Lotensin HCT

Lotensin HCT is part of the drug class:

• ACE inhibitors and diuretics

Serious side effects have been reported with Lotensin HCT  or its ingredients including the following:

• Allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • swelling of the face, limbs, lips, tongue, throat
  • difficulty breathing
  • stomach (abdominal) pain (intestinal angioedema) with or without nausea or vomiting
• Low blood pressure.
• Lowered white blood cell count (neutropenia/agranulocytosis) increasing the risk of infections
• Harm to an unborn baby (fetal toxicity). Do not take Lotensin HCT if you are pregnant or will become pregnant.
• Liver damage
• An autoimmune disease in which the body's immune system mistakenly attacks healthy tissue (systemic lupus erythematosus)
• A condition in which close objects appear clearly, but far ones don't (myopia) or a buildup of pressure in the eye that can cause blindness (glaucoma). Tell your healthcare provider right away if you experience ​visual changes or eye pain.
• Imbalances in the levels of salts and fluids in your body (electrolyte and fluid imbalance). Tell your healthcare provider right away if you have some or all of the following symptoms:
  • dry mouth
  • thirst
  • weakness
  • drowsiness
  • restlessness
  • muscle pains or cramps
  • low blood pressure
  • low output of urine
  • fast heart rate
  • nausea
  • vomiting

Lotensin HCT can cause drowsiness. Do not drive or operate heavy machinery until you know how Lotensin HCT affects you.

Do not take Lotensin HCT if you:

• are allergic to Lotensin HCT, benazepril, to any other ACE inhibitor, to hydrochlorothiazide, or to other sulfonamide-derived drugs
• kidneys are unable to produce urine (anuric)
• history of a type of swelling that affects deeper layers in your skin, often around your eyes and lips (angioedema)
• are diabetic and also using aliskiren (Tekturna)

• Take Lotensin HCT exactly as prescribed. 
• Lotensin HCT comes in a tablet form and is taken by mouth once daily with or without food. 

If you take too much Lotensin HCT, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking hydrochlorothiazide and benazepril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

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.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and benazepril. You may need to stop using the medicine for a short time.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• lithium;

• a diuretic or "water pill";

• heart rhythm medication--amiodarone, dofetilide;

• medicine to prevent organ transplant rejection--everolimus, sirolimus, tacrolimus; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with hydrochlorothiazide and benazepril, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Benazepril and hydrochlorothiazide is a combination of medicines that 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.

Benazepril is an angiotensin-converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, benazepril 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.

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell 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 benazepril and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of benazepril and hydrochlorothiazide combination in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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

• Aliskiren
• Dofetilide
• Sacubitril

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

• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Alteplase, Recombinant
• Amiloride
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Azathioprine
• Azilsartan
• Azilsartan Medoxomil
• Benzphetamine
• Bromfenac
• Bufexamac
• Candesartan Cilexetil
• Canrenoate
• Celecoxib
• Choline Salicylate
• Clonixin
• Cyclophosphamide
• Deslanoside
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Droperidol
• Droxicam
• Eplerenone
• Eprosartan
• Etodolac
• Etofenamate
• Etoricoxib
• Everolimus
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Irbesartan
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Lisdexamfetamine
• Lithium
• Lornoxicam
• Losartan
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mercaptopurine
• Methamphetamine
• Methotrexate
• Metildigoxin
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olmesartan Medoxomil
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Potassium
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sirolimus
• Sodium Salicylate
• Sotalol
• Spironolactone
• Sulindac
• Telmisartan
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Triamterene
• Trimethoprim
• Valdecoxib
• Valsartan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Aminolevulinic Acid
• Amtolmetin Guacil
• Azosemide
• 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
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Furosemide
• 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
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Topiramate
• 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 medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angioedema (swelling of the face, lips, tongue, or throat) with other ACE inhibitors, history of or
• Anuria (not able to pass urine) or
• Diabetic patients who are also taking aliskiren (Tekturna®) or
• Sulfa drug allergy (e.g., sulfamethoxazole, Bactrim®, Septra®)—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 problems.

• Congestive heart failure—Use may lead to kidney problems.

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

• Electrolyte imbalance (e.g., low magnesium, potassium, or sodium in the blood) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Glaucoma, secondary angle closure or
• Gout or
• Hypercalcemia (high calcium in the blood) or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertriglyceridemia (high triglycerides in the blood) or
• Kidney disease or
• Liver disease or
• Myopia, acute (changes in the eyeball causing vision problems) or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

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 a change in the types of foods you eat, especially foods high in sodium (salt). 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. 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.

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—One tablet once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 milligrams (mg) of benazepril and 25 mg of hydrochlorothiazide.
    • 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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

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:

• Blurred vision
• confusion
• decreased urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• 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 the legs
• wrinkled skin

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:

• Cough
• decreased interest in sexual intercourse
• excessive muscle tone
• feeling of constant movement of self or surroundings
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• muscle stiffness
• muscle tension or tightness
• nausea
• sensation of spinning
• sleepiness or unusual drowsiness

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.

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

Lotensin HCT has been evaluated for safety in over 2500 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 200 were treated for more than 1 year.

The reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy due to side effects was required in approximately 7% of U.S. patients treated with Lotensin HCT and in 4% of patients treated with placebo.

The most common reasons for discontinuation of therapy with Lotensin HCT in U.S. studies were cough (1.0%; see PRECAUTIONS), "dizziness" (1.0%), headache (0.6%), and fatigue (0.6%).

The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with Lotensin HCT are shown in the table below.

Other side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in 0.3% to 1.0% of patients treated with Lotensin HCT were the following:

Cardiovascular: Palpitations, flushing.

Gastrointestinal: Vomiting, diarrhea, dyspepsia, anorexia, and constipation.

Neurologic and Psychiatric: Insomnia, nervousness, paresthesia, libido decrease, dry mouth, taste perversion, and tinnitus.

Dermatologic: Rash and sweating.

Other: Urinary frequency, arthralgia, myalgia, asthenia, and pain (including chest pain and abdominal pain).

Other adverse experiences reported in 0.3% or more of Lotensin HCT patients in U.S. controlled clinical trials, and rarer events seen in post-marketing experience, were the following; asterisked entries occurred in more than 1% of patients (in some, a causal relationship to Lotensin HCT is uncertain):

Cardiovascular: Syncope, peripheral vascular disorder, and tachycardia.

Body as a Whole: Infection, back pain*, flu syndrome*, fever, chills, and neck pain.

Dermatologic: Photosensitivity and pruritus.

Gastrointestinal: Gastroenteritis, flatulence, and tooth disorder.

Neurologic and Psychiatric: Hypesthesia, abnormal vision, abnormal dreams, and retinal disorder.

Respiratory: Upper respiratory infection*, epistaxis, bronchitis, rhinitis*, sinusitis*, and voice alteration.

Other: Conjunctivitis, arthritis, urinary tract infection, alopecia, and urinary frequency*.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of either benazapril or hydrochlorothiazide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure:

Benazepril Stevens-Johnson syndrome, pancreatitis, hemolytic anemia, pemphigus, and thrombocytopenia, eosinophilic pneumonitis

Hydrochlorothiazide

Digestive: Pancreatitis, small bowel angioedema, jaundice (intrahepatic cholestatic), sialadenitis, vomiting, diarrhea, cramping, nausea, gastric irritation, constipation, and anorexia.

Neurologic: Vertigo, lightheadedness, transient blurred vision, headache, paresthesia, xanthopsia, weakness, and restlessness.

Musculoskeletal: Muscle spasm.

Hematologic: Aplastic anemia, agranulocytosis, leukopenia, neutropenia and thrombocytopenia.

Metabolic: Hyperglycemia, glycosuria, and hyperuricemia, pyrexia, asthenia, parathyroid gland changes with hypercalcemia and hypophosphatemia.

Hypersensitivity: Anaphylactoid reactions, necrotizing angiitis, respiratory distress (including pneumonitis and pulmonary edema), purpura, urticaria, rash, and photosensitivity.

Skin: Erythema multiforme including Stevens-Johnson syndrome, and exfoliative dermatitis including toxic epidermal necrolysis.

Clinical Laboratory Test Findings

Serum Electrolytes: See PRECAUTIONS.

Creatinine and BUN: Minor reversible increases in serum creatinine and BUN were observed in patients with essential hypertension treated with Lotensin HCT. Such increases occurred most frequently in patients with renal artery stenosis (see PRECAUTIONS).

Lotensin HCT is available in tablets of four different strengths:

Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.

The National Drug Codes for the various packages are

Tablets are oblong and scored, with "Lotensin HCT" on one side and appropriate number imprinted on the other side.

Storage: Do not store above 30°C (86°F). Protect from moisture and light. Dispense in tight, light-resistant container (USP).

Distributed by:

Validus Pharmaceuticals LLC
Parsippany, New Jersey 07054
info@validuspharma.com
www.validuspharma.com
1-866-9VALIDUS

© 2013 Validus Pharmaceuticals LLC

April 2013

455000-01

PRINCIPAL DISPLAY PANEL - 10 mg benazepril/12.5 mg hydrochlorothiazide Tablet

NDC 30698-452-01

Lotensin HCT® 10/12.5
benazepril HCl 10 mg
hydrochlorothiazide USP 12.5 mg

100 Tablets

Rx Only

PRINCIPAL DISPLAY PANEL - 20 mg benazepril/12.5 mg hydrochlorothiazide Tablet

NDC 30698-453-01

Lotensin HCT® 20/12.5
benazepril HCl 20 mg
hydrochlorothiazide USP 12.5 mg

100 Tablets

Rx Only

PRINCIPAL DISPLAY PANEL - 20 mg benazepril/25 mg hydrochlorothiazide Tablet

NDC 30698-454-01

Lotensin HCT® 20/25
benazepril HCl 20 mg
hydrochlorothiazide USP 25 mg

100 Tablets

Rx Only