Myungmoon Rosuvastatin

Rosuvastatin.

Each tablet contains Rosuvastatin (as calcium) 10 mg or 20 mg.
Excipients/Inactive Ingredients: The other excipients are Microcrystalline Cellulose, Precipitated Calcium Carbonate, Lactose Hydrate, Crospovidone, Magnesium Stearate, Opadry Pink 03B54445, Ethanol, Purified water.

MYUNGMOON ROSUVASTATIN is an HMG-CoA reductase inhibitor indicated for: Adult patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non-HDL-C and TG levels and increase HDL-C; Pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy; Adult patients with hypertriglyceridemia as an adjunct to diet; Adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet; Adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB; Slowing the progression of atherosclerosis as part of a treatment strategy to lower total-C and LDL-C as an adjunct to diet; Risk reduction of MI, stroke and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors.

General Dosing Information: The usual starting dose is 10 mg to 20 mg once daily. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily.
The maximum rosuvastatin dose of 40 mg (take two 20 mg tablets) should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose.
Rosuvastatin can be administered as a single dose at any time of day, with or without food. The tablet should be swallowed whole.
When initiating Rosuvastatin therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rosuvastatin starting dose should first be utilized and only then titrated according to the patient's response and individualized goal of therapy.
After initiation or upon titration of Rosuvastatin, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.
Pediatric Dosing: In heterozygous familial hypercholesterolemia, the recommended dose range is 5 to 20 mg orally once daily in patients 10 to 17 years of age.
Dosing in Asian Patients: Pharmacokinetic studies have demonstrated an increase in exposure to rosuvastatin in Asian subjects when compared with Caucasians. Initiation of rosuvastatin therapy with 5 mg* once daily should be considered in Asian patients.
Use with Concomitant Therapy: Patients taking cyclosporine: The dose of Rosuvastatin should not exceed 5 mg* once daily.
Patients taking gemfibrozil: Avoid concomitant use of Rosuvastatin with gemfibrozil. If concomitant use cannot be avoided, initiate rosuvastatin at 5 mg* once daily. The dose of rosuvastatin should not exceed 10 mg once daily.
Patients taking atazanavir and ritonavir, lopinavir and ritonavir or simeprevir: Initiate rosuvastatin therapy with 5 mg* once daily. The dose of rosuvastatin should not exceed 10 mg once daily.
Dosing in Patients with Severe Renal Impairment: For patients with severe renal impairment (CL_cr < 30 mL/min/1.73 m²) not on hemodialysis, dosing of rosuvastatin should be started at 5 mg* once daily and not exceed 10 mg once daily.
* 5 mg dose is to be provided by other preparation instead.

Rosuvastatin Tablets are contraindicated: Patients with hypersensitivity to the active substance or any of the excipients listed in Description; Patients with active liver disease including unexplained, persistent elevation of serum transaminases and any serum transaminase elevation exceeding 3x the upper limit of normal (ULN); Patients with severe renal impairment; Patients with myopathy; Patients receiving concomitant ciclosporin; During pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measure.
The 40 mg dose is contraindicated in patients with pre-deposing factors for myopathy/rhabdomyolysis. Such factors include: Moderate renal impairment; Hypothyroidism; Personal or family history of hereditary muscular disorders; Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate; Alcohol abuse; Situations when an increase in plasma levels may occur; Asian patients; Concomitant use of fibrates; The concomitant use with protease inhibitors is not recommended.

Talk to the doctor or pharmacist before taking Rosuvastatin Tablets: If having problem with the kidneys.
If having problem with the liver.
If taking or have taken in the last 7 days a medicine called fusidic acid, orally or by injection. The combination of fusidic acid and Rosuvastatin Tablets even lead to serious muscle problem, see Interactions.
If having had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems with taking other cholesterol-lowering medicines. Tell the doctor immediately if unexplained muscle aches or pains occur especially if feeling unwell or having a fever. Also tell if feeling unwell or having a fever. Also tell the doctor or pharmacist if having constant muscle weakness.
If regularly drinking large amounts of alcohol.
If taking medicines used to fight the HIV infection e.g. ritonavir with lopinavir and/or atazanavir, see Interactions.
If thyroid gland is not working properly.
If over 70.
If having severe respiratory failure.
If of Asian origin.
If taking other medicines called fibrates to lower the cholesterol. Please read this monograph carefully even if other medicines for high cholesterol have been taken before.
It is recommended that liver function tests should be performed before the initiation of MYUNGMOON ROSUVASTATIN and thereafter when clinically indicated.
There has been rare postmarketing reports of cognitive impairment (e.g. memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statin. The reports are generally non-serious and reversible upon statin discontinuation with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitor in JUPITER study. There was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with a HbA1c > 6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients.
MYUNGMOON ROSUVASTATIN contains Lactose: If the patient has been told by the doctor that he/she has intolerance to some sugars (lactose or milk sugar), the doctor should be contacted before taking Rosuvastatin Tablets.

Do not take Rosuvastatin Tablets if pregnant or breast-feeding. If pregnancy occurs while taking Rosuvastatin Tablets, stop taking them immediately and tell the doctor. Women should avoid becoming pregnant while taking Rosuvastatin Tablets by using suitable contraception.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Rosuvastatin Tablets and seek medical help immediately if any following allergic reactions is experienced: Difficulty in breathing with or without swelling of the face, lips, tongue and/or throat; Swelling of the face, lips tongue and/or throat, which may cause difficulty in swallowing; Severe itching of the skin (with raised lumps).
Also, stop taking Rosuvastatin Tablet and talk to the doctor immediately if any unusual aches or pains in the muscles is experienced which go on for longer than might be expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects and rarely these have gone on to become potentially life threatening muscle damage known as rhabdomyolysis.
Common possible side effects: Headache, Stomach pain, Constipation, Feeling sick, Muscle pain, Feeling weak, Dizziness.
An increase in the amount of protein in the urine. This usually returns to normal on its own without having to stop taking Rosuvastatin Tablets (only for patients taking dose of Rosuvastatin 40 mg).
Diabetes. This is more likely if the patient has high levels of sugars and fats in the blood, is overweight and has high blood pressure. The doctor will monitor the patient while he/she is taking this medicine.

Tell the doctor if taking or have recently taken or might take any other medicines: Ciclosporin; Warfarin or clopidogrel; Fibrate or any other medicine used to lower cholesterol; Indigestion remedies; Erythromycin; Oral contraceptive; Regorafenib; Hormone replacement therapy; Anti-viral medications such as ritonavir or lopinavir and/or atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
The effects of these medicines could be changed by Rosuvastatin Tablets or they could change the effect of Rosuvastatin Tablets.
Rosuvastatin Tablets with fusidic acid may rarely lead to muscle weakness, tenderness or pain. See more information regarding rhabdomyolysis in Side Effects. If the patient needs to take oral fusidic acid to treat a bacterial infection, he/she will need to temporarily stop using this medicine. The doctor will tell the patient when it is safe to restart Rosuvastatin Tablets.

Store below 30°C in original pack.

Dyslipidaemic Agents

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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