MECLIZINE HYDROCHLORIDE
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meclizine hydrochloride tablet
Epic Pharma, LLC
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DESCRIPTION
Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.
C25H27CIN2·2HCl·H20 M.W. 481.89
Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg. Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate. The 12.5 mg tablet also contains FD&C Blue #1 Aluminum Lake.
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
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 Use
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 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.
HOW SUPPLIED
Meclizine Hydrochloride Tablets USP are available as:
12.5 mg, blue, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “12” to the right of bisect on one side, and plain on the other side. They are supplied as follows:
NDC 42806-012-01 in bottles of 100
NDC 42806-012-10 in bottles of 1000
25 mg, white, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “14” to the right of bisect on one side, and plain on the other side. They are supplied as follows:
NDC 42806-014-01 in bottles of 100
NDC 42806-014-10 in bottles of 1000
Store at 20º to 25ºC (68 to 77ºF) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required.
Manufactured by:
Epic Pharma, LLC
Laurelton, NY 11413
Made in USA
Issued 01/11
MF012ISS 01/11
OE1035
| MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA200294 | 07/15/2011 | |
| MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA200294 | 07/15/2011 | |
| Labeler - Epic Pharma, LLC (827915443) |
Revised: 12/2010 Epic Pharma, LLC