semprex-d- acrivastine and pseudoephedrine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

acrivastine (UNII: A20F9XAI7W) (acrivastine - UNII:A20F9XAI7W), pseudoephedrine hydrochloride (UNII: 6V9V2RYJ8N) (pseudoephedrine - UNII:7CUC9DDI9F)

Available from:

UCB, Inc.

INN (International Name):

acrivastine and pseudoephedrine hydrochloride

Pharmaceutical form:

CAPSULE

Composition:

8 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SEMPREX-D Capsules are indicated for relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion. SEMPREX-D Capsules should be administered when both the antihistaminic activity of acrivastine and the nasal decongestant activity of pseudoephedrine are desired (see CLINICAL PHARMACOLOGY). The efficacy of SEMPREX-D Capsules beyond 14 days of continuous treatment in patients with seasonal allergic rhinitis has not been adequately investigated in clinical trials. SEMPREX-D Capsules have not been adequately studied for effectiveness in relieving the symptoms of the common cold. SEMPREX-D Capsules are contraindicated in patients with a known sensitivity to acrivastine, other alkylamine antihistamines (e.g., triprolidine), pseudoephedrine, other sympathomimetic amines (e.g., phenylpropanolamine), or to any other components of the formulation. SEMPREX-D Capsules are contraindicated in patients with severe hypertension or severe coronary arter

Product summary:

SEMPREX-D Capsules (dark green opaque cap and white opaque body with a yellow band) contain acrivastine 8 mg and pseudoephedrine hydrochloride 60 mg. The cap is printed with “404” in white ink, and the body is printed with “SEMPREX-D” in black ink. NDC 53014-404-10 Bottle of 100’s Store at 15° to 25° C (59° to 77° F) in a dry place and protected from light. Keep out of the reach of children.

Summary of Product characteristics

SEMPREX-D- ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULE
UCB, INC.
----------
SEMPREX
-D CAPSULES
(ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE)
DESCRIPTION
SEMPREX-D Capsules (acrivastine and pseudoephedrine hydrochloride) are
a fixed combination
product formulated for oral administration. Acrivastine is an
antihistamine and pseudoephedrine is a
decongestant. Each capsule contains 8 mg acrivastine and 60 mg
pseudoephedrine hydrochloride and
the inactive ingredients: lactose, magnesium stearate and sodium
starch glycolate. The green and white
capsule shell consists of gelatin, D&C Yellow No. 10, FD&C Green No.
3, and titanium dioxide. The
yellow band around the capsule consists of gelatin and D&C Yellow No.
10. The capsules may contain
one or more parabens and are printed with edible black and white inks.
The chemical name of acrivastine is
(_E,E_)-3-[6-[1-(4-methylphenyl)-3-(1-pyrrolidinyl)-1-propenyl]-2-
pyridinyl]-2-propenoic acid; the molecular formula is C
H N O . As an analog of triprolidine
hydrochloride, acrivastine is classified as an alkylamine
antihistamine. Acrivastine is an odorless, white
to pale cream crystalline powder that is soluble in chloroform and
alcohol and slightly soluble in water.
The chemical name of pseudoephedrine hydrochloride is
[S-(_R_*,_R_*)]-α-[1-
(methylamino)ethyl]benzenemethanol hydrochloride; the molecular
formula is C
H NO•HCl.
Pseudoephedrine is one of the naturally occurring dextrorotatory
diastereoisomers of ephedrine and is
classified as an indirect sympathomimetic amine. Pseudoephedrine
hydrochloride occurs as odorless,
fine white to off-white crystals or powder; the drug is soluble in
water, alcohol and chloroform.
Structural formulae for the active ingredients of SEMPREX-D Capsules
are as follows:
CLINICAL PHARMACOLOGY
Acrivastine, a structural analog of triprolidine hydrochloride,
exhibits H -antihistaminic activity in
isolated tissues, animals, and humans, and has sedative effects in
humans (see PRECAUTIONS). The
propionic acid derivative of acrivastine