Embelin 5

Introduction
Embelin 5 is a prescription medicine used to treat pulmonary arterial hypertension (high pressure in the blood vessels that carry blood from the heart to the lungs). It even helps to improve your quality of life, exercising ability and delay in disease progression. This medication may be taken with or without food and It is better to take it in a dose and duration as advised by the doctor. In case, you have missed any dose than it is better to take another one as soon as you remember it. Dizziness may occur as its side effect, so do not drive or do anything that requires mental focus.

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Uses of Embelin 5
Pulmonary arterial hypertension (PAH)
Side effects of Embelin 5
Common
Headache
Dizziness
Palpitations
Breathlessness
Runny nose
Feeling sick
Diarrhea
Fatigue
How to use Embelin 5
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Embelin 5 may be taken with or without food, but it is better to take it at a fixed time.
How Embelin 5 works
Embelin 5 is an endothelin receptor blocker. It blocks the action of endothelin (a natural substance) that causes blood vessels to narrow (constrict). This narrowing increases the pressure in the blood vessels of the lungs. Embelin 5 helps relax these blood vessels and increases the supply of blood to the lungs.
What if you forget to take Embelin 5?
If you miss a dose of Embelin 5, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
Your doctor has prescribed Embelin 5 to treat high pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries).
It helps improve your quality of life, exercising ability, and delay disease progression.
Your doctor may ask you to get routine blood tests done to check for anemia and to assess the functioning of your liver.
Do not drive or do anything requiring concentration until you know how Embelin 5 affects you.
Notify your doctor if you are pregnant or planning to conceive or breastfeeding.
Females with reproductive potential should use a reliable form of birth control while using and 1 month after stopping Embelin 5 as it is toxic to an unborn baby.
Inform your doctor if you notice weight gain, swelling of your arms and legs, or difficulty breathing.
Brief Description
Indication
Pulmonary Arterial Hypertension
Administration
May be taken with or without food: Swallow whole.
Adult Dose
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 qDay, with or without tadalafil 20 mg PO qDay 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 Hepatic impairment: Ambrisentan is not recommended in patients with moderate or severe hepatic impairment.

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Child Dose
Safety and efficacy not established

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Renal Dose
Dose adjustment in patients with mild or moderate renal impairment is therefore not required. There is no information on the exposure to ambrisentan in patients with severe renal impairment.

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Contraindication
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).
Mode of Action
High affinity endothelin (ETa) receptor subtype antagonist, resulting in inhibition of vasoconstriction.
Precaution
Fluid Retention: Peripheral oedema has been observed with ERAs including ambrisentan. It is also a clinical consequence of PAH and worsening PAH. Pulmonary Veno-occlusive Disease: If patients develop acute pulmonary edema during initiation of therapy with vasodilating agents such as Ambrisentan, the possibility of pulmonary veno-occlusive disease should be considered, and if confirmed. Ambrisentan should be discontinued. Hematological Changes: Decreases in hemoglobin concentration and hematocrit have followed administration of other endothelin receptor antagonists and were observed in clinical studies with Ambrisentan. Lactation: Excretion in milk unknown; not recommended

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Side Effect
>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%)

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Pregnancy Category Note
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

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Interaction
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.

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