"The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure."...
ATACAND is indicated for the treatment of heart failure (NYHA class II-IV) in adults with left ventricular systolic dysfunction (ejection fraction ≤ 40%) to reduce cardiovascular death and to reduce heart failure hospitalizations [see Clinical Studies]. ATACAND also has an added effect on these outcomes when used with an ACE inhibitor.
DOSAGE AND ADMINISTRATION
Dosage must be individualized. Blood pressure response is dose related over the range of 2 to 32 mg. The usual recommended starting dose of ATACAND is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Larger doses do not appear to have a greater effect, and there is relatively little experience with such doses. Most of the antihypertensive effect is present within 2 weeks, and maximal blood pressure reduction is generally obtained within 4 to 6 weeks of treatment with ATACAND.
Use in Hepatic Impairment: Initiate with 8 mg ATACAND in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see CLINICAL PHARMACOLOGY].
ATACAND may be administered with or without food.
If blood pressure is not controlled by ATACAND alone, a diuretic may be added. ATACAND may be administered with other antihypertensive agents.
Pediatric Hypertension 1 to < 17 Years of age
ATACAND may be administered once daily or divided into two equal doses. Adjust the dosage according to blood pressure response. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate ATACAND under close medical supervision and consider administration of a lower dose [see WARNINGS AND PRECAUTIONS].
Children 1 to < 6 years of age
The dose range is 0.05 to 0.4 mg/kg per day. The recommended starting dose is 0.20 mg/kg (oral suspension).
Children 6 to < 17 years of age
For those less than 50 kg, the dose range is 2 to 16 mg per day. The recommended starting dose is 4 to 8 mg.
For those greater than 50 kg, the dose range is 4 to 32 mg per day. The recommended starting dose is 8 to 16 mg.
Doses above 0.4 mg/kg (1 to < 6 year olds) or 32 mg (6 to < 17 year olds) have not been studied in pediatric patients [see Clinical Studies].
An antihypertensive effect is usually present within 2 weeks, with full effect generally obtained within 4 weeks of treatment with ATACAND.
Children < 1 year of age must not receive ATACAND for hypertension.
All pediatric patients with a glomerular filtration rate less than 30 ml/min/1.73m² should not receive ATACAND since ATACAND has not been studied in this population [see Special Populations].
For children who cannot swallow tablets, an oral suspension may be substituted as described below:
Preparation of Oral Suspension
ATACAND oral suspension can be prepared in concentrations within the range of 0.1 to 2.0 mg/mL. Typically, a concentration of 1 mg/mL will be suitable for the prescribed dose. Any strength of ATACAND tablets can be used in the preparation of the suspension.
Follow the steps below for preparation of the suspension. The number of tablets and volume of vehicle specified below will yield 160 mL of a 1 mg/mL suspension.
- Prepare the vehicle by adding equal volumes of 1Ora-Plus®(80 mL) and 1Ora-Sweet SF®(80 mL) or, alternatively, use 1,2Ora-Blend SF®(160 mL).
- Add a small amount of vehicle to the required number of ATACAND tablets (five 32 mg tablets) and grind into a smooth paste using a mortar and pestle.
- Add the paste to a preparation vessel of suitable size.
- Rinse the mortar and pestle clean using the vehicle and add this to the vessel. Repeat, if necessary.
- Prepare the final volume by adding the remaining vehicle.
- Mix thoroughly.
- Dispense into suitably sized amber PET bottles.
- Label with an expiry date of 100 days and include the following instructions:
Store at room temperature (below 30°C/86°F). Use within 30 days after first opening. Do not use after the expiry date stated on the bottle.
Do not freeze.
Shake well before each use.
Adult Heart Failure
The recommended initial dose for treating heart failure is 4 mg once daily. The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient.
Dosage Forms And Strengths
4 mg are white to off-white, circular/biconvex-shaped, non-film-coated scored tablets, coded ACF on one side and 004 on the other.
8 mg are light pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACG on one side and 008 on the other.
16 mg are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACH on one side and 016 on the other.
32 mg are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACL on one side and 032 on the other.
Storage And Handling
No. 3782 — Tablets ATACAND, 4 mg, are white to off-white, circular/biconvex-shaped, non-film-coated scored tablets, coded ACF on one side and 004 on the other. They are supplied as follows:
NDC 0186-0004-31 unit of use bottles of 30.
No. 3780 — Tablets ATACAND, 8 mg, are light pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACG on one side and 008 on the other. They are supplied as follows:
NDC 0186-0008-31 unit of use bottles of 30.
No. 3781 — Tablets ATACAND, 16 mg, are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACH on one side and 016 on the other. They are supplied as follows:
NDC 0186-0016-31 unit of use
bottles of 30
NDC 0186-0016-54 unit of use bottles of 90
NDC 0186-0016-28 unit dose packages of 100.
No. 3791 — Tablets ATACAND, 32 mg, are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACL on one side and 032 on the other. They are supplied as follows:
NDC 0186-0032-31 unit of use
bottles of 30
NDC 0186-0032-54 unit of use bottles of 90
NDC 0186-0032-28 unit dose packages of 100.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
Manufactured under the license from Takeda Pharmaceutical Company, Ltd. by: AstraZeneca AB, S-151 85 Sodertalje, Sweden for: AstraZeneca LP, Wilmington, DE 19850. Revised: Apr 2013.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/20/2015
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