Last reviewed · How we verify
Hydrocortisone acetate and lidocaine hydrochloride
Hydrocortisone acetate reduces inflammation and itching while lidocaine hydrochloride provides local anesthetic relief through topical application.
Hydrocortisone acetate reduces inflammation and itching while lidocaine hydrochloride provides local anesthetic relief through topical application. Used for Hemorrhoids (internal and external), Anal fissures, Pruritus ani.
At a glance
| Generic name | Hydrocortisone acetate and lidocaine hydrochloride |
|---|---|
| Sponsor | Citius Pharmaceuticals, Inc. |
| Drug class | Topical corticosteroid and local anesthetic combination |
| Target | Glucocorticoid receptor (hydrocortisone); voltage-gated sodium channels (lidocaine) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Hydrocortisone acetate is a corticosteroid that suppresses inflammatory responses and pruritus by inhibiting phospholipase A2 and reducing prostaglandin and leukotriene production. Lidocaine hydrochloride is a local anesthetic that blocks sodium channels in nerve fibers, preventing pain signal transmission. Together, this combination provides both anti-inflammatory and analgesic effects for topical use.
Approved indications
- Hemorrhoids (internal and external)
- Anal fissures
- Pruritus ani
Common side effects
- Local irritation or burning
- Allergic contact dermatitis
- Skin atrophy (with prolonged use)
- Systemic corticosteroid absorption (rare with topical use)
Key clinical trials
- Microneedling for Burn Hypertrophic Scars (NA)
- Sore Throat After Open Neck Elective Surgery (PHASE4)
- Effects of RF Microneedle on Photoaging Skin (NA)
- Splint Versus Steroid Randomized Trial (NA)
- Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss (PHASE2)
- Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome (NA)
- Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids (PHASE2)
- Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape: