Manufacturer: Alkem Laboratories Ltd
Salt Composition : Tolvaptan(15mg)
Shiokem 15mg 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.
Shiokem 15mg Tablet is a vasopressin antagonist. It works by blocking the effect of the hormone vasopressin in the body. This increases urine production, reduces the amount of water in the blood and raises the blood sodium level.
The pharmacokinetics and pharmacodynamics of tolvaptan have been evaluated in multiple trials in healthy subjects. Dose-proportional increases in exposure to tolvaptan, as measured by area under the curve to infinity (AUC∞) and maximum plasma concentration (Cmax), were observed for doses of 15–60 mg.
Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them
Common side effects of Shiokem
Frequent urge to urinate
Nocturia (increased urge to urinate during the night)
Dryness in mouth
Increased thirst
Constipation
Tolvaptan is contraindicated with the use of a strong CYP 3A inhibitor due to drug interaction. It is also contraindicated in hypovolemic hyponatremia because it might precipitate hypotension and renal failure. It should not be administered in anuric patients due to expected lack of clinical benefit.
Shiokem 15mg 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.
Caution is advised when consuming alcohol with Shiokem 15mg Tablet. Please consult your doctor.
Shiokem 15mg Tablet is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
Use with caution
Below 9years: Contraindicated
Tolvaptan is used to treat hyponatremia (low sodium in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH). Tolvaptan is also used to slow kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
TOLVAPTAN may have interaction with antibiotic (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).
Do not chew, crush or break it. Shiokem 15mg Tablet may be taken with or without food, but it is better to take it at a fixed time.
Store below 30°C
If you miss a dose of Shiokem 15mg Tablet, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Consult a doctor before taking any medicines.
Shiokem 15mg Tablet treats low sodium levels in the blood.
It also improves urine flow without causing the body to lose too much sodium as you urinate.
Take it at the same time everyday. Take it according to the dose and duration prescribed by your doctor.
To avoid dehydration, it is best to drink something as soon as you feel thirsty, but avoid alcoholic drinks.
Do not take Shiokem 15mg Tablet if you are unable to urinate, if you are unable to tell when you are thirsty, or if you are severely dehydrated.
You will need to be in a hospital under observation any time you start or restart treatment with Shiokem 15mg Tablet.
Inform your doctor if you notice problems with speech or muscle control, trouble swallowing, trouble moving your arms and legs, or mood changes.
Your doctor may check your liver function before starting treatment and regularly thereafter. Inform your doctor if you notice yellowing of eyes or skin, dark urine, or stomach pain.
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Shiokem 15mg Tablet may be taken with or without food, but it is better to take it at a fixed time.
Q. What is the most important information I need to be aware of while taking Shiokem 15mg Tablet?
Shiokem 15mg 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 Shiokem 15mg Tablet?
Shiokem 15mg Tablet is used for correction of sodium levels in blood. Though the dose and duration are prescribed by the doctor, Shiokem 15mg 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 Shiokem 15mg Tablet affect the sugar levels in blood?
Yes, Shiokem 15mg Tablet may increase the blood sugar levels. Therefore, patients with diabetes mellitus need to be extra careful while taking Shiokem 15mg Tablet and should keep a check on blood sugar levels regularly.
Q. Who should not take Shiokem 15mg Tablet?
You should not take Shiokem 15mg 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 Shiokem 15mg Tablet if your body is not able to make urine, you are allergic to Shiokem 15mg Tablet or if you are on certain medicines which interfere with the working of Shiokem 15mg Tablet.
Q. Can I have grapefruit juice while taking Shiokem 15mg Tablet?
No, you should not take grapefruit or grapefruit juice while on Shiokem 15mg Tablet. The reason being, grapefruit or grapefruit juice may increase the levels of Shiokem 15mg Tablet in your blood and your sodium levels may rise too quickly.
Q. What will happen if I take excess of Shiokem 15mg 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.
