Quinapril and hydrochlorothiazide (Oral)

Quinapril 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 goes on for a long time, the heart and arteries may not work properly. This can damage the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. Hypertension may also raise the risk of heart attacks. These issues may be less likely to happen if blood pressure is controlled.

Quinapril is an angiotensin converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, quinapril 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 decreases the amount of water in the body by increasing urine flow, which helps lower blood pressure.

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

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

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

You should not use this medicine together with sacubitril. Do not use this medicine and sacubitril/valsartan (Entresto®) within 36 hours of each other.

This medicine may cause serious allergic reactions, including anaphylaxis, which 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 using this medicine.

Call your doctor right away if you have severe stomach pain (with or without nausea or vomiting). This could be a symptom of intestinal angioedema.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up from lying down or sitting, or 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. If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to prevent the dizziness from returning.

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 and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Check with your doctor if you have a fever, chills, or a sore throat. These may be symptoms of an infection due to low white blood cells.

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

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 right away if you have lower back or side pain, decreased frequency or amount of urine, bloody urine, increased thirst, swelling of the face, fingers, or lower legs, weight gain, or increased blood pressure. These could be symptoms of a serious kidney problem.

Check with your doctor immediately if you have blurred vision, difficulty reading, eye pain, or any other changes in vision during or after treatment. This could be a sign of a serious eye problem. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

Hyperkalemia (high potassium in the blood) may occur while using this medicine. Check with your doctor right away if you have stomach pain, confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, trouble breathing, or weakness or heaviness in the legs. Do not use supplements or salt substitutes containing potassium without first checking with your doctor.

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.

This medicine may increase your risk of getting skin cancer (e.g., non-melanoma skin cancer). Avoid sun exposure. Use sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.

This medicine may be less effective in black patients. Black patients also have an increased risk of swelling of the hands, arms, face, mouth, or throat. Talk with your doctor if you have concerns about this.

Alcohol, narcotic pain relievers, or sleeping pills may make you feel more lightheaded, dizzy, or faint when used with this medicine. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

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, as they may tend to increase your blood pressure.

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

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medication or any other drugs. 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 quinapril 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 issues that would limit the usefulness of quinapril and hydrochlorothiazide combination in the elderly. Nevertheless, elderly patients are more likely to have age-related heart, kidney, or liver issues, which may require caution and an adjustment in the dose for patients receiving quinapril and hydrochlorothiazide combination.

Breast Feeding

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

Interactions with Drugs

Although certain medicines should not be used together at all, in other cases two different medications 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 using this medication, it is especially important that your healthcare professional know if you are taking any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following drugs is not advised. Your physician may decide not to treat you with this medication or change some of the other medicines you take.

• Aliskiren
• Dofetilide
• Sacubitril

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

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Albuterol
• Alogliptin
• Alteplase, Recombinant
• Amiloride
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Azathioprine
• Azilsartan
• Azilsartan Medoxomil
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Candesartan
• Canrenoate
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Clonixin
• Codeine
• Dapagliflozin
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Eplerenone
• Eprosartan
• Etodolac
• Etofenamate
• Etoricoxib
• Everolimus
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Furosemide
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Irbesartan
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lithium
• Lixisenatide
• Lornoxicam
• Losartan
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Melphalan
• Mercaptopurine
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olmesartan
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Porfimer
• Potassium
• Potassium Citrate
• Potassium Phosphate
• Pramlintide
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sirolimus
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Spironolactone
• Sulindac
• Tacrolimus
• Tapentadol
• Telmisartan
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Triamterene
• Trimethoprim
• Valdecoxib
• Valsartan
• Vildagliptin

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

• Aceclofenac
• Acemetacin
• Aminolevulinic Acid
• Amtolmetin Guacil
• Bepridil
• Bromfenac
• Bufexamac
• Bumetanide
• Bupivacaine
• Bupivacaine Liposome
• Capsaicin
• Carbamazepine
• Celecoxib
• Cholestyramine
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ginkgo
• Gold Sodium Thiomalate
• Gossypol
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Licorice
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Nesiritide
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piretanide
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Valdecoxib

Interactions with Food/Tobacco/Alcohol

Certain medications 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 medications may also cause interactions to occur. Discuss with your healthcare professional the use of your medication with food, alcohol, or tobacco.

Other Medical Issues

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

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

• Anuria (not capable to pass urine) or
• Diabetic patients or those with kidney issues who are also taking aliskiren (Tekturna®) or
• Sulfa drug allergy (eg, sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions.

• Collagen vascular disease (an autoimmune disease) or
• Kidney disease—Increased risk of blood issues.

• Congestive heart failure, severe—Use may lead to kidney issues.

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

• Electrolyte imbalance (eg, high or low calcium, magnesium, potassium, or sodium in the blood) or
• Fluid imbalance (due to excessive perspiration, vomiting, diarrhea) or
• Glaucoma, secondary angle closure or
• Gout or
• Heart or blood vessel disease or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Kidney disease or
• Liver disease or
• Myopia, acute (changes in the eyeball causing vision issues) or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

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

Less common

• Cough producing mucus
• Diarrhea
• Difficulty breathing
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Tightness in the chest

Rare

• Black, tarry stools
• Bleeding gums
• Blistering, peeling, loosening of skin
• Blood in the urine or stools
• Blurred vision
• Confusion
• Decreased urination
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dry mouth
• Fast or irregular heartbeat
• Increased sensitivity of skin to sunlight
• Muscle cramps or pain
• Numbness, tingling, pain, or weakness in the hands or feet
• Pinpoint red spots on the skin
• Rapid breathing
• Seizures
• Sunken eyes
• Sweating
• Thirst
• Trembling
• Unusual tiredness or weakness
• Weakness and heaviness of the legs
• Wrinkled skin

Incidence not known

• Persistent non-healing sore
• Pink growth
• Reddish patch or irritated area
• Shiny bump
• Shock
• Speech problems
• Swelling of the hands, ankles, or feet
• Unusual bleeding or bruising
• White, yellow or waxy scar-like area

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. Your health care professional may also 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:

More common

• Headache

Less common

• Back pain
• Coughing
• Lack or loss of strength
• Sleepiness or unusual drowsiness
• Trouble sleeping

Rare

• Change in vision
• Constipation
• Discouragement
• Feeling sad or empty
• General feeling of discomfort or illness
• Impaired vision
• Irritability
• Lack of appetite
• Loss of interest or pleasure
• Trouble concentrating

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.

Available Dosage Forms:

• Tablet

Therapeutic Class: ACE Inhibitor/Thiazide Combination

Pharmacologic Class: Diuretic

Chemical Class: Thiazide

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.

Swallow the tablet whole. Do not break, crush, or chew it. You may take this medicine with or without food.

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—At first, 10 milligrams (mg) quinapril and 12.5 mg hydrochlorothiazide once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg quinapril and 50 mg hydrochlorothiazide per 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.