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

Givarorock 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.

Givarorock is used in patients who cannot control cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. Givarorock 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, Givarorock 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.

Givarorock will not help you lose weight, it will only reduce the levels of fats in your bloodstream. Givarorock 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 Givarorock

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

Side effects

Givarorock 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.

Givarorock 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.

Givarorock 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 Givarorock, 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 Givarorock-related muscular damage:

Taking high doses of Givarorock.
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.

Givarorock Tablets may affect liver function

Your physician will perform a blood test before start treating you with Givarorock, 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 Givarorock.

Givarorock – FAQs

When Does Givarorock Take Effect?

2 to 4 weeks: blood tests are performed in order to see the effect of the drug on cholesterol levels, it may take 2 to 4 weeks to start see a diferances in your boold fat levels. Yours doctor will advise you to keep taking Givarorock for a while according to your respone to the medicien.

When Should I Take Givarorock Morning Or Night?

Givarorock may be taken at any time of the day, with or without food.

Manufacturers of statins recommend that they are taken at night, on the basis of physiological studies which show that most cholesterol is synthesised when dietary intake is at its lowest.

Does Givarorock Affect Sleep?

Givarorock can cause insomnia: The most common side effect of all types of statins (including Givarorock) is muscle pain, which can keep people who take them awake at night and unable to rest. if you feel a muscle pain, while on Givarorock, consult your doctor.

Can Givarorock Make You Tired?

Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your doctor right away if: You have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take Givarorock.

Givarorock – medical care providers information

Indications And Usage

Givarorock 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 Givarorock 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 Givarorock

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 Givarorock dosage.
Discontinue Givarorock if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue Givarorock 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 Givarorock 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 Givarorock.

Drug Interactions

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

Use In Specific Populations

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

For Arabic information about statin/ezetimibe combination:

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