Doloproct® (Fluocortolone/Lidocaine)

Doloproct® is a prescription-only combination product for the treatment of hemorrhoids and other inflammatory conditions of the anal area. It contains fluocortolone pivalate as the corticosteroid component, as well as lidocaine as a local anesthetic.

Fluocortolone pivalate inhibits inflammatory and allergic skin reactions. Lidocaine numbs the affected area and relieves pain and itching immediately.

Doloproct® is available as a rectal cream and as suppositories and is used for grade I–II hemorrhoids, anal fissures, anal eczema, and proctitis.

Doloproct® works through two mechanisms:

1. Fluocortolone (corticosteroid):

• Strong local anti-inflammatory effect
• Contained as fluocortolone pivalate
• Reduces swelling, redness, and inflammation
• Inhibits the release of inflammatory mediators
• Reduces itching and burning

2. Lidocaine (local anesthetic):

• Blocks the sodium channels of nerve fibers
• Immediate local numbing
• Relieves pain, burning, and itching
• Onset of action within minutes
• Duration of action: 1–2 hours

Combined effect: Lidocaine immediately relieves the acute symptoms, while fluocortolone treats the inflammation.

Doloproct® is suitable for:

• Grade I and II hemorrhoids
• Anal eczema (eczema in the anal area)
• Anal fissures (superficial tears)
• Proctitis (inflammation of the rectum)

Particularly suitable for:

• Acute symptoms with pain and itching
• Inflammatory hemorrhoid flare-ups
• Short-term treatment of anal complaints

Not suitable:

• Grade III–IV hemorrhoids (medical treatment/surgery required)
• Fungal or viral infections in the anal area (e.g., herpes, candidiasis)
• Tuberculosis or syphilis in the area of application
• Long-term use (max. 2 weeks)

Rectal cream:

• Apply thinly 2 × daily (morning and evening)
• In the first days of treatment, 3 × daily if needed
• After improvement: reduce the dose to 1 × daily
• Duration of use: maximum 2 weeks

Suppositories:

• Insert 1 suppository rectally 2 × daily (morning and evening)
• After improvement: 1 × daily or every other day
• Duration of use: maximum 2 weeks

Important:

• Do not use for longer than 2 weeks in total
• When symptoms improve, gradually reduce the dose and frequency
• Do not stop abruptly after prolonged use

Available dosage forms:

• Doloproct® rectal cream (with applicator)
• Doloproct® suppositories

Rectal cream:

• Gently clean the anal region before use
• Apply a thin layer to the affected area
• For internal hemorrhoids: screw the applicator onto the tube and insert the cream rectally
• Wash your hands after use

Suppositories:

• Insert after a bowel movement and cleansing
• Remove the suppository from the packaging
• Insert into the anus (rounded end first)
• Use after a bowel movement if possible

Important notes:

• Do not use on open, weeping wounds without medical instruction
• If symptoms persist after 1 week: medical check-up
• Do not combine with latex condoms (excipients of the cream and the suppositories can reduce the effectiveness of the condoms)
• No long-term use due to the risk of skin atrophy (corticosteroid)

Doloproct® must not be used in cases of:

• Hypersensitivity to fluocortolone, lidocaine, or any of the other ingredients
• Viral infections in the area of application (herpes, varicella)
• Fungal infections (candidiasis) in the anal area
• Tuberculosis or syphilis in the area of application
• Bacterial skin infections (impetigo) in the area

Use with caution in:

• Diabetes mellitus (the corticosteroid can affect blood sugar)
• Long-term use (skin atrophy, telangiectasia)
• Pregnancy and breastfeeding (only after medical assessment)
• Use over large areas (increased systemic absorption)

Pregnancy: Only after a strict benefit-risk assessment, especially in the 1st trimester. Do not use over large areas or for prolonged periods.

Common (1–10%):

• Burning at the application site

Uncommon (0.1–1%):

• Itching at the application site
• Contact dermatitis

With long-term use:

• Skin atrophy (thinning of the skin)
• Telangiectasia (visible small blood vessels)
• Striae (stretch marks)
• Perianal dermatitis
• Increased susceptibility to infection in the area of application

Rare:

• Allergic reactions to lidocaine or fluocortolone
• Systemic cortisone effects (only with use over very large areas/long-term use)

Note: With short-term use as directed (max. 2 weeks), burning at the application site is common. The risk of skin atrophy exists mainly with prolonged use.

Clinically relevant interactions: With rectal use as directed, systemic interactions are unlikely because systemic absorption is low.

Theoretically possible:

• Other local anesthetics: additive lidocaine effect
• Class I antiarrhythmics: theoretical potentiation by lidocaine
• Latex condoms: excipients of the cream and the suppositories can reduce the effectiveness of the condoms

Note: Due to the local application and low systemic absorption, clinically relevant drug interactions with Doloproct® are extremely rare.