Generic Accutane, Isotretinoin Capsule Patient Information Sheet
PATIENT INFORMATION LEAFLET
WHAT IS ISOTROIN?
ISOTROIN contains Isotretinoin and is prescribed to treat severe form of pimples which in medical terminology is called as severe refractory nodulocystic acne
WHAT FACTS 001 NEED TO KNOW ABOUT ISOTROIN?
e ISOTROIN is indicated in severe pimples in both, males and females and is to be taken under doctor's supervision only.
• ISOTROIN is strictly a prescription based drug Under no circumstances you should suggest it to anyone else even if his or her condition resembles yours
• You might have difficulty in using contact lenses
• Vrtamrn A Supplements should be avoided while on therapy
• Patients with family or personal history of diabetes, liver disease heart disease or depression should inform their doctor before the start of the therapy
• If your acne returns do not take ISOTROIN ol your own on your old prescription Consult your doctor again
WHAT PRECAUTIONS DO INEEDTOTAKE WHEN I AM ON ISOTROINTHEFtAPY ?
• Do not donate blood during the course of therapy and 1 month after discontinuation of therapy
• Avoid prolonged exposure to sunlight.Use sunscreen
• Avoid night dnving
• Avoid removal of hair by using wax due to the increased chances of scarring and tor at least 6 months thereafter
Special precautions to be taken by female patients of childbearing potential
• Patients should not be pregnant before starting this medication.
• Patients should use effective contraceptive methods one month prior to starting the therapy, during the therapy and one month after stopping the therapy
• Avoid breastfeeding
Female patients are required to sign a consent form prior to starting ISOTROIN therapy.
For the use only of a Dermatologist
ISOTROIN
CONTRAINDICATIONS AND WARNINGS: Isotretinoin must not he used by females who are pregnant or who may become pregnant while undergoing treatment Although not every tetus exposed to Isotretinoin has resulted n a detormed chid, there is an extremely high risk that a deformed infant can result if pregnancy occurs while taking isotretinoin in any amount even for short periods ol lime. Potentially any fetus exposed during pregnancy can be affected Presently, there are no accurate means ot determining after Isotretinoin exposure, which fetus has been affected and which fetus has not been affected Isotretinoin is contralndlcaled in lemales of childbearing potential unless the
conditions;
• MiiSLhave severe disfiguring nodular acne that Is recalcitrant to standard therapies (see INDICATIONS AND USAGE for definition)
• Musi be capable of complying with the mandatory contraceptive measures required for Isotretinoin therapy
and understand behaviours associated with an increased risk ol pregnancy
• Must have had a negative uhne or serum pregnancy test when the patient is qualified for Isotretinoin therapy by the prescriber, and must have had a second negative urine or serum pregnancy test on the second
day of the next normal menstrual period or at least 11 days after the last unprotected act of sexual intercourse, whichever is later Mak>r human letal abnormalities related to Isotretinoin administration have been documented CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); skull abnormality; external ear abnormalities (Including anotla. micropinna. small or absent external auditory canals), eye abnormalities (including microphthalmia); cardiovascular abnormalities: facial dysmorphla; cletl palate; thymus gland abnormality; parathyroid hormone deficiency Effective contraception must be used for at least 1 month before beginning Isotretinoin therapy, during therapy, and for 1 month lollowing discontinuation of therapy even where there has been a history of infertility, unless due to hysterectomy. Any birth control method can tall Therefore. It is critically Important that women of childbearing potential use two effective forms ol contraception simultaneously, unless absolute abstinence Is the chosen method even when one of the forms is a hormonal contraceptive method If a pregnancy does occur during treatment the prescriber and patient should discuss the desirability of continuing the pregnancy
AVOO X PREGNANCY
COMPOSITION lsotroln-10
Each soft gelatin capsule contains
Isotretinoin USP .................. to mg
lsotroln-20
Each soft gelatin capsule contains
Isotretinoin USP ..................20 mg
DESCRIPTION
Isotretinoin is a retinoid, which inhibits sebaceous gland function and keratlnization. The exact mechanism ol action of Isotretinoin is unknown Clinical improvement In nodular acne patients occurs in association with a reduction in sebum secretion The decrease in sebum secretion is temporary and is related to the dose and duration ol treatment with Isotretinoin, and reflects a reduction In sebaceous gland size and an inhibition of sebaceous gland differentiation
INDICATIONS
Cystic and conglobate acne, severe recalcitrant nodular acne: Isotroin
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, means "many' as opposed to few or several nodules Because of significant adverse effects associated with its use Isotroin snould be reserved lor patients with severe nodular acne who are unresponsive
10 conventional therapy including systemic antibiotics In addition for female patients of childbearing potential Isotroin is indicated only for those lemales who are not pregnant DOSAGE AND ADMINISTRATION
The recommended dosage range lor Isotroin is 0 5 to 2 mg/kg given in 2 divided doses dally lor 15 to 20 weeks It is recommended that lor most patients the initial dosage ol Isotroin be 0.5 to t mg,Vgrday Patients whose disease Is very severe or is primarily manifested on the trunk may require up to the maximum recommended dosage. 2 mg' Kg/day. During treatment, the dose may be ad|usted according to response of the disease and/or the appearance ot clinical side effects, some ot which may be dose related
A single course ot therapy lor 15 to 20 weeks has been shown to result in complete and prolonged remission ot disease in many patients II a second course of therapy is needed, it should not be nitiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Isotretinoin The optimal interval before re-treatment has not been defined tor parents who have not completed skeletal growth
11 the total nodule count has been reduced by more than 70°© prior to completing 15 to 20 weeks ol treatment the drug may be discontinued After a period of 2 months or mce oft therapy, and If warranted by persistent or recurring severe nodular acne, a second course of therapy may be Initiated Contraceptive measures must be followed tor any subsequent course of therapy isotretinoin should be administered with food
ISOTROIN DOSING BY BODY WEIGHT
Body Weight Total mg/Day
Kilograms 0 5 mg/kg 1 mg/kg 2 mg/kg
j 40 ~a> 40 80
50 25 »| 100
[56 30 60 120
i 70 36 70 140
40 J80.
80_ 45 90 180
1100 50 100 200
CON 1R ABDICATIONS Isotroin is contraindicated in patien's who are hypersensitive to this medication or to any ol its components Isotroin should nol be gwen lo patients who are sensitive to parabens, which are used as preservatives in the gelatin capsules Isotroin is contraindicated in pregnancy, hypervilammosis A. hepatic ano renal insufficiency, in patients with excessively elevaled blood lipid values, and as supplementary treatment with letraciclines
WARNINGS AND PRECAUTIONS Hypersensitivity: Anaphylactic reactions, cutaneous allergic reactions and serious cases of allergic vasculitis, often with purpura ■ bruises and red patches) of the extremities and extracutaneous involvement (including renal > have been reported Severe allergic reaction necessitates discontinuation ol therapy and appropriate medical management
Drug Interactions.
Vitamin A Because ol the relationship of isotretinoin to vitamin A patients should be advised against laking vitamin supplements containing vitamin A to avoid additive toxic effects.
'etracyclines: Concomitant treatment with isotretinoin and tetracyclines should be avoided because Isotretinoin use has been associated with a numbei ol cases ot pseudotumor cerebri (benign intracranial hypertension) some ol which Involved concomitant use of tetracyclines
Oral conlraceptlvcs: It is not known If hormonal contraceptives differ in their elfectiveness when used with Isotretinoin Therefore, It is critically important that women of childbearing potential use two effective forms of contraception simultaneously unless absolute abstinence is the chosen method, even when one of the forms is a hormonal contraceptive method
Laboratory Tests:
• Pregnancy Test: Female patients ol childbearing potential must have negative results from two urine or serum pregnancy lesls The first test is lo be performed when the patient is qualified for Isotroin therapy by her prescriber The second test is to be performed on the second day of her next menstrual cycle or 11 days after her last unprotected act of sexual intercourse whichever is later Additional pregnancy tests are to be conducted monthly during treatment
e Lipids: Pretreatment and follow-up blood lipids should be obtained under fasting conditions II is recommended that these tests be performed at weekly or biweekly intervals until the lipid response to Isotroin is established
e Livei function Tests: Pretreatment and tollow-up liver lunction tests should be performed al weekly or biweekly intervals until the response to Isotroin has been established
Psychiatric Disorders: Isotroin may cause depression, psychosis and. rarely, suicidal ideation, suicide attempts and suicide Discontinuation ot Isotretinoin therapy may be insufficient; lurthei evaluation may be necessary
Pseudotumor Cerebri: Isotretinoin use has been associated with a number of cases ol pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines Concomitant treatment with tetracyclines should therefore he avoided Early signs and symptoms ot pseudotumor cerebn include papilledema headache nausea and vomiting, and visual disturbances Patients with these symptoms should be screened lor papilledema and it present they should be told lo discontinue Isotroin immediately and be relerred lo a neurologist lor lunher diagnosis and care
Pancreatitis Acute pancreatitis has been reported in patients with either elevated oi normal serum triglycerides levels Isotroin should be stopped il hypertriglyceridemia cannot be controlled at an acceptable level or il symptoms ol pancreatitis occur Lipids: Elevations ol serum triglycerides have been reported in patients treated with Isotretinoin Decrease in high-density llpoproleins and increase in cholesterol levels have also been reported Some patients have been able to reverse triglycerides elevation by reduction in weight, restriction of dietary tat and alcohol and reduction in dose while continuing isotretinoin
Blood lipid determinations should be performed before Isotroin is given and then " at intervals until the lipid response lo isotroin c
is established, which usually occurs within 4 weeks Especially careful consideration must be given to risk/benefit for patients who may be at high risk during Isotroin therapy (patients with diabetes obesity, increased alcohol intake lipid metabolism disorder or familial history of lipid metabolism disorder) II Isotroln therapy is Instituted, more frequent checks ol serum values lor lipids and/or blood sugar are recommended The cardiovascular consequences ol hypertriglyceridemia associated with Isotretinoin are unknown Hearing Impairment: Patients who experience tinnitus or hearing impairment should discontinue Isotroln treatment and be referred lo specialized care for lurlher evaluation
Hepatotoxiclty Clinical hepatitis considered to be possibly or probably related to Isotretinoin therapy has been reported Additionally, mild to moderate elevations ol liver enzymes have been observed, some ol which normalize with dosage reduction or continued administration of the drug If normalization does not readily occur or if hepatitis is suspected during treatment with Isotretinoin the drug should be discontinued and the etiology further Investigaled
Inflammatory Bowel Disease: Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis) In patients without a prior history of intestinal disorders Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Isotroln immediately
Skeletal Hyperostosis: Minimal skeletal hyperostosis and calcification of ligaments and tendons have also been observed by x-ray in prospective studies ol nodular acne patients Ireated with a single course ot therapy at recommended doses The skeletal eltects of multiple Isotretinoin treatment courses lor acne are unknown
Premature Epiphyseal Closure: There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses bul a causal relationship is not known
Decroased Night Vision: Visual problems should be carefully monitored All Isotroin patients experiencing visual difficulties should discontinue Isotroin treatment and have an ophthalmological examination Because ot the onset of decreased mghi vision in some patients, patients should be warned to be cautious when driving or operating any vehicle al night.
Cornoal Opacities: Corneal opacities have occurred in patients receiving Isotretinoin tor acne and more frequently when higher drug dosages were used In patients with disorders of kerallnization The corneal opacities that have been observed in clinical tnal patients treated with Isotretinoin have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation ot the drug
Carcinogenesis. Mutagenesis and Impairment ot Fertility: The relevance of the clinical findings of animal studies in humans is uncertain With Isotretinoin therapy for nodular acne no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose. Nursing Mothers: It is not known whether this drug Is excreted in human milk Because of the potential for adverse effects nursing mothers should not receive Isotroin
ADVERSE REACTIONS Body as a Whole Allergic reactions. Including vasculitis systemic
hypersensitivity edema. fatigue, lymphadenopathy. weight loss.
Cardiovascular: Palpitation, tachycardia vascular thrombotic disease, stroke ondocrine/Metabolic: Hypertriglyceridemia alterations in blood sugar levels. Gastrointestinal: Inflammatory bowel disease hepatitis pancreatitis, colitis, ileitis. nausea. other nonspecific gastrointestinal symptoms Hematologic: Anaemia, thrombocytopenia neutropenia.
Musculoskeletal: Skeletal hyperostosis, calcilication of lendons and ligaments, premature epiphyseal closure, mild to moderate musculoskeletal symptoms including arthralgia, elevations of CPK. arlhritis. tendonitis, other types ol bone abnormalities
Neurological Pseudotumor cerebri dizziness. drowsiness. headache, insomnia lethargy malaise, nervousness paresthesias, seizures stroke syncope Psychiatric: Suicidal Ideation suicide attempts suicide depression, psychosis emotional instability
Reproductive System: Abnormal menses Respiratory: Bronchospasms (with or without a history ol asthma), respiratory inlection. voice alteration
Skin and Appendages Acne fulminans alopecia (which in some cases persists | bruising, cheilitis (dry lips), dry mouth dry nose, dry skin epistaxis. eruptive xanthomas flushing, fragility ol skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmenlation. nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), sunburn susceptibility increased, (including Wegener's granulomatosis.), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting Special Senses Hearing impairment, tinnitus, corneal opacities, decreased night vision, cataracts color vision disorder. con|unctivitis. dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia visual disturbances
Urinary System: Glomerulonephritis, nonspecific urogenital lindings Laboratory: Elevation of plasma triglycerides decrease in serum high-density lipoprotein (HDL) levels elevations of serum cholesterol during treatment Increased alkaline phosphalase. SGOT |AST| SGPT (ALTi GGTP or LDH elevation ol fasting blood sugar elevations ot CPK hyperuricemia
Decreases in red blood cell parameters decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis elevated sedimentation rales, elevated platelet counts, thrombocytopenia White cells in the urine proteinuria microscopic or gross hematuria
OVERDOSAGE:
In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. All symptoms quickly resolved without apparent residual effects
STORAGE
Store in a cool dry place Protect from light
PRESENTATION:
Isotroin-10 Blister Pack of 10 capsules
Isotroin-20 Blister Pack of 10 capsules 
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