Crestor Tablets

Crestor (Rosuvastatin Calcium Tablets) - Product Information

Crestor (Rosuvastatin Calcium Tablets) is used together with a proper diet to lower bad cholesterol (LDL) and triglycerides (fats) in the blood, and to increase your good cholesterol (HDL). It is also used to treat adults who cannot control their cholesterol levels by diet and exercise alone.
It belongs to a group of medications called statins.
Rosuvastatin Rosuvastatin may help prevent or slow down medical problems, like atherosclerosis (hardening of the arteries), that are caused by fats clogging the blood vessels. It may also be used to reduce the risk of death, heart attack, stroke, or other blood vessel problems in patients with risk factors for heart problems.
Crestor tablets (Rosuvastatin tablets) are manufactured by IPR Pharmaceuticals INC, USA and marketed by AstraZeneca Pharma India Limited in the strengths of 5 mg, 10 mg, 20 mg and 40 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

Crestor Tablets.

Manufacturer of Crestor Tablets

IPR Pharmaceuticals INC, USA and marketed by AstraZeneca Pharma India Limited  
Website: www.astrazeneca.in/

Active Pharmaceutical Ingredient

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

Uses of Rosuvastatin Calcium Tablets (Crestor Tablets)

Treatment of Hypertriglyceridemia
Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
Treatment of Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.

Rosuvastatin Calcium Tablets (Crestor Tablets) - Dosage

Rosuvastatin Calcium tablets should be administered exactly as suggested by your doctor. Your doctor may recommend a dosage of Crestor tablets depending on your age, medical requirement, body weight, other medical conditions, and current medications. Rosuvastatin (Crestor Tablets) may be given at any time of day, with or without food.
The dose range for Crestor tablets in adults are 5 to 40 mg orally once daily. The usual starting dose is 10 to 20 mg once daily. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily.
The maximum rosuvastatin calcium tablet dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose
In Asian patients, consider initiation of Rosuvastatin Calcium tablets therapy with 5 mg once daily due to increased rosuvastatin plasma concentrations. The increased systemic exposure should be taken into consideration when treating Asian patients not adequately controlled at doses up to 20 mg/day.
Crestor 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. Crestor tablets ( 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 (Crestor 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 Rosuvastatin Tablets (Crestor Tablets)

Store Crestor 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 Rosuvastatin tablets past its expiration date printed on the blister pack. Keep the pack of Crestor tablets away from the reach of children and pets. Do not dispose Rosuvastatin tablets along with domestic waste or sewage. Consult your doctor or pharmacist about the correct method of disposal.

Contraindications

Crestor tablets are contraindicated in patients with a hypersensitivity to Rosuvastatin Calcium or any inactive ingredient present in Crestor tablets. Crestor 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 Crestor 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 Crestor if markedly elevated CK levels occur or myopathy is diagnosed or suspected.
Rhabdomyolysis:
Temporarily discontinue Crestor 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 Crestor 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 Crestor 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 Crestor.
Concomitant Coumarin Anticoagulants
Caution should be exercised when anticoagulants are given in conjunction with rosuvastatin calcium tablets because of its potentiation of the effect of coumarin-type anticoagulants in prolonging the prothrombin time/INR. In patients taking coumarin anticoagulants and rosuvastatin calcium tablets concomitantly, INR should be determined before starting rosuvastatin calcium tablets and frequently enough during early therapy to ensure that no significant alteration of INR occurs
Proteinuria and Hematuria
In the rosuvastatin calcium tablets clinical trial program, dipstick-positive proteinuria and microscopic hematuria were observed among rosuvastatin calcium tablets treated patients.
Endocrine Effects
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including rosuvastatin calcium tablets. Based on clinical trial data with rosuvastatin calcium tablets, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus

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 (Crestor 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 (Crestor 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: arthralgia, fatal and non-fatal hepatic failure, hepatitis, jaundice, thrombocytopenia, depression, sleep disorders (including insomnia and nightmares), peripheral neuropathy, interstitial lung disease and gynecomastia.

Rosuvastatin Calcium (Crestor Tablets) During Pregnancy

Rosuvastatin Calcium (Crestor Tablets) has been classified by the US FDA as Pregnancy Category X. Women of child bearing potential should use appropriate contraceptive measures.
Rosuvastatin calcium tablets are contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with rosuvastatin calcium tablets during pregnancy.
Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin calcium tablets may cause fetal harm when administered to pregnant women. Rosuvastatin calcium tablets should be discontinued as soon as pregnancy is recognized.
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 Crestor 5 mg, 10 mg, 20 mg and 40 mg Pills Online From Only $0.60 per Pill

You can buy Rosuvastatin Calcium tablets online from Everest Online Pharmacy at a cheap price. Crestor 5 mg, 10 mg, 20 mg and 40 mg pills, manufactured by IPR Pharmaceuticals INC, USA and marketed by AstraZeneca Pharma India Limited, are supplied in a blister strip of 10 or 30 tablets.The 5 mg tablets cost only $0.60 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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