CLEMASTINE FUMARATE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

CLEMASTINE FUMARATE (UNII: 19259EGQ3D) (CLEMASTINE - UNII:95QN29S1ID)

Beszerezhető a:

Teva Pharmaceuticals USA, Inc.

INN (nemzetközi neve):

CLEMASTINE FUMARATE

Összetétel:

CLEMASTINE FUMARATE 2.68 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Clemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only. Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Antihistamines should not be used to treat lower respiratory tract symptoms including asthma. Antihistamines are also contraindicated in the following conditions: Hypersensitivity to clemastine fumarate or other antihistamines of similar chemical structure. Monoamine oxidase inhibitor therapy (see Drug Interactions section).

Termék összefoglaló:

Clemastine Fumarate Tablets USP, 2.68 mg are white, round, scored tablets debossed with "93" and "308". Tablets are packaged in bottles of 100. (NDC 0093-0308-01) Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. J 4/2022

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CLEMASTINE FUMARATE- CLEMASTINE FUMARATE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
CLEMASTINE FUMARATE TABLETS, USP
RX ONLY
DESCRIPTION
Clemastine belongs to the benzhydryl ether group of antihistaminic
compounds. The
chemical name is
(+)-(2_R_)-2-[2-[[(_R_)-_p_-Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-
methylpyrrolidine fumarate (1:1).
C
H
C1NO C H O M.W. 459.97
Each tablet for oral administration contains 2.68 mg of clemastine
fumarate, USP.
Inactive ingredients: colloidal silicon dioxide, corn starch, lactose
monohydrate,
povidone, pregelatinized starch and stearic acid.
CLINICAL PHARMACOLOGY
Clemastine fumarate is an antihistamine with anticholinergic (drying)
and sedative side
effects. Antihistamines appear to compete with histamine for cell
receptor sites on
effector cells. The inherently long duration of antihistaminic effects
of clemastine
fumarate has been demonstrated in wheal and flare studies. In normal
human subjects
who received histamine injections over a 24-hour period, the
antihistaminic activity of
clemastine reached a peak at 5 to 7 hours, persisted for 10 to 12
hours and, in some
cases, for as long as 24 hours. Pharmacokinetic studies in man
utilizing
H and
C
labeled compound demonstrates that: clemastine is rapidly and nearly
completely
absorbed from the gastrointestinal tract, peak plasma concentrations
are attained in 2
to 4 hours, and urinary excretion is the major mode of elimination.
INDICATIONS AND USAGE
Clemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief
of symptoms
21
26
.
4
4
4
3
14
associated with allergic rhinitis such as sneezing, rhinorrhea,
pruritus, and lacrimation.
Clemastine Fumarate Tablets USP, 2.68 mg are also indicated for the
relief of mild,
uncomplicated allergic skin manifestations of urticaria and
angioedema.
It should be noted that clemastine fumarate is indicated for the
dermatologic indications
at the 2.68 mg dosage level only.
CONTRAINDICATIONS
USAGE IN NURSING MOTHERS
Because of the higher risk of antihistamines for infants generall