Crestor 20 mg/1

Rosuvastatin · TABLET, FILM COATED · AstraZeneca Pharmaceuticals LP

No Recall History

Plain English

Crestor is a tablet, film coated containing rosuvastatin at 20 mg/1, taken oral. Manufactured by AstraZeneca Pharmaceuticals LP.

Key Facts

Brand Name: Crestor
Generic Name: Rosuvastatin
NDC Code (Product): 0310-7580
Manufacturer: AstraZeneca Pharmaceuticals LP
Strength: 20 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA021366
Marketing Start: 01/24/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue12,008 reports

nausea10,311 reports

diarrhoea9,475 reports

drug ineffective9,418 reports

dyspnoea9,403 reports

myalgia8,941 reports

off label use8,776 reports

pain8,560 reports

headache8,001 reports

dizziness7,902 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE CRESTOR is indicated: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): ∘ in adults with hypercholesterolemia. ∘ and slow the progression of atherosclerosis in adults. ∘ in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). ∘ 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. CRESTOR is an HMG Co‑A reductase inhibitor (statin) indicated: ( 1 ) • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): ∘ in adults with primary hypercholester…

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 CRESTOR, and adjust dosage if necessary. ( 2.1 ) Adults: Recommended dosage range is 5 to 40 mg once daily. ( 2.2 ) 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. ( 2.3 ) Pediatric Patients with HoFH: Recommended dosage is 20 mg once daily for patients aged 7 years and older. ( 2.3 ) Asian Patients: Initiate at 5 mg once daily. Consider risks and benefits of treatment if not adequately controlled at dosages 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 ) See full prescribing information for CRESTOR dosage and administration modifications due to drug interactions. ( 2.6 ) 2.1 General Dosage and Administration Information • Administer CRESTOR orally as a single dose at any time of day, with or without food. Swallow the tablets whole. • Assess LDL-C when clinical…

Contraindications

4 CONTRAINDICATIONS CRESTOR is contraindicated in patients with: • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . • Hypersensitivity to rosuvastatin or any excipients in CRESTOR. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with CRESTOR [see Adverse Reactions (6.1) ] . Acute liver failure or decompensated cirrhosis. ( 4 ) Hypersensitivity to rosuvastatin or any excipients in CRESTOR. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of CRESTOR with other drugs that increase the risk of myopathy and rhabdomyolysis. ( 7.1 ) Aluminum and Magnesium Hydroxide Combination Antacids : Administer CRESTOR at least 2 hours before the antacid. ( 7.2 ) Warfarin : Obtain INR prior to starting CRESTOR. Monitor INR frequently until stable upon initiation, dosage titration or discontinuation. ( 7.3 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with CRESTOR 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 CRESTOR 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 CRESTOR Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Prevention or Management: Avoid concomitant use w…

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 AstraZeneca at 1-800-236-9933 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 up to 12 …

Frequently Asked Questions

What is Crestor used for?

Crestor contains Rosuvastatin. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Crestor a controlled substance?

Crestor is not classified as a controlled substance by the DEA.

What is the generic name for Crestor?

The generic name for Crestor is Rosuvastatin. There are 12 other brand versions of Rosuvastatin.

What is the NDC code for Crestor 20 mg/1?

The NDC (National Drug Code) for Crestor 20 mg/1 is 0310-7580, listed by AstraZeneca Pharmaceuticals LP.

Product NDC

0310-7580

Package NDC

0310-7580-90

Other Rosuvastatin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)