Diltiazem; Enalapril tablets

What are diltiazem-enalapril tablets?

DILTIAZEM-ENALAPRIL (Teczem®) is a combination of two drugs used to lower blood pressure. They lower, but do not cure high blood pressure. Generic diltiazem-enalapril tablets are not yet available.

NOTE: This drug is discontinued in the United States.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• autoimmune disease (such as lupus), or suppressed immune function

• previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat (angioedema)

• bone marrow disease

• heart or blood vessel disease

• liver disease

• low blood pressure

• kidney disease

• if you are on a special diet, such as a low-salt diet

• an unusual or allergic reaction to enalapril, diltiazem, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

• difficulty swallowing (or narrowing of the esophagus)

How should I take this medicine?

Take diltiazem; enalapril tablets by mouth. Follow the directions on the prescription label. Swallow the tablets whole with a drink of water, do not break, crush or chew. Do not significantly increase grapefruit juice intake while taking this drug, or avoid grapefruit juice if possible. Take diltiazem; enalapril regularly. Do not take your medicine more often than directed. Do not stop taking except on your prescriber's advice.

You may notice something in your stool that looks like a tablet. The medication in Teczem® is contained in a outer shell that has been specially designed to slowly release the drug in the stomach. Once this process is finished, the empty shell is eliminated from the body.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

Elderly patients over 65 years old may have a stronger reaction to this medicine and need smaller doses.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with Diltiazem; Enalapril?

Do not take Diltiazem; Enalapril with any of the following:

• alfuzosin

• astemizole

• cisapride

• grapefruit juice

• pimozide

• substitute salts which contain potassium

• terfenadine

Diltiazem-enalapril may also interact with the following medications:

• alosetron

• antiinflammatory drugs (NSAIDs, such as ibuprofen)

• aspirin

• azathioprine

• barbiturates such as phenobarbital

• bee venom (hymenoptera venom)

• bosentan

• certain antibiotics (clarithromycin, erythromycin, telithromycin, trimethoprim, troleandomycin)

• certain drugs used to treat cancer

• certain medicines to treat migraine (ergotamine, dihydroergotamine, methysergide)

• cevimeline

• cilostazol

• cimetidine

• clonidine

• cyclosporine

• doxercalciferol

• drospirenone; ethinyl estradiol

• fentanyl

• galantamine

• gold compounds, often used for arthritis

• heparin

• herbal or dietary supplements such as ginger, ginkgo biloba, ginseng, hawthorn, ma huang (ephedra), melatonin, St. John's wort, red yeast rice

• lithium

• local anesthetics or general anesthetics

• medicines for anxiety or difficulty sleeping (examples: alprazolam, buspirone, midazolam, triazolam)

• medicines for depression or mental problems (imipramine, fluoxetine, fluvoxamine, nefazodone, ziprasidone)

• medicines for diabetes

• medicines for fungal infections (fluconazole, itraconazole, ketoconazole, voriconazole)

• medicines for heart-rhythm problems (amiodarone, digoxin, disopyramide, dofetilide, encainide, flecainide, moricizine, procainamide, quinidine)

• medicines for high cholesterol (atorvastatin, cerivastatin, colesevelam, lovastatin, simvastatin)

• medicines for high blood pressure or heart problems

• medicines for HIV infection or AIDS

• medicines for prostate problems

• medicines for seizures (carbamazepine, clonazepam, ethosuximide, phenobarbital, phenytoin, zonisamide)

• methadone

• monoamine oxidase inhibitors (Azilect®, Eldepryl®, Emsam®, Marplan®, Nardil®, Parnate®, Zelapar™)

• paricalcitol

• potassium salts (examples: potassium chloride, potassium gluconate)

• rifampin, rifabutin, or rifapentine

• sildenafil

• sirolimus

• sodium ferric gluconate complex

• tacrolimus

• theophylline or aminophylline

• water pills or diuretics (especially amiloride, triamterene, or spironolactone)

• yohimbine

• zafirlukast

• zileuton

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking diltiazem-enalapril?

Check your blood pressure and pulse rate regularly; this is important while you are taking diltiazem-enalapril. Ask your prescriber or health care professional what your blood pressure and pulse rate should be and when you should contact him or her.

You may feel dizzy or lightheaded. Do not drive, use machinery, or do anything that needs mental alertness until you know how diltiazem-enalapril affects you. To reduce the risk of dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Avoid alcoholic drinks; they can make you more dizzy or increase flushing and rapid heartbeats.

Do not suddenly stop taking diltiazem-enalapril. Ask your prescriber or health care professional how you can gradually reduce the dose.

If you are going to have surgery, tell your prescriber or health care professional that you are taking diltiazem-enalapril.

Check with your prescriber or health care professional if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of body fluid can make it dangerous to take diltiazem-enalapril.

Avoid salt substitutes or other foods or substances high in potassium salts.

Do not treat yourself for coughs, colds, or pain while you are taking diltiazem-enalapril without asking your prescriber for advice.

Diltiazem infrequently can cause dental problems for some patients. Clean and floss your teeth carefully and regularly. Check with your dentist if your gums get swollen or inflamed and have the dentist clean your teeth regularly.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child, particularly in the second or third trimester. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from taking diltiazem-enalapril?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• swelling of your face, lips, or tongue

• cough that is dry and persistent

• dizziness, lightheadedness, confusion, or fainting spells

• decreased amount of urine passed

• difficulty breathing, or swallowing

• fast or uneven heartbeat, chest pain, palpitations

• persistent muscle pain

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• skin rash, itching

• swelling of your legs or ankles

• sore throat with fever

• tingling, burning or numbness in the fingers and toes

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• drowsiness

• flushed or reddened skin

• headache

• nausea

• weakness or tiredness

• diarrhea or constipation

• increased sensitivity to sunlight

• change in taste sensation

• overgrowth of the gums

• sexual dysfunction

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15—30 degrees C (59—86 degrees F). Protect from moisture and light. Keep container tightly closed. Throw away any unused medicine after the expiration date.