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CATAPRES (CLONIDINE HCL) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Catapres (Clonidine Hydrochloride) 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, dibasic calcium phosphate, corn starch, FD&C Yellow No. 6, glycerin, gelatin, lactose, 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.

Clonidine Hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.


CLINICAL PHARMACOLOGY

Catapres clinical pharmacology


INDICATIONS AND USAGE

Catapres (Clonidine Hydrochloride) tablets are indicated in the treatment of hypertension. Catapres tablets may be employed alone or concomitantly with other antihypertensive agents.


CONTRAINDICATIONS

Catapres tablets should not be used in patients with known hypersensitivity to clonidine.


WARNINGS

Catapres warnings


PRECAUTIONS

Catapres precautions


TOXICOLOGY

Catapres toxicology


USE IN SPECIFIC POPULATIONS

Catapres use in specific populations


ADVERSE REACTIONS

Catapres adverse reactions


OVERDOSAGE

Catapres overdosage


DOSAGE AND ADMINISTRATION

Catapres dosage and administration


HOW SUPPLIED

Catapres (Clonidine Hydrochloride, USP) tablets are supplied as follows:

Catapres (Clonidine HCl) 0.1 mg tablets, tan color, marking "BI 6"
Catapres (Clonidine HCl) 0.2 mg tablets, orange color, marking "BI 7"
Catapres (Clonidine HCl) 0.3 mg tablets, peach color, marking "BI 11"

Storage

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.

Manufactured and distributed by Boehringer Ingelheim pharmaceutical company and its divisions.

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