Product Overview
[Drug Name]
Generic Name: H Rosuvastatin Calcium Tablets
Trade Name: Haishuyan H Rosuvastatin Calcium Tablets 10mg x 28 Tablets
[Main Ingredients]
The main ingredient of this product is rosuvastatin calcium. Chemical Name: Bis-[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]-pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt (2:1)
[Properties]
This product is a film-coated tablet that appears white or off-white after removal of the coating.
[Indications/Main Functions]
It is indicated for primary hypercholesterolemia (type Ila, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb), whose dyslipidemia cannot be adequately controlled with diet and other non-drug therapies (e.g., exercise therapy, weight loss).
[Specifications]
10mg*28 tablets
[Dosage and Administration]
1. Oral. The usual starting dose is 5mg once daily. 2. The maximum daily dose is 20mg. This product can be taken at any time of day, with or without food.
[Adverse Reactions]
1. Adverse reactions observed with this product are generally mild and transient. In controlled clinical trials conducted internationally, less than 4% of patients withdrew due to adverse events. The frequency of adverse events is ranked as follows: common (incidence >1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); and extremely rare (<1/10,000). 2. Rare: Allergic reactions, including angioedema. 3. Neurological disorders. Common: Headache, dizziness. 4. Gastrointestinal disorders. Common: Constipation, nausea, abdominal pain. 5. Skin and subcutaneous tissue abnormalities. Uncommon: Pruritus, rash, and urticaria. 6. Skeletal muscle, joint, and bone disorders. Common: Myalgia. Rare: Myopathy and rhabdomyolysis. 7. Systemic disorders. Common: Asthenia. As with other HMG-CoA reductase inhibitors, the incidence of adverse reactions with this drug tends to increase with increasing dose. 8. Renal effects: Proteinuria (as determined by dipstick) has been observed in patients receiving this drug, with the majority of the protein originating from the renal tubules. Approximately 1% of patients experienced an increase in proteinuria from none or trace levels to + or greater at certain times during treatment with the 10 mg and 20 mg doses, and approximately 3% of patients receiving the 40 mg dose experienced this increase. With the 20 mg dose, a slight increase in proteinuria from none or trace levels to + was observed. In most cases, proteinuria spontaneously decreased or resolved with continued treatment. Contraindications: Hypersensitivity to rosuvastatin or any of its ingredients; patients with active liver disease, including unexplained persistent elevations in serum transaminases and any elevation in serum transaminases exceeding three times the upper limit of normal (ULN); patients with severe renal impairment (creatinine clearance <30 mL/min); patients with myopathy; patients taking cyclosporine concomitantly; and women who are pregnant, breastfeeding, or who may become pregnant but are not using adequate contraceptive measures.
