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Drug overview for PIMECROLIMUS (pimecrolimus):
Generic name: pimecrolimus (pim-eck-row-LEE-muss)
Drug class: Macrolide Immunosuppressants - Topical
Therapeutic class: Dermatological
Pimecrolimus, a derivative of the macrolactam ascomycin, is an immunosuppressant.
No enhanced Uses information available for this drug.
Generic name: pimecrolimus (pim-eck-row-LEE-muss)
Drug class: Macrolide Immunosuppressants - Topical
Therapeutic class: Dermatological
Pimecrolimus, a derivative of the macrolactam ascomycin, is an immunosuppressant.
No enhanced Uses information available for this drug.
DRUG IMAGES
PIMECROLIMUS 1% CREAM
The following indications for PIMECROLIMUS (pimecrolimus) have been approved by the FDA:
Indications:
Atopic dermatitis
Intractable eczema
Professional Synonyms:
Atopic eczema
Disseminated neurodermatitis
Refractory eczema
Indications:
Atopic dermatitis
Intractable eczema
Professional Synonyms:
Atopic eczema
Disseminated neurodermatitis
Refractory eczema
The following dosing information is available for PIMECROLIMUS (pimecrolimus):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PIMECROLIMUS 1% CREAM | Maintenance | Adults apply a thin layer to the affected area(s) by topical route 2 times per day ; rub in gently and completely |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PIMECROLIMUS 1% CREAM | Maintenance | Adults apply a thin layer to the affected area(s) by topical route 2 times per day ; rub in gently and completely |
The following drug interaction information is available for PIMECROLIMUS (pimecrolimus):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for PIMECROLIMUS (pimecrolimus):
Drug contraindication overview.
Known hypersensitivity to pimecrolimus or any ingredient in the formulation.
Known hypersensitivity to pimecrolimus or any ingredient in the formulation.
There are 0 contraindications.
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Cutaneous t-cell lymphoma |
| Herpes simplex infection |
| Herpes zoster |
| Immunosuppression |
| Malignant neoplasm of skin |
| Netherton's syndrome |
| Pre-malignant skin lesion |
There are 0 moderate contraindications.
The following adverse reaction information is available for PIMECROLIMUS (pimecrolimus):
Adverse reaction overview.
The most common adverse effects of topical pimecrolimus therapy are upper respiratory tract infection, cough, nasopharyngitis, application site reactions (e.g., sensation of burning or warmth), and headache. In addition, an increased incidence of impetigo, skin infection, superinfection (i.e., infected atopic dermatitis), rhinitis, and urticaria has been reported in patients receiving topical pimecrolimus 1% cream and topical corticosteroids sequentially compared with those receiving pimecrolimus 1% cream alone.
The most common adverse effects of topical pimecrolimus therapy are upper respiratory tract infection, cough, nasopharyngitis, application site reactions (e.g., sensation of burning or warmth), and headache. In addition, an increased incidence of impetigo, skin infection, superinfection (i.e., infected atopic dermatitis), rhinitis, and urticaria has been reported in patients receiving topical pimecrolimus 1% cream and topical corticosteroids sequentially compared with those receiving pimecrolimus 1% cream alone.
There are 22 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bronchitis Fever Gastroenteritis Influenza Otitis externa Pharyngitis due to streptococcus pyogenes Skin and skin structure infection Tonsillitis Upper respiratory infection Viral infection |
Asthma Bacterial infection Chickenpox Dyspnea Herpes simplex infection Hypersensitivity drug reaction Lacerations Molluscum contagiosum infection Pneumonia Superficial ocular infection Urticaria |
| Rare/Very Rare |
|---|
|
Malignancy |
There are 29 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cough Diarrhea Folliculitis Headache disorder Pharyngitis Pruritus of skin Skin irritation Sore throat Treatment site sequelae |
Abdominal pain with cramps Acne vulgaris Acute bacterial otitis media Arthralgia Back pain Constipation Dysmenorrhea Epistaxis Erythema Impetigo Loose stools Nasal congestion Nausea Rhinorrhea Sinusitis Skin nodules Toothache Vomiting Wheezing |
| Rare/Very Rare |
|---|
|
Dyschromia |
The following precautions are available for PIMECROLIMUS (pimecrolimus):
Safety and efficacy of topical pimecrolimus not established in children younger than 2 years of age. Not recommended for use in children younger than 2 years of age. In clinical trials, an increased incidence of upper respiratory tract infections was observed in children younger than 2 years of age receiving pimecrolimus cream compared with those receiving placebo.
In pharmacokinetic studies, following multiple topical applications of pimecrolimus 1% cream, a higher incidence of upper respiratory symptoms and/or infections was observed in infants 3-23 months of age than in older children; however, the relationship to pimecrolimus therapy is not known. Not recommended for use in immunocompromised children. Long-term effects on the developing immune system in infants and children are not known.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
In pharmacokinetic studies, following multiple topical applications of pimecrolimus 1% cream, a higher incidence of upper respiratory symptoms and/or infections was observed in infants 3-23 months of age than in older children; however, the relationship to pimecrolimus therapy is not known. Not recommended for use in immunocompromised children. Long-term effects on the developing immune system in infants and children are not known.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.)
Not known whether pimecrolimus is distributed into milk. Discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Experience with topical pimecrolimus therapy in those 65 years of age and older insufficient to determine whether they respond differently than younger adults.
The following prioritized warning is available for PIMECROLIMUS (pimecrolimus):
WARNING: The long-term safety of this drug is not known. There have been rare reports of cancer (such as skin cancer, lymphoma) in patients using pimecrolimus on the skin. It is unknown if pimecrolimus caused these cancers.
Because of this possible risk, this drug should be used only if other drugs have not worked or if your doctor decides that other medications should not be used for your condition. Pimecrolimus should be used on the skin for short treatment periods only. If needed, treatment may be repeated with breaks in between.
Use the smallest amount that will treat your condition properly, and apply only on the affected skin. This medication should not be used by children younger than 2 years. Discuss the risks, benefits, and proper use of this medication with your doctor. Tell your doctor right away if you develop any of the following: unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, or swollen lymph nodes.
WARNING: The long-term safety of this drug is not known. There have been rare reports of cancer (such as skin cancer, lymphoma) in patients using pimecrolimus on the skin. It is unknown if pimecrolimus caused these cancers.
Because of this possible risk, this drug should be used only if other drugs have not worked or if your doctor decides that other medications should not be used for your condition. Pimecrolimus should be used on the skin for short treatment periods only. If needed, treatment may be repeated with breaks in between.
Use the smallest amount that will treat your condition properly, and apply only on the affected skin. This medication should not be used by children younger than 2 years. Discuss the risks, benefits, and proper use of this medication with your doctor. Tell your doctor right away if you develop any of the following: unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, or swollen lymph nodes.
The following icd codes are available for PIMECROLIMUS (pimecrolimus)'s list of indications:
| Atopic dermatitis | |
| L20 | Atopic dermatitis |
| L20.0 | Besnier's prurigo |
| L20.8 | Other atopic dermatitis |
| L20.81 | Atopic neurodermatitis |
| L20.82 | Flexural eczema |
| L20.84 | Intrinsic (allergic) eczema |
| L20.89 | Other atopic dermatitis |
| L20.9 | Atopic dermatitis, unspecified |
| Intractable eczema | |
| L20.82 | Flexural eczema |
| L20.84 | Intrinsic (allergic) eczema |
Formulary Reference Tool