Drugs Details

Drugs Info of Glauctabs, MZM, Neptazane
Drugs Details
  • Drugs Type  : Multum
  • Date : 5th Mar 2015 09:35 pm
  • Brand Name : Glauctabs, MZM, Neptazane
  • Generic Name : methazolamide (Pronunciation: meth a ZOLE a mide)
Descriptions

Methazolamide, a sulfonamide derivative, is a white crystalline powder, weakly acidic, and slightly soluble in water, alcohol and acetone. It is available as 25 mg and 50 mg tablets. The chemical name for methazolamide is N -[5-(aminosulfonyl)-3-methyl-1,3,4-thiadiazol-2(3H )-ylidene]-acetamide and it has the following structural formula:

 

Methazolamide Structural Formula Illustration

 

Methazolamide tablets, USP contain 25mg or 50mg of methazolamide. Inactive ingredients: croscarmellose sodium, hydroxypropyl methylcellulose,lactose (monohydrate), magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.

 

What are the possible side effects of methazolamide (Glauctabs, MZM, Neptazane)?

If you experience any of the following serious side effects, stop taking methazolamide and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • a sore throat or a fever;
  • unusual bleeding or bruising;
  • side or groin pain;
  • tingling or tremors in the hands or feet; or
  • a rash.

Other, less serious side effects may be more likely to occur. Continue to take methazolamide and talk to...

Read All Potential Side Effects and See Pictures of Methazolamide »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

Methazolamide is 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.

Dosage Administration

The effective therapeutic dose administered varies from 50mg to 100mg 2 or 3 times daily. The drug may be used concomitantly with miotic and osmotic agents.

How Supplied

Methazolamide tablets, USP for oral administration are available as:

25mg: Round, white, unscored tablets debossed GG78 on one side and plain on the reverse side, and supplied as:

NDC 0781-1072-01 bottles of 100
NDC 0781-1072-10 bottles of 1000

50mg: Round, white, scored tablets debossed GG181 on one side and plain on the reverse side, and supplied as:

NDC 0781-1071-01 bottles of 100
NDC 0781-1071-10 bottles of 1000

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Dispense in a tight, light-resistant container.

Rev. 01-2007. Sandoz Inc. Princeton, NJ 08540. FDA Rev date: n/a


his monograph has been modified to include the generic and brand name in many instances.

Side Effects

Adverse reactions, occurring most often early in therapy, include paresthesias, particularly a "tingling" feeling in the extremities; hearing dysfunction or tinnitus; fatigue; malaise; loss of appetite; taste alteration; gastrointestinal disturbances such as nausea, vomiting and diarrhea; polyuria; and occasional instances of drowsiness and confusion.

Metabolic acidosis and electrolyte imbalance may occur.

Transient myopia has been reported. This condition invariably subsides upon diminution or discontinuance of the medication.

Other occasional adverse reactions include urticaria, melena, hematuria, glycosuria, hepatic insufficiency, flaccid paralysis, photosensitivity, convulsions, and, rarely, crystalluria and renal calculi. Also seePRECAUTIONS: Information for Patients for possible reactions common to sulfonamide derivatives. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see WARNINGS).

Read the Methazolamide (methazolamide) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

Methazolamide should be used with caution in patients on steroid therapy because of the potential for developing hypokalemia. Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly, as anorexia, tachypnea, lethargy, coma and death have been reported with concomitant use of high-dose aspirin and carbonic anhydrase inhibitors (seeWARNINGS).

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epider-mal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration.

If hypersensitivity or other serious reactions occur, the use of this drug should be discontinued.

Caution is advised for patients receiving high-dose aspirin and metha-zolamide concomitantly, as anorexia, tachypnea, lethargy, coma and death have been reported with concomitant use of high-dose aspirin and carbonic anhydrase inhibitors.

Precautions

General: Potassium excretion is increased initially upon administration of methazolamide and in patients with cirrhosis or hepatic insufficiency could precipitate a hepatic coma.

In patients with pulmonary obstruction or emphysema, where alveolar ventilation may be impaired methazolamide should be used with caution because it may precipitate or aggravate acidosis.

Laboratory Tests: To monitor for hematologic reactions common to all sulfonamides, it is recommended that a baseline CBC and platelet count be obtained on patients prior to initiating methazolamide therapy and at regular intervals during therapy. If significant changes occur, early discontinuance and institution of appropriate therapy are important. Periodic monitoring of serum electrolytes is also recommended.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate methazolamide's carcinogenic potential and its effect on fertility have not been conducted. Methazolamide was not mutagenic in the Ames bacterial test.

Pregnancy: Teratogenic effects. Pregnancy Category C. Methazolamide has been shown to be teratogenic (skeletal anomalies) in rats when given in doses approximately 40 times the human dose. There are no adequate and well controlled studies in pregnant women. Methazolamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from methazolamide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness of methazolamide in children have not been established.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No data are available regarding methazolamide overdosage in humans as no cases of acute poisoning with this drug have been reported. Animal data suggest that even a high dose of methazolamide is nontoxic. No specificantidote 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 may be required to restore electrolyte and pH balance.

 
 

ContrainDications

Methazolamide therapy is contraindicated in situations in which sodium and/or potassium serum levels are depressed, in cases of marked kidney orliver disease or dysfunction, in adrenal gland failure, and in hyperchloremic acidosis. In patients with cirrhosis, use may precipitate the development ofhepatic 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.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Methazolamide is a potent inhibitor of carbonic anhydrase.

Methazolamide is well absorbed from the gastrointestinal tract. Peak plasmaconcentrations are observed 1 to 2 hours after dosing. In a multiple-dose, pharmacokinetic study, administration of methazolamide 25 mg b.i.d., 50 mg b.i.d. and 100 mg b.i.d. demonstrated a linear relationship between plasma methazolamide levels and methazolamide dose. Peak plasma concentrations (Cmax) for the 25mg, 50mg and 100mg b.i.d. regimens were 2.5mcg/mL, 5.1mcg/mL and 10.7mcg/mL, respectively. The area under the plasma concentration-time curves (AUC) were 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 (Varea/F) ranges from 17 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 metha-zolamide 25 mg b.i.d., 50 mg b.i.d. and 100 mg b.i.d., respectively.

The mean steady-state plasma elimination half-life for methazolamide is approximately 14 hours. At steady-state approximately 25% of the dose is recovered unchanged in the urine over the dosing interval. Renal clearance accounts for 20 to 25% of the total clearance of drug. After repeated b.i.d.-t.i.d. dosing, methazolamide accumulates to steady state concentrations in seven days.

Methazolamide's secretion of aqueous humor and results in a decrease inintraocular pressure. The onset of the decrease in intraocular pressure generally occurs within two to four hours, has a peak effect in six to eight hours, and a total duration of ten to eighteen hours.

Methazolamide is a sulfonamide derivative; however, it does not have any clinically significant antimicrobial properties. Although methazolamide achieves a high concentration in the cerebrospinal fluid, it is not considered an effective anticonvulsant.

Methazolamide has a weak and transient diuretic effect, therefore use results in an increase in urinary volume, with excretion of sodium, potassiumand chloride. The drug should not be used as a diuretic. Inhibition of renal bicarbonate reabsorption produces an alkaline urine. Plasma bicarbonate decreases, and a relative, transient metabolic acidosis may occur due to a disequilibrium in carbon dioxide transport in the red cell. Urinary citrate excretion is decreased by approximately 40% after doses of 100mg every 8 hours. Uric acid output has been shown to decrease 36% in the first 24 hour period.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Adverse reactions common to all sulfonamide derivatives may occur:anaphylaxis, fever, rash (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), crystalluria, renal calculus, bone marrow depression, thrombocytopenic purpura, hemolytic anemia,leukopenia, pancytopenia and agranulocytosis. Precaution is advised for early detection of such reactions and the drug should be discontinued and appropriate therapy instituted.

Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Glauctabs, MZM, Neptazane

Generic Name: methazolamide (Pronunciation: meth a ZOLE a mide)

  • What is methazolamide (Methazolamide)?
  • What are the possible side effects of methazolamide (Methazolamide)?
  • What is the most important information I should know about methazolamide (Methazolamide)?
  • What should I discuss with my healthcare provider before taking methazolamide (Methazolamide)?
  • How should I take methazolamide (Methazolamide)?
  • What happens if I miss a dose (Methazolamide)?
  • What happens if I overdose (Methazolamide)?
  • What should I avoid while taking methazolamide (Methazolamide)?
  • What other drugs will affect methazolamide (Methazolamide)?
  • Where can I get more information?

What is methazolamide (Methazolamide)?

 

Methazolamide is a carbonic anhydrase inhibitor. Carbonic anhydrase is a protein in the body. Methazolamide reduces the activity of this protein.

Methazolamide is used to treat glaucoma. By inhibiting the actions of carbonic anhydrase, methazolamide reduces the amount of fluid produced in the eyes and therefore also reduces pressure.

Methazolamide may also be used for purposes other than those listed in this medication guide.

Methazolamide 50 mg-ESI

round, white, imprinted with LL, J 2

What are the possible side effects of methazolamide (Methazolamide)?

 

If you experience any of the following serious side effects, stop taking methazolamide and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • a sore throat or a fever;
  • unusual bleeding or bruising;
  • side or groin pain;
  • tingling or tremors in the hands or feet; or
  • a rash.

Other, less serious side effects may be more likely to occur. Continue to take methazolamide and talk to your doctor if you experience

  • decreased appetite, nausea, vomiting, constipation, diarrhea, or changes in taste;
  • drowsiness, dizziness, fatigue, or weakness;
  • nervousness or tremor;
  • headache or confusion;
  • increased sensitivity of the skin to sunlight;
  • worsening gout;
  • loss of blood sugar control (if you are diabetic);
  • ringing in your ears or hearing problems; or
  • changes in vision.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Methazolamide (methazolamide) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about methazolamide (Methazolamide)?

 

Contact your doctor immediately if you experience a sore throat, fever, unusual bleeding or bruising, tingling or tremors in the hands or feet, pain in the side or groin, or a rash. These symptoms could be early signs of a serious side effect.

Use caution when driving, operating machinery, or performing other hazardous activities. Methazolamide may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Avoid prolonged exposure to sunlight. Methazolamide may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Side Effects Centers
  • Methazolamide

Patient Detailed How Take

What should I discuss with my healthcare provider before taking methazolamide (Methazolamide)?

 

Tell your doctor if you have ever had an allergic reaction to a sulfa-based drug such as sulfamethoxazole (e.g., Bactrim, Septra, Gantanol). Methazolamide is also a sulfa-based drug, and you may have a similar reaction to it.

Before taking methazolamide, tell your doctor if you

  • are on aspirin therapy,
  • have liver disease,
  • have kidney disease,
  • have heart disease,
  • have lung disease, or
  • have a hormonal disease.

You may not be able to take methazolamide, or you may require a dosage adjustment special monitoring during treatment if you have any of the conditions listed above.

Methazolamide is in the FDA pregnancy category C. This means that it is not known whether methazolamide will be harm an unborn baby. Do not take methazolamide without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether methazolamide passes into breast . Do not take methazolamide without first talking to your doctor if you are breast-feeding a baby.

How should I take methazolamide (Methazolamide)?

 

Take methazolamide exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Take methazolamide with food if it causes stomach upset.

It is important to take methazolamide regularly to get the most benefit.

Store methazolamide at room temperature away from moisture and heat.

Side Effects Centers
  • Methazolamide

Patient Detailed Avoid Taking

What happens if I miss a dose (Methazolamide)?

 

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose (Methazolamide)?

 

Seek emergency medical attention if an overdose is suspected.

Symptoms of a methazolamide overdose include drowsiness, decreased appetite, nausea, vomiting, dizziness, numbness or tingling, shaking, and ringing in the ears.

What should I avoid while taking methazolamide (Methazolamide)?

 

Use caution when driving, operating machinery, or performing other hazardous activities. Methazolamide may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Avoid prolonged exposure to sunlight. Methazolamide may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

What other drugs will affect methazolamide (Methazolamide)?

 

Before taking this medication, tell your doctor if you are taking any of the following medicines:

  • cyclosporine (Sandimmune);
  • primidone (Mysoline);
  • diflunisal (Dolobid;
  • aspirin, salsalate (Disalcid, Salflex, Salsitab, others), choline salicylate (Arthropan), magnesium salicylate (Doan's, Magan, Mobidin), or other aspirin-like products (salicylates); or
  • lithium (Lithobid, Eskalith, others).

You may not be able to take methazolamide, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with methazolamide. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

 

Your pharmacist has more information about methazolamide written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.04. Revision date: 12/15/2010.

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Side Effects Centers
  • Methazolamide

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