Romazik pills p/o 20mg №10×3

Romazik Tablets 20mg: Effective Cholesterol Management

Romazik Tablets 20mg are a prescription medication used to lower cholesterol levels. This comprehensive guide provides essential information on Romazik, including its uses, dosage, potential side effects, and important precautions.

Description:

Romazik tablets are coated white or almost white, round and biconvex, engraved on one side. The active ingredient is rosuvastatin, a statin medication that works by inhibiting the production of cholesterol in the liver.

Uses:

Romazik is prescribed for:

• Hypercholesterolemia: High cholesterol levels (Type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (Type IIb) when diet and other non-pharmacological treatments (e.g., exercise, weight loss) are insufficient.
• Homozygous Familial Hypercholesterolemia: A rare genetic disorder causing very high cholesterol levels, as an adjunct to diet and other cholesterol-lowering therapy, or when such therapy is not appropriate.

Dosage and Administration:

• Recommended Initial Dose: 10mg once daily.
• Dose Increase: If necessary, the dose can be increased to 20mg after 4 weeks.
• Higher Doses: Increasing the dose to 40mg is possible only for patients with severe hypercholesterolemia and high cardiovascular risk (especially those with familial hypercholesterolemia) with insufficient efficacy at 20mg, under medical supervision.

Important Precautions:

• Risk Factors for Rhabdomyolysis: Use with caution if you have risk factors for rhabdomyolysis (muscle breakdown), including:
  • Renal failure
  • Hypothyroidism
  • Personal or family history of hereditary muscle diseases
  • Previous history of muscle toxicity with other statins or fibrates
• Other Precautions: Exercise caution in cases of:
  • Chronic alcoholism
  • Patients over 65 years old
  • History of liver disease
  • Sepsis
  • Arterial hypotension
  • Extensive surgical interventions
  • Trauma
  • Severe metabolic, endocrine, or electrolyte disorders
  • Uncontrolled epilepsy
  • Individuals of Asian origin (Chinese, Japanese)
• Muscle Symptoms: Discontinue therapy if CPK levels are significantly elevated (more than 5 times the upper limit of normal) or if muscle symptoms are pronounced and cause daily discomfort (even if CPK is 5 times lower than the upper limit of normal).
• Kidney Function: Monitor kidney function when using rosuvastatin at 40mg.
• Drug Interactions:
  • Fibrates (e.g., gemfibrozil), niacin: Increased risk of myopathy. Simultaneous use with gemfibrozil is not recommended.
  • Cyclosporine: Increases rosuvastatin levels.
  • Vitamin K Antagonists (e.g., warfarin): May increase prothrombin time and INR.
  • Antacids: May decrease rosuvastatin levels.
  • Erythromycin: May decrease rosuvastatin levels.
  • Oral Contraceptives: May increase ethinylestradiol and norgestrel levels.
• Liver Function: Monitor liver function before starting therapy and 3 months after starting. Discontinue or reduce the dose if liver transaminase levels are 3 times the upper limit of normal.
• Underlying Conditions: Treat underlying conditions like hypothyroidism or nephrotic syndrome before starting Romazik.
• Driving and Operating Machinery: Be aware of possible dizziness during therapy and avoid potentially hazardous activities.

Contraindications:

• Active liver disease
• Severe renal dysfunction
• Myopathy
• Concomitant use of cyclosporine
• Pregnancy
• Lactation
• Women of reproductive age not using reliable contraception
• Children and adolescents under 18 years old
• Hypersensitivity to rosuvastatin

Side Effects:

• Common: Headache, dizziness, fatigue, constipation, nausea, abdominal pain, pharyngitis, myalgia.
• Possible: Anxiety, depression, insomnia, neuralgia, paresthesia, reversible transient increase in liver transaminase activity, dyspepsia, gastritis, gastroenteritis, rhinitis, sinusitis, bronchial asthma, bronchitis, cough, dyspnea, pneumonia, angina pectoris, increased blood pressure, palpitations, vasodilation, arthralgia, arthritis, muscle hypertonicity, back pain, pathological limb pearl, myopathy, rhabdomyolysis, tubular proteinuria, peripheral edema, pain in the lower abdomen, urinary tract infections, skin rash, skin itching, angioedema, accidental injury, anemia, chest pain, diabetes mellitus, ecchymosis, flu-like syndrome, periodontal abscess.

This information is intended for informational purposes only and does not substitute for professional medical advice. It is essential to consult with your doctor or healthcare provider for a proper diagnosis, treatment plan, and to answer any questions you may have about Romazik.

Please remember:

• Never take any medication without consulting a healthcare professional.
• Always follow your doctor’s instructions and warnings carefully.
• It is crucial to be aware of potential side effects and interactions, and report any unusual symptoms or concerns to your doctor.
• Keep all medications out of reach of children.