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.
