Remus 0.1% Ointment 30g

Indications

Remus 0.1% 10gm is an eczema treatment (atopic dermatitis). It works by inhibiting the activity of certain immune cells that cause skin inflammation (redness and swelling). In atopic dermatitis, this relieves itching and improves rashes. Externally, Remus 0.1% 10gm is used.

Pharmacology

Tacrolimus is a macrolide immunomodulator produced by Streptomyces tsukubaensis. Tacrolimus has been shown to inhibit T-cell activation by binding to an intracellular protein known as FKBP-12. Tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin form a complex that inhibits the phosphatase activity of calcineurin. As a result, the entire inflammatory cascade is suppressed.

Dosage & Administration

• Adults should apply a thin layer of Tacrolimus ointment to the affected skin areas twice daily and gently rub it in.
• Treatment should be continued for one week after the signs and symptoms of atopic dermatitis have resolved.
• Tacrolimus ointment has not been evaluated for safety under occlusion, which may promote systemic exposure.
• Tacrolimus ointment should never be used in conjunction with occlusive dressings.

Use in Children:

• Pediatric patients 2 years of age and older can use Tacrolimus 0.03% ointment.
• Tacrolimus 0.1% ointment is appropriate for children aged 16 and up.
• Tacrolimus ointment was given to patients over the age of 65 in phase 3 studies. These patients’ adverse event profile was consistent with that of other adult patients.

Interaction

Tacrolimus ointment has not been the subject of any formal topical medication interaction studies. Concurrent administration of known CYP3A4 inhibitors should be done with caution in patients with extensive and/or erythrodermic illnesses. Such medications include erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers, and cimetidine.

Contraindications

Patients having a history of hypersensitivity to Tacrolimus or any other component of the product should not use Tacrolimus ointment.

Side Effects

Skin burning, pruritus, flu-like symptoms, allergic responses, skin erythema, skin infections, headache, and other adverse effects are relatively infrequent with topically administered Tacrolimus ointment.

Pregnancy & Lactation

Pregnancy Classification C. There have been no good and well-controlled studies of Tacrolimus used topically in pregnant women. Although systemic absorption of Tacrolimus after topical application is modest compared to systemic dosing, it is known that Tacrolimus is eliminated in human milk. Because of the risk of major Tacrolimus side effects in nursing infants, a decision should be made whether to stop breastfeeding or stop taking the drug, taking into account the drug’s importance to the mother.

Precautions & Warnings

• Tacrolimus ointment should be used with caution in patients with atopic dermatitis who are prone to superficial skin infections.
• Tacrolimus ointment has not been shown to be safe in patients with generalized erythroderma.

Storage Conditions

Do not store at temperatures above 30?C. Keep out of the reach of youngsters and away from light.