Properties
What is it?
Olyx-0.03% Ointment (Tacrolimus Ointment 0.03% w/w) Composition: Tacrolimus USP 0.03% w/w Ointment Base q.s. Indication: Treatment of moderate to severe atopic dermatitis in adults who are inadequately responsive to or intolerant of conventional therapy. Treatment of moderate to severe atopic dermatitis in children (over 2 years of age) who have not responded adequately to conventional therapy. Dosage and Administration: Olyx should only be prescribed by dermatologists and physicians experienced in the treatment of atopic dermatitis with immunomodulatory therapy. A thin layer of Olyx ointment should be applied to the affected skin area. Olyx ointment can be used on any part of the body, including the face, neck, and flexures, with the exception of mucous membranes. Olyx ointment should not be applied under occlusion. Treatment of each affected skin area with Olyx should continue until healing occurs and then be discontinued. Improvement is usually seen within one week of starting treatment. If there are no signs of improvement after two weeks of treatment, other treatment options should be considered. Olyx may be used for short periods and for intermittent long-term periods. Use in children (over 2 years of age): Treatment should be initiated with twice daily application for three weeks. Then, the frequency of application should be reduced to once daily until the lesion clears. Use in adults (over 16 years of age): Olyx 0.03% twice daily. If the clinical picture allows, an attempt should be made to reduce the frequency of application. Treatment should continue until the lesion clears. Use in elderly (over 65 years of age): No specific studies have been conducted in elderly patients. However, clinical experience in this patient population has not revealed the need for dose adjustment. Clinical efficacy studies were conducted with abrupt discontinuation of treatment, so there is no information on whether gradual dose reduction would lead to a decrease in the frequency of relapse. Possible Side Effects: The most frequent adverse reactions associated with the topical use of tacrolimus ointment, especially when applied over large areas, include a sensation of burning and itching upon initial use, along with increased sensitivity of affected areas to sunlight and heat. Less common are flu-like symptoms, headache, cough, and eye irritation. Skin stinging, skin irritation, intolerance to heat or cold, headache, cough, nasal congestion, flu-like signs, blisters (acne), nodules of hair follicles, gastrointestinal discomfort. If any of the side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. Pregnancy and Lactation: Olyx ointment should not be used during pregnancy except when absolutely necessary. Following systemic administration, tacrolimus is excreted in milk. However, clinical data have shown that systemic exposure is low with the use of tacrolimus ointment, and lactation is not recommended during its use. Effect on ability to drive and operate machinery: Olyx ointment is used topically and is unlikely to affect the ability to drive or operate machinery. Overdose: Overdose is unlikely with topical application. In case of accidental ingestion, general supportive measures should be used. This may include monitoring vital signs and observing clinical status. Due to the nature of the ointment, inducing vomiting and gastric lavage are not recommended. Storage: Store in a dark, dry place, inaccessible to children, at a temperature not exceeding 25C. Dispensing Rule: Pharmaceutical product group III, available without prescription. Manufacturer: ZEE Laboratories Limited, India.