Meclozine

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).

• Recommended dosage: 25 mg to 100 mg daily, in divided doses
• Tablets: Swallow whole
• Recommended Dosage The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response
• Administration Instructions Tablets: Meclizine hydrochloride tablets must be swallowed whole

Meclizine Hydrochloride Tablets, USP are available containing 12.5 mg, 25 mg or 50 mg of meclizine dihydrochloride equivalent to 10.53 mg, 21.07 mg or 42.14 mg of meclizine free base, respectively. The 12.5 mg tablets are a white to off-white 7.14 mm round, biconvex, beveled edge tablets debossed with 12 on one side of tablet and C on the other side of tablet. …

• Safety and effectiveness
• In pediatric patients have not been established

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Administration Instructions: Advise patients that the tablets must be swallowed whole, but chewable tablets must be chewed or crushed completely before swallowing [see Dosage and Administration ]
• Adverse Reactions: Advise patients that meclizine hydrochloride tablets may cause anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision [see Warnings and Precautions , Adverse Reactions ]
• Inform patients that meclizine hydrochloride tablets may impair their ability to engage in potentially dangerous activities, such as operating machinery or vehicles. …

• Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions and Description ]
• Meclizine hydrochloride tablets are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients

Coadministration of meclizine hydrochloride tablets with other CNS depressants, including alcohol, may result in increased CNS depression ( 7.1 ). CYP2D6 inhibitors: As meclizine is metabolized by CYP2D6, there is a potential for drug-drug interactions between meclizine hydrochloride tablets and CYP2D6 inhibitors ( 7.2 ). 7.1 CNS Depressants There may be increased CNS depression when meclizine hydrochloride tablets are administered concurrently with other CNS depressants, including alcohol [see Warnings and Precautions (5.1) ] . 7.2 CYP2D6 Inhibitors Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. …

May cause drowsiness: Use caution when driving a car or operating dangerous machinery ( 5.1 ). Potential anticholinergic action: this drug should be prescribed with care to patients with a history of asthma, glaucoma, or enlargement of the prostate gland ( 5.2 ). 5.1 Drowsiness Since drowsiness may occur with use of meclizine hydrochloride tablets, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking meclizine hydrochloride tablets [see Drug Interactions (7.1) ] . …

The following adverse reactions associated with the use of meclizine hydrochloride were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported. Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported ( 6 ). …

8.1 Pregnancy Risk Summary: Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. In the U.S. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.