• Tabuvan indications
• Uses of Tabuvan in details
• Tabuvan description
• Tabuvan dosage
• Tabuvan interactions
• Tabuvan side effects
• Tabuvan contraindications

What is Tabuvan?

Tabuvan is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Tabuvan is also used to treat heart failure and left ventricular failure after a heart attack. Left ventricular failure occurs when the left side of the heart (the main pumping chamber) becomes stiff and enlarged or swollen. This causes pooling of blood in the lungs because the heart is not pumping properly.

Tabuvan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. Tabuvan relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart.

Tabuvan is available only with your doctor's prescription.

Tabuvan indications

Hypertension

Tabuvan (Tabuvan) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which Tabuvan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Tabuvan.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Tabuvan may be used alone or in combination with other antihypertensive agents.

Heart Failure

Tabuvan is indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, Tabuvan significantly reduced hospitalizations for heart failure. There is no evidence that Tabuvan provides added benefits when it is used with an adequate dose of an ACE inhibitor.

Post-Myocardial Infarction

In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Tabuvan is indicated to reduce cardiovascular mortality.

How should I use Tabuvan?

Use Tabuvan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Tabuvan. Talk to your pharmacist if you have questions about this information.
• Take Tabuvan by mouth with or without food.
• If you cannot swallow capsules or tablets, ask your doctor or pharmacist about preparing a suspension of Tabuvan.
• Take Tabuvan on a regular schedule to get the most benefit from it. Taking Tabuvan at the same time each day will help you remember to take it.
• Continue to take Tabuvan even if you feel well. Do not miss any doses.
• If you miss a dose of Tabuvan, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tabuvan.

Uses of Tabuvan in details

Tabuvan is used to treat high blood pressure and heart failure. It is also used to improve the chance of living longer after a heart attack. In people with heart failure, it may also lower the chance of having to go to the hospital for heart failure. Tabuvan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to help protect the kidneys from damage due to diabetes.

How to use Tabuvan

Read the Patient Information Leaflet if available from your pharmacist before you start taking Tabuvan and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily. The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on weight.

If you are using the liquid form of this medication, shake the bottle well for at least 10 seconds before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

Tell your doctor if you do not get better or if you get worse (for example, your blood pressure readings remain high or increase).

Tabuvan description

Tabuvan is an angiotensin-receptor blocker (ARB) that may be used to treat a variety of cardiac conditions including hypertension, diabetic nephropathy and heart failure. Tabuvan lowers blood pressure by antagonizing the renin-angiotensin-aldosterone system (RAAS); it competes with angiotensin II for binding to the type-1 angiotensin II receptor (AT1) subtype and prevents the blood pressure increasing effects of angiotensin II. Unlike angiotensin-converting enzyme (ACE) inhibitors, ARBs do not have the adverse effect of dry cough. Tabuvan may be used to treat hypertension, isolated systolic hypertension, left ventricular hypertrophy and diabetic nephropathy. It may also be used as an alternative agent for the treatment of heart failure, systolic dysfunction, myocardial infarction and coronary artery disease.

Tabuvan dosage

Tabuvan Dosage

Generic name: Tabuvan

Dosage form: Capsules

See also:

• Tabuvan Tablets tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

The recommended starting dose of Tabuvan is 80 mg once daily when used as monotherapy in patients who are not volume-depleted. Tabuvan may be used over a dose range of 80 mg to 320 mg daily, administered once-a-day.

The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required, the dosage may be increased to 160 mg or 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.

No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of Tabuvan in patients with hepatic or severe renal impairment.

Tabuvan may be administered with other antihypertensive agents.

Tabuvan may be administered with or without food.

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Other formulations

• Tabuvan HCT

Related treatment guides

• Heart Attack
• Heart Failure
• High Blood Pressure
• Left Ventricular Dysfunction

Tabuvan interactions

See also:
What other drugs will affect Tabuvan?

No clinically significant pharmacokinetic interactions were observed when Tabuvan (Tabuvan) was coadministered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. The Tabuvan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone.

Coadministration of Tabuvan and warfarin did not change the pharmacokinetics of Tabuvan or the timecourse of the anticoagulant properties of warfarin.

CYP 450 Interactions

In vitro metabolism studies indicate that CYP 450 mediated drug interactions between Tabuvan and coadministered drugs are unlikely because of the low extent of metabolism.

Transporters

The results from an in vitro study with human liver tissue indicate that Tabuvan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Coadministration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to Tabuvan.

Potassium

Concomitant use of Tabuvan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If comedication is considered necessary, monitoring of serum potassium is advisable.

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Tabuvan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Tabuvan and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including Tabuvan, may be attenuated by NSAIDs including selective COX-2 inhibitors.

Dual Blockade of the Renin-Angiotensin System (RAS)

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on Tabuvan and other agents that affect the RAS.

Do not coadminister aliskiren with Tabuvan in patients with diabetes. Avoid use of aliskiren with Tabuvan in patients with renal impairment (GFR <60 mL/min).

Lithium

Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Tabuvan. Monitor serum lithium levels during concomitant use.

Clinical Laboratory Test Findings

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Tabuvan.

Creatinine

Minor elevations in creatinine occurred in 0.8% of patients taking Tabuvan and 0.6% given placebo in controlled clinical trials of hypertensive patients. In heart failure trials, greater than 50% increases in creatinine were observed in 3.9% of Tabuvan-treated patients compared to 0.9% of placebotreated patients. In post-myocardial infarction patients, doubling of serum creatinine was observed in 4.2% of Tabuvan-treated patients and 3.4% of captopril-treated patients.

Hemoglobin And Hematocrit

Greater than 20% decreases in hemoglobin and hematocrit were observed in 0.4% and 0.8%, respectively, of Tabuvan patients, compared with 0.1% and 0.1% in placebo-treated patients. One Tabuvan patient discontinued treatment for microcytic anemia.

Liver Function Tests

Occasional elevations (greater than 150%) of liver chemistries occurred in Tabuvan-treated patients. Three patients (<0.1%) treated with Tabuvan discontinued treatment for elevated liver chemistries.

Neutropenia

Neutropenia was observed in 1.9% of patients treated with Tabuvan and 0.8% of patients treated with placebo.

Serum Potassium

In hypertensive patients, greater than 20% increases in serum potassium were observed in 4.4% of Tabuvan-treated patients compared to 2.9% of placebo-treated patients. In heart failure patients, greater than 20% increases in serum potassium were observed in 10.0% of Diovantreated patients compared to 5.1% of placebo-treated patients.

Blood Urea Nitrogen (BUN)

In heart failure trials, greater than 50% increases in BUN were observed in 16.6% of Tabuvan-treated patients compared to 6.3% of placebo-treated patients.

Tabuvan side effects

See also:
What are the possible side effects of Tabuvan?

Tabuvan has been evaluated for safety in more than 4000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse experiences with Tabuvan was similar to placebo.

The overall frequency of adverse experiences was neither dose-related nor related to gender, age, race, or regimen. Discontinuation of therapy due to side effects was required in 2.3% of Tabuvan patients and 2.0% of placebo patients. The most common reasons for discontinuation of therapy with Tabuvan were headache and dizziness.

The adverse experiences that occurred in placebo-controlled clinical trials in at least 1% of patients treated with Tabuvan and at a higher incidence in Tabuvan (n=2316) than placebo (n=888) patients included viral infection (3% vs. 2%), fatigue (2% vs. 1%), and abdominal pain (2% vs. 1%).

Headache, dizziness, upper respiratory infection, cough, diarrhea, rhinitis, sinusitis, nausea, pharyngitis, edema, and arthralgia occurred at a more than 1% rate but at about the same incidence in placebo and Tabuvan patients.

In trials in which Tabuvan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE-inhibitor group (7.9%) than in the groups who received Tabuvan (2.6%) or placebo (1.5%). In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received Tabuvan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p<0.001).

Dose-related orthostatic effects were seen in less than 1% of patients. An increase in the incidence of dizziness was observed in patients treated with Tabuvan 320 mg (8%) compared to 10 to 160 mg (2% to 4%).

Tabuvan has been used concomitantly with hydrochlorothiazide without evidence of clinically important adverse interactions.

Other adverse experiences that occurred in controlled clinical trials of patients treated with Tabuvan (> 0.2% of Tabuvan patients) are listed below. It cannot be determined whether these events were causally related to Tabuvan.

Body as a Whole: Allergic reaction and asthenia

Cardiovascular: Palpitations

Dermatologic: Pruritus and rash

Digestive: Constipation, dry mouth, dyspepsia, and flatulence

Musculoskeletal: Back pain, muscle cramps, and myalgia

Neurologic and Psychiatric: Anxiety, insomnia, paresthesia, and somnolence

Respiratory: Dyspnea

Special Senses: Vertigo

Urogenital: Impotence

Other reported events seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.

Post-Marketing Experience

The following additional adverse reactions have been reported in post-marketing experience:

Hypersensitivity: There are rare reports of angioedema.

Digestive: Elevated liver enzymes and very rare reports of hepatitis.

Renal: Impaired renal function.

Clinical Laboratory tests: Hyperkalemia

Dermatologic: Alopecia

Clinical Laboratory Test Findings

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Tabuvan.

Creatinine: Minor elevations in creatinine occurred in 0.8% of patients taking Tabuvan and 0.6% given placebo in controlled clinical trials.

Hemoglobin and Hematocrit: Greater than 20% decreases in hemoglobin and hematocrit were observed in 0.4% and 0.8%, respectively, of Tabuvan patients, compared with 0.1% and 0.1% in placebo-treated patients. One Tabuvan patient discontinued treatment for microcytic anemia.

Liver function tests: Occasional elevations (greater than 150%) of liver chemistries occurred in Tabuvan-treated patients. Three patients (< 0.1%) treated with Tabuvan discontinued treatment for elevated liver chemistries.

Neutropenia: Neutropenia was observed in 1.9% of patients treated with Tabuvan and 0.8% of patients treated with placebo.

Serum Potassium: Greater than 20% increases in serum potassium were observed in 4.4% of Tabuvan-treated patients compared to 2.9% of placebo-treated patients.

Tabuvan contraindications

See also:
What is the most important information I should know about Tabuvan?

Do not use Tabuvan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Tabuvan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking Tabuvan.

You should not use this medication if you are allergic to Tabuvan. Before you take Tabuvan, tell your doctor if you have ever had a severe allergic reaction to any blood pressure medication.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of Tabuvan.

Do not use potassium supplements or salt substitutes while you are taking Tabuvan, unless your doctor has told you to.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

In rare cases, Tabuvan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Active ingredient matches for Tabuvan:

Valsartan in Oman.

References

1. DailyMed. "AMLODIPINE BESYLATE; VALSARTAN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "valsartan". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "valsartan". http://www.drugbank.ca/drugs/DB00177 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology