Shubatan Tablet 10 mg (Rosuvastatin Calcium)

Adult dosage

Administer 5 mg once daily as the initial dose at any time of day, regardless of meals. The maintenance dose is 10 mg once daily and may be adjusted at intervals of 4 weeks or more as needed, up to a maximum of 20 mg per day.

Children's dosage

For pediatric patients aged 10 to 17 years, a dose of 5 mg to 20 mg is administered once daily. The dosage should be adjusted according to the treatment goals and changes should be made at intervals of 4 weeks or more. For children under 10 years of age,

This medication should not be administered to certain patients. For example, individuals allergic to any ingredients of this drug, those with severely impaired liver function, those with muscle diseases, those taking specific medications concomitantly, those with severely impaired kidney function, pregnant or breastfeeding women, and those with certain genetic disorders should not take this medication. Caution should be exercised in patients with a history of excessive alcohol consumption or liver disease. Liver function tests should be routinely performed before and during treatment. Patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome should treat the underlying cause before using this medication. Muscle-related side effects such as myalgia or myopathy, and rarely serious muscle destruction known as rhabdomyolysis, may occur; any unusual muscle symptoms should be reported to a healthcare professional immediately. If there is a significant increase in muscle enzyme levels, this medication should be discontinued, and it may be restarted at a lower dose once symptoms improve. This medication contains lactose, so patients with lactose intolerance should not take it. It may affect liver and kidney function, so regular monitoring of liver and kidney function is necessary. Additionally, blood sugar levels may increase in some patients; hence, those at risk of diabetes should regularly check their blood glucose levels. This drug may interact with other medications, so patients must inform their healthcare provider of all concurrent medications. Special attention is needed when used with drugs that increase the risk of muscle toxicity, and the use of some medications concomitantly is prohibited. Women who are pregnant or may become pregnant should not take this medication and should use effective contraception. Nursing mothers are also advised not to take this medication. There is no specific antidote in case of overdose, so treatment will be symptomatic, along with monitoring of liver function and muscle enzyme levels. This medication is not known to significantly affect the ability to drive or operate machinery, but caution is advised as dizziness may occur. Lastly, if severe rashes or allergic reactions occur during treatment with this drug, use should be discontinued immediately and a healthcare provider should be consulted.

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular myasthenia, dyspnea, jaundice, hepatitis, serious skin reactions, acute renal failure, oliguria, severe edema, chest tightness, difficulty breathing

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash
• myalgia
• weakness
• chest pain

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is advisable to keep it at room temperature, between 1 to 30 degrees Celsius, avoiding extremely hot or cold environments.

Appearance

Pink round film-coated tablet

Package unit

For domestic use (30 tablets) - 30 tablets/bottle, For domestic use (100 tablets) - 100 tablets/bottle