"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
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.
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.
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.
Concomitant Use With Other Cardiovascular Agents
- Sublingual NTG. May be taken as required to abort acute anginal attacks during CARDIZEM CD (diltiazem hydrochloride) therapy.
- Prophylactic Nitrate Therapy. CARDIZEM CD may be safely coadministered with short- and long-acting nitrates.
- Beta-blockers (see WARNINGS AND PRECAUTIONS).
- Antihypertensives. CARDIZEM CD has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of CARDIZEM CD or the concomitant antihypertensives may need to be adjusted when adding one to the other.
|CARDIZEM® CD (diltiazemhydrochloride)|
|Capsules Strength||Quantity||NDC Number||Description|
|240 mg||bottles of 60||54868-2149-0||Blue/blue capsule imprinted with cardizem CD and 240 mg on one end.|
Storage Conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity.
Manufactured by: s anofi-aventis U.S. LLC, Kansas City, MO, 64137, USA. For: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, 08807, USA. Revised: Nov 2010This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/29/2016
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