Zestoretic

Generic Name: lisinopril and hydrochlorothiazide (Oral route)

hye-droe-klor-oh-THYE-a-zide, lye-SIN-oh-pril

Oral route(Tablet)

ACE inhibitors can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Commonly used brand name(s)

In the U.S.

• Prinzide


• Zestoretic

Available Dosage Forms:

• Tablet

Therapeutic Class: ACE Inhibitor/Thiazide Combination

Pharmacologic Class: Diuretic

Chemical Class: Thiazide

Uses For Zestoretic

Lisinopril and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Lisinopril is an angiotensin converting enzyme (ACE) inhibitor. It works by blocking an enzyme in the body that is necessary to produce a substance that causes blood vessels to tighten. As a result, lisinopril relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide is a diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine which helps lower the blood pressure.

This medicine is available only with your doctor's prescription.

Before Using Zestoretic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lisinopril and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lisinopril and hydrochlorothiazide combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving lisinopril and hydrochlorothiazide combination.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetyldigoxin


• Alteplase, Recombinant


• Amiloride


• Arsenic Trioxide


• Azathioprine


• Azilsartan Medoxomil


• Candesartan Cilexetil


• Canrenoate


• Deslanoside


• Digitalis


• Digitoxin


• Digoxin


• Droperidol


• Eplerenone


• Eprosartan


• Flecainide


• Ketanserin


• Levomethadyl


• Lithium


• Losartan


• Metildigoxin


• Olmesartan Medoxomil


• Ouabain


• Potassium


• Proscillaridin


• Sotalol


• Spironolactone


• Telmisartan


• Triamterene


• Valsartan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac


• Acemetacin


• Alacepril


• Alclofenac


• Aliskiren


• Apazone


• Aspirin


• Azosemide


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benoxaprofen


• Benzthiazide


• Bepridil


• Bromfenac


• Bufexamac


• Bumetanide


• Bupivacaine


• Buthiazide


• Capsaicin


• Captopril


• Carbamazepine


• Carprofen


• Celecoxib


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cholestyramine


• Cilazapril


• Clometacin


• Clonixin


• Clopamide


• Cyclopenthiazide


• Cyclophosphamide


• Cyclothiazide


• Delapril


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Enalaprilat


• Enalapril Maleate


• Ethacrynic Acid


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Fosinopril


• Furosemide


• Ginkgo


• Glipizide


• Gold Sodium Thiomalate


• Gossypol


• Hydrochlorothiazide


• Hydroflumethiazide


• Ibuprofen


• Ibuprofen Lysine


• Imidapril


• Indapamide


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Licorice


• Lisinopril


• Lithium


• Lornoxicam


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Methyclothiazide


• Metolazone


• Moexipril


• Nabumetone


• Naproxen


• Nepafenac


• Nesiritide


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Pentopril


• Perindopril


• Phenylbutazone


• Pirazolac


• Piretanide


• Piroxicam


• Pirprofen


• Polythiazide


• Propyphenazone


• Proquazone


• Quinapril


• Quinethazone


• Ramipril


• Salicylic Acid


• Salsalate


• Spirapril


• Sulindac


• Suprofen


• Temocapril


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tizanidine


• Tolmetin


• Topiramate


• Torsemide


• Trandolapril


• Trichlormethiazide


• Xipamide


• Zofenopril


• Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Airway surgery, history of—At risk for severe complications from angioedema (swelling of the face, lips, tongue, throat, arms, or legs).

• Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history of—May increase the risk of this condition from occurring again.

• Anuria (not able to pass urine) or


• Sulfa drug allergy (e.g., sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions.

• Asthma, history of—May increase likelihood of having an allergic reaction.

• Bee-sting allergy treatments or


• Dialysis—Increased risk of serious allergic reaction occurring.

• Collagen vascular disease (an autoimmune disease) or


• Kidney disease, severe—Increased risk of blood problems caused by ACE inhibitors.

• Congestive heart failure (severe) or


• Dehydration or


• Diarrhea or


• Heart or blood vessel disease (e.g., aortic stenosis) or


• Hyponatremia (low sodium in the blood) or


• Hypovolemia (low blood volume) or


• Kidney problems—Use with caution. These conditions may cause the blood pressure to fall too low with this medicine.

• Diabetes—Increased risk of potassium levels in the body becoming too high.

• Edema (swelling or fluid in the body) or


• Electrolyte imbalance (e.g., hypercalcemia, hypochloremic alkalosis, hypomagnesemia) or


• Glaucoma, secondary angle closure or


• Gout or


• Hyperglycemia or


• Hyperlipidemia (high cholesterol or fats in the blood) or


• Hyperuricemia (high uric acid in the blood) or


• Hypokalemia (low potassium in the blood) or


• Liver disease (including hepatitis) or


• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of lisinopril and hydrochlorothiazide

This section provides information on the proper use of a number of products that contain lisinopril and hydrochlorothiazide. It may not be specific to Zestoretic. Please read with care.

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For high blood pressure:
    
    • Adults—1 or 2 tablets once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Zestoretic

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant (especially in your second or third trimester) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt which may cause low blood pressure.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium in the body).

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Check with your doctor if you notice any signs of fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Stop using this medicine and call your doctor right away if you have swelling of the face, arms, legs, eyes, lips, or tongue, or problems with swallowing or breathing. These are symptoms of a condition called angioedema.

Stop using this medicine and call your doctor right away if you have severe stomach pain (with or without nausea or vomiting). This could be a symptom of a condition called intestinal angioedema.

Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

This medicine may increase the amount of potassium in your blood. Do not use salt substitutes containing potassium without first checking with your doctor.

Black patients may be less sensitive to the blood pressure-lowering effects of this medicine. In addition, the risk of a serious allergic reaction involving swelling of the face, mouth, hands, or feet may be increased.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Zestoretic Side Effects

Along with its needed effects, a medicine 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:

Less common

• Blurred vision


• body aches or pain


• chills


• confusion


• cough


• diarrhea


• difficulty in breathing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• ear congestion


• fever


• headache


• loss of voice


• nasal congestion


• nausea


• runny nose


• sneezing


• sore throat


• sweating


• unusual tiredness or weakness


• vomiting

Some side effects 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:

Less common

• Acid or sour stomach


• belching


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• decreased interest in sexual intercourse


• heartburn


• inability to have or keep an erection


• indigestion


• lack or loss of strength


• loss in sexual ability, desire, drive, or performance


• muscle cramps


• rash


• stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Zestoretic side effects (in more detail)

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More Zestoretic resources

• Zestoretic Side Effects (in more detail)
• Zestoretic Dosage
• Zestoretic Use in Pregnancy & Breastfeeding
• Drug Images
• Zestoretic Drug Interactions
• Zestoretic Support Group
• 4 Reviews for Zestoretic - Add your own review/rating

• Zestoretic Prescribing Information (FDA)


• Zestoretic MedFacts Consumer Leaflet (Wolters Kluwer)


• Zestoretic Consumer Overview


• Prinzide Prescribing Information (FDA)

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