Alitretinoin Douglas

Alitretinoin Douglas

Manufacturer:

Douglas

Distributor:

Apex Pharma Marketing
Concise Prescribing Info
Contents
Alitretinoin
Indications/Uses
Adults w/ severe chronic hand eczema that has not got better after any other topical treatments, including steroids.
Dosage/Direction for Use
Recommended dose: 30 mg once daily, if cannot be tolerated may lower the dose to 10 mg once daily. Duration of treatment: 12-24 wk.
Contraindications
Hypersensitivity to alitretinoin, to other retinoids (eg, isotretinoin), peanut or soya. Patient w/ high blood fats (eg, high cholesterol or triglycerides); thyroid disease (not sufficiently treated); hypervitaminosis A; concomitant use of tetracycline. Liver & severe kidney disease. Pregnancy & lactation.
Special Precautions
Possible risk of neuropsychiatric disorders. Do not donate blood during treatment & for 1 mth after discontinuation. May affect mood while on treatment. Immediately discontinue if any kind of mental health problems (depression, aggressive tendencies or mood changes, thoughts about hurting one's self or ending his/her life) develops; or if signs of benign intracranial HTN (eg, persistent headache, nausea or vomiting & blurred vision), or if bloody diarrhea occurs. Patient w/ high blood fats; diabetes; thyroid disease. Monitor patient's sight. Minimize sunlight exposure & avoid sun lamps. Cut down on intensive physical exercise. Dry eyes & sight problems may develop. May increase liver enzyme levels. Do not take other retinoid medicines (eg, isotretinoin), vit A supplement or tetracyclines while on treatment. Not recommended to concomitantly use w/ amiodarone. Concomitant use w/ ketoconazole, fluconazole, miconazole; gemfibrozil, oxandrolone; simvastatin; paclitaxel, rosiglitazone or repaglinide. Do not use if allergic to peanut or soya. May not see well at night during treatment; patient should not drive or operate machinery. Contains sorbitol. Kidney disease; not recommended for patient w/ moderate kidney disease. Women must use effective contraception 1 mth before, during treatment & 1 mth afterwards. Regularly perform pregnancy tests, ideally every mth, during treatment & 1 mth after discontinuation. Do not use if pregnant or might be pregnant; do not get pregnant for 1 mth after discontinuation of treatment. Do not use during lactation. May cause serious harm on unborn baby. Not recommended in childn & adolescent <18 yr.
Adverse Reactions
Headache; higher levels of triglycerides & cholesterol. Increased blood platelets, decreased RBC & WBC; decreased thyroid hormone levels; eye (conjunctivitis) & eyelid inflammation, dry & irritated eyes; tinnitus; dizziness; flushing, HTN; nausea, vomiting, dry mouth; muscle & joint pain, fatigue, high muscle breakdown product levels in the blood (if patient exercises vigorously); skin dryness, dry & inflamed lips, skin redness, itchy skin rash, inflamed skin, hair loss; raised liver enzymes.
Drug Interactions
Do not take other retinoid medicines (eg, isotretinoin), vit A supplement or tetracyclines while on treatment. Not recommended to concomitantly use w/ amiodarone. Consider dose reduction when used concomitantly w/ ketoconazole, fluconazole, miconazole; gemfibrozil, oxandrolone. May decrease amount of simvastatin. May increase amount of paclitaxel, rosiglitazone or repaglinide.
MIMS Class
Emollients, Cleansers & Skin Protectives
ATC Classification
D11AH04 - alitretinoin ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.
Additional Information
Alitretinoin Douglas is an exemption drug. Import is approved by HSA under specific conditions.
Please check with the distributor on conditions of use.
Presentation/Packing
Form
Alitretinoin Douglas 10 mg cap
Packing/Price
30's
Form
Alitretinoin Douglas 30 mg cap
Packing/Price
30's
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