Ambrisentan Tablet, Film Coated
Product Images NDC 47335-237

NDC 47335-237-83 is a prescription drug called Ambrisentan Tablets that comes in a pack of 30 tablets. A medication guide is provided separately to each patient.*

This is a label of Ambrisentan Tablets with NDC 47335-236-83, containing 30 tablets. It indicates that the medication guide will be provided separately to each patient by the pharmacist.*

Ambrisentan is a prescription drug contained in 10mg film-coated tablets. It is dispensed with a medication guide, and the pharmacist should provide one separately to each patient. The tablets should not be crushed, chewed, or split. It is important to store the medication between 20°C and 25°C (68°F to 77°F) with permitted excursions between 15°C and 30°C (59°F and 86°F). Sun Pharmaceutical Industries Limited manufactures this medication in India. The dosage should be as per the prescribing physician's direction, which is not included in this text. Keep the medication out of reach of children.*

Ambrisentan Tablets are prescription only medications with NDC number 47335-236-66. The medication guide provided separately should be dispensed by the pharmacist to each patient. The tablets are film-coated and each tablet has 5 mg of ambrisentan. Do not split, crush, or chew the tablets. The usual dosage should be confirmed by referring to the prescribing information for dosage and administration. Store the tablets at a controlled room temperature between 20° to 25°C (68° 0 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. The medication should be kept out of reach of children. Sun Pharmaceutical Industries Ltd., India, manufactures the tablets.*

This is a chart showing the effects of other drugs on Ambrisentan's pharmacokinetics. It lists the fold change and recommendation for each drug that interacts with Ambrisentan, such as Cyclosporine, Mycophenolate Mofetil, Ketoconazole, Omeprazole, Rifampin, Ritonavir, Sildenafil, Tacrolimus, Tadalafil, and Warfarin. The chart also provides information on the relationship between the drugs' Cmax and AUC and whether they require dose adjustments. The chart notes that a transient increase in AUC was observed for Rifampin on Day 3 of co-administration, but it was no longer evident by Day 7.*

This text provides information on the effects of Ambrisentan on other drugs such as Cyclosporine, Ethinylestradiol, and Warfarin among others. The effects are measured using PK (pharmacokinetic) parameters such as Cmax and AUC. The text also suggests that there is no need for dose adjustment when using Ambrisentan with these drugs.*

This is a figure showing the mean change in 6-minute walk distance for two studies (ARIES-1 and ARIES-2). The figure includes a graph with the baseline and the 4th, 8th, and 12th week measurements for each study. It compares the placebo group's results in both studies. The units for the measurement of the walk distance are in meters.*

The text shows a figure labeled "Time to Clinical Worsening" in two separate trials, ARIES-1 and ARIES-2. The figure displays time in weeks on the x-axis and the percentage of patients not experienced clinical worsening on the y-axis. Two groups are plotted in each trial: the Ambrisentan group and the Placebo group. The figure also shows P-values for ARIES-1. However, more context is needed to understand the clinical significance of these results.*