Vastatinal contains a combination of two active ingredients (Ezetimibe and Simvastatin). Vastatinal is a medicine used to lower the levels of total cholesterol, low-density lipoprotein (LDL) cholesterol and triglycerides in the blood. Vastatinal raises levels of “good” cholesterol (HDL cholesterol).

Vastatinal lowers cholesterol in two ways:

• Active ingredient Ezetimibe: reduces the absorption of cholesterol from food during the digestion of food from the gastrointestinal tract.
• The active ingredient Simvastatin, which belongs to the class of “statins”, blocks or inhibits the production of more cholesterol by the liver.

Vastatinal is used in patients who cannot control cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. Vastatinal is used in addition to your cholesterol-lowering diet to treat:

• High blood cholesterol, which is not adequately controlled with statin drugs alone.
• in Heart disease,  Vastatinal reduces the risk of heart attacks and strokes and reduces the possibility of coronary artery bypass grafting or angina attacks.

This medicine is intended for the treatment of adults and children over 10 years of age.

Vastatinal will not help you lose weight, it will only reduce the levels of fats in your bloodstream. Vastatinal is used (in addition to the diet) in the treatment of high blood cholesterol, and in the prevention of diseases caused by high cholesterol and blood fats.

How to use Vastatinal

• Continue to take Vastatinal exactly as your physician has told you.
• Although you are taking Vastatinal, you should continue to follow a low fat diet to lower your cholesterol level.
• Vastatinal is usually taken once a day, and it is recommended to take it in the evening, and it can be taken with or without food.
• If you miss a dose:  if you remember it on the same day, take the tablet as soon as you remember it, but if you remember it the next day, do not take an extra dose, just take your regular dose of Vastatinal, and continue to your regular schedule.
• In general, try to take Vastatinal at least 2 hours before taking other medicines, or 4 hours after taking other medicines (especially cholestyramine).

Dosage

• Your doctor will determine the appropriate concentration of Vastatinal, depending on your condition, other treatments you’re taking, as well as your general health.
• Vastatinal tablets should not be divided. Always take this medicine exactly as your doctor or pharmacist has told you.
• Before starting Vastatinal, you must follow a diet to lower your cholesterol. You should also maintain this cholesterol-lowering diet while taking Vastatinal.
• Adult dose: The dose is one tablet orally once a day.
• Use in adolescents (10 to 17 years): The dose is one Vastatinal tablet orally, once a day .
• Vastatinal should be taken in the evening. You can take the dose with or without food.
• If your doctor prescribes Vastatinal with another cholesterol-lowering medicine that contains the active ingredient cholestyramine or another bile acid, you should take Vastatinal at least 2 hours before or 4 hours after taking it.

Side effects

Vastatinal is a combination of both (Simvastatin & Ezetimibe), there are some side effects related to each drug.

Most common adverse reactions for Simvastatin – (incidence >2% and greater than placebo) are: headache, nausea, myalgia, arthralgia, dizziness, asthenia, constipation, and abdominal pain.

Most common adverse reactions for Ezetimibe – (incidence >2% and greater than placebo) are: upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.

Most common adverse reactions for Ezetimibe co-administered with a statin (incidence >2% and greater than statin alone) are: nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue.

Vastatinal may cause the following side effects, do not stop using your medicine cause of these side effects (which may not happen), just consult your medical care provider

• Elevation in laboratory blood tests for liver function (transaminase enzymes).
• Elevation in laboratory blood tests of the muscle enzyme CK (creatine kinase).
• Bloating and abdominal pain.
• muscle pain
• Nausea (tendency to vomit).
• vertigo
• pain of the joints.

Vastatinal tablets may cause muscle pain

One of the most famous and most serious side effects that can be caused by drugs to lower cholesterol and blood fats, including Vastatinal, is muscle pain. It is known that, in some rare cases, muscle problems may be very serious, including muscle breakdown that can cause kidney damage, and may cause extremely rare cases of death.

The following factors increase the risk of developing Vastatinal-related muscular damage:

• Taking high doses of Vastatinal.
• Patients with kidney problems.
• Patients with thyroid problems.
• If over 70 years of age.
• If you suffer from genetic disorders of the muscles.
• If you have previously suffered from muscle pain as a result of taking cholesterol-lowering drugs.

Vastatinal Tablets may affect liver function

Your physician will perform a blood test before start treating you with  Vastatinal, in order to verify the extent of the proper functioning of the liver. The doctor may ask the patient to take blood tests to check how well the liver is performing its functions after starting treatment with Vastatinal.

Vastatinal – FAQs

Vastatinal – medical care providers information

Indications And Usage

Vastatinal is a combination of Simvastatin, an HMG CoA-reductase inhibitor (statin), and ezetimibe, a dietary cholesterol absorption inhibitor, indicated in adults:

• As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDLC).
• Alone or as an adjuct to other LDL-C lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Dosage And Administration

• Dose range is 10/10 mg/day to 10/40 mg/day.
• Recommended usual starting dose is 10/10 or 10/20 mg/day.
• Dosing of Vastatinal should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

Contraindications

• Active liver failure or decompensated cirrhosis
• Hypersensitivity to any component of Vastatinal

Warnings And Precautions

Myopathy and Rhabdomyolysis

• Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher Vastatinal dosage.
• Discontinue Vastatinal if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue Vastatinal in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis.
• Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing Vastatinal dosage.
• Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

Immune-Mediated Necrotizing Myopathy (IMNM)

Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use.

Hepatic Dysfunction

• Increases in serum transaminases have occurred, some persistent.
• Rare reports of fatal and non-fatal hepatic failure have occurred.
• Consider testing liver enzyme tests before initiating therapy and as clinically indicated thereafter.
• If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue Vastatinal.

Drug Interactions

• Gemfibrozil or Cyclosporin: Avoid concomitant use with Vastatinal.
• Antivirals: Avoid concomitant use of Vastatinal with certain antivirals and adjust the dose of Vastatinal with other antivirals.
• Darolutamide: Do not exceed Vastatinal 5 mg/10 mg once daily.
• Regorafenib: Do not exceed Vastatinal 10 mg/10 mg once daily.
• Fenofibrates, Niacin, Colchine: Consider the risks and benefits of concomitant use with Vastatinal.
• Warfarin: Obtain INR before Vastatinal initiation and monitor INR during Vastatinal dosage initiation or adjustment.

Use In Specific Populations

• Pregnancy: May cause fetal harm.
• Lactation: Breastfeeding not recommended during treatment with Vastatinal.

For Arabic information about statin/ezetimibe combination:

• إينيجي أقراص فموية للتحكم في دهون الدم والوقاية من تصلب وإنسداد الشرايين
• إينيجي أقراص فموية لخفض الكوليستيرول و الدهون فى الدم

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