Acetazolamide

Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.
Human Prescription Drug
NDC 23155-787

Acetazolamide is a human prescription drug labeled by 'Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.'. National Drug Code (NDC) number for Acetazolamide is 23155-787. This drug is available in dosage form of Capsule, Extended Release. The names of the active, medicinal ingredients in Acetazolamide drug includes Acetazolamide - 500 mg/1 . The currest status of Acetazolamide drug is Active.

Drug Information:

Drug NDC:	23155-787
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Acetazolamide
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Acetazolamide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule, Extended Release
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ACETAZOLAMIDE - 500 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	15 Feb, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	26 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA040904
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	562524
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0323155787016
UPC stands for Universal Product Code.
NUI:	N0000175517 N0000000235 M0020790
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	O3FX965V0I
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:	Carbonic Anhydrase Inhibitors [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Carbonic Anhydrase Inhibitor [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Sulfonamides [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Carbonic Anhydrase Inhibitor [EPC] Carbonic Anhydrase Inhibitors [MoA] Sulfonamides [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
23155-787-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (23155-787-01)	15 Feb, 2021	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Acetazolamide acetazolamide acetazolamide acetazolamide ammonio methacrylate copolymer type a ammonio methacrylate copolymer type b fd&c yellow no. 6 gelatin cellulose, microcrystalline sodium lauryl sulfate talc titanium dioxide ferrosoferric oxide orange opaque cap white opaque body ep;107

Indications and Usage:

Indications and usage: for adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angleclosure 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.

Warnings:

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.

Dosage and Administration:

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, 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. a Read more...

cute mountain sickness dosage is 500 mg to 1,000 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 1,000 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.

Contraindications:

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.

Adverse Reactions:

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. âskin: allergic skin reactions including urticaria, photosensitivity, stevens-johnson syndrome, toxic epidermal necrolysis. specia Read more...

l senses: hearing disturbances, tinnitus, 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 avet pharmaceuticals inc. at 1-866-901-drug (3784) or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Overdosage:

Overdosage: 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.

Description:

Description: acetazolamide extended-release capsules are an inhibitor of the enzyme carbonic anhydrase. acetazolamide 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: each acetazolamide extended-release capsule intended for oral administration contains 500 mg of acetazolamide. in addition, each capsule contains the following inactive ingredients: ammonio methacrylate copolymer dispersion type a and b, fd&c yellow #6, gelatin, microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. the capsule is printed with black pharmaceutical ink which contains black iron oxide as a coloring agent. chemical-structure

Clinical Pharmacology:

Clinical pharmacology: 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 t Read more...

o 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 hco 3 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 acetazolamide extended-release capsules 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.

How Supplied:

How supplied: acetazolamide extended-release capsules, 500 mg are white to off-white pellets filled in empty hard gelatin capsules with orange opaque cap imprinted with âepâ in black ink and white opaque body imprinted with â107â in black ink and are supplied as follows: ndc 23155-787-01 in bottle of 100 capsules storage: store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. dispense in well-closed containers. distrbuted by: âavet pharmaceuticals inc. âeast brunswick, nj 08816 1.866.901.drug (3784) 51u000000380us02 revised: 06/2022 avet-logo

Package Label Principal Display Panel:

Package label.principal display panel - 500 mg âacetazolamide extended-release capsules 500 mg 100 capsules ârx only 500mg-100s

Comments/ Reviews:

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