Combipack of Ambrisentan and Tadalafil Tablets: Dosage, Side Effects, Uses and more information

Combipack of ambrisentan and tadalafil tablets

If you or a loved one is prescribed a combipack of ambrisentan and tadalafil tablets, notably under the brand name AMBRISTAR 5 + DURA 20, it is essential to understand the medication thoroughly. This effective combination therapy is often used for managing pulmonary arterial hypertension (PAH), a serious condition affecting the lungs and heart. This guide covers everything from chemical composition to side effects, usage, and patient advice, ensuring you have a clear, well-rounded understanding of this lifesaving treatment.

The combipack of ambrisentan and tadalafil tablets—specifically AMBRISTAR 5 + DURA 20—is a combination medication designed to improve exercise capacity and delay clinical worsening in patients suffering from pulmonary arterial hypertension (PAH). This synergistic therapy combines two powerful drugs: ambrisentan, an endothelin receptor antagonist, and tadalafil, a phosphodiesterase type 5 inhibitor.

Pulmonary arterial hypertension is a life-threatening condition characterized by high blood pressure in the arteries supplying the lungs, leading to symptoms such as shortness of breath, fatigue, and dizziness. The combination of ambrisentan and tadalafil in AMBRISTAR 5 + DURA 20 addresses PAH by dilating blood vessels and reducing vascular resistance, thus facilitating better blood flow and oxygen delivery.

This combination has become a vital part of PAH treatment due to its enhanced efficacy, better patient adherence, and convenience of dosage, providing an integrated approach to symptom relief and disease management.

Chemical Composition and Formulations

AMBRISTAR 5 + DURA 20 consists of:

• Ambrisentan 5 mg: Ambrisentan is a selective endothelin A receptor antagonist that helps relax blood vessels and prevent the narrowing caused by high levels of endothelin-1, a naturally occurring peptide that causes vasoconstriction.

• Tadalafil 20 mg: Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor that promotes relaxation of the pulmonary arteries by increasing cyclic GMP levels, leading to vasodilation.

This fixed-dose combipack formulation allows for once-daily oral administration, improving patient convenience and compliance.

Mechanism of Action: How Does Ambrisentan and Tadalafil Work?

The therapeutic effects of the combipack of ambrisentan and tadalafil tablets stem from their complementary mechanisms that target different pathways involved in PAH:

• Ambrisentan blocks the endothelin-1 receptors (especially endothelin type A receptors) in the vascular smooth muscle, preventing vasoconstriction and promoting vasodilation. It also helps inhibit smooth muscle cell proliferation, reducing vascular remodeling.

• Tadalafil inhibits PDE5, an enzyme responsible for degrading cyclic GMP—a molecule that signals smooth muscle relaxation. By increasing cGMP levels, tadalafil causes relaxation of the pulmonary arterial vessels, improving blood flow and reducing pulmonary vascular resistance.

Together, the combination works to lower pulmonary arterial pressure, reduce the workload on the heart, and improve oxygen delivery, effectively addressing the key pathological aspects of PAH.

Uses and Indications of Ambrisentan and Tadalafil Combination

AMBRISTAR 5 + DURA 20 is primarily indicated for:

• Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in patients classified as functional class II or III, to improve exercise capacity and delay disease progression.

• Management aimed at reducing symptoms such as dyspnea (shortness of breath), fatigue, and other PAH-related limitations.

• May be prescribed as first-line combination therapy or as an addition to monotherapy depending on clinical judgement.

This combination is not intended for other types of pulmonary hypertension unless explicitly directed by a healthcare provider.

Dosage and Administration Guidelines

AMBRISTAR 5 + DURA 20 comes as a fixed-dose tablet pack with ambrisentan 5 mg and tadalafil 20 mg, designed for once-daily oral intake.

• Recommended Dose: One tablet daily with or without food, at approximately the same time each day.

• Do not crush or split the tablet; swallow it whole with water.

• Usually started under medical supervision with periodic monitoring of liver function and hemoglobin levels.

• Dosage adjustment may be required in patients with liver or kidney impairment—consult your healthcare provider for personalized instructions.

• Avoid abrupt discontinuation unless directed by a physician.

Efficacy and Clinical Evidence Backing the Combination

Clinical trials and studies have demonstrated the superior efficacy of the ambrisentan and tadalafil combination compared to monotherapies:

• Studies such as the AMBITION trial showed significant improvement in exercise capacity (measured by the 6-minute walk distance) and a marked reduction in clinical failure events.

• The combination delays the worsening of PAH symptoms better than single-agent therapy.

• Patient quality of life improved significantly due to better symptom control.

• Recent guidelines for PAH support early initiation of combination therapy for eligible patients.

Side Effects and Safety Profile of Ambrisentan and Tadalafil

While generally well-tolerated, the combipack of ambrisentan and tadalafil tablets may cause some side effects:

• Common Side Effects:

  • Headache

  • Nasal congestion

  • Flushing

  • Peripheral edema (swelling of legs/ankles)

  • Fatigue

  • Dizziness

  • Nausea

• Serious but Rare Side Effects:

  • Liver enzyme elevations requiring monitoring

  • Anemia or hemoglobin reduction

  • Hypotension (low blood pressure)

  • Rare allergic reactions

Patients should report any symptoms of dizziness, fainting, chest pain, or signs of an allergic reaction immediately. Regular monitoring by your doctor helps detect and manage side effects early.

Contraindications and Precautions

Before starting AMBRISTAR 5 + DURA 20, certain medical conditions require caution or may contraindicate its use:

• Known hypersensitivity to ambrisentan, tadalafil, or any components of the tablets.

• Severe liver impairment (Child-Pugh class C) – contraindicated.

• Concurrent use with nitrates or nitric oxide donors is contraindicated due to risk of severe hypotension.

• Pregnancy is contraindicated due to teratogenic effects—women of childbearing potential must use effective contraception.

• Patients with hypotension or unstable cardiovascular conditions need close monitoring.

• Use caution in patients with renal impairment—dose adjustment may be necessary.

Drug Interactions to Consider

The ambrisentan and tadalafil side effects can be exacerbated or complicated by drug interactions:

• Nitrates (e.g., nitroglycerin): Absolute contraindication with tadalafil due to risk of life-threatening hypotension.

• CYP3A4 inhibitors or inducers: Ambrisentan metabolism is affected; drugs like ketoconazole or rifampin may require dose adjustments.

• Antihypertensives: Concurrent use may amplify blood pressure-lowering effects.

• Other PDE5 inhibitors/vasodilators: Increased risk of hypotension.

• HIV protease inhibitors: May increase plasma levels of ambrisentan.

Always disclose all medications and supplements to your healthcare provider to avoid adverse interactions.

Warnings and Regulatory Status

• Black Box Warning: Use in pregnancy is contraindicated due to risk of fetal harm.

• Liver function tests and hemoglobin monitoring are mandatory during therapy.

• Approved by regulatory authorities like the CDSCO (India), FDA (USA - as separate agents), and equivalent bodies in other countries.

• AMBRISTAR 5 + DURA 20 is manufactured according to stringent regulatory guidelines ensuring safety and quality.

Patient Advice and Tips for Safe Use

To make the most of your combipack of ambrisentan and tadalafil tablets, follow these tips:

• Adhere strictly to prescribed doses; do not skip or double doses.

• Avoid alcohol as it may increase side effects like dizziness or hypotension.

• Inform your doctor about any side effects promptly.

• Have regular blood tests as advised.

• Store tablets in a cool, dry place away from children.

• Do not share your medication with others.

• Pregnant or breastfeeding women should avoid this medication and consult the doctor.

• Maintain a healthy lifestyle and communicate any changes in symptoms.

Cost and Availability of AMBRISTAR 5 + DURA 20

• AMBRISTAR 5 + DURA 20 is competitively priced, making it an affordable option for many PAH patients.

• Steris Healthcare Pvt Ltd ensures consistent stock and ease of accessibility in urban and rural areas.

• For best prices check our website sterisonline.com and buy now.

Frequently Asked Questions (FAQs)

Q: What is AMBRISTAR 5 + DURA 20 used for?
A: It is used to treat pulmonary arterial hypertension to improve exercise capacity and reduce disease progression.

Q: How should I take the combipack of ambrisentan and tadalafil tablets?
A: Take one tablet orally once daily, at the same time each day, with or without food.

Q: Can I stop taking AMBRISTAR 5 + DURA 20 suddenly?
A: No, always consult your doctor before stopping the medication to avoid worsening symptoms.

Q: What should I do if I miss a dose?
A: Take it as soon as you remember, but if it’s close to the next dose, skip the missed one—do not double-dose.

Q: Are there any foods or drugs I should avoid?
A: Avoid nitrates and grapefruit juice, inform your doctor about all medications, and limit alcohol consumption.

Q: Can pregnant women take this medication?
A: No, it is contraindicated in pregnancy due to risks of fetal harm.

Q: What side effects should I watch for?
A: Common ones include headache and flushing; seek immediate medical help for chest pain, fainting, or severe allergic reactions.

Conclusion: Why Choose Steris Healthcare Pvt Ltd’s AMBRISTAR 5 + DURA 20?

In summary, the combipack of ambrisentan and tadalafil tablets marketed as AMBRISTAR 5 + DURA 20 by Steris Healthcare Pvt Ltd offers a reliable, effective, and well-studied approach to managing pulmonary arterial hypertension. The combination targets key disease pathways with proven clinical efficacy, improving symptoms and quality of life while being easy to administer once daily.

Steris Healthcare Pvt Ltd is committed to delivering high-quality pharmaceuticals that meet rigorous safety standards. Choosing AMBRISTAR 5 + DURA 20 means trusting a brand dedicated to patient safety, affordability, and accessibility, supported by ongoing research and compliance with global regulatory requirements.

If you or someone you know needs effective management of PAH, talk to your healthcare provider about AMBRISTAR 5 + DURA 20 — the trusted combipack of ambrisentan and tadalafil tablets.