Fosinopril and hydrochlorothiazide (Oral)

Fosinopril and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). High blood pressure increases the workload on your heart and arteries. If it lasts for a long time, it can cause the heart and arteries to not work properly. This may damage the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. High blood pressure can also increase the risk of heart attacks. Controlling blood pressure may help reduce the chances of these problems occurring.

Fosinopril works by blocking an enzyme in the body that is needed to make a substance that tightens blood vessels. This helps the blood vessels to relax. Hydrochlorothiazide helps to lower the amount of salt and water in the body by acting on the kidneys to increase urine flow. Together, these medicines lower blood pressure and improve the supply of blood and oxygen to the heart.

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

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to look 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 pregnancy. If you think you may be pregnant while using this medicine, tell your doctor right away.

Check with your doctor immediately if you have large, hive-like swelling on your face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs. These may be symptoms of a condition called angioedema. Black patients also have an increased risk of angioedema. Talk with your doctor if you have concerns about this.

Check with 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.

Dizziness, lightheadedness, or fainting may also happen, especially when you get up suddenly from lying down or sitting, or if you have been taking a diuretic (water pill). If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to prevent the dizziness from coming back. If you faint, stop using this medicine and call your doctor right away.

Check with your doctor if you have a fever, chills, or sore throat. These could be signs 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 symptoms of jaundice (yellow skin or eyes) because these may indicate a serious liver problem.

Hyperkalemia (high potassium in the blood) may happen while you are 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 your hands, feet, or lips, trouble breathing, or weakness or heaviness in your legs. Ask your doctor before using medicines, supplements, or salt substitutes that contain potassium.

Check with your doctor right away if you have bloody urine, a decrease in how often you urinate or how much urine you produce, increased blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Check with your doctor right away if you become ill while taking this medicine, especially with severe or ongoing 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.

This medicine may increase your risk of developing 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.

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.

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.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

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

Allergies

Tell your physician if you have ever had any unusual or allergic reaction to this medicine or any other medications. As well inform 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 fosinopril and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific issues that would limit the usefulness of fosinopril and hydrochlorothiazide combination in the elderly. Nevertheless, elderly patients are more likely to have age-related liver, kidney, or heart issues, which may require an adjustment of dose in patients receiving fosinopril and hydrochlorothiazide combination.

Breast Feeding

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

Interactions with Medicines

Although certain medications should not be used together at all, in other cases two different drugs 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 drug, it is especially critical that your healthcare professional know if you are using 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 medication with any of the following medicines is not recommended. Your clinician may decide not to treat you with this medication or change some of the other medications you take.

• Aliskiren
• Dofetilide
• Sacubitril

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

• 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 drug with any of the following drugs may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your clinician may change the dose or how frequently 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 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 medications may additionally cause interactions to occur. Discuss with your healthcare professional the use of your drug with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical issues may affect the use of this drug. Make sure you tell your physician if you have any other medical issues, especially:

• Angioedema, history of—May increase the chance of this condition occurring again.

• Anuria (not able to pass urine) or
• Sulfa drug allergy—Should not be used in patients with these conditions.

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

• Collagen vascular disease (an autoimmune disease) together with kidney disease—Increased risk of blood issues.

• Congestive heart failure or
• Electrolyte imbalance (eg, low magnesium, potassium, or sodium in the blood) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Gout or
• Heart disease or
• Hypercalcemia (high calcium in the blood) or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hyperuricemia (high uric acid in the blood) or
• Liver disease or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

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

• Sympathectomy (nerve surgery)—Use with caution. The effects of this medication may be increased.

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
• chest pain or discomfort
• chills
• cold sweats
• confusion
• decreased urination
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• dry mouth
• fainting
• fast, slow, or irregular heartbeat
• muscle cramps or pain
• numbness, tingling, pain, or weakness in the hands or feet
• rapid breathing
• seizures
• sunken eyes
• sweating
• thirst
• trembling
• unusual tiredness or weakness
• weakness and heaviness of legs
• wrinkled skin

Incidence not known

• Persistent non-healing sore
• pink growth
• reddish patch or irritated area
• shiny bump
• 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. 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:

More common

• Cough

Less common

• Body aches or pain
• diarrhea
• difficult breathing
• ear congestion
• fever
• headache
• loss of voice
• muscle or bone pain
• nausea and vomiting
• runny or stuffy nose
• sneezing
• sore throat

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: Fosinopril

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. 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 crush, break, or chew it.

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. Your doctor may adjust your dose as needed. 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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.