CLONIDINE HYDROCHLORIDE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

American Health Packaging

INN (nemzetközi neve):

CLONIDINE HYDROCHLORIDE

Összetétel:

CLONIDINE HYDROCHLORIDE 0.1 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 ).

Termék összefoglaló:

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 unit dose packages of 100 (10 x 10) NDC 60687-113-01. 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 unit dose packages of 100 (10 x 10) NDC 60687-124-01. Store at 25°C (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from BluePoint Laboratories as follows: (0.1 mg / 100 UD) NDC 60687-113-01 packaged from NDC 68001-237 (0.2 mg / 100 UD) NDC 60687-124-01 packaged from NDC 68001-238 Distributed by: American Health Packaging Columbus, OH 43217 8411301/0523

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
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CLONIDINE HYDROCHLORIDE TABLETS, USP
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 mo