Rosuvastatin Calcium Tablets

Generic Rosuvastatin Calcium Tablets (Rostar) - Product Information

Rostar (Generic Rosuvastatin Calcium Tablets) treats high cholesterol and reduces the risk of heart attack and stroke. It works by decreasing bad cholesterol and fats (such as LDL, triglycerides) and increasing good cholesterol (HDL) in your blood.
It belongs to a group of medications called statins.
Changes to diet and exercise are often combined with this medication.
Rostar tablets (Generic Rosuvastatin tablets) are manufactured by Torrent Pharmaceuticals Limited, India in the strengths of 5 mg, 10 mg and 20 mg.
We also have in stock Atorvastatin Calcium Tablets (Lipvas 10 mg 20 mg and 40 mg) which is also used to treat the same indications.

Name of the Drug

Rostar Tablets.

Manufacturer of Rostar Tablets

Torrent Pharmaceuticals Limited, India  
Website: www.torrentpharma.com

Active Pharmaceutical Ingredient

The active ingredient present in Rostar tablets is Rosuvastatin Calcium.
Each film-coated Rostar tablet contains Rosuvastatin Calcium equivalent to 5 mg, 10 mg or 20 mg of Rosuvastatin.

Uses of Generic Rosuvastatin Calcium Tablets (Rostar Tablets)

Treatment of hypercholesterolaemia
Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Adults, adolescents and children aged 6 years or older with homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
Prevention of Cardiovascular Events
Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event), as an adjunct to correction of other risk factors.

Rosuvastatin Calcium Tablets (Rostar Tablets) - Dosage

Generic Rosuvastatin Calcium tablets should be administered exactly as suggested by your doctor. Your doctor may recommend a dosage of Rostar tablets depending on your age, medical requirement, body weight, other medical conditions, and current medications. Rosuvastatin (Rostar Tablets) may be given at any time of day, with or without food.
Treatment of Hypercholesterolaemia:
The recommended start dose is 5 or 10 mg orally once daily in both statin naï ve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions.
A dose adjustment to the next dose level can be made after 4 weeks, if necessary. In light of the increased reporting rate of adverse reactions with the 40 mg dose compared to lower doses, a final titration to the maximum dose of 40 mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg, and in whom routine follow-up will be performed. Specialist supervision is recommended when the 40 mg dose is initiated.
Rostar tablets work effectively if the amount of Rosuvastatin is maintained at a constant level in the body. You should be systematic about the daily schedule for the medication such that you take tablets at about the same time every day, to get the maximum benefit of the medication. Continue taking tablets without missing any doses for the recommended treatment period and do not stop the treatment suddenly even if you feel better.

Please consult your doctor for exact dosing instructions. Rostar tablets (Generic Rosuvastatin Calcium tablets) should be administered in the dose prescribed by the doctor and for the duration recommended by the doctor.

Missed Dose

If you forget to take your regular tablet dose on time, take it whenever you remember.
If you remember the next day, skip the missed dose and take your scheduled dose. Do not take a double dose to compensate the missed dose.

Rosuvastatin Calcium Tablets (Rostar Tablets) Mechanism of Action

Rosuvastatin works by competitively inhibiting HMG-CoA reductase, the enzyme that catalyzes the rate-limiting step in cholesterol synthesis in the liver. This action decreases mevalonate production, reducing the liver's cholesterol concentration, which in turn increases the number of LDL receptors on liver cells to clear more LDL cholesterol from the blood.
Additionally, rosuvastatin inhibits the liver's synthesis of VLDL (very low-density lipoprotein), which further contributes to lower levels of LDL and total cholesterol, as well as triglycerides, while increasing HDL cholesterol.

Storage Instructions for Generic Rosuvastatin Tablets (Rostar Tablets)

Store Rostar Tablets at controlled room temperature (20°C to 25°C),protected from heat, moisture, and sunlight. Excursions are permitted from 15°C to 30°C.
Retain the original packing of the medication and do not consume Generic Rosuvastatin tablets past its expiration date printed on the blister pack. Keep the pack of Rostar tablets away from the reach of children and pets. Do not dispose Generic Rosuvastatin tablets along with domestic waste or sewage. Consult your doctor or pharmacist about the correct method of disposal.

Contraindications

Rostar tablets are contraindicated in patients with a hypersensitivity to Rosuvastatin Calcium or any inactive ingredient present in tablets. Rostar tablets are also contraindicated in the following cases:

• in patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal (ULN).
• in patients with severe renal impairment (creatinine clearance <30 ml/min).
• in patients with myopathy.
• in patients receiving concomitant combination of sofosbuvir/velpatasvir/voxilaprevir
• in patients receiving concomitant ciclosporin.
• during pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures.

Rosuvastatin 40 mg dose is contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis. Such factors include:

• moderate renal impairment (creatinine clearance < 60 ml/min)
• 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 where an increase in plasma levels may occur
• Asian patients
• concomitant use of fibrates.

Overdose

There is no specific treatment in the event of overdose. In the event of Generic Rosuvastatin tablets overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function and CK levels should be monitored. Haemodialysis is unlikely to be of benefit.

Warnings and Precautions

Myopathy and Rhabdomyolysis:
Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher Rosuvastatin Calcium tablets dosage. Asian patients may be at higher risk for myopathy. Discontinue Rostar if markedly elevated CK levels occur or myopathy is diagnosed or suspected.
Rhabdomyolysis:
Temporarily discontinue Rostar in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing Rostar dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
Immune-Mediated Necrotizing Myopathy (IMNM):
Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue Rostar if IMNM is suspected.
Hepatic Dysfunction:
Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue Rostar.

Effects on ability to drive and use machines

Studies to determine the effect of rosuvastatin on the ability to drive and use machines have not been conducted. However, based on its pharmacodynamic properties, Rosuvastatin is unlikely to affect this ability. When driving vehicles or operating machines, it should be taken into account that dizziness may occur during treatment.

Side Effects of Rosuvastatin Calcium Tablets (Rostar Tablets)

Most frequent side effects with an incidence rate of 2% or more are headache, nausea, myalgia, asthenia, and constipation.
The following side effects have been identified during postapproval use of Rosuvastatin tablets (Rostar tablets). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Blood Disorders: thrombocytopenia
• Hepatobiliary Disorders: hepatitis, jaundice, fatal and non-fatal hepatic failure
• Musculoskeletal Disorders: arthralgia, rare reports of immune-mediated necrotizing myopathy associated with statin use
• Nervous System Disorders: peripheral neuropathy, rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with the use of all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). There have been rare reports of new-onset or exacerbation of myasthenia gravis, including ocular myasthenia, and reports of recurrence when the same or a different statin was administered.
• Psychiatric Disorders: depression, sleep disorders (including insomnia and nightmares)
• Reproductive System and Breast Disorders: gynecomastia
• Respiratory Disorders: interstitial lung disease
• Skin and Subcutaneous Tissue Disorders: drug reaction with eosinophilia and systemic symptoms (DRESS), lichenoid drug eruption

Rosuvastatin Calcium (Rostar Tablets) During Pregnancy

Rosuvastatin Calcium (Rostar Tablets) has been classified by the US FDA as Pregnancy Category X. Rosuvastatin is contraindicated in pregnancy and lactation. Women of child bearing potential should use appropriate contraceptive measures.
Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the foetus, the potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. Animal studies provide limited evidence of reproductive toxicity. If a patient becomes pregnant during use of this product, treatment should be discontinued immediately.
Do not use this medicine without your doctor's consent in case you are pregnant. Stop using this medication and inform your doctor immediately if you become pregnant during treatment.

Nursing Considerations

Limited data from case reports in published literature indicate that rosuvastatin tablets are present in human milk. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Statins, including rosuvastatin tablets, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant.
Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with rosuvastatin tablets
Do not use this medication without telling your doctor if you are breast-feeding a baby.

Buy Generic Rosuvastatin 5 mg, 10 mg and 20 mg Pills Online From Only $0.45 per Pill

You can buy Rosuvastatin Calcium tablets online from Everest Online Pharmacy at a cheap price. Rostar 5 mg, 10 mg and 20 mg pills, manufactured by Torrent Pharmaceuticals Limited, India, are supplied in a blister strip of 10 or 15 tablets.The 5 mg tablets cost only $0.45 per unit when you place an order for 360 tablets.

Disclaimer

The above information is provided to the best of our knowledge and in good faith. It is without a warrant of any kind, expressed or implied.

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