United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin 10 mg - severe recalcitrant nodular acne isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. nodules are inflammatory lesions with a diameter of 5 mm or greater. the nodules may become suppurative or hemorrhagic. “severe,” by definition,2 means “many” as opposed to “few or several” nodules. because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics . in addition, isotretinoin capsulesare indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see boxed contraindications and warnings ). a single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 if a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. the optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see warnings, skeletal, bone mineral density, hyperostosis, premature epiphyseal closure ). pregnancy: category x. see boxed contraindications and warnings . allergic reactions isotretinoin capsules are contraindicated in patients who are hypersensitive to this medication or to any of its components (see precautions, hypersensitivity ).

Australia - English - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - isotretinoin -

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - isotretinoin, quantity: 20 mg - capsule, soft - excipient ingredients: soya oil; yellow beeswax; hydrogenated soya oil; partially hydrogenated soya oil; gelatin; glycerol; titanium dioxide; iron oxide red; iron oxide yellow; propylene glycol; brilliant blue fcf; ethanol; purified water; shellac; strong ammonia solution - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - isotretinoin, quantity: 10 mg - capsule, soft - excipient ingredients: soya oil; yellow beeswax; hydrogenated soya oil; partially hydrogenated soya oil; gelatin; glycerol; titanium dioxide; iron oxide red; iron oxide yellow; propylene glycol; brilliant blue fcf; ethanol; purified water; shellac; strong ammonia solution - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance pharmaceuticals ltd - isotretinoin - oral capsule - 20mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - isotretinoin - oral capsule - 20mg

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of isotretinoin capsules therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)]. isotretinoin capsules are contraindicated in pregnancy [see warnings and precautions (5.1)and use in specific populations (8.1)]. isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see warnings and precautions (5.14)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to isotretinoin during pregnancy. report any suspected fetal exposure during or 1 month after isotretinoin capsules therapy immediately to the fda via the medwatch telephone number 1-800-fda-1088 and also to the ipledge pregnancy registry at 1-866-495-0654 or via the internet ( www.ipledgeprogram.com). risk summary isotretinoin capsules are contraindicated during pregnancy because isotretinoin can cause fetal harm when administered to a pregnant patient. there is an increased risk of major congenital malformations, spontaneous abortions, and premature births following isotretinoin exposure during pregnancy in humans. if isotretinoin capsules are used during pregnancy, or if the patient becomes pregnant while taking isotretinoin capsules, the patient should be apprised of the potential hazard to a fetus. if pregnancy occurs during treatment of a patient who is taking isotretinoin capsules, isotretinoin capsules must be discontinued immediately and the patient should be referred to an obstetrician-gynecologist experienced in reproductive toxicity for further evaluation and counseling. data human data major congenital malformations that have been documented following isotretinoin exposure include malformations of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. external malformations include: skull; ear (including anotia, micropinna, small or absent external auditory canals); eye (including microphthalmia); facial dysmorphia and cleft palate. internal abnormalities include: cns (including cerebral and cerebellar malformations, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular; thymus gland; parathyroid hormone deficiency. in some cases, death has occurred as a result of the malformations. cases of iq scores less than 85 with or without other abnormalities have been reported in children exposed in utero to isotretinoin. an increased risk of spontaneous abortion and premature births have been reported with isotretinoin exposure during pregnancy. risk summary there are no data on the presence of isotretinoin in either animal or human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions in nursing infants from isotretinoin, advise patients that breastfeeding is not recommended during treatment with isotretinoin capsules, and for at least 8 days after the last dose of isotretinoin capsules. all patients who can become pregnant must comply with the ipledge program requirements [see warnings and precautions (5.2)]. pregnancy testing isotretinoin capsules must only be prescribed to patients who are known not to be pregnant as confirmed by a negative clia-certified laboratory conducted pregnancy test. patients who can become pregnant must have had two negative urine or serum pregnancy tests with a sensitivity of at least 25 miu/ml before receiving the initial isotretinoin capsules prescription (the interval between the two tests must be at least 19 days). - the first test (a screening test) is obtained by the prescriber when the decision is made to prescribe isotretinoin capsules therapy. - the second pregnancy test (a confirmation test) is performed after the patient has used 2 forms of contraception for 1 month and during the first 5 days of the menstrual period immediately preceding the beginning of isotretinoin capsules therapy (for patients with regular menstrual cycles) or immediately preceding the beginning of isotretinoin capsules therapy (for patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding). a pregnancy test must be repeated each month, in a clia-certified laboratory prior to the patient receiving each prescription. a pregnancy test must also be completed at the end of the entire course of isotretinoin capsules therapy and 1 month after the discontinuation of isotretinoin capsules. contraception patients who can become pregnant must use 2 forms of contraception simultaneously, at least 1 of which must be a primary form, for at least 1 month prior to initiation of isotretinoin capsules therapy, during isotretinoin capsules therapy, and for 1 month after discontinuing isotretinoin capsules therapy. however, 2 forms of contraception is not required if the patient commits to continuous abstinence from not having any sexual contact with a partner which may result in pregnancy, has undergone a hysterectomy or bilateral oophorectomy, or has been medically confirmed to be post-menopausal. micro-dosed progesterone preparations (“minipills” that do not contain an estrogen) are an inadequate method of contraception during isotretinoin capsules therapy. primary forms secondary forms - tubal sterilization barrier: - male vasectomy - male latex condom with or without spermicide - intrauterine device - diaphragm with spermicide - hormonal (combination oral contraceptives, vaginal systems, vaginal inserts, transdermal systems, injections, or implants) - cervical cap with spermicide other: - vaginal sponge (contains spermicide) any birth control method can fail. there have been reports of pregnancy from patients who have used combination oral contraceptives, as well as contraceptive vaginal systems, vaginal inserts, transdermal systems, and injections; these pregnancies occurred while taking isotretinoin. these reports are more frequent for patients who use only a single method of contraception. therefore, it is critically important that patients who can become pregnant use 2 methods of contraception simultaneously. a clinical drug interaction study did not show any clinically significant interaction between isotretinoin and norethindrone and ethinyl estradiol; however, it is not known if there is an interaction between isotretinoin with other progestins [see drug interactions (7.5)]. prescribers are advised to consult the prescribing information of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products. patients who can become pregnant should be prospectively cautioned not to self-medicate with the herbal supplement st. john’s wort because of a possible interaction with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting st. john’s wort. pregnancies have been reported by users of combined hormonal contraceptives who also used some form of st. john’s wort. if the patient has unprotected sexual contact with a partner that could result in pregnancy at any time 1 month before, during, or 1 month after therapy, the patient must: - stop taking isotretinoin capsules immediately, if on therapy - have a pregnancy test at least 19 days after the last act of unprotected sexual contact with a partner that could result in pregnancy - start using 2 forms of contraception simultaneously again for 1 month before resuming isotretinoin capsules therapy - have a second pregnancy test after using 2 forms of contraception for 1 month. infertility in a trial of female acne patients (n = 79) receiving another isotretinoin capsule product, the mean total ovarian volume, the total antral follicle count and mean anti-mullerian hormone decreased at the end of the treatment (sixth month). however, the values returned to normal at the 18 th month (12 months after the end of treatment). there were no statistically significant changes in terms of follicle-stimulating hormone and luteinizing hormone, both at the end of the treatment and 12 months after the end of treatment. although the results suggest that possible deteriorative effects of isotretinoin on ovarian reserve may be reversible, the study has important methodological limitations, including a small sample size, lack of a control group, and lack of generalizability. sperm study in trials of 66 men, 30 of whom were patients with nodular acne under treatment with oral isotretinoin, 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 isotretinoin therapy for nodular acne, no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose. the safety and effectiveness of isotretinoin capsules for the treatment of severe recalcitrant nodular acne have been established in pediatric subjects ages 12 to 17 years. use of isotretinoin capsules in this age group for this indication is supported by evidence from a clinical trial (study 1) that compared the use isotretinoin capsules to another isotretinoin capsule product in 397 pediatric subjects (12 to 17 years) [see clinical studies (14)] and pharmacokinetic data in pediatric subjects [see clinical pharmacology (12.3)] . the safety and effectiveness of isotretinoin capsules in pediatric patients less than 12 years of age have not been established. adverse reactions in pediatric subjects in trials with isotretinoin capsules, adverse reactions reported in pediatric subjects aged 12 to 17 years old were similar to those described in adults except for the increased incidence of back pain and arthralgia (both of which were sometimes severe) and myalgia in pediatric subjects. in a trial of pediatric subjects aged 12 to 17 years old treated with isotretinoin capsules, approximately 29% (104/358) developed back pain. back pain was severe in 14% (14/104) of the cases and occurred at a higher frequency in female subjects than male subjects. arthralgias were experienced in 22% (79/358) of pediatric subjects including severe arthralgias in 8% (6/79) of subjects. appropriate evaluation of the musculoskeletal system should be done in adolescents who present with these symptoms during or after a course of isotretinoin capsules. consider discontinuing isotretinoin capsules if any significant abnormality is found. effects on bone mineral density in pediatric subjects the effect on bone mineral density (bmd) of a 20-week course of therapy with isotretinoin capsules or another isotretinoin capsule product was evaluated in a double-blind, randomized clinical trial involving 396 adolescents with severe recalcitrant nodular acne (mean age 15.4 years old, range 12 to 17 years old, 80% males). given that there were no statistically significant differences between the two isotretinoin capsule groups following 20 weeks of treatment, the results are presented for the pooled treatment groups. the mean changes in bmd from baseline for the overall trial population were 1.8% for lumbar spine, -0.1% for total hip and -0.3% for femoral neck. mean bmd z-scores declined from baseline at each of these sites (-0.053, -0.109 and -0.104 respectively). out of 306 adolescents, 27 (9%) had clinically significant bmd declines defined as ≥4% lumbar spine or total hip, or ≥5% femoral neck, including 2 subjects for lumbar spine, 17 for total hip and 20 for femoral neck. repeat dxa scans within 2 to 3 months after the post treatment scan showed no recovery of bmd. long-term follow-up at 4 to 11 months showed that 3 out of 7 subjects had total hip and femoral neck bmd below pre-treatment baseline, and 2 others did not show the increase in bmd above baseline expected in this adolescent population. the significance of these changes in regard to long-term bone health and future fracture risk is unknown [see warnings and precautions (5.12)] . in an open-label clinical trial (n=217) of a single course of therapy with isotretinoin capsules for adolescents with severe recalcitrant nodular acne, bmd at several skeletal sites were not significantly decreased (lumbar spine change >-4% and total hip change >-5%) or were increased in the majority of subjects. one patient had a decrease in lumbar spine bmd >4% based on unadjusted data. sixteen (8%) subjects had decreases in lumbar spine bmd >4%, and all the other subjects (92%) did not have significant decreases or had increases (adjusted for body mass index). nine subjects (5%) had a decrease in total hip bmd >5% based on unadjusted data. twenty-one (11%) subjects had decreases in total hip bmd >5%, and all the other subjects (89%) did not have significant decreases or had increases (adjusted for body mass index). follow-up trials performed in 8 of the subjects with decreased bmd for up to 11 months thereafter demonstrated increasing bmd in 5 subjects at the lumbar spine, while the other 3 subjects had lumbar spine bmd measurements below baseline values. total hip bmd remained below baseline (range −1.6% to −7.6%) in 5 of 8 subjects (63%). in a separate open-label extension trial of 10 subjects including those ages 13 to 17 years, who started a second course of isotretinoin capsules 4 months after the first course, two subjects showed a decrease in mean lumbar spine bmd up to 3.3%. epiphyseal closure there are reports of premature epiphyseal closure in acne patients who used isotretinoin at recommended doses. the effect of multiple courses of isotretinoin on epiphyseal closure is unknown. in a 20-week clinical trial that included 289 adolescents who had hand radiographs taken to assess bone age, a total of 9 subjects had bone age changes that were clinically significant and for which an isotretinoin-related effect cannot be excluded [see warnings and precautions (5.12)] . clinical studies of isotretinoin capsules did not include sufficient numbers of geriatric subjects (subjects aged 65 years of age and older) to determine whether they respond differently from younger adults. although reported clinical experience has not identified differences in responses between geriatric and younger adults, effects of aging may increase some risks associated with isotretinoin capsules therapy.

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of isotretinoin capsules therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)] . isotretinoin is contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)] . isotretinoin is contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other all

United States - English - NLM (National Library of Medicine)

upsher-smith laboratories, llc - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)] . isotretinoin capsules are contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)] . isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis an

United States - English - NLM (National Library of Medicine)

mayne pharma - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)] . isotretinoin capsules are contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)] . isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis an