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Trandolapril

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(CAS: 87679-37-6)

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CAS: 87679-37-6

Chemical Name: benzeneacetonitrile, (alpha)[3-[[2-(3,4-dimethoxyphenyl) ethyl] methylamino] propyl]-3,4-dimethoxy-(alpha)-(1-methylethyl) hydrochloride.

Trade Name: TARKA (Abbott)

Molecular Formula: C27H38N2O4.HCl

Structure of trandolapril:

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

# Do not take trandolapril if you are pregnant or could become pregnant. When used during the second and third trimesters of pregnancy, trandolapril can cause injury and even death to the developing baby. Notify your doctor immediately if you think you might be pregnant.
# Trandolapril may increase the risk of dangerous allergic reactions. Before taking trandolapril, tell your doctor if you have ever had an allergic reaction that involved swelling of your lips, face, tongue, or throat or difficulty breathing. Seek emergency medical attention if you develop any of these symptoms while taking trandolapril.
# Use caution when driving, operating machinery, or performing other hazardous activities. Trandolapril may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities and notify your doctor. Also use caution when rising from a sitting or lying position.
# Heavy sweating, vomiting, diarrhea, or other causes of fluid loss may lead to very low blood pressure, dizziness, and fainting during therapy with trandolapril. Maintain proper fluid intake to prevent dehydration and related side effects.

What is trandolapril?

# Trandolapril is in a class of drugs called angiotensin-converting-enzyme inhibitors (ACE inhibitors).
# Trandolapril is used to lower high blood pressure.
# Trandolapril may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking trandolapril?

# Trandolapril may increase the risk of dangerous allergic reactions. Before taking trandolapril, tell your doctor if you have ever had an allergic reaction that involved swelling of your lips, face, tongue, or throat or difficulty breathing. Seek emergency medical attention if you develop any of these symptoms while taking trandolapril.
# Before taking trandolapril, tell your doctor if you
, have kidney disease;
, have liver disease;
, are on a salt-restricted diet or have high levels of potassium in your blood;
, are using a salt substitute or taking a potassium supplement (e.g., K-Dur, Klor-Con) or a potassium-sparing diuretic such as amiloride (Midamor), triamterene (Dyrenium, Dyazide, Maxzide), or spironolactone (Aldactone);
, have diabetes;
, have scleroderma or lupus; or
, have any type of heart disease or have had a stroke.
# You may not be able to take trandolapril, or you may require a dosage adjustment special monitoring during treatment if you have any of the conditions listed above.
# Trandolapril is in the FDA pregnancy category D. This means that trandolapril is known to be harmful to an unborn baby. When used during the second and third trimesters of pregnancy, trandolapril can cause injury and even death to the developing baby.Do not take trandolapril if you are pregnant or could become pregnant during treatment.
# It is not known whether trandolapril passes into breast milk. Do not take trandolapril without first talking to your doctor if you are breast-feeding a baby.

How should I take trandolapril?

#Take trandolapril exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
# Take each dose with a full glass of water.
# Trandolapril can be taken with or without food.
# Do not stop taking this medication without first talking to your doctor. If you stop taking this medication suddenly, your condition could become worse.
# Store trandolapril at room temperature away from moisture and heat.

What happens if I miss a dose?

# Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

# Seek emergency medical attention.
# Symptoms of an overdose of trandolapril include extreme dizziness, weakness, fainting, and fatigue.

What should I avoid while taking trandolapril?

# Use caution when driving, operating machinery, or performing other hazardous activities. Trandolapril may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities and notify your doctor. Also use caution when rising from a sitting or lying position.
# Use alcohol cautiously. Alcohol may further lower blood pressure and increase drowsiness and dizziness while taking trandolapril.
# Do not use salt substitutes or potassium supplements while taking trandolapril except under the direction of your doctor.
# Heavy sweating, vomiting, diarrhea, or other causes of fluid loss may lead to very low blood pressure, dizziness, and fainting during therapy with trandolapril. Maintain proper fluid intake to prevent dehydration and related adverse effects.

What are the possible side effects of trandolapril?

# If you experience any of the following serious side effects, stop taking trandolapril and call your doctor immediately or seek emergency medical treatment:
, an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
, little or no urine;
, chest pain;
, an irregular heartbeat or changes in your heartbeat;
, severe dizziness or fainting; or
, signs of an infection including a sore throat or a fever.
# Other, less serious side effects may be more likely to occur. Continue to take trandolapril and talk to your doctor if you experience
, headache, dizziness, or lightheadedness;
, fatigue;
, dry, tickling cough;
, anxiety;
, weakness, numbness, or tingling in the hands, feet, arms, or legs;
, nausea, diarrhea, or constipation;
, taste disturbances; or
, itching, rash, or increased sweating.
# Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect trandolapril?

# Before taking trandolapril, tell your doctor if you are taking any of the following drugs:
, a potassium supplement such as K-Dur, Klor-Con, and others;
, a salt substitute that contains potassium;
, the diuretic (water pill) triamterene (Dyrenium, Maxzide, Dyazide), spironolactone (Aldactone), or amiloride (Midamor);
, any other diuretic (water pill) such as hydrochlorothiazide (HCTZ, HydroDiuril, others), furosemide (Lasix), bumetanide (Bumex), indapamide (Lozol), and others;
, lithium (Lithobid, Eskalith, others);
, digoxin (Lanoxin);
, indomethacin (Indocin);
, heparin; or
, cyclosporine (Neoral, Sandimmune).
# You may not be able to take trandolapril, or you may require a dosage adjustment or special monitoring treatment if you are taking any of the medicines listed above.
# Drugs other than those listed here may also interact with trandolapril or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

What is the recommend dosage of trandolapril?

The recommended usual dosage range of trandolapril for hypertension is 1 to 4 mg per day administered in a single dose or two divided doses. The recommended usual dosage range of Isoptin-SR for hypertension is 120 to 480 mg per day administered in a single dose or two divided doses.

The hazards (see WARNINGS ) of trandolapril are generally independent of dose; those of verapamil are a mixture of dose-dependent phenomena (primarily dizziness, AV block, constipation) and dose-independent phenomena, the former much more common than the latter. Therapy with any combination of trandolapril and verapamil will thus be associated with both sets of dose-independent hazards. The dose-dependent side effects of verapamil have not been shown to be decreased by the addition of trandolapril nor visa versa.

Rarely, the dose-independent hazards of trandolapril are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with trandolapril only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy at its respective maximally recommended dose and shortest dosing interval, or (b) the dose of one or the other monotherapy cannot be increased further because of dose-limiting side effects.

Clinical trials with trandolapril have explored only once-a-day doses. The antihypertensive effect and or adverse effects of adding 4 mg of trandolapril once-a-day to a dose of 240 mg Isoptin-SR administered twice-a-day has not been studied, nor have the effects of adding as little of 180 mg Isoptin-SR to 2 mg trandolapril administered twice-a-day been evaluated. Over the dose range of Isoptin-SR 120 to 240 mg once-a-day and trandolapril 0.5 to 8 mg once-a-day, the effects of the combination increase with increasing doses of either component.

Replacement therapy: For convenience, patients receiving trandolapril (up to 8 mg) and verapamil (up to 240 mg) in separate tablets, administered once-a-day, may instead wish to receive tablets of trandolapril containing the same component doses.

Trandolaprilshould be administered with food.

Where can I get more information about trandolapril?

# Your pharmacist has additional information about trandolapril written for health professionals that you may read.