Soricap Capsule 10mg

Product Information

SORICAP

Presentation

Soricap 10mg capsule: Each capsule contains Acitretin BP 10mg.

Soricap 25mg capsule: Each capsule contains Acitretin BP 25mg.

Indication

Soricap is indicated in severe extensive psoriasis which is resistant to other forms of therapy, palmo-plantar pustular psoriasis,

severe congenital ichthyosis, severe Darier’s disease (keratosis follicularis).

Dosage and administration

Adult and elderly

Initial daily dose should be 25mg or 30mg for 2 to 4 weeks. After this initial treatment period the involved areas of the skin

should show a marked response and/or side-effects should be apparent. In general, a daily dosage of 25 – 50mg taken for a further

6 to 8 weeks to achieve optimal therapeutic results. However, it may be necessary in some cases to increase the dose up to a

maximum of 75mg/day.

In patients with Darier’s disease a starting dose of 10 mg may be appropriate. The dose should be increased cautiously as

isomorphic reactions may occur. Patients with severe congenital ichthyosis and severe Darier’s disease may require therapy beyond

3 months. The lowest effective dosage, not exceeding 50mg/day, should be given. Continuous use beyond 6 months is contra-indicated

as only limited clinical data are available on patients treated beyond this length of time.

Children

The daily dosage is about 0.5mg/kg. Higher doses (up to 1mg/kg daily) may be necessary in some cases for limited periods, but only

up to a maximum of 35mg/day.

Contraindications

Acitretin is highly teratogenic and must not be used by women who are pregnant. The same applies to women of childbearing

potential unless strict contraception is practiced 4 weeks before, during and for 2 years after treatment. The use of Acitretin is

contra-indicated in women who are breast feeding.Acitretin is contraindicated in patients with severe hepatic or renal impairment

and in patients with chronic abnormally elevated blood lipid values. Concomitant administration of Acitretin with other retinoids

or Vitamin A is contra-indicated due to the risk of hypervitaminosisA.Acitretin is contra-indicated in cases of hypersensitivity

to the preparation (acitretin or excipients) or to other retinoids. Patients with rare glucose-galactosemalabsorption should not

take this medicine.

Warning and precautions

The risk of giving birth to a deformed child is exceptionally high if Acitretin is taken before or during pregnancy, no matter for

how long or at what dosage. Women of childbearing potential must not receive blood from patients being treated with acitretin.

Donation of blood by a patient being treated with acitretin is prohibited during and for two years after completion of treatment

with acitretin. The effects of UV light are enhanced by retinoid therapy; therefore patients should avoid excessive exposure to

sunlight. Hepatic function should be checked before starting treatment with Acitretin, every 1-2 weeks for the first 2 months

after commencement and then every 3 months during treatment. Serum cholesterol and serum triglycerides (fasting values) must be

monitored before starting treatment, one month after the commencement and then every 3 months during treatment, especially in

high-risk patients and during long-term treatment. Retinoids can alter glucose tolerance, blood sugar levels should therefore be

checked. Patients should be warned of the possibility of alopecia. Decreased night vision has been reported with acitretin

therapy. Patients with severe headache, nausea, vomiting, and visual disturbances should discontinue acitretin immediately.

Drug interactions

Existing data suggests that concurrent intake of acitretin with ethanol led to the formation of etretinate. Concomitant

administration of methotrexate, tetracyclines or vitamin A and other retinoids with acitretin is contraindicated. In concurrent

treatment with phenytoin, it must be remembered that Acitretin partially reduces the protein binding of phenytoin. Low dose

progesterone-only products (minipills) may be an inadequate method of contraception during acitretin therapy, Investigations into

the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.

Use in pregnancy & lactation

Acitretin is contraindicated in pregnant women or nursing mother. It is highly teratogenic. Its use is contraindicated in women

who might become pregnant during or within 2 years of the cessation of treatment.

Side effects

Adverse effects are seen in most patients receiving acitretin. Most of the clinical side-effects of Acitretin are dose-related and

are usually well-tolerated at the recommended dosages. However, the toxic dose of Acitretin is close to the therapeutic dose and

most patients experience some side-effects during theinitial period whilst dosage is being adjusted. The skin and mucous membranes

are most commonly affected. An initial worsening of psoriasis symptoms issometimes seen at the beginning of the treatment period.

Overdose

Manifestations of acute Vitamin A toxicity include severe headache, vertigo, nausea or vomiting, drowsiness, irritability and

pruritus. Signs and symptoms of accidental or deliberate overdosage with Acitretin would probably be similar.

Specific treatment is unnecessary because of the low acute toxicity of the preparation.

Pharmaceutical precautions

Store in a cool & dry place, protected from light. Do not store above 25°C.

Packaging quantity

Soricap 10mg capsule: Carton of 7 capsules in alu-pvdc blister.

Soricap 25mg capsule: Carton of 7 capsules in alu-pvdc blister.