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:

Bryant Ranch Prepack

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 follow: 0.2 mg: An orange tablet, in the shape of " NDC: 72162-1680-1: 100 Tablets in a BOTTLE NDC: 72162-1680-5: 500 Tablets in a BOTTLE NDC: 72162-1680-0: 1000 Tablets in a BOTTLE 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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CLONIDINE HYDROCHLORIDE TABLETS
CLONIDINEHYDROCHLORIDE TABLETS,USP
ORALANTIHYPERTENSIVE
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