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:

MedVantx, 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 should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).

Product summary:

Clonidine Hydrochloride Tablets, USP, are supplied in 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 ‘Ll67’ on one side and break line on other side. NDC 16714-341-01    bottle of 30 tablets NDC 16714-341-03    bottle of 100 tablets NDC 16714-341-04    bottle of 500 tablets NDC 16714-341-02    bottle of 1000 tablets NDC 16714-341-11    carton of 100 (10 x 10) unit dose tablets 0.2 mg tablets are orange colored, oval shape, biconvex, uncoated tablet debossed with ‘Ll66’ on one side and break line on other side. NDC 16714-342-01    bottle of 30 tablets NDC 16714-342-03    bottle of 100 tablets NDC 16714-342-04    bottle of 500 tablets NDC 16714-342-02    bottle of 1000 tablets NDC 16714-342-11    carton of 100 (10 x 10) unit dose tablets 0.3 mg tablets are peach colored, oval shape, biconvex, uncoated tablet debossed with ‘Ll65’ on one side and break line on other side. NDC 16714-343-01    bottle of 30 tablets NDC 16714-343-03    bottle of 100 tablets NDC 16714-343-04    bottle of 500 tablets NDC 16714-343-02    bottle of 1000 tablets NDC 16714-343-11    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 tight, light-resistant container.   Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.  Manufactured for: Northstar Rx LLC                            Memphis, TN38141                            Toll free: 1-800-206-7821  Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division),                            Village Panelav, P. O. Tajpura, Near Baska,                            Taluka-Halol, Panchmahal, Gujarat, India. Revised: 12/2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
MEDVANTX, 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
9
9
2
3
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
thera