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:

Richmond Pharmaceuticals, 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 USP should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ). Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal ).

Product summary:

Clonidine hydrochloride tablets USP are supplied as follows: Clonidine hydrochloride tablets USP 0.1 mg, yellow, round, debossed MP 657 on one side and plain on the other side. Clonidine hydrochloride tablets USP 0.2 mg, white, round, debossed MP 658 on one side and plain on the other side. Clonidine hydrochloride tablets USP 0.3 mg, green, round, debossed MP 659 on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Address medical inquiries to: 1-888-351-3786.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
RICHMOND PHARMACEUTICALS, INC.
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CLONIDINE HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Clonidine hydrochloride tablets 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.
Clonidine hydrochloride tablets USP contain the following inactive
ingredients: lactose, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, and
sodium starch glycolate. The 0.1 mg also
contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C
yellow #10 aluminum lake and
FD&C blue #1 aluminum lake.
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:
C H Cl
N • HCl Mol. Wt. 266.56
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 USP 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 out