CATAPRES- clonidine hydrochloride tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

clonidine hydrochloride (UNII: W76I6XXF06) (clonidine - UNII:MN3L5RMN02)

Διαθέσιμο από:

Boehringer Ingelheim Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

clonidine hydrochloride

Σύνθεση:

clonidine hydrochloride 0.100 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

CATAPRES tablets are indicated in the treatment of hypertension. CATAPRES tablets may be employed alone or concomitantly with other antihypertensive agents. Catapres® (clonidine hydrochloride, USP) tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).

Περίληψη προϊόντος:

Catapres® (clonidine hydrochloride, USP) tablets are supplied as follows: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

CATAPRES- CLONIDINE HYDROCHLORIDE TABLET
BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
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CATAPRES
(CLONIDINE HYDROCHLORIDE, USP)
Oral Antihypertensive
Tablets of 0.1, 0.2 and 0.3 mg
PRESCRIBING INFORMATION
DESCRIPTION
Catapres
(clonidine hydrochloride, USP) is a centrally acting alpha-agonist
hypotensive agent
available as tablets for oral administration in three dosage
strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1
mg tablet is equivalent to 0.087 mg of the free base.
The inactive ingredients are colloidal silicon dioxide, corn starch,
dibasic calcium phosphate, FD&C
Yellow No. 6, gelatin, glycerin, lactose, and magnesium stearate. The
Catapres 0.1 mg tablet also
contains FD&C Blue No.1 and FD&C Red No.3.
Clonidine hydrochloride is an imidazoline derivative and exists as a
mesomeric compound. The
chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline
hydrochloride. The following is the
structural formula:
Clonidine hydrochloride is an odorless, bitter, white, crystalline
substance soluble in water and
alcohol.
CLINICAL PHARMACOLOGY
Clonidine stimulates alpha-adrenoreceptors in the brain stem. This
action results in reduced sympathetic
outflow from the central nervous system and in decreases in peripheral
resistance, renal vascular
resistance, heart rate, and blood pressure. CATAPRES tablets act
relatively rapidly. The patient’s
blood pressure declines within 30 to 60 minutes after an oral dose,
the maximum decrease occurring
within 2 to 4 hours. Renal blood flow and glomerular filtration rate
remain essentially unchanged.
Normal postural reflexes are intact; therefore, orthostatic symptoms
are mild and infrequent.
Acute studies with clonidine hydrochloride in humans have demonstrated
a moderate reduction (15% to
20%) of cardiac output in the supine position with no change in the
peripheral resistance: at a 45° tilt
there is a smaller reduction in cardiac output and a decrease of
peripheral resistance. During long term
®
®
therapy, cardiac output tends to return to control values, while
peripheral re