What is tacrolimus ointment, and how does it work (mechanism of action)?
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.
What brand names are available for tacrolimus ointment?
Is tacrolimus ointment available as a generic drug?
GENERIC AVAILABLE: No
Do I need a prescription for tacrolimus ointment?
What are the side effects of tacrolimus ointment?
The most common side effects of tacrolimus ointment are
skin reactions at the site of use, including:
What is the dosage for tacrolimus ointment?
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.
Which drugs or supplements interact with tacrolimus ointment?
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.
Is tacrolimus ointment safe to take if I’m pregnant or breastfeeding?
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.
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.
What else should I know about tacrolimus ointment?
What preparations of tacrolimus ointment are available?
Ointment: 0.03% and 0.1%.
How should I keep tacrolimus ointment stored?
Tacrolimus should be stored at room temperature 15 C – 30 C
(59 F – 86 F).
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Medically Reviewed on 3/1/2019
Reference: FDA Prescribing Information