Amsartan 5/80mg Tab 14’s-Potential Overview

Brand Name: Amsartan
Generic Name: Amlodipine and Valsartan
Active Ingredient(s): Amlodipine 5mg, Valsartan 80mg

For the General Public:

Uses:
This medicine is commonly used to treat hypertension (high blood pressure) and angina (chest pain). It works by relaxing blood vessels, which helps lower blood pressure and improve blood flow to the heart.

Dosage:
Take one tablet daily, with or without food. Always follow the instructions on the packaging or as prescribed by your doctor.

Possible Side Effects:
Some common side effects may include dizziness, headache, nausea, fatigue, swelling in the legs, and flushing. If you experience anything unusual, contact your healthcare provider.

Common Side Effects:
Dizziness, swelling in the legs, headache, fatigue, nausea.

Serious (Less Common) Side Effects:
Severe allergic reactions, difficulty breathing, rapid weight gain, chest pain, irregular heartbeat. Seek immediate medical attention if you experience these.

Important Information:

• Dosage Instruction: The usual dose is one tablet per day, as prescribed by your doctor.
• Usage Instruction: This medicine can be taken with or without food. If it causes stomach upset, taking it with food may help.
• General Information:
  • Do not take this medicine if you are allergic to amlodipine, valsartan, or any of the excipients.
  • If you are pregnant, breastfeeding, or planning to become pregnant, consult your doctor before use.
  • Keep out of reach of children.
  • If you miss a dose, take it as soon as you remember unless it’s almost time for the next dose. Do not double the dose.

Drug Interactions:

• Interactions with Other Medications: May interact with other blood pressure medications, potassium-sparing diuretics, and certain antifungals.
• Interactions with Food: No major food interactions noted, but it’s best to avoid high-potassium foods if you are on a potassium-sparing diuretic.

Regulatory Approval & Manufacturer:

• Approved by regulatory agencies like the FDA (for use in certain countries).
• Manufactured by [Company Name].

Antidotes (If Over Dosage or Misused by Patients):
In case of overdose, contact a healthcare professional immediately. Overdose symptoms may include severe dizziness, rapid heartbeat, or fainting.

For Pharmacists:

Medicine Name: Amsartan
Brand: Amsartan
Active Ingredient(s): Amlodipine, Valsartan

Indications:
Indicated for the management of hypertension and angina.

Pharmacodynamics:

• Mechanism of Action: Amlodipine is a calcium channel blocker that works by relaxing the blood vessels. Valsartan is an angiotensin II receptor blocker (ARB) that helps relax blood vessels, lowering blood pressure and improving blood flow.
• Pharmacological Effects: Lowers blood pressure, reduces chest pain, improves heart function.

Receptor Binding:

• Amlodipine binds to calcium channels to prevent calcium entry into cells, thereby reducing vascular smooth muscle contraction.
• Valsartan blocks the angiotensin II receptors, preventing vasoconstriction and reducing blood pressure.

Pharmacokinetics:

• Absorption: Rapidly absorbed after oral administration.
• Distribution: Amlodipine has high plasma protein binding; valsartan also binds extensively to plasma proteins.
• Metabolism: Amlodipine is metabolized in the liver by cytochrome P450 enzymes. Valsartan is not extensively metabolized.
• Elimination: Both drugs are eliminated primarily through the urine, with minor amounts excreted in feces.
• Half-Life: Amlodipine has a half-life of 30-50 hours, while Valsartan’s half-life is about 9 hours.
• Bioavailability: Amlodipine’s bioavailability is approximately 64-80%. Valsartan’s bioavailability is about 23%.
• Time to Peak Concentration: Amlodipine peaks in about 6-12 hours, and Valsartan reaches peak concentration in about 2-4 hours.
• Effect of Food: Food does not significantly affect the absorption of amlodipine or valsartan.

Dosage and Administration:

• Adults: One tablet (5mg Amlodipine, 80mg Valsartan) once daily.
• Pediatric: Safety and efficacy have not been established in children.
• Special Populations: Dose adjustment may be needed in elderly or patients with hepatic impairment.

Contraindications:

• Known hypersensitivity to amlodipine, valsartan, or any excipients in the formulation.
• Contraindicated in patients with severe liver disease or certain heart conditions.

Warnings and Precautions:

• Use with caution in patients with kidney or liver disease, or those who are pregnant.
• Regular blood pressure monitoring is recommended.

Drug-Drug Interactions:

• May interact with other antihypertensives, potassium supplements, and NSAIDs.

Drug-Food Interactions:

• No significant food interactions; however, avoid high potassium foods with potassium-sparing diuretics.

Adverse Reactions:

• Common: Dizziness, headache, swelling, fatigue.
• Serious: Hypotension, hyperkalemia, angioedema, liver dysfunction.

Therapeutic Effects:
Reduces blood pressure, reduces chest pain (angina), and improves overall heart function.

Storage:
Store at room temperature, in a dry, air-tight container away from direct sunlight.

Packaging:
Available in tablet form, in 14-tablet packs.

Clinical Considerations:

• Pregnancy Category: Category D (not recommended during pregnancy).
• Lactation Category: Not recommended during breastfeeding.
• Pediatric Category: Not recommended for children.
• Geriatric Category: Caution in elderly patients, monitor blood pressure.
• Adult Category: Recommended for adult hypertension and angina management.
• Child Category: Not applicable.

Conclusion:

Amsartan 5/80mg is an effective treatment for hypertension and angina. When used according to the prescribed instructions, it can help manage blood pressure and reduce chest pain, improving the quality of life for patients. However, it is essential to follow proper dosage guidelines and remain vigilant for potential side effects. Always consult with a healthcare professional if you have any concerns or experience unusual symptoms. Pharmacists should educate patients about potential drug interactions and advise on appropriate usage, especially in special populations such as pregnant women, elderly individuals, and those with underlying health conditions. Proper storage and disposal of the medication are also important for maintaining its effectiveness and safety.