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AURO-AMBRISENTAN is a brand name for Ambrisentan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Auro-Ambrisentan (ambrisentan tablets) is indicated for treatment of idiopathic (‘primary’) pulmonary arterial hypertension (IPAH) and pulmonary arterial hypertension (PAH) associated with connective tissue disease in adult patients with WHO functional class II or III symptoms. Auro-Ambrisentan should only be used by…
Verbatim from this product's HC label. Tap a section to expand.
). Patients with baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT)) >3x ULN (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, and 4 DOSAGE AND ADMINISTRATION).
Patients with idiopathic pulmonary fibrosis (IPF), with or without pulmonary hypertension. 1 Dosing Considerations Treatment should only be initiated by a physician experienced in the treatment of PAH. Assess liver function before starting Auro-Ambrisentan (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, and Monitoring and Laboratory Tests).
1 Pregnant Women). Auro-Ambrisentan is contraindicated in patients with severe hepatic impairment and those with baseline AST or ALT >3x ULN. 3 Pharmacokinetics, and Special Populations and Conditions, Hepatic Insufficiency). Patients with PAH associated with connective tissue disease may require 10 mg Auro-Ambrisentan Auro-Ambrisentan Page 5 of 34 for optimal efficacy.
Consider increasing the dose to 10 mg Auro-Ambrisentan providing the 5 mg dose is well tolerated (see 8 ADVERSE REACTIONS). 2 Recommended Dose and Dosage Adjustment Auro-Ambrisentan should be initiated at a dose of 5 mg once daily. Additional benefit may be obtained by increasing the dose to 10 mg once daily.
The maximum recommended daily dose is 10 mg. 4 Drug-Drug Interactions, Cyclosporine A). Auro-Ambrisentan can be administered with or without food. Safety and efficacy of Auro-Ambrisentan have not been established in patients under 18 years of age.
Health Canada has not authorized an indication for pediatric use (see 16 NON-CLINICAL TOXICOLOGY). No dose adjustment is required in patients aged 65 years and over. In clinical monotherapy studies, peripheral edema was reported as dose dependent and more common in patients≥65 years of age.
Renal metabolism and excretion of Auro-Ambrisentan is minimal, so dose adjustment is unlikely to be required in patients with renal impairment. 5 Missed Dose If a dose of Auro-Ambrisentan is missed, the patient should be advised to take it as soon as they remember, and then continue with the next dose at the regular interval.
Two doses should not be taken at the same time to make up for a missed dose.
). 2 Recommended Dose and Dosage Adjustment Auro-Ambrisentan should be initiated at a dose of 5 mg once daily. Additional benefit may be obtained by increasing the dose to 10 mg once daily. The maximum recommended daily dose is 10 mg.
4 Drug-Drug Interactions, Cyclosporine A). Auro-Ambrisentan can be administered with or without food. Safety and efficacy of Auro-Ambrisentan have not been established in patients under 18 years of age. Health Canada has not authorized an indication for pediatric use (see 16 NON-CLINICAL TOXICOLOGY).
No dose adjustment is required in patients aged 65 years and over. In clinical monotherapy studies, peripheral edema was reported as dose dependent and more common in patients≥65 years of age. Renal metabolism and excretion of Auro-Ambrisentan is minimal, so dose adjustment is unlikely to be required in patients with renal impairment.
5 Missed Dose If a dose of Auro-Ambrisentan is missed, the patient should be advised to take it as soon as they remember, and then continue with the next dose at the regular interval. Two doses should not be taken at the same time to make up for a missed dose.
5 OVERDOSAGE In healthy volunteers, single doses of 50 and 100 mg (5 to 10 times the maximum recommended dose) were associated with headache, flushing, dizziness, nausea, and nasal congestion. Due to the mechanism of action of ambrisentan, an overdosage of Auro-Ambrisentan could potentially result in hypotension.
In the case of pronounced hypotension, active cardiovascular support may be required. No specific antidote is available. For management of a suspected drug overdose, contact your regional poison control centre. Auro-Ambrisentan Page 6 of 34 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 Dosage forms, Strengths, Composition and Packaging Route of Administration Dosage Forms / Strengths / Composition Non-medicinal Ingredients Oral Tablet, 5 mg and 10 mg Cellulose microcrystalline, Croscarmellose sodium, FD&C Red #40 Aluminum Lake, Lactose monohydrate, Lecithin (soya), Macrogol, Magnesium Stearate, polyvinyl alcohol, Talc, Titanium dioxide.
, Hepatic/Biliary/Pancreatic, and 4 DOSAGE AND ADMINISTRATION). Patients with baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT)) >3x ULN (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, and 4 DOSAGE AND ADMINISTRATION).
Patients with idiopathic pulmonary fibrosis (IPF), with or without pulmonary hypertension. 1 Dosing Considerations Treatment should only be initiated by a physician experienced in the treatment of PAH. Assess liver function before starting Auro-Ambrisentan (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, and Monitoring and Laboratory Tests).
1 Pregnant Women). Auro-Ambrisentan is contraindicated in patients with severe hepatic impairment and those with baseline AST or ALT >3x ULN. 3 Pharmacokinetics, and Special Populations and Conditions, Hepatic Insufficiency). Patients with PAH associated with connective tissue disease may require 10 mg Auro-Ambrisentan Auro-Ambrisentan Page 5 of 34 for optimal efficacy.
Consider increasing the dose to 10 mg Auro-Ambrisentan providing the 5 mg dose is well tolerated (see
Auro-Ambrisentan is contraindicated in: Patients with a known or suspected hypersensitivity to Auro-Ambrisentan or any of the ingredients in the formulation (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). 1 Pregnant Women).
2 Breast-feeding ). Patients with severe hepatic impairment (with or without cirrhosis) (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, and
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ambrisentan in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
9 mm Square shaped convex tablets debossed with "AS" on one side and "5" on other side. 9 mm oval shaped convex tablets debossed with "AS" on one side and "10" on other side. Auro-Ambrisentan tablets are available in blister packs of 30 (3 x 10’s) tablets.
7 WARNINGS AND PRECAUTIONS Carcinogenesis and Mutagenesis There are no human data available (see 16 NON-CLINICAL TOXICOLOGY, Carcinogenesis and Mutagenesis). Driving and Operating Machinery There have been no studies to investigate the effect of ambrisentan on driving performance or the ability to operate machinery.
Further, a detrimental effect on such activities cannot be predicted from the pharmacology of the active substance. Fluid Retention Peripheral edema (fluid retention) has been observed with endothelin receptor antagonists (ERAs) including ambrisentan.
Peripheral edema may also be a clinical consequence of PAH. Ambrisentan induced a dose-dependent increased incidence of mild to moderate peripheral edema (see 8 ADVERSE REACTIONS). 2 Clinical Trial Adverse Reactions, Table 2). If patients have pre-existing fluid overload, this should be managed as clinically appropriate prior to starting Auro-Ambrisentan.
If clinically significant peripheral edema develops during therapy with Auro-Ambrisentan, with or without associated weight gain, further evaluation should be undertaken to determine the cause, such as the use of Auro-Ambrisentan or the existence of underlying heart failure.
The possible need for specific treatment or discontinuation of Auro-Ambrisentan therapy should also be evaluated. Hematologic The development of drug -related decreases in hemoglobin concentration and hematocrit has been associated with administration of endothelin receptor antagonists and was observed in clinical studies Auro-Ambrisentan Page 7 of 34 with ambrisentan in monotherapy.
There have been cases where this has resulted in anemia requiring transfusion. These decreases were generally observed within the first few weeks of treatment with ambrisentan, and stabilized thereafter (see 8 ADVERSE REACTIONS). Initiation of Auro-Ambrisentan is not recommended for patients with clinically significant anemia (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Hepatic/Biliary/Pancreatic Liver function abnormalities have been associated with pulmonary arterial hypertension. Hepatic enzyme elevations potentially related to therapy have been observed with endothelin receptor antagonists (ERAs).
Therefore, hepatic function should be evaluated prior to initiation of Auro-Ambrisentan. Monitor liver function as clinically indicated for patients with normal liver function or mild hepatic impairment. Initiation of Auro-Ambrisentan is contraindicated for patients with aminotransferase (alanine aminotransferase, ALT or aspartate aminotransferase, AST) concentrations greater than 3 times the upper limit of normal (>3x ULN) or patients with severe hepatic impairment.
Auro-Ambrisentan should be used with caution in patients with moderate hepatic impairment and monthly monitoring of ALT and AST is recommended (see 4 DOSAGE AND ADMINISTRATION, and 10 CLINICAL PHARMACOLOGY). Although the incidence of aminotransferase abnormalities was low, the possibility of serum aminotransferase elevations associated with ambrisentan administration cannot be excluded.
Therefore […]