CLONIDINE HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02)

Tilgjengelig fra:

PD-Rx Pharmaceuticals, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 ).

Produkt oppsummering:

Clonidine Hydrochloride Tablets, USP are supplied as: 0.2 mg White rounded off oval shaped, biconvex tablets, with score line having "U" and "136" debossed across the score line on one side and plain on other side. Bottles of 30: NDC 43063-925-30 Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Please address medical inquiries to Unichem's toll free # 1-866-562-4616.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
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 inactive ingredients are colloidal silicon dioxide, corn starch,
dibasic calcium
phosphate, sodium starch glycolate, glycerin, lactose monohydrate,
magnesium
stearate, povidone.
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 tablets 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 no