MECLIZINE HYDROCHLORIDE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)

Pieejams no:

Direct_Rx

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride is 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 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data Epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects. Animal Data In a published study, oral administration of meclizine (25-250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations. These effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m2) basis. 8.2 Lactation Risk Summary There are no data on the presence of meclizine in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meclizine hydrochloride and any potential adverse effects on the breastfed infant from meclizine hydrochloride or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use 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. 8.6 Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As meclizine hydrochloride undergoes metabolism, hepatic impairment may result in increased systemic exposure of meclizine. Treatment with meclizine hydrochloride should be administered with caution in patients with hepatic impairment. 8.7 Renal Impairment The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. Because of a potential for drug/metabolite accumulation, meclizine hydrochloride should be administered with caution in patients with renal impairment and in the elderly, as renal function generally declines with age. 8.8 Genetic CYP2D6 Polymorphism The genetic polymorphism of CYP2D6 that results in poor-, intermediate-, extensive-, and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure. Therefore, when meclizine hydrochloride is administered to patients with CYP2D6 polymorphism, monitor for adverse reactions and clinical effect accordingly.

Produktu pārskats:

16.1 How Supplied Tablets Meclizine hydrochloride 12.5 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “34” and one white to off white layer debossed with “L”. Bottles of 100 NDC 16571-660-01 Bottles of 500 NDC 16571-660-50 Meclizine hydrochloride 25 mg tablets are oval shaped, biconvex, two-layered tablet, one yellow to pale yellow layer debossed with “49” and one white to off white layer debossed with “L”. Bottles of 100 NDC 16571-661-01 Bottles of 1000 NDC 16571-661-10 Meclizine hydrochloride 50 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “50” and one yellow to pale yellow layer and debossed with “L”. Bottles of 100 NDC 16571-662-01 Chewable Tablets Meclizine hydrochloride 25 mg chewable tablets are pink colored round tablets debossed with “M 25” on one side and break line on other side. Bottles of 100 NDC 16571-663-01 16.2 Storage and Handling Store at 20oC to 25oC (68oF to 77oF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

Autorizācija statuss:

New Drug Application Authorized Generic

Produkta apraksts

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
DIRECT_RX
----------
MECLIZINE HYDROCHLORIDE
Meclizine hydrochloride is 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.
Chewable Tablets
Meclizine hydrochloride chewable tablets must be chewed or crushed
completely before
swallowing. Do not swallow chewable tablets whole.
Tablets
12.5 mg: oval-shaped, biconvex, two-layered tablet, one blue to pale
blue layer debossed
with “34” and one white to off white layer debossed with “L”.
25 mg: oval-shaped, biconvex, two-layered tablet, one yellow to pale
yellow layer
debossed with “49” and one white to off white layer debossed with
“L”.
50 mg: oval-shaped, biconvex, two-layered tablet, one blue to pale
blue layer debossed
with “50” and one yellow to pale yellow layer and debossed with
“L”.
Meclizine hydrochloride is 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 siz