Vitilimus Ointment 30gm

Product Information

VITILIMUS

Vitilimus ® Tacrolimus

Presentation

Vitilimus 0.03% Ointment : Each gram ointment contains Tacrolimus Monohydrate INN equivalent to Tacrolimus 0.3mg

Vitilimus 0.1% Ointment : Each gram ointment contains Tacrolimus Monohydrate INN equivalent to Tacrolimus 1mg

Indications

Flare treatment

Adults and adolescents (16 years of age and above): Treatment of moderate to severe atopic dermatitis in adults who are not

adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.

Maintenance treatment

Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in

patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial

response to a maximum of 6 weeks treatment of twice daily Vitilimus (Tacrolimus) ointment (lesions cleared, almost cleared or

mildly affected).

Dosage and administration

Flare treatment

Vitilimus (Tacrolimus) ointment can be used for short-term and intermittent long-term treatment. Treatment should not be

continuous on a long-term basis. Vitilimus (Tacrolimus) treatment should begin at the first appearance of signs and symptoms. Each

affected region of the skin should be treated with Vitilimus (Tacrolimus) until lesions are cleared, almost cleared or mildly

affected. Thereafter, patients are considered suitable for maintenance treatment. At the first signs of recurrence (flares) of the

disease symptoms, treatment should be re-initiated. Adults and adolescents (16 years of age and above): Treatment should be

started with Vitilimus (Tacrolimus) 0.1% ointment twice a day and treatment should be continued until clearance of the lesion.

If symptoms recur, twice daily treatment with Vitilimus (Tacrolimus) 0.1% should be restarted. An attempt should be made to reduce

the frequency of application or to use the lower strength Vitilimus (Tacrolimus) 0.03% ointment if the clinical condition allows.

Generally, improvement is seen within one week of starting treatment. If no signs of improvement are seen after two weeks of

treatment, further treatment options should be considered.

Elderly patient: Specific studies have not been conducted in elderly patients. However, the clinical experience available in this

patient population has not shown the necessity for any dosage adjustment.

Pediatric population: Only Vitilimus (Tacrolimus) 0.03% ointment should be used in children from the age of 2 to 16 years.

Vitilimus (Tacrolimus) ointment should not be used in children aged below 2 years until further data are available.

Maintenance treatment

Patients who are responding to up to 6 weeks treatment using Vitilimus (Tacrolimus) ointment twice daily (lesions cleared, almost

cleared or mildly affected) are suitable for maintenance treatment. Adults and adolescents (16 years of age and above): Adult

patients (16 years of age and above) should use Vitilimus (Tacrolimus) 0.1% ointment. Vitilimus (Tacrolimus) ointment should be

applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression

to flares. Between applications there should be 2-3 days without Vitilimus (Tacrolimus) treatment. After 12 months treatment, a

review of the patient`s condition should be conducted by the physician and a decision taken whether to continue maintenance

treatment in the absence of safety data for maintenance treatment beyond 12 months. If signs of a flare reoccur, twice daily

treatment should be re-initiated.

Elderly patients: Specific studies have not been conducted in elderly patients. Paediatric population: Only Vitilimus (Tacrolimus)

0.03 % ointment should be used in children from the age of 2 to 16 years. Vitilimus (Tacrolimus) ointment should not be used in

children aged below 2 years until further data are available.

Method of administration:

Vitilimus (Tacrolimus) ointment should be applied as a thin layer to affected or commonly affected areas of the skin. Tacrolimus

ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. Tacrolimus

ointment should not be applied under occlusion because this method of administration has not been studied in patients.

Contra-indications, warnings, etc.

Contra-indications: Vitilimus (Tacrolimus) ointment is contra-indicated to known hypersensitivity to Tacrolimus, macrolides in

general, or to any of the excipients. Warning and precautions: Exposure of the skin to sunlight should be minimized and the use of

ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use

of Tacrolimus ointment. Physicians should advise patients on appropriate sun protection methods, such as minimization of the time

in the sun, use of a sunscreen product and covering of the skin with appropriate clothing. Tacrolimus ointment should not be

applied to lesions that are considered to be potentially malignant or pre-malignant. The development of any new change different

from previous eczema within a treated area should be reviewed by the physician. The use of Tacrolimus ointment is not recommended

in patients with a skin barrier defect. These skin conditions may increase systemic absorption of Tacrolimus. Oral use of

Tacrolimus is also not recommended to treat these skin conditions. Post-marketing cases of increased Tacrolimus blood level have

been reported in these conditions. Care should be exercised if applying Tacrolimus to patients with extensive skin involvement

over an extended period of time; especially in children. Patients, particularly paediatric patients should be

continuously evaluated during treatment with Tacrolimus with respect to the response to treatment and the continuing need for

treatment. After 12 months this evaluation should include suspension of Tacrolimus treatment in paediatric patients. The potential

for local immunosuppression (possibly resulting in infections or cutaneous malignancies) in the long term (i.e. over a period of

years) is unknown. Vitilimus ointment contains the active substance Tacrolimus, a calcineurin inhibitor. In transplant patients,

prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been

associated with an increased risk of developing lymphomas and skin malignancies. In patients using Tacrolimus ointment, cases of

malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers have been

reported. Tacrolimus should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that

cause immunosuppression. Patients with atopic dermatitis treated with Tacrolimus have not been found to have significant systemic

Tacrolimus levels. Lymphadenopathy was uncommonly (0.8%) reported in clinical trials. The majority of these cases were related to

infections (skin, respiratory tract, and tooth) and resolved with appropriate antibiotic therapy. Transplant patients receiving

immunosuppressive regimens (e.g. systemic Tacrolimus) are at increased risk for developing lymphoma; therefore patients

who receive Tacrolimus and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy

resolves. Lymphadenopathy present at initiation of therapy should be investigated and kept under review. In case of

persistent lymphadenopathy, the aetiology of the lymphadenopathy should be investigated. In the absence of a clear aetiology for

the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Tacrolimus should be

considered. Tacrolimus ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic

dermatitis. Before commencing treatment with Tacrolimus ointment, clinical infections at treatment sites should be cleared.

Patients with atopic dermatitis are predisposed to superficial skin infections. Treatment with Tacrolimus may be associated with

an increased risk of folliculitis and herpes viral infections. In the presence of these infections, the balance of risks

and benefits associated with Tacrolimus use should be evaluated. Emollients should not be applied to the same area within 2 hours

of applying Tacrolimus ointment. Concomitant use of other topical preparations has not been assessed. There is no experience

with concomitant use of systemic steroids or immunosuppressive agents. Care should be taken to avoid contact with eyes and

mucous membranes. If accidentally applied to these areas, the ointment should be thoroughly wiped off and/or rinsed off with

water. The use of Tacrolimus ointment under occlusion has not been studied in patients. Occlusive dressings are not recommended.

As with any topical medicinal product, patients should wash their hands after application if the hands are not intended for

treatment. Tacrolimus is extensively metabolized in the liver and although blood concentrations are low following topical therapy,

the ointment should be used with caution in patients with hepatic failure. Drug interactions: Formal topical drug interaction

studies with Tacrolimus ointment have not been conducted. Tacrolimus is not metabolised in human skin, indicating that there is

no potential for percutaneous interactions that could affect the metabolism of Tacrolimus. Systemically available Tacrolimus is

metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4). Systemic exposure from topical application of Tacrolimus ointment is low

(< 1.0 ng/ml) and is unlikely to be affected by concomitant use of substances known to be inhibitors of CYP3A4. However, the

possibility of interactions cannot be ruled out and the concomitant systemic administration of known CYP3A4 inhibitors (e.g.

erythromycin, itraconazole, ketoconazole and diltiazem) in patients with widespread and/or erythrodermic disease should be done

with caution. Use in Pregnancy: There are no adequate data from the use of Tacrolimus ointment in pregnant women. Studies in

animals have shown reproductive toxicity following systemic administration. The potential risk for humans is unknown. Tacrolimus

ointment should not be used during pregnancy unless clearly necessary. Use in lactation: Human data demonstrate that, after

systemic administration, Tacrolimus is excreted into breast milk. Although clinical data have shown that systemic exposure

from application of Tacrolimus ointment is low, breast-feeding during treatment with Tacrolimus ointment is not recommended.

Side effects: pplication-site reactions including rash, irritation, pain and paraesthesia; herpes simplex infection;

application-site infections (with preventative therapy); less commonly acne; rosacea and skin malignancy also reported. Overdose:

Overdosage following topical administration is unlikely. If ingested, general supportive measures may be appropriate. These may

include monitoring of vital signs and observation of clinical status. Due to the nature of the ointment vehicle, induction of

vomiting or gastric lavage is not recommended.

Pharmaceutical precautions

Store in a cool & dry place, protected from light.

Packaging quantities

Vitilimus 0.03% Ointment: Carton containing 30g ointment in alu tube.

Vitilimus 0.1% Ointment: Carton containing 30g ointment in alu tube.