CLONIDINE HYDROCHLORIDE tablet
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
03-05-2017
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Active ingredient:
CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02)
Available from:
Aphena Pharma Solutions - Tennessee, LLC
INN (International Name):
CLONIDINE HYDROCHLORIDE
Composition:
CLONIDINE HYDROCHLORIDE 0.3 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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 ).
Product summary:
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) [See USP Controlled Room Temperature]. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9183 Revised — October 2015
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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
decr
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