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

Indications of 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

It promotes the differentiation of malignant promyelocytes into normal hematopoietic cells by inducing the differentiation of APL cells and inhibiting their proliferation.

Specifications and Properties of Tretinoin Capsules

Dosage Form and Strength

Dosage Form: Hard capsules, each containing 10 mg of tretinoin (existing in the form of 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: Including 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: Do not chew, break, or dissolve the capsules, so as not to damage the sustained-release structure.

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

Storage Method of Tretinoin Capsules

Environmental Requirements

Temperature: Store at 20°C to 25°C (68°F to 77°F), with allowable short-term exposure to an environment of 15°C to 30°C (59°F to 86°F).

Protection from Light and Moisture: Store in the original container with the cap tightly closed, and avoid 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 medicine; expired medicines shall be disposed of as medical waste.

Handling of Abnormalities: If the capsules show discoloration, abnormal odor, or physical damage, discontinue use immediately.