(meclizine hydrochloride 12.5 mg) Dailymed
Generic: is used for the treatment of Motion Sickness Vertigo
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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 Sickness The initial dose of 25 to 50 mg of Meclizine HCI 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.
How Supplied
Meclizine HCI Tablets, USP are available in the following strengths and package sizes: 12.5 mg (Blue, oval-shaped, scored, debossed with TL122) NDC: 35356-901-30Â Bottles of 30
NDC: 35356-901-60Â Bottles of 60
NDC: 35356-901-90Â Bottles of 90 25Â mg (Yellow, oval-shaped, scored, debossed with TL121)
NDC: 35356-914-20Â Bottles of 20
NDC: 35356-914-30Â Bottles of 30
NDC: 35356-914-60Â Bottles of 60
NDC: 35356-914-90 Bottles of 90 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
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