CLEMASTINE FUMARATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northwind Pharmaceuticals, LLC

INN (International Name):

CLEMASTINE FUMARATE

Composition:

CLEMASTINE FUMARATE 2.68 mg

Administration route:

Oral

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clemastine Fumarate Tablets 1.34 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets 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. Usage in Nursing Mothers Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Usage in Lower Respiratory Disease Antihistamines should not be used to treat lower respiratory tract symptoms including asthma. Antihistamines are also contraindicated in the following conditions: Hypersensitivit

Product summary:

Clemastine Fumarate Tablets 2.68 mg are white, round, scored tablets debossed with "93" and "308". Tablets are packaged in bottles of 100. Store at controlled room temperature, between 20o and 25oC (68o and 77oF) (see USP). Dispense in a tight, light-resistant container as defined in the USP/NF, with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLEMASTINE FUMARATE- CLEMASTINE FUMARATE TABLET
NORTHWIND PHARMACEUTICALS, LLC
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CLEMASTINE FUMARATE
DES CRIPTION
Clemastine belongs to the benzhydryl ether group of antihistaminic
compounds. The chemical name is
(+)-(2R)-2-[2-[[(R)-p-Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine
fumarate (1:1).
Each tablet for oral administration contains 1.34 or 2.68 mg of
clemastine fumarate.
Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Lactose,
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 5-7 hours,
persisted for 10-12 hours and, in some
cases, for as long as 24 hours. Pharmacokinetic studies in man
utilizing 3H and 14C labeled compound
demonstrates that: clemastine is rapidly and nearly completely
absorbed from the gastrointestinal tract,
peak plasma concentrations are attained in 2-4 hours, and urinary
excretion is the major mode of
elimination.
INDICATIONS AND USAGE
Clemastine Fumarate Tablets 1.34 mg are indicated for the relief of
symptoms associated with allergic
rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation.
Clemastine Fumarate Tablets 2.68 mg are indicated for the relief of
symptoms associated with allergic
rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation.
Clemastine Fumarate Tablets 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 MOT