CLONIDINE HYDROCHLORIDE- clonidine hydrochloride tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

A-S Medication Solutions

INN (mednarodno ime):

CLONIDINE HYDROCHLORIDE

Sestava:

CLONIDINE HYDROCHLORIDE 0.1 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Product: 50090-0135 NDC: 50090-0135-0 30 TABLET in a BOTTLE NDC: 50090-0135-1 60 TABLET in a BOTTLE NDC: 50090-0135-2 100 TABLET in a BOTTLE NDC: 50090-0135-7 90 TABLET in a BOTTLE NDC: 50090-0135-8 180 TABLET in a BOTTLE Product: 50090-2531 NDC: 50090-2531-1 60 TABLET in a BOTTLE Product: 50090-2600 NDC: 50090-2600-0 30 TABLET in a BOTTLE NDC: 50090-2600-1 60 TABLET in a BOTTLE NDC: 50090-2600-5 180 TABLET in a BOTTLE NDC: 50090-2600-6 90 TABLET in a BOTTLE

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE TABLET
A-S MEDICATION SOLUTIONS
----------
CLONIDINE HYDROCHLORIDE TABLETS, USP
Oral Antihypertensive
Tablets of 0.1 mg, 0.2 mg and 0.3 mg
RX ONLY
PRESCRIBING INFORMATION
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,
calcium phosphate dibasic,
hydroxypropyl cellulose, microcrystalline cellulose, lactose
monohydrate and magnesium stearate. In
addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg
and 0.3 mg tablets contain FD&C
Yellow No. 6 as color additives respectively.
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 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 r