Country: United States
Language: English
Source: NLM (National Library of Medicine)
CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02)
State of Florida DOH Central Pharmacy
ORAL
PRESCRIPTION DRUG
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 ).
Clonidine Hydrochloride Tablets, USP are available as: 0.1 mg: light tan, oval, scored, convex, debossed "25" bisect "41" on one side and debossed "V" on the reverse side. 0.2 mg: orange, oval, scored, convex, debossed "25" bisect "42" on one side and debossed "V" on the reverse side. 0.3 mg: peach, oval, scored, convex, debossed "25" bisect "43" on one side and debossed "V" on the reverse side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CLONIDINE HYDROCHLORIDE - CLONIDINE HYDROCHLORIDE TABLET STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- CLONIDINE HYDROCHLORIDE TABLETS, USP RX ONLY Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg 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 dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 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: 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 resistance. During Read the complete document