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INTRODUCTION TOLSAMA 15MG 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...
TOLSAMA 15MG 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. TOLSAMA 15MG 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 TOLSAMA 15MG TABLET. TOLSAMA 15MG TABLET should not be used in children or adolescents under the age of 18. The most common side effects of taking TOLSAMA 15MG TABLET are thirst, dehydration, nausea, headache, and diarrhea. Consult your doctor if the symptom worsens.
TOLSAMA 15MG 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.
Take TOLSAMA 15MG 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.
Stop taking TOLSAMA 15MG TABLET and contact your doctor immediately if you experience any of the following 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.
TOLSAMA 15MG 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 TOLSAMA 15MG TABLET.
TOLSAMA 15MG TABLET is not recommended for use in breastfeeding women. Discuss with your doctor before taking TOLSAMA 15MG TABLET.
Do not drive or operate any machines if you feel dizzy, weak or feeling of fainting for a short period after taking TOLSAMA 15MG TABLET. Consult your doctor before taking TOLSAMA 15MG TABLET.
Avoid consumption of alcohol as it may increase the risk of side effects of TOLSAMA 15MG TABLET.
TOLSAMA 15MG TABLET is not recommended for use if you have improper kidney function (no urine production). TOLSAMA 15MG 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 TOLSAMA 15MG TABLET.
TOLSAMA 15MG TABLET should be used with caution in patients having liver disease. Consult your doctor before taking TOLSAMA 15MG TABLET.
TOLSAMA 15MG TABLET is not recommended for use if you are allergic to Tolvaptan or Benzazepine derivatives (Ex. benazepril, conivaptan, fenoldopam mesylate or mirtazapine).
TOLSAMA 15MG TABLET should be used with caution in patients having congestive heart failure. Consult your doctor before taking TOLSAMA 15MG TABLET.
TOLSAMA 15MG TABLET is not recommended for use if you have:
Before taking TOLSAMA 15MG TABLET, inform your doctor if you have:
Use in pediatrics:
TOLSAMA 15MG TABLET is not recommended for use in children and adolescents (under 18 years of age). Consult your doctor before taking TOLSAMA 15MG TABLET.
Use in geriatrics:
TOLSAMA 15MG TABLET is used with caution in patients above 65 years of age. Consult your doctor before taking TOLSAMA 15MG TABLET.
A. Drug-Drug interactions:
Before taking TOLSAMA 15MG TABLET, inform your doctor if you are taking any of the following medicine:
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 TOLSAMA 15MG TABLET.
Overdosage:
If you or anyone else accidentally take too much of TOLSAMA 15MG 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).
| Drug | : | Tolvaptan |
| Pharmacological Category | : | Vasopressin antagonists |
| Therapeutic Indication | : | Low serum sodium levels |
| Dosage Forms | : | Tablet |
Can TOLSAMA 15MG TABLET cause high blood pressure?
TOLSAMA 15MG 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 TOLSAMA 15MG TABLET?
Patients taking TOLSAMA 15MG 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 TOLSAMA 15MG TABLET.
How much water should I drink while taking TOLSAMA 15MG TABLET?
TOLSAMA 15MG 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 TOLSAMA 15MG TABLET cause high blood sugar levels?
TOLSAMA 15MG 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 TOLSAMA 15MG TABLET be used by children and elderly people?
TOLSAMA 15MG 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 TOLSAMA 15MG TABLET.
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
Written By Dr. Dhivakaran R, BDS
Last updated on 26 Nov 2022 | 03:15 PM(IST)