Drug Catalog - Product Detail
PINDOLOL TAB 5 MG 100 CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 62559-0560-01 | ANI PHARMACEUTICALS | 100 | 5MG | TABLET |
PACKAGE FILES
Generic Name
PINDOLOL
Substance Name
PINDOLOL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA073609
Description
DESCRIPTION Pindolol, a synthetic beta-adrenergic receptor blocking agent with intrinsic sympathomimetic activity is 1-(Indol-4-yloxy)-3-(isopropylamino)-2-propanol. Pindolol, USP is a white to off-white, crystalline powder having a faint odor which is practically insoluble in water; slightly soluble in methanol; and very slightly soluble in chloroform. Each tablet for oral administration contains pindolol and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide and magnesium stearate. structure.jpg
How Supplied
HOW SUPPLIED Pindolol Tablets USP are available as 5 mg and 10 mg tablets. The 5 mg tablets are a 1/4”, round, white, standard cup tablet, scored, debossed GG 438 on one side and plain on the reverse side. They are available in bottles of 100 tablets (NDC 62559-560-01). The 10 mg tablets are a 5/16”, round, white, standard cup tablet, scored, debossed GG 439 on one side and plain on the reverse side. They are available in bottles of 100 tablets (NDC 62559-561-01). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. All brand names listed are the registered trademarks of their respective owners and are not trademarks of ANI Pharmaceuticals, Inc. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Issued: 08/2022 LB4535-00 ani.jpg
Indications & Usage
INDICATIONS AND USAGE Pindolol tablets are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.
Dosage and Administration
DOSAGE AND ADMINISTRATION The dosage of pindolol tablets should be individualized. The recommended initial dose of pindolol tablets is 5 mg b.i.d. alone or in combination with other antihypertensive agents. An antihypertensive response usually occurs within the first week of treatment. Maximal response, however, may take as long as or occasionally longer than 2 weeks. If a satisfactory reduction in blood pressure does not occur within 3 to 4 weeks, the dose may be adjusted in increments of 10 mg/day at these intervals up to a maximum of 60 mg/day.