País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
Blenheim Pharmacal, Inc.
MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE 25 mg
ORAL
PRESCRIPTION DRUG
For the management of nausea and vomiting, and dizziness associated with motion sickness. Meclizine Hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
Meclizine HCI Tablets, USP are available in the following strengths and package sizes: 12.5 mg (Blue, oval-shaped, scored, debossed with TL122) Bottles of 100 NDC 59746-122-06 Bottles of 1000 NDC 59746-122-10 25 mg (Yellow, oval-shaped, scored, debossed with TL121) Bottles of 100 NDC 59746-121-06 Bottles of 1000 NDC 59746-121-10 Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 03/11
Abbreviated New Drug Application
MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCLORIDE TABLET BLENHEIM PHARMACAL, INC. ---------- MECLIZINE HYDROCHLORIDE TABLETS, USP RX ONLY CLINICAL PHARMACOLOGY Meclizine Hydrochloride is an antihistamine which shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum. INDICATIONS AND USAGE For the management of nausea and vomiting, and dizziness associated with motion sickness. CONTRAINDICATIONS Meclizine Hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it. WARNINGS Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking this drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma or enlargement of the prostate gland. PRECAUTIONS _PREGNANCY, Teratogenic Effects _ Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that medicine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary. _Pediatric Use _ Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age. ADVERSE REACTIONS Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported. DOSAGE AND ADMINISTRATION _MOTION SI Llegiu el document complet