CLONIDINE HYDROCHLORIDE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Major Pharmaceuticals

INN (nume internaţional):

CLONIDINE HYDROCHLORIDE

Compoziție:

CLONIDINE HYDROCHLORIDE 0.1 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 ).

Rezumat produs:

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 cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5656-61. 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 cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5657-61. 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 cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5658-61. 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 by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Distributed by: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA 40-9183 Revised — October 2015

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
MAJOR PHARMACEUTICALS
----------
CLONIDINE HYDROCHLORIDE TABLETS, USP
40-9183
Revised — October 2015
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 t