Viemm tablets

Viemm

  • Active Ingredient: Ezetimibe
  • 10 mg
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What is Viemm?

The active ingredient of Viemm brand is ezetimibe. Ezetimibe reduces the amount of cholesterol absorbed by the body.

Used for

Viemm is used to treat diseases such as: High Cholesterol, High Cholesterol, Familial Heterozygous, Sitosterolemia.

Side Effect

Possible side effects of Viemm include: coughing; light-colored stools; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; gaseous abdominal pain; Back pain; loss of appetite; pain in joints.

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What should I avoid while taking Viemm?

Avoid eating foods that are high in fat or cholesterol. This medicine will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

More common side effects

Some of the more common side effects that can occur with use of Viemm include:

  • diarrhea
  • stuffy nose
  • viral infection of your nose, throat, and airways
  • joint pain

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Blood thinner

Taking warfarin with Viemm can cause warfarin to work too well or not well enough. Your doctor may monitor you more closely if you take a blood thinner with Viemm.

Cyclosporine

Caution should be exercised when using ZETIA and cyclosporine concomitantly due to increased exposure to both Viemm and cyclosporine. Cyclosporine concentrations should be monitored in patients receiving ZETIA and cyclosporine.

The degree of increase in Viemm exposure may be greater in patients with severe renal insufficiency. In patients treated with cyclosporine, the potential effects of the increased exposure to Viemm from concomitant use should be carefully weighed against the benefits of alterations in lipid levels provided by Viemm.

OVERDOSE

In clinical studies, administration of Viemm, 50 mg/day to 15 healthy subjects for up to 14 days, 40 mg/day to 18 patients with primary hyperlipidemia for up to 56 days, and 40 mg/day to 27 patients with homozygous sitosterolemia for 26 weeks was generally well tolerated. One female patient with homozygous sitosterolemia took an accidental overdose of Viemm 120 mg/day for 28 days with no reported clinical or laboratory adverse events.

In the event of an overdose, symptomatic and supportive measures should be employed.

What Is Zetia (Viemm)?

Zetia is the brand name for Viemm, a drug that lowers LDL cholesterol levels by reducing cholesterol absorption in the small intestine.

LDL ("bad") cholesterol builds up in the walls of arteries and forms plaque, which narrows arteries and can lead to heart disease. High LDL cholesterol levels are a major cause of heart attacks and stroke.

Zetia is often prescribed along with a low-fat diet. It may be used by itself or in conjunction with a statin to reduce cholesterol. Zetia may increase LDL-cholesterol uptake into cells and decrease levels of LDL in blood plasma.

One clinical study showed that adding Zetia to statin medicine reduced LDL levels by an average of an additional 25 percent. It may take two weeks before cholesterol levels improve, so patients should continue to take Zetia as prescribed, on a daily basis.

Reducing LDL cholesterol may not always reduce atherosclerosis (plaque build-up in the arteries). Trials found that Zetia, in combination with statins, may not be as effective as Zetia by itself. More studies are needed to evaluate this.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

A 104-week dietary carcinogenicity study with Viemm was conducted in rats at doses up to 1500 mg/kg/day (males) and 500 mg/kg/day (females) (

20 x the human exposure at 10 mg daily based on AUC0-24hr for total Viemm). A 104-week dietary carcinogenicity study with Viemm was also conducted in mice at doses up to 500 mg/kg/day ( > 150 x the human exposure at 10 mg daily based on AUC0-24hr for total Viemm). There were no statistically significant increases in tumor incidences in drug-treated rats or mice.

No evidence of mutagenicity was observed in vitro in a microbial mutagenicity (Ames) test with Salmonella typhimurium and Escherichia coli with or without metabolic activation. No evidence of clastogenicity was observed in vitro in a chromosomal aberration assay in human peripheral blood lymphocytes with or without metabolic activation. In addition, there was no evidence of genotoxicity in the in vivo mouse micronucleus test.

In oral (gavage) fertility studies of Viemm conducted in rats, there was no evidence of reproductive toxicity at doses up to 1000 mg/kg/day in male or female rats (

7 x the human exposure at 10 mg daily based on AUC0-24hr for total Viemm).

Animal Toxicology And/Or Pharmacology

The hypocholesterolemic effect of Viemm was evaluated in cholesterol-fed Rhesus monkeys, dogs, rats, and mouse models of human cholesterol metabolism. Viemm was found to have an ED50 value of 0.5 μg/kg/day for inhibiting the rise in plasma cholesterol levels in monkeys. The ED50 values in dogs, rats, and mice were 7, 30, and 700 μg/kg/day, respectively. These results are consistent with ZETIA being a potent cholesterol absorption inhibitor.

In a rat model, where the glucuronide metabolite of Viemm (SCH 60663) was administered intraduodenally, the metabolite was as potent as the parent compound (SCH 58235) in inhibiting the absorption of cholesterol, suggesting that the glucuronide metabolite had activity similar to the parent drug.

In 1-month studies in dogs given Viemm (0.03 to 300 mg/kg/day), the concentration of cholesterol in gallbladder bile increased

2- to 4-fold. However, a dose of 300 mg/kg/day administered to dogs for one year did not result in gallstone formation or any other adverse hepatobiliary effects. In a 14-day study in mice given Viemm (0.3 to 5 mg/kg/day) and fed a low-fat or cholesterol-rich diet, the concentration of cholesterol in gallbladder bile was either unaffected or reduced to normal levels, respectively.

A series of acute preclinical studies was performed to determine the selectivity of ZETIA for inhibiting cholesterol absorption. Viemm inhibited the absorption of 14 C-cholesterol with no effect on the absorption of triglycerides, fatty acids, bile acids, progesterone, ethinyl estradiol, or the fatsoluble vitamins A and D.

In 4- to 12-week toxicity studies in mice, Viemm did not induce cytochrome P450 drug metabolizing enzymes. In toxicity studies, a pharmacokinetic interaction of Viemm with statins (parents or their active hydroxy acid metabolites) was seen in rats, dogs, and rabbits.

Before taking this medicine

You should not use Viemm if you are allergic to it, or if you have:

moderate to severe liver disease.

You should not use Viemm with a "statin" cholesterol medicine (Zocor, Lipitor, Crestor, and others) if:

you have active liver disease;

you are pregnant; or

you are breast-feeding a baby.

To make sure this medicine is safe for you, tell your doctor if you have:

kidney disease; or

a thyroid disorder.

Before you start taking this medicine, tell your doctor if you already take a statin cholesterol medicine.

Some cholesterol medications can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

You should not take Viemm with a statin medication if you are pregnant or breast-feeding.

It is not known whether Viemm alone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are using Viemm with a statin medication.

It is not known whether Viemm alone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. You should not breast-feed if you take this medicine with a statin medication.

Pediatric Use

The effects of ZETIA coadministered with simvastatin (n=126) compared to simvastatin monotherapy (n=122) have been evaluated in adolescent boys and girls with heterozygous familial hypercholesterolemia (HeFH). In a multicenter, double-blind, controlled study followed by an openlabel phase, 142 boys and 106 postmenarchal girls, 10 to 17 years of age (mean age 14.2 years, 43% females, 82% Caucasians, 4% Asian, 2% Blacks, 13% multi-racial) with HeFH were randomized to receive either ZETIA coadministered with simvastatin or simvastatin monotherapy. Inclusion in the study required 1) a baseline LDL-C level between 160 and 400 mg/dL and 2) a medical history and clinical presentation consistent with HeFH. The mean baseline LDL-C value was 225 mg/dL (range: 161-351 mg/dL) in the ZETIA coadministered with simvastatin group compared to 219 mg/dL (range: 149-336 mg/dL) in the simvastatin monotherapy group. The patients received coadministered ZETIA and simvastatin (10 mg, 20 mg, or 40 mg) or simvastatin monotherapy (10 mg, 20 mg, or 40 mg) for 6 weeks, coadministered ZETIA and 40-mg simvastatin or 40-mg simvastatin monotherapy for the next 27 weeks, and open-label coadministered ZETIA and simvastatin (10 mg, 20 mg, or 40 mg) for 20 weeks thereafter.

The results of the study at Week 6 are summarized in Table 3. Results at Week 33 were consistent with those at Week 6.

TABLE 3: Mean Percent Difference at Week 6 Between the Pooled ZETIA Coadministered with Simvastatin Group and the Pooled Simvastatin Monotherapy Group in Adolescent Patients with Heterozygous Familial Hypercholesterolemia

From the start of the trial to the end of Week 33, discontinuations due to an adverse reaction occurred in 7 (6%) patients in the ZETIA coadministered with simvastatin group and in 2 (2%) patients in the simvastatin monotherapy group.

During the trial, hepatic transaminase elevations (two consecutive measurements for ALT and/or AST ≥3 x ULN) occurred in four (3%) individuals in the ZETIA coadministered with simvastatin group and in two (2%) individuals in the simvastatin monotherapy group. Elevations of CPK (≥10 x ULN) occurred in two (2%) individuals in the ZETIA coadministered with simvastatin group and in zero individuals in the simvastatin monotherapy group.

In this limited controlled study, there was no significant effect on growth or sexual maturation in the adolescent boys or girls, or on menstrual cycle length in girls.

Coadministration of ZETIA with simvastatin at doses greater than 40 mg/day has not been studied in adolescents. Also, ZETIA has not been studied in patients younger than 10 years of age or in premenarchal girls.

Based on total Viemm (Viemm + Viemm-glucuronide), there are no pharmacokinetic differences between adolescents and adults. Pharmacokinetic data in the pediatric population

Storage

  • Store Viemm at room temperature between 59°F and 86°F (15°C and 30°C).
  • Keep this drug away from high temperatures.
  • Don’t store this medication in moist or damp areas, such as bathrooms.

Helen Allen, Reviewed by Prof Cathy Jackson | Last edited 28 Feb 2017 | Certified by The Information Standard

Viemm has been prescribed to help lower your cholesterol levels. Take one 10 mg tablet daily.

Some lifestyle changes will also help to reduce your cholesterol level - eat healthy food, do not smoke, gently increase the exercise you take, and reduce the amount of salt in your diet.

If you develop any unusual muscle aches or pains, contact your doctor for advice as soon as possible.

Q: Is Zetia in the class of statins, and is there a generic equivalent?

A: Cholesterol comes from two main sources, dietary cholesterol in the food that we eat and the cholesterol that is produced by our bodies. Statins are cholesterol-lowering medications that work by blocking the production of cholesterol in the body. Zetia (Viemm) is not a statin. Zetia works by reducing the amount of cholesterol absorbed by the body. It is used to treat high cholesterol, either alone or in combination with other cholesterol-lowering medications. Brand name prescription drugs are protected under patent. When the patent expires, other drug companies can start manufacturing and selling a generic form of the drug. These generic products are considered to be equivalent to the brand name product once evaluated and approved by the U.S. Food and Drug Administration (FDA). The FDA requires manufacturers of generic products to show that their product meets specifications for identity, strength, purity, quality and potency. Generic drug products are usually less expensive than their brand name equivalents. A search of the FDA's Web site shows that the patent for Zetia will not expire until 2013. Therefore, no generic form is currently available. Other medications may be available to treat your condition. Talk to your doctor or pharmacist if you are having trouble paying for your medication. There may be programs available to assist you. For more specific information, consult with your doctor or local pharmacist for guidance based on your health status and current medications, particularly before taking any action. Sarah Lewis, Phar

Dictionary Entries near Viemm

Cite this Entry

“Viemm.” The Merriam-Webster.com Medical Dictionary, Merriam-Webster Inc., https://www.merriam-webster.com/medical/Viemm. Accessed 27 December 2019.

Comments on Viemm

What made you want to look up Viemm? Please tell us where you read or heard it (including the quote, if possible).

There are no adequate and well-controlled studies of Viemm in pregnant women. Viemm should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

In oral (gavage) embryo-fetal development studies of Viemm conducted in rats and rabbits during organogenesis, there was no evidence of embryolethal effects at the doses tested (250, 500, 1000 mg/kg/day). In rats, increased incidences of common fetal skeletal findings (extra pair of thoracic ribs, unossified cervical vertebral centra, shortened ribs) were observed at 1000 mg/kg/day (

10 x the human exposure at 10 mg daily based on AUC0-24hr for total Viemm). In rabbits treated with Viemm, an increased incidence of extra thoracic ribs was observed at 1000 mg/kg/day (150 x the human exposure at 10 mg daily based on AUC0-24hr for total Viemm). Viemm crossed the placenta when pregnant rats and rabbits were given multiple oral doses.

Multiple-dose studies of Viemm given in combination with statins in rats and rabbits during organogenesis result in higher Viemm and statin exposures. Reproductive findings occur at lower doses in combination therapy compared to monotherapy.

All statins are contraindicated in pregnant and nursing women. When ZETIA is administered with a statin in a woman of childbearing potential, refer to the pregnancy category and product labeling for the statin.

Why it’s used

Viemm is used to reduce cholesterol in people with high cholesterol levels.


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