Maxzide

Maxzide, Dyazide

• Mylan Pharmaceuticals, Inc.

Serious side effects have been reported with Maxzide. See “Drug Precautions” section.

Common side effects of Maxzide include:

• frequent urination
• headache
• dizziness
• weakness
• dry mouth
• fatigue

This is not a complete list of Maxzide side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Serious side effects have been reported with Maxzide including:

• Hyperkalemia: Maxzide can raise your body's potassium to harmful levels, possibly causing the heart to stop beating. Tell your doctor if you have kidney disease or diabetes.
• Metabolic or respiratory acidosis: Maxzide can increase your potassium levels, leading to acidosis.
• Myopia (nearsightedness) or glaucoma, or vision loss due to an increase in eye pressure: Tell your healthcare provider right away if you have some or all of the following symptoms of myopia or glaucoma:
  • sudden, severe pain in one eye
  • decreased or cloudy vision
  • nausea and vomiting
  • rainbow-like halos around lights
  • red eye
  • eye feels swollen
• Electrolyte imbalances: Maxzide can dangerously alter your electrolyte levels. Electrolytes are important for the body to maintain normal functioning. Tell your doctor if you have a history of kidney disease.
• Hepatic coma: Tell your doctor if you have a history of liver disease.
• Renal stones: Treatment with Maxzide can cause kidney stones.
• Hyperuricemia: Maxzide can increase your levels of uric acid, leading to gout. Symptoms of gout include:
  • pain
  • swelling
  • discolored, peeling, or itchy skin
• Folic acid deficiency: Periodic blood tests are recommended for patients who may be affected by a decrease in folate levels.
• Metabolic and endocrine effects: Maxzide can impair your body’s metabolism and endocrine system. Tell your doctor if you have diabetes or parathyroid problems.
• Hypersensitivity reaction: An allergic reaction to Maxzide can occur. Call your doctor if you have one or more of the following symptoms of a hypersensitivity reaction:
  • rash or hives
  • difficulty breathing or swallowing
  • hoarseness
  • swelling

Maxzide can cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Do not take Maxzide if you:

• have high potassium levels
• take other potassium-sparing medications such as spironolactone (Aldactone) and amiloride (Midamor)
• take potassium supplements
• have a history of poorly functioning kidneys
• are allergic to either triamterene or hydrochlorothiazide

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Maxzide falls into category C. It is not known if Maxzide will harm your unborn baby. There are no well-controlled studies that have been done in pregnant women. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

In the U.S.

• Dyazide
• Maxzide

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Diuretic, Potassium Sparing/Thiazide Combination

Pharmacologic Class: Diuretic, Potassium Sparing

Chemical Class: Thiazide

• 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 Maxzide affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• Have your blood pressure checked often. Talk with your 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.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Watch for gout attacks.
• If you have lupus, Maxzide can make your lupus active or get worse. Tell your doctor right away if you get any new or worse signs.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
• 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 Maxzide while you are pregnant.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Dark urine or yellow skin or eyes.
• A burning, numbness, or tingling feeling that is not normal.
• Chest pain or pressure or a fast heartbeat.
• Fever or chills.
• Sore throat.
• Restlessness.
• Shortness of breath.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Change in sex ability.
• This medicine can cause certain eye problems. If left untreated, this can lead to lasting eyesight loss. If eye problems happen, signs like change in eyesight or eye pain most often happen within hours to weeks of starting this medicine. Call your doctor right away if you have these signs.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loose stools (diarrhea).
• Dizziness.
• Headache.
• Not hungry.
• Upset stomach or throwing up.
• Hard stools (constipation).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.

Maxzide may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since Maxzide (triamterene and hydrochlorothiazide) may enhance the actions of these drugs, dosage adjustments may be necessary.

Usage in Pregnancy

The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.

Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

The usual dose of Maxzide-25 MG is one or two tablets daily, given as a single dose, with appropriate monitoring of serum potassium (see WARNINGS). The usual dose of Maxzide is one tablet daily, with appropriate monitoring of serum potassium (see WARNINGS). There is no experience with the use of more than one Maxzide tablet daily or more than two Maxzide-25 MG tablets daily. Clinical experience with the administration of two Maxzide-25 MG tablets daily in divided doses (rather than as a single dose) suggests an increased risk of electrolyte imbalance and renal dysfunction.

Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be transferred to Maxzide (triamterene and hydrochlorothiazide) directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to Maxzide-25 MG (37.5 mg triamterene/25 mg hydrochlorothiazide) directly.

In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked therapy may be initiated with Maxzide-25 MG. If an optimal blood pressure response is not obtained with Maxzide-25 MG, the dose should be increased to two Maxzide-25 MG tablets daily as a single dose, or one Maxzide tablet daily. If blood pressure still is not controlled, another antihypertensive agent may be added (see PRECAUTIONS: Drug Interactions).

Clinical studies have shown that patients taking less bioavailable formulations of triamterene and hydrochlorothiazide in daily doses of 25 mg to 50 mg hydrochlorothiazide and 50 mg to 100 mg triamterene may be safely changed to one Maxzide-25 MG tablet daily. All patients changed from less bioavailable formulations to Maxzide should be monitored clinically and for serum potassium after the transfer.