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TOLVARISE 30 Tablet 4's

Patanjali Pharma (15.9 km)

₹968

INTRODUCTION TOLVARISE 30 TABLET contains Tolvaptan, which belongs to the group of medicines called Vasopressin antagonists. It is used to treat low serum sodium levels in adults who have a "syndrome of inappropriate antidiuretic hormone secretion" (SIADH), a condition in which the kidneys ret...

Category: Hyponatremia

INTRODUCTION

TOLVARISE 30 TABLET contains Tolvaptan, which belongs to the group of medicines called Vasopressin antagonists. It is used to treat low serum sodium levels in adults who have a "syndrome of inappropriate antidiuretic hormone secretion" (SIADH), a condition in which the kidneys retain too much water.

The symptoms of SIADH may include nausea, vomiting, headache, confusion, weakness, and feeling sick; muscle weakness, irritability, mental confusion, and tremors (involuntary shaking or movements affecting hands, legs, face, head, or vocal cords).

[GBNKNOWN] is not recommended for use in patients having problems with kidney function. TOLVARISE 30 TABLET should be used with caution in patients with diabetes, heart disease, liver problems, and a kidney disease called autosomal dominant polycystic kidney disease (ADPKD).

If you are pregnant or breastfeeding, consult your doctor for advice before taking TOLVARISE 30 TABLET. TOLVARISE 30 TABLET should not be used in children or adolescents under the age of 18. The most common side effects of taking TOLVARISE 30 TABLET are thirst, dehydration, nausea, headache, and diarrhea. Consult your doctor if the symptom worsens.

USES OF TOLVARISE 30 TABLET

  • Treats low serum sodium levels (hyponatremia) in adults who have “syndrome of inappropriate antidiuretic hormone secretion” (SIADH)

HOW TOLVARISE 30 TABLET WORKS

TOLVARISE 30 TABLET works by suppressing vasopressin (a hormone that helps prevent the loss of water from the body by reducing urine output) leading to increased urine production and a raise in sodium concentration in blood.

DIRECTIONS FOR USE

Take TOLVARISE 30 TABLET as advised by your physician. Swallow this medicine, do not crush, or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

SIDE EFFECTS OF TOLVARISE 30 TABLET

COMMON

  • thirst
  • signs of high sodium level such as restlessness, extreme thirst, confusion, and lethargy)
  • excessive drinking of water
  • dehydration
  • nausea
  • signs of high potassium levels like shortness of breath, chest pain, nausea, or vomiting
  • signs of high creatinine in the blood such as swelling or oedema, high blood pressure, muscle cramps and chest pain
  • signs of high uric acid (severe pain in joints, joint stiffness, difficulty in moving affected joints)
  • increase or decrease in blood sugar level
  • decreased appetite
  • fainting
  • headache
  • dizziness
  • low blood pressure when standing up
  • constipation
  • diarrhoea
  • dry mouth
  • patchy bleeding in the skin
  • itching
  • frequent urination
  • tiredness, general weakness
  • fever
  • general feeling of being unwell
  • blood in the urine
  • signs of raised levels of liver enzymes in the blood include stomach pain, dark urine, itching, jaundice

UNCOMMON

  • altered taste sensation
  • signs of kidney problems such as loss of appetite, decreased urinary output, fatigue

RARE

Stop taking TOLVARISE 30 TABLET and contact your doctor immediately if you experience any of the following side effects:

  • difficulty in urination
  • symptoms of allergic reaction included swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness
  • feel sick, loss of appetite, upper right abdominal discomfort, dark urine, yellowing of skin or eyes (jaundice)

HOW TO MANAGE SIDE EFFECTS

Diarrhoea:

Drink lots of fluids, such as water or fruit juice, to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor. Consult your doctor if your symptoms do not improve.

Dizziness:

When you feel dizzy, lie down or sit down immediately. If you're experiencing a severe episode of vertigo, lie in a dark, quiet place with your eyes closed. Vehicle driving should be avoided if you experience frequent dizziness without warning. Consult your doctor if your symptoms do not improve.

Dry mouth:

A dry mouth can be managed by chewing sugar-free gum or sucking on sugar-free hard candies to stimulate the flow of saliva. Drink water at regular intervals. Do not use mouthwashes that contain alcohol because they can be drying. Consult your doctor if your symptoms do not improve.

WARNING & PRECAUTIONS

PREGNANCY

TOLVARISE 30 TABLET is not recommended for use in pregnant women or if you think you might become pregnant. Women should use appropriate contraceptive measures to avoid pregnancy while taking this medicine. Consult your doctor before taking TOLVARISE 30 TABLET.

BREASTFEEDING

TOLVARISE 30 TABLET is not recommended for use in breastfeeding women. Discuss with your doctor before taking TOLVARISE 30 TABLET.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel dizzy, weak or feeling of fainting for a short period after taking TOLVARISE 30 TABLET. Consult your doctor before taking TOLVARISE 30 TABLET.

ALCOHOL

Avoid consumption of alcohol as it may increase the risk of side effects of TOLVARISE 30 TABLET.

KIDNEY

TOLVARISE 30 TABLET is not recommended for use if you have improper kidney function (no urine production). TOLVARISE 30 TABLET should be taken with caution in patients suffering from a kidney disease called autosomal dominant polycystic kidney disease (ADPKD). Consult your doctor before taking TOLVARISE 30 TABLET.

LIVER

TOLVARISE 30 TABLET should be used with caution in patients having liver disease. Consult your doctor before taking TOLVARISE 30 TABLET.

ALLERGY

TOLVARISE 30 TABLET is not recommended for use if you are allergic to Tolvaptan or Benzazepine derivatives (Ex. benazepril, conivaptan, fenoldopam mesylate or mirtazapine).

HEART DISEASE

TOLVARISE 30 TABLET should be used with caution in patients having congestive heart failure. Consult your doctor before taking TOLVARISE 30 TABLET.

OTHERS

TOLVARISE 30 TABLET is not recommended for use if you have:

  • hypernatremia (a condition which increases the salt in blood)
  • any condition which is associated with a very low blood volume
  • feeling of not realising when you are thirsty

Before taking TOLVARISE 30 TABLET, inform your doctor if you have:

  • cannot drink enough water or in fluid restricted diet
  • have difficulties in urination or have an enlarged prostate
  • diabetes

Use in pediatrics:

TOLVARISE 30 TABLET is not recommended for use in children and adolescents (under 18 years of age). Consult your doctor before taking TOLVARISE 30 TABLET.

Use in geriatrics:

TOLVARISE 30 TABLET is used with caution in patients above 65 years of age. Consult your doctor before taking TOLVARISE 30 TABLET.

INTERACTIONS

A. Drug-Drug interactions:

Before taking TOLVARISE 30 TABLET, inform your doctor if you are taking any of the following medicine:

  • ketoconazole (a medicine used against fungal infections)
  • macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin (medicines used to treat bacterial infections)
  • diltiazem (a medicine used in the treatment of high blood pressure and chest pain)
  • medicines that increase the salt in your blood or which contain large amounts of salt (Ex. Sodium bicarbonate, sodium chloride, diuretics like furosemide, and bumetanide)
  • barbiturates like phenobarbital, and pentobarbital (medicines used to treat epilepsy/seizures and some sleep disorders)
  • rifampicin (a medicine used against tuberculosis)
  • digoxin (medicine used in the treatment of irregular heartbeat and heart failure)
  • desmopressin (a medicine used to increase blood clotting factors)

B . Drug–Food interactions:

Do not eat grapefruit or drink grapefruit juice while you are taking this medicine as it can increase the risk of side effects of this medicine. Consult your doctor before taking TOLVARISE 30 TABLET.

Overdosage:

If you or anyone else accidentally take too much of TOLVARISE 30 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are a rise in serum sodium concentration, polyuria, thirst, and dehydration/hypovolemia (profuse and prolonged aquaresis).

SYNOPSIS

Drug : Tolvaptan
Pharmacological Category : Vasopressin antagonists
Therapeutic Indication : Low serum sodium levels
Dosage Forms : Tablet

MORE INFORMATION

  • Keep TOLVARISE 30 TABLET out of reach from children
  • Store at room temperature

FAQs ABOUT TOLVARISE 30 TABLET

Can TOLVARISE 30 TABLET cause high blood pressure?

TOLVARISE 30 TABLET did not cause any significant change in the heart rate or blood pressure. If you experience any high blood pressure symptoms, consult your doctor.

What precautions do I need to follow while taking TOLVARISE 30 TABLET?

Patients taking TOLVARISE 30 TABLET must notify their doctor if they have any pre-existing disease conditions such as heart, kidney, liver, or diabetes. Consult your doctor immediately if you experience any unusual symptoms after taking TOLVARISE 30 TABLET.

How much water should I drink while taking TOLVARISE 30 TABLET?

TOLVARISE 30 TABLET causes thirst and excessive drinking, increased urine volume, and frequent urination. Typically, patients will pass 5–6 litres of urine per day. Therefore, you will need to drink 5 to 6 litres of water or non-caffeinated drinks per day.

Does TOLVARISE 30 TABLET cause high blood sugar levels?

TOLVARISE 30 TABLET may cause an increase in blood sugar levels or may lead to a loss of blood glucose control, and glucose tolerance may change. Your doctor may check your blood sugar level before and after taking this medicine.

Can TOLVARISE 30 TABLET be used by children and elderly people?

TOLVARISE 30 TABLET should not be used in children or adolescents under the age of 18. It is used with caution in people over the age of 65. Kindly take your physician’s advice before using TOLVARISE 30 TABLET.

REFERENCES

1. KD Tripathi. Vasopressin antagonists. Essentials of medical pharmacology. Eighth edition. 2019. Page – 644.

2. Hammam D Zmily, Suleiman Daifallah, and Jalal K Ghali. Tolvaptan, hyponatremia, and heart failure. NIH National Library of Medicine, National center for biotechnology information. PubMed Central. March 2011. [Accessed 17th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3108793/

3. Shunji Suzuki, Norio Hanafusa, Kenji Kubota, Ken Tsuchiya, and Kosaku Nitta. Effects of tolvaptan on renal function in chronic kidney disease patients with volume overload. NIH National Library of Medicine, National center for biotechnology information. PubMed Central. August 2018. [Accessed 17th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6103308/

4. AndersonBrecon (UK) Ltd. Electronic Medicines Compendium (EMC). [Revised in September 2021] [Accessed 17th May 2022] https://www.medicines.org.uk/emc/files/pil.6635.pdf

5. Otsuka Pharmaceutical Co., Ltd. U.S. Food & Drug Administration. [Revised in October 2012] [Accessed 17th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s007lbl.pdf

AUTHOR DETAILS

Written By Dr. Dhivakaran R, BDS
Last updated on 26 Nov 2022 | 03:15 PM(IST)

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