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Lotrel (Amlodipine Besylate / Benazepril Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Lotrel is indicated for the treatment of hypertension.

      This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).

      In using Lotrel, consideration should be given to the fact that an ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis).

      Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks.

DOSAGE AND ADMINISTRATION

Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups. All patient groups benefited from the reduction in amlodipine-induced edema (see below).

      The hazards (see WARNINGS) of benazepril are generally independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter. When benazepril is added to a regimen of amlodipine, the incidence of edema is substantially reduced. Therapy with any combination of amlodipine and benazepril will thus be associated with both sets of dose-independent hazards, but the incidence of edema will generally be less than that seen with similar (or higher) doses of amlodipine monotherapy.

      Rarely, the dose-independent hazards of benazepril are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with Lotrel only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

Dose Titration Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with Lotrel. The addition of benazepril to a regimen of amlodipine should not be expected to provide additional antihypertensive effect in African-Americans. However, all patient groups benefit from the reduction in amlodipine-induced edema. Dosage must be guided by clinical response; steady-state levels of benazepril and amlodipine will be reached after approximately 2 and 7 days of dosing, respectively.

      In patients whose blood pressures are adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control without edema. Especially in nonblacks, it may be prudent to minimize the risk of excessive response by reducing the dose of amlodipine as benazepril is added to the regimen.

Replacement Therapy: For convenience, patients receiving amlodipine and benazepril from separate tablets may instead wish to receive capsules of Lotrel containing the same component doses.

Use in Patients With Metabolic Impairments: Regimens of therapy with Lotrel need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, the recommended initial dose of benazepril is 5 mg. Lotrel is not recommended in these patients.

      In small, elderly, frail, or hepatically impaired patients, the recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.

HOW SUPPLIED

Lotrel is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. All six strengths are packaged in bottles of 100 capsules.

      Capsules are imprinted with “Lotrel” and appropriate code.

Dose Capsule Color/Code NDC Code
Bottle of 100
2.5/10 mgwhite with 2 gold bands/2255NDC 0078-0404-05
5/10 mglight brown with 2 white bands/2260NDC 0078-0405-05
5/20 mgpink with 2 white bands/2265NDC 0078-0406-05
5/40 mglight blue with 2 white bands/0384NDC 0078-0384-05
10/20 mgpurple (amethyst) with 2 white bands/0364NDC 0078-0364-05
10/40 mgdark blue with 2 white bands/0379NDC 0078-0379-05

Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

[See USP controlled room temperature.]

Protect from moisture. Dispense in tight container (USP).

** Trademark of Thomson Healthcare, Inc.

REV: JUNE 2007                                              T2007-57

Patient Summary of Information

LOTREL ® ‚ (low-TREL)

amlodipine besylate/benazepril hydrochloride capsules

2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5   mg/40 mg, 10 mg/20 mg , 10   mg/40 mg

Rx only

Read this Patient Information leaflet before you start taking LOTREL and each time you get a refill. There may be new information. This leaflet does not replace talking with your doctor. If you have any questions, ask your doctor or pharmacist.

What is the most important information I should know about LOTREL?

LOTREL can harm an unborn baby and even cause death. If you get pregnant, stop taking LOTREL. Call your doctor right away. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.

What is LOTREL?

LOTREL contains two prescription medicines that work together to lower blood pressure: amlodipine besylate (the active ingredient found in Norvasc®), a calcium channel blocker, and benazepril hydrochloride (Lotensin®), an ACE inhibitor. Your doctor will prescribe LOTREL only after other medicines haven’t worked.

High Blood Pressure (hypertension). Blood pressure is the force of blood in your blood vessels. You have high blood pressure when the force is too much. LOTREL can help your blood vessels relax so your blood pressure is lower.

LOTREL has not been studied in children.

Who should not take LOTREL?

Don’t take LOTREL if you are allergic to any of the ingredients.  There is a complete list at the end of this leaflet.

What should I tell my Doctor before taking LOTREL?

Tell your doctor about all your medical conditions, including if:

•      you are pregnant or plan to become pregnant. See “What is the most important information I should know about LOTREL?”

•      you are breastfeeding. LOTREL may pass into your milk. Don’t breastfeed while you are taking LOTREL.

•      you have a heart condition

•      you have liver problems

•      you have kidney problems

•      you have diabetes (high blood sugar)

•      you have systemic lupus erythematosus (SLE), scleroderma or a collagen vascular disease. Ask your doctor if you are not sure.

Keep a list of your medicines with you, including vitamins and natural or herbal remedies, to show your doctor or pharmacist. Some of your other medicines and LOTREL could affect each other, causing serious side effects. Tell your doctor about all your medicines, especially:

•      medicines for high blood pressure or heart failure

•      water pills, extra potassium or a salt substitute

•      Lithium (Eskalith®, Lithobid®)

How do I take LOTREL?

•      Take LOTREL exactly as your doctor tells you.

•      Take LOTREL at the same time each day, with or without food.

•      If you miss a dose, take it as soon as you remember. If it is more than 12 hours, just take your next dose at the regular time.

•      Your doctor may test for kidney problems or check your blood potassium level.

•      If you take too much LOTREL, call your doctor or Poison Control Center, or go to the emergency room.

•      Tell all your doctors or dentist you are taking LOTREL if you:

      -      are going to have surgery

      -      are getting allergy shots for bee stings

      -      go for kidney dialysis

What are the possible side effects of LOTREL?

LOTREL can cause serious side effects including:

•      serious allergic reactions that can be life threatening.

      Stop LOTREL and get emergency help right away if you get:

      -      swelling of your face, eyelids, lips, tongue or throat

      -      have trouble swallowing

      -      asthma (wheezing) or other breathing problems

These allergic reactions are rare but happen more times in people who are African-American.

•      low blood pressure (hypotension). Low blood pressure is most likely to happen if you also take water pills, are on a low salt diet, get dialysis treatments, have heart problems or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy.

•      liver problems. Call your doctor if:

•      you have nausea

•      you feel more tired or weaker than usual

•      you have itching

•      your skin or eyes look yellow

•      you have pain in your upper right stomach

•      you have flu-like symptoms

•      low white blood cells. Low white blood cells happen more in people who have kidney problems and collagen vascular diseases. Low white blood cells can give you a higher chance for getting infections. Call your doctor if you get a fever, sore throat, or other signs of infection that do not go away.

•      kidney problems. Kidney problems may get worse in people that already have kidney disease. Some people will have changes on blood tests for kidney function and need a lower dose of LOTREL. Call your doctor if you get swelling in your feet, ankles, or hands or unexplained weight gain.

•      more chest pain and heart attacks in people that already have severe heart problems. Get emergency help if you get worse chest pain or chest pain that does not go away.

The more common side effects of LOTREL are:

•      Cough     

•      Dizziness

•      Headache

•      Swelling of the feet, ankles, and hands

These are not all side effects of LOTREL. For a complete list, ask your doctor or pharmacist.

How do I store LOTREL?

•      Store LOTREL at room temperature (59-86°F).

•      Keep LOTREL in a closed container in a dry place.

•      Keep LOTREL and all medicines out of the reach of children.

General Information about LOTREL

Doctors can also use medicine for a condition that is not in the patient information leaflet. Take LOTREL the way your doctor tells you. Do not share it with other people. It may harm them.

For more information, ask your doctor or pharmacist, visit www.LOTREL.com on the Internet, or call 1-888-669-6682.

What are the ingredients in LOTREL?

Active ingredients: amlodipine besylate (the active ingredient found in Norvasc®), benazepril hydrochloride (Lotensin®)

Inactive ingredients: calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg and 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.

APRIL 2006      T2006-27

REV: JUNE 2007      T2007-57/T2006-27

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

© Novartis

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