Ambrisan Tablet
Ambrisentan
5mg
Square Pharmaceuticals PLC.
| Pack size | 20's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 40.13 AED |
Indications
Ambrisan Tablet is used for:
Pulmonary Arterial Hypertension
Adult Dose
Oral
Tablet
Indicated for WHO group 1 PAH to 1) improve exercise ability and delay clinical worsening; and 2) in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability
Initiate treatment at 5 mg PO once daily, with or without tadalafil 20 mg PO once daily
At 4-week intervals, either ambrisentan or tadalafil dose can be increased, as needed and tolerated, not to exceed ambrisentan 10 mg/day or tadalafil 40 mg/day
Coadministration with cyclosporine: Limit ambrisentan to 5 mg/day
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
Mild-to-moderate: No dosage adjustment required
Severe: Not studied
Hemodialysis: Not studied
Administration
May be taken with or without food: Swallow whole.
Contra Indications
Ambrisentan may cause fetal harm when administered to a pregnant woman. Ambrisentan is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Pregnancy must be excluded before the initiation of treatment with Ambrisentan and prevented during treatment and for one month after stopping treatment. Ambrisentan is contraindicated in patients with Idiopathic Pulmonary Fibrosis (IPF) including IPF patients with pulmonary hypertension (WHO Group 3).
Precautions
Embryo-fetal toxicity
Do not administer ambrisentan to a pregnant female because it may cause fetal harm
Females of reproductive potential: Exclude pregnancy before starting treatment, monthly during treatment, and 1 month after stopping treatment
Prevent pregnancy during treatment and for 1 month after stopping treatment by using acceptable methods of contraception
Fluid retention may require intervention.
• If patients develop acute pulmonary edema during initiation of therapy with Letairis, consider underlying pulmonary venoocclusive disease and discontinue treatment if necessary.
• Decreases in sperm count have been observed in patients taking endothelin receptor antagonists.
• Decreases in hemoglobin have been observed within the first few weeks
Monitoring Parameters
Monitor haemoglobin concentration or haematocrit after 1 month and 3 months of starting treatment, and periodically thereafter (reduce dose or discontinue
treatment if significant decrease in haemoglobin concentration or haematocrit observed).
Monitor liver function before treatment, and monthly thereafter—discontinue if liver enzymes raised significantly or if symptoms of liver impairment develop.
Pregnancy-Lactation
Pregnancy
Based on data from animal reproduction studies, fetal harm may occur when administered to a pregnant woman and is contraindicated during pregnancy
There are limited data on use in pregnant women
Advise patient of the potential hazard to a fetus
Animal data
In animal reproduction studies, ambrisentan was teratogenic in rats and rabbits at doses which resulted in exposures of 3.5 and 1.7 times, respectively, the human dose of 10 mg/day
Contraception
Female patients of reproductive potential must use acceptable methods of contraception during treatment and for 1 month after stopping treatment
Patients should choose one highly effective form of contraception (intrauterine device [IUD], contraceptive implant, or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods)
If a partner’s vasectomy is one method of contraception, a hormone or barrier method must be used along with this method
Counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling
Infertility
Males: Based on findings and preclinical data, endothelin receptor antagonists have an adverse effect on spermatogenesis; counsel patients about the potential effects on fertility
Lactation
Unknown whether present in human milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Cyclosporine
Exposure to ambrisentan may be increased (approximately 2-fold). Limit the dosage of ambrisentan to 5 mg daily with coadministration.
Rifampin
Coadministration was associated with a 2-fold increase in ambrisentan AUC. Use with caution.
Contraindicated (1)
sparsentan
Serious - Use Alternative (11)
apalutamide
ceftobiprole medocaril sodium
cyclosporine
enasidenib
idelalisib
lasmiditan
leniolisib
lonafarnib
sotorasib
tepotinib
trofinetide
Adverse Effects
Side effects of Ambrisentan :
>10%
Peripheral edema (17%),Headache (15%)
1-10%
Nasal congestion (6%),Palpitations (5%),Constipation (4%),Dyspnea (4%),Flushing (4%),Abdominal pain (3%),Nasopharyngitis (3%),Sinusitis (3%)
Mechanism of Action
High affinity endothelin (ETa) receptor subtype antagonist, resulting in inhibition of vasoconstriction.
Note
Ambrisan 5mg Tablet manufactured by Square Pharmaceuticals PLC.. Its generic name is Ambrisentan. Ambrisan is availble in Bangladesh.
Farmaco BD drug index information on Ambrisan Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.