Tretinoin Capsules are an oral retinoid medication used to treat 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 recurrence: APL patients who are resistant to anthracycline chemotherapy or experience recurrence after treatment.

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

Clinical Precautions

Before medication use, the presence of t(15,17) or PML/RARα must be confirmed through cytogenetic or molecular testing. Use is not recommended without this genetic marker.

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

Specifications and Properties of Tretinoin Capsules

Dosage Form and Content

Capsule dosage form, with 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" markings printed on the surface.

Excipient Ingredients

Active ingredient: All-trans retinoic acid (chemical name: all-trans retinoic 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 Methods for Tretinoin Capsules

Temperature Requirements

Store at 20°C to 25°C (68°F to 77°F), with brief exposure to 15°C to 30°C (59°F to 86°F) allowed.

Light and Moisture Protection

Keep the bottle cap tightly closed and avoid direct light exposure.

Packaging Specifications

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

Precautions

After opening, use as soon as possible to avoid long-term exposure to humid and hot environments.

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