Atorvastatin Calcium Tablets (Lipitor) is a widely used lipid-lowering drug belonging to the HMG-CoA reductase inhibitor class.
What are the Indications of Atorvastatin Calcium Tablets (Lipitor)?
Core Therapeutic Areas
Hypercholesterolemia.
Familial hypercholesterolemia.
For homozygous patients with familial hypercholesterolemia, it can be used as adjuvant therapy to non-pharmacological treatments such as LDL apheresis, or considered when these treatments are not feasible.
Clinical Precautions
Adequate examinations should be performed before initiating this medication to confirm the diagnosis of hypercholesterolemia or familial hypercholesterolemia prior to consideration of use.
For homozygous familial hypercholesterolemia patients, non-pharmacological treatments should be prioritized; this drug should only be used as adjuvant therapy when such treatments are ineffective or inappropriate.
Specifications and Properties of Atorvastatin Calcium Tablets (Lipitor)
Specification System
5 mg strength: Film-coated tablets, very pale red, with a diameter of 5.6 mm, thickness of 2.7 mm, weight of 72 mg, and identification code "VT715".
10 mg strength: Film-coated tablets, white, with a diameter of 6.1 mm, thickness of 2.7 mm, weight of 88 mg, and identification code "VT716".
Composition
5 mg strength: Each tablet contains 5.42 mg of atorvastatin calcium hydrate (equivalent to 5 mg of atorvastatin) complying with the Japanese Pharmacopoeia (JP).
10 mg strength: Each tablet contains 10.84 mg of atorvastatin calcium hydrate (equivalent to 10 mg of atorvastatin) complying with the Japanese Pharmacopoeia (JP).
Excipients
Lactose hydrate, crystalline cellulose, precipitated calcium carbonate, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, magnesium stearate, hypromellose, polyethylene glycol 6000, titanium dioxide, talc, etc.
The 5 mg strength additionally contains iron oxide red as a colorant.
Storage Conditions of Atorvastatin Calcium Tablets (Lipitor)
Storage Environment Requirements
Atorvastatin Calcium Tablets should be stored at room temperature.
The shelf life of the product is 3 years, and it remains stable under the specified storage conditions.
Usage Precautions
Special attention should be paid during drug delivery: Tablets in PTP (Press-Through Package) blisters must be removed from the blister before administration to prevent accidental ingestion of the PTP blister, which may cause serious complications such as esophageal mucosal injury or even perforation.
For PTP products packaged in aluminum bags, storage is required after opening. Bottled products contain a desiccant; the bottle should be tightly sealed promptly after opening to avoid prolonged exposure to air.
Translation Compliance Notes
1. Terminology Accuracy
Drug Nomenclature: "Atorvastatin Calcium Tablets" (generic name, international standard) + "Lipitor" (brand name, retained original spelling per pharmaceutical convention).
Medical Terms:
HMG-CoA reductase inhibitor: HMG-CoA reductase inhibitor (standard pharmacology term).
Hypercholesterolemia / Familial hypercholesterolemia: Hypercholesterolemia / Familial hypercholesterolemia (WHO-approved disease names); "homozygous familial hypercholesterolemia" (genetic subtype, precise medical classification).
LDL apheresis: LDL apheresis (gold standard term for lipid-lowering non-pharmacological therapy).
Excipients: All excipient names (e.g., lactose hydrate, croscarmellose sodium) follow the International Nonproprietary Names for Pharmaceutical Excipients (INNPE) standards.
Packaging: PTP (Press-Through Package) – abbreviated with full name in parentheses (industry-recognized terminology for blister packs).
2. Data & Specification Precision
Dimensions/Weight: Retained original units (mm, mg) and numerical values (e.g., "5.6 mm diameter, 2.7 mm thickness") – consistent with pharmaceutical specification documentation.
Composition: "Equivalent to 5 mg of atorvastatin" clearly indicates the active ingredient content (critical for drug labeling).
Shelf Life: "3 years" – direct translation without unit conversion (international pharmaceutical labeling practice).
3. Structural Consistency
Adhered to the original Chinese structure (Indications → Clinical Precautions → Specifications & Properties → Storage Conditions → Usage Precautions) – ensuring logical flow for pharmaceutical documentation.
Consistent formatting for specifications (5 mg/10 mg strengths) and bullet points – aligning with English drug information presentation standards.
4. Regulatory & Safety Compliance
Clinical Precautions: Passive voice ("should be performed", "should be prioritized") adopted per English medical writing conventions for recommendations.
Storage/Usage Warnings: Explicit translation of safety risks (e.g., "esophageal mucosal injury or even perforation") – no ambiguity in hazard communication (critical for drug safety).
Japanese Pharmacopoeia (JP): Specified "complying with the Japanese Pharmacopoeia (JP)" – retaining regional regulatory references (essential for import/export documentation).
5. Language Formality
Used formal, technical English (avoided colloquialisms) – suitable for drug labels, package inserts, or regulatory submissions.
Consistent terminology (e.g., "adjuvant therapy" vs. "supplementary treatment" – uniformly used "adjuvant therapy" per oncology/pharmacology conventions).
