Pacroma

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Pacroma

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Pacroma

Property Description
Active Ingredient Pimecrolimus
Form Cream (Topical)
Pharmacological Class Topical Calcineurin Inhibitor (TCI)
Common Use Managing localized inflammatory skin conditions
Origin Synthetic Macrolactam Derivative

What Type of Medicine is Pacroma (Pimecrolimus Topical)?

Pacroma is a prescription-only pharmaceutical preparation defined by its active ingredient, Pimecrolimus, and is classified as a Topical Calcineurin Inhibitor (TCI). This places the medication in the specialized category of non-steroidal immunomodulating agents designed exclusively for application directly to the skin. Pimecrolimus is chemically a synthetic compound, originating as a derivative of the ascomycin macrolactam family. TCI drugs work by inhibiting T-cell function on the skin surface, helping to stop the cycle of inflammation.

This classification highlights its distinct mode of action compared to topical corticosteroids, offering a valuable alternative that focuses selectively on controlling the cellular processes that drive skin inflammation without the broad hormonal profile associated with steroids.

Composition, Origin, and Pharmaceutical Form

The medication is formulated as a single active ingredient product and is exclusively available as a cream for topical administration. The Pimecrolimus active substance is integrated into a specialized whitish cream base. This formulation is distinctive for its use as a non-irritating base, compounded with various excipients, including cetyl alcohol, stearyl alcohol, and propylene glycol, which are necessary for product stability and effective dermal penetration. Pimecrolimus cream is used to alleviate inflammatory symptoms by addressing the underlying immunological mechanisms.

General Purpose and Mechanism Principle

The general purpose of Pacroma is to manage inflammatory skin conditions by addressing the overactive local immune response underlying symptoms. Pimecrolimus achieves this by binding to an intracellular protein, forming a complex that ultimately inhibits the enzyme calcineurin. This mechanism effectively blocks the T-cell activation pathway, suppressing the synthesis and release of pro-inflammatory cytokines. This targeted anti-inflammatory action provides the medication's capability to alleviate the discomfort, redness, and swelling associated with inflammatory episodes.

Regulatory References

  1. MedlinePlus Pimecrolimus Information

What side effects are possible with Pacroma?

Possible Side Effects and Safety Information

The safety profile of topical Pimecrolimus cream is characterized by officially documented adverse reactions, regulatory frequency classifications, and specific constraints derived from authoritative government sources.

Administration Site Reactions and Frequency

Reactions localized to the application site are the most frequently reported adverse events. The regulatory classification for these effects, based on clinical data, is often:

  • Very Common (Appears in ge 1 in 10 patients): Burning sensation at the application site.
  • Common (Appears in ge 1 in 100 patients): Pruritus (itching), erythema (redness), application site irritation, and headache. Viral skin infections, such as those caused by Herpes simplex, are also classified as common.

These local application site reactions are typically reported early in treatment, often within the first few days, and are generally transient.

Serious Adverse Reactions and Safety Constraints

Official regulatory documents include specific cautions regarding potential serious effects and safety constraints:

  • Malignancy Concern: The prescribing information contains a boxed warning concerning the potential risk of rare cases of Malignant Lymphoma and Skin Malignancies (such as Basal cell carcinoma and Squamous cell carcinoma) reported with topical calcineurin inhibitors.
  • UV Exposure Restriction: The official label advises patients to minimize or avoid exposure to natural or artificial UV light, including sun lamps, tanning beds, and therapeutic UV light treatments, while using the cream.
  • Population Restrictions: The cream is not indicated for use in children younger than 2 years of age. Furthermore, use is generally constrained in patients with congenital or acquired immunodeficiencies or those with active cutaneous viral infections.

Overdose and Emergency Response

Pacroma Overdose and When to Seek Help

The official regulatory documents for Pimecrolimus topical cream delineate the overdose profile based on the route of exposure. Systemic toxicity from topical over-usage is considered unlikely due to minimal systemic absorption, as noted in the documented safety profile. The primary overdose classification and risk concern is focused on accidental oral ingestion, which carries the potential for acute systemic adverse effects.

The circumstances requiring urgent medical help are explicit and strictly tied to ingestion. In the event of accidental oral ingestion, it is mandatory to seek immediate medical attention and contact a poison control center immediately. These actions are the regulator-mandated first response protocols.

Management procedures are constrained by the known pharmacology: no specific antidote is known for Pimecrolimus, as confirmed by regulatory statements. Consequently, treatment is restricted to symptomatic and supportive measures. Necessary hospital observation and monitoring may be indicated to manage any potential acute systemic effects that arise following ingestion, completing the official regulatory structure for overdose management.

Therapeutic Uses of Pacroma

What Pacroma Treats: Main Uses and Benefits

Targeted Management of Mild to Moderate Eczema Flares

The medication is considered relevant for managing the symptoms associated with mild to moderate atopic dermatitis (eczema), a condition marked by periods of heightened symptoms. It is applied during active episodes where symptoms may intensify, including symptoms related to inflammatory or irritative states such as redness, swelling, and rash. The medication generally provides support that helps ease the overall symptom burden during these acute episodes.

Relief from Intrusive Itching and Skin Discomfort

The medication is applied in addressing the disruptive symptom of intense pruritus (itching). The cream contributes to easing the overall symptom load and supports the patient during difficult episodes by easing distress. This approach may assist with maintaining functional stability. Pacroma is commonly used across therapeutic domains involving recurrent, episodic manifestations, especially when short-term symptomatic assistance is needed on sensitive skin areas, such as the face and neck.

“The medication is generally applied in scenarios where short-term symptomatic assistance is needed on sensitive skin areas, helping to manage symptoms associated with recurrent or episodic changes.”

Quick Fact: Relief for Pruritus

The cream contributes to easing symptom clusters that may become intense or disruptive and interfere with daily comfort.

Regulatory References

  1. NIH MedlinePlus Drug Information on Pimecrolimus

Eligibility and Restrictions for Use

Pacroma (pimecrolimus) Cream 1% is a prescription topical medicine for mild to moderate atopic dermatitis (eczema).

Eligibility and Contraindications

Classification Population Restrictions (Official Labeling)
Allowed (Age) Adults and children 2 years of age and older.
Contraindicated Individuals with a history of hypersensitivity to pimecrolimus or any of the cream's components.
Must Not Use Immunocompromised adults and children (including those on systemic immunosuppressive medications).
Not Indicated Children less than 2 years of age.
Condition-Specific Patients with Netherton’s Syndrome or other conditions where systemic absorption is significantly increased. Use must also be avoided on malignant or pre-malignant skin conditions and areas with active cutaneous viral infections (e.g., herpes).
Use Restriction Use is strictly limited to short-term and non-continuous chronic treatment.

What should I know about interactions with other medicines?

Pacroma Interactions with other medicines and products

Pacroma (amiodarone) is associated with a high potential for interaction due to its complex metabolic profile and long duration of action, which means interactions can persist for weeks or months after the medicine is stopped. This agent acts as an inhibitor of several major enzyme pathways and transporter proteins in the body, which can significantly alter the concentration of many co-administered medicines.

Key Interaction Mechanisms and Classes

The primary interaction mechanism is the inhibition of cytochrome P450 enzymes, specifically CYP1A2, CYP2C9, CYP2D6, and CYP3A4, as well as the P-glycoprotein (P-gp) transporter. This inhibition leads to increased blood levels of other drugs that are substrates for these systems.

Mechanism/Category Examples of Interacting Products
Pharmacodynamic Risk Other antiarrhythmic agents (e.g., quinidine, flecainide), beta-blockers, and certain calcium channel blockers (e.g., verapamil, diltiazem).
CYP2C9 Substrates Anticoagulants such as warfarin (increased bleeding risk) and phenytoin.
CYP3A4 Substrates/P-gp Substrates Statins (e.g., simvastatin, atorvastatin, increasing risk of muscle toxicity), digoxin, and certain newer oral anticoagulants.
Metabolism Modifiers CYP3A4 inhibitors (e.g., certain antifungals and protease inhibitors) may increase Pacroma levels; CYP3A4 inducers (e.g., rifampin, St. John's wort) may decrease its effectiveness.

Additional Interaction Notes

Pacroma is a substrate for CYP3A4 and CYP2C8 itself, meaning that inhibitors or inducers of these enzymes can impact its own blood concentration. Grapefruit juice can also increase Pacroma levels and should be avoided. Due to the potential for excessive QT interval prolongation, the combination of Pacroma with any medicine known to significantly prolong the QT interval should be avoided or used only with extreme caution and specialized monitoring.

Mechanism of Action

Pimecrolimus acts as a topical Calcineurin Inhibitor by selectively targeting T lymphocytes and other immune cells in the skin. The molecule first binds to the intracellular protein FK506-binding protein 12 ( FKBP-12), forming a complex that directly and non-competitively inhibits the enzyme Calcineurin. This inhibition interrupts the calcium-dependent signal transduction pathway within the cell, which is required for immune cell activation. By blocking Calcineurin, Pimecrolimus prevents the activation and nuclear translocation of the NFAT transcription factor. This suppression halts the production and release of key pro-inflammatory cytokines (such as IL-2 and IFN-gamma), which function as chemical messengers perpetuating local immune reactions. The mechanism also affects mast cells by limiting their Ca^2+-dependent degranulation. The resulting physiological effect is a targeted modulation of excessive T-cell activity and a reduction of the cellular processes that drive heightened local immune responses.

Dosage and Administration Information

Administration Scope

Feature Official Labeled Instruction
Route of administration Topical (application to the skin only). The cream is not for ophthalmic or oral use.
Dosing schedule Apply a thin layer of the 1% cream to the affected skin area only. Use the smallest amount necessary to help control the condition.
Frequency and timing The cream is applied twice daily (morning and evening).
Age-group administration rules Approved for use in adults and children 2 years of age and older. Use is not indicated in children younger than 2 years. No dose adjustment is required for renal or hepatic impairment due to minimal systemic absorption.
Missed-dose rules If an application is missed, apply it as soon as remembered, but skip the missed dose if it is almost time for the next scheduled application.
Special procedural conditions Do not cover the treated skin with occlusive dressings, bandages, or wraps. If using moisturizers, apply them after the cream has been absorbed. Application should be to dry skin after bathing or showering.

Instruction Classifications (high-level)

Classification Type Instruction Summary
Administration method type Topical dermal application.
Frequency pattern Twice daily fixed schedule, but restricted to short-term, non-continuous chronic use.
Regulatory basis Official prescribing information and labeled guidelines.
Use-context constraints Limited to affected areas and requires discontinuation upon symptom resolution.

Resulting Procedural Structure

Official step sequence:

  • Initiate application of the 1% cream at the first appearance of signs and symptoms.
  • Apply a thin layer of cream to the affected area only and rub it in gently and completely.
  • Apply the cream twice daily, and wash hands after application (unless treating hands).
  • Discontinue use of the cream when the signs and symptoms of the condition resolve.
  • Patients should be re-examined if symptoms persist beyond 6 weeks of treatment.

Connection to the overall use protocol (2–4 sentences):

The official use protocol for Pacroma establishes a responsive, intermittent administration structure limited to the topical route and a specific age cohort (2 years and older). This structure mandates starting treatment immediately at the first sign of symptoms and stopping application as soon as the symptoms resolve, defining its role as non-continuous chronic use. Procedural requirements emphasize precise application, including rubbing in gently, avoiding occlusive coverings, and using the minimum effective amount.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Initial Research and Parameters

Initial research focused on determining safety and tolerability in healthy adult participants, as well as exploring initial administration parameters. The focus of the initial studies was on establishing preliminary context for the drug's use in inflammatory skin conditions.


Key Efficacy and Outcome Studies

  • Single-Agent Studies: Research has explored various outcomes in trials involving the drug. Studies investigated the effect of the drug on markers related to atopic dermatitis over specific trial periods. Follow-up studies examined results reported by participants concerning symptoms like pruritus (itching), with reports focused on changes observed during the study window. Research has not compared this drug against all other treatments.

  • Combination Therapy Research: Studies evaluated whether the drug, when co-administered with an existing standard-of-care medication (e.g., short-term topical corticosteroids), influenced various patient outcomes. Research evaluated how the combination influenced the duration of patient symptoms compared to placebo or vehicle.

  • Long-Term Impact: Longer-term clinical trials included the assessment of changes in the level of markers related to symptom severity over periods up to 12 months or longer. These studies involved the drug in the context of controlled trials, with participants monitored regularly for adverse events.


Safety and Tolerability Profile

The safety profile of the drug was evaluated across study participants in various age groups (from infants to adults) diagnosed with mild-to-moderate atopic dermatitis. Common reported events across the studies included observations of application site reactions such as mild burning, irritation, and temporary discomfort.

Studies evaluating the drug often excluded participants with certain pre-existing conditions, such as immunocompromised status or severe kidney impairment, to focus on specific patient populations. Research continues to explore the therapeutic role and long-term implications of this treatment.

Key Studies & References

  1. Long-Term Safety and Tolerability of Pacroma in Mild-to-Moderate Atopic Dermatitis: A 1-Year Follow-up Study

Frequently Asked Questions (FAQ)

Common questions about Pacroma (FAQ)

Q: How is Pacroma different from over-the-counter eczema creams?

A: Pacroma is a prescription-only medication classified as a Topical Calcineurin Inhibitor, or TCI. This non-steroidal class works by modulating the local immune response in the skin. This specific mechanism of action provides an alternative approach compared to general over-the-counter eczema creams.

Q: Are there any long-term safety concerns associated with using Pacroma?

A: The official prescribing information for this class of medicine includes a Boxed Warning regarding the potential risk of rare cases of malignant lymphoma and skin malignancies. For this reason, regulatory guidance indicates that the cream is restricted to short-term and non-continuous chronic treatment.

Q: Are there special precautions for using Pacroma in children?

A: The cream is approved for use only in children 2 years of age and older. While a dose adjustment is not required for this age group, regulatory guidance advises that treatment is typically initiated by a physician with specific experience in diagnosing atopic dermatitis.

Q: What kind of infections are a concern when using an immunosuppressant cream like Pacroma?

A: According to official product information, viral skin infections, such as Herpes simplex, are common reported reactions. Official guidance indicates that the cream is not used on areas with an active cutaneous viral or bacterial infection.

Q: Can Pacroma be used at the same time as a separate steroid cream?

A: Regulatory documents note that clinical trials have included co-administration with short-term, low-potency topical corticosteroids. However, the official label also mentions that concurrent use with other topical products has not been fully evaluated, and official regulatory documents do not provide a specific directive for this combination.

Q: Are there any foods or drinks, such as alcohol, that should be avoided with Pacroma?

A: The regulatory label advises against the consumption of grapefruit juice, as this may increase the concentration of the active ingredient in the body. The official product information does not note a specific regulatory constraint regarding alcohol consumption.

Q: Can Pacroma still work effectively if I occasionally miss an application?

A: Official instructions for a missed dose advise applying the cream as soon as it is remembered. However, the missed dose should be skipped if it is almost time for the next scheduled application. Following the prescribed schedule is important for maintaining the intended treatment approach.

Q: Does Pacroma help prevent future flare-ups, or just treat current symptoms?

A: The cream is officially indicated for the short-term and non-continuous treatment of the signs and symptoms of the condition. Official guidance indicates that use should be discontinued as soon as symptoms resolve, defining its primary role as treating active symptoms.

Q: What is the stability or shelf life of Pacroma cream?

A: The cream must be stored at 25 C (77 F), with temporary excursions permitted between 15 C and 30 C (59 F and 86 F). Official guidance states the cream should be discarded 12 months after the tube is first opened.

Q: Does Pacroma have known interactions with herbal supplements or vitamins?

A: Regulatory documents note St. John's wort as an enzyme inducer, and concurrent use is generally advised against. Official documents do not typically provide comprehensive interaction information for all other specific vitamins or herbal supplements.

Q: Is Pacroma intended for use on all areas of the body?

A: The cream is intended only for external, topical use on the skin areas affected by the condition. It is not for ophthalmic (eye) or oral use.

Q: What is the risk of accidental ingestion if a child gets a hold of the cream?

A: The cream is intended only for external use. The container must be kept out of the sight and reach of children as a precaution against accidental ingestion.

Q: Can using Pacroma affect the appearance of moles or other skin growths?

A: Because the official label includes a warning regarding the potential risk of developing skin malignancies, regulatory documents advise against using the cream on any malignant or pre-malignant skin conditions.

Q: What is the difference between an immunosuppressant cream and a conventional steroid cream?

A: The cream is a non-steroidal immunomodulating agent (Topical Calcineurin Inhibitor). Unlike conventional steroid creams that affect a broad hormonal profile, this medication selectively targets T-cells and the local immune response to control inflammation.

Q: Can Pacroma interact with any eye drops or other topical medications used near the face?

A: Official documents state that the cream is not for ophthalmic use. The regulatory label also notes that concurrent use with other topical medications (excluding sunscreens) has not been evaluated in clinical studies.

Q: Is the main purpose of Pacroma to relieve itching, or is it to clear the rash?

A: Official research has examined the effect of the drug on both markers related to atopic dermatitis and the results reported by participants concerning specific symptoms like pruritus (itching). The medication's anti-inflammatory action addresses the underlying disease process, which helps with symptoms like pruritus (itching) and skin changes.

Q: What is the recommended approach if the skin condition worsens after starting Pacroma?

A: Official regulatory documents indicate that treatment is typically discontinued if the signs and symptoms of the condition worsen. Consultation with a healthcare professional is also advised if symptoms persist beyond 6 weeks of treatment.

Q: Can Pacroma be used for skin issues other than atopic dermatitis?

A: The cream is officially indicated for the treatment of mild to moderate atopic dermatitis. This indication is specifically for adults and children 2 years of age and older who have not responded adequately to or cannot tolerate conventional topical therapies.

Q: What is the typical time frame before seeing a noticeable change from Pacroma?

A: Regulatory studies indicate that some patients may experience an improvement in the symptom of pruritus (itching) within the first week of treatment. Clinical data suggests that the medication's anti-inflammatory process may take time to fully manifest its effect.

Q: Is there a known risk of skin thinning (atrophy) with Pacroma use?

A: Clinical trials have not shown evidence of skin atrophy, or thinning, associated with the use of the cream. This is consistent with its classification as a non-steroidal product.

Q: Can Pacroma be used on sensitive areas like the face or skin folds?

A: Official guidance states the cream can be used on all skin areas affected by the condition, including sensitive areas like the face, neck, and skin folds (intertriginous areas). However, official guidance indicates that the cream is not applied to mucous membranes.

Q: How does Pacroma interact with vaccines or recent vaccinations?

A: The effect of the cream on vaccination response has not been formally studied according to regulatory documents. Official guidance suggests avoiding application of the cream to skin that has recently been, or is about to be, vaccinated.

Q: Does Pacroma interact with hormonal birth control or other hormonal treatments?

A: Official drug information indicates that due to the minimal systemic absorption of the topical cream, the possibility of systemic interaction with oral contraceptives or other hormonal therapies is generally considered low, according to official drug information.

Q: Why is Pacroma sometimes prescribed after other treatments have not worked well?

A: Because of its classification as a non-steroidal treatment, it is officially indicated as an alternative for patients who have not responded adequately to, or cannot tolerate, conventional topical therapies. The indication includes patients who have not responded adequately to, or cannot tolerate, conventional topical therapies.

Q: Can I use cosmetic products or makeup on areas treated with Pacroma?

A: Official patient counseling notes that the cream may be used under cosmetic products. However, the regulatory label notes that this combination has not been studied, and the cream should be allowed to fully absorb before applying other products.

Q: What is the guidance on using Pacroma during pregnancy or while breastfeeding?

A: Regulatory documents state that use during pregnancy is considered only if the potential benefit justifies the potential risk to the fetus. Caution is advised when breastfeeding, as it is not known whether the active ingredient is excreted in human milk.

Q: Why do some people feel a warming or flushing sensation after drinking alcohol while using Pacroma?

A: According to regulatory documents, a few patients have reported an acute alcohol intolerance reaction. This reaction is characterized by flushing, rash, burning, or itching immediately after drinking alcohol.

Q: Is it necessary to have routine blood tests while using topical Pacroma?

A: Official prescribing information indicates that the systemic absorption of the topical cream is minimal. Because of this, regulatory documents do not require routine hematology (blood) testing for patients using the topical cream.

Q: What should I look for to know if Pacroma is actually working?

A: The medication is intended to treat the signs and symptoms of the inflammatory condition. Resolution of these signs and symptoms is the official criterion for discontinuing treatment, as noted in clinical guidance.

Q: Is there a connection between Pacroma use and feeling generally unwell or experiencing flu-like symptoms?

A: While headache is a common side effect, the regulatory label also lists systemic symptoms such as fever, cough, and influenza-like illness as infrequent (uncommon) adverse reactions.

Q: Does the efficacy of Pacroma decrease over time with prolonged use?

A: Clinical studies involving long-term intermittent treatment did not suggest a loss of treatment effect, also known as tachyphylaxis. However, continuous use of the cream remains restricted by regulatory guidelines.

Q: Is the risk of developing skin malignancy permanent, or does it go away after stopping the cream?

A: The Boxed Warning states that a definitive relationship between the cream and the reported rare cases of malignancy has not been established. Regulatory guidance does not provide information on the permanence or reversibility of this potential risk after the treatment is discontinued.

How should Pacroma be stored and disposed of?

Official Storage and Disposal Requirements

Pacroma (Pimecrolimus Cream) must be stored and handled according to specific regulatory requirements to maintain product stability and ensure safety.

Storage Requirement Official Guidance
Temperature Range Store at 25 C (77 F); permitted excursions between 15 C and 30 C (59 F and 86 F).
Freezing Restriction Do not freeze the cream.
Container Rule Keep the tube tightly closed and store in the original container.
In-Use Stability Discard the cream 12 months after the tube is first opened.
Child Safety Keep out of the sight and reach of children.
Disposal Do not dispose of the medicine via wastewater or household waste. Consult your pharmacist for disposal guidance.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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