What happens if I overdose Rosugraf?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Rosugraf:
Store Rosugraf at room temperature, between 68 and 77 degrees F (20 to 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rosugraf out of the reach of children and away from pets.
Overdose of Rosugraf in details
There is no specific treatment in the event of 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 Rosugraf.
However, no specific symptoms of an overdose have been reported.
What should I avoid while taking Rosugraf?
Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.
Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends, and do not take it within 2 hours after taking Rosugraf. Some antacids can make it harder for your body to absorb Rosugraf.
Avoid eating foods that are high in fat or cholesterol. Rosugraf will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
Rosugraf warnings
Skeletal Muscle Effects
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including Rosugraf. These risks can occur at any dose level, but are increased at the highest dose (40 mg).
Rosugraf should be prescribed with caution in patients with predisposing factors for myopathy (e.g., age ≥ 65 years, inadequately treated hypothyroidism, renal impairment).
The risk of myopathy during treatment with Rosugraf may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir. Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors, including Rosugraf, coadministered with colchicine, and caution should be exercised when prescribing Rosugraf with colchicine.
Rosugraf therapy should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. Rosugraf therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).
There have been rare reports of immune-mediated necrotizing myopathy (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; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
All patients should be advised to promptly report to their physician unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing Rosugraf.
Liver Enzyme Abnormalities
It is recommended that liver enzyme tests be performed before the initiation of Rosugraf, and if signs or symptoms of liver injury occur.
Increases in serum transaminases [AST (SGOT) or ALT (SGPT)] have been reported with HMG‑CoA reductase inhibitors, including Rosugraf. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy. There were two cases of jaundice, for which a relationship to Rosugraf therapy could not be determined, which resolved after discontinuation of therapy. There were no cases of liver failure or irreversible liver disease in these trials.
In a pooled analysis of placebo-controlled trials, increases in serum transaminases to >3 times the upper limit of normal occurred in 1.1% of patients taking Rosugraf versus 0.5% of patients treated with placebo.
There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including Rosugraf. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Rosugraf, promptly interrupt therapy. If an alternate etiology is not found, do not restart Rosugraf.
Rosugraf should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease. Active liver disease, which may include unexplained persistent transaminase elevations, is a contraindication to the use of Rosugraf.
Concomitant Coumarin Anticoagulants
Caution should be exercised when anticoagulants are given in conjunction with Rosugraf because of its potentiation of the effect of coumarin-type anticoagulants in prolonging the prothrombin time/INR. In patients taking coumarin anticoagulants and Rosugraf concomitantly, INR should be determined before starting Rosugraf and frequently enough during early therapy to ensure that no significant alteration of INR occurs.
Proteinuria and Hematuria
In the Rosugraf clinical trial program, dipstick-positive proteinuria and microscopic hematuria were observed among Rosugraf treated patients. These findings were more frequent in patients taking Rosugraf 40 mg, when compared to lower doses of Rosugraf or comparator HMG‑CoA reductase inhibitors, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, a dose reduction should be considered for patients on Rosugraf therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing.
Endocrine Effects
Increases in HbA1c and fasting serum glucose levels have been reported with HMG‑CoA reductase inhibitors, including Rosugraf. Based on clinical trial data with Rosugraf, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus.
Although clinical studies have shown that Rosugraf alone does not reduce basal plasma cortisol concentration or impair adrenal reserve, caution should be exercised if Rosugraf is administered concomitantly with drugs that may decrease the levels or activity of endogenous steroid hormones such as ketoconazole, spironolactone, and cimetidine.
What should I discuss with my healthcare provider before taking Rosugraf?
- If you have an allergy to Rosugraf or any other part of Rosugraf (Rosugraf sprinkle capsules).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have any of these health problems: Active liver disease or a rise in liver enzymes.
- If you are taking gemfibrozil.
- If you are pregnant or may be pregnant. Do not take Rosugraf (Rosugraf sprinkle capsules) if you are pregnant.
- If you are breast-feeding. Do not breast-feed while you take Rosugraf (Rosugraf sprinkle capsules).
This is not a list of all drugs or health problems that interact with Rosugraf (Rosugraf sprinkle capsules).
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Rosugraf (Rosugraf sprinkle capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Rosugraf precautions
Renal and hepatic impairment; severe respiratory failure. Repeated or unexplained muscle aches or pains (myopathy), a personal or family history of muscle problems or a previous history of muscle problems when taking other cholesterol-lowering drugs; regular consumption of large amounts of alcohol; thryoid gland disorders; if taking fibrates to lower cholesterol, drugs used for HIV infection eg, lopinavir, ritonavir; Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
If the patient has an intolerance to some sugars (lactose or milk sugar), consult doctor before taking Rosugraf Sandoz.
In a small number of people, statins can affect the liver. This is identified by a simple test which looks for increased levels of liver enzymes in the blood. For this reason, the physician will usually carry out a blood test (liver function test) before and during treatment with Rosugraf Sandoz.
Effects on the Ability to Drive or Operate Machinery: Most patients can drive a car and operate machinery while using Rosugraf Sandoz- it will not affect their ability. However, some people feel dizzy during treatment with Rosugraf Sandoz. If dizziness occurs, consult the physician before attempting to drive or use machines.
Use in children: If the patient is <10 years, Rosugraf Sandoz should not be given. If the patient is <18 years, Rosugraf Sandoz 40 mg is not suitable for use.
Use in the
Elderly: If the patient is >70 years, the physician needs to choose the right starting dose of Rosugraf Sandoz that will best suit the patient.
What happens if I miss a dose of Rosugraf?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "ROSUVASTATIN CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "Rosuvastatin". http://www.drugbank.ca/drugs/DB01098 (accessed September 17, 2018).
- MeSH. "Hydroxymethylglutaryl-CoA Reductase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
