Acetazolamide (Acetazolamide)

Trade Name : Acetazolamide

Heritage Pharmaceuticals Inc.

CAPSULE, EXTENDED RELEASE

Strength 500 mg/1

ACETAZOLAMIDE Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Acetazolamide (Acetazolamide) which is also known as Acetazolamide and Manufactured by Heritage Pharmaceuticals Inc.. It is available in strength of 500 mg/1 per ml. Read more

Acetazolamide (Acetazolamide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

tAcetazolamide Extended-Release Capsules are an inhibitor of the enzyme carbonic anhydrase.
tAcetazolamide is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for Acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)acetamide and has the following chemical structure :
tAcetazolamide Extended-Release Capsules are extended-release capsules, for oral administration, each containing 500 mg of Acetazolamide and the following inactive ingredients:
tMicrocrystalline cellulose, sodium lauryl sulfate, hydroxypropyl cellulose and talc.
tThe ingredients in the capsule shell are FD&C green # 3, FDA/E172 black iron oxide, FDA/E172 yellow iron oxide, titanium dioxide and gelatin.
tThe ingredients in the imprinting ink are shellac, propylene glycol, potassium hydroxide and black iron oxide.

Acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion (e.g., some types of glaucoma), in the treatment of certain convulsive disorders (e.g., epilepsy) and in the promotion of diuresis in instances of abnormal fluid retention (e.g., cardiac edema).
Acetazolamide is not a mercurial diuretic. Rather, it is a non-bacteriostatic sulfonamide possessing a chemical structure and pharmacological activity distinctly different from the bacteriostatic sulfonamides.
Acetazolamide is an enzyme inhibitor that acts specifically on carbonic anhydrase, the enzyme that catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In the eye, this inhibitory action of Acetazolamide decreases the secretion of aqueous humor and results in a drop in intraocular pressure, a reaction considered desirable in cases of glaucoma and even in certain non-glaucomatous conditions. Evidence seems to indicate that Acetazolamide has utility as an adjuvant in treatment of certain dysfunctions of the central nervous system (e.g., epilepsy). Inhibition of carbonic anhydrase in this area appears to retard abnormal, paroxysmal, excessive discharge from central nervous system neurons. The diuretic effect of Acetazolamide is due to its action in the kidney on the reversible reaction involving hydration of carbon dioxide and dehydration of carbonic acid. The result is renal loss of HCOn- ion, which carries out sodium, water, and potassium. Alkalinization of the urine and promotion of diuresis are thus affected. Alteration in ammonia metabolism occurs due to increased reabsorption of ammonia by the renal tubules as a result of urinary alkalinization.
Acetazolamide Extended-Release Capsules provide prolonged action to inhibit aqueous humor secretion for 18 to 24 hours after each dose, whereas tablets act for only eight to 12 hours. The prolonged continuous effect of pellets permits a reduction in dosage frequency.
Plasma concentrations of Acetazolamide peak from three to six hours after administration of Acetazolamide Extended-Release Capsules, compared to one to four hours with tablets. Food does not affect bioavailability of Acetazolamide Extended Release Capsules.
Placebo-controlled clinical trials have shown that prophylactic administration of Acetazolamide at a dose of 250 mg every eight to 12 hours (or a 500 mg controlled-release capsule once daily) before and during rapid ascent to altitude results in fewer and/or less severe symptoms of acute mountain sickness (AMS) such as headache, nausea, shortness of breath, dizziness, drowsiness, and fatigue. Pulmonary function (e.g., minute ventilation, expired vital capacity, and peak flow) is greater in the Acetazolamide treated group, both in subjects with AMS and asymptomatic subjects. The Acetazolamide treated climbers also had less difficulty in sleeping.

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.

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.

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.

No data

Body as a whole:n- Headache, malaise, fatigue, fever, pain at injection site, flushing, growth retardation in children, flaccid paralysis, anaphylaxis.
Digestive:n- Gastrointestinal disturbances such as nausea, vomiting, diarrhea.
Hematological/Lymphatic: n- Blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, thrombocytopenic purpura, melena.
Hepato-biliary disorders:n- Abnormal liver function, cholestatic jaundice, hepatic insufficiency, fulminant hepatic necrosis
Metabolic/Nutritional:n- Metabolic acidosis, electrolyte imbalance, including hypokalemia, hyponatremia, osteomalacia with long-term phenytoin therapy, loss of appetite, taste alteration, hyper/hypoglycemia
Nervous:n- Drowsiness, paresthesia (including numbness and tingling of extremities and face), depression, excitement, ataxia, confusion, convulsions dizziness
Skin:n- Allergic skin reactions including urticaria, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis
Special senses:n- Hearing disturbances, tinnitus, transient myopia
Urogenital:n- Crystalluria, increased risk of nephrolithiasis with long-term therapy, hematuria, glycosuria, renal failure polyuria

No specific antidote is known. Treatment should be symptomatic and supportive.
Electrolyte imbalance, development of an acidotic state, and central nervous system effects might be expected to occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
Supportive measures are required to restore electrolyte and pH balance. The acidotic state can usually be corrected by the administration of bicarbonate.
Despite its high intraerythrocytic distribution and plasma protein binding properties, Acetazolamide may be dialyzable. This may be particularly important in the management of Acetazolamide overdosage when complicated by the presence of renal failure.

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, 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:n- 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.

Acetazolamide Extended-Release Capsules are available as 500 mg :
Size u201800u2019 capsules with light green opaque body, imprinted u2018HP120u2019 in black ink on light green opaque cap. Contains white to off white pellets.
Available in bottles of :
Store at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).[ See USP Controlled Room temperature].
MANUFACTURED FOR: n- Heritage Pharmaceuticals Inc.n- East Brunswick, NJ 08816u00a0 1.866.901.DRUG (3784)
Made in India
Issued:10/17

Acetazolamide Extended-Release Capsules, 500 mg, 100 countu00a0
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Acetazolamide (Acetazolamide)

Trade Name : Acetazolamide

CAPSULE, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Acetazolamide (Acetazolamide)

Trade Name : Acetazolamide

CAPSULE, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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