Meclizine Hydrochloride 25 MG Oral Tablet
Generic Name: MECLIZINE HYDROCHLORIDE
Brand Name: Meclizine Hydrochloride
- Substance Name(s):
- MECLIZINE HYDROCHLORIDE
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 the 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. Usage in Children Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age. Usage in Pregnancy Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25 to 50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine 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.
DESCRIPTION
Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless. It has the following structural formula: C25H27CIN2•2HCI•H2O M.W. 481.89 The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) – piperazine dihydrochloride monohydrate. Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg strengths for oral administration. *Contains FD&C Yellow #5 (see PRECAUTIONS). Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, and stearic acid. In addition, the 12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5. chemical structure
HOW SUPPLIED
Meclizine Hydrochloride Tablets, USP 25 mg – yellow, oval tablets debossed with “035” on one side and “par” on the other side. They are supplied in bottles of 8 (NDC 00440–1736-08). Dispense in tight, light-resistant containers as defined in the USP. Store at controlled room temperature 15° to 30°C (59° to 86°F). Manufactured by: PAR PHARMACEUTICAL COMPANIES, INC. Spring Valley, NY 10977 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Revised: 11/2012 OS034-01-1-12
INDICATIONS AND USAGE
INDICATIONS Based on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows: Effective: Management of nausea and vomiting, and dizziness associated with motion sickness. Possibly Effective: Management of vertigo associated with diseases affecting the vestibular system. Final classification of the less than effective indications required further investigation.
DOSAGE AND ADMINISTRATION
Vertigo For the control of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 to 100mg daily, in divided dosage, depending upon clinical response. Motion Sickness: The initial dose of 25 to 50 mg meclizine hydrochloride, should be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.