Neptazane

Methazolamide comes as a tablet to take by mouth. It is usually taken two or three times a day. Take methazolamide at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take methazolamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Methazolamide controls glaucoma but does not cure it. Continue to take methazolamide even if you feel well. Do not stop taking methazolamide without talking to your doctor.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to methazolamide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• blood in urine or stools;
• a seizure (convulsions);
• loss of movement in any part of your body;
• a blood cell disorder--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, pale skin, feeling tired or short of breath, rapid heart rate, nosebleeds, bleeding gums;
• liver problems--nausea, upper stomach pain or swelling, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of metabolic acidosis--confusion, vomiting, lack of energy, irregular heartbeats;
• signs of a kidney stone--pain in your side or lower back, blood in your urine, painful or difficult urination; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, loss of appetite, diarrhea;
• numbness or tingling, especially in your arms and legs;
• drowsiness, confusion;
• hearing problems, ringing in your ears;
• increased urination; or
• altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

While using methazolamide, you may need frequent blood tests.

Methazolamide may be only part of a complete treatment program that may also include other medications. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Methazolamide reduces the activity of a protein in your body called carbonic anhydrase. Blocking this protein can help reduce the amount of fluid in the eye, which decreases pressure inside the eye.

Methazolamide is used to lower pressure inside the eye (intraocular pressure) in people with certain types of glaucoma.

Methazolamide is also used as a diuretic ("water pill") in people with congestive heart failure, to reduce the build-up of fluid in the body. This build-up is called edema.

Methazolamide is also used to treat certain types of seizures, and to treat or prevent altitude sickness.

Methazolamide may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Neptazane affects you.
• Have your eye pressure and eyesight checked as you have been told by the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• This medicine may make you sunburn more easily. Use care if you will be in the sun. Tell your doctor if you sunburn easily while taking this drug.
• If you are also taking aspirin, talk with your doctor. Loss of hunger, fast breathing, sluggishness, coma, and death have happened in people taking high doses of aspirin with Neptazane.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Neptazane while you are pregnant.

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 angleclosure glaucoma, since organic closure of the angle may occur in spite of lowered intraocular pressure.

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.

Information for Patients:

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.

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.

Drug 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 (see WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals to evaluate the carcinogenic potential of methazolamide and its effect on fertility have not been conducted. Methazolamide was not mutagenic in the Ames bacterial test.

Pregnancy

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.

Applies to methazolamide: oral tablets

Side effects include:

Paresthesia, hearing dysfunction or tinnitus, fatigue, malaise, anorexia, altered taste, nausea, vomiting, diarrhea, polyuria, drowsiness, confusion.