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Hansepran

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Clofazimine (Clofazimine) Instructions Common name: Clofazimine soft capsules
Trade name: Clofazimine gelatin pills
Full names: Clofazimine soft capsules, clofazimine, spiramycin, chlorphenazine, clofazimine gelatin pills, Clofazimine, Clofaziminum, Lamprene


Indications:
As a drug of choice for the treatment of tumor-type leprosy, it should usually be used in combination with dapsone.
In combination with rifampicin or ethionamide, it is used to treat infections caused by strains resistant to sulfone drugs.
This product can also be used for erythematous nodular leprosy reactions and acute leprosy reactions caused by other drugs.
It is also effective for tuberculosis, erythema nodosum, acne, abscessary skin diseases, pemphigoid, necrotizing skin diseases, etc.
Skin diseases such as discoid lupus erythematosus, pyoderma gangrenosum, palmoplantar pustulosis, etc.


Usage and dosage:
For various types of dapsone-resistant leprosy, take orally, 50 to 100 mg once a day, combined with one or several other anti-leprosy drugs.
Various types of leprosy with erythematous nodule leprosy reaction: For those with severe signs of nerve damage or skin ulcers, 100 to 300 mg orally taken daily can help reduce and eliminate prednisone (40 to 80 mg daily). After the reaction is controlled, gradually decrease to 100 mg per day. In order to achieve sufficient drug concentration in the tissue, the dosage of prednisone was gradually reduced after 2 months of medication. In the absence of severe signs of nerve damage or skin ulcers, treat the patient as dapsone-resistant leprosy.
Treatment of various types of leprosy sensitive to dapsone: This product can be combined with two other anti-leprosy drugs. If possible, the three drugs should be used together for at least 2 years until the skin smear turns negative. Thereafter, proceed with an appropriate medication.
The maximum daily dose for adults is not to exceed 300mg. Pediatric dosage has not been confirmed.
For drug-resistant tuberculosis and non-tuberculous mycobacterial disease, 100 mg three times a day, combined with anti-tuberculosis drugs.
Treatment of multibacillary leprosy: Clofazimine, 300 mg, once a month, supervised, and 50 mg daily, self-administered, combined with rifampicin and DDS to form a combined chemotherapy regimen, with a course of treatment of at least 2 months, or until the skin smear turns negative for bacteria.
Treatment of leprosy reactions: Start with a larger dose, 200 to 400 mg per day, and gradually reduce the dose after the reaction is controlled. For severe cases, glucocorticoid treatment should be used in the initial stage.
Treatment of other skin diseases: 100-400 mg orally daily, gradually reduce the dosage after the condition is controlled.


Adverse reactions:
Skin redness and pigmentation: the most common, usually appearing 2 to 4 weeks after treatment, and most obvious at 6 to 12 months. The skin will appear light red at first, and then turn from tan to purple-black, making the exposed parts more obvious. In addition, the conjunctiva, urine, sputum, and sweat all appear red. Clofazimine can pass through the placenta and enter breast milk, causing skin staining in newborns and infants. The degree of skin redness and pigmentation is directly proportional to the dose and course of treatment, and will gradually subside after stopping the drug.
Dry skin and ichthyosis-like changes: They usually appear 2 to 3 months after taking the drug, and are most obvious on the extended sides of the limbs (especially the lower limbs). They gradually subside about 3 months after stopping the drug. Topical emollients can alleviate the symptoms.
Digestive tract reactions: A few patients have adverse reactions such as nausea, vomiting, anorexia, abdominal pain, constipation and diarrhea, which are generally mild and do not affect treatment. Changing clofazimine to be taken with food can alleviate the symptoms. If the abdominal pain is severe, the medication should be discontinued.
Others: drowsiness, dizziness, insomnia, etc.


Contraindications:
Contraindicated for those allergic to this product.
Patients with severe liver and kidney dysfunction and gastrointestinal diseases.


Precautions:
People with a history of gastrointestinal diseases or liver function impairment and those who are intolerant to this product should use with caution.
Should be taken with food or milk.
To prevent the development of drug resistance, this product should be combined with one or more other anti-leprosy drugs.
When treating multiple bacterial leprosy with erythematous nodule leprosy reaction, if there are ominous signs of nerve damage or skin ulcers, this product can be combined with adrenocortical hormones.
The treatment course for multiple bacillary (borderline, borderline-tumor and neoplastic leprosy) leprosy should last for more than 2 years, or even for life.
Careful observation should be made when the daily dose exceeds 100mg, and the course of treatment should be as short as possible.
Interference with diagnosis: It can cause accelerated erythrocyte sedimentation rate, increased blood sugar, albumin, serum aminotransferase and bilirubin, and decreased serum potassium.
During medication, if the patient experiences abdominal cramps, nausea, vomiting, or diarrhea, the dosage should be reduced, the dosage interval should be extended, or the medication should be discontinued.
This product can pass through the placenta and enter breast milk, staining the skin of newborns and nursing infants. Pregnant women should avoid using this product, and lactating women should not use this product.
In case of drug overdose, induce vomiting, gastric lavage, and catharsis, and provide symptomatic and supportive treatment if necessary.


Storage:
Sealed


Mechanism of action:
Clofazimine has multiple anti-MTB action mechanisms. The most likely action mechanism is by interfering with the nucleic acid metabolism of MTB, binding to its DNA, inhibiting DNA-dependent RNA polymerase, preventing RNA synthesis, thereby inhibiting bacterial protein synthesis and exerting its antibacterial effect. Less likely to develop resistance than other anti-tuberculosis drugs (1B).


Safety and efficacy:
Clofazimine is the drug of choice for the treatment of tumorous leprosy. It is also used clinically for patients who are intolerant to sulfone drugs. In addition, this product also has certain effects on chronic discoid lupus erythematosus, skin ulcers, and pyoderma gangrenosum. Clofazimine has positive effects on leprosy, and is also very effective on patients with tumors that are resistant to sulfone drugs. It is manifested in the reduction of skin lesions and the significant decrease in bacterial morphological index. Clofazimine has both preventive and therapeutic effects on leprosy erythema nodosum. The incidence and severity of leprosy erythema nodosum in tumor-type patients treated with this drug are significantly lower than those in patients treated with DDS. For long-term glucocorticoid-dependent erythema nodosum, glucocorticoids can be gradually withdrawn after treatment with clofazimine. In addition, clofazimine is also effective in treating neuritis caused by type I leprosy.