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:

Mylan Institutional Inc.

INN (International Name):

CLONIDINE HYDROCHLORIDE

Composition:

CLONIDINE HYDROCHLORIDE 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets 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 available containing 0.1 mg, 0.2 mg or 0.3 mg of clonidine hydrochloride, USP. The 0.1 mg tablets are white round scored tablets debossed with MYLAN above the score and 152 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-299-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 0.2 mg tablets are white round scored tablets debossed with MYLAN above the score and 186 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-300-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-300-56 – Unit dose punch cards of 300 (10 cards of 30 tablets each). The 0.3 mg tablets are white round scored tablets debossed with MYLAN above the score and 199 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-301-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12204 5/15

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
MYLAN INSTITUTIONAL INC.
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DESCRIPTION
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.
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, USP is an odorless, bitter, white,
crystalline substance soluble in water and
alcohol.
Each tablet for oral administration contains ammonium chloride,
colloidal silicon dioxide,
croscarmellose sodium (Type A), magnesium stearate, microcrystalline
cellulose, sodium lauryl
sulfate.
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
peripheral resistance. During long-term
therapy, cardiac output tends to return to control values, while
peripheral resistance remains decreased.
Slowing of the pulse rate has been observed in most patients given
clonidine, but the drug does not alter
normal hemodynamic response to exerc