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

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:

0.1 mg — Each orange, round tablet imprinted with and 127 on one side and bisect on the other side contains 0.1 mg of Clonidine hydrochloride USP. 0.2 mg — Each orange, round tablet imprinted with on one side and 128 and bisect on the other side contains 0.2 mg of Clonidine hydrochloride USP. 0.3 mg — Each orange, round tablet imprinted with on one side and 129 and bisect on the other side contains 0.3 mg of Clonidine hydrochloride USP. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 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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CLONIDINE HYDROCHLORIDE TABLETS, USP
RX ONLY
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.
The following inactive ingredients are contained in these products:
corn starch, D&C yellow #10
Aluminum Lake, FD&C yellow #6 Aluminum Lake (Sunset Yellow Lake),
lactose monohydrate,
magnesium stearate, and sodium starch glycolate.
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,
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 pa