Soritec Capsule

Soritec Capsule is used for: Lichen planus, Psoriasis, Congenital icthyosis, Darier's disease

Oral Darier's disease Adult: Initially, 10 mg daily for 2-4 wk. Max: 50 mg/day. Congenital icthyosis Adult: Initially, 25-30 mg daily for 2-4 wk before dose adjustments are done. Usual range: 25-50 mg daily for further 6-8 wk. Max: 75 mg daily for short periods. Severe psoriasis Adult: Initially, 25-30 mg daily for 2-4 wk before dose adjustments are done. Usual range: 25-50 mg daily for further 6-8 wk. Max: 75 mg daily for short periods. Severe lichen planus Adult: Initially, 25-30 mg daily for 2-4 wk before dose adjustments are done. Usual range: 25-50 mg daily for further 6-8 wk. Max: 75 mg daily for short periods.

RENAL IMPAIRMENT Avoid in severe impairment (increased risk of toxicity).

Should be taken with food. Take w/ main meals or w/ a glass of milk.

Hypersensitivity to retinoids (eg, angioedema, urticaria), parabens Coadministration with methotrexate (increased risk for hepatitis) Coadministration with tetracyclines (increases ICP, pseudotumor cerebri) Alcohol Severely impairment of liver or kidney function and in patients with chronic abnormally elevated blood lipid values Pregnancy: teratogenic

Elevated liver enzymes and hepatitis-related deaths reported Use only for severe psoriasis in women who are unresponsive or have contraindications to other therapy Should be prescribed by those who understand risk of teratogenic effects and those who are competent in the diagnosis and treatment of severe psoriasis and use of systemic retinoids Teratogenic agent; do not use in females who are pregnant, who intend to become pregnant during therapy or within 3 years after discontinuation of therapy, or who may not use reliable contraception during this time period Alcohol is contraindicated during treatment with acitretin and for 2 months after stopping therapy as ethanol promotes the formation of etretinate, which has prolonged half-life and teratogenic risk Females with childbearing potential must participate in Do Your P.A.R.T. (Pregnancy Prevention Actively Required During and After Treatment) program and have signed Patient Agreement/Informed Consent for Female Patients Do not use St. John’s wort due to the effect of decreased birth control effectiveness and potential breakthrough bleeding If pregnancy occurs during therapy or 3 yr after discontinuation, prescribers should discuss possible risks for the pregnancy Patients should not donate blood during therapy and 3 yr after discontinuation because women with childbearing potential should not receive blood from treated patients Elevations of AST (SGOT), ALT (SGPT), GGT (GGTP), or LDH reported; if hepatotoxicity suspected during treatment, discontinue therapy and investigate etiology further Males have shown residual amounts of acitretin in seminal fluid, which appears to pose little risk to the fetus, but data are limited Hyperostosis reported with long-term treatment New or progression of preexisting vertebral/skeletal abnormalities (eg, degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, and narrowing and destruction of cervical disc space) Exfoliative dermatitis and erythroderma reported Depression and/or other psychiatric symptoms such as aggressive feelings or thoughts of self-harm reported in patients taking retinoids; since other factors may contribute to these events, it is not known if they are related to therapy; counsel patients to stop taking this drug and to notify their prescriber immediately if they experience psychiatric symptoms Minimize exposing treated areas to sun or other UV light; significantly lower doses of phototherapy are required when this drug is used; effects on the stratum corneum induced by this drug can increase the risk of erythema (burning) Monitoring Parameters Check liver function at start, then every 2–4 weeks for first 2 months and then every 3 months, pregnancy test 2 wk prior to starting therapy Monitor serum triglyceride and serum cholesterol concentrations before treatment, 1 month after starting, then every 3 months.

Pregnancy May cause severe birth defects; female patients must not be pregnant when therapy is initiated; they must not become pregnant while taking this drug and for at least 3 years after stopping therapy, so that the drug can be eliminated to below a blood concentration that would be associated with an increased incidence of birth defects; because this threshold has not been established for this drug in humans and because elimination rates vary among patients, the duration of posttherapy contraception to achieve adequate elimination cannot be calculated precisely Major human fetal abnormalities have been reported including meningomyelocele, meningoencephalocele, multiple synostoses, facial dysmorphia, syndactyly, absence of terminal phalanges, malformations of bones (hip, ankle, forearm, skull, cerebral vertebrae), low-set ears, high palate, decreased cranial volume, and cardiovascular malformations Lactation Studies on lactating rats have shown that retinoids are excreted in the milk; there is one prospective case report where acitretin is reported to be excreted in human milk; nursing mothers should not receive the drug prior to or during nursing because of potential for serious adverse reactions in nursing infants

Concomitant use with keratolytics or high dose vitamin A. Reduces anticoagulant effect of coumarins e.g. warfarin. Concomitant use of microdised progestin oral contraceptives. Concomitant use of methotrexate can potentiate hepatotoxicty. Concomitant use with tetracycline. Contraindicated (8) demeclocycline doxycycline ethanol methotrexate minocycline omadacycline sarecycline tetracycline Serious - Use Alternative (7) aminolevulinic acid oral aminolevulinic acid topical medroxyprogesterone methyl aminolevulinate norethindrone norethindrone acetate palovarotene

Side effects of Acitretin : Cheilitis (>75%),Alopecia (50-75%),Hypertriglyceridemia (50-75%),Skin peeling (50-75%),Dry skin (25-50%),Dysglycemia (25-50%),Increased LFT (25-50%),Nail disorder (25-50%),Pruritus (25-50%),Rhinitis (25-50%),Arthralgia (10-25%),Changes in phosphorus, potassium, sodium, & magnesium levels (10-25%),Dry mouth (10-25%),Epistaxis (10-25%),Erythematous rash (10-25%),Hepatotoxicity (10-25%),Hyperesthesia (10-25%),Paresthesia (10-25%),Paronychia (10-25%),Rigors (10-25%),Skin atrophy (10-25%),Spinal hyperostosis (10-25%),Sticky skin (10-25%),Xerophthalmia (10-25%) 1-10% Edema,Flushing,Depression,Fatigue,Headache,Insomnia,Somnolence,Abdominal pain,Anorexia,Diarrhea,Gingivitis,Increased appetite,Nausea,Stomatitis,Vomiting,Hot flashes,Vision changes,Corneal epithelial abnormality,Sinusitis Potentially Fatal: Phototoxicity, jaundice, hepatitis and hepatotoxity.

Acitretin is an active metabolite of etretinate but its mechanism of action is unknown.

Soritec 25mg Capsule manufactured by ACI Limited. Its generic name is Acitretin. Soritec is availble in Bangladesh. Farmaco BD drug index information on Soritec Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.