What happens if I overdose Pitavastatin Calcium KO?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Pitavastatin Calcium KO:
Store Pitavastatin Calcium KO at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pitavastatin Calcium KO out of the reach of children and away from pets.
Overdose of Pitavastatin Calcium KO in details
There is no known specific treatment in the event of overdose of Pitavastatin Calcium KO. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis is unlikely to be of benefit due to high protein binding ratio of Pitavastatin Calcium KO.
What should I avoid while taking Pitavastatin Calcium KO?
Avoid eating foods that are high in fat or cholesterol. Pitavastatin Calcium KO will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.
Pitavastatin Calcium KO 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 Pitavastatin Calcium KO. These risks can occur at any dose level, but increase in a dose-dependent manner.
Pitavastatin Calcium KO should be prescribed with caution in patients with predisposing factors for myopathy. These factors include advanced age (≥65 years), renal impairment, and inadequately treated hypothyroidism. The risk of myopathy may also be increased with concurrent administration of fibrates or lipid-modifying doses of niacin. Pitavastatin Calcium KO should be administered with caution in patients with impaired renal function, in elderly patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin.
Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors coadministered with colchicine, and caution should be exercised when prescribing Pitavastatin Calcium KO with colchicine.
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.
Pitavastatin Calcium KO therapy should be discontinued if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. Pitavastatin Calcium KO 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). All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing Pitavastatin Calcium KO.
Liver Enzyme Abnormalities
Increases in serum transaminases (aspartate aminotransferase [AST]/serum glutamic-oxaloacetic transaminase, or alanine aminotransferase [ALT]/serum glutamic-pyruvic transaminase) have been reported with HMG-CoA reductase inhibitors, including Pitavastatin Calcium KO. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy.
In placebo-controlled Phase 2 studies, ALT >3 times the upper limit of normal was not observed in the placebo, Pitavastatin Calcium KO 1 mg, or Pitavastatin Calcium KO 2 mg groups. One out of 202 patients (0.5%) administered Pitavastatin Calcium KO 4 mg had ALT >3 times the upper limit of normal.
It is recommended that liver enzyme tests be performed before the initiation of Pitavastatin Calcium KO and if signs or symptoms of liver injury occur.
There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including Pitavastatin Calcium KO. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Pitavastatin Calcium KO, promptly interrupt therapy. If an alternate etiology is not found do not restart Pitavastatin Calcium KO.
As with other HMG-CoA reductase inhibitors, Pitavastatin Calcium KO should be used with caution in patients who consume substantial quantities of alcohol. Active liver disease, which may include unexplained persistent transaminase elevations, is a contraindication to the use of Pitavastatin Calcium KO.
Endocrine Function
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Pitavastatin Calcium KO.
What should I discuss with my healthcare provider before taking Pitavastatin Calcium KO?
- If you have an allergy to Pitavastatin Calcium KO or any other part of Pitavastatin Calcium KO (Pitavastatin Calcium KO).
- 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 are pregnant or may be pregnant. Do not take Pitavastatin Calcium KO (Pitavastatin Calcium KO) if you are pregnant.
- If you are breast-feeding. Do not breast-feed while you take Pitavastatin Calcium KO (Pitavastatin Calcium KO).
- If you are taking any of these drugs: Cyclosporine or gemfibrozil.
- If you have any of these health problems: Active liver disease or a rise in liver enzymes.
This is not a list of all drugs or health problems that interact with Pitavastatin Calcium KO (Pitavastatin Calcium KO).
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 Pitavastatin Calcium KO (Pitavastatin Calcium KO) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Pitavastatin Calcium KO precautions
Skeletal Muscle Effects
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including Pitavastatin Calcium KO. These risks can occur at any dose level, but increase in a dose-dependent manner.
Pitavastatin Calcium KO should be prescribed with caution in patients with predisposing factors for myopathy. These factors include advanced age (≥65 years), renal impairment, and inadequately treated hypothyroidism. The risk of myopathy may also be increased with concurrent administration of fibrates or lipid-modifying doses of niacin. Pitavastatin Calcium KO should be administered with caution in patients with impaired renal function, in elderly patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin.
Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors coadministered with colchicine, and caution should be exercised when prescribing Pitavastatin Calcium KO with colchicine.
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.
Pitavastatin Calcium KO therapy should be discontinued if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. Pitavastatin Calcium KO 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). All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing Pitavastatin Calcium KO.
Liver Enzyme Abnormalities
Increases in serum transaminases (aspartate aminotransferase [AST]/serum glutamic-oxaloacetic transaminase, or alanine aminotransferase [ALT]/serum glutamic-pyruvic transaminase) have been reported with HMG-CoA reductase inhibitors, including Pitavastatin Calcium KO. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy.
In placebo-controlled Phase 2 studies, ALT >3 times the upper limit of normal was not observed in the placebo, Pitavastatin Calcium KO 1 mg, or Pitavastatin Calcium KO 2 mg groups. One out of 202 patients (0.5%) administered Pitavastatin Calcium KO 4 mg had ALT >3 times the upper limit of normal.
It is recommended that liver enzyme tests be performed before the initiation of Pitavastatin Calcium KO and if signs or symptoms of liver injury occur.
There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including Pitavastatin Calcium KO. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Pitavastatin Calcium KO, promptly interrupt therapy. If an alternate etiology is not found do not restart Pitavastatin Calcium KO.
As with other HMG-CoA reductase inhibitors, Pitavastatin Calcium KO should be used with caution in patients who consume substantial quantities of alcohol. Active liver disease, which may include unexplained persistent transaminase elevations, is a contraindication to the use of Pitavastatin Calcium KO.
Endocrine Function
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Pitavastatin Calcium KO.
What happens if I miss a dose of Pitavastatin Calcium KO?
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. "PITAVASTATIN 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. "Pitavastatin". http://www.drugbank.ca/drugs/DB08860 (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
