Tvaptan 15 Tablet (4 Tab)

TVAPTAN 15 TABLET

TVAPTAN 15 TABLET is a medication primarily used to address imbalances in the body's water and sodium levels.

• Name:
  • Brand Name: Tvaptan 15 Tablet
  • Common Name: Tolvaptan
• Composition:
  • Each tablet contains Tolvaptan 15 mg as the active ingredient.
• Uses:
  • TVAPTAN 15 TABLET is prescribed for the treatment of hyponatremia (low sodium levels in the blood).
  • This includes hyponatremia associated with conditions such as:
    • Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).
    • Heart failure.
    • Liver cirrhosis.
  • It is also used to slow the progression of autosomal dominant polycystic kidney disease (ADPKD) in adults with rapidly progressing disease.
• Dosage and Administration:
  • The typical starting dose for adults is 15 mg once daily.
  • It can be taken with or without food.
  • Swallow the tablet whole with a glass of water; do not crush, break, or chew it.
  • The first few doses may be initiated in a hospital setting under close medical supervision to monitor sodium levels.
  • Dosage adjustments are made by a doctor based on the patient's condition and response. It should not be taken for more than 30 days unless directed by a doctor.
• Side Effects:
  • Common Side Effects: Frequent urination (especially at night), dry mouth, headache, dizziness, fatigue, nausea, diarrhea, constipation, increased thirst, and increased blood creatinine levels.
  • Serious Side Effects: A rapid increase in blood sodium levels can lead to serious neurological damage (osmotic demyelination syndrome), which can manifest as trouble speaking or swallowing, confusion, mood changes, fits, and muscle weakness. Liver injury or liver failure are also possible.
• Precautions:
  • Contraindications: Do not take if allergic to tolvaptan, have severe dehydration, are unable to urinate (urine output less than 100ml/day), have very high blood sodium levels, or have acute liver injury.
  • Pregnancy and Breastfeeding: Use is generally not recommended during pregnancy or breastfeeding due to potential harm to the fetus or infant.
  • Alcohol: Avoid alcohol consumption as it can worsen side effects like dizziness and increase the risk of dehydration.
  • Drug Interactions: Inform your doctor about all other medications, including herbal preparations and supplements. Notable interactions include strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin), strong CYP3A inducers (e.g., rifampin, phenytoin), vasopressin analogues (e.g., desmopressin), and diuretics.
  • Food Interactions: Avoid grapefruit and grapefruit juice, as they can increase tolvaptan levels in the blood and lead to more side effects.
  • Medical Conditions: Use with caution in patients with liver disease, kidney disease, diabetes, or those with high uric acid levels.
  • Driving and Operating Machinery: This medicine may cause dizziness, weakness, or tiredness; exercise caution when driving or operating heavy machinery.
  • Children: Not recommended for individuals under 18 years of age.
• Storage:
  • Store below 30°C.
  • Keep in a dry place, away from direct light and moisture.
  • Store in the original packaging.
  • Keep out of reach and sight of children.
  • Check the expiry date and do not use after this date.

TVAPTAN 15 TABLET contains tolvaptan as its active ingredient. It is primarily used to manage low sodium levels in the blood (hyponatremia) and to slow the decline of kidney function in certain individuals with autosomal dominant polycystic kidney disease (ADPKD).

Here are some frequently asked questions about TVAPTAN 15 TABLET:

What is TVAPTAN 15 TABLET used for?

TVAPTAN 15 TABLET is used to treat hyponatremia (low blood sodium levels) in adults with conditions such as heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone (SIADH). It is also prescribed to slow the decline of kidney function in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

How does TVAPTAN 15 TABLET work?

TVAPTAN 15 TABLET contains tolvaptan, which is a selective vasopressin V2-receptor antagonist. It works by blocking the action of vasopressin (also known as antidiuretic hormone) in the kidneys. This blockage increases the amount of water released from the body as urine without losing too much sodium, helping to increase blood sodium levels and remove excess body water. In ADPKD, it slows down the development of cysts in the kidneys.

What is the usual dosage of TVAPTAN 15 TABLET?

For hyponatremia, the typical starting dose for adults is 15 mg once daily. Your doctor may adjust the dose as needed, usually not exceeding 60 mg per day. For slowing kidney function decline in ADPKD, the initial adult dose is often 60 mg per day, taken as 45 mg upon waking and 15 mg eight hours later. This dose can be adjusted by your doctor as needed and tolerated. It is important to take the first dose or restart treatment in a hospital setting for close monitoring.

What are the possible side effects of TVAPTAN 15 TABLET?

Common side effects include increased thirst, dry mouth, frequent or increased urination, hunger, constipation, and weakness. More serious side effects can include liver injury (symptoms like pain in the upper stomach, nausea, vomiting, loss of appetite, dark urine, yellowing of skin or eyes), dehydration, and a serious neurological condition called osmotic demyelination syndrome (ODS) if blood sodium levels rise too quickly. Report any signs of confusion, trouble speaking or swallowing, muscle weakness, or seizures to your doctor immediately.

Is TVAPTAN 15 TABLET safe during pregnancy or breastfeeding?

TVAPTAN 15 TABLET is generally not recommended during pregnancy and is considered contraindicated by some authorities, as animal studies have shown potential harm to the fetus. It is also not recommended for use while breastfeeding, as it is unknown if it passes into human milk, but it does in animal milk. Women of childbearing potential should use adequate contraception during treatment.

Can TVAPTAN 15 TABLET be taken with other medications?

Tolvaptan can interact with many other medications. It is crucial to inform your doctor about all prescription, over-the-counter, herbal, and vitamin supplements you are taking. Concomitant use with strong CYP3A inhibitors (e.g., certain antifungals, antivirals) is contraindicated, and dose adjustments may be needed with moderate CYP3A inhibitors. Strong CYP3A inducers should also be avoided. Additionally, avoid consuming grapefruit or grapefruit juice while taking TVAPTAN 15 TABLET, as it can increase the effects of tolvaptan.

What precautions should be taken while on TVAPTAN 15 TABLET?

You will typically start or restart this medicine in a hospital to allow for close monitoring of your serum sodium levels, as rapid correction can lead to serious neurological issues. Regular liver function tests are necessary, especially for patients with ADPKD, due to the risk of liver injury. Always have water available to drink when you are thirsty, unless your doctor advises otherwise, to prevent dehydration. Avoid fluid restriction during the first 24 hours of therapy for hyponatremia.

What happens if a dose of TVAPTAN 15 TABLET is missed?

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

How should TVAPTAN 15 TABLET be stored?

Store TVAPTAN 15 TABLET in a closed container at room temperature, typically between 20°C to 25°C (68°F to 77°F), away from heat, moisture, and direct light. Do not freeze the medicine and keep it out of the reach of children.