Vaseretic

What Is Vaseretic?

Vaseretic (enalapril maleate-hydrochlorothiazide) is a combination of an ACE (angiotensin converting enzyme) inhibitor and a thiazide diuretic (water pill) used to treat hypertension (high blood pressure). Vaseretic is available in generic form.

What Are Side Effects of Vaseretic?

Common side effects of Vaseretic include:

• dizziness,
• lightheadedness, or
• tiredness as the body adjusts to the medication.

Other side effects of Vaseretic include:

• dry cough,
• headache,
• blurred vision,
• diarrhea,
• constipation,
• upset stomach,
• skin rash, or
• increased sweating.

Vaseretic may cause a loss of too much body water (dehydration) and salt or minerals. Tell your doctor if you have symptoms of dehydration or mineral loss, including extreme thirst, very dry mouth, muscle cramps or weakness, fast/slow/irregular heartbeat, confusion, or decreased urination. Tell your doctor if you have unlikely but serious side effects of Vaseretic including:

• toe or joint pain,
• irregular heartbeat,
• decrease in vision,
• eye pain, or
• symptoms of a high potassium blood level (such as muscle weakness, or slow or irregular heartbeat).

Dosage for Vaseretic

Each tablet of Vaseretic contains 10 mg of enalapril maleate and 25 mg of hydrochlorothiazide. The usual dosage range of enalapril is 10 to 40 mg per day administered in a single or two divided doses; hydrochlorothiazide is effective in doses of 12.5 to 50 mg daily.

What Drugs, Substances, or Supplements Interact with Vaseretic?

Vaseretic may interact with cold or allergy medicine, sedatives, narcotics, sleeping pills, muscle relaxers, medicine for seizures, depression or anxiety, other diuretics (water pills) or blood pressure medications, gold injections to treat arthritis, lithium, digoxin, cholestyramine, colestipol, steroids, NSAIDs (nonsteroidal anti-inflammatory drugs), aspirin, or insulin or oral diabetes medicines. Tell your doctor all medications and supplements you use.

Vaseretic During Pregnancy and Breastfeeding

Vaseretic is not recommended for use during pregnancy due to the risk for harm to a fetus. This drug passes into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Vaseretic (enalapril maleate-hydrochlorothiazide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Vaseretic Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, severe stomach pain, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

You may be more likely to have an allergic reaction if you are African-American.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• jaundice (yellowing of the skin or eyes);
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• fever, chills, flu-like symptoms, sore throat, mouth sores;
• signs of an electrolyte imbalance--leg cramps, constipation, muscle pain or weakness, irregular heartbeats, feeling jittery, increased thirst or urination, numbness or tingling, loss of movement;
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Common side effects may include:

• dizziness;
• cough;
• headache; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vaseretic (Enalapril Maleate-Hydrochlorothiazide Tablets)

 

Vaseretic Professional Information

SIDE EFFECTS

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.

	Percent of Patients in Controlled Studies
	VASERETIC (n=1580) Incidence (discontinuation)	Placebo (n=230) Incidence
Dizziness	8.6 (0.7)	4.3
Headache	5.5 (0.4)	9.1
Fatigue	3.9 (0.8)	2.6
Cough	3.5 (0.4)	0.9
Muscle Cramps	2.7 (0.2)	0.9
Nausea	2.5 (0.4)	1.7
Asthenia	2.4 (0.3)	0.9
Orthostatic Effects	2.3 (<0.1)	0.0
Impotence	2.2 (0.5)	0.5
Diarrhea	2.1 (<0.1)	1.7

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.

Postmarketing Experience

Non-melanoma Skin Cancer

Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-3214576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Vaseretic (Enalapril Maleate-Hydrochlorothiazide Tablets)