Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
clonidine hydrochloride (UNII: W76I6XXF06) (clonidine - UNII:MN3L5RMN02)
Blenheim Pharmacal, Inc.
clonidine hydrochloride
clonidine hydrochloride 0.2 mg
ORAL
PRESCRIPTION DRUG
Clonidine hydrochloride USP tablets are indicated in the treatment of hypertension. Clonidine hydrochloride USP tablets may be employed alone or concomitantly with other antihypertensive agents. Clonidine hydrochloride USP tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS).
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 53489-215-01 Bottles of 1000 NDC 53489-215-10 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 53489-216-01 Bottles of 1000 NDC 53489-216-10 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 53489-217-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
CLONIDINE HYDROCHLORIDE - CLONIDINE HYDROCHLORIDE TABLET BLENHEIM PHARMACAL, INC. ---------- CLONIDINE HYDROCHLORIDE USP ORAL ANTIHYPERTENSIVE TABLETS OF 0.1, 0.2 AND 0.3 MG 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. Clonidine hydrochloride tablets 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 USP 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. 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. D Прочетете целия документ