WHAT ARE THE SIDE EFFECTS OF LOTENSIN HCT® (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLETS?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Lotensin HCT® (benazepril hydrochloride and hydrochlorothiazide) Tablets.

Get emergency medical help if you have any of the following signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue or throat.

Stop using this medicine and call your doctor at once if you have:

  • A light-headed feeling, like you might pass out
  • Eye pain, vision problems
  • High potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling)
  • Urinating less than usual or not at all
  • Weakness, confusion, sweating, trembling, increased thirst, loss of appetite, vomiting, rapid breathing, pounding heartbeats or fluttering in your chest
  • Swelling, weight gain, feeling short of breath
  • Easy bruising, unusual bleeding (nose, mouth, vagina or rectum), purple or red pinpoints spots under your skin
  • Pale or yellowed skin, dark colored urine, fever, jaundice (yellowing of the skin or eyes)
  • Wheezing, trouble breathing
  • Dry mouth
  • Seizures
  • Severe skin reaction (this may include fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads – especially in the face or upper body – and causes blistering and peeling).

Common side effects may include:

  • Cough
  • Headache, dizziness, drowsiness, tired feeling
  • Nausea, constipation, upset stomach
  • Mild skin rash, increased sweating

Some people may have other side effects not yet known or mentioned.

PREGNANCY WARNINGS:

Exposure to ACE inhibitors during the first trimester is associated with prematurity, intrauterine growth retardation; structural heart malformations and neurological malformations. Fetal and neonatal toxicity, death and congenital abnormalities have been reported with use of ACE inhibitors during the second and third trimesters.

NURSING MOTHERS:

Benazepril and hydrochlorothiazide are excreted in small amounts into human breast milk; but, adverse effects on the nursing infant are unlikely. However, due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

OVERDOSAGE:

Overdose symptoms may include dizziness or feeling like you might pass out.

Seek immediate emergency medical attention.

IMPORTANT SAFETY INFORMATION


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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 casuse 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.

NSAID’s and Cox-2 selective agents: Administration of NSAID’s, 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 NSAID’s.

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