Daranide

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:

• the first sign of any skin rash, no matter how mild;
• accidental falls while taking Keveyis;
• worsening of your paralysis symptoms while taking Keveyis;
• confusion, thinking problems;
• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling; 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.

Accidental falls are more likely in older adults or in people who take high doses of Keveyis. Use caution to avoid falling or accidental injury while you are taking this medicine.

Common side effects may include:

• nausea, vomiting, loss of appetite;
• numbness or tingling; 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.

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.

Dichlorphenamide is usually taken twice per day. Follow your doctor's dosing instructions very carefully.

While using dichlorphenamide, you may need frequent blood tests. This will help your doctor determine how long to treat you with dichlorphenamide.

Call your doctor at once if you have accidental falls while taking Keveyis. Your dose may need to be changed.

Store at room temperature away from moisture and heat.

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

Overdose symptoms may include dizziness, drowsiness, vomiting, loss of appetite, numbness, weakness, tremors, or ringing in your ears.

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.

• Merck & Co., Inc.

• Taro Pharmaceuticals Usa, Inc.

Daranide is part of the drug class:

• Carbonic anhydrase inhibitors

You should not use dichlorphenamide if you are allergic to it, or if you have:

• severe breathing problems;

• kidney failure;

• liver disease;

• an allergy to sulfa drugs; or

• if you also take aspirin in high doses.

In addition to the above, you should not use Daranide if you have an electrolyte imbalance (such as acidosis or low levels of potassium or sodium in your blood).

To make sure dichlorphenamide is safe for you, tell your doctor if you have:

• kidney disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether dichlorphenamide passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Daranide® (dichlorphenamide tablets USP) is indicated for the treatment of elevated intraoculr pressure.

Pregnancy

Pregnancy Category C. Dichlorphenamide has been shown to be teratogenic in the rat (skeletal anomalies) when given in doses 100 times the human dose. There are no adequate and well-controlled studies in pregnant women. Daranide® (dichlorphenamide tablets USP) should not be used in women of childbearing age or in pregnancy, especially during the first trimester, unless the potential benefits outweigh the potential risks.

Nursing Mothers

It is not known whether dichlorphenamide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dichlorphenamide is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Metabolic acidosis, which can be severe, may occur in the elderly with reduced renal function.

Applies to dichlorphenamide: oral tablet

Along with its needed effects, dichlorphenamide (the active ingredient contained in Daranide) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dichlorphenamide:

• Abdominal or stomach pain
• black, tarry stools
• blistering, peeling, or loosening of the skin
• chest pain or discomfort
• chills
• confusion
• convulsions
• cough or hoarseness
• dark urine
• decreased urine
• diarrhea
• dilated neck veins
• dizziness
• drowsiness
• dry mouth
• extreme fatigue
• fever with or without chills
• general feeling of tiredness or weakness
• headache
• increased thirst
• irregular breathing
• irregular heartbeat
• itching or rash
• joint or muscle pain
• light-colored stools
• loss of appetite
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• rapid, deep breathing
• red skin lesions, often with a purple center
• red, irritated eyes
• restlessness
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach cramps
• swelling of the face, fingers, feet, or lower legs
• swollen or painful glands
• tightness in the chest
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood
• weight gain
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking dichlorphenamide:

• Bloody or cloudy urine
• bloody, black, or tarry stools
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• continuing ringing or buzzing or other unexplained noise in the ears
• difficult or painful urination
• fainting
• hearing loss
• high fever
• pale skin
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• sudden decrease in the amount of urine
• unsteadiness, trembling, or other problems with muscle control or coordination

Some side effects of dichlorphenamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• difficulty with moving
• general feeling of discomfort or illness
• loss of taste
• muscle pain or stiffness
• muscle spasms
• muscle twitching
• pain in the joints
• trouble performing routine tasks
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

• Decreased awareness or responsiveness
• loss of memory
• problems with memory
• seeing, hearing, or feeling things that are not there
• severe sleepiness

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. US FDA pregnancy category: C

Teratogenic effects (fetal limb reduction defects) were reported following oral administration of this drug in pregnant animals during organogenesis at 350 mg/kg, or 17 times the maximum recommended human dose (200 mg/day) on a body surface area (mg/m2) basis. A no-effect dose has not been established. There are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.