International name (active ingredient): rosuvastatin
Clinical-pharmacological group: Metabolic disorders → Lipid metabolism regulators → Cholesterol synthesis inhibitors
Manufacturer: Ilko Ilac San. Ve Tic. A.S.
Country of manufacture: Turkey
Dosage form: 10 mg film-coated tablets #28
Dispensing regime: Group II (prescription required, form N3)
Pharmacological Properties
Dirosat is prescribed for high cholesterol levels, which indicates an increased risk of heart attack or stroke development.
Statins are prescribed when changes in diet and physical exercise are insufficient to regulate cholesterol levels. With the use of Dirosat, you can continue a cholesterol-lowering diet and exercise.
There are other factors that also increase the risk of heart attack, stroke, or other health problems. Heart attack, stroke, or other issues can be caused by atherosclerosis, which is the buildup of fats in the blood vessels.
Dirosat is prescribed to correct the levels of fat substances in the blood, known as lipids, among which cholesterol is the main type. There are different types of cholesterol in the blood – “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).
Dirosat can reduce the level of “bad” cholesterol and increase the level of “good” cholesterol.
It prevents the formation of “bad” cholesterol in the body and enhances the body’s ability to remove it from the bloodstream.
In most people, high cholesterol does not affect their overall condition as it has no symptoms. Because treatment is often not sought, fatty deposits accumulate on the walls of blood vessels, narrowing them. Sometimes, narrowed blood vessels become blocked, preventing them from supplying blood to the heart and brain, leading to heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other health problems is reduced.
The use of Dirosat should continue, whether cholesterol has reached the desired level or not, as it helps maintain proper cholesterol levels and protects the blood vessel walls from fat buildup.
However, the use of the medication should be discontinued during pregnancy or according to a doctor’s recommendation.
Indications
Dirosat is used to regulate the levels of fats (lipids) in the blood.
Dosage Regimen
Dirosat should be used as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Initial Dose
The starting dose of Dirosat, if you have not taken any statins before, is 5 mg. If you have previously taken a statin, the starting dose of either 5 mg or 10 mg will be determined based on:
- Your cholesterol levels.
- Your risk level for heart attack or stroke.
- The presence of any factors that may increase the risk of side effects.
Discuss with your doctor to determine the most suitable starting dose of Dirosat for you.
Your doctor may prescribe the lowest dose (5 mg) if:
- You are over 70 years of age.
- You have moderate kidney problems.
- You are at risk of developing muscle pain (myopathy).
The maximum daily dose of Dirosat is 40 mg. This dose is intended for patients with very high cholesterol levels and a significant risk of heart attack or stroke, and only if cholesterol levels do not adequately decrease with a 20 mg dose.
Administration Instructions
The medication should be swallowed whole with water.
Take Dirosat once daily, at any time of the day. Try to take it at the same time each day.
It is recommended to regularly monitor cholesterol levels to ensure they have returned to a proper range. Your doctor may adjust the dosage to ensure the appropriate dose for you.
If you miss a dose, take the next dose at the scheduled time.
Do not take a double dose to compensate for a missed dose.
Consult your doctor before stopping Dirosat.
Stopping the medication may cause cholesterol levels to rise again.
Side Effects
Like other medications, Dirosat can cause side effects in some individuals who are sensitive to its components.
Most side effects are mild and short-lived.
Stop taking Dirosat and contact your doctor or the nearest emergency center immediately if you experience:
- Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat.
- Swelling of the face, lips, tongue, and/or throat, causing difficulty swallowing.
- Severe skin itching.
Stop taking Dirosat and consult your doctor immediately if you experience unusual, prolonged muscle pain.
While rare, statins, including Dirosat, can cause severe muscle issues, such as rhabdomyolysis, a potentially life-threatening condition.
Contact your doctor if you experience:
- Severe abdominal pain (indicative of pancreatitis).
- Jaundice (yellowing of the skin or eyes).
- Muscle issues or persistent pain without a known cause.
Side Effects Frequency Categories:
- Very Common: Occurs in more than 1 in 10 patients.
- Common: Occurs in up to 1 in 10 patients.
- Uncommon: Occurs in up to 1 in 1,000 patients.
- Rare: Occurs in up to 1 in 10,000 patients.
- Very Rare: Occurs in fewer than 1 in 10,000 patients.
Common Side Effects:
- Headache.
- Stomach pain.
- Constipation.
- Muscle pain.
- Dizziness.
- Protein in urine.
- Weakness.
- Increased blood sugar levels (diabetes).
Uncommon Side Effects:
- Rash, itching, or other skin reactions.
- Mild increases in protein in the urine (may resolve without stopping the medication).
Rare Side Effects:
- Severe allergic reactions (swelling, difficulty breathing, rash).
- Muscle damage.
- Acute pancreatitis.
- Increased liver enzymes.
Very Rare Side Effects:
- Hepatitis.
- Nerve damage in limbs (numbness).
- Joint pain.
- Memory loss.
If side effects worsen or new symptoms appear, consult your doctor or pharmacist.
Contraindications
Do not take Dirosat if you:
- Are allergic to its ingredients.
- Are pregnant or breastfeeding.
- Have liver disease.
- Have severe kidney problems.
- Are taking cyclosporine.
Consult your doctor if any of these apply to you.
Pregnancy and Breastfeeding
Dirosat must not be taken during pregnancy or breastfeeding. Use adequate contraception during treatment to prevent pregnancy.
Storage
Store at a temperature not exceeding 25°C (77°F) and keep out of reach of children.
For further clarification or concerns, always consult your healthcare provider.
