Yosovaltan tablets

Yosovaltan

  • Active Ingredient: Valsartan
  • 160 mg, 80 mg, 40 mg
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What is Yosovaltan?

The active ingredient of Yosovaltan brand is valsartan. Valsartan is an angiotensin II receptor antagonist. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Used for

Yosovaltan is used to treat diseases such as: Heart Attack, Heart Failure, High Blood Pressure, Left Ventricular Dysfunction.

Side Effect

Possible side effects of Yosovaltan include: cold sweats; irregular heartbeat; nausea; numbness or tingling in the hands, feet, or lips; Bloody urine; weight gain; Chills.

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Does Losartan Cause Digestive Difficulties?

Both losartan and Yosovaltan are in the same drug class called ARBs (angiotensin receptor blockers). Losartan can cause indigestion, stomachache, nausea and diarrhea. So can metformin.

Please let your doctor know about these symptoms. He may want to adjust the dose of one or the other of your medications or even reconsider the substitution of losartan for Yosovaltan.

Other possible losartan side effects include fatigue, cough, muscle or joint pain, low blood pressure and dizziness. Such drugs may also cause an allergic reaction that makes the face, lips and throat swell. If this occurs in the digestive tract it can cause severe abdominal pain.

What blood pressure drugs have been recalled?

Yosovaltan. There have been so many types of Yosovaltan recalled this year that the FDA has created a website listing just for them. The latest is American Health Packaging's 160 mg Yosovaltan tablets, lot number 179791 that expire on March 31, 2020. The pills come in 100-count blister packs with NDC number 60687-139-01.В

The agency has also created a page that lists the drugs that have not been recalled.

Losartan. In December, the FDA announced a voluntary recall of losartan potassium tablets USP.В An addition eight lots of Torrent Pharmaceuticals' losartan tablets were added to a previous recall in January.В See which products were affected by the recall.

In November, the FDA announced a voluntary recall of losartan potassium/hydrochlorothiazide, 100 mg/25 mg tablets in 1,000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912, Exp. Date 06/2020.

Torrent's recall was expanded on Jan. 22 to include 10 additional lots of losartan potassium tablets, and six lots of losartan potassium and hydrochlorothiazide tablets. Torrent further expanded the recall in April for 36 more lots of losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets. In September, Torrent announced thatВ an additional threeВ lots of losartan potassium tablets in 100 mg and 50 mg doses, and two lots of losartan potassium/hydrochlorothiazide tablets 50 mg/12.5 mg, and 100 mg/25 mg are being recalled as well.В See the full list here.В

Macleods Pharmaceuticals Limited on Feb. 25 recalled one lot of losartan potassium/hydrochlorothiazide combination tablets 100mg/25mg, with a July 2019 expiration date. Macleods on June 26 also recalled 32 lots of losartan potassium including two lots of 50 mg tablets and losartan potassium/hydrochlorothiazide tablets, including 12 lots of 50 mg/12.5 mg strength, three lots of 100 mg/12.5 mg and 15 lots of 100 mg/25 mg strength.В

Camber Pharmaceuticals on Feb. 28 recalled 87 lots of losartan tablets USP 25mg, 50 mg and 100 mg. See the affected products and what the label looks like.В

Legacy Pharmaceutical Packaging, LLC on March 15 recalled 43 lots of losartan tablets. On April 24, the company recalled an additional lot of 50mg losartan tablets. See a list of affected products here and here.В

Teva Pharmaceuticals USA on April 26 recalled 35 lots of losartan potassium tablets (6 lots of 25 mg pills and 29 lots of 100 mg) that were sold exclusively to the Golden State Medical Supply of Camarillo, CA. Golden State re-packages the tablets under its own label for retail sale. Teva expanded this recall on June 10, 2019, with another six lots of losartan potassium USP tablets in 50mg and 100mg strength.В В See all the affected products here.В

On May 4, Vivimed Life Sciences Pvt Ltd recalled 19 lots of losartan potassium tablets in 25 mg, 50 mg and 100 mg doses. The drugs were made in India and distributed by Heritage Pharmaceuticals of East Brunswick, NJ. For details on the recalled drugs, visit the FDA's website.В

Irbesartan. In July, the FDA announced a voluntary recall of irbesartan tablets.В See which products were affected by the recall.В In January 2019,В Prinston Pharmaceutical Inc., doing business as Solco Healthcare LLC, voluntarily recalled eight llots of irbersartan-based drugs. These are not yet listed on the FDA's website of all recalled ibersartan products. The recall involves irbersartan and irbersartan HCTZ tabletes manufactured in China.В

Transporters

The results from an in vitro study with human liver tissue indicate that Yosovaltan 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 Yosovaltan.

What should I avoid while taking Yosovaltan?

Drinking alcohol can increase certain side effects of Yosovaltan.

Do not use potassium supplements or salt substitutes unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

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What Is Diovan (Yosovaltan)?

Diovan is the brand name of Yosovaltan, a prescription drug used to treat high blood pressure, congestive heart failure, and heart attack.

Specifically, the drug is prescribed to people who have problems with the functioning of their left ventricle, the chamber of your heart that pumps blood out to the rest of your body

Manufactured by Norvartis Pharmaceuticals, Diovan was originally approved in 40 milligram (mg) and 80 mg capsules by the Food and Drug Administration (FDA) in 1996.

The capsules have been removed from the market. Currently, Diovan is only available in tablet form, which was approved by the FDA in 2001.

Diovan belongs to group of drugs known as angiotensin receptor blockers (ARBs), which work by preventing a chemical called angiotensin from binding to its receptor.

Angiotensin is a chemical the body produces that can raise blood pressure by causing blood vessels to narrow. Its receptors are located on blood vessels throughout the body.

By blocking the action of angiotensin binding to its receptors, ARBs help to lower blood pressure.

Other warnings

  • Low blood pressure warning: This drug can cause your blood pressure to drop too low. This can cause dizziness, lightheadedness, and headache. You may have a higher risk if you’re dehydrated or take high doses of diuretics (water pills).
  • High blood potassium warning: This drug can increase your potassium levels. Your risk may be higher if you have k >

Yosovaltan is a prescription drug. It comes in two forms: an oral tablet and an oral solution.

Yosovaltan oral tablet is available as the brand-name drug Diovan. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Yosovaltan may be taken as part of a combination therapy with other drugs.

Diovan (Yosovaltan) Interactions

It is always important to share with your doctor and pharmacist all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking.

You should NOT take Diovan if you are taking the following drugs:

  • Tekturna (aliskiren)
  • Any blood pressure medications belonging to a group called ACE inhibitors, such as Lotensin (benazepril), Capoten (captopril), and Vasotec (enalapril)
  • Lithium

Be careful if you are taking any of the following:

  • Beta blockers like Sectral (acebutolol), Kerlone (betaxolol), Zebeta (bisoprolol), and Coreg (carvedilol)
  • Aspirin and aspirin-containing products
  • Other angiotensin receptor blockers (ARBs) like Atacand (candesartan) or Tevetan (eprosartan)
  • Midadmor (Amiloride)
  • Biaxin (clarithromycin)
  • NSAIDs like sulindac, diclofenac, etodolac, feniprofen, fluribuprofen, ibuprofen, etodolac
  • Betapace and Betapace AF (sotalol)
  • Azulfidine (sulfasalazine)

Hypertension

Diovan ® (Yosovaltan) 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 Yosovaltan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Diovan.

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.

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

Post-Myocardial Infarction

The VALsartan In Acute myocardial iNfarcTion trial (VALIANT) was a randomized, controlled, multinational, double-blind study in 14,703 patients with acute myocardial infarction and either heart failure (signs, symptoms or radiological evidence) or left ventricular systolic dysfunction (ejection fraction ≤40% by radionuclide ventriculography or ≤35% by echocardiography or ventricular contrast angiography). Patients were randomized within 12 hours to 10 days after the onset of myocardial infarction symptoms to one of three treatment groups: Yosovaltan (titrated from 20 or 40 mg twice daily to the highest tolerated dose up to a maximum of 160 mg twice daily), the ACE inhibitor, captopril (titrated from 6.25 mg three times daily to the highest tolerated dose up to a maximum of 50 mg three times daily), or the combination of Yosovaltan plus captopril. In the combination group, the dose of Yosovaltan was titrated from 20 mg twice daily to the highest tolerated dose up to a maximum of 80 mg twice daily; the dose of captopril was the same as for monotherapy. The population studied was 69% male, 94% Caucasian, and 53% were 65 years of age or older. Baseline therapy included aspirin (91%), betablockers (70%), ACE inhibitors (40%), thrombolytics (35%) and statins (34%). The mean treatment duration was 2 years. The mean daily dose of Diovan in the monotherapy group was 217 mg.

The primary endpoint was time to all-cause mortality. Secondary endpoints included (1) time to cardiovascular (CV) mortality, and (2) time to the first event of cardiovascular mortality, reinfarction, or hospitalization for heart failure. The results are summarized in the following table.

There was no difference in overall mortality among the three treatment groups. There was thus no evidence that combining the ACE inhibitor captopril and the angiotensin II blocker Yosovaltan was of value.

The data were assessed to see whether the effectiveness of Yosovaltan could be demonstrated by showing in a non-inferiority analysis that it preserved a fraction of the effect of captopril, a drug with a demonstrated survival effect in this setting. A conservative estimate of the effect of captopril (based on a pooled analysis of 3 post-infarction studies of captopril and 2 other ACE inhibitors) was a 14% to 16% reduction in mortality compared to placebo. Yosovaltan would be considered effective if it preserved a meaningful fraction of that effect and unequivocally preserved some of that effect. As shown in the table, the upper bound of the CI for the hazard ratio (Yosovaltan/captopril) for overall or CV mortality is 1.09 to 1.11, a difference of about 9% to 11%, thus making it unlikely that Yosovaltan has less than about half of the estimated effect of captopril and clearly demonstrating an effect of Yosovaltan. The other secondary endpoints were consistent with this conclusion.

Effects on Mortality Amongst Subgroups in VALIANT

There were no clear differences in all-cause mortality based on age, gender, race, or baseline therapies, as shown in the figure above.

7. Pregnancy and breastfeeding

Yosovaltan is not normally recommended in pregnancy or when breastfeeding. However, your doctor may prescribe it if they think the benefits of the medicine outweigh the risks.

If you're trying to get pregnant or you're already pregnant, talk to your doctor about the benefits and possible harms of taking Yosovaltan. These will depend on how many weeks pregnant you are and the reason you need to take it. There may be other treatments that are safer for you.

For more information about how Yosovaltan can affect you and your baby during pregnancy, visit the Best Use of Medicines in Pregnancy (BUMPS) website.

1. About Yosovaltan

Yosovaltan is a medicine widely used to treat high blood pressure and heart failure. It's also sometimes prescribed after a heart attack.

Yosovaltan is only available on prescription. It comes as tablets, capsules and as a liquid that you swallow.

Exposure (measured by AUC) to Yosovaltan is higher by 70% and the half-life is longer by 35% in the elderly than in the young. No dosage adjustment is necessary .

What is the dosage for Yosovaltan?

The usual dose of Yosovaltan for adults with high blood pressure is 80 to 160 mg once daily. The maximum dose is 320 mg daily. Maximum blood pressure reduction occurs within 4 weeks. For congestive heart failure, the usual dose is 40 mg twice daily. The doses may be increased to 80-160 mg twice daily. The initial dose after a heart attack is 20 mg twice daily. The dose may be increased to 160 mg twice daily if tolerated without side effects.

Q: I have been taking Diovan for the past few years. I am overweight and it is the main reason I have high blood pressure. My doctor has acknowledged this. However, I have not lost the weight. If I do make the lifestyle changes, I am confident my blood pressure will go down. If that happens, can I stop taking Diovan. Also, will I have to be weaned off of Diovan?

A: Your question regards losing weight to help lower your blood pressure and being able to possibly stop taking the medication Diovan (Yosovaltan). //www.everydayhealth.com/drugs/diovan Losing excess weight has many health benefits. Often when patients lose weight their blood pressure drops. Some patients are able to completely stop medications, others may take lower dosages of blood pressure meds. Since weight loss is a gradual process, the lowering of blood pressure is also usually a gradual process. As you lose the weight, keep a close eye on your blood pressure. Monitor it at home or monitor it as often at available blood pressure machines throughout your community and of course at your doctor's office. According to Lexi-Comp, Diovan comes in 40mg, 80mg, 160mg, and 320mg strengths. As your blood pressure lowers, your physician may choose to change your dosage to 40mg and possibly even discontinue the med. As always, all dosage adjustments should be made by your physician. Do not adjust your dosage without speaking to your health care provider. Jen Marsico, RPh

How should I take Yosovaltan?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take Yosovaltan at the same time(s) each day, with or without food.

If a child taking Yosovaltan cannot swallow a capsule whole, your pharmacist can mix the medicine into a liquid. Shake this liquid well just before you measure a dose. Measure the medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

You may have very low blood pressure while taking Yosovaltan. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

It may take 2 to 4 weeks of using this medicine before your blood pressure is under control. 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 medicine for the rest of your life.

Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

Store at room temperature away from moisture and heat.

Contraindications

  • Hypersensitivity
  • Do not co-administer with aliskiren in patients with diabetes mellitus

Effects of Drug Abuse

  • No information provided

  • See "What Are Side Effects Associated with Using Yosovaltan?"

  • See "What Are Side Effects Associated with Using Yosovaltan:"

There is no apparent correlation between renal function (measured by creatinine clearance) and exposure (measured by AUC) to Yosovaltan in patients with different degrees of renal impairment. Consequently, dose adjustment is not required in patients with mild-to-moderate renal dysfunction. No studies have been performed in patients with severe impairment of renal function (creatinine clearance 2 basis. Calculations assume an oral dose of 320 mg/day and a 60-kg patient.


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