Samsca

The active ingredient in Samsca is tolvaptan. Samsca acts as a vasopressin V2 receptor antagonist or a receptor blocker. Vasopressin (also known as antidiuretic hormone, ADH) works on the kidneys to help the body retain water.

Samsca causes the kidneys to excrete more free water by inhibiting the impact of vasopressin while losing little sodium or potassium. This assists in raising low sodium levels (hyponatremia) in the blood, particularly in circumstances such as heart failure or SIADH (syndrome of inappropriate antidiuretic hormone).

Follow all directions provided by your doctor and read all documents carefully, including the full Prescribing Information, FDA-approved Product Labeling, Instructions for Use, and Medication Guide, before using Samsca. However, the following is a synopsis of the general guidelines for the use of Samsca:

• Drink plenty of fluids when on Samsca, but avoid grapefruit juice and alcoholic beverages.
• You can take the tablet with or without food.
• Samsca is typically taken once a day. Follow your doctor's dosing recommendations carefully.
• You will need to be monitored in a hospital whenever you begin or restart Samsca medication to rapidly treat any major adverse effects. If you have stopped taking this medication for an extended period of time, do not resume at home.
• Long-term usage of tolvaptan can harm your liver. You should not use this medication for more than 30 days.

Some mild and common side effects of Samsca seen in clinical trials as compared to placebo include:

• Dry mouth.
• Constipation.
• Loss of appetite.
• Drowsiness.
• Mood changes or confusion.
• Trouble speaking or muscle control.
• Unusual tiredness.
• High blood glucose levels (hyperglycemia).
• High potassium level (hyperkalemia).

Some individuals may experience serious side effects while using Samsca. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Irregular heartbeats.
• Symptoms of liver problems include stomach pain, vomiting, fever, itching, and yellowing of your skin or the white of your eyes (jaundice).
• Allergic reaction to the medication, such as hives, skin rash, or swelling.
• Gastrointestinal bleeding in patients with cirrhosis in the hyponatremia trials.

These are not all of the possible side effects of Samsca. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Samsca, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Unable to urinate.
• Severely dehydrated.
• Kidney problems.
• Underlying liver disease or liver injury.
• Desmopressin (dDAVP) is a diuretic or a “water pill”.
• Serum potassium levels should be monitored during concomitant drug therapy.
• Too rapid correction of hyponatremia can cause osmotic demyelination syndrome, which can cause neurological changes and result in coma or death.

Boxed Warning

Samsca should only be begun or restarted in a hospital where sodium levels can be continuously monitored, as treating hyponatraemia too soon can result in serious and often deadly brain damage. Patients with malnutrition, drunkenness, or advanced liver disease may require a slower correction rate. It is not licensed for ADPKD due to the potential of liver toxicity; instead, tolvaptan (Jynarque) is used in that situation.

• Concurrent usage of powerful CYP3A inhibitors.
• Hypersensitivity (such as anaphylactic shock or a generalised rash).
• Anuria.
• Inability of the patient to detect or respond effectively to thirst.
• Hypovolamic hyponatremia.

Samsca normally begins acting within 2 to 4 hours of the first dose, with the largest effect on boosting sodium levels occurring between 4 and 8 hours. The majority of patients' salt levels improve during the first 24 to 48 hours, but cautious monitoring in the hospital is required to avoid correcting levels too soon.

When Samsca is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Nefazodone.
• An antibiotic - clarithromycin or telithromycin.
• Antifungal medications include itraconazole and ketoconazole.
• HIV/AIDS medications include indinavir, nelfinavir, ritonavir, and saquinavir.

The standard adult beginning dose of Samsca for hyponatraemia is 15 mg once a day, which can be increased to 30 mg after 24 hours and up to 60 mg once daily if necessary.

The duration of therapy should not last more than 30 days. Sodium levels and fluid balance must be constantly maintained throughout therapy, with fluid restriction avoided in the first 24 hours.

Samsca is used to treat hypervolemic or euvolemic hyponatraemia, including situations associated with heart failure or SIADH, particularly when fluid restriction has not corrected sodium levels.

Store at room temperature and keep out of reach of children.

Otsuka Pharmaceutical Co., Ltd. is the company that manufactures Samsca.

Yes, there are several generic versions of Samsca available.

You should not discontinue taking Samsca (tolvaptan) without consulting your doctor. Because it corrects low sodium levels, abruptly discontinuing may cause your sodium levels to fall again, which is harmful.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you, as it is not known if this medication will harm an unborn baby.

You should not breastfeed while using Samsca.