;0 1 1 1
Myalgia* 0 3 2 0 0 2 1 1
Cyst* 0 1 3 0 0 1 0 1
Cellulitis 1 1 1 0 0 1 1 1
Exacerbation of Untreated Area 1 0 1 1 0 1 1 1
Procedural Complication 1 0 0 1 0 1 1 1
Hypertension 0 0 1 0 0 2 0 1
Tooth Disorder 0 1 1 1 0 2 1 1
Arthralgia 1 1 3 2 0 2 1 2
Depression 1 2 1 0 0 1 0 1
Paresthesia 1 3 3 0 0 2 1 2
Alopecia 0 1 1 0 0 1 1 1
Urinary Tract Infection
0 0 1 0 0 2 1 2
Ear Pain 1 0 1 0 1 0 1 1
Other adverse events which occurred at an incidence between 0.2% and less than 1% in clinical studies in the above table include: abnormal vision, abscess, anaphylactoid reaction, anemia, anorexia, anxiety, arthritis, arthrosis, bilirubinemia, blepharitis, bone disorder, breast neoplasm benign, bursitis, cataract NOS, chest pain, chills, colitis, conjunctival edema, constipation, cramps, cutaneous moniliasis, cystitis, dehydration, dizziness, dry eyes, dry mouth/nose, dyspnea, ear disorder, ecchymosis, edema, epistaxis, eye pain, furunculosis, gastritis, gastrointestinal disorder, hernia, hypercholesterolemia, hypertonia, hypothyroidism, joint disorder, laryngitis, leukoderma, lung disorder, malaise, migraine, moniliasis, mouth ulceration, nail disorder, neck pain, neoplasm benign, oral moniliasis, otitis externa, photosensitivity reaction, rectal disorder, seborrhea, skin carcinoma, skin discoloration, skin hypertrophy, skin ulcer, stomatitis, tendon disorder, thinking abnormal, tooth caries, sweating, syncope, tachycardia, taste perversion, unintended pregnancy, vaginal moniliasis, vaginitis, valvular heart disease, vasodilatation, and vertigo.
Post-Marketing Events
The following adverse reactions have been identified during postapproval use of PROTOPIC Ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
CNS
Seizures
Neoplasms
Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma
Infections
Bullous impetigo, osteomyelitis, septicemia
Renal
Acute renal failure in patients with or without Netherton’s syndrome, renal impairment
Skin
Rosacea
OVERDOSAGE
PROTOPIC Ointment is not for oral use. Oral ingestion of PROTOPIC Ointment may lead to adverse effects associated with systemic administration of tacrolimus. If oral ingestion occurs, medical advice should be sought.
DOSAGE AND ADMINISTRATION
Adult
PROTOPIC Ointment 0.03% and 0.1%
Apply a thin layer of PROTOPIC (tacrolimus) Ointment to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and sympto |
