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:

Actavis Pharma, 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 supplied as follows: 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 and is supplied in bottles of 100 (NDC 0228-2127-10) and 500 (NDC 0228-2127-50). 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 and is supplied in bottles of 100 (NDC 0228-2128-10) and 500 (NDC 0228-2128-50). 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 and is supplied in bottles of 100 (NDC 0228-2129-10). Dispense in a tight, light-resistant container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 9/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
ACTAVIS PHARMA, INC.
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CLONIDINE HYDROCHLORIDE TABLETS, USP
RX ONLY
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 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, USP 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.
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 degree 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