Pimecrolimus (pimecrolimus)
Macrolide Immunosuppressants - Topical Topical Cream (Gram)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Pimecrolimus, a derivative of the macrolactam ascomycin, is an immunosuppressant.
Pimecrolimus, a derivative of the macrolactam ascomycin, is an immunosuppressant. Pimecrolimus is structurally related to tacrolimus. The exact mechanism(s) of action of pimecrolimus in the management of atopic dermatitis has not been elucidated but appears to be similar to that of tacrolimus and to involve inhibition of the activation of T cells.
Pimecrolimus, like tacrolimus, also has been shown to prevent release of inflammatory mediators from mast cells. Although pimecrolimus is not genotoxic and does not interact directly with DNA, the drug may impair local immunosurveillance.
Following multiple topical applications of pimecrolimus 1% cream to atopic dermatitis lesions in adults or in children 2-14 years of age, pimecrolimus is not appreciably absorbed into the systemic circulation. However, detectable amounts of pimecrolimus were present in a greater proportion of plasma samples obtained following topical application of the drug in infants and children with atopic dermatitis compared with adults, possibly because of the large skin surface area-to-body mass ratio in pediatric patients. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.) Studies in adults suggest that pimecrolimus does not accumulate systemically following intermittent topical application of the cream for periods up to 1 year. Following oral administration, pimecrolimus is metabolized in the liver principally via demethylation by cytochrome P-450 (CYP) 3A isoenzymes.
USES: Pimecrolimus is used to treat certain skin conditions such as eczema (atopic dermatitis) in people who should not use or have not responded to other eczema medications (such as topical steroids). Eczema is an allergic-type condition that causes red, irritated, and itchy skin. This drug works by changing the skin's defense (immune) system, thereby decreasing the allergic reaction that causes eczema.
Pimecrolimus belongs to a class of drugs known as topical calcineurin inhibitors (TCIs).
Generic name: pimecrolimus
Pronunciation: (pim-eck-row-LEE-muss)
Drug class: Macrolide Immunosuppressants - Topical
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Pimecrolimus
Indications
The following indications are listed for Pimecrolimus:
- Atopic Dermatitis
- Intractable Eczema
Also known as: Atopic Eczema, Disseminated Neurodermatitis, Refractory Eczema.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Pimecrolimus 1% Cream | Maintenance | 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 | Instructions |
|---|---|---|
| Pimecrolimus 1% Cream | Maintenance | Apply a thin layer to the affected area(s) by topical route 2 times per day ; rub in gently and completely. |
Drug interactions
No formal drug interaction studies have been performed.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Known hypersensitivity to pimecrolimus or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
- Cutaneous t-cell lymphoma
- Herpes simplex infection
- Herpes zoster
- Immunosuppression
- Malignant neoplasm of skin
- Netherton's syndrome
- Pre-malignant skin lesion
There are no moderate contraindications for this drug.
Adverse reactions
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.
More Frequent
- Bronchitis
- Fever
- Gastroenteritis
- Influenza
- Otitis externa
- Pharyngitis due to streptococcus pyogenes
- Skin and skin structure infection
- Tonsillitis
- Upper respiratory infection
- Viral infection
Less Frequent
- Asthma
- Bacterial infection
- Chickenpox
- Dyspnea
- Herpes simplex infection
- Hypersensitivity drug reaction
- Lacerations
- Molluscum contagiosum infection
- Pneumonia
- Superficial ocular infection
- Urticaria
Rare or Very Rare
- Malignancy
More Frequent
- Cough
- Diarrhea
- Folliculitis
- Headache disorder
- Pharyngitis
- Pruritus of skin
- Skin irritation
- Sore throat
- Treatment site sequelae
Less Frequent
- 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 or Very Rare
- Dyschromia
Precautions
No enhanced messaging available.
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.
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.
ICD codes
| Code | Type | Description |
|---|---|---|
| Atopic dermatitis | ||
| L20 | ICD10CM | Atopic dermatitis |
| L20.0 | ICD10CM | Besnier's prurigo |
| L20.8 | ICD10CM | Other atopic dermatitis |
| L20.81 | ICD10CM | Atopic neurodermatitis |
| L20.82 | ICD10CM | Flexural eczema |
| L20.84 | ICD10CM | Intrinsic (allergic) eczema |
| L20.89 | ICD10CM | Other atopic dermatitis |
| L20.9 | ICD10CM | Atopic dermatitis, unspecified |
| Intractable eczema | ||
| L20.82 | ICD10CM | Flexural eczema |
| L20.84 | ICD10CM | Intrinsic (allergic) eczema |
ICD code information from First Databank (FDB).
Formulary status
Search health-plan coverage for this drug by ZIP code.
Choose the first character of a health plan name.
Last reviewed · Source: First Databank (FDB) drug data
On this page
Actions
Sign in to save favorites
Saving this drug requires a free Physicians Office Resource account.