Mavik Indications, Dosage, Storage, Stability - Trandolapril

Mavik Indications, Dosage, Storage, Stability - Trandolapril

INDICATIONS AND USAGE

MAVIK is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide.

In considering the use of MAVIK, it should be noted that in controlled trials ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. (See Warnings: Angioedema.)

When using MAVIK, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, cap-topril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that MAVIK does not have a similar risk. (See WARNINGS.)

MAVIK is indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocar-dial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (See CLINICAL PHARMACOLOGY, Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for details of the survival trial.)

The recommended initial dosage of MAVIK for patients not receiving a diuretic is 1 mg once daily in non-black patients and 2 mg in black patients. Dosage should be adjusted according to the blood pressure response. Generally, dosage adjustments should be made at intervals of at least 1 week. Most patients have required dosages of 2 to 4 mg once daily. There is little clinical experience with doses above 8 mg.

Patients inadequately treated with once-daily dosing at 4 mg may be treated with twice-daily dosing. If blood pressure is not adequately controlled with MAVIK monotherapy, a diuretic may be added.

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of MAVIK. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with MAVIK^®. (See WARNINGS.) Then, if blood pressure is not controlled with MAVIK alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 0.5 mg MAVIK should be used with careful medical supervision for several hours until blood pressure has stabilized. The dosage should subsequently be titrated (as described above) to the optimal response. (See WARNINGS, PRECAUTIONS, and DRUG INTERACTIONS.) Concomitant administration of MAVIK with potassium supplements, potassium salt substitutes, or potassium sparing diuretics can lead to increases of serum potassium. (See PRECAUTIONS.)

The recommended starting dose is 1 mg, once daily. Following the initial dose, all patients should be titrated (as tolerated) toward a target dose of 4 mg, once daily. If a 4 mg dose is not tolerated, patients can continue therapy with the greatest tolerated dose.

For patients with a creatinine clearance <30 mL/min. or with hepatic cirrhosis, the recommended starting dose, based on clinical and pharmacokinetic data, is 0.5 mg daily. Patients should subsequently have their dosage titrated (as described above) to the optimal response.

MAVIK^® (trandolapril tablets) are supplied as follows:

1 mg tablet – salmon colored, round shaped, scored, compressed tablets, with aon one side and Abbo-Code identification letters FT on the other side.

NDC 0074-2278-13 - bottles of 100

NDC 0074-2278-11 - unit dose packs of 100

2 mg tablet – yellow colored, round shaped, compressed tablets with aon one side and Abbo-Code identification letters FX on the other side.

NDC 0074-2279-13 - bottles of 100

NDC 0074-2279-11 - unit dose packs of 100

4 mg tablet – rose colored, round shaped, compressed tablets, with aon one side and Abbo-Code identification letters FZ on the other side.

NDC 0074-2280-13 - bottles of 100) NDC 0074-2280-11 - unit dose packs of 100 Dispense in well-closed container with safety closure.

Storage: Store at controlled room temperature: 20-25°C (68-77°F) see USP. Revised: September, 2001 Ref.: 03-5144

ABBOTT LABORATORIES, NORTH CHICAGO, IL 60064, U.S.A., 02A-620-2311-1 MASTER

Updated Apr 09, 2004