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Jinarc

Jinarc

(tolvaptan)

Jinarc (Tolvaptan) belongs to the class of medications called vasopressin receptor antagonists. It is used to treat autosomal dominant Kidney Disease (ADPKD), a genetic disorder which results in cysts (fluid filled sacs) on the kidneys.

Available form

Dosage

Tablet

45/15MG

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Jinarc information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

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.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Jinarc (Tolvaptan). If you are concerned about side effects, discuss the risks and benefits of Jinarc (Tolvaptan) with your doctor.

The following side effects have been reported by at least 1% of people taking Jinarc (Tolvaptan). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

Constipation
decreased appetite
Diarrhea
dizziness
Dry Mouth
fatigue
headache
increased urine volume
indigestion
itchy skin
loss of appetite
more frequent urination
muscle spasms
rash
stomach pain
thirst
trouble sleeping
weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

signs of dehydration (e.g., dry or sticky mouth, decreased urine production, decreased tear production, dizziness, thirst, nausea, vomiting)
signs of Gout (e.g., joint pain, usually in the big toe, followed by redness, swelling, warmth)
signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
signs of high levels of potassium in the blood (e.g., irregular heartbeats, muscle weakness, general feeling of being unwell)

Stop taking the medication and seek immediate medical attention if any of the following occur:

signs of angioedema (e.g., swelling of the face, mouth, hands, or feet)
signs of a serious allergic reaction (e.g., swelling of face or throat, Hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Jinarc (Tolvaptan).

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.

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.

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