Tretinoin Capsules are an oral retinoid medication used for the treatment of specific types of leukemia.

Indications for Tretinoin Capsules

Main Indications

Tretinoin Capsules are primarily used for the induction of remission in acute promyelocytic leukemia (APL).

Adult and pediatric patients aged 1 year and older: Patients diagnosed with APL by morphology, with the presence of t(15,17) chromosomal translocation or PML/RARα gene expression.

Patients with treatment failure or relapse: APL patients who are resistant to anthracycline chemotherapy or experience relapse after treatment.

Patients with contraindications to anthracycline chemotherapy: APL patients who cannot receive anthracycline chemotherapy due to contraindications.

Clinical Precautions

Before initiating medication, the presence of t(15,17) chromosomal translocation or PML/RARα gene must be confirmed through cytogenetic or molecular testing. Use of this medication is not recommended if such genetic markers are absent.

During treatment, close monitoring is required for severe adverse reactions such as differentiation syndrome and leukocytosis.

Specification and Characteristics of Tretinoin Capsules

Dosage Form and Content

Capsule dosage form, each capsule containing 10mg of Tretinoin.

Appearance Characteristics

The capsules feature a two-color design (orange-yellow and reddish-brown distributed longitudinally) with black "10mg" marking printed on the surface.

Excipient Ingredients

Active ingredient: All-trans retinoic acid (chemical name: all-transretinoic acid).

Excipients include: Beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil, and refined soybean oil. The capsule shell contains gelatin, glycerin, titanium dioxide, etc.

Physicochemical Properties

It appears as a yellow to light orange crystalline powder, with a melting point of approximately 182°C (with decomposition). It is almost insoluble in water and slightly soluble in ethanol.

Storage Method for Tretinoin Capsules

Temperature Requirement

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

Protection from Light and Moisture

Keep the bottle cap tightly closed and protect from direct light.

Packaging Specification

Each bottle contains 100 capsules, equipped with a child-resistant cap.

Precautions

After opening the bottle, use the capsules as soon as possible to avoid prolonged exposure to humid and hot environments.

Discarded expired or unused capsules must be handled in accordance with medical waste disposal regulations.