INTRODUCTION

TOFANTA 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.

TOFANTA 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.

USES OF TOFANTA 15MG

• Treat a disease called “autosomal dominant polycystic kidney disease” (ADPKD)
• Treat significant hypervolemic and euvolemic hyponatremia (low serum sodium levels in adults)

HOW TOFANTA 15MG WORKS

TOFANTA 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.

DIRECTIONS FOR USE

Always take TOFANTA 15MG exactly as prescribed by your doctor. Swallow the medicine whole with plenty of water.

SIDE EFFECTS OF TOFANTA 15MG

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.

WARNING & PRECAUTIONS

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)

SYNOPSIS

MORE INFORMATION

Store at room temperature 15-25°C and keep out of reach of children.

FAQs ABOUT TOFANTA 15MG

What is TOFANTA 15MG used to treat?

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.

Can TOFANTA 15MG be used in pregnant women?

No. It is not recommended for use in the pregnant women. Consult your doctor before taking.

What causes low sodium?

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.

REFERENCES

1. Eline A. Dubois, Robert Rissmann & Adam F. Cohen, New drug mechanisms: Tolvaptan, [Revised on Jan 2012] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3248250/

2. Goodman and Gilman’s: The Pharmacological Basis of Therapeutics. Chapter 25 - Regulation of renal function and vascular volume, 12th edition 2011. Page: 739.

3. AndersonBrecon (UK) Limited; Electronic Medicines Compendium (EMC); [Revised on April 2020] [Accessed 26 Oct 2020] https://www.medicines.org.uk/emc/files/pil.6849.pdf

4. Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan; U.S. Food & Drug Administration; [Revised on Oct 2012] [Accessed 26 Oct 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s007lbl.pdf

5. Laia Sans-Atxer and Dominique Joly; Tolvaptan in the treatment of autosomal dominant polycystic kidney disease: patient selection and special considerations; [Published on 31 Jan 2018] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797468/