Calculation of Largest Recomended Daily Dose in units

Name of the product is diltiazem HCl

DOSAGE AND ADMINISTRATION Patients controlled on diltiazem alone or in combination with other medications may be switched to Cardizem CD capsules at the nearest equivalent total daily dose. Higher doses of Cardizem CD may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose. Hypertension. Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. Angina. Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.

Strengths are 120 mg,180 mg,240 mg,300 mg and 360 mg.

Maximum daily dose is 540 mg.

How to calculate Largest recommended Daily Dose of Product ‘B’ (in units) ?

Please clarify me.

Dear Vadla,

First thing to know the purpose of calculating maximum dose per day.

The maximum recommended dose per day in 480 mg, however during clinical trials upto 540 mg has been used. different strengths are useful for adjusting the dose as per patient’s need & dose titration requirement. i.e. for lowest titration dose (120mg) 1 unit of 120 mg can be given.

deepa