tacrolimus ointment, Protopic

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GENERIC NAME: tacrolimus ointment

BRAND NAME: Protopic

DRUG CLASS AND MECHANISM: Tacrolimus ointment is a topical drug (a drug that is applied to the skin) that is used for the treatment of atopic dermatitis (eczema). Atopic dermatitis is a chronic (long-lasting) disease of skin in which the skin becomes inflamed, causing itchiness, redness, swelling, cracking, weeping, crusting, and scaling. The inflammation is caused by activation of the immune system though the reason for the activation is unknown. Tacrolimus ointment suppresses the immune system and the inflammation by inhibiting an enzyme (calcineurin) crucial for the multiplication of T-cells, cells that are required for activation of the immune system. Tacrolimus ointment was approved for the treatment of atopic dermatitis in December 2000.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Ointment: 0.03% and 0.1%.

STORAGE: Tacrolimus should be stored at room temperature 15-30 C (59-86 F).

PRESCRIBED FOR: Tacrolimus ointment is used for the treatment of moderate to severe atopic dermatitis in adults and children who have normal immune systems and have not responded to other topical treatments or in whom other topical treatments cannot be used.

DOSING: Tacrolimus ointment is applied to the affected areas of skin twice daily. The 0.1% concentration of tacrolimus ointment is approved for the treatment of adults, while the 0.03% concentration is approved for the treatment of both children (ages two and older) and adults.

DRUG INTERACTIONS: No studies have been done to determine if tacrolimus ointment has important interactions with other drugs. Interactions are unlikely because only small amounts of tacrolimus are absorbed from the skin; however, it still is possible that important interactions might occur.

PREGNANCY: Only small amounts of tacrolimus are absorbed from the ointment, and it is not known if these amounts are toxic to the fetus. Among women who have received oral tacrolimus while pregnant, high potassium levels and kidney injury have been reported in their newborns. Therefore, tacrolimus ointment should be used during pregnancy only if the benefits outweigh the potential risks to the fetus.

NURSING MOTHERS: Only small amounts of tacrolimus are absorbed from the ointment, and it is not known how much, if any, appears in breast milk. However, it is known that tacrolimus, when taken orally, passes into breast milk. Consideration should be given to discontinuing either breastfeeding or tacrolimus ointment in nursing mothers.

SIDE EFFECTS: The most common side effects of tacrolimus ointment are skin reactions at the site of use, including redness, burning, and itching. Flu-like symptoms, allergic reactions, and headache also have been reported. Continuous long-term use of tacrolimus should be avoided because rare cases of skin cancer and lymphoma have occurred during tacrolimus treatment.

Reference: FDA Prescribing Information


Last Editorial Review: 4/27/2012




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