CLEMASTINE FUMARATE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ayurax, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION). It should be noted that clemastine fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only. Antihistamines are contraindicated in patients hypersensitive to the drug or to other antihistamines of similar chemical structure (see PRECAUTIONS-Drug Interactions). Antihistamines should not be used in newborn or premature Infants. Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers (See PRECAUTIONS-Nursing Mothers).

Product summary:

Clemastine Fumarate Syrup: clemastine 0.5 mg/5 mL (present as clemastine fumarate 0.67 mg/5 mL). A clear, colorless liquid with a citrus flavor (Passion Fruit), in 120 mL bottle. 120 mL bottle (NDC 73308-358-12) Store at controlled room temperature, between 20° and 25°C (68° and 77°F) (see USP). Manufactured For: Ayurax, LLC Fairhope, AL 36532 Distributed By: Solubiomix, LLC Madisonville, LA 70447 Rev. 09/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLEMASTINE FUMARATE- CLEMASTINE FUMARATE SYRUP
AYURAX, LLC
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CLEMASTINE FUMARATE SYRUP
DESCRIPTION
Each teaspoonful (5 mL) of Clemastine Fumarate Syrup for oral
administration contains
clemastine 0.5 mg (present as clemastine fumarate 0.67 mg). Other
ingredients: alcohol
5.5%, flavor, fumaric acid, methylparaben, propylene glycol,
propylparaben, purified
water, saccharin sodium, sorbitol in a buffered solution. Clemastine
fumarate 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 and has the following structural formula:
C
H
CINO.C H O M.W. 459.97
CAS Registration Number 145976-57-9
Clemastine fumarate occurs as a colorless to faintly yellow,
practically odorless,
crystalline powder. Clemastine Fumarate Syrup has an approximate pH of
6.2.
CLINICAL PHARMACOLOGY
Clemastine fumarate is an antihistamine with anticholinergic (drying)
and sedative side
effects. Antihistamines competitively antagonize various physiological
effects of
histamine including increased capillary permeability and dilatation,
the formation of
edema, the "flare" and "itch" response, and gastrointestinal and
respiratory smooth
muscle constriction. Within the vascular tree, H1-receptor antagonists
inhibit both the
vasoconstrictor and vasodilator effects of histamine. Depending on the
dose, H1-
receptor antagonists can produce CNS stimulation or depression. Most
antihistamines
exhibit central and/or peripheral anticholinergic activity.
Antihistamines act by
competitively blocking H1-receptor sites. Antihistamines do not
pharmacologically
antagonize or chemically inactivate histamine, nor do they prevent the
release of
histamine.
21
26
4
4
4
PHARMACOKINETICS
Antihistamines are well-absorbed following oral administration.
Chlorpheniramine
maleate, clemastine fumarate, and diphenhydramine hydrochloride
achieve peak blood
levels within 2-5 hours following oral administration. The absorption
of antihistamines i