Vaseretic

Vaseretic is a combination of enalapril and hydrochlorothiazide (HCTZ) and is used for treating high blood pressure (hypertension). It is in a class of drugs called angiotensin converting enzyme (ACE) inhibitors. ACE is an enzyme in the body that causes the formation of angiotensin II. Angiotensin II causes the muscles surrounding the arteries in the body to contract, thereby narrowing the arteries and elevating the blood pressure. ACE inhibitors such as enalapril (Vasotec) lower blood pressure by preventing the formation of angiotensin II thereby relaxing the arteries.

HCTZ is a diuretic (water pill) used for treating high blood pressure and accumulation of fluid. It works by blocking salt and water reabsorption in the kidneys, thus causing increased urine output (diuresis). The mechanism of its action in lowering high blood pressure is not well understood. The combination of enalapril and HCTZ reduces blood pressure better than either drug alone. The FDA approved Vaseretic in October 1986.

Your pharmacist can provide more information about hydrochlorothiazide and enalapril.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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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.

Vaseretic falls into category D. When pregnancy is detected, discontinue Vaseretic as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the unborn baby.

• Take Vaseretic exactly as prescribed. 
• This medication comes in tablet form and is typically given once or twice daily with or without food.

In the U.S.

• Vaseretic

Available Dosage Forms:

• Tablet

Therapeutic Class: ACE Inhibitor/Thiazide Combination

Pharmacologic Class: Enalapril

Chemical Class: Thiazide

Enalapril 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. Lowering blood pressure can reduce the risk of strokes and heart attacks.

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

Hydrochlorothiazide is a thiazide 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.

• If you have an allergy to enalapril, hydrochlorothiazide, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have ever had a very bad or life-threatening reaction called angioedema. Signs may be swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; unusual hoarseness.
• If you are taking dofetilide.
• If you are not able to pass urine.
• If you have kidney disease.
• If you are taking a drug that has aliskiren in it and you also have high blood sugar (diabetes) or kidney problems. Check with your doctor or pharmacist if you are not sure if a drug you take has aliskiren in it.
• If you have taken a drug that has sacubitril in it in the last 36 hours.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Vaseretic.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Vaseretic has been evaluated for safety in more than 1500 patients, including over 300 patients treated for one year or more. In clinical trials with Vaseretic no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with enalapril or hydrochlorothiazide.

The most frequent clinical adverse experiences in controlled trials were: dizziness (8.6 percent), headache (5.5 percent), fatigue (3.9 percent) and cough (3.5 percent). Generally, adverse experiences were mild and transient in nature. Adverse experiences occurring in greater than two percent of patients treated with Vaseretic in controlled clinical trials are shown below.

Clinical adverse experiences occurring in 0.5 to 2.0 percent of patients in controlled trials included:

Body As A Whole: Syncope, chest pain, abdominal pain
Cardiovascular: Orthostatic hypotension, palpitation, tachycardia
Digestive: Vomiting, dyspepsia, constipation, flatulence, dry mouth
Nervous/Psychiatric: Insomnia, nervousness, paresthesia, somnolence, vertigo
Skin: Pruritus, rash
Other: Dyspnea, gout, back pain, arthralgia, diaphoresis, decreased libido, tinnitus, urinary tract infection

Angioedema: Angioedema has been reported in patients receiving Vaseretic, with an incidence higher in black than in non-black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with Vaseretic should be discontinued and appropriate therapy instituted immediately (see WARNINGS).

Hypotension: In clinical trials, adverse effects relating to hypotension occurred as follows: hypotension (0.9 percent), orthostatic hypotension (1.5 percent), other orthostatic effects (2.3 percent). In addition syncope occurred in 1.3 percent of patients (see WARNINGS).

Cough: See PRECAUTIONS, Cough.

Clinical Laboratory Test Findings

Serum Electrolytes: See PRECAUTIONS.

Creatinine, Blood Urea Nitrogen: In controlled clinical trials minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 0.6 percent of patients with essential hypertension treated with Vaseretic. More marked increases have been reported in other enalapril experience. Increases are more likely to occur in patients with renal artery stenosis (see PRECAUTIONS).

Serum Uric Acid, Glucose, Magnesium, and Calcium: See PRECAUTIONS.

Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g percent and 1.0 vol percent, respectively) occur frequently in hypertensive patients treated with Vaseretic but are rarely of clinical importance unless another cause of anemia coexists. In clinical trials, less than 0.1 percent of patients discontinued therapy due to anemia.

Liver Function Tests: Rarely, elevations of liver enzymes and/or serum bilirubin have occurred (see WARNINGS, Hepatic Failure).

Other adverse reactions that have been reported with the individual components are listed below and, within each category, are in order of decreasing severity.

Enalapril Maleate – Enalapril has been evaluated for safety in more than 10,000 patients. In clinical trials adverse reactions which occurred with enalapril were also seen with Vaseretic. However, since enalapril has been marketed, the following adverse reactions have been reported: Body As A Whole: Anaphylactoid reactions (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure); Cardiovascular: Cardiac arrest; myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients (see WARNINGS, Hypotension); pulmonary embolism and infarction; pulmonary edema; rhythm disturbances including atrial tachycardia and bradycardia; atrial fibrillation; hypotension; angina pectoris, Raynaud's phenomenon; Digestive: Ileus, pancreatitis, hepatic failure, hepatitis (hepatocellular [proven on rechallenge] or cholestatic jaundice) (see WARNINGS, Hepatic Failure), melena, anorexia, glossitis, stomatitis, dry mouth; Hematologic: Rare cases of neutropenia, thrombocytopenia and bone marrow depression. Hemolytic anemia, including cases of hemolysis in patients with G6PD deficiency, has been reported; a causal relationship to enalapril cannot be excluded. Nervous System/Psychiatric: Depression, confusion, ataxia, peripheral neuropathy (e.g., paresthesia, dysesthesia), dream abnormality; Urogenital: Renal failure, oliguria, renal dysfunction, (see PRECAUTIONS and DOSAGE AND ADMINISTRATION), flank pain, gynecomastia; Respiratory: Pulmonary infiltrates, eosinophilic pneumonitis, bronchospasm, pneumonia, bronchitis, rhinorrhea, sore throat and hoarseness, asthma, upper respiratory infection; Skin: Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, herpes zoster, erythema multiforme, urticaria, pemphigus, alopecia, flushing, photosensitivity; Special Senses: Blurred vision, taste alteration, anosmia, conjunctivitis, dry eyes, tearing.

Miscellaneous: A symptom complex has been reported which may include some or all of the following: a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia/myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity, rash and other dermatologic manifestations.

Hydrochlorothiazide – Body as a Whole: Weakness; Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation, anorexia; Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia; Hypersensitivity: Purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions; Musculoskeletal: Muscle spasm; Nervous System/Psychiatric: Restlessness; Renal: Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS); Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia; Special Senses: Transient blurred vision, xanthopsia.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

NDC 0187-0146-01

Vaseretic®
(Enalapril Maleate – Hydrochlorothiazide)

10/25 mg

100 Tablets

RxONLY