What is the most important information I should know about Zestoretic?

• Zestoretic is in the FDA pregnancy category D. This means that Zestoretic is known to harm an unborn baby. When used during the second and third trimesters of pregnancy, Zestoretic can cause injury and even death to the developing fetus. Do not take Zestoretic if you are pregnant.
• Zestoretic may increase the risk of dangerous allergic reactions. Before taking Zestoretic, tell your doctor if you have ever had an allergic reaction that involved swelling of your lips, face, tongue, or throat or difficulty breathing. Seek emergency medical attention if you develop any of these symptoms while taking Zestoretic.
• Use caution when driving, operating machinery, or performing other hazardous activities. Zestoretic may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Also use caution when rising from a sitting or lying position.

What is Zestoretic?

• Zestoretic is a thiazide diuretic (water pill). It increases the amount of salt and water you lose in your urine. Zestoretic is used to lower blood pressure and to decrease edema (swelling).
• Zestoretic is in a class of drugs called angiotensin-converting-enzyme inhibitors (ACE inhibitors). Zestoretic is used to lower blood pressure and to relieve the symptoms of congestive heart failure, including shortness of breath and swelling of the legs.
• Zestoretic is used to treat hypertension (high blood pressure) and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
• Zestoretic may also be used for purposes other than those listed in this medication guide.

Who should not take Zestoretic?

• Do not take Zestoretic if you have an allergy to sulfa-based drugs such as sulfa antibiotics. You may have an allergic reaction to Zestoretic.
• Zestoretic is in the FDA pregnancy category D. This means that Zestoretic is known to harm an unborn baby. When used during the second and third trimesters of pregnancy, Zestoretic can cause injury and even death to the developing fetus. Do not take Zestoretic if you are pregnant.
• Before taking Zestoretic, tell your doctor if you
  • have diabetes,
  • have gout,
  • have a collagen vascular disease such as systemic lupus erythematosus or scleroderma,
  • have pancreatitis,
  • have kidney disease,
  • have liver disease,
  • have a blood or bone marrow disease,
  • have any type of heart disease or have had a stroke,
  • are taking salt substitutes, potassium supplements (e.g., K-Dur, Klor-Con), or potassium-sparing diuretics such as amiloride (Midamor), triamterene (Dyrenium, Dyazide, Maxzide), or spironolactone (Aldactone); or
  • are on a salt-restricted diet or have high levels of potassium in your blood.
• You may not be able to take Zestoretic, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Zestoretic is in the FDA pregnancy category D. This means that Zestoretic is known to harm an unborn baby. When used during the second and third trimesters of pregnancy, Zestoretic can cause injury and even death to the developing fetus. Do not take Zestoretic if you are pregnant.
• Zestoretic passes into breast milk and may harm a nursing infant. It is not known whether Zestoretic passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.
• If you are over 60 years of age, you may be more likely to experience side effects from Zestoretic. Your doctor may prescribe a lower dose of this medication.

How should I take Zestoretic?

• Take Zestoretic 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.
• Do not stop taking this medication without first talking to your doctor. If you stop taking your medication, your condition could become worse.
• Store Zestoretic at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

• Seek emergency medical attention.
• Symptoms of a Zestoretic overdose include increased urination, nausea, vomiting, diarrhea, dizziness, fainting, weakness, fatigue, and unconsciousness.

What should I avoid while taking Zestoretic?

• Use caution when driving, operating machinery, or performing other hazardous activities. Zestoretic may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Also use caution when rising from a sitting or lying position.
• Use alcohol cautiously. Alcohol may further lower blood pressure, causing increased drowsiness and dizziness while you are taking Zestoretic.
• Avoid a diet high in salt. Too much salt may cause your body to retain water and may decrease the effects of Zestoretic. Ask your doctor or nurse about low-salt diet alternatives.
• Do not use salt substitutes or potassium supplements without first talking to your doctor while taking Zestoretic. These products could cause potassium levels in your blood to become dangerously high.
• Avoid prolonged exposure to sunlight. Zestoretic may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.
• Heavy sweating, vomiting, diarrhea, or other causes of fluid loss may lead to very low blood pressure, dizziness, and fainting during therapy with Zestoretic. Maintain proper fluid intake to prevent dehydration and related adverse effects.

What are the possible side effects of Zestoretic?

• If you experience any of the following serious side effects, stop taking Zestoretic and seek emergency medical attention:
  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • fainting spells;
  • unusual fatigue or abnormal bleeding or bruising;
  • yellow skin or eyes;
  • confusion;
  • fever, chills, or a sore throat;
  • little or no urine;
  • irregular heartbeats; or
  • increased swelling.
• Other, less serious side effects may be more likely to occur. Continue to take Zestoretic and talk to your doctor if you experience
  • dizziness or lightheadedness;
  • headache;
  • fatigue;
  • tingling or numbness in your arms, legs, hands, or feet;
  • excessive urination;
  • muscle weakness or cramps;
  • increased hunger or thirst;
  • nausea, vomiting, diarrhea, constipation, decreased appetite, or changes in taste;
  • sensitivity to sunlight;
  • dry, tickling cough;
  • anxiety or depression; or
  • itching, rash, or increased sweating.
• 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.

What other drugs will affect Zestoretic?

• Before taking Zestoretic, tell your doctor if you are taking any of the medicines listed below:
  • a potassium supplement such as K-Dur, Klor-Con, and others;
  • a salt substitute that contains potassium;
  • another diuretic (water pill) especially triamterene (Dyrenium, Maxzide, Dyazide), spironolactone (Aldactone), or amiloride (Midamor);
  • cholestyramine (Questran) or colestipol (Colestid);
  • a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), diclofenac (Cataflam, Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), mefenamic acid (Ponstel), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin);
  • an oral diabetes medication such as glipizide (Glucotrol), glyburide (Micronase, Glynase, Diabeta), chlorpropamide (Diabinese), tolazamide (Tolinase), tolbutamide (Orinase), and others;
  • tetracycline (Sumycin, others);
  • lithium (Lithane, Lithobid, Eskalith, others);
  • a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor XR, Tiazac), nifedipine (Adalat, Procardia), verapamil (Calan, Verelan, Isoptin), and others;
  • doxazosin (Cardura), prazosin (Minipress), or terazosin (Hytrin);
  • reserpine, guanadrel (Hylorel), or guanethidine (Ismelin);
  • a nitrate such as nitroglycerin (Nitrostat, Transderm-Nitro, Nitro-Dur, Nitro-Bid, Minitran, others), isosorbide mononitrate (Imdur, ISMO), or isosorbide dinitrate (Isordil, Sorbitrate);
  • a pain reliever such as codeine, morphine (MS Contin, MSIR, Roxanol, others), propoxyphene (Darvocet, Darvon, Wygesic), oxycodone (Percocet, Percodan), meperidine (Demerol), and others;
  • a barbiturate such as phenobarbital (Luminal, Solfoton), amobarbital (Amytal), secobarbital (Seconal), and butabarbital (Butisol); or
  • a steroid medicine such as cortisone (Cortone), dexamethasone (Decadron, Hexadrol), betamethasone (Celestone), hydrocortisone (Cortef, Hydrocortone), prednisone (Orasone, Deltasone), prednisolone (Delta Cortef, Prelone), methylprednisolone (Medrol), and others.
• You may not be able to take Zestoretic, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Zestoretic or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.