Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
Direct_Rx
ORAL
PRESCRIPTION DRUG
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions (6) and Description (11)]. 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data E
Meclizine Hydrochloride Tablets USP, 12.5 mg are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. They are available as follows: Bottles of 30: Bottles of 100: Bottles of 500: Bottles of 1000: Blister packs: (Packages of 100 unit doses, 10 cards of 10 tablets each) Meclizine Hydrochloride Tablets USP, 25 mg are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. They are available as follows: Bottles of 30: Bottles of 100: Bottles of 500: Bottles of 1000: Blister packs: (Packages of 100 unit doses, 10 cards of 10 tablets each) Meclizine Hydrochloride Tablets USP, 50 mg are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side. They are available as follows: Bottles of 30: Bottles of 100: Bottles of 500: Bottles of 1000: Blister packs: (Packages of 100 unit doses, 10 cards of 10 tablets each) 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep this and all medication out of the reach of children.
Abbreviated New Drug Application
MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET DIRECT_RX ---------- MECLIZINE HYDROCHLORIDE Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. 2.1 Recommended Dosage The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response. 2.2 Administration Instructions Tablets Meclizine hydrochloride tablets must be swallowed whole. Close 12.5 mg: light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. 25 mg: light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. 50 mg: white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side. Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions (6) and Description (11)]. 5.1 Drowsiness Since drowsiness may occur with use of meclizine hydrochloride, 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 [see Drug Interactions (7.1)]. 5.2 Concurrent Medical Conditions Because of its potential anticholinergic action, meclizine hydrochloride should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland. 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. 7.1 CNS Depress Lestu allt skjalið