CLONIDINE HYDROCHLORIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Unichem Pharmaceuticals (USA), Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Clonidine hydrochloride tablets 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 ).

Přehled produktů:

Clonidine Hydrochloride Tablets, USP are supplied as: 0.1 mg White round shaped, biconvex, scored tablets, debossed with "U" and "135" on either side of breakline on one side and plain on other side. Bottles of 100: NDC 29300-468-01 Bottles of 500: NDC 29300-468-05 Bottles of 1,000: NDC 29300-468-10 Bottles of 5,000: NDC 29300-468-50 0.2 mg White rounded off oval shaped, biconvex tablets, with score line having "U" and "136" debossed across the score line on one side and plain on other side. Bottles of 100: NDC 29300-136-01 Bottles of 500: NDC 29300-136-05 Bottles of 1,000: NDC 29300-136-10 Bottles of 5,000: NDC 29300-136-50 0.3 mg White rounded off oval shaped, biconvex tablets with score line having "U" and "137" debossed across the score line on one side and plain on other side. Bottles of 100: NDC 29300-137-01 Bottles of 500: NDC 29300-137-05 Bottles of 1,000: NDC 29300-137-10 Bottles of 2,500: NDC 29300-137-25 Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Please address medical inquiries to Unichem's toll free # 1-866-562-4616. Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: East Brunswick, NJ 08816 07-R-08/2020 13012905

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CLONIDINE HYDROCHLORIDE - CLONIDINE HYDROCHLORIDE TABLET
UNICHEM PHARMACEUTICALS (USA), INC.
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CLONIDINE HYDROCHLORIDE TABLETS, USP
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 inactive ingredients are colloidal silicon dioxide, corn starch,
dibasic calcium phosphate, sodium
starch glycolate, glycerin, lactose monohydrate, magnesium stearate,
povidone.
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:
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 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 term
therapy, cardiac output tends to return to control values, while
peripheral resistance remains decreased.
Slowing of the pulse rate has been observed in most patients given
clonidine, but the drug does not