Acetazolamide Extended-Release

Prescription

Ticari adlar: ACETAZOLAMIDE EXTENDED-RELEASE

Farmasötik Form

Capsule

Uygulama Yolu

ORAL

Üretici

Micro Labs Limited

About This Medication

DESCRIPTION: Acetazolamide extended-release capsules, USP are an inhibitor of the enzyme carbonic anhydrase. Acetazolamide USP is a white to faintly yellowish-white, crystalline, odorless powder. Sparingly soluble in practically boiling water; slightly soluble in alcohol; very slightly soluble in water. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3, 4-thiadiazol-2-yl) acetamide and has the following chemical structure: Molecular Weight 222.24 Chemical Formula C 4 H 6 N 4 O 3 S 2 Acetazolamide extended-release capsules, USP are, for oral administration, each containing 500 mg of acetazolamide and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate and talc. The ingredients in the capsule shell are D&C RED no. 28, D&C YELLOW no. 10, FD&C RED no. 40, gelatin and titanium dioxide. The ingredients in the imprinting ink are shellac (24 to 27%), dehydrated alcohol (23 to 26%), isopropyl alcohol (1 to 3%), butyl alcohol (1 to 3%), propylene glycol (3 to 7%), strong ammonia solution (1 to 2%), black iron oxide (24 to 28%), potassium hydroxide (0.05 to 0.1%) and purified water (15 to 18%). FDA approved dissolution test specifications differ from USP acetazolamide-str.jpg

Etken Maddeler

Bileşen	Güç
Acetazolamide	-

Endikasyonlar ve Kullanım

INDICATIONS AND USAGE: For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.

Dozaj ve Uygulama

DOSAGE AND ADMINISTRATION: Glaucoma The recommended dosage is 1 capsule (500 mg) two times a day. Usually 1 capsule is administered in the morning and 1 capsule in the evening. It may be necessary to adjust the dose, but it has usually been found that dosage in excess of 2 capsules (1 g) does not produce an increased effect. The dosage should be adjusted with careful individual attention both to symptomatology and intraocular tension. In all cases, continuous supervision by a physician is advisable. In those unusual instances where adequate control is not obtained by the twice-a-day administration of acetazolamide extended-release capsules, USP the desired control may be established by means of acetazolamide (tablets or parenteral). Use tablets or parenteral in accordance with the more frequent dosage schedules recommended for these dosage forms, such as 250 mg every four hours, or an initial dose of 500 mg followed by 250 mg or 125 mg every four hours, depending on the case in question. Acute Mountain Sickness Dosage is 500 mg to 1000 mg daily, in divided doses using tablets or extended-release capsules as appropriate. In circumstances of rapid ascent, such as in rescue or military operations, the higher dose level of 1000 mg is recommended. It is preferable to initiate dosing 24 to 48 hours before ascent and to continue for 48 hours while at high altitude, or longer as necessary to control symptoms.

Side Effects Overview

ADVERSE REACTIONS: Body as a whole: Headache, malaise, fatigue, fever, pain at injection site, flushing, growth retardation in children, flaccid paralysis, anaphylaxis. Digestive: Gastrointestinal disturbances such as nausea, vomiting, diarrhea. Hematological/Lymphatic: Blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, thrombocytopenic purpura, melena. Hepato-biliary disorders: Abnormal liver function, cholestatic jaundice, hepatic insufficiency, fulminant hepatic necrosis. Metabolic/Nutritional: Metabolic acidosis, electrolyte imbalance, including hypokalemia, hyponatremia, osteomalacia with long-term phenytoin therapy, loss of appetite, taste alteration, hyper/hypoglycemia. Nervous: Drowsiness, paresthesia (including numbness and tingling of extremities and face), depression, excitement, ataxia, confusion, convulsions, dizziness. Skin: Allergic skin reactions including urticaria, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis. Otologic: Hearing disturbances, tinnitus. Eye Disorders : Choroidal effusion, choroidal detachment, transient myopia. Transient myopia is the result of forward movement of the ciliary body leading to a narrowing of the angle. Urogenital: Crystalluria, increased risk of nephrolithiasis with long-term therapy, hematuria, glycosuria, renal failure, polyuria. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc., at 1-855-839-8195 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Uyarılar ve Önlemler

WARNINGS: Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, anaphylaxis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitizations may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue use of this drug. Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as anorexia, tachypnea, lethargy, metabolic acidosis, coma, and death have been reported.

Kontrendikasyonlar

CONTRAINDICATIONS: Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible. Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis. It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy. Long-term administration of acetazolamide is contraindicated in patients with chronic non-congestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

Frequently Asked Questions

INDICATIONS AND USAGE: For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.

DOSAGE AND ADMINISTRATION: Glaucoma The recommended dosage is 1 capsule (500 mg) two times a day. Usually 1 capsule is administered in the morning and 1 capsule in the evening. It may be necessary to adjust the dose, but it has usually been found that dosage in excess of 2 capsules (1 g) does not produce an increased effect. The dosage should be adjusted with careful individual attention both to symptomatology and intraocular tension. In all cases, continuous supervision by …

WARNINGS: Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, anaphylaxis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitizations may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue use of this drug. Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as anorexia, tachypnea, lethargy, metabolic acidosis, coma, and death have been reported.

CONTRAINDICATIONS: Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible. Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis. It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy. Long-term administration of …

Acetazolamide Extended-Release is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Acetazolamide Extended-Release drug label (National Library of Medicine)
• openFDA — Acetazolamide Extended-Release label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 562524 (NLM Normalized Drug Names)
• NDC Directory — Acetazolamide Extended-Release (FDA National Drug Code)

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Veri kaynakları: DailyMed (NLM), openFDA, MFDS