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Isotretinoin soft capsule (thals)

It is applicable to severe refractory nodular acne (nodular acne, i.e. inflammatory damage with diameter ≥ 5mm, and the nodule may be suppurative or bleeding). Because there are obvious adverse reactions after using isotretinoin, it should be tested only when other conventional treatments (including systemic antibiotic treatment) are ineffective. In addition, because isotretinoin may cause serious birth defects, it is only suitable for those who are not prepared or unable to conceive in female patients. More role
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Common name:
Isotretinoin soft capsule
Product No.:
B14201012022
Approval No.:
Gyzz h10930210 (inquired by the State Drug Administration)
Jianke price:
¥49.80
Product specification:
10mg * 10s * 2 plate 10mg * 10s * 1 plate
Manufacturer:
Shanghai Xinyi Yan'an pharmaceutical Co., Ltd
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Product name Isotretinoin soft capsule (thals)
Main raw materials The main component of this product is isotretinoin, also known as 13 CIS tretinoin.
Main role It is applicable to severe refractory nodular acne (nodular acne, i.e. inflammatory damage with diameter ≥ 5mm, and the nodule may be suppurative or bleeding). Because there are obvious adverse reactions after using isotretinoin, it should be tested only when other conventional treatments (including systemic antibiotic treatment) are ineffective. In addition, because isotretinoin may cause serious birth defects, it is only suitable for those who are not prepared or unable to conceive in female patients.
Product specification 10mg * 10s * 2 plate
Usage and dosage This product should be used under the guidance of a doctor. Should be taken with food. The dose of oral treatment should vary from person to person, ranging from 0.1 ~ 1mg / kg / D. It is generally recommended that the initial dose is 0.5mg/kg/d, which should be taken together with food in two times. After 2-4 weeks of treatment, the whole dose can be adjusted according to the clinical effect and adverse reactions. 6-8 weeks is a course of treatment or as directed by the doctor (see [precautions]). Because not taking with food can significantly reduce drug absorption, the patient's compliance with taking with food should be consulted in detail before increasing the dose. The safety of once daily administration of isotretinoin has not been determined, so once daily administration is not recommended. If the skin lesions persist or severe nodular acne recur more than 2 months after drug withdrawal, the second course of treatment can be considered. Experience shows that symptoms can be continuously improved in a short time after drug withdrawal, so if a second course of treatment is required, the interval between the two courses should be more than 8 weeks. The optimal treatment interval for patients with incomplete bone development is unclear. Effective contraceptive measures should be taken in any course of treatment.
manufacturing enterprise Shanghai Xinyi Yan'an pharmaceutical Co., Ltd
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[drug name] Isotretinoin soft capsule (thals)

[common name] Isotretinoin soft capsule

[specification and model] 10mg * 10s * 2 plate

[manufacturer] Shanghai Xinyi Yan'an pharmaceutical Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz h10930210

[validity period] 24 months

[functional indications] It is applicable to severe refractory nodular acne (nodular acne, i.e. inflammatory damage with diameter ≥ 5mm, and the nodule may be suppurative or bleeding). Because there are obvious adverse reactions after using isotretinoin, it should be tested only when other conventional treatments (including systemic antibiotic treatment) are ineffective. In addition, because isotretinoin may cause serious birth defects, it is only suitable for those who are not prepared or unable to conceive in female patients.

[usage and dosage] This product should be used under the guidance of a doctor. Should be taken with food. The dose of oral treatment should vary from person to person, ranging from 0.1 ~ 1mg / kg / D. It is generally recommended that the initial dose is 0.5mg/kg/d, which should be taken together with food in two times. After 2-4 weeks of treatment, the whole dose can be adjusted according to the clinical effect and adverse reactions. 6-8 weeks is a course of treatment or as directed by the doctor (see [precautions]). Because not taking with food can significantly reduce drug absorption, the patient's compliance with taking with food should be consulted in detail before increasing the dose. The safety of once daily administration of isotretinoin has not been determined, so once daily administration is not recommended. If the skin lesions persist or severe nodular acne recur more than 2 months after drug withdrawal, the second course of treatment can be considered. Experience shows that symptoms can be continuously improved in a short time after drug withdrawal, so if a second course of treatment is required, the interval between the two courses should be more than 8 weeks. The optimal treatment interval for patients with incomplete bone development is unclear. Effective contraceptive measures should be taken in any course of treatment.

[adverse reactions] Listed below are the clinical trials of isotretinoin and the adverse reactions monitored after listing. The relationship between some adverse events and isotretinoin treatment is not clear. Most of the adverse reactions of isotretinoin are similar to the symptoms of excessive vitamin A (mainly dry skin and mucosa, such as lips, nose and eyes). Dose related adverse reactions: cheilitis and hypertriglyceridemia are often dose related. Most adverse reactions reported in clinical trials are reversible and gradually recover after drug withdrawal, but some will continue after drug withdrawal. Systemic damage; Allergic reaction (including vasculitis, systemic allergic reaction), edema, fatigue, lymphadenopathy, weight loss! Cardiovascular system: palpitation, tachycardia, thrombosis, stroke. Endocrine / metabolic system: hypertriglyceridemia, blood glucose fluctuation. Digestive system: inflammatory bowel disease, hepatitis, pancreatitis, gingival bleeding, gingivitis, colitis, esophagitis / esophageal ulcer, ileitis, nausea and other nonspecific gastrointestinal symptoms. See the inner packaging instructions for details.

[precautions] 1. patients with diabetes, obesity, increased alcohol intake, abnormal lipid metabolism or familial lipid metabolism are used cautiously. 2. The clinical research of foreign isotretinoin a fusion products shows that most patients with severe refractory nodular acne After 15-20 weeks of treatment with this drug, the symptoms can be completely eliminated or relieved, so the recommended course of treatment is 15-20 weeks. It shows that before the end of 15-20 weeks of treatment, if the total count of acne nodules has been reduced by more than 70%, the drug can be stopped. Due to individual differences among patients, the following relevant information can be used as a reference for clinical individualized treatment. 3. Long term use of isotretinoin (even in small doses) has not been studied, and long-term use is not recommended. The effect of long-term use of isotretinoin on bone loss is unclear (see [adverse reactions] for details). 4. Women of childbearing age should take pregnancy tests before, during and after withdrawal. -Women of childbearing age. Before prescribing this product, it must be confirmed twice that the urine or serum pregnancy test is negative (minimum sensitive concentration 25miu / ml), the first test (screening test) shall be determined by the prescribing person before determining whether it is matched When qualified patients use this product, the second test (confirmatory test) must be carried out in a laboratory with qualified quality control, and the interval between the two tests shall not be less than 19 days. -Patients with regular menstruation should take two effective contraceptive measures for one month before taking this product A second pregnancy test was performed within the first 5 days of the menstrual period. -Patients with amenorrhea, irregular menstruation or who can stop menstruation by using contraceptive methods must take it before they begin to take it Two kinds of effective contraceptives were used for 1 month before this product, and the second pregnancy test was carried out. -Urine or serological pregnancy tests must be performed every month during treatment to exclude pregnancy. Female patients Pregnancy test shall be conducted in a qualified laboratory before each prescription. 5. Blood glucose, blood lipid, liver function and creatine phosphate stimulation should be carried out regularly (weekly or every 2 weeks) during medication Enzyme test. 6. In case of depression, agitation, mental disorder or aggressive behavior, the patient should stop taking the medicine immediately and get sick The applicant or his family members shall contact the prescription physician in time. 7. This drug should not be taken at the same time with tetracyclines, such as pseudobrain tumor (benign intracranial pressure) For symptoms such as optic nerve papilledema, headache, nausea, vomiting and blurred vision, the drug should be stopped immediately, the optic nerve examination should be carried out, and the neurologist should be handed over for further diagnosis and treatment if necessary. 8. Patients who may suffer from osteoporosis (such as the elderly or previous osteoporosis, osteomalacia and other bone substitutes) (abnormal patients) should be used with caution. Attention should also be paid to patients with anorexia nervosa and combined use of other drugs that can lead to drug-induced osteoporosis, osteomalacia and / or affect vitamin D metabolism. 9. For mild adverse reactions, it is not necessary to stop the drug or reduce the use; In case of the following serious adverse reactions, it shall be immediately Stop the drug immediately and go to the hospital for corresponding treatment by the doctor, including: triglyceridemia can not be controlled to an acceptable level, pancreatitis, serious skin adverse reactions (such as Stevens Johnson syndrome, toxic epidermal necrolysis), tinnitus, hearing impairment, continuous increase of liver enzymes, no decline or suspected hepatitis, abdominal pain, rectal bleeding or severe diarrhea Visual difficulties, severe allergic reactions, etc. 10. This product should not be used together with vitamin supplement containing vitamin A. 11. Avoid prolonged exposure to sunlight and ultraviolet rays. 12. Blood donation is not allowed during the medication period and within three months after withdrawal. 13. Acne symptoms may be temporarily aggravated at the initial stage of treatment. If there are no other abnormalities, they can be treated in strict Continue to use the drug under close observation, and should not take other keratinocytes or exfoliative anti acne drugs at the same time. 14. Mild topical drugs can be used as adjuvant treatment when necessary. 15. This product should be prescribed by a doctor with licensed doctor qualification and rich clinical experience. Please read the instructions carefully and follow the doctor's advice.

[taboo] It is forbidden for those who are allergic to any component of this product. This product is prohibited for pregnant women or women about to be pregnant. Women of childbearing age or their spouses should take effective contraceptive measures 3 months before starting isotretinoin treatment, during treatment and 3 months after withdrawal.

[listing Permit Holder] Shanghai Xinyi Yan'an pharmaceutical Co., Ltd

[packaging unit] box

[main ingredients] The main component of this product is isotretinoin, also known as 13 CIS tretinoin.

[character] This product is a dark brown soft capsule with orange yellow oily suspension.

[applicable population] unlimited

[medication for pregnant and lactating women] Women of childbearing age or their spouses should strictly prevent pregnancy within three months before and after taking the medicine and during the period of taking the medicine. It is unknown whether isotretinoin is secreted through milk. In view of the potential adverse reactions of the drug, it is strictly prohibited for lactating women to use isotretinoin preparations.

[medication for children] The use of isotretinoin in children under 12 years of age has not been studied. Drug overdose can lead to changes in bone structure, including premature fusion of epiphyseal disc in children. In 12-17-year-old children with severe refractory nodular acne, especially when they are known to be complicated with metabolic or skeletal diseases, isotretinoin treatment should be cautious. In the clinical study of isotretinoin, except that the incidence of back pain, Guanshi pain and myalgia in children was higher than that in adults, other adverse reactions were similar to those in adults.

[medication for elderly patients] A sufficient number of subjects over 65 years old have not been included in the clinical study to determine whether their drug response is consistent with that of younger subjects. Although there is no difference between elderly patients and other populations in clinical use, considering the influence of age factors, it is expected that the risk of elderly patients treated with isotretinoin will increase.

[storage] Sealed and stored in a cool and dry place

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    Isotretinoin soft capsule (thals)

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