CLONIDINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Inc.

INN (International Name):

CLONIDINE HYDROCHLORIDE

Composition:

CLONIDINE HYDROCHLORIDE 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents. Clonidine hydrochloride tablets USP should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).

Product summary:

Clonidine Hydrochloride Tablets, USP, are supplied as scored oval tablets containing 0.1 mg, 0.2 mg or 0.3 mg of clonidine hydrochloride. 0.1 mg tablets are light tan colored, oval shape, biconvex, uncoated tablet debossed with 'L167' on one side and break line on other side. NDC 62332-054-30                bottle of 30 tablets NDC 62332-054-31                bottle of 100 tablets NDC 62332-054-71                bottle of 500 tablets NDC 62332-054-91                bottle of 1000 tablets NDC 62332-054-10                carton of 100 (10 x 10) unit dose tablets 0.2 mg tablets are orange colored, oval shape, biconvex, uncoated tablet debossed with 'L166' on one side and break line on other side. NDC 62332-055-30                bottle of 30 tablets NDC 62332-055-31                bottle of 100 tablets NDC 62332-055-71                bottle of 500 tablets NDC 62332-055-91                bottle of 1000 tablets NDC 62332-055-10                carton of 100 (10 x 10) unit dose tablets 0.3 mg tablets are peach colored, oval shape, biconvex, uncoated tablet debossed with 'L165' on one side and break line on other side. NDC 62332-056-30               bottle of 30 tablets NDC 62332-056-31               bottle of 100 tablets NDC 62332-056-71               bottle of 500 tablets NDC 62332-056-91               bottle of 1000 tablets NDC 62332-056-10               carton of 100 (10 x 10) unit dose tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).[see USP controlled room temperature]. Dispense in a tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to Alembic Pharmaceuticals Limited at 1-866 210 9797 or FDA at 1-800-FDA-1088. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 07/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE - CLONIDINE HYDROCHLORIDE TABLET
ALEMBIC PHARMACEUTICALS INC.
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CLONIDINE HYDROCHLORIDE TABLETS, USP
ORAL ANTIHYPERTENSIVE
TABLETS OF 0.1, 0.2 AND 0.3 MG
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Clonidine hydrochloride 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 lactose monohydrate, microcrystalline
cellulose,
pregelatinized starch, sodium starch glycolate, magnesium stearate and
FD&C Yellow
No. 6 Aluminum Lake. Clonidine hydrochloride 0.1 mg tablets also
contain FD&C Red No.
40 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.
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:
C H Cl
N .HCl Mol Wt. 266.56
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 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 ter