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:

State of Florida DOH Central Pharmacy

INN (International Name):

CLONIDINE HYDROCHLORIDE

Composition:

CLONIDINE HYDROCHLORIDE 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride 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 152 . The 0.2 mg tablets are white, round scored tablets debossed with MYLAN 186 . The 0.3 mg tablets are white, round scored tablets debossed with MYLAN 199 . They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE - CLONIDINE HYDROCHLORIDE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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:
C H CL
N • HCL M.W. 266.56
Clonidine hydrochloride 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
acts 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
norma