Meclizine Hydrochloride 12.5 MG Oral Tablet
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.
DRUG INTERACTIONS
Drug Interactions There may be increased CNS depression when meclizine is administered concurrently with other CNS depressants, including alcohol, tranquilizers, and sedatives (see WARNINGS ).
Based on in vitro evaluation, meclizine is metabolized by CYP2D6.
Therefore there is a possibility for a drug interaction between meclizine and CYP2D6 inhibitors.
DESCRIPTION
Chemically, meclizine hydrochloride, USP is 1-( p -Chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate.
The molecular weight is 481.88 g/mole.
It has the following structural formula: Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg.
Inert ingredients for the tablets are: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.
Meclizine Structural Formula
HOW SUPPLIED
: Meclizine Hydrochloride Tablets, USP are available containing 12.5 mg and 25 mg of meclizine hydrochloride, USP.
The 12.5 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 12 on the other side.
They are available as follows: NDC 51079-423-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
The 25 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 25 on the other side.
They are available as follows: NDC 51079-511-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.] Manufactured by: Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Distributed by: Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.
S-12121 R2 9/17
INDICATIONS AND USAGE
For the management of nausea and vomiting, and dizziness associated with motion sickness.
PEDIATRIC USE
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.
PREGNANCY
Pregnancy Use 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.
NUSRING MOTHERS
Nursing Mothers It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when meclizine is administered to a nursing woman.
DOSAGE AND ADMINISTRATION
Motion Sickness The initial dose of 25 mg to 50 mg of meclizine hydrochloride tablets should be taken one hour prior to travel for protection against motion sickness.
Thereafter, the dose may be repeated every 24 hours for the duration of the journey.