CLONIDINE HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

DIRECT RX

INN (국제 이름):

CLONIDINE HYDROCHLORIDE

구성:

CLONIDINE HYDROCHLORIDE 0.1 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Clonidine hydrochloride tablets, USP 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

제품 요약:

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). Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-9183 Revised — July 2012

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
DIRECT RX
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CLONIDINE HYDROCHLORIDE
DESCRIPTION SECTION
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 SECTION
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° 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