Tretinoin Capsules are a formulation of all-trans retinoic acid, used as a differentiation inducer for the treatment of specific types of leukemia.

Indications for Tretinoin Capsules

Core Target Population

Acute Promyelocytic Leukemia (APL): Adult patients and pediatric patients aged 1 year and above who are diagnosed by morphology and have t(15;17) chromosomal translocation or PML/RARα gene expression.

Patients with Treatment Failure or Contraindications: APL patients who are resistant to anthracycline chemotherapy drugs, have relapsed, or have contraindications to anthracycline use.

Pharmacological Action

By inducing the differentiation of APL cells and inhibiting their proliferation, it promotes the differentiation of malignant promyelocytes into normal hematopoietic cells.

Specification and Properties of Tretinoin Capsules

Dosage Form and Strength

Dosage form: Hard capsules, each containing 10 mg of tretinoin (present as tretinoin triethanolamine salt, equivalent to 12.5 mg of the salt).

Appearance: Two-color capsules (longitudinally orange-yellow and reddish-brown), printed with black "10mg" marking.

Composition

Active ingredient: Tretinoin triethanolamine salt.

Excipients: Include beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil, etc.; the capsule shell contains gelatin, glycerin, titanium dioxide, and iron oxide pigments.

Physical properties: It is a crystalline powder at room temperature, almost insoluble in water, and has poor light stability.

Administration Characteristics

Swallow whole: The capsules must be swallowed whole; chewing, breaking, or dissolving them is not allowed, as this will destroy the sustained-release structure.

Effect of food: It is recommended to take with food to improve absorption rate.

Storage Method for Tretinoin Capsules

Environmental Requirements

Temperature: Store at 20°C to 25°C (68°F to 77°F). Brief exposure to temperatures between 15°C and 30°C (59°F and 86°F) is permitted.

Light and moisture protection: Store in the original bottle with the cap tightly closed, avoiding direct light and humid environments.

Expiration Date and Packaging

Packaging specification: 100 capsules per bottle, equipped with a child-resistant cap.

Expiration date management: Regularly check the expiration date of the drug. Expired drugs should be disposed of as medical waste.

Abnormal situation handling: If the capsules show discoloration, abnormal odor, or physical damage, use should be discontinued immediately.