Drug Catalog - Product Detail
Clonidine HCl Tab 0.1 MG 100 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 58657-0647-01 | METHOD PHARMACEUTICALS | 100 | 0.1MG | TABLET |
PACKAGE FILES
Generic Name
CLONIDINE HYDROCHLORIDE
Substance Name
CLONIDINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202297
Description
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. desc
How Supplied
HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are supplied as follows: 0.1 mg: A pink tablet, in the shape of “ ". NDC 58657-647-01 (Bottle of 100) NDC 58657-647-50 (Bottle of 500) NDC 58657-647-10 (Bottle of 1000) 0.2 mg: An orange tablet, in the shape of " ”. NDC 58657-648-01 (Bottle of 100) NDC 58657-648-50 (Bottle of 500) NDC 58657-648-10 (Bottle of 1000) 0.3 mg: A light orange tablet, in the shape of " ". NDC 58657-649-01 (Bottle of 100) NDC 58657-649-50 (Bottle of 500) NDC 58657-649-10 (Bottle of 1000) Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Manufactured by: Yung Shin Pharmaceutical Ind. Co., Ltd. Tachia, Taichung 43769 TAIWAN Distributed by: Method Pharmaceuticals, LLC 7333 Jack Newell Blvd. North, Suite 300 Fort Worth, Texas 76118 To report ADVERSE DRUG EXPERIENCE, please call Method Pharmaceuticals at 1-877-250-3427 Revised: 06/20 1 2 3
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose. Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.