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| Meclizine Hydrochloride

05:56 EDT 27th August 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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:

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, stearic acid and other ingredients. 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.

IMAGE formula.jpg
C25H27CIN2•2HCI•H2O M.W. 481.89

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.

For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

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

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. Do not give to children under 12 years of age unless directed by a doctor.

The Meclizine Hydrochloride Tablets, 25 mg contain FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow #5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

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

Usage in Pregnancy: 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 hydrochloride 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 hydrochloride, or any other medication should be used during pregnancy only if clearly necessary.

Drowsiness, dry mouth, and on rare occasions, blurred vision have been reported.

Motion Sickness: The initial dose of 25 to 50 mg meclizine hydrochloride, 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.

Meclizine Hydrochloride Tablets, USP 12.5 mg - blue, oval tablets debossed with “034” on one side and “par” on the other side. Tablets may contain characteristic dye spots.

Meclizine Hydrochloride Tablets, USP 25 mg - yellow, oval tablets debossed with “035” on one side and “par” on the other side.

They are supplied by State of Florida DOH Central Pharmacy as follows:

Dispense in tight, light-resistant containers as defined in the USP.

Store at controlled room temperature 15°-30°C (59°-86°F).

Manufactured by:

PAR PHARMACEUTICAL COMPANIES, INC.

Spring Valley, NY 10977

This Product was Repackaged By:

State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

NDC Strength Quantity/Form Color Source Prod. Code
53808-0380-1 25 mg 30 Tablets in a Blister Pack YELLOW 49884-035
IMAGE Meclizine 25mg(PAR).jpg

Manufacturer

State of Florida DOH Central Pharmacy

Active Ingredients

Source

Clinical Trials [1815 Associated Clinical Trials listed on BioPortfolio]

Meclizine for Hepatocellular Carcinoma

Meclizine hydrochloride is an antihistamine widely used for treatment of vertigo and motion sickness. In HCC it has been used for anti-emetic effects, but it is used here as a CAR (constit...

Double-blind Comparative Study of SYR-322-MET.

To evaluate the safety and efficacy of treatment with metformin hydrochloride in diabetic patients when used in combination with SYR-322.

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PubMed Articles [206 Associated PubMed Articles listed on BioPortfolio]

Spectrophotometric determination of meclizine hydrochloride and pyridoxine hydrochloride in laboratory prepared mixtures and in their pharmaceutical preparation.

In this paper, three rapid, simple, accurate and precise spectrophotometric methods were developed for the determination of meclizine hydrochloride in the presence of pyridoxine hydrochloride without ...

Validated Chromatographic Methods for the Analysis of Two Binary Mixtures Containing Pyridoxine Hydrochloride.

Accurate and precise TLC-densitometric and HPLC-diode-array detector (DAD) methods have been developed and validated toresolve two binary mixtures containing pyridoxine hydrochloride (PYH) with either...

Effects of oxycodone on immune function in patients undergoing radical resection of rectal cancer under general anesthesia.

This study aims to explore the effect of oxycodone hydrochloride injection on the immune function of patients who underwent radical resection of rectal cancer under general anesthesia.Eighty patients ...

Nanosized complexation assemblies housed inside reverse micelles churn out monocytic delivery cores for bendamustine hydrochloride.

We explore a plausible method of targeting bendamustine hydrochloride (BM) to circulatory monocytes by exploiting their intrinsic endocytic/phagocytic capability.

Long-term efficacy and safety of nalfurafine hydrochloride on pruritus in chronic liver disease patients: Patient-reported outcome based analyses.

Among various symptoms accompanied with chronic liver disease, pruritus affects the quality of life of patients, causing physical and mental stress, and worsens hepatic function. Recently, κ-opioid r...

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