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Meclizine - FDA prescribing information, side effects and uses



Salvanets.bizMeclizine 12.5 mg tablet


4/19/2014
01:52 | Author: Evan Martin

Meclizine 12.5 mg tablet
Meclizine - FDA prescribing information, side effects and uses

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Each tablet contains: Meclizine hydrochloride, USP 12.5 mg.

Store at 20° to 25°C (68° to 77°F ).

Always get your pet's drug and dose recommendation from the veterinarian.

Nevertheless, Meclizine, or any other medication, should be used during pregnancy only if clearly necessary. Reproduction studies in rats have shown cleft palates at 25 to 50 times the human dose. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Epidemiological studies in pregnant women, however, do not indicate that Meclizine increases the risk of abnormalities when administered during pregnancy.

Usual Dosage: See accompanying prescribing information.

Meclizine Hydrochloride Tablets, USP 25 mg.

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It has the following structural formula:. The molecular weight is 481.88 g/mole. Chemically, Meclizine hydrochloride, USP is 1-( p -Chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate.

Mylan.com RM5486MM1. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg.

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:.

The available pharmacokinetic information for Meclizine following oral administration has been summarized from published literature.

Availability Rx/OTC Rx and/or OTC.

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Keep this and all medication out of the reach of children.

Meclizine is absorbed after oral administration with maximum plasma concentrations reaching at a median T max value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form.

Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

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( 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. There may be increased CNS depression when Meclizine is administered concurrently with other CNS depressants, including alcohol, tranquilizers, and sedatives.

NDC bottles of 1000 tablets.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

NDC bottles of 1000 tablets.

Inert ingredients for the tablets are: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.

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:.

The effect of hepatic impairment on the pharmacokinetics of Meclizine has not been evaluated. Treatment with Meclizine should be administered with caution in patients with hepatic impairment. As Meclizine undergoes metabolism, hepatic impairment may result in increased systemic exposure of the drug.

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Patients should avoid alcoholic beverages while taking this drug.

CSA Schedule N Not a controlled drug.

Drug distribution characteristics for Meclizine in humans are unknown.

Pregnancy Category B No proven risk in humans.

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Meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

Rx only 90 Tablets.

PRINCIPAL DISPLAY PANEL - 12.5 mg NDC.

Each tablet contains: Meclizine hydrochloride, USP 25 mg.

The genetic polymorphism of CYP2D6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in Meclizine exposure.

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Thereafter, the dose may be repeated every 24 hours for the duration of the journey. 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.

Keep container tightly closed.

Meclizine Hydrochloride Tablets, USP are available containing 12.5 mg and 25 mg of Meclizine hydrochloride, USP.

PRINCIPAL DISPLAY PANEL - 25 mg NDC.

MOTION SICKNESS: 25 mg to 50 mg daily.

Due to a potential for drug/metabolite accumulation, Meclizine should be administered with caution in patients with renal impairment and in the elderly as renal function generally declines with age. The effect of renal impairment on the pharmacokinetics of Meclizine has not been evaluated.

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Store at 20° to 25°C (68° to 77°F).

Usual Dosage: See accompanying prescribing information.

Rx only 90 Tablets.

Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

MOTION SICKNESS: 25 mg to 50 mg daily.

Generic Name: Meclizine hydrochloride Dosage Form: tablet.

For the management of nausea and vomiting, and dizziness associated with motion sickness.

Keep this and all medication out of the reach of children.

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.

Meclizine has a plasma elimination half-life of about 5 to 6 hours in humans.

The metabolic fate of Meclizine in humans is unknown. In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP2D6 was found to be the dominant enzyme for metabolism of Meclizine.

Mylan.com RM5485MM1. Morgantown, WV 26505 U.S.A. Mylan Pharmaceuticals Inc.

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Because many drugs are excreted in human milk, caution should be exercised when Meclizine is administered to a nursing woman. It is not known whether this drug is excreted in human milk.

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Approval History Calendar Drug history at FDA.

NDC bottles of 90 tablets.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Store at 20° to 25°C (68° to 77°F ).

Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.

Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Meclizine hydrochloride is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs.

anticholinergic antiemetics Benadryl, diphenhydramine, Antivert, scopolamine, Dramamine, dimenhydrinate.

Meclizine Hydrochloride Tablets, USP 12.5 mg.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

NDC bottles of 90 tablets.

REVISED MARCH 2014 MECL:R2.

Keep container tightly closed.

Data sources include Micromedex (updated Sep 26th, 2014), Cerner Multum (updated Oct 16th, 2014), Wolters Kluwer (updated Oct 9th, 2014) and others. To view content sources and attributions, refer to our editorial policy.


Meclizine 12.5 mg tablet