Những điều bạn cần lưu ý khi dùng thuốc cho những trường hợp đặc biệt (mang thai, cho con bú, phẫu thuật…)
Vì Acnotin có thể được hấp thu qua da và phổi và gây hại cho thai nhi, phụ nữ có thai hoặc đang mang thai không nên dùng thuốc này.
Accutane (Acnotin) must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Accutane (Acnotin) must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive Accutane (Acnotin) only from wholesalers registered with iPLEDGE.
iPLEDGE program requirements for wholesalers, prescribers, and pharmacists are described below:
Following oral administration of Acnotin, at least three metabolites have been identified in human plasma: 4-oxo-Acnotin, retinoic acid (tretinoin), and 4-oxo-retinoic acid (4-oxotretinoin). Retinoic acid and 13-cis-retinoic acid are geometric isomers and show reversible interconversion. The administration of one isomer will give rise to the other. Acnotin is also irreversibly oxidized to 4-oxo-Acnotin, which forms its geometric isomer 4-oxo-tretinoin.
After a single 80 mg oral dose of Accutane (Acnotin) to 74 healthy adult subjects, concurrent administration of food increased the extent of formation of all metabolites in plasma when compared to the extent of formation under fasted conditions.
All of these metabolites possess retinoid activity that is in some in vitro models more than that of the parent Acnotin. However, the clinical significance of these models is unknown. After multiple oral dose administration of Acnotin to adult cystic acne patients ( ≥ 18 years), the exposure of patients to 4-oxo-Acnotin at steady-state under fasted and fed conditions was approximately 3.4 times higher than that of Acnotin.
In vitro studies indicate that the primary P450 isoforms involved in Acnotin metabolism are 2C8, 2C9, 3A4, and 2B6. Acnotin and its metabolites are further metabolized into conjugates, which are then excreted in urine and feces.
Thuốc Acnotin có thể tương tác với thuốc nào?
Thuốc này có thể làm thay đổi khả năng hoạt động của thuốc khác mà bạn đang dùng hoặc gia tăng ảnh hưởng của các tác dụng phụ. Để tránh tình trạng tương tác thuốc, tốt nhất là bạn viết một danh sách những thuốc bạn đang dùng (bao gồm thuốc được kê toa, không kê toa, thảo dược và thực phẩm chức năng) và cho bác sĩ hoặc dược sĩ xem. Để đảm bảo an toàn khi dùng thuốc, bạn không tự ý dùng thuốc, ngưng hoặc thay đổi liều lượng của thuốc mà không có sự cho phép của bác sĩ.
Những thuốc tương tác với thuốc Acnotin gồm:
- Chlortetracycline, demeclocycline, desogestrel, dienogest, doxycycline, drospirenone, estradiol cypionate, estradiol valerate, ethinyl estradiol, ethynodiol diacetate, etonogestrel, levonorgestrel, lymecycline, meclocycline, medroxyprogesterone acetate, mestranol, methacycline, minocycline, norelgestromin, norethindrone, norgestrel, oxytetracycline, rolitetracycline, tetracycline, norgestimate.
- Vitamin A: Because of the relationship of Accutane (Acnotin) to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avo >REFERENCES
7. Dicken CH, Connolly SM. Eruptive xanthomas associated with Acnotin (13-cis-retinoic acid). Arch Dermatol 116:951-952, 1980.
Impaired hearing has been reported in patients taking Accutane (Acnotin) ; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued. Mechanism(s) and causality for this event have not been established. Patients who experience tinnitus or hearing impairment should discontinue Accutane (Acnotin) treatment and be referred for specialized care for further evaluation (see ADVERSE REACTIONS: Special Senses).
Serious side effects
Serious side effects are rare and happen in less than 1 in 1,000 people.
Stop taking Acnotin capsules and call a doctor straight away if you get:
- anxiety, aggression and violence, changes in mood, or suicidal thoughts - these can be signs of depression or other mental health problems
- severe pain in your stomach with or without diarrhoea, feeling or being sick (nausea or vomiting) - these can be signs of a serious problem called pancreatitis
- bloody diarrhoea – this may be a sign of gastrointestinal bleeding
- a serious skin rash that peels or has blisters - the skin rash may come with eye infections, ulcers, a fever, and headaches
- difficulty moving your arms or legs, and painful, swollen or bruised areas of the body, or dark pee - these can be signs of muscle weakness
- yellow skin or the whites of your eyes turn yellow, difficulty peeing, or feeling very tired - these are signs of liver or kidney problems
- a bad headache that doesn't go away and makes you feel sick or be sick
- sudden changes in eyesight, including not seeing as well at night
It's very rare, but Acnotin capsules can sometimes cause depression or make it worse, and even make people feel suicidal.
Can Acnotin be used again if acne recurs?
At least fifty per cent of patients with acne have a long-lasting response after a single adequate course of Acnotin. In others, acne may recur a few months to a few years after the medication has been discontinued. Relapse is more common in females than in males, and in patients > 25 years of age. These patients may receive further courses of Acnotin.
Long-term treatment (> 1 year) is often used for patients with: