Monday 1 October 2012

amlodipine and benazepril



am-LOE-di-peen BES-i-late, ben-AZ-e-pril hye-droe-KLOR-ide


Oral route(Capsule)

When pregnancy is detected, discontinue amlodipine besylate/benazepril hydrochloride as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus .



Commonly used brand name(s)

In the U.S.


  • Lotrel

Available Dosage Forms:


  • Capsule

Therapeutic Class: ACE Inhibitor/Calcium Channel Blocker Combination


Pharmacologic Class: Amlodipine


Chemical Class: Amlodipine


Uses For amlodipine and benazepril


Amlodipine and benazepril 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. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.


Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.


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 blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.


amlodipine and benazepril is available only with your doctor's prescription.


Before Using amlodipine and benazepril


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 amlodipine and benazepril, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to amlodipine and benazepril 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 amlodipine and benazepril 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 amlodipine and benazepril combination in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving amlodipine and benazepril combination.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


Amlodipine

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.


Benazepril

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 amlodipine and benazepril, 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 amlodipine and benazepril 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.


  • Alteplase, Recombinant

  • Amiloride

  • Amiodarone

  • Atazanavir

  • Azathioprine

  • Azilsartan Medoxomil

  • Candesartan Cilexetil

  • Canrenoate

  • Conivaptan

  • Dantrolene

  • Droperidol

  • Eplerenone

  • Eprosartan

  • Losartan

  • Olmesartan Medoxomil

  • Potassium

  • Simvastatin

  • Spironolactone

  • Telaprevir

  • Telmisartan

  • Triamterene

  • Valsartan

Using amlodipine and benazepril 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.


  • Acebutolol

  • Aceclofenac

  • Acemetacin

  • Alclofenac

  • Aliskiren

  • Alprenolol

  • Apazone

  • Atenolol

  • Azosemide

  • Bemetizide

  • Bendroflumethiazide

  • Benoxaprofen

  • Benzthiazide

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bromfenac

  • Bucindolol

  • Bufexamac

  • Bumetanide

  • Bupivacaine

  • Buthiazide

  • Capsaicin

  • Carprofen

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Chlorothiazide

  • Chlorthalidone

  • Clometacin

  • Clonixin

  • Clopamide

  • Clopidogrel

  • Cyclopenthiazide

  • Cyclothiazide

  • Dalfopristin

  • Dexketoprofen

  • Diclofenac

  • Diflunisal

  • Dilevalol

  • Diltiazem

  • Dipyrone

  • Droxicam

  • Esmolol

  • Ethacrynic Acid

  • Etodolac

  • Etofenamate

  • Felbinac

  • Fenbufen

  • Fenoprofen

  • Fentiazac

  • Floctafenine

  • Fluconazole

  • Flufenamic Acid

  • Flurbiprofen

  • Furosemide

  • Gold Sodium Thiomalate

  • Hydrochlorothiazide

  • Hydroflumethiazide

  • Ibuprofen

  • Imatinib

  • Indapamide

  • Indinavir

  • Indomethacin

  • Indoprofen

  • Isoxicam

  • Itraconazole

  • Ketoconazole

  • Ketoprofen

  • Ketorolac

  • Labetalol

  • Levobunolol

  • Lithium

  • Lornoxicam

  • Meclofenamate

  • Mefenamic Acid

  • Meloxicam

  • Mepindolol

  • Methyclothiazide

  • Metipranolol

  • Metolazone

  • Metoprolol

  • Nabumetone

  • Nadolol

  • Naproxen

  • Nebivolol

  • Nesiritide

  • Niflumic Acid

  • Nimesulide

  • Oxaprozin

  • Oxprenolol

  • Oxyphenbutazone

  • Penbutolol

  • Phenylbutazone

  • Pindolol

  • Pirazolac

  • Piretanide

  • Piroxicam

  • Pirprofen

  • Polythiazide

  • Propranolol

  • Propyphenazone

  • Proquazone

  • Quinethazone

  • Quinupristin

  • Rifapentine

  • Ritonavir

  • Sotalol

  • St John's Wort

  • Sulindac

  • Suprofen

  • Talinolol

  • Tenidap

  • Tenoxicam

  • Tertatolol

  • Tiaprofenic Acid

  • Timolol

  • Tolmetin

  • Torsemide

  • Trichlormethiazide

  • Xipamide

  • Zomepirac

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 amlodipine and benazepril. Make sure you tell your doctor if you have any other medical problems, especially:


  • Angina (chest pain) or

  • Heart attack, acute or

  • Heart or blood vessel disease (e.g., coronary artery disease) or

  • Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

  • Angioedema (swelling of the face, lips, tongue, or throat), history of—Should not be used in patients with these conditions.

  • Bee-sting allergy treatments or

  • Dialysis—Increased risk of serious allergic reaction occurring.

  • Dehydration or

  • Heart failure or other heart problems (e.g., aortic stenosis) or

  • Hyponatremia (low sodium in the blood) or

  • Hypovolemia (low blood volume)—Use with caution. The blood pressure-lowering effects of amlodipine and benazepril may be increased.

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

  • Kidney disease or

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • Kidney disease, severe or

  • Scleroderma (an autoimmune disease) or

  • Systemic lupus erythematosus (SLE), history of—Increased risk of blood problems caused by ACE inhibitors.

Proper Use of amlodipine and benazepril


In addition to the use of amlodipine and benazepril, 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 amlodipine and benazepril 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 amlodipine and benazepril 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 amlodipine and benazepril. 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 (capsules):
    • For high blood pressure:
      • Adults—At first, one capsule containing 2.5 milligrams (mg) of amlodipine and 10 mg of benazepril once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg of amlodipine and 40 mg of benazepril per day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of amlodipine and benazepril, 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.


Precautions While Using amlodipine and benazepril


It is very important that your doctor check your progress at regular visits to make sure amlodipine and benazepril is working properly. Blood tests may be needed to check for unwanted effects.


Using amlodipine and benazepril while you are pregnant can harm your unborn baby. If you think you have become pregnant while using amlodipine and benazepril, tell your doctor right away.


amlodipine and benazepril may cause serious allergic reactions including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, lips, tongue, or throat while you are using amlodipine and benazepril.


Check with your doctor right away if you have a strong stomach pain (with or without nausea or vomiting). This could be a symptom of a condition called intestinal angioedema.


Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert.


Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.


Check with your doctor if you notice any signs of fever, sore throat, or chills. These could be symptoms of an infection resulting from low white blood cell counts.


Check with your doctor if you become sick while taking amlodipine and benazepril, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water, possibly resulting in low blood pressure.


Liver problems may occur while you are using amlodipine and benazepril. Stop using amlodipine and benazepril and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.


Hyperkalemia (high potassium in the blood) may occur while you are using amlodipine and benazepril. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.


In some patients, tenderness, swelling, or bleeding of the gums may appear soon after treatment with amlodipine and benazepril is started. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.


Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking amlodipine and benazepril.


Black patients may be less sensitive to the blood pressure-lowering effects of amlodipine and benazepril. In addition, the risk of a serious allergic reaction involving swelling of the face, mouth, hands, or feet may be increased.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


amlodipine and benazepril Side Effects


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:


Less common
  • Dizziness, lightheadedness, or fainting

  • swelling of the ankles, feet, or lower legs

Signs and symptoms of too much potassium in the body
  • Confusion

  • irregular heartbeat

  • nervousness

  • numbness or tingling in the hands, feet, or lips

  • shortness of breath

  • weakness or heaviness of the legs

Rare
  • Bleeding gums

  • blisters in the mouth spreading to the trunk, scalp, or other areas

  • chills

  • fever

  • nausea or vomiting

  • nosebleeds

  • pale skin

  • sore throat

  • sores in the mouth, or on the arms, feet, hands, legs, or lips (sudden)

  • stomach pain or bloating with fever, nausea, or vomiting

  • swelling of the face, mouth, hands, or feet

  • trouble with swallowing or breathing (sudden) or hoarseness

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • yellow eyes or skin

Incidence not known
  • Chest pain

  • difficulty with swallowing

  • heartburn

  • pain or burning in the throat

  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth

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:


Less common
  • Awareness of heartbeat

  • cough (dry, continuing)

  • feeling of warmth

  • redness of the face, neck, arms, and occasionally upper chest

  • sleepiness

Incidence not known
  • Acid or sour stomach

  • belching

  • blistering, crusting, irritation, itching, or reddening of the skin

  • body aches or pain

  • congestion

  • cracked, dry, or scaly skin

  • decreased interest in sexual intercourse

  • difficulty having a bowel movement (stool)

  • fear

  • frequent urination

  • inability to have or keep an erection

  • increased volume of pale, dilute urine

  • indigestion

  • lack or loss of strength

  • loss in sexual ability, desire, drive, or performance

  • muscle or bone pain

  • runny nose

  • shakiness in the legs, arms, hands, or feet

  • sleeplessness

  • small lump under the skin

  • stomach discomfort or upset

  • sudden sweating

  • swelling

  • tender, swollen glands in the neck

  • trembling or shaking of the hands or feet

  • trouble with sleeping

  • trouble with swallowing

  • unable to sleep

  • voice changes

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.

See also: amlodipine and benazepril side effects (in more detail)



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More amlodipine and benazepril resources


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