Rosuvastain Calcium 20 mg/1
Rosuvastain Calcium · TABLET, FILM COATED · Chartwell RX, LLC
Rosuvastain Calcium is a tablet, film coated containing rosuvastain calcium at 20 mg/1, taken oral. Manufactured by Chartwell RX, LLC.
Key Facts
- Brand Name
- Rosuvastain Calcium
- Generic Name
- Rosuvastain Calcium
- NDC Code (Product)
62135-692- Manufacturer
- Chartwell RX, LLC
- Strength
- 20 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA079168
- Marketing Start
- 07/19/2016
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Rosuvastatin tablets are indicated: To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce LDL-C in adults with primary hyperlipidemia. Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: ( 1 ) To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Take orally with or without food, at any time of day. ( 2.1 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust dosage if necessary. ( 2.1 ) Adults: Recommended dosage range is 5 to 40 mg once daily. ( 2.1 ) Pediatric Patients with HeFH : Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older.( 2.2 ) Pediatric Patients with HoFH : Recommended dosage is 20 mg once daily for patients aged 7 years and older. ( 2.2 ) Asian Patients: Initiate at 5 mg once daily. Consider risks and benefits of treatment if not adequately controlled at doses up to 20 mg once daily. ( 2.4 ) Patients with Severe Renal Impairment (not on hemodialysis): Initiate at 5 mg once daily; do not exceed 10 mg once daily. ( 2.5 , 5.1 , 8.6 ) See full prescribing information for rosuvastatin tablets dosage and administration modifications due to drug interactions. ( 2.6 ) 2.1 General Dosage and Administration Information Administer rosuvastatin tablets orally as a single dose at any time of day, with or without food. The tab…
Contraindications
4 CONTRAINDICATIONS Rosuvastatin tablets are contraindicated in the following conditions: Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ]. Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets [see Adverse Reactions (6.1) ] . Acute liver failure or decompensated cirrhosis. ( 4) Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of rosuvastatin tablets with other drugs that increase the risk of myopathy and rhabdomyolysis. ( 2.6 , 7.1 ) Aluminum and Magnesium Hydroxide Combination Antacids : Administer rosuvastatin tablets at least 2 hours after the antacid. ( 2.6 , 7.2 ) Wafarin: Obtain INR prior to starting rosuvastatin tablets. Monitor INR frequently until stable upon initiation, dose titration or discontinuation. ( 7.3 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Rosuvastatin is a substrate of CYP2C9 and transporters (such as OATP1B1, BCRP). Rosuvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP2C9 and transporters. Table 5 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with rosuvastatin and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Cyclosporine Clinical Impact: Cyclosporine increas…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Proteinuria and Hematuria [see Warnings and Precautions (5.4) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.5) ] Most frequent adverse reactions (rate ≥2%) are headache, nausea, myalgia, asthenia, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 2. These studies had a treatment duration of u…
Frequently Asked Questions
What is Rosuvastain Calcium used for?
Rosuvastain Calcium contains Rosuvastain Calcium. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Rosuvastain Calcium a controlled substance?
Rosuvastain Calcium is not classified as a controlled substance by the DEA.
What is the generic name for Rosuvastain Calcium?
The generic name for Rosuvastain Calcium is Rosuvastain Calcium. There are no other listed brand versions of Rosuvastain Calcium.
What is the NDC code for Rosuvastain Calcium 20 mg/1?
The NDC (National Drug Code) for Rosuvastain Calcium 20 mg/1 is 62135-692, listed by Chartwell RX, LLC.
Other Rosuvastain Calcium Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)