TVAPTAN 15MG contains tolvaptan belongs to a group of medicines called vasopressin antagonists. This medicine is indicated in Autosomal dominant polycystic kidney disease? (ADPKD) and also clinically significant hypervolemic and euvolemic hyponatremia in adults with conditions such as heart failure, liver disease, and certain hormone imbalances.
Vasopressin by reducing urine output causes fluid retention and prevent the loss of water from the body. Autosomal dominant polycystic kidney disease? (ADPKD) is a condition where fluid-filled cysts grow in the kidneys leading to increased pressure on the surrounding tissues that impairs the kidney function leading to kidney failure.
TVAPTAN 15MG prevents the vasopressin having effect on the water retention. This reduces the amount of water in the body which slows the growth of kidney cysts in patients with ADPKD, reduces symptoms of the disease and increases urine production.
It also increases the sodium and salt levels in your blood by removing extra water content in the body as urine in patients with heart failure, liver disease, and certain hormone imbalances.
Tablet is a medicine used in the treatment of low levels of sodium in the blood. It treats low levels of sodium in the blood, which can result from conditions such as heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormone (SIADH).
Tablet can be taken with or without food. It should be taken exactly as prescribed by your doctor. Your doctor will decide the dose and how often you should take them. You should take this medicine regularly to get the most benefit from it. Do not stop taking the medicine even if you feel better unless the doctor tells you so.
Using this medicine may cause few common side effects such as frequent urge to urinate, nocturia (increased urge to urinate during the night), dryness in mouth, increased thirst, constipation. Let your doctor know if any of these side effects do not go away with time or get worse.
Before using this medicine, inform your doctor if you have any problems with your kidneys or liver. While on this medicine, your doctor will closely monitor the sodium levels in your blood. You should also tell your doctor all the other medications you are taking.
USES OF TVAPTAN 15MG:
Treat a disease called autosomal dominant polycystic kidney disease (ADPKD)
Treat significant hypervolemic and euvolemic hyponatremia (low serum sodium levels in adults)
HOW TVAPTAN 15MG WORKS:
TVAPTAN 15MG prevents the vasopressin having effect on the water retention. This reduces the amount of water in the body which slows the growth of kidney cysts in patients with ADPKD, reduces symptoms of the disease and increases urine production.
It also increases the sodium and salt levels in your blood by removing extra water content in the body as urine in patients with heart failure, liver disease, and certain hormone imbalances.
TVAPTAN 15MG TABLET belongs to a group of medicines called vasopressin V2 receptor antagonist 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,TABLET is also used to treat autosomal dominant polycystic kidney disease (ADPKD).
TVAPTAN 15MG 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
Take TABLET with or without food. Swallow TABLET as a whole with a glass of water, do not crush, break or chew the tablet. You are advised to take TABLET for 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 15MG TABLET if you are pregnant as it may cause foetal harm. Consult your doctor before taking TABLET if you are breastfeeding.
TABLET is not recommended for children below 18 years as the efficacy and safety have not been established. 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.
DIRECTIONS FOR USE:
Always take TVAPTAN 15MG exactly as prescribed by your doctor. Swallow the medicine whole with plenty of water.
SIDE EFFECTS OF TVAPTAN 15MG:
SERIOUS
Difficult to urinate
Swelling of the face, lips or tongue, itching, generalized rash, or severe wheezing or breathlessness (symptoms of an allergic reaction)
COMMON
Dizziness, drowsiness, headache
Dehydration
High levels of sodium, potassium, creatinine, uric acid and blood sugar
Decrease in level of blood sugar
Decreased appetite
Fainting
Low blood pressure when standing up
Constipation
Diarrhea
Dry mouth
Feeling sick, thirst, rapid rise in level of sodium
Patchy bleeding in the skin
Itching
General feeling of being unwell
Blood in urine
Raised levels of liver enzymes in the blood
HOW TO MANAGE SIDE EFFECTS:
Skin rash and itching:
Avoid bathing with hot water because hot water can irritate the skin. Moisturizers can be used regular basis to soothe and hydrate the affected area.
Headache:
Apply hot or cold-water bag on your head. Take rest in a quiet and dark room. Drink tea or coffee.
Diarrhea:
Drink lot of fluid, such as water or squash, to avoid dehydration. Do not take any other medicines consulting your doctor.
SAFETY ADVICE
Alcohol
CAUTION
Caution is advised when consuming alcohol with Tablet. Please consult your doctor.
Pregnancy
CONSULT YOUR DOCTOR
Tablet may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
Breast feeding
CONSULT YOUR DOCTOR
Tablet is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
Driving
UNSAFE
Tvaptan 15 Tablet may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
Kidney
SAFE IF PRESCRIBED
Tvaptan 15 Tablet is safe to use in patients with kidney disease. No dose adjustment of Tablet is recommended.
However, the use of Tablet is not recommended in patients with severe kidney disease.
Liver
CAUTION
Tvaptan 15 Tablet should be used with caution in patients with liver disease. Dose adjustment of Tvaptan 15 Tablet may be needed. Please consult your doctor.
Use of Tablet is not recommended in patients with severe liver disease.
INTERACTIONS:
Talk to your doctor if you are taking:
Ketoconazole
Macrolide antibiotics
Medicines to treat high blood pressure and chest pain
Medicines used to treat epilepsy/seizures and some sleep disorders
Rifampicin (used to treat tuberculosis)
Digoxin (used for treatment of irregularities of heartbeat and heart failure)
Desmopressin (used to increase blood clotting factors)
Store at room temperature 15-25°C and keep out of reach of children.
FAQs ABOUT TOLVASCA:
Q: What is TVAPTAN 15MG used to treat?
A: It is used to treat low levels of salt (sodium) in the blood, which can result from conditions such as heart failure and certain hormone imbalances.
Q: Can TVAPTAN 15MG be used in pregnant women?
A: No. It is not recommended for use in the pregnant women. Consult your doctor before taking.
Q: What causes low sodium?
A: A low sodium level has many causes, including consumption of too many fluids, kidney failure, heart failure, cirrhosis, and use of diuretics. Symptoms result from brain dysfunction.
Q. What is the most important information I need to be aware of while taking Tvaptan 15 Tablet?
Tablet may cause the level of sodium in your blood to increase too quickly. This quick increase in sodium levels [osmotic demyelination syndrome (ODS)] may cause serious nerve damage, which can further cause coma and even death.
The symptoms of ODS could be trouble in speaking, trouble in swallowing or a feeling of food or liquid getting stuck while swallowing, drowsiness, confusion, mood changes, fits, trouble controlling body movement (involuntary movement) and weakness in muscles of the arms and legs.
Q. For how long do I need to take Tvaptan 15 Tablet?
Tvaptan 15 Tablet is used for correction of sodium levels in blood. Though the dose and duration are prescribed by the doctor, Tvaptan 15 Tablet should not be taken for more than 30 days. Once the sodium levels return to normal, it can be stopped after talking to the doctor.
Q. Does Tvaptan 15 Tablet affect the sugar levels in blood?
Yes, Tablet may increase the blood sugar levels. Therefore, patients with diabetes mellitus need to be extra careful while taking Tvaptan 15 Tablet and should keep a check on blood sugar levels regularly.
Q. Who should not take Tvaptan 15 Tablet?
You should not take Tvaptan 15 Tablet if you have low sodium levels, cannot replace fluids by drinking or if you cannot tell when you are thirsty, dizzy or feeling faint or if your kidneys are not working properly because of excessive loss of fluids.
You should also avoid Tablet if your body is not able to make urine, you are allergic to Tvaptan 15 Tablet or if you are on certain medicines which interfere with the working of Tablet.
Q. Can I have grapefruit juice while taking Tvaptan 15 Tablet?
No, you should not take grapefruit or grapefruit juice while on Tvaptan 15 Tablet. The reason being, grapefruit or grapefruit juice may increase the levels of Tablet in your blood and your sodium levels may rise too quickly.
Q. What will happen if I take excess of Tvaptan 15 Tablet?
You may need urgent medical attention. Call your doctor or seek emergency service at a nearby hospital. Symptoms of taking too much Tolvaptan may include thirst, dry and flaky skin, sunken eyes, rapid heartbeat, rapid and shallow breathing, very low blood pressure, passing more urine than normal and fainting.
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