3. Who can and can't take Tretinac capsules
Tretinac capsules are for teenagers and adults with severe acne. Do not give Tretinac capsules to children under the age of 12 years or before puberty.
Tretinac capsules aren't suitable for some people.
Do not take Tretinac capsules if you:
- have had an allergic reaction to Tretinac, soya (the capsules contain soya) or any other medicines in the past
- have an inherited digestive disorder called fructose intolerance (the capsules contain sorbitol)
To make sure Tretinac capsules are safe for you, tell your doctor if you:
- have had a mental health illness like depression
- are pregnant or think you could be, or you're breastfeeding
- have ever had an allergic reaction to Tretinac or any other medicine
- have liver or kidney disease
- have high levels of cholesterol or other fats in your blood
- have high levels of vitamin A
- have Crohn's disease or ulcerative colitis
If you have diabetes, talk to your doctor before beginning treatment with Tretinac capsules. You may need extra monitoring while you take Tretinac capsules as this medicine can cause a rise in blood sugar levels.
Like all medicines, Tretinac capsules can cause side effects, although not everyone gets them. Side effects will usually go away when you stop treatment.
Dry skin and lips are very common side effects. For safety, do not have any waxing, dermabrasion, or laser skin treatment while you're taking this medicine and for at least 6 months after you stop, as this could cause scarring or skin irritation.
Carcinogenesis, Mutagenesis and Impairment of Fertility
In male and female Fischer 344 rats given oral Tretinac at dosages of 8 or 32 mg/kg/day (1.3 to 5.3 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area) for greater than 18 months, there was a dose-related increased incidence of pheochromocytoma relative to controls. The incidence of adrenal medullary hyperplasia was also increased at the higher dosage in both sexes. The relatively high level of spontaneous pheochromocytomas occurring in the male Fischer 344 rat makes it an equivocal model for study of this tumor; therefore, the relevance of this tumor to the human population is uncertain.
The Ames test was conducted with Tretinac in two laboratories. The results of the tests in one laboratory were negative while in the second laboratory a weakly positive response (less than 1.6 x background) was noted in S. typhimurium TA100 when the assay was conducted with metabolic activation. No dose-response effect was seen and all other strains were negative. Additionally, other tests designed to assess genotoxicity (Chinese hamster cell assay, mouse micronucleus test, S. cerevisiae D7 assay, in vitro clastogenesis assay with human-derived lymphocytes, and unscheduled DNA synthesis assay) were all negative.
In rats, no adverse effects on gonadal function, fertility, conception rate, gestation or parturition were observed at oral dosages of Tretinac of 2, 8, or 32 mg/kg/day (0.3, 1.3, or 5.3 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area).
In dogs, testicular atrophy was noted after treatment with oral Tretinac for approximately 30 weeks at dosages of 20 or 60 mg/kg/day (10 or 30 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area). In general, there was microscopic evidence for appreciable depression of spermatogenesis but some sperm were observed in all testes examined and in no instance were completely atrophic tubules seen. In studies of 66 men, 30 of whom were patients with nodular acne under treatment with oral Tretinac, no significant changes were noted in the count or motility of spermatozoa in the ejaculate. In a study of 50 men (ages 17 to 32 years) receiving Accutane (Tretinac) therapy for nodular acne, no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.
Liều dùng thuốc Tretinac cho trẻ em như thế nào?
Liều thông thường dành cho trẻ em
Tình trạng mụn trứng cá nặng ở trẻ 12 tuổi trở lên: bạn cho trẻ dùng 0,5 đến 1mg/kg/ngày, chia làm 2 lần.
Liều thông thường ở trẻ em mắc bệnh bạch cầu cấp tính không ứ huyết
Trẻ từ 1 tháng tuổi trở lên: bạn cho trẻ dùng 100mg/m 2 da/ngày, trong 4 tuần.
Bạn nên tham khảo ý kiến bác sĩ trước khi dùng thuốc cho trẻ.
What is the dosage for Tretinac?
- The recommended dose of Tretinac is 0.5 to 2 mg per kg of body weight daily.
- The daily dose usually is administered in two divided doses for 15-20 weeks.
- Tretinac should be taken with food in order to improve its absorption.
Effects of multiple courses of Accutane (Tretinac) on the developing musculoskeletal system are unknown. There is some ev > -4% and total hip change > -5%) or were increased in the majority of patients. One patient had a decrease in lumbar spine bone mineral density > 4% based on unadjusted data. Sixteen (7.9%) patients had decreases in lumbar spine bone mineral density > 4%, and all the other patients (92%) did not have significant decreases or had increases (adjusted for body mass index). Nine patients (4.5%) had a decrease in total hip bone mineral density > 5% based on unadjusted data. Twenty-one (10.6%) patients had decreases in total hip bone mineral density > 5%, and all the other patients (89%) did not have significant decreases or had increases (adjusted for body mass index). Follow-up studies performed in 8 of the patients with decreased bone mineral density for up to 11 months thereafter demonstrated increasing bone density in 5 patients at the lumbar spine, while the other 3 patients had lumbar spine bone density measurements below baseline values. Total hip bone mineral densities remained below baseline (range –1.6% to –7.6%) in 5 of 8 patients (62.5%).
In a separate open-label extension study of 10 patients, ages 13-18 years, who started a second course of Accutane (Tretinac) 4 months after the first course, two patients showed a decrease in mean lumbar spine bone mineral density up to 3.25% (see PRECAUTIONS: Pediatric Use).
Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been seen in the Accutane (Tretinac) population. While causality to Accutane (Tretinac) has not been established, an effect cannot be ruled out. Longer term effects have not been studied. It is important that Accutane (Tretinac) be given at the recommended doses for no longer than the recommended duration.
Contraception in females considering Tretinac
Tretinac must not be taken in pregnancy because of a very high risk of serious congenital abnormalities in the baby. Caution needs to be used during breast-feeding as it enters the breast milk and might affect the baby.
All females who could biologically have a child should take the following precautions during treatment with Tretinac and for four weeks after the medication has been discontinued:
- Abstinence. The most reliable method of avo >sex . No method of contraception is completely reliable. "Natural" family planning is particularly risky.
- If sexually active, two reliable methods of contraception should be used. Discuss contraception with your doctor (general practitioner, family planning specialist, gynaecologist or dermatologist). The combined oral contraceptive, IUD ( intrauterine device), a progesterone implant, or medroxyprogesterone injection may be suitable.
- The low-dose progesterone mini-pill on its own is not recommended.
A prescription for emergency contraception may be available from a medical practitioner (GP or family planning clinic) or accredited pharmacy. It prevents 85% of pregnancies if taken within 72 hours of unprotected sexual intercourse.
If contraception fails, termination of pregnancy (an abortion) may be advised if pregnancy arises during treatment with Tretinac or within a month of discontinuing it.
There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses of Accutane (Tretinac) . The effect of multiple courses of Accutane (Tretinac) on epiphyseal closure is unknown.
Missed Dose of Tretinac
If you miss a dose of Tretinac, try to take it as soon as you remember.
If it's almost time for the next dose, just skip the missed dose and take your next dose as you normally would.
Don't take two doses of Tretinac at the same time.
What brand names are available for Tretinac?
Claravis, Amnesteem, Absorica, Myorisan, Zenatane, Sotret
DOSAGE AND ADMINISTRATION
Accutane (Tretinac) should be administered with a meal (see PATIENT INFORMATION).
The recommended dosage range for Accutane (Tretinac) is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1.0 mg/kg/day, 8 it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2.0 mg/kg/day, as tolerated. Failure to take Accutane (Tretinac) with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.
The safety of once daily dosing with Accutane (Tretinac) has not been established. Once daily dosing is not recommended.
If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Accutane (Tretinac) , even in low doses, has not been studied, and is not recommended. It is important that Accutane (Tretinac) be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Accutane on bone loss is unknown (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure).
Contraceptive measures must be followed for any subsequent course of therapy (see PRECAUTIONS).
Table 4 : Accutane (Tretinac) Dosing by Body Weight (Based on Administration With Food)
INFORMATION FOR PHARMACISTS
Access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866495-0654) to obtain an authorization and the “do not dispense to patient after” date. Accutane (Tretinac) must only be dispensed in no more than a 30-day supply.
REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM.
An Accutane (Tretinac) Medication Guide must be given to the patient each time Accutane (Tretinac) is dispensed, as required by law. This Accutane (Tretinac) Medication Guide is an important part of the risk management program for the patient.
Oral Tretinac is clearly more effective than oral antibiotics in acne of all grades of severity. However, its relative expense and side effects have deterred some physicians from prescribing it. Cost-effectiveness comparisons prior to the EU directive and iPLEDGE in the UK, 61 , 62 France, 63 New Zealand 64 and Australia 65 have shown that a 4–6-month course of Tretinac is significantly cheaper than a 3-year therapeutic regimen of rotational courses of antibiotics and topical treatment. In fact, only patients treated with Tretinac achieved complete clearance of acne when assessed 3–5 years post-treatment. Generic Tretinac has made the cost effectiveness more apparent. However, the extra investigations, monitoring and prescription control introduced with the European Directive and iPLEDGE have negatively impacted on this cost effectiveness.
Is Tretinac safe to take if I'm pregnant or breastfeeding?
- Tretinac is harmful to the fetus and therefore should not be used during pregnancy. Women of childbearing age must have two negative pregnancy test results before therapy is started, and a pregnancy test must be conducted during each month of therapy. Two effective forms of birth control must be used during therapy, and pregnancy should be avoided one month before, during, and at least one month after stopping Tretinac.
- It is not known whether Tretinac is secreted in breast milk, but because of its potentially serious side effects, it should not be used by nursing mothers.
S >Tretinac has many side effects but most are predictable and rarely interfere with the patient management. The common mucocutaneous side effects are dose dependent and rendered tolerable by modification of the dose and/or additional symptomatic therapy.
Teratogenicity is well recognized and regarded as one of the most serious potential adverse effects. 52 Fifty percent of pregnancies spontaneously abort, and of the remainder about half of the infants are born with cardiovascular or skeletal deformities. The European Directive and iPLEGDE in the USA have addressed the importance of pregnancy prevention as discussed previously. Discussion about the teratogenicity and recognized side effects should be recorded in the notes at each visit, and patients should be given appropriate written information.
Mood changes including depression are common among adolescents and have been reported in acne patients treated with Tretinac. Two studies that looked at spontaneous reports of side effects for the FDA in the USA 53 , 54 found little or no increase in psychiatric disease including depression and suicide over the background prevalence in the adolescent population. A further study of general practice databases in Canada and the UK showed similar findings as have subsequent studies. 55 A more recent controlled case cross-over study demonstrated a relative risk for depression of 2.68 (95% CI = 1.03 to 3.89) for acne patients exposed to oral Tretinac. 56 This is the first controlled study to find a statistically significant association between Tretinac and depression. Despite contradictory reports clinicians have been advised of a potential rare idiosyncratic reaction in some young vulnerable patients which could lead to mood changes and clinical depression during treatment with Tretinac. It is therefore advisable to specifically enquire about related symptoms at each clinic visit.
If significant depression is identified, then a psychiatric referral may be indicated. Increased aggression has been identified in some male patients and the FDA in the USA has advised clinicians to warn potential patients about this side effect. If there is any doubt, the drug must be stopped.
The mucocutaneous side effects are dose dependent and can usually be controlled with regular use of moisturizers and lip salves. Occasionally retinoid dermatitis, a severe retinoid cheilitis or conjunctivitis occur, often complicated by secondary infection with S. aureus. These patients may need treatment with an intermediate-strength steroid ointment combined with an antiseptic. If there is impetiginization, oral anti-staphylococcal therapy such as flucloxacillin and/or topical mupirocin 2% ointment may be required. 57 A nasal preparation of mupirocin can be used to eradicate nasal carriage of staphylococci. Table 4 summarizes the most common mucocutaneous problems that may arise from Tretinac use.