Advertisement

Topics

NA | Meclizine Hydrochloride [H.J. Harkins Company, Inc.] | BioPortfolio

12:08 EST 27th January 2019 | 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:

CHCIN•2HCI•HO M.W. 481.89

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, and stearic acid. 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.

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. They are supplied in bottles of 100 (NDC 49884-034-01) and 1000 (NDC 49884-034-10).

Meclizine Hydrochloride Tablets, USP 25 mg - yellow, oval tablets debossed with “035” on one side and “par” on the other side. They are supplied in bottles of 100 (NDC 49884-035-01) and 1000 (NDC 49884-035-10).

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

Repacked by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

Revised: 11/11

OS034-01-1-11

Manufacturer

H.J. Harkins Company, Inc.

Active Ingredients

Source

Drugs and Medications [276 Associated Drugs and Medications listed on BioPortfolio]

Meclizine hydrochloride [directrx]

MECLIZINE HYDROCHLORIDE

Meclizine hydrochloride [pd-rx pharmaceuticals, inc.]

MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only

Meclizine hydrochloride [blenheim pharmacal, inc.]

MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only

Meclizine [direct rx]

MECLIZINE HYDROCHLORIDE 12.5mg 30

Meclizine hydrochloride [proficient rx lp]

MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only

Clinical Trials [2273 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.

Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions

The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the ...

Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed by Surgery

This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and dasatinib when given together with erlotinib hydrochloride in treating patients with pancreatic c...

Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level

The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes ...

PubMed Articles [194 Associated PubMed Articles listed on BioPortfolio]

Protective effects of berberine hydrochloride on DSS-induced ulcerative colitis in rats.

Berberine hydrochloride is one the effective compound among Rhizoma Coptidis, Cortex Phellodendri, and other plants. There are several clinical functions of berberine hydrochloride including anti-infl...

Mutagenicity and recombinogenicity evaluation of bupropion hydrochloride and trazodone hydrochloride in somatic cells of Drosophila melanogaster.

The aim of the present study was to appraise the mutagenic and recombinogenic potential of bupropion hydrochloride (BHc) and trazodone hydrochloride (THc). We used standard (ST) and the high bioactiva...

In vitro and in vivo performance of epinastine hydrochloride-releasing contact lenses.

A number of drug-releasing contact lenses are currently being studied to address issues inherent in eye drops as a drug delivery method. In this study, we developed epinastine hydrochloride-releasing ...

In vitro and ex vivo studies on Diltiazem hydrochloride-loaded microsponges in rectal gels for chronic anal fissures treatment.

Diltiazem hydrochloride, topically applied at 2% concentration, is considered effective for the treatment of chronic anal fissures, althought it involves several side effects among which anal pruritus...

Tramadol hydrochloride: An alternative to conventional local anaesthetics for intraoral procedures- a preliminary study.

To evaluate and compare the soft tissue anaesthesia produced by tramadol hydrochloride on gingival tissues in maxilla.

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record