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Home > Products > Isotretinoin |
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| Isotretinoin
20mg Capsules |
Isotretinoin 20mg Capsules
- Prescribing Information
Please refer to full Summary of Product Characteristics
(SmPC) before Prescribing
Presentation: Oval shaped, maroon coloured,
opaque soft gelatin capsules imprinted with ‘RR’
in black edible ink containing orange-yellow coloured
oily suspension
Indications: Severe forms of acne resistant
to adequate courses of standard therapy with antibacterials
and topical therapy
Dosage: Isoretinoin should only be prescribed
by or under the supervision of physicians with expertise
in the use of systemic retinoids. The capsules should
be taken with food once or twice daily. Adults:
The starting dose is 0.5 mg/kg daily, and the dose adjusted
on an individual basis. For most patients, the dose ranges
from 0.5-1.0 mg/kg per day.
Long-term remission and relapse rates are closely related
to the total dose administered. No substantial additional
benefit occurs beyond a cumulative dose of 120-150 mg/kg.
A usual treatment course is 16-24 weeks. Usually remission
occurs after a single treatment course. In a relapse a
further course can be given. Further improvement can be
seen up to 8 weeks after finishing treatment, so another
course should not be given until at least this time. Children:
not indicated in patients less than 12 years of age. Patients
with severe renal insufficiency: Treatment should
be started at a lower dose (e.g. 10 mg/day) and increased
up to 1 mg/kg/day or until the patient is receiving the
maximum tolerated dose. Patients with intolerance:
Continue treatment at a lower dose at the highest tolerated
dose.
Contraindications: Pregnancy and breastfeeding,
and in women of child bearing potential unless all of
the conditions of the Pregnancy Prevention Programme are
met (see section 4.4. of the SmPC), hypersensitivity to
isotretinoin or any of the excipients, including peanut
and soya. Also in patients with hepatic insufficiency,
very high blood lipid values, hypervitaminosis A and receiving
concomitant treatment with tetracyclines.
Warnings and Precautions:This medicinal
product is TERATOGENIC.
Isotretinoin is contraindicated in women of childbearing
potential unless all of the conditions of the Pregnancy
Prevention Programme are met. Prescriptions for women
of childbearing potential should be limited to 30 days.
Continuation of treatment requires a new prescription.
Ideally, pregnancy testing and dispensing of isotretinoin
should occur on the same day up to 7 days. Male patients:
the level of maternal exposure from the semen is too small
to be teratogenic. Male patients must not share their
medication with anyone, particularly not females. Additional
precautions: Patients must never give isotretinoin
to anyone else and must return any unused capsules to
their pharmacist. Patients should not donate blood during
therapy and for 1 month after discontinuation.
Educational material: The Marketing Authorisation
Holder will provide educational material to reinforce
the warnings about teratogenicity and to provide advice
on contraception and the need for pregnancy testing. Full
patient information, as in the Pregnancy Prevention Programme,
should be given to all patients. Psychiatric disorders:
Particular care in patients with a history of depression.
All patients should be monitored for depression and referred
for treatment if necessary. Symptoms may not resolve on
discontinuation so further evaluation may be necessary. Skin and subcutaneous tissues disorders: Worsening
of acne is occasionally seen initially but this subsides
with continued treatment, usually within 7 - 10 days,
and usually does not need dose adjustment. Exposure to
intense sunlight or to UV rays should be avoided and concurrent
administration with topical keratolytic or exfoliative
anti-acne agents. Aggressive chemical dermabrasion and
cutaneous laser treatment should be avoided for 5-6 months
after the end of the treatment and wax depilation for
at least 6 months Advise patients to use a skin moisturiser
and a lip balm from the start of treatment. Eye disorders:Dry
eyes, corneal opacities, decreased night vision and keratitis
usually resolve after discontinuation of therapy. Intolerance
to contact lenses may occur. Patients experiencing visual
difficulties should be referred to an ophthalmologist.
Withdrawal of isotretinoin may be necessary. Musculo-skeletal
and connective tissue disorders: Myalgia, arthralgia
and increased serum creatine phosphokinase, especially
in patients doing vigorous physical activity. Bone changes
including premature epiphyseal closure, hyperostosis,
and calcification of tendons and ligaments have occurred
after several years of treatment at very high doses, much
higher than for the treatment of acne. Benign intracranial
hypertension: Isotretinoin should be discontinued
immediately. Hepatobiliary disorders: Check liver
enzymes before treatment, 1 month after initiation, and
3 monthly thereafter. Transient reversible increases in
liver transaminases occur, which may be clinically relevant,
consider reducing dose or discontinuation. Renal insufficiency:
Start on a low dose and titrate up to the maximum tolerated
dose .Lipid metabolism: Check fasting lipids
at beginning of treatment, at 1 month and then at 3 monthly
intervals. Raised lipids usually return to normal on dose
reduction or discontinuation of treatment or dietary measures.
Discontinue if hypertriglyceridaemia cannot be controlled
or if symptoms of pancreatitis occur. Gastrointestinal
disorders: Inflammatory bowel disease may occur.
Discontinue treatment immediately in patients with severe
(haemorrhagic) diarrhoea. Allergic reactions:
Anaphylactic reactions occur rarely, in some cases after
previous topical exposure to retinoids. Allergic cutaneous
reactions are reported infrequently. Serious cases of
allergic vasculitis have been reported. In severe allergic
reactions interrupt treatment and monitor. High Risk
Patients:In patients with diabetes, obesity, alcoholism
or a lipid metabolism disorder, more frequent checks of
serum values for lipids and/or blood glucose may be necessary.
Elevated fasting blood glucose and new cases of diabetes
may occur.
Interactions: Patients should not take
vitamin A or tetracyclines as concurrent medication.
Pregnancy and lactation: Pregnancy is
an absolute contraindication due to teratogenicity.
If pregnancy occurs during treatment or in the month following,
there is a great risk of very severe serious foetal malformation.
Stop treatment and refer to a specialist for assessment.
Contra-indicated in breastfeeding.
Adverse Reactions: Some of the side effects
are dose-related and are generally reversible.
Very common (>= 1/10) Anaemia, increased ESR,
thrombocytopenia, thrombocytosis, blepharitis, conjunctivitis,
dry eye, eye irritation, elevated transaminase , cheilitis,
dermatitis, dry skin, localised exfoliation, pruritus,
rash erythematous, skin fragility (risk of frictional
trauma), arthralgia, myalgia, back pain (particularly
adolescent patients) triglycerides increased, high density
lipoprotein decreased.
Common (>= 1/100, < 1/10) Neutropenia,
headache, epistaxis, nasal dryness, nasopharyngitis, raised
cholesterol, raised blood glucose, haematuria, proteinuria.
Rare (>= 1/10 000, < 1/1000) Allergic skin
reaction, anaphylactic reactions, hypersensitivity, depression,
depression aggravated, aggressive tendencies, anxiety,
mood alternations, alopecia.
Very Rare (<= 1/10 000:): Gram positive (mucocutaneous)
bacterial infection, lymphadenopathy, diabetes mellitus,
hyperuricaemia, abnormal behaviour, psychotic disorder,
suicidal ideation, suicide attempt, suicide, benign intracranial
hypertension, convulsions, drowsiness, blurred vision,
cataract, colour blindness (colour vision deficiencies),
contact lens intolerance, corneal opacity, decreased night
vision, keratitis, papilloedema (a sign of benign intracranial
hypertension), photophobia, hearing impaired, vasculitis
(for example Wegener's granulomatosis, allergic vasculitis),
bronchospasm (particularly in patients with asthma), hoarseness,
colitis, ileitis, dry throat, gastrointestinal haemorrhage,
haemorrhagic diarrhoea and inflammatory bowel disease,
nausea, pancreatitis, hepatitis, acne fulminans, acne
aggravated (acne flare), erythema (facial), exanthema,
hair disorders, hirsutism, nail dystrophy, paronychia,
photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation,
sweating increased, arthritis, calcinosis (calcification
of ligaments and tendons), epiphyses premature fusion,
exostosis, (hyperostosis), reduced bone density, tendonitis,
glomerulonephritis, granulation tissue (increased formation
of), malaise, creatine phosphokinase increased.
Legal Category: POM
Marketing Authorisation Number, Package quantities
and basic NHS price: PL 14894/0162. Pack size:30
Marketing Authorisation Holder: Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road,
London W4 5YE, United Kingdom.
Further information is available from Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road,
London W4 5YE, United Kingdom.
Date of Preparation: September 2007
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CAUSES BIRTH
DEFECTS
Do not take if you are pregnant, planning
to get pregnant or if you are not using at
least one (preferably two) methods of contraception |
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Pregnancy Prevention
Programme |
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 Pharmacist
Pack
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Consultant
Dermatologist Pack
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| Adverse events should be reported
to Ranbaxy on 020 8280 1986. Information on Adverse Event
Reporting can also be found at www.yellowcard.gov.uk |
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