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Composition

TOLVAPTAN-15MG

Manufacturer/Marketer

Msn Laboratories Pvt Ltd

Consume Type

ORAL

Return Policy

Not Returnable

Expires on or after

Jan-25

for this medicine

About Tvaptan 15 Tablet

Tvaptan 15 Tablet is used to treat hyponatremia (low levels of sodium) in patients with heart failure, liver disease and hormonal imbalances such as Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Additionally, Tvaptan 15 Tablet is also used to treat autosomal dominant polycystic kidney disease (ADPKD).
 
Tvaptan 15 Tablet contains ‘tolvaptan’ that works by blocking the effect of vasopressin, resulting in decreased water reabsorption, a net increase in free water excretion (aquaresis) and an increase in serum sodium concentrations. This decrease in free water is not associated with an increased excretion of sodium or potassium ions; the increase in serum sodium concentration is solely a result of increased urine production.
 
You are advised to take Tvaptan 15 Tablet as long as your doctor has prescribed it for you, depending on your medical condition. In some cases, you may experience certain common side effects such as dizziness, headache, dry mouth, fatigue, diarrhoea, thirst and increased urge to urinate. Most of these side effects do not require medical attention and will resolve gradually over time. However, you are advised to talk to your doctor if you experience these side effects persistently.
 
Do not take Tvaptan 15 Tablet if you are pregnant as it may cause foetal harm. Consult your doctor before taking Tvaptan 15 Tablet if you are breastfeeding. Tvaptan 15 Tablet is not recommended for children below 18 years as the efficacy and safety have not been established. Tvaptan 15 Tablet may cause dizziness, so drive with caution. Avoid consuming alcohol as it might cause increased dizziness. Inform your doctor about all the medicines you are taking and about your health condition to rule out any unpleasant side effects.

Uses of Tvaptan 15 Tablet

Treatment of Hyponatremia (low sodium levels) and autosomal dominant polycystic kidney disease (ADPKD).

Medicinal Benefits

Tvaptan 15 Tablet belongs to a group of medicines called vasopressin V2 receptor antagonist. Tvaptan 15 Tablet is used to treat hyponatremia (low levels of sodium) in patients with heart failure, liver disease and hormonal imbalances such as Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Besides this, Tvaptan 15 Tablet is also used to treat autosomal dominant polycystic kidney disease (ADPKD). Tvaptan 15 Tablet works by blocking the effect of vasopressin, a hormone which is involved in the formation of cysts in ADPKD patients. By blocking the effect of vasopressin, Tvaptan 15 Tablet slows down the development of cysts in kidneys and reduces the symptoms of the disease. Tvaptan 15 Tablet antagonises the effect of vasopressin; this results in an increase in free water clearance and decreases urine osmolality due to increased urinary excretion, thereby increasing serum sodium concentrations.

Side Effects of Tvaptan 15 Tablet

  • Dizziness
  • Headache
  • Dry mouth
  • Fatigue
  • Weakness
  • Diarrhoea
  • Thirst
  • Increased urge to urinate

Directions for Use

Swallow the medicine as a whole with a glass of water, and do not crush, break, or chew it.

Storage

Store in a cool and dry place away from sunlight

Drug Warnings

Do not take Tvaptan 15 Tablet if you are allergic to any of its contents, if you have raised liver enzymes in the blood, very low blood volume, if there is no urine production, if you cannot tell that you are thirsty. Inform your doctor if you have liver disease, difficulty in urination, diabetes, high levels of uric acid, advanced kidney disease or if you have to restrict fluid intake due to certain medical conditions. Do not take Tvaptan 15 Tablet if you are pregnant as it may cause foetal harm. Consult your doctor before taking Tvaptan 15 Tablet if you are breastfeeding. Tvaptan 15 Tablet is not recommended for children below 18 years as efficacy and safety have not been established. Tvaptan 15 Tablet may cause dizziness, so drive with caution. Avoid consuming alcohol as it might cause increased dizziness. 

Therapeutic Class

CARDIOVASCULAR AGENTS

Drug Interactions

Drug-Drug Interaction:  Inform the doctor if you are taking antibiotics (clarithromycin, telithromycin, sulfamethoxazole, trimethoprim), anti-fungal (ketoconazole, itraconazole), anti-HIV (ritonavir, indinavir, nelfinavir, saquinavir), antidepressant (nefazodone), aldosterone receptor antagonist (spironolactone), angiotensin receptor inhibitor (valsartan, sacubitril), blood thinner (heparin).

Drug-Food Interaction: Avoid consuming grapefruit juice and St. John’s wort (herbal supplement used to treat depression) while taking Tvaptan 15 Tablet

Drug-Disease Interaction: Inform the doctor if you have liver disease, difficulty in urination, diabetes, high levels of uric acid or kidney disease.

Drug-Drug Interactions Checker List

  • CLARITHROMYCIN
  • TELITHROMYCIN
  • SULPHAMETHOXAZOLE+TRIMETHOPRIM
  • KETOCONAZOLE
  • ITRACONAZOLE
  • RITONAVIR
  • INDINAVIR
  • SAQUINAVIR
  • NELFINAVIR
  • NEFAZODONE
  • SPIRONOLACTONE
  • VALSARTAN
  • SACUBITRIL
  • HEPARIN

Diet & Lifestyle Advise

  • Eat a diet rich in whole grains, vegetables, and fruits.
  • Avoid smoking and alcohol consumption.
  • Maintain a healthy weight with proper diet and exercise.
  • Manage stress with meditation, yoga, and massage.
  • Drink plenty of fluids.
  • Rehydration beverages that contain electrolytes are also helpful.

Habit Forming

No

What if I have taken an overdose of Tvaptan 15 Tablet

Take Tvaptan 15 Tablet only as prescribed by the physician. Avoid exceeding the recommended dose as it could lead to an overdose. Symptoms of overdose may include excessive urination, excessive thirst, dizziness, and faintness. If you experience these symptoms or suspect you have taken an overdose, seek immediate medical attention.

Special Advise

  • Regular monitoring of liver functioning and electrolyte levels while taking Tvaptan 15 Tablet is advised.
  • Treatment with Tvaptan 15 Tablet should be started and re-started in a hospital or in the presence of a healthcare professional to monitor the sodium levels in your blood closely.

Disease/Condition Glossary

Hyponatremia: Sodium is an important electrolyte that helps in maintaining water balance in and around the cells. It helps in proper nerve and muscle functioning and maintains stable blood pressure levels. Low levels of sodium in the blood are referred to as hyponatremia. Normal levels of sodium are 135-145 milliequivalent per litre. Hyponatremia occurs when the level is below 135mEq/L. Symptoms include weakness, tiredness, nausea, vomiting, headache, irritability, confusion and muscle spasms.

Autosomal Dominant Polycystic Kidney Disease (ADPKD): It is an inherited disorder in which cysts are developed in the kidney. These cysts are non-cancerous sacs that contain a water-like fluid which puts pressure on the surrounding tissues, leading to reduced kidney function. Symptoms include high blood pressure, swollen abdomen, and back or side pain.

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Alcohol

Unsafe

Avoid consuming alcohol while taking Tvaptan 15 Tablet as it may cause increased dizziness.

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Pregnancy

Unsafe

Tvaptan 15 Tablet belongs to pregnancy category C. Tvaptan 15 Tablet is not recommended for use in pregnant women as it may cause foetal harm. Women of childbearing age must use effective contraception while taking Tvaptan 15 Tablet.

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Breast Feeding

Unsafe

Tvaptan 15 Tablet is not recommended for use in breastfeeding women. Consult your doctor if you are breastfeeding; your doctor will decide whether Tvaptan 15 Tablet can be taken by breastfeeding mothers or not.

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Driving

Caution

Tvaptan 15 Tablet may cause dizziness, weakness and tiredness. Do not drive or operate heavy machinery if you feel dizzy.

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Liver

Caution

Dose adjustment may be needed. Tvaptan 15 Tablet should be used with caution in patients with liver impairment/liver disease. Please consult your doctor if you have liver problems or any concerns regarding this.

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Kidney

Caution

Tvaptan 15 Tablet should be used with caution in patients with kidney impairment/kidney disease. Please consult your doctor if you have kidney problems or any concerns regarding this.

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Children

Unsafe

Tvaptan 15 Tablet is not recommended for children below 18 years as efficacy and safety have not been established.

Country of origin

India

Manufacturer/Marketer address

CENTAUR HOUSE, Near Grand Hyatt, Vakola ,Santacruz – East, Mumbai – 400 055, India.
Other Info - TVA0005

Author Details

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FAQs

Tvaptan 15 Tablet is used to treat hyponatremia (low levels of sodium) in patients with heart failure, liver disease and hormonal imbalances such as Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Additionally, Tvaptan 15 Tablet is also used to treat autosomal dominant polycystic kidney disease (ADPKD).
Tvaptan 15 Tablet works by blocking the effect of vasopressin, a hormone which is involved in the formation of cysts in ADPKD patients. By blocking the effect of vasopressin, Tvaptan 15 Tablet slows down the development of cysts in the kidneys, reduces the symptoms of the disease, and increases urine production. Thereby increases serum sodium concentrations.
Dry mouth could be a side-effect of Tvaptan 15 Tablet. Limiting caffeine intake, avoiding smoking and mouthwashes containing alcohol, drinking water regularly and chewing sugar-free gum/candy might help in stimulating saliva and thereby prevents drying of the mouth.
Diarrhoea could be a side-effect of Tvaptan 15 Tablet. Drink plenty of fluid to prevent dehydration if you experience diarrhoea. Consult your doctor if you have severe diarrhoea or if you find blood in stools.
Tvaptan 15 Tablet may cause the liver to not work properly. Consult your doctor immediately if you experience nausea, vomiting, fever, loss of appetite, abdominal pain, tiredness, dark urine, jaundice, itching and flu-like symptoms.
Tvaptan 15 Tablet may cause water loss due to increased urine production. This might result in side-effects such as thirst, dry mouth and kidney problems. To prevent this, drink plenty of water regularly. Drink 1-2 glasses of water before going to bed even though you are not thirsty. Special care must be taken in patients with diseases that might reduce fluid intake.
Consult your doctor before taking Tvaptan 15 Tablet if you are diabetic as Tvaptan 15 Tablet might increase the blood sugar levels. Regular monitoring of blood glucose levels while taking Tvaptan 15 Tablet is advised.
You are advised to take Tvaptan 15 Tablet for the duration prescribed by the doctor. Tvaptan 15 Tablet should not be taken for more than 30 days.
Tvaptan 15 Tablet might increase the blood sugar levels. Consult the doctor if you are diabetic.
Do not take Tvaptan 15 Tablet if you are allergic to any of its components, if you have raised liver enzymes in the blood, very low blood volume, if there is no urine production, or if you cannot tell that you are thirsty.
Avoid consuming grapefruit or its juice while taking Tvaptan 15 Tablet as it might increase the effects of the medicine in the body.
Do not exceed the prescribed dose as it might cause an overdose. Taking an excess of Tvaptan 15 Tablet may cause excessive thirst, dizziness, excessive urination, or fainting. Consult the doctor if you experience these symptoms.
Tvaptan 15 Tablet is not recommended for patients with severe kidney disease. It should be used with caution in patients with mild to moderate kidney problems.
If you miss a dose of Tvaptan 15 Tablet take it as soon as you remember, However, if it is almost time for the scheduled dose, skip the missed dose and take the next dose at the scheduled time.
Tvaptan 15 Tablet is not recommended for use during pregnancy and breastfeeding.
Common side effects are dizziness, headache, dry mouth, fatigue, diarrhoea, thirst and increased urge to urinate. Talk to your doctor if you experience these side effects persistently.
Store Tvaptan 15 Tablet at room temperature, in a dry place. Keep out of sight and reach of children.
Treatment with Tvaptan 15 Tablet should be started and re-started in a hospital or in the presence of a healthcare professional to monitor the sodium levels in your blood closely. Too rapid correction of hyponatremia (low sodium levels) may cause osmotic demyelination syndrome (serious nerve damage). Consult the doctor if you notice symptoms of osmotic demyelination syndrome such as difficulty speaking, feeling that food or drinks are getting stuck in your throat, difficulty swallowing, mood changes, drowsiness, confusion, body movements that are difficult to control, weakness of the arms or legs, or seizures.

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