HOW SHOULD THIS MEDICINE BE USED?

Lotensin HCT® (benazepril hydrochloride and hydrochlorothiazide) Tablets come in tablet form, which can be taken by mouth. The specific dosage of Lotensin HCT that your doctor prescribes for you will depend on your medical condition and your response to treatment.

Lotensin HCT may be taken with or without food. Use this medicine as your doctor prescribed. Take Lotensin HCT at the same time each day in order to get the most benefit from it. Do not take this medicine in larger or smaller amounts or for longer than your doctor recommends. Do not suddenly stop taking this medicine without consulting your doctor because your condition may worsen if you stop taking Lotensin HCT.

The conditions that may cause low blood pressure include vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked. Your blood and urine may also be tested if you have been vomiting or are dehydrated. Always tell your doctor if you have any abnormal symptoms.

Because of the potential for serious side effects to an unborn child, DO NOT USE THIS MEDICINE IF YOU ARE PREGNANT. TELL YOUR DOCTOR RIGHT AWAY IF YOU BECOME PREGNANT SO HE OR SHE CAN SLOWLY TAKE YOU OFF THIS MEDICINE.

WHO SHOULD NOT TAKE LOTENSIN HCT® (benazepril hydrochloride and hydrochlorothiazide) Tablets?

DO NOT USE THIS MEDICINE IF YOU ARE PREGNANT. TELL YOUR DOCTOR RIGHT AWAY IF YOU BECOME PREGNANT.

If you have diabetes, do not use Lotensin HCT with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

You should not use this medication if you are allergic to hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic), benazepril (Lotensin) or any ACE inhibitor (captopril, enalapril, lisinopril, ramipril, and others) or if you have ever have angioedema (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction).

Do not take Lotensin HCT after the expiry date printed on the bottle label or if the packaging is torn or shows signs of tampering.

Before you start to take Lotensin HCT:

Tell your doctor if you have any of the following health problems/medical conditions:

  • You are pregnant, planning to become pregnant, or are breast-feeding
  • You are able to become pregnant
  • You are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • You are a diabetic
  • You have allergies to medicines, foods, or other substances
  • You have a history of heart problems (eg, heart failure, aortic stenosis), blood vessel problems, blood flow problems, bone marrow problems, kidney problems (eg, renal artery stenosis), liver problems, high cholesterol or lipid levels, diabetes, or gout
  • You have a history of a stroke, a recent heart attack, a kidney transplant, allergies, or asthma
  • You have an autoimmune disease (eg, rheumatoid arthritis, lupus, scleroderma)
  • You are dehydrated, have low blood volume, or low blood pressure
  • You have high blood potassium levels, low blood sodium levels, or are on a low-salt (sodium) diet
  • You are receiving treatments to reduce sensitivity to bee or wasp stings
  • You are having dialysis or apheresis or are scheduled to have surgery or receive anesthesia
  • You have recently had a certain type of nerve surgery (sympathectomy)
  • You have never taken another medicine for high blood pressure

TAKING OTHER MEDICINES:

Some MEDICINES MAY INTERACT with benazepril or hydrochlorothiazide. Tell your doctor if you are taking any other medicines, especially any of the following:

  • Digoxin, dofetilide, or ketanserin because the risk of irregular heartbeat may be increased
  • Everolimus or sirolimus because the risk of angioedema may be increased
  • Adrenocorticotropic hormone (ACTH), corticosteroids (eg, prednisone), dextran sulfate, diazoxide, diuretics (eg, furosemide), or other medicines for high blood pressure because an increased risk of low blood pressure may occur
  • Aliskiren or angiotensin receptor blockers (ARBs) (eg, losartan) because the risk of certain side effects (eg, serious kidney problems, high blood potassium levels, low blood pressure) may be increased
  • Eplerenone, potassium-sparing diuretics (eg, spironolactone, triamterene), potassium supplements, salt substitutes containing potassium, or trimethoprim because the risk of high blood potassium levels may be increased
  • Certain gold-containing medicines (eg, sodium aurothiomalate) because flushing, nausea, vomiting, and low blood pressure may occur
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen, indomethacin) because the risk of serious damage to the kidneys (eg, decrease in amount of urine, weight gain) may be increased or they may decrease benazepril or hydrochlorothiazide’s effectiveness
  • Lithium or thiopurines (eg, azathioprine) because the risk of their side effects may be increased by benazepril or hydrochlorothiazide
  • Insulin or other diabetes medicines (eg, glyburide ) because their effectiveness may be decreased by benazepril or hydrochlorothiazide

This may not be a complete list of all interactions that may occur. Ask your doctor if benazepril or hydrochlorothiazide may interact with any other medicines that you are taking. Check with your doctor before you start, stop, or change the dose of any medicine.

Be sure to tell your doctor about any conditions you have before you start taking Lotensin HCT.

Do NOT use Lotensin HCT if:

  • You are allergic to any ingredient in benazepril or hydrochlorothiazide, any other sulfonamide medicine (eg, sulfamethoxazole, glyburide, probenecid), or other ACE inhibitors (eg, lisinopril)
  • You have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or unusual hoarseness)
  • You are unable to urinate
  • You are pregnant
  • You are also taking aliskiren and you have either diabetes or kidney problems
  • You are also taking dofetilide or ketanserin

Contact your doctor or health care provider right away if any of these apply to you.

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IMPORTANT SAFETY INFORMATION

Download Full Prescribing Information

Lotensin HCT® (benazepril hydrochloride and hydrochlorothiazide) Tablets

WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue Lotensin HCT as soon as possible.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity

CONTRAINDICATIONS

This medicine should not be used if you have trouble urinating.

Do not use Lotensin HCT® (benazepril hydrochloride and hydrochlorothiazide) Tablets if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant.

You should not use this medication if you are allergic to hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoric) or benazepril (Lotensin), or if you have ever had angioderma (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction).

You should not use this medication if you are allergic to any other ACE inhibitor, such as captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramapril (Altace), or trandolapril (Mavik), or to other sulfonamide-derived drugs.

Before taking Lotensin HCT, tell your doctor if you have kidney disease (or are on dialysis), liver disease, glaucoma, congestive heart failure, lupus, diabetes, asthma, or an allergy to sulfa drugs or penicillin.

Avoid the regular use of salt substitutes in your diet, and do not take potassium supplements while taking Lotensin HCT, unless your doctor has told you otherwise.

Some things can cause your blood pressure to get too low.This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking other diuretics (water pills). Follow your doctor’s instructions about the type and amount of liquids you should drink while taking Lotensin HCT. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

WARNINGS

Anaphylactoid and Possibly Related Reactions

These reactions may begin within minutes or even seconds of exposure, and rapidly progress to cause airway constriction, skin and intestinal irritation, as well as altered heart rhythms. In severe cases, it can result in complete airway obstruction, shock and death. If any of these reactions occur, GET IMMEDIATE EMERGENCY HELP.

Head and Neck Angiodema

Swelling of the face, extremities, lips, tongue, glottis and larynx may occur. If any of these symptoms occur, Lotensin HCT should be discontinued and appropriate therapy should be started immediately. When involvement of the tongue, glottis or larynx appears likely to cause airway obstruction, appropriate therapy such as epinephrine injection should be promptly administered.

Intestinal Angiodema

Should you have abdominal pain (with or without vomiting) notify your doctor immediately.

Anaphylactoid Reactions when using Antivenom for Bee, Wasp Stings, etc.

Treatment with antisting venom (e.g., hymenoptera venom) may cause anaphylactoid reactions. Tell your doctor if you have an allergy that requires treatment with hymenoptera venom and get emergency help should an anaphylactoid reaction occur.

Anaphylactoid Reactions during Dialysis

Anaphylactoid reactions have been reported during dialysis. Should this occur, get immediate emergency help.

Hypotension

Lotension HCT can cause symptomatic hypotension (low blood pressure). This is most likely to occur if you are on prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting.

Lotensin HCT should be used cautiously at the same time as other high blood pressure drugs. The thiazide component of Lotensin HCT may potentiate the action of other hypertensive drugs.

Congestive heart failure, with or without renal insufficiency, is often associated with high blood pressure but can also be associated with symptomatic low blood pressure. New onset congestive heart failure is an emergency. You should let your doctor know if you have had congestive heart failure before, or at any time during your treatment with Lotensin HCT.

If hypotension occurs, lie down, and if necessary, seek medical attention. You may require treatment with intravenous saline infusion.

Impaired Renal Function

Your doctor should monitor your kidney function on a regular basis. If you have renal artery stenosis, chronic kidney disease, severe congestive heart failure or volume depletion, you are at particular risk for acute kidney failure and should be monitored closely.

Neutropenia/Agranulocytosis

ACE inhibitors are known to cause agranulocytosis and bone marrow depression. Your doctor should monitor your white blood cell count if you have collagen-vascular disease, particularly if the disease is associated with impaired renal function.

Fetal toxicity

Pregnancy Category D

The use of Lotensin HCT during the second and third trimesters of pregnancy reduces fetal kidney function and increases the chance of fetal and neonatal morbidity and death. Amniotic fluid may be decreased which is associated with fetal lung hypoplasia and skeletal deformations. When pregnancy is detected, discontinue Lotensin HCT as soon as possible. Appropriate management of maternal hypertension during pregnancy is important to optimize the outcome for both mother and fetus. In the unusual case where there is no alternative than to use Lotensin HCT during pregnancy; you should understand the potential risk to the fetus. Serial ultrasounds should be performed to assess the intra-amniotic environment. If a decrease in amniotic fluid is detected, Lotensin HCT should be discontinued immediately, unless it is considered lifesaving for the mother. However, you should be aware that a decrease in amniotic fluid may not be detectable until the fetus has sustained irreversible injury.

You should also be aware that hydrochlorothiazide, like other diuretics, can accumulate in the amniotic fluid. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia (low blood platelet count).

Hepatic Failure

Should you develop jaundice or marked elevations of hepatic (kidney) enzymes, you should stop taking Lotensin HCT immediately and your doctor should conduct the appropriate follow-up.

Systemic Lupus Erthematosus

Thiazide diuretics have been reported to cause an increase of activation of systemic lupus erythematosus (systemic autoimmune disease).

Acute Myopia and Secondary Angle-Closure Glaucoma

Hydrochlorothizide can result in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. Should this occur, discontinue hydrochlorothiazide as soon as possible. Prompt medical or surgical treatment may need to be considered if the intraocular pressure remains uncontrolled. Risk factors include a history of sulfonamide or penicillin allergy.

PRECAUTIONS

General

Serum Electrolyte Abnormalities

Hydochlorothiazide can cause hypokalemia and hyponatremia. Serum electrolytes should be monitored periodically.

Metabolic Disturbances

Hydrochlorothiazide

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hydrochlorothiazide may raise the serum uric acid level which may exacerbate hyperuricemia and precipitate gout in susceptible patients, as well as decrease urinary calcium excretion and cause mild elevation of serum calcium. Lotensin HCT should not be used in patients with hypercalcemia.

Cough

Persistent nonproductive cough has been reported with ACE inhibitors, which resolves after discontinuation of therapy.

Surgery/Anesthesia

Benazepril may cause hypotension in patients undergoing surgery or during anesthesia with agents that produce hypotension.

Drug Interactions

Interactions Common for Both Benazepril and Hydrochlorothiazide

Potassium Supplements and Potassium-Sparing Diuretics: Use of potassium supplements and potassium-sparing diuretics during Lotensin HCT therapy may affect potassium levels.

Lithium: Lithium toxicity has been reported for patients treated with thiazides. Increased serum lithium and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during lithium therapy.

Dual Blockade of the Renin-Angiotension System (RAS): Blood pressure, renal function and electrolytes should be monitored in patients on Lotensin HCT and other agents that affect the RAS due to increased risks of hypertension, hyperkalemia, and changes in renal function (including acute renal failure). In general, avoid combined use of RAS inhibitors.

NSAIDS and Cox-2 selective agents: Administration of NSAIDS, including selective Cox-2 inhibitors, with ACE inhibitors may result in generally reversible loss of renal function and renal failure and these patients should be monitored periodically. The antihypertensive effect of benazepril and hydrochlorothiazide may be attenuated by NSAIDS.

Benazepril

Gold: Nitroid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and ACE inhibitor therapy.

Hydrochlorothiazide

If you are on ACE inhibitor therapy and also taking any of the following, your doctor should monitor you and possibly adjust your medicines: ion exchange resins, digitalis glycosides, skeletal muscle relaxants, antidiabetic agents, antineoplastic agents, drugs that alter gastrointestinal motility, cyclosporine, alcohol, barbiturates or narcotics, and pressor amines.

Use in Special Populations

Nursing Mothers:

Because of the potential for serious adverse reactions in nursing infants from hydrochlorothiazide and the unknown effects of benazepril in infants, a decision should be made whether to discontinue nursing or to discontinue Lotensin HCT, taking into account the importance of the drug to the mother.

Geriatric Use:

A limited amount of data suggests that the systemic clearance of hydrochlorothiazide is reduced in both healthy and hypertensive elderly subjects compared to young healthy volunteers.

Pediatric Use:

Safety and efficacy in pediatric patients has not been established.

Adverse Reactions

The most common reasons for discontinuation of therapy with Lotensin HCT are cough, dizziness, headache and fatigue. The reported side effects are generally mild and transient, and there is no relationship between side effects and age, sex, race, or duration of therapy.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch