Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Roseday:
Store Roseday 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 Roseday out of the reach of children and away from pets.
Overdose of Roseday in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
sponsored
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 Roseday.
However, no specific symptoms of an overdose have been reported.
What should I avoid while taking Roseday?
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 Roseday. Some antacids can make it harder for your body to absorb Roseday.
Avoid eating foods that are high in fat or cholesterol. Roseday will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
Roseday warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Skeletal Muscle Effects
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including Roseday. These risks can occur at any dose level, but are increased at the highest dose (40 mg).
Roseday 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 Roseday 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 Roseday, coadministered with colchicine, and caution should be exercised when prescribing Roseday with colchicine.
Roseday therapy should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. Roseday 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 Roseday.
Liver Enzyme Abnormalities
It is recommended that liver enzyme tests be performed before the initiation of Roseday, 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 Roseday. 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 Roseday 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 Roseday 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 Roseday. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Roseday, promptly interrupt therapy. If an alternate etiology is not found, do not restart Roseday.
Roseday 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 Roseday.
Concomitant Coumarin Anticoagulants
Caution should be exercised when anticoagulants are given in conjunction with Roseday because of its potentiation of the effect of coumarin-type anticoagulants in prolonging the prothrombin time/INR. In patients taking coumarin anticoagulants and Roseday concomitantly, INR should be determined before starting Roseday and frequently enough during early therapy to ensure that no significant alteration of INR occurs.
Proteinuria and Hematuria
In the Roseday clinical trial program, dipstick-positive proteinuria and microscopic hematuria were observed among Roseday treated patients. These findings were more frequent in patients taking Roseday 40 mg, when compared to lower doses of Roseday 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 Roseday 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 Roseday. Based on clinical trial data with Roseday, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus.
Although clinical studies have shown that Roseday alone does not reduce basal plasma cortisol concentration or impair adrenal reserve, caution should be exercised if Roseday 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 Roseday?
If you have an allergy to Roseday or any other part of Roseday (Roseday 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 Roseday (Roseday sprinkle capsules) if you are pregnant.
If you are breast-feeding. Do not breast-feed while you take Roseday (Roseday sprinkle capsules).
This is not a list of all drugs or health problems that interact with Roseday (Roseday 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 Roseday (Roseday 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.
Roseday precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
sponsored
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 Roseday 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 Roseday Sandoz.
Effects on the Ability to Drive or Operate Machinery: Most patients can drive a car and operate machinery while using Roseday Sandoz- it will not affect their ability. However, some people feel dizzy during treatment with Roseday Sandoz. If dizziness occurs, consult the physician before attempting to drive or use machines.
Use in children: If the patient is <10 years, Roseday Sandoz should not be given. If the patient is <18 years, Roseday 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 Roseday Sandoz that will best suit the patient.
What happens if I miss a dose of Roseday?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
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.
sponsored
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).
