CLONIDINE HYDROCHLORIDE- clonidine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02)

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

CLONIDINE HYDROCHLORIDE

Composition:

CLONIDINE HYDROCHLORIDE 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Clonidine Hydrochloride Tablets, USP are supplied as follows: 0.1 mg: A pink tablet, in the shape of “ ”.      NDC 60429-921-01 (Bottle of 100) NDC 60429-921-05 (Bottle of 500) 0.2 mg: An orange tablet, in the shape of “ ”.      NDC 60429-922-01 (Bottle of 100) NDC 60429-922-05 (Bottle of 500) 0.3 mg: A light orange tablet, in the shape of “ ”.      NDC 60429-923-01 (Bottle of 100) Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Manufactured by: Yung Shin Pharmaceutical Ind. Co., Ltd. Tachia, Taichung 43769 TAIWAN Distributed by: Carlsbad Technology, Inc. 5923 Balfour Ct., Carlsbad, CA 92008, USA Marketed/ Packaged by: GSMS, Inc. Camarillo, CA 93012 USA To report ADVERSE DRUG EXPERIENCE, please call Carlsbad Technology, Inc. at 1-760-431-8284 Revised: 06/14

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
CLONIDINE HYDROCHLORIDE TABLETS, USP
Oral Antihypertensive
Tablets of 0.1 mg, 0.2 mg and 0.3 mg
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
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,
calcium phosphate dibasic,
hydroxypropyl cellulose, microcrystalline cellulose, lactose
monohydrate and magnesium stearate. In
addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg
and 0.3 mg tablets contain FD&C
Yellow No. 6 as color additives respectively.
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. Clonidine hydrochloride
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
per