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Isotretinoin capsules

Function and Efficacy

Pharmacology: The mechanism of action of this drug is not yet fully understood. When used to treat acne, it can shrink sebaceous gland tissue, inhibit sebaceous gland activity, reduce sebum secretion, reduce epithelial cell keratinization and keratin plugging at the mouth of hair follicle sebaceous glands, and inhibit 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 a therapeutic effect. Toxicology: Tests have shown that it has severe teratogenic effects.

Ingredients

Isotretinoin

Name Description Content CAS NO. Manufacturer
IsotretinoinIngredients

It shrinks sebaceous gland tissue, inhibits sebaceous gland activity, reduces sebum secretion, alleviates epithelial cell keratinization and keratin plugging at the opening of the sebaceous glands of hair follicles, and inhibits the growth and reproduction of Propionibacterium acnes; regulates inflammatory immune mediators related to the pathogenesis of acne and selectively binds to retinoic acid nuclear receptors to exert a therapeutic effect.

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4759-48-2 20

Appearance

This product is dark brown capsules containing orange-yellow oily suspension.

Indication

It is suitable for severe acne, especially nodular cystic acne, and can also be used for diseases such as pityriasis rubra pilaris.

Usage and Dosage

This product should be used under the guidance of a doctor. The oral dose for the treatment of acne should vary from person to person, ranging from 0.1 to 1 (mg/kg)/day. The generally recommended starting dose is 0.5 (mg/kg)/day, taken orally twice. This drug is fat-soluble, and taking it with meals can promote absorption. After 2 to 4 weeks of treatment, the dose can be adjusted as appropriate based on clinical effects and adverse reactions. A course of treatment is 6 to 8 weeks, and the drug can be discontinued for 8 weeks between courses. Symptoms can be continuously improved in the short term after discontinuation of the drug.

Adverse Reactions

1. The side effects of this drug are similar to the clinical manifestations of vitamin A overdose. Common side effects include dry lips and skin, cheilitis, desquamation, itching, pain, rash, increased skin fragility, peeling of the palms and soles, ecchymosis, and secondary infection may also occur; 2. Conjunctivitis, and in severe cases, corneal opacities, visual impairment, papilledema, headache, dizziness, mental symptoms, depression, and benign intracranial hypertension; 3. Loose hair and soft nails; 4. Osteoporosis, muscle weakness, pain, gastrointestinal symptoms, epistaxis, etc.; 5. Taking the drug during pregnancy may lead to spontaneous abortion and fetal malformations; 6. Laboratory tests may cause rapid erythrocyte sedimentation rate, elevated liver enzymes, elevated blood lipids, elevated blood sugar, and decreased platelets. Most of the above side effects are reversible and can be gradually recovered after discontinuation of the drug. The severity of side effects

Precautions

It is contraindicated for use by pregnant women, lactating women, patients with liver and kidney dysfunction, vitamin A excess and hyperlipidemia.

Special Population Medication

Precautions for children: The safety for children is not yet known. Overdose may cause changes in bone structure, including premature fusion of epiphyseal discs in children. Precautions for pregnancy and lactation: Women of childbearing age or their spouses should strictly avoid pregnancy during the three months before and after taking the drug and during the medication period. Precautions for the elderly: It is contraindicated for patients with impaired liver and kidney function.

Drug Interactions

1. The combination of isotretinoin and tetracycline antibiotics can lead to pseudotumor cerebri and cause benign intracranial hypertension, with clinical manifestations of hypertension accompanied by headache, dizziness and visual impairment. 2. The simultaneous use of isotretinoin and vitamin A can produce symptoms similar to those of vitamin A overdose. 3. The simultaneous use of isotretinoin and carbamazepine can lead to a decrease in the blood concentration of carbamazepine. The simultaneous use of isotretinoin and warfarin can enhance the therapeutic effect of warfarin. The simultaneous use of isotretinoin and methotrexate (MTX) can increase liver damage due to the increase in the blood concentration of MTX.

Storage

Keep away from light, tightly closed, in a cool and dry place.

Packaging Specification

10mg

Validity Period

24 months

Manufacturer

Harbin Center Pharmaceutical Co., Ltd.

  • Founded in:

    2004-03-05
  • Address:

    4th Floor, Building 20, Harbin High-tech Development Zone (Production site: No. 1, Jingbo Road, Haping Road, Harbin Development Zone)
  • Tax NO.:

    91230199756324136E
  • Registered Funds:

    19 million yuan
  • Website:

  • Email:

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