tacrolimus ointment (Rx)Brand and Other Names:Protopic

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ointment

  • 0.03%
  • 0.1%
more...

Atopic Dermatitis

0.03% or 0.1% ointment: Apply thin layer to affected area q12hr; discontinue treatment when symptoms have cleared; if no improvement within 6 weeks, reassess diagnosis

Dosage Forms & Strengths

ointment

  • 0.03%
  • 0.1%
more...

Atopic Dermatitis

<2 years old: Not recommended

2-15 years: 0.03% ointment: Apply thin layer to affected area q12hr

>15 years: Apply 0.03% or 0.1% ointment as thin layer to affected area q12hr; discontinue treatment when symptoms have cleared; if no improvement within 6 weeks, reassess diagnosis

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Adverse Effects

>10%

Burning sensation (43-58%)

Pruritus (41-46%)

Flu-like symptoms (23-31%)

Skin erythema (12-28%)

Headache (5-20%)

Postmarketing Reports

CNS: Seizures

Infections: Bullous impetigo, osteomyelitis, septicemia

Neoplasms: Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma

Renal: Acute renal failure in patients with or without Netherton’s syndrome, renal impairment

Skin: Rosacea, application site edema

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Warnings

Black Box Warnings

Rare cases of malignancy reported (although causal relationship not identified)

Avoid long-term use and limit application to areas of atopic dermatitis

Not indicated for use in children <2 yr

Only 0.03% ointment indicated for children aged 2-15 years

Contraindications

Hypersensitivity

Age <2 yr

Cautions

Preferably use as second-line agents for short-term & intermittent treatment in unresponsive to, or intolerant of other treatments

Do not use with occlusive dressings

May be associated with development of lymphadenopathy

Not for application in areas with active viral or bacterial infections

Acute renal failure reported (rare)

Potential risk of lymphoma and skin cancer

Not recommended in patients having skin conditions with a skin barrier defect where there is the potential for increased systemic absorption of tacrolimus (eg, Netherton's syndrome, lamellar ichthyosis, generalized erythroderma, cutaneous graft vs host disease)

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Not known whether tacrolimus is distributed in milk following topical administration to skin

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Unknown; inhibits T-cell activation by binding to intracellular protein FKBP-12 and complexes with calcineurin dependent proteins

Pharmacokinetics

Absorption: No systemic absorption detected

Bioavailability: 0.5%

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Images

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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