Information on LOTREL

Do NOT use Lotrel if:
•you are allergic to any ingredient in Lotrel or similar medicines (eg, any other ACE inhibitor)
•you are using iron dextran by injection
•you are in your second or third trimester of pregnancy
Contact your doctor or health care provider right away if any of these apply to you.

Before using Lotrel :
Some medical conditions may interact with Lotrel . Tell your doctor or pharmacist if you have anymedical conditions, especially if any of the following apply to you:
•if you are pregnant, planning to become pregnant, or are breast-feeding
•if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement, especially extra potassium or a salt substitute
•if you have allergies to medicines, foods, or other substances
•if you have or ever had heart failure, any heart disease, aortic stenosis (an abnormal narrowing of the opening of the aortic valve in the heart), liver or kidney problems, a kidney transplant, or diabetes
•if you have systemic lupus erythematosus (SLE or lupus), hardening of skin disease (scleroderma), bone marrow suppression, low blood counts, low blood pressure, low blood sodium, high blood potassium, or narrowing or hardening of the arteries of the brain, or you are dehydrated
•if you are scheduled to have surgery or are to receive anesthesia or kidney dialysis Some MEDICINES MAY INTERACT with Lotrel . Tell your health care provider if you are taking other medicines, especially any of the following:
•Lithium, sulfonylureas (eg, glipizide), thiazide diuretics (eg, hydrochlorothiazide), thiopurines (eg,azathioprine), or vasopressin receptor antagonists (eg, conivaptan) because they may increase the risk of Lotrel 's side effects
•Dextran or sildenafil because the risk of serious side effects, including low blood pressure or severe allergic reactions, may be increased
•Potassium-sparing diuretics (eg, amiloride) or potassium supplements because the risk of side effects, including high potassium levels resulting in possible irregular heartbeat and stopping of the heart, may be increased

How to use Lotrel :
Use Lotrel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
•Take Lotrel by mouth with or without food.
•Grapefruit and grapefruit juice may increase the risk of side effects from Lotrel . Talk with you doctor before including grapefruit or grapefruit juice in your diet.
•Do not take more medicine than prescribed unless advised to do so by your doctor.
•If you miss a dose of Lotrel , take it as soon as possible. If it is almost time for your next dose,

skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Ask your health care provider any questions you may have about how to use Lotrel .

Important safety information:
•Lotrel may cause dizziness, lightheadedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Lotrel with caution. Do not drive or perform other possibly

unsafe tasks until you know how you react to it.
•Lotrel may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
•Check with your doctor before you use a salt substitute or a product that has potassium in it.
•A persistent, unproductive cough may occur. Tell your doctor if this occurs. Recovery is rapid when the medicine is stopped.
•Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
•Lab tests, including blood pressure, may be performed while you use Lotrel . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
•Lotrel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
•PREGNANCY and BREAST-FEEDING: Lotrel may cause fetal and newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Lotrel is found in breast milk. Do not breast-feed while taking Lotrel .

Possible side effects of Lotrel :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness or lightheadedness when sitting or standing; headache; persistent, dry cough; swelling of the hands or feet.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; infection (fever, sore throat); irregular or slow heartbeat; yellowing of skin or eyes.

Proper storage of Lotrel :
Store Lotrel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lotrel out of the reach of children and away from pets.

2.5/10mg  white with 2 gold bands/2255 NDC 0078-0404-05
5/10mg     light brown with 2 white bands/2260 NDC 0078-0405-05
5/20mg    pink with 2 white bands/2265 NDC 0078-0406-05
5/40mg    light blue with 2 white bands/0384 NDC 0078-0384-05
10/20mg  purple (amethyst) with 2 white bands/0364 NDC 0078-0364-05
10/40mg  dark blue with 2 white bands/0379 NDC 0078-0379-05

【通用名称】苯磺酸氨氯地平/盐酸贝那普利
【剂型】胶囊
【药理作用】
贝那普利是一种血管紧张素转化酶(ACE)抑制剂.它的降压作用机制是,通过原发性抑制肾素-血管紧张素-醛固酮(系统)来发挥作用。对低肾素高血压患者贝那普利可以起到平稳降压的效果。
氨氯地平属长效二氢吡啶类钙离子拮抗剂，是二氢吡啶类衍生物可以阻滞心肌和血管平滑肌细胞上的钙离子通道，直接舒张血管平滑肌，扩张外周动脉，从而降低血压，保护靶器官。
【适应症】
本品用于高血压的治疗，且给药剂量须遵循个体化原则，不是固定的。
【用法用量】
视病情或个体差异而定。本品给药剂量须遵循个体化原则，按疗效而予以调整。每天一次，服用氨氯地平2.5-10mg同时服用贝那普利10-80 mg可以有效治疗高血压。氨氯地平贝那普利复合制剂，氨氯地平用量2.5-10mg，贝那普利用量10-40 mg，临床试验中本品抗高血压的作用随氨氯地平用量的增加而增加，随贝那普利用量的增加而增加。
【不良反应】
轻至中度：水肿，心悸，直立位低血压，眩晕，倦因，头痛和咳嗽。服用 LOTREL 后，从坐、卧位起立时要慢，以免发生轻度头痛、眩晕、乏力和直立位低血压。

Lotrel

What is Lotrel?

 

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Lotrel contains a combination of amlodipine and benazepril. Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow. Benazepril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme. Benazepril also widens blood vessels and also prevents the body from retaining water.

Lotrel is used to treat high blood pressure (hypertension). It is usually given after other blood pressure medications have been tried without successful treatment.

Lotrel may also be used for other purposes not listed in this medication guide.

Important information about Lotrel

You should not use Lotrel if you are allergic to amlodipine (Norvasc) or benazepril (Lotensin), or if you have ever had angioedema (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction).

You should not use Lotrel 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), ramipril (Altace), or trandolapril (Mavik).

Do not take Lotrel if you are pregnant. Amlodipine and benazepril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Stop using this medication and tell your doctor right away if you become pregnant. Lotrel may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Some side effects of Lotrel may not occur until after you have been using the medication for several months.

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 Lotrel, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Before taking Lotrel

You should not use Lotrel if:

• you are allergic to amlodipine (Norvasc) or benazepril (Lotensin);

• you have ever had angioedema (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction); or

• 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), ramipril (Altace), or trandolapril (Mavik).

If you have any of these other conditions, you may need to adjust the dose of Lotrel or have special tests:

• kidney disease (or if you are on dialysis);

• liver disease;

• heart disease or congestive heart failure;

• diabetes; or

• if you are on a low-salt diet.

FDA pregnancy category D. Do not take Lotrel if you are pregnant. Lotrel can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Stop using this medication and tell your doctor right away if you become pregnant. Amlodipine and benazepril can pass into breast milk and may harm a nursing baby. Do not use Lotrel without telling your doctor if you are breast-feeding a baby.

How should I take Lotrel?

Take Lotrel exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Lotrel can be taken with or without food. Space your doses evenly by taking the medication at the same times each day.

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 Lotrel, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Your blood pressure will need to be checked often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

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

Keep using Lotrel 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.

See also: Lotrel dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include feeling extremely dizzy or light-headed, or fainting.

What should I avoid while taking Lotrel?

Lotrel may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of Lotrel. Do not use salt substitutes or potassium supplements while taking Lotrel, unless your doctor has told you to.

Lotrel side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Lotrel: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Some side effects of Lotrel may not occur until after you have been using the medication for several months.

Call your doctor at once if you have any of these serious side effects:

• trouble swallowing;

• chest pain;

• feeling like you might pass out;

• urinating more or less than usual, or not at all;

• swelling, rapid weight gain;

• fever, chills, sore throat, body aches, flu symptoms; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Lotrel side effects may include:

• cough;

• dizziness, headache;

• sleep problems (insomnia);

• flushing (warmth, redness, or tingling under your skin);

• diarrhea, constipation;

• muscle pain; or

• loss of interest in sex.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Lotrel side effects (in more detail)

What other drugs will affect Lotrel?

Tell your doctor about all other medicines you use, especially:

• gold injections to treat arthritis;

• a shot for bee-sting allergy;

• lithium (Lithobid, Eskalith);

• a potassium supplement such as K-Dur, Klor-Con;

• salt substitutes that contain potassium; or

• a diuretic (water pill) such as amiloride (Midamor), bumetanide (Bumex), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), spironolactone (Aldactone), triamterene (Dyrenium, Maxzide, Dyazide), torsemide (Demadex).

This list is not complete and other drugs may interact with Lotrel. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.