CLONIDINE HYDROCHLORIDE tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

clonidine hydrochloride (UNII: W76I6XXF06) (clonidine - UNII:MN3L5RMN02)

MAH:

Proficient Rx LP

INN:

clonidine hydrochloride

composition:

clonidine hydrochloride 0.1 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 USP should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).

leaflet_short:

Clonidine hydrochloride tablets USP are supplied as follows: Clonidine hydrochloride tablets USP 0.1 mg, yellow, round, debossed MP 657 on one side and plain on the other side. Bottles of 30 NDC 63187-202-30 Bottles of 60 Bottles of 90 NDC 63187-202-60 NDC 63187-202-90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

authorization_status:

Abbreviated New Drug Application

SPC

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
PROFICIENT RX LP
----------
CLONIDINE HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Clonidine hydrochloride tablets 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.
Clonidine hydrochloride tablets USP contain the following inactive
ingredients: lactose, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, and
sodium starch glycolate. The 0.1 mg also
contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C
yellow #10 aluminum lake and
FD&C blue #1 aluminum lake.
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:
C9H9CL2N3 • HCL MOL. WT. 266.56
C9H9Cl2N3 • HCl Mol. Wt. 266.56
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 USP 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