HUAPONT WEIDOU Isotretinoin Soft Capsules For Acne 10mg*24

【Drug Name】
Generic Name: Isotretinoin Soft Capsules
English Name: Isotretinoin Soft Capsules
Pinyin: Yiwei A suanruan jiaonang

【Ingredients】
The main ingredient of this product is isotretinoin.

【Appearance】
This product is a dark brown soft capsule containing an orange-yellow oily suspension.

【Indications】
It is indicated for severe, refractory nodular acne (nodular acne is defined as inflammatory lesions ≥5 mm in diameter, with nodules that may suppurate or bleed).

Due to significant adverse reactions following the use of isotretinoin, it should only be considered when other conventional treatments (including systemic antibiotics) are ineffective. Furthermore, because isotretinoin may cause serious birth defects, it is only suitable for female patients who do not intend to or cannot conceive.

【Specifications】
10 mg

【Dosage and Administration】
This product should be used under the guidance of a physician. It should be taken with food.

The dosage for oral treatment varies from person to person, ranging from 0.1 to 1 mg/kg/day. A starting dose of 0.5 mg/kg/day, divided into two doses taken with food, is generally recommended. The dosage can be adjusted after 2-4 weeks of treatment based on clinical efficacy and adverse reactions. A course of treatment is 6-8 weeks, or as directed by a physician (see [Precautions]). Because not taking the medication with food can significantly reduce drug absorption, patient adherence to taking the medication with food should be carefully inquired before increasing the dosage.

The safety of once-daily administration of isotretinoin has not been established; therefore, once-daily administration is not recommended.

If skin lesions persist or severe nodular acne recurrence occurs more than 2 months after discontinuation of treatment, a second course of treatment may be considered. Because experience shows that symptoms can continue to improve in the short term after discontinuation of treatment, if a second course of treatment is required, the interval between the two courses should be at least 8 weeks. The optimal treatment interval for patients with incomplete bone development is unclear.

Effective contraception should be used during any course of treatment. [Adverse Reactions] The following are adverse reactions observed in clinical trials and post-marketing surveillance of isotretinoin. The relationship between some adverse events and isotretinoin treatment is unclear. Most adverse reactions of isotretinoin are similar to symptoms of vitamin A overdose (primarily dry skin and mucous membranes, such as lips, nasal cavity, 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 discontinuation of the drug, but some persist after discontinuation.

Systemic damage: Allergic reactions (including vasculitis, systemic anaphylaxis), edema, fatigue, lymphadenopathy, weight loss.

Cardiovascular system: Palpitation, tachycardia, thrombosis, stroke.

Endocrine/metabolic system: Hypertriglyceridemia, blood glucose fluctuations.

Digestive system: Inflammatory bowel disease, hepatitis, pancreatitis, gingival bleeding, gingivitis, colitis, esophagitis/esophageal ulcer, ileitis, nausea, and other nonspecific gastrointestinal symptoms.

Hematologic system: Anemia, thrombocytopenia, neutropenia; rare reports of agranulocytosis.

Musculoskeletal system: Osteophyte formation, tendon and ligament calcification, premature epiphyseal closure, decreased bone density, musculoskeletal symptoms (some severe) including back pain, myalgia, arthralgia, transient chest pain, arthritis, tendinitis and other bone abnormalities; elevated creatine phosphokinase/rare reports of rhabdomyolysis, etc.

Nervous system: Benign intracranial hypertension (also known as pseudotumor cerebri), dizziness, drowsiness, headache, insomnia, excessive salivation, malaise, nervousness, sensory abnormalities, seizures, stroke, syncope, weakness.

Psychiatric system: Suicidal ideation, suicidal tendency, suicide, depression, mental confusion, aggressive behavior, violent behavior. In reports related to depression, some patients experienced relief of depressive symptoms after discontinuing the medication, but relapsed upon re-administration.

Reproductive system: Menstrual disorders. Respiratory system: bronchospasm (with or without a history of asthma), respiratory infection, voice changes.

Skin and skin appendages: acne flare-ups, hair loss (persistent in some patients after discontinuation), ecchymosis, cheilitis, dry mouth, dry nose, dry skin, epistaxis, erythema multiforme, facial flushing, increased skin fragility, hirsutism, hyperpigmentation and hypopigmentation, infections (including diffuse herpes simplex), nail dystrophy, paronychia, palmar-plantar peeling, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, pruritus, pyogenic granuloma, rashes (including facial erythema, seborrheic dermatitis, and eczema), urticaria, vasculitis (including Wegener's granulomatosis), delayed wound healing.

Other sensory: hearing, hearing impairment, tinnitus. Vision: corneal opacity, potentially persistent night vision loss after discontinuation, cataracts, color blindness, conjunctivitis. Dry eyes, blepharitis, keratitis, optic neuritis, photophobia, visual impairment.

Urinary tract infections: glomerulonephritis, nonspecific findings during urological examination.

Laboratory tests: Elevated serum triglycerides, decreased high-density lipoprotein (HDL), and elevated serum cholesterol during treatment. Elevated alkaline phosphatase, ALT, AST, GGTP, or LDH.

Elevated fasting blood glucose, elevated CPK, and elevated serum uric acid.

Decreased red blood cell count, decreased white blood cell count (including severe neutropenia and rare agranulocytosis), accelerated erythrocyte sedimentation rate, elevated platelet count, and thrombocytopenia. White blood cells, proteinuria, microscopic or gross hematuria in the urine.

【Contraindications】
This product is contraindicated in patients with known hypersensitivity to any component. This product is contraindicated in pregnant women or women who are about to become pregnant. Women of childbearing age or their partners should use effective contraception for 3 months before starting isotretinoin treatment, during treatment, and for 3 months after discontinuation.

Contraindicated in breastfeeding women, patients with hepatic or renal insufficiency, and patients with vitamin A overdose.

【Precautions】
1. Use with caution in patients with diabetes, obesity, increased alcohol intake, and those with abnormal or familial lipid metabolism disorders.

2. Clinical studies of the original isotretinoin product abroad show that most patients with severe refractory nodular acne can achieve complete clearance or symptom relief after 15-20 weeks of treatment with this drug. Therefore, the recommended treatment course is 15-20 weeks. It is stated that if the total number of acne nodules has decreased by more than 70% before the end of the 15-20 week treatment course, the drug can be discontinued. Due to individual differences among patients, the following information can be used as a reference for individualized clinical treatment.

3. Long-term use of isotretinoin (even at low doses) has not been studied, and long-term use is not recommended. The effect of long-term isotretinoin use on bone loss is unclear (see 【Adverse Reactions】).

4. Women of childbearing age should perform a pregnancy test before, during, and after taking the drug. - Women of childbearing age must undergo two confirmatory urine or serum pregnancy tests (minimum sensitive concentration 25 mIU/mL) before prescribing this product. The first test (screening test) should be performed by the prescribing person to determine if the patient is eligible for this product. The second test (confirmatory test) must be performed in a quality-controlled laboratory, with an interval of at least 19 days between the two tests.

- Patients with regular menstrual cycles must use two effective contraceptive methods for one month before starting this product and undergo a second pregnancy test within the first 5 days of their menstrual period.

- Patients with amenorrhea, irregular menstruation, or whose menstruation can be stopped by contraception must use two effective contraceptive methods for one month before starting this product and undergo a second pregnancy test.

- A urine or serum pregnancy test must be performed monthly during treatment to rule out pregnancy. Female patients should undergo a pregnancy test in a quality-controlled laboratory before each prescription.

5. Blood glucose, blood lipids, liver function, and creatine phosphokinase should be checked regularly (weekly or every 2 weeks) during medication.

6. If depression, agitation, mental abnormalities, or aggressive behavior occur, the patient should immediately discontinue the medication, and the patient or their family should contact the prescribing physician promptly.

7. This medication should not be taken concurrently with tetracycline antibiotics. If the patient experiences symptoms of pseudotumor cerebri (benign intracranial hypertension), such as papilledema, headache, nausea, vomiting, and blurred vision, the medication should be discontinued immediately, and an optic nerve examination should be performed. If necessary, the patient should be referred to a neurologist for further diagnosis and treatment.

8. Patients who may have osteoporosis (such as the elderly or those with a history of osteoporosis, osteomalacia, or other bone metabolic abnormalities) should use this medication with caution. Caution should also be exercised in patients with anorexia nervosa and those using other medications that can cause drug-induced osteoporosis, osteomalacia, and/or affect vitamin D metabolism.

9. Mild adverse reactions do not require discontinuation of the medication, or the dosage may be reduced. However, if the following severe adverse reactions occur, the medication should be discontinued immediately, and the patient should seek medical attention: uncontrolled hypertriglyceridemia, pancreatitis, severe skin adverse reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis), tinnitus, hearing impairment, persistently elevated liver enzymes, failure to decrease liver enzymes or suspected hepatitis, abdominal pain, rectal bleeding or severe diarrhea, visual impairment, severe allergic reactions, etc.

10. This product should not be used concurrently with vitamin A supplements.

11. Avoid prolonged exposure to sunlight and ultraviolet radiation.

12. Blood donation is prohibited during medication and for three months after discontinuation.

13. Acne symptoms may temporarily worsen during the initial treatment phase. If no other abnormalities are observed, medication can be continued under close observation. It is not advisable to take other keratolytic agents or exfoliating anti-acne medications concurrently.

14. Mild topical medications can be used as adjunctive therapy when necessary.

15. This product should be prescribed by a licensed physician with extensive clinical experience.

【Use in Pregnant and Lactating Women]
Women of childbearing age or their partners should strictly avoid pregnancy for three months before, during, and after taking this medication. It is unknown whether isotretinoin is excreted in breast milk; given the potential adverse reactions, isotretinoin preparations are strictly prohibited for breastfeeding women.

【Use in Children】
No studies have been conducted on the use of isotretinoin in children under 12 years of age. Overdose can cause changes in bone structure, including premature fusion of the epiphyseal plate in children. Caution should be exercised when using isotretinoin in children aged 12-17 years with severe, refractory nodular acne, especially if they have known metabolic or skeletal disorders.

In clinical studies of isotretinoin, the incidence of back pain, joint pain, and myalgia was higher in children than in adults; other adverse reactions were comparable to those in adults.

【Use in the Elderly】
Clinical studies have not yet included a sufficient number of subjects aged 65 and older to determine whether their drug response is consistent with that of younger subjects. Although no differences in drug use between elderly patients and other populations have been observed in clinical use, considering the influence of age, an increased risk is expected in elderly patients when using isotretinoin.

【Drug Interactions】
1. Concomitant use of isotretinoin with tetracycline antibiotics may lead to the formation of pseudotumors, 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 produced by vitamin A overdose.

3. Concomitant use of isotretinoin with carbamazepine may lead to a decrease in carbamazepine blood concentrations; 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 concentrations.

1. Tetracycline: Concomitant use of isotretinoin with tetracycline antibiotics can lead to the formation of "pseudotumor cerebri," causing benign intracranial hypertension, clinically manifested as hypertension accompanied by headache, dizziness, and visual disturbances.

2. Vitamin A: Concomitant use of isotretinoin with vitamin A may increase the toxicity of isotretinoin and may produce symptoms similar to those of vitamin A overdose.

3. Carbamazepine: 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.

4. Low-dose progesterone preparations (low-dose oral contraceptives without estrogen): Low-dose progesterone preparations are not a suitable method of contraception during isotretinoin treatment, although other hormonal contraceptives are more effective. There are still reports of pregnancy resulting from the use of topical, intramuscular, implantable, or insertive hormonal contraceptives. Patients using a single contraceptive method have a higher pregnancy rate. Whether concomitant use of isotretinoin affects the contraceptive efficacy of hormones is unclear. Therefore, it is strongly recommended that women of reproductive age using isotretinoin use two or more effective contraceptive methods simultaneously, with at least one being the primary recommended method.

5. Norethindrone/Diethylestradiol: In a study of 31 premenopausal women with severe, refractory nodular acne who received 1 mg/kg/day of isotretinoin concurrently with oral OrthoNovum tablets for contraception, no clinically significant changes were observed in the pharmacokinetics of diethylestradiol and norethindrone, or in plasma progesterone, follicle-stimulating hormone, and luteinizing hormone levels.

6. St. John's wort: Isotretinoin use has been associated with depression in some cases. Patients should be advised against using St. John's wort for treatment without medical advice, as studies have shown an interaction between St. John's wort and hormonal contraceptives, and there have been reports of pregnancy despite taking contraceptives while using St. John's wort.

7. Phenytoin: A study of seven healthy subjects showed that isotretinoin did not alter the pharmacokinetics of phenytoin, consistent with in vitro results. In vitro studies found that neither isotretinoin nor its metabolites induced or inhibited the activity of the human liver P450 enzyme CYP2C9. Phenytoin is known to cause osteomalacia, but there are no formal clinical trials evaluating the interaction between isotretinoin and phenytoin in terms of bone loss; therefore, caution should be exercised when using them together.

8. Systemic corticosteroids: Systemic corticosteroids are known to cause osteoporosis. However, there are no formal clinical trials investigating the interaction between isotretinoin and systemic corticosteroids in terms of bone loss; therefore, caution should be exercised when using them together. [Overdosage] Overdose may cause vomiting, facial flushing, chapped lips, abdominal pain, headache, dizziness, and ataxia. These symptoms usually disappear quickly without significant long-term effects.

【Pharmacology and Toxicology】
See package insert for details.

【Pharmacokinetics】
See package insert for details.

【Storage】
Sealed, store in a cool (not exceeding 20°C) and dry place.

【Packaging】
Pharmaceutical-grade PVC aluminum-plastic packaging, 12 tablets/blister × 2 blisters/box.

【Shelf Life】
24 months

【Approval Number】
National Drug Approval Number H20113060

【Manufacturer】
Chongqing Huabang Pharmaceutical Co., Ltd.