307 supplied in bottles of 100 and 1000.DAN and5319 supplied in bottles of 100.
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDE TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
