Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
METHAZOLAMIDE (UNII: W733B0S9SD) (METHAZOLAMIDE - UNII:W733B0S9SD)
ANI Pharmaceuticals, Inc.
METHAZOLAMIDE
METHAZOLAMIDE 25 mg
ORAL
PRESCRIPTION DRUG
Methazolamide Tablets are indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery. Methazolamide therapy is contraindicated in situations in which sodium and/or potassium serum levels are depressed, in cases of marked kidney or liver disease or dysfunction, in adrenal gland failure, and in hyperchloremic acidosis. In patients with cirrhosis, use may precipitate the development of hepatic encephalopathy. Long-term administration of methazolamide is contraindicated in patients with angle-closure glaucoma, since organic closure of the angle may occur in spite of lowered intraocular pressure.
Methazolamide Tablets USP, 25 mg, are white, square, un-scored tablets, debossed “ANI” on one side and “240” on the other side; supplied in bottles of 100 (NDC 62559-240-01). Methazolamide Tablets USP, 50 mg, are white, round tablets, scored on one side and debossed “ANI” and “241” on the other side; supplied in bottles of 100 (NDC 62559-241-01). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Rx only Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9656 Rev 07/23
Abbreviated New Drug Application
METHAZOLAMIDE- METHAZOLAMIDE TABLET ANI PHARMACEUTICALS, INC. ---------- METHAZOLAMIDE TABLETS USP RX ONLY DESCRIPTION Methazolamide, a sulfonamide derivative, is a white crystalline powder, weakly acidic, slightly soluble in water, alcohol and acetone. The chemical name for methazolamide is: N-[5-(aminosulfonyl)-3-methyl-1,3,4-thiadiazo1-2(3H)-ylidene]-acetamide and it has the following structural formula: Molecular Formula: C H N O S Molecular Weight: 236.26 Each tablet, for oral administration, contains 25 mg or 50 mg of methazolamide USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, glyceryl behenate, povidone, pregelatinized starch, and sodium starch glycolate. CLINICAL PHARMACOLOGY Methazolamide is a potent inhibitor of carbonic anhydrase. Methazolamide is well absorbed from the gastrointestinal tract. Peak plasma concentrations are observed 1 to 2 hours after dosing. In a multiple-dose, pharmacokinetic study, administration of methazolamide 25 mg bid, 50 mg bid, and 100 mg bid demonstrated a linear relationship between plasma methazolamide levels and methazolamide dose. Peak plasma concentrations (C ) for the 25 mg, 50 mg and 100 mg bid regimens were 2.5 mcg/mL, 5.1 mcg/mL, and 10.7 mcg/mL, respectively. The area under the plasma concentration-time curves (AUC) was 1130 mcg.min/mL, 2571 mcg.min/mL, and 5418 mcg.min/mL for the 25 mg, 50 mg, and 100 mg dosage regimens, respectively. Methazolamide is distributed throughout the body including the plasma, cerebrospinal fluid, aqueous humor of the eye, red blood cells, bile and extra-cellular fluid. The mean apparent volume of distribution (V /F) ranges from 17 L to 23 L. Approximately 55% is bound to plasma proteins. The steady-state methazolamide red blood cell:plasma ratio varies with dose and was found to be 27:1, 16:1, and 10:1 following the administration of methazolamide 25 mg bid, 50 mg bid, and 100 mg bid, respectively. 5 8 4 3 2 max area The mean steady-state plasma elimination half-life for Preberite celoten dokument