Product Overview
【Drug Name】
Generic Name: Isotretinoin Soft Capsules
Brand Name: Tevis
English Name: Isotretinoin Soft Capsules
Pinyin: YiweiAsuan Jiaowan
【Ingredients】
The main ingredient of this product is isotretinoin, also known as 13-cis-retinoic acid.
【Appearance】
This product is a dark brown capsule containing an orange-yellow oily suspension.
【Indications】
Suitable for severe acne, especially nodular cystic acne, and can also be used for pityriasis rubra pilaris and other conditions.
【Dosage and Administration】
This product should be used under the guidance of a physician. The oral dosage for acne treatment varies from person to person, ranging from 0.1 to 1 mg/kg/day. It is generally recommended to start with a dose of 0.5 mg/kg/day, divided into two oral doses. This drug is lipid-soluble; taking it with meals can promote absorption. After 2-4 weeks of treatment, the dosage can be adjusted according to clinical efficacy and adverse reactions. A course of treatment lasts 6-8 weeks, with an 8-week break between courses. Symptoms may continue to improve for a short period after discontinuation.
【Adverse Reactions】
1. The side effects of this drug are similar to those of vitamin A overdose. Common side effects include dry lips and skin, cheilitis, desquamation, itching, pain, rash, increased skin fragility, palmar-plantar peeling, ecchymosis, and secondary infections.
2. Conjunctivitis, and in severe cases, corneal opacity, visual impairment, papilledema, headache, dizziness, mental symptoms, depression, and benign intracranial hypertension.
3. Hair thinning and nail softening.
4. Osteoporosis, muscle weakness, pain, gastrointestinal symptoms, and epistaxis.
5. Use during pregnancy may lead to spontaneous abortion and fetal malformations.
6. Laboratory tests may show elevated erythrocyte sedimentation rate, elevated liver enzymes, elevated blood lipids, elevated blood glucose, and decreased platelet count. Most of these side effects are reversible and gradually recover after discontinuation. Mild Side Effects
【Contraindications】
This medication is contraindicated in pregnant women, breastfeeding women, patients with hepatic or renal insufficiency, those with vitamin A overdose, and those with hyperlipidemia.
【Precautions】
1. Avoid concurrent use with vitamin A and tetracycline.
2. Do not donate blood during medication and for three months after discontinuation.
3. Avoid excessive exposure to sunlight and UV rays.
4. Use with caution in patients with diabetes, obesity, alcoholism, hyperlipidemia, or lipid metabolism disorders.
5. Acne symptoms may temporarily worsen during the initial treatment phase. If no other abnormalities occur, continue medication under close observation. Do not take other keratolytic agents or exfoliating anti-acne medications concurrently.
6. Mild topical medications can be used as adjunctive therapy if necessary.
【Special Populations】
Precautions for Children: Safety in children is unclear. Overdose may cause changes in bone structure, including premature fusion of the epiphyseal plate in children.
Precautions during pregnancy and lactation: Women of childbearing age and their partners should strictly avoid pregnancy during medication, before starting medication, and for 3 months after stopping medication. A pregnancy test should be performed 2 weeks before starting treatment, and once a month thereafter to ensure no pregnancy.
Precautions for the elderly: Contraindicated in patients with hepatic or renal insufficiency.
【Drug Interactions】
1. Concomitant use of isotretinoin with tetracycline antibiotics may lead to the formation of pseudotumor cerebri, causing benign intracranial hypertension, clinically manifested as hypertension accompanied by headache, dizziness, and visual disturbances.
2. Concomitant use of isotretinoin with vitamin A may produce symptoms similar to those of vitamin A overdose.
3. Concomitant use of isotretinoin with carbamazepine may lead to a decrease in carbamazepine blood concentration; concomitant use with warfarin may enhance the therapeutic effect of warfarin; and concomitant use with methotrexate (MTX) may increase liver damage due to increased MTX blood concentration.
【Pharmacological Actions】
1. Pharmacology: The mechanism of action of this drug is not fully understood. When used to treat acne, it shrinks sebaceous gland tissue, inhibits sebaceous gland activity, reduces sebum secretion, alleviates epithelial cell keratinization and keratin plugging of the pilosebaceous gland opening, and inhibits the growth and reproduction of Propionibacterium acnes. Recent studies have also shown that this drug can regulate inflammatory immune mediators related to the pathogenesis of acne and selectively bind to retinoic acid nuclear receptors to exert its therapeutic effect.
2. Toxicology: Tests have shown serious teratogenic effects.
【Storage】
Sealed, store in a cool place.
【Specifications】
10 mg
【Packaging Specifications】
Pharmaceutical packaging PTP aluminum foil, 24 tablets/box.
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20055201
【Manufacturer】
Company Name: Donghai Pharmaceutical (Hebei) Co., Ltd.
