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:

Asclemed USA, Inc.

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 20                         NDC 76420-283-20 (repackaged from NDC 52817-180-XX) Bottles of 30                         NDC 76420-283-30 (repackaged from NDC 52817-180-XX) Bottles of 60                         NDC 76420-283-60 (repackaged from NDC 52817-180-XX) Bottles of 90                         NDC 76420-283-90 (repackaged from NDC 52817-180-XX) Bottles of 100                       NDC 76420-283-01 (relabeled from NDC 52817-180-10) Clonidine hydrochloride tablets USP 0.2 mg, white, round, debossed MP 658 on one side and plain on the other side. Bottles of 20                         NDC 76420-285-20 (repackaged from NDC 52817-181-XX) Bottles of 30                         NDC 76420-285-30 (repackaged from NDC 52817-181-XX) Bottles of 60                         NDC 76420-285-60 (repackaged from NDC 52817-181-XX) Bottles of 90                         NDC 76420-285-90 (repackaged from NDC 52817-181-XX) Bottles of 100                       NDC 76420-285-01 (relabeled from NDC 52817-181-10) Clonidine hydrochloride tablets USP 0.3 mg, green, round, debossed MP 659 on one side and plain on the other side. Bottles of 20                        NDC 76420-286-20 (repackaged from NDC 52817-182-XX) Bottles of 30                        NDC 76420-286-30 (repackaged from NDC 52817-182-XX) Bottles of 60                        NDC 76420-286-60 (repackaged from NDC 52817-182-XX) Bottles of 90                        NDC 76420-286-90 (repackaged from NDC 52817-182-XX) Bottles of 100                      NDC 76420-286-01 (relabeled from NDC 52817-182-10) 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 . Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
ASCLEMED USA, INC.
----------
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.
9
9
2
3
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 therapy, c