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:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP 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 follows: Clonidine hydrochloride tablets USP 0.1 mg, yellow, round, debossed MP 657 on one side and plain on the other side. Bottles of 100                         NDC 52817-180-10 Bottles of 500                         NDC 52817-180-50 Bottles of 1000                   NDC 52817-180-00 Clonidine hydrochloride tablets USP 0.2 mg, white, round, debossed MP 658 on one side and plain on the other side. Bottles of 100                         NDC 52817-181-10 Bottles of 500                         NDC 52817-181-50 Bottles of 1000                   NDC 52817-181-00 Clonidine hydrochloride tablets USP 0.3 mg, green, round, debossed MP 659 on one side and plain on the other side. Bottles of 100                         NDC 52817-182-10 Bottles of 500                         NDC 52817-182-50 Bottles of 1000                   NDC 52817-182-00 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Add ress medical inquiries to: 1-877-541-5504 . Manufactured by:       Frontida BioPharm, Inc       Philadelphia, PA 19124 Distributed by:       TruPharma, LLC             Tampa, FL 33609 Rev00, March 2017

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
RX ONLY
CLONIDINE HYDROCHLORIDE TABLETS USP
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.
Clonidine hydrochloride tablets USP contain the following inactive
ingredients: lactose, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, and
sodium starch glycolate. The 0.1 mg also
contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C
yellow #10 aluminum lake and
FD&C blue #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
tablets USP 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-t