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Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Crestor (Rosuvastatin Calcium Tablets) is used
together with exercise, diet, and weight-loss to treat
high cholesterol, lower triglycerides and related
conditions. It is also indicated for risk reduction of MI,
stroke, heart attack and certain other heart
complications in men 50 years and older and women
60 years and older who have coronary heart disease or
other risk factors.
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Crestor Tablets are manufactured by Astra Zeneca
Limited in the strengths of 5 mg, 10 mg, 20 mg and 40 mg.
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Chemical Structure
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
The active ingredient contained in
Crestor tablets is Rosuvastatin Calcium.
Each Crestor tablet contains
Rosuvastatin Calcium equivalent to 5
mg, 10 mg, 20 mg or 40 mg of
Rosuvastatin.
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Uses of Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets:
Crestor (Rosuvastatin Calcium Tablets) should be used as an adjunct to diet
when the response to diet and exercise is inadequate. Crestor is used for
prevention of major cardiovascular events in men 50 years and older and
women 60 years and older with no clinically evident cardiovascular disease but
with at least two conventional risk factors for cardiovascular disease
(hypertension, low HDL-C, smoking, or a family history of premature coronary
heart disease).
Crestor is indicated to reduce the risk of nonfatal myocardial infarction, reduce
the risk of nonfatal stroke, reduce the risk of coronary artery revascularisation
procedures.
In patients with hypercholesterolaemia, Crestor is indicated for the treatment
of hypercholesterolaemia (including familial hypercholesterolaemia).
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Recommended Adult Dosage
The dose of Crestor (Rosuvastatin Calcium Tablets) can be taken
with or without food, at any time of day.
The dose range is 5 to 40 mg once daily. Use 40 mg dose only for
patients not reaching LDL-C goal with 20 mg. The adult starting
dose for Homozygous Familial Hypercholesterolemia (HoFH) is 20
mg/day
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Recommended Dosage
In pediatric patients 10 to 17 years of age with HeFH, the
usual dose range is 5 mg to 20 mg/day; doses greater
than 20 mg have not been studied in this patient
population.
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Contraindications
➔Crestor tablets are contraindicated in patients with a
known hypersensitivity to Rosuvastatin Calcium or any
component of the tablet.
➔Active liver disease, which may include unexplained
persistent elevations in hepatic transaminase levels
➔Women who are pregnant or may become pregnant
➔Nursing mothers
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Storage Instructions
Crestor (Rosuvastatin Calcium Tablets)
has to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to
77°F) with excursions permitted between
15° to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Warnings
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase
with use of 40 mg dose, advanced age (65 or greater), hypothyroidism, renal
impairment, and combination use with cyclosporine, darolutamide,
regorafenib, certain anti-viral medicines or their combinations. Cases of
myopathy and rhabdomyolysis with acute renal failure secondary to
myoglobinuria have been reported. Advise patients to promptly report to
their physician unexplained and/or persistent muscle pain, tenderness, or
weakness and discontinue Crestor (Rosuvastatin Calcium Tablets) if signs or
symptoms appear.
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Warnings
Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare
reports of IMNM, an autoimmune myopathy, associated with statin use.
IMNM is characterized by: proximal muscle weakness and elevated serum
creatine kinase, which persist despite discontinuation of statin treatment;
positive anti-HMG CoA reductase antibody; muscle biopsy; and improvement
with immunosuppressive agents.
Liver enzyme abnormalities: Persistent elevations in hepatic transaminases
can occur. Perform liver enzyme tests before starting therapy and as
clinically indicated thereafter.
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Possible Side Effects
Most common Crestor (Rosuvastatin Calcium Tablets)
side effects with an incidence rate of greater than or
equal to 2% are headache, myalgia, abdominal pain,
asthenia, and nausea.
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Possible Side Effects
The following side effects have been identified during post approval use of Crestor
(Rosuvastatin Calcium Tablets) : arthralgia, fatal and non-fatal hepatic failure,
hepatitis, jaundice, thrombocytopenia, depression, sleep disorders (including
insomnia and nightmares), peripheral neuropathy, interstitial lung disease and
gynecomastia.
There have been rare reports of immune-mediated necrotizing myopathy associated
with statin use.
There have been rare postmarketing reports of cognitive impairment (e.g., memory
loss, forgetfulness, amnesia, memory impairment, and confusion) associated with
statin use.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).
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Crestor Tablets Overdosage
There is no specific treatment in the event of Crestor
(Rosuvastatin Calcium Tablets) overdose. In the event of
overdose, the patient should be treated symptomatically
and supportive measures instituted as required.
Hemodialysis does not significantly enhance clearance of
Rosuvastatin.
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Crestor Tablets During Pregnancy
Crestor (Rosuvastatin Calcium Tablets) has been classified by the US FDA as
Pregnancy Category X.
Crestor is contraindicated in women who are or may become pregnant.
Serum cholesterol and triglycerides increase during normal pregnancy, and
cholesterol products are essential for fetal development. Atherosclerosis is a
chronic process and discontinuation of lipid-lowering drugs during pregnancy
should have little impact on long-term outcomes of primary
hyperlipidemia therapy.
There are no adequate and well-controlled studies of Crestor in
pregnant women. There have been rare reports of congenital anomalies
following intrauterine exposure to HMG-CoA reductase inhibitors.
Crestor (Rosuvastatin Tablets)
© The Swiss Pharmacy
Crestor Tablets are manufactured by Astra
Zeneca Limited.
For More details Click Here

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Crestor (Rosuvastatin Calcium Tablets)

  • 2. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Crestor (Rosuvastatin Calcium Tablets) is used together with exercise, diet, and weight-loss to treat high cholesterol, lower triglycerides and related conditions. It is also indicated for risk reduction of MI, stroke, heart attack and certain other heart complications in men 50 years and older and women 60 years and older who have coronary heart disease or other risk factors.
  • 3. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Crestor Tablets are manufactured by Astra Zeneca Limited in the strengths of 5 mg, 10 mg, 20 mg and 40 mg.
  • 4. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Chemical Structure
  • 5. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy The active ingredient contained in Crestor tablets is Rosuvastatin Calcium. Each Crestor tablet contains Rosuvastatin Calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of Rosuvastatin.
  • 6. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Uses of Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets: Crestor (Rosuvastatin Calcium Tablets) should be used as an adjunct to diet when the response to diet and exercise is inadequate. Crestor is used for prevention of major cardiovascular events in men 50 years and older and women 60 years and older with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). Crestor is indicated to reduce the risk of nonfatal myocardial infarction, reduce the risk of nonfatal stroke, reduce the risk of coronary artery revascularisation procedures. In patients with hypercholesterolaemia, Crestor is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia).
  • 7. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Recommended Adult Dosage The dose of Crestor (Rosuvastatin Calcium Tablets) can be taken with or without food, at any time of day. The dose range is 5 to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. The adult starting dose for Homozygous Familial Hypercholesterolemia (HoFH) is 20 mg/day
  • 8. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Recommended Dosage In pediatric patients 10 to 17 years of age with HeFH, the usual dose range is 5 mg to 20 mg/day; doses greater than 20 mg have not been studied in this patient population.
  • 9. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Contraindications ➔Crestor tablets are contraindicated in patients with a known hypersensitivity to Rosuvastatin Calcium or any component of the tablet. ➔Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ➔Women who are pregnant or may become pregnant ➔Nursing mothers
  • 10. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Storage Instructions Crestor (Rosuvastatin Calcium Tablets) has to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets.
  • 11. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Warnings Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (65 or greater), hypothyroidism, renal impairment, and combination use with cyclosporine, darolutamide, regorafenib, certain anti-viral medicines or their combinations. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue Crestor (Rosuvastatin Calcium Tablets) if signs or symptoms appear.
  • 12. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Warnings Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy; and improvement with immunosuppressive agents. Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Perform liver enzyme tests before starting therapy and as clinically indicated thereafter.
  • 13. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Possible Side Effects Most common Crestor (Rosuvastatin Calcium Tablets) side effects with an incidence rate of greater than or equal to 2% are headache, myalgia, abdominal pain, asthenia, and nausea.
  • 14. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Possible Side Effects The following side effects have been identified during post approval use of Crestor (Rosuvastatin Calcium Tablets) : arthralgia, fatal and non-fatal hepatic failure, hepatitis, jaundice, thrombocytopenia, depression, sleep disorders (including insomnia and nightmares), peripheral neuropathy, interstitial lung disease and gynecomastia. There have been rare reports of immune-mediated necrotizing myopathy associated with statin use. There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with statin use.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).
  • 15. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Crestor Tablets Overdosage There is no specific treatment in the event of Crestor (Rosuvastatin Calcium Tablets) overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis does not significantly enhance clearance of Rosuvastatin.
  • 16. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Crestor Tablets During Pregnancy Crestor (Rosuvastatin Calcium Tablets) has been classified by the US FDA as Pregnancy Category X. Crestor is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hyperlipidemia therapy. There are no adequate and well-controlled studies of Crestor in pregnant women. There have been rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors.
  • 17. Crestor (Rosuvastatin Tablets) © The Swiss Pharmacy Crestor Tablets are manufactured by Astra Zeneca Limited. For More details Click Here