Ambrican 5 Mg Tablet (10 Tab)

AMBRICAN 5 MG TABLET

AMBRICAN 5 MG TABLET by LUPIN LTD. is a medication primarily used for the management of pulmonary arterial hypertension (PAH).

Name

• Brand Name: AMBRICAN 5 MG TABLET
• Common Name (Active Ingredient): Ambrisentan

Composition

Each tablet contains Ambrisentan 5 mg.

Uses

AMBRICAN 5 MG TABLET is prescribed for the treatment of Pulmonary Arterial Hypertension (PAH), specifically WHO Group 1, in adults. It works by blocking endothelin-1, a substance that narrows blood vessels, thereby relaxing and widening the pulmonary arteries.

• Medical Conditions:
  • Treats high blood pressure in the arteries connecting the heart and lungs (Pulmonary Arterial Hypertension).
• Benefits:
  • Improves exercise ability and delays clinical worsening.
  • Decreases high blood pressure in lung arteries.
  • Reduces the workload on the heart.
  • Can be used alone (monotherapy) or in combination with other PAH medications, such as tadalafil.

Dosage and Administration

• Typical Dosage: The usual starting dose for adults is 5 mg once daily. The dose may be increased to 10 mg once daily, as needed and tolerated, at 4-week intervals.
• Administration:
  • Swallow the tablet whole with water; do not split, crush, or chew.
  • Can be taken with or without food.
  • If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue your regular schedule. Do not double the dose.
• Pediatric Use: Safety and efficacy have not been established for patients under 18 years of age.

Side Effects

• Common Side Effects: Headache, dizziness, swelling in hands, legs, ankles, or feet (peripheral edema), palpitations, breathlessness, chest pain or discomfort, stuffy nose or sinus pain (nasal congestion, sinusitis), flushing (redness of the skin), feeling sick (nausea), diarrhea, feeling tired (fatigue), and rash.
• Serious Side Effects: These may include severe swelling, difficulty breathing or swallowing, sudden weight gain, extreme tiredness, yellowing of the skin or eyes (jaundice), dark urine, severe itching, liver damage or elevated liver enzymes, anemia (low red blood cell count), decreased white blood cell count, acute pulmonary edema, and severe allergic reactions (e.g., breathing problems, wheezing, swelling of the face/lips/tongue). Decreases in sperm count have also been observed.

Precautions

• Pregnancy: AMBRICAN is contraindicated during pregnancy as it may cause fetal harm, including birth defects and fetal death. Females of reproductive potential must have a negative pregnancy test before starting treatment, use effective contraception during treatment, and for one month after discontinuation. Monthly pregnancy tests are recommended.
• Breastfeeding: It is not known if Ambrisentan passes into breast milk, and breastfeeding is generally not recommended during treatment.
• Liver Function: Use with caution in patients with liver disease. It is not recommended in moderate to severe hepatic impairment. Regular monitoring of liver enzymes is advised, and the medication may need to be discontinued if liver function tests are significantly elevated or if signs of liver injury appear.
• Heart Conditions: Exercise caution in patients with heart failure. Monitor for fluid retention, which can be a sign of worsening heart failure.
• Kidney Disease: Use with caution in patients with kidney disease. Dose adjustment may be necessary, although no adjustment is typically recommended for mild to moderate kidney impairment.
• Anemia: Decreases in hemoglobin (indicating anemia) have been observed. Blood tests to monitor hemoglobin levels are recommended at baseline, at one month, and periodically thereafter.
• Driving and Operating Machinery: AMBRICAN may cause dizziness or weakness, which can impair the ability to drive or operate machinery. Patients should be aware of how they react to the medicine before engaging in such activities.
• Alcohol Consumption: Limit alcohol intake while taking this medicine as it may increase the risk of side effects like low blood pressure.
• Drug Interactions:
  • Cyclosporine: Concomitant use with cyclosporine can significantly increase ambrisentan exposure; therefore, the ambrisentan dose should be limited to 5 mg once daily.
  • Rifampicin: May transiently affect ambrisentan exposure, but generally, no clinically relevant effect is seen at steady state.
  • Hormonal Contraceptives: The effectiveness of hormonal contraceptives may be altered; additional contraception methods should be used.
  • Grapefruit Juice: Avoid consuming grapefruit juice as it can increase the levels of ambrisentan in the body.
  • Inform your doctor about all other medications, including over-the-counter drugs, herbal supplements, and vitamins, to check for potential interactions.

Storage

• Store AMBRICAN 5 MG TABLET in its original packaging.
• Keep at room temperature, typically between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F).
• Protect from moisture and heat. Do not freeze.
• Keep out of the reach of children.

What is AMBRICAN 5 MG TABLET used for?

AMBRICAN 5 MG TABLET, containing Ambrisentan, is primarily used to treat pulmonary arterial hypertension (PAH). PAH is a condition characterized by high blood pressure in the arteries that carry blood from the heart to the lungs. This medication helps to improve exercise ability and delay the worsening of the condition. It can be prescribed alone or in combination with other medications for PAH, such as tadalafil.

How does AMBRICAN 5 MG TABLET work?

Ambrisentan, the active ingredient in AMBRICAN 5 MG TABLET, belongs to a class of drugs called endothelin receptor antagonists. It works by blocking the effects of endothelin-1, a natural substance in the body that causes blood vessels to narrow and tighten. By inhibiting endothelin-1, Ambrisentan helps relax and widen the blood vessels in the lungs (vasodilation). This action reduces the pressure in the pulmonary arteries and improves blood flow to the lungs, thereby easing the workload on the heart.

What is the usual dosage for AMBRICAN 5 MG TABLET?

The typical starting dosage for adults is one 5 mg tablet taken once daily. Your doctor may increase the dose to 10 mg once daily if a higher dose is needed and tolerated. The tablet should be swallowed whole with water and should not be split, crushed, or chewed. It can be taken with or without food, but it is recommended to take it at a similar time each day to help remember your dose.

What are the possible side effects of AMBRICAN 5 MG TABLET?

Common side effects include headache, swelling of the hands, ankles, feet, or abdomen (fluid retention), stuffy nose (nasal congestion), sinus inflammation, and flushing (a warm, red, or tingly feeling). More serious side effects can include severe allergic reactions, liver damage (symptoms like yellowing of the skin or eyes, dark urine, nausea, vomiting, or stomach pain), and anemia (low red blood cell count). Regular blood tests are necessary to monitor for potential liver problems and anemia.

Is AMBRICAN 5 MG TABLET safe during pregnancy or breastfeeding?

No, AMBRICAN 5 MG TABLET is not safe during pregnancy and is contraindicated because it can cause serious birth defects. Women who are able to become pregnant must have a negative pregnancy test before starting treatment, every month during treatment, and for one month after stopping the medication. They must also use at least two reliable forms of birth control during this period. It is not known if Ambrisentan passes into breast milk, and therefore, breastfeeding is not recommended while taking this medicine.

Can AMBRICAN 5 MG TABLET be taken with other medications?

AMBRICAN 5 MG TABLET can interact with other medications. A notable interaction is with cyclosporine, which can significantly increase the levels of Ambrisentan in the body; if taken together, the ambrisentan dose should be limited to 5 mg once daily. It's crucial to inform your doctor about all medications you are taking, including over-the-counter drugs, herbal supplements (like St. John's Wort, which may decrease its effect), and vitamins. Avoid consuming grapefruit juice as it can increase the medication's levels.

What precautions should be taken while on AMBRICAN 5 MG TABLET?

It is very important for women of reproductive potential to use effective birth control and undergo monthly pregnancy tests due to the risk of severe birth defects. Regular blood tests are essential to monitor for liver damage and anemia. Watch for signs of fluid retention, such as rapid weight gain or swelling, and report them to your doctor. Men should be aware that this medicine may decrease sperm count, potentially affecting fertility. Patients with pre-existing conditions like idiopathic pulmonary fibrosis, heart failure, or liver/kidney disease should discuss these with their doctor. Alcohol consumption may increase the risk of liver problems.

What happens if a dose of AMBRICAN 5 MG TABLET is missed?

If you miss a dose of AMBRICAN 5 MG TABLET, take it as soon as you remember on the same day. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should AMBRICAN 5 MG TABLET be stored?

AMBRICAN 5 MG TABLET should be stored in its original packaging at room temperature, ideally between 20°C and 25°C (68°F and 77°F). It can tolerate temporary excursions between 15°C and 30°C (59°F and 86°F). Keep the tablets in a dry, cool, and well-ventilated place, protected from moisture and out of the reach of children.