Jinarc

Jinarc (Tolvaptan) is usually taken twice a day in two different doses. The recommended starting dose of Jinarc (Tolvaptan) is a total daily dose of 60 mg taken as a split dose of 45 mg + 15 mg. The dose may be increased after seven days to a total of 90 mg daily, taken as a split dose of 60 mg + 30 mg. The maximum daily dose is 120 mg, taken as a split dose of 90 mg + 30 mg.

The higher dose tablet in the combination pack should be taken in the morning, and the lower dose tablet should be taken approximately 8 hours later.

Jinarc (Tolvaptan) may be taken with food or on an empty stomach. If you become thirsty, fluids may be consumed. Avoid grapefruit or grapefruit juice while you are taking Jinarc (Tolvaptan).

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Jinarc (Tolvaptan) exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular prescribe dose and dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Jinarc (Tolvaptan) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

45mg + 15 mg

45 mg
Each non-scored, blue, square, shallow-convex tablet debossed with "otsuka" and "45" on one side, contains 45 mg of Jinarc (Tolvaptan). Nonmedicinal ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake as colourant.

15 mg
Each non-scored, bevelled-edged, shallow-convex, blue, triangular tablet debossed with "otsuka" and "15" on one side, contains 15 mg of Jinarc (Tolvaptan). Nonmedicinal ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake as colourant.

60mg + 30 mg

60 mg
Each non-scored, bevelled-edge, blue, modified rectangular, shallow- convex, beveled-edge tablet, debossed with "otsuka" and "60" on one side, contains 60 mg of Jinarc (Tolvaptan). Nonmedicinal ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake as colourant.

30 mg
Each non-scored, bevelled-edged, shallow-convex, blue, round tablet debossed with "otsuka" and "30" on one side contains 30 mg of Jinarc (Tolvaptan). Nonmedicinal ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake as colourant.

90mg + 30 mg

90 mg
Each non-scored, blue, pentagonal, shallow-convex tablet debossed with "otsuka" and "90" on one side, contains 90 mg of Jinarc (Tolvaptan). Nonmedicinal ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake as colourant.

30 mg
Each non-scored, bevelled-edged, shallow-convex, blue, round tablet debossed with "otsuka" and "30" on one side, contains 30 mg of Jinarc (Tolvaptan). Nonmedicinal ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake as colourant.

Do not take Jinarc (Tolvaptan) if you:

• are allergic to Jinarc (Tolvaptan) or any ingredients of the medication
• are allergic to benzazepine or benzazepine derivatives (e.g., Mirtazapine)
• have been asked by your doctor to permanently stop taking Jinarc (Tolvaptan) in the past
• are not producing urine
• have high blood sodium
• have excessive loss of body water
• cannot sense or respond to thirst
• have impaired liver function
• have galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• are using certain other medications, such as itraconazole, ketoconazole, clarithromycin, HIV protease inhibitors, nefazodone
• are pregnant or breastfeeding

There may be an interaction between Jinarc (Tolvaptan) and any of the following:

• angiotensin converting enzyme inhibitors (ACEIs; e.g., Captopril, Lisinopril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• anticancer medications (e.g., Doxorubicin, Irinotecan, Topotecan)
• Amiodarone
• Apalutamide
• Aprepitant
• "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole, Voriconazole)
• Bosentan
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Carvedilol
• cefaclor
• Cimetidine
• Cobicistat
• conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Deferasirox
• Desipramine
• Desmopressin
• Dexamethasone
• Digoxin
• Dipyridamole
• Dronedarone
• Eluxadoline
• Empagliflozin
• Enzalutamide
• Eslicarbazepine
• Ezetimibe
• fosaprepitant
• Furosemide
• Glyburide
• grapefruit juice
• Hepatitis C antivirals (e.g., asunaprevir, daclatasvir, grazoprevir)
• HIV non-nucleoside reverse transcriptase inhibitors (e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
• Idelalisib
• imatinib
• lumacaftor
• Ketoprofen
• Lapatinib
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methotrexate
• mifepristone
• Modafinil
• mycophenolate
• Nilotinib
• Oxcarbazepine
• Pemetrexed
• penicillin
• Phenobarbital
• Phenytoin
• potassium-sparing diuretics (water pills; e.g., Amiloride, Spironolactone, triamterene)
• primidone
• Propafenone
• Propranolol
• quinidine
• quinine
• rifabutin
• rifampin
• St. John's wort
• siltuximab
• sodium chloride
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Sulfasalazine
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tetracycline
• Tocilizumab
• Trazodone
• zidovudine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Jinarc (Tolvaptan). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Jinarc (Tolvaptan).

Blood pressure: Jinarc (Tolvaptan) may cause a decrease in blood pressure in people who are taking medication to lower blood pressure. You should move slowly when you are rising from a reclining to an upright position to reduce the risk of dizziness. If you are being treated for high blood pressure, discuss with your doctor how Jinarc (Tolvaptan) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jinarc (Tolvaptan), and whether any special monitoring is needed.

Dehydration: Jinarc (Tolvaptan) causes an increase in the amount of urine produced as it causes the body to eliminate fluid. As a result, it is possible for dehydration to occur. Drink fluids when you feel thirsty and be aware of other signs of dehydration such as muscle cramps, nausea and vomiting, rapid pounding heartbeat, as well as a feeling of dry stickiness in the mouth.

Dizziness: Jinarc (Tolvaptan) may cause dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Jinarc (Tolvaptan) affects you.

Fluid and electrolyte balance: Jinarc (Tolvaptan) may cause the levels of electrolytes such as potassium and sodium in the blood to change while taking Jinarc (Tolvaptan). If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking Jinarc (Tolvaptan).

Gout: Jinarc (Tolvaptan) may cause an increase in uric acid in the blood, causing gout. Symptoms of an acute gout attack include sudden pain, swelling, and stiffness in the affected joint, often the big toe. You may also experience a Fever. If this is your first attack, seek medical attention as soon as possible. If you have had gout attacks before, discuss with your doctor how Jinarc (Tolvaptan) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jinarc (Tolvaptan), and whether any special monitoring is needed.

Grapefruit juice: Grapefruit juice affects how Jinarc (Tolvaptan) is removed from the body and may cause too much of the medication to build up in the body and cause possibly harmful side effects. Do not drink grapefruit juice or eat grapefruit at any time while taking Jinarc (Tolvaptan) for treatment.

Liver function: Decreased liver function or liver disease can cause Jinarc (Tolvaptan) to build up in the body, causing side effects. Jinarc (Tolvaptan) may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Jinarc (Tolvaptan) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jinarc (Tolvaptan), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Jinarc (Tolvaptan). If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Pregnancy: Jinarc (Tolvaptan) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Jinarc (Tolvaptan), contact your doctor immediately.

Breast-feeding: It is not known if Jinarc (Tolvaptan) passes into breast milk. If you are a breast-feeding mother and are taking Jinarc (Tolvaptan), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Jinarc (Tolvaptan) have not been established for children.