CLONIDINE HYDROCHLORIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (Nome Internazionale):

CLONIDINE HYDROCHLORIDE

Composizione:

CLONIDINE HYDROCHLORIDE 0.2 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 ).

Dettagli prodotto:

Clonidine hydrochloride tablets, USP are supplied as follows: 0.1 mg — Each orange, round tablet imprinted with  and 127 on one side and bisect on the other side contains 0.1 mg of clonidine hydrochloride USP and is supplied in blistercards of 30 (NDC 0615-2572-39), blistercards of 15 (NDC 0615-2572-05), blistercards of 10 (NDC 0615-2572-10) and unit-dose boxes of 30 (NDC 0615-2572-30). 0.2 mg — Each orange, round tablet imprinted with  on one side and 128 and bisect on the other side contains 0.2 mg of clonidine hydrochloride USP. 0.3 mg — Each orange, round tablet imprinted with  on one side and 129 and bisect on the other side contains 0.3 mg of clonidine hydrochloride USP. Dispense in a tight, light-resistant container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 8/2022

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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CLONIDINE HYDROCHLORIDE TABLETS, USP
40-9183 REVISED — OCTOBER 2015
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 following inactive ingredients are contained in these products:
corn starch, D&C
yellow #10 Aluminum Lake, FD&C yellow #6 Aluminum Lake (Sunset Yellow
Lake),
lactose monohydrate, magnesium stearate, and sodium starch glycolate.
Clonidine hydrochloride, USP 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, USP 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 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 degree 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
de