Partial
Partially Aligned
Patient Risk:
Low
Summary
Several generic/labeling logistics claims (active ingredient identity, strength availability, dosing frequency) are not supported or contradicted by the provided CRESTOR label excerpts. The included excerpt does support that CRESTOR is rosuvastatin and provides dosing range/frequency guidance, but it does not support pharmacy substitution/DAW or salt-form labeling claims.
Category Scores
Accurate Statements
Crestor is the brand name for rosuvastatin.
Label mechanism section states: “CRESTOR is an inhibitor of HMG‑CoA reductase…” and the provided label context identifies CRESTOR (rosuvastatin) as the drug. (1, 12.1)
Generic rosuvastatin is designed to work the same way as Crestor for lowering cholesterol.
Label states mechanism of action for CRESTOR (rosuvastatin) as an HMG‑CoA reductase inhibitor. (12.1) (Note: label excerpt does not explicitly discuss generics, but the mechanism claim aligns with CRESTOR’s stated mechanism.)
Rosuvastatin is typically taken by mouth once daily.
“Administer CRESTOR orally as a single dose at any time of day, with or without food.” and dosage range “5 to 40 mg orally once daily.” (2.1, 2.2)
The prescription label may include the manufacturer and strength (e.g., rosuvastatin 5 mg, rosuvastatin 10 mg).
The label excerpt provides strength range for CRESTOR (5 to 40 mg) but does not mention manufacturer labeling. (2.2)
Generic rosuvastatin product is designed to contain the same active ingredient as Crestor (rosuvastatin).
The provided label text identifies CRESTOR as rosuvastatin in the prompt-provided context (Drug/active ingredient) and the label discusses rosuvastatin exposure. (Label context, 12.3)
Unsupported Statements
The generic equivalent of Crestor is rosuvastatin.
Provided label excerpts do not discuss generic equivalence of CRESTOR.
Generic rosuvastatin is available in different strengths.
Label excerpts specify CRESTOR dosing strengths/range, but do not state generic rosuvastatin availability by strength.
On a prescription or medication label, generic Crestor will usually be listed as rosuvastatin.
Label excerpts do not address how prescriptions/medication labels list generic names.
On a prescription or medication label, rosuvastatin may be followed by a salt form, such as rosuvastatin calcium.
Label excerpts do not mention salt forms or how rosuvastatin appears on labels.
A generic rosuvastatin product is designed to contain the same active ingredient as Crestor (rosuvastatin).
The provided label excerpts support CRESTOR contains/relates to rosuvastatin pharmacology, but they do not explicitly state generic product composition requirements.
If a prescription specifies brand only (DAW/no substitutions), the pharmacy may have to fill Crestor rather than a generic.
Label excerpts do not cover pharmacy substitution/DAW rules.
If a prescription does not specify brand only, the pharmacist can generally substitute an approved generic for rosuvastatin.
Label excerpts do not address substitution practices or substitution legality.
Contradictions
Important Omissions
For the dosing/frequency claim, the label also states oral administration “with or without food” and that tablets should be swallowed whole; the evaluated response did not mention these administration details.
Importance:
Low
Safety Assessment
Potential Patient Risk:
Low
Most claims are generic/labeling logistics not directly tied to contraindications, warnings, dosing limits, drug interactions, or specific population risks in the provided excerpts. The dosing frequency claim is broadly consistent with the label’s once-daily oral single-dose guidance.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Several statements about generic labeling, salt forms, and DAW/substitution are not supported by the provided CRESTOR prescribing information excerpts.
Suggested Improvement
Limit claims to what the label excerpt supports: that CRESTOR is rosuvastatin and that it is administered orally as a once-daily single dose (with or without food), and avoid assertions about prescription label wording or pharmacy substitution/DAW rules unless supported by the provided label text.