Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
ACTIQ vs ACLOVATE
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Opioid agonist; binds to mu-opioid receptors in the CNS, altering pain perception and response.
Aclovate (alclometasone dipropionate) is a synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Its mechanism involves binding to glucocorticoid receptors, modulating gene expression to inhibit phospholipase A2, reducing arachidonic acid release, and decreasing prostaglandin and leukotriene synthesis.
Management of breakthrough pain in cancer patients aged 16 and older who are already receiving and tolerant to opioid therapy for their underlying persistent cancer pain
Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (e.g., atopic dermatitis, contact dermatitis, eczema, psoriasis) - FDA approved,Off-label: Treatment of mild to moderate plaque psoriasis, seborrheic dermatitis, and lichen planus
200 mcg transmucosally, titrated upward as needed; initial dose for opioid-tolerant patients is 200 mcg, with additional doses possible after 15 minutes if needed. Maximum 4 doses per episode. At least 4 hours between episodes.
Apply a thin film to affected skin areas twice daily. Not for ophthalmic, oral, or intravaginal use.
Terminal half-life 0.83–2 hours (mean 1.3 h) in adults; note that context: transmucosal absorption leads to rapid onset but short duration; half-life is not correlated with clinical effect due to oral transmucosal route and rapid redistribution.
Terminal elimination half-life: approximately 6-8 hours after topical application; systemic absorption is minimal under normal use.
Primarily hepatic via CYP3A4 to inactive metabolites (norfentanyl, despropionylfentanyl, hydroxyfentanyl) and other metabolites; <7% excreted unchanged in urine.
Aclovate is metabolized in the skin and liver via ester hydrolysis to inactive metabolites. Systemic metabolism primarily involves cytochrome P450 enzymes (CYP3A4) for any absorbed fraction, but extensive first-pass metabolism limits systemic exposure.
Primarily renal as metabolites (about 75% as metabolites, <10% unchanged). Fecal excretion accounts for <9%. Biliary excretion is minor.
Renal (primarily as metabolites, <5% unchanged), biliary/fecal (minor).
Fentanyl is 80–85% bound to plasma proteins (primarily albumin and α1-acid glycoprotein).
Approximately 90%, primarily to albumin and corticosteroid-binding globulin (CBG).
Approximately 4 L/kg (range 3–6 L/kg); large Vd indicates extensive tissue distribution and redistribution contributing to short duration.
Not well-characterized in topical use; after systemic absorption, Vd is approximately 1-2 L/kg, indicating distribution into tissues.
Oral transmucosal: 50% (range 47–54%) relative to IV; variable and enhanced by rapid absorption through buccal mucosa.
Topical: approximately 1-3% systemic absorption on intact skin; increased up to 15% on occluded or damaged skin.
No specific GFR-based dose adjustment recommended; use with caution in severe renal impairment (Cr Cl < 30 m L/min) and consider dose reduction due to potential accumulation.
No dose adjustment required. Topical use with minimal systemic absorption.
Child-Pugh Class A/B: No adjustment. Child-Pugh Class C: Reduce initial dose to 100 mcg and titrate slowly; monitor closely for prolonged effects.
No dose adjustment required. Topical use with minimal systemic absorption.
Not approved for pediatric use; safety and efficacy not established in patients under 16 years.
Use smallest amount effective for shortest duration. Avoid prolonged use, occlusive dressings, or application to large surface areas. Safety in children <1 year not established.
Initiate at 100 mcg transmucosally; titrate slowly due to increased sensitivity and risk of respiratory depression. Monitor for adverse effects.
Use with caution due to increased risk of skin atrophy and systemic absorption. Limit frequency and duration; avoid occlusive dressings.
Risk of respiratory depression, addiction, abuse, and misuse; accidental ingestion can be fatal; concomitant use with benzodiazepines or CNS depressants may cause profound sedation, respiratory depression, coma, and death; not for use in opioid non-tolerant patients; risk of neonatal opioid withdrawal syndrome with prolonged use during pregnancy; serious, life-threatening, or fatal respiratory depression may occur even at recommended doses.
No FDA black box warning.
Risk of respiratory depression; addiction, abuse, and misuse; interactions with CNS depressants; serotonin syndrome; adrenal insufficiency; severe hypotension; seizures; withdrawal; use in patients with head injuries, increased intracranial pressure, biliary tract disease, pancreatitis; risk of choking with lozenge; oral mucosal irritation; dental caries; hypokalemia; hyponatremia; use in elderly, cachectic, or debilitated patients.
Topical corticosteroids can cause hypothalamic-pituitary-adrenal (HPA) axis suppression, especially with prolonged use, large surface area, occlusion, or in pediatric patients.,Reversible HPA axis suppression may occur after discontinuation.,Systemic effects including Cushing's syndrome, hyperglycemia, and glucosuria have been reported.,Local adverse reactions: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, maceration, secondary infection, skin atrophy, striae, and miliaria.,Use caution in patients with impaired skin integrity or areas of skin atrophy.,Pediatric patients may be more susceptible to systemic toxicity due to higher skin surface-to-body-weight ratio.
Significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment; known or suspected paralytic ileus; hypersensitivity to fentanyl or any component; opioid non-tolerant patients; management of acute or postoperative pain including headache/migraine, dental pain, or emergency department use.
Hypersensitivity to alclometasone dipropionate or any component of the formulation.,Untreated bacterial, fungal, or viral skin infections (e.g., herpes simplex, varicella, tuberculosis of the skin).
No significant food interactions. Grapefruit juice may increase fentanyl levels, but specific studies with ACTIQ are lacking. Avoid alcohol, as it may increase sedation and respiratory depression risk.
No known food interactions with topical Aclovate.
FDA Pregnancy Category C. First trimester: limited human data; animal studies show increased resorptions and fetal growth restriction. Second/third trimester: chronic use may cause neonatal opioid withdrawal syndrome; avoid use during labor due to risk of neonatal respiratory depression.
Topical corticosteroids like ACLOVATE (alclometasone dipropionate) are generally considered low risk in pregnancy, but systemic absorption can occur. Class C: Fetal risk cannot be ruled out. Avoid extensive use or prolonged treatment, especially in first trimester. Second and third trimester: Use only if clearly needed, minimal area and duration.
Excreted in breast milk; M/P ratio not established. Limited data suggest low levels, but risk of infant sedation and respiratory depression. Avoid use while breastfeeding unless potential benefit outweighs risk.
Safety unknown; likely minimal systemic absorption due to low potency. M/P ratio not established. Avoid application to breasts or large areas; use caution.
Due to increased plasma volume and hepatic metabolism in pregnancy, dose requirements may increase; adjust based on clinical response and tolerance. Avoid use during labor and delivery due to risk of neonatal respiratory depression; short-term use preferred.
No standard dose adjustment required; however, limit potency, frequency, and duration to lowest effective due to altered skin permeability. No pharmacokinetic changes necessitate dose change.
ACTIQ is a transmucosal immediate-release fentanyl formulation indicated for breakthrough cancer pain in opioid-tolerant patients. Initiate with the lowest strength (200 mcg) and titrate upward. Avoid use in opioid-naive patients due to risk of fatal respiratory depression. Place the unit between cheek and lower gum, not sublingually. Instruct patient not to bite or suck the unit. Monitor for sedation and respiratory depression. Multiple units may be used per episode if needed, but wait at least 4 hours before next episode. Dispose of partially used units by flushing down toilet.
Topical corticosteroids like Aclovate are classified as low-potency (Group VI). They are suitable for thin skin areas (e.g., face, flexures) and for children. Avoid prolonged use without interruption to minimize systemic absorption, especially in pediatric patients due to higher skin surface area-to-body weight ratio.
Only use ACTIQ if you are already taking regular around-the-clock opioid pain medicine and are tolerant to opioids.,Do not use ACTIQ for short-term pain like after surgery, headache, or dental pain.,Place the unit in your cheek pouch, not under your tongue. Do not chew or suck it.,If you need more than 4 units per day, contact your doctor as your dose may need adjustment.,Store ACTIQ in a safe place away from children, as accidental ingestion can be fatal.,Dispose of unused or partially used units by flushing them down the toilet.
Apply a thin layer to affected skin only, not to normal surrounding skin.,Do not cover with bandages or dressings unless directed by your doctor.,Use for the prescribed duration; do not use longer than 2 weeks at a time.,Avoid contact with eyes, mouth, and open wounds.,Report any signs of skin thinning, redness, or irritation to your healthcare provider.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about ACTIQ vs ACLOVATE, answered by our medical review team.
ACTIQ is a Opioid Analgesic that works by Opioid agonist; binds to mu-opioid receptors in the CNS, altering pain perception and response.. ACLOVATE is a Topical Corticosteroid that works by Aclovate (alclometasone dipropionate) is a synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Its mechanism involves binding to glucocorticoid receptors, modulating gene expression to inhibit phospholipase A2, reducing arachidonic acid release, and decreasing prostaglandin and leukotriene synthesis.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between ACTIQ and ACLOVATE depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of ACTIQ is: 200 mcg transmucosally, titrated upward as needed; initial dose for opioid-tolerant patients is 200 mcg, with additional doses possible after 15 minutes if needed. Maximum 4 doses per episode. At least 4 hours between episodes.. The standard adult dose of ACLOVATE is: Apply a thin film to affected skin areas twice daily. Not for ophthalmic, oral, or intravaginal use.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between ACTIQ and ACLOVATE in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. ACTIQ is classified as Category C. FDA Pregnancy Category C. First trimester: limited human data; animal studies show increased resorptions and fetal growth restriction. Second/third trimester: chronic use may cause. ACLOVATE is classified as Category C. Topical corticosteroids like ACLOVATE (alclometasone dipropionate) are generally considered low risk in pregnancy, but systemic absorption can occur. Class C: Fetal risk cannot be . Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.