Ultraproct

Pronunciation: UL-tra-prokt.

Generic name
fluocortolone pivalate and fluocortolone hexanoate with cinchocaine hydrochloride
Drug class
Topical (rectal) corticosteroid combined with a local anaesthetic
Form
Rectal ointment and suppositories
Route
Rectal / topical (perianal application)
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United Kingdom · Australia · New Zealand

Australia: Ultraproct (ointment, ARTG 70064; suppositories) (6) · Full directory

What fluocortolone pivalate and fluocortolone hexanoate with cinchocaine hydrochloride is and how it works

Ultraproct is a prescription-only rectal ointment or suppository that combines a corticosteroid (fluocortolone) with a local anaesthetic (cinchocaine) to relieve the pain, swelling, and itching of haemorrhoids (piles), superficial anal fissures, and proctitis. (1) (5)

Use Ultraproct exactly as your prescriber or the product's instructions direct, and only for the short period recommended -- typically no more than about 1-2 weeks, and not beyond 4 weeks in any case. If your symptoms have not clearly improved, or you feel you need to keep using it for longer, contact your prescriber for reassessment rather than continuing on your own.

Mechanism of action: how fluocortolone pivalate and fluocortolone hexanoate with cinchocaine hydrochloride works

Fluocortolone hexanoate and fluocortolone pivalate are two esters of the corticosteroid fluocortolone with different onset/duration profiles (pivalate: rapid-onset; hexanoate: slower-onset, more prolonged), giving a fast-and-lasting anti-inflammatory, antiallergic, and antipruritic effect. Cinchocaine (or, in some markets, lidocaine) is a local anaesthetic providing additional pain relief. Rectal absorption of fluocortolone pivalate is low (roughly 5-15% of the applied dose per the sources reviewed); systemic anaesthetic absorption is low enough, when used as directed, that systemic effects are not expected. (1) (5)

What fluocortolone pivalate and fluocortolone hexanoate with cinchocaine hydrochloride is used for

Haemorrhoids (piles)

Relieves the pain, swelling, and itching of internal and external haemorrhoids. (1) (5)

Anal fissures and proctitis

Used for superficial anal fissures and proctitis (inflammation of the lining of the rectum). (5)

Anal itching (pruritus ani)

Relieves itching around the anus. (1)

Before taking fluocortolone pivalate and fluocortolone hexanoate with cinchocaine hydrochloride

Do not take / not appropriate for

  • Do not use Ultraproct if you are allergic to fluocortolone, cinchocaine (or, in some markets, lidocaine), or any other ingredient. (all countries) (1)
  • Do not use Ultraproct if you have a known sensitivity to local anaesthetics. (all countries) (1)
  • Do not use Ultraproct on skin with an untreated viral infection (such as chickenpox, shingles, or cold sores), or an untreated bacterial or fungal infection, unless your prescriber has also arranged appropriate anti-infective treatment. (all countries) (1) (5)
  • Do not use on skin affected by tuberculosis or syphilis-related skin conditions. (New Zealand, European Union) (5) (3)

Tell your clinician about

  • Any known allergies to corticosteroids or local anaesthetics.
  • Any current skin infection (viral, bacterial, or fungal) in the area to be treated.
  • If you are pregnant, planning pregnancy, or breastfeeding.
  • If you are considering use in a child or adolescent -- Ultraproct's safety has not been specifically studied in this age group.
  • If your symptoms have not improved after a short course of treatment -- you may need a proctological examination rather than continued self-treatment.
(1) (5) (3)

How to take fluocortolone pivalate and fluocortolone hexanoate with cinchocaine hydrochloride

  • Clean the anal area thoroughly, ideally after a bowel movement, before applying.
  • Ointment: smear a small (pea-sized) amount around the anus and just inside the anal opening; a nozzle is provided if internal (intrarectal) application is needed.
  • Suppositories: insert one suppository well into the rectum, generally once daily; if symptoms are severe, your prescriber's instructions or the product information may allow up to two or three times on the first day or two.
  • Wash your hands carefully after each application, and avoid any contact with your eyes.
  • Symptoms often improve quickly, but do not stop too soon -- continuing at a lower frequency for about a week after symptoms clear can help prevent relapse.
  • Do not use Ultraproct for longer than the short course recommended on your product's label (commonly around 5-7 days, with an absolute upper limit that varies by market from about 2 to 4 weeks) -- if you feel you need it for longer, this is a signal to contact your prescriber for reassessment rather than continuing on your own.
(1) (5)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (5) (6)

Missed dose

If you miss an application, apply it when you next remember and continue your normal short-course schedule. Do not apply extra amounts to make up for a missed dose.

Overdose

No specific overdose syndrome is described for correct topical/rectal use of Ultraproct in the sources reviewed. If Ultraproct is accidentally swallowed by a child, or applied in unusually large amounts over a wide area, contact a poisons information service or seek medical advice, since excessive absorption of the corticosteroid component is a theoretical risk. (1) (5)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Local burning, stinging, or tingling sensation on application (usually brief).

What to notice: Local burning, stinging, or tingling sensation on application (usually brief).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (5)

Allergic skin reactions (uncommon but can occur).

What to notice: Allergic skin reactions (uncommon but can occur).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (5)

Thinning of the skin (atrophy) in the treated area if used for longer than recommended.

What to notice: Thinning of the skin (atrophy) in the treated area if used for longer than recommended.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (5)

Serious warnings

Signs of local skin thinning (atrophy) or ongoing local skin changes — high caution

Symptoms: Thin, fragile, shiny, or easily-bruised skin in the treated area.

Action: This risk increases the longer Ultraproct is used beyond the short course recommended on the label. Contact your prescriber if you notice these changes or feel you need treatment for longer than recommended -- do not simply continue using it yourself; your prescriber can reassess and advise on a clinician-directed plan. (1) (5)

Signs of excess corticosteroid absorbed into the body (from prolonged or excessive use) — high caution

Symptoms: Unusual tiredness, weight change, or other new symptoms with heavy or prolonged use over large areas.

Action: Using unusually large amounts, or for longer than recommended, can lead to the corticosteroid being absorbed into the body in amounts that can affect you systemically. Use only the amount and duration your prescriber or the product information recommends, and get medical advice before continuing use beyond that. (1)

Signs of a severe allergic reaction — emergency

Symptoms: Sudden rash, swelling of the face/lips/tongue, difficulty breathing, or hives.

Action: Stop using Ultraproct and seek emergency medical help immediately. (1)

Symptoms not improving with short-term use — high caution

Symptoms: Haemorrhoid or anal symptoms that persist or worsen despite treatment as directed.

Action: Contact your prescriber for reassessment, including a possible proctological examination -- persistent symptoms should not simply be treated with continued or repeated self-directed courses of Ultraproct. (3)

Interactions

  • Medicines that strongly inhibit a liver enzyme called CYP3A (including some HIV medicines such as ritonavir or cobicistat-containing products) may increase how much corticosteroid is absorbed into the body from Ultraproct -- this combination should generally be avoided unless your prescriber decides the benefit outweighs the risk, with monitoring for corticosteroid side effects. (1)
  • In markets where Ultraproct is formulated with lidocaine rather than cinchocaine, caution is advised if you take anti-arrhythmic heart medicines, since lidocaine can interact with them. (3)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Data on use in human pregnancy are limited. Topical corticosteroids have shown a possible small risk of effects on fetal development in animal studies. Ultraproct should be used in pregnancy only if your prescriber judges the benefit outweighs the risk, generally avoiding the first trimester and avoiding prolonged use. (1) (2) (3) (5) (6)

Breastfeeding

Excretion of meaningful amounts of the corticosteroid into breast milk is considered unlikely, but discuss use with your prescriber, particularly for prolonged treatment. (1) (2) (3) (5) (6)

Children

Not recommended for children and adolescents in some markets, since clinical studies have not been done in this age group; long-term continuous use of topical corticosteroids should be avoided in infants. (1) (2) (3) (5) (6)

Elderly

No specific dose adjustment based on age alone is described in the sources reviewed, but the same short-course duration limits and skin-atrophy precautions apply. (1) (2) (3) (5) (6)

Hepatic_impairment

Not specifically addressed in the sources reviewed for this dossier. (1) (2) (3) (5) (6)

Renal_impairment

Not specifically addressed in the sources reviewed for this dossier. (1) (2) (3) (5) (6)

Source_ids

UK-MHRA-ULTRAPROCT-OINTMENT-2017,NZ-MEDSAFE-ULTRAPROCT-2020,EU-BAYER-PORTUGAL-ULTRAPROCT-SMPC-2017 (1) (2) (3) (5) (6)

Monitoring

Before starting

  • Confirm the diagnosis (haemorrhoids/fissure/proctitis) rather than self-diagnosing persistent or unusual rectal symptoms
  • Check for any active local infection that would need separate treatment first or alongside

During treatment

  • Watch for skin thinning or unusual local skin changes, especially if use extends beyond the recommended short course.
  • Seek reassessment if symptoms do not improve within the expected short timeframe.
(1) (5)

Storage

Ointment: store below 25°C (77°F), do not refrigerate. Suppositories: store in a refrigerator (2-8°C/36-46°F); if a suppository has softened from heat, it can be firmed up again by placing it in cold water before removing the wrapper. Keep out of reach of children.

Professional information

Clinician-facing context only, sourced from the current UK MHRA SmPCs, the New Zealand Medsafe data sheet, and the Bayer Portugal SmPC; verify against the current full label in your market before prescribing, and note the cinchocaine-vs-lidocaine formulation variance across EU markets.

United Kingdom / New Zealand (cinchocaine formulation)

Indication: Haemorrhoids, pruritus ani, superficial anal fissures, proctitis

Dose summary: Ointment: thin layer twice daily, 3-4 times on day one for faster relief. Suppositories: one daily, 2-3 times daily at the start if severe. UK label states 5-7 day short-term use; NZ label allows continuation at reduced frequency for relapse prevention with an absolute upper limit of about 4 weeks.

Renal context: Not addressed in the sources reviewed. (1) (2) (5)

European Union -- Portugal (lidocaine formulation)

Indication: Symptomatic relief of pain, oedema, or pruritus from haemorrhoidal disease

Dose summary: Cream twice daily (up to 3 times on initial days); suppositories twice daily (up to 3 times in the first 3 days if severe), reducing frequency as symptoms improve. Maximum treatment duration 2 weeks.

Renal context: Not addressed in the source reviewed. (3)

Mechanism of action

Hepatic guidance

Not specifically addressed in the sources reviewed.

Overdose note

No specific overdose syndrome described for topical/rectal use as directed; theoretical risk of excess systemic corticosteroid absorption with gross overuse. (1) (5)

Frequently asked questions

How long can I use Ultraproct for?

Only for a short course -- typically around 5-7 days as a first course, and it should not be used beyond the label's stated maximum (which varies by market from about 2 to 4 weeks). If you still need it after that, or your symptoms are not improving, contact your prescriber rather than continuing to use it on your own. (1) (5)

Is Ultraproct the same everywhere in the world?

The brand name Ultraproct is used in several countries, but the exact local anaesthetic ingredient can differ: the UK, New Zealand, and Germany use cinchocaine, while the version sold in Portugal uses lidocaine instead. Always check the ingredients listed on your specific product's packaging. (1) (3)

Is Ultraproct available in the US, UK, Europe, Canada, Australia, and New Zealand?

It is confirmed authorised in the United Kingdom, the European Union (e.g. Portugal, Germany), and New Zealand. It was previously registered in Australia but the sponsor cancelled that registration in 2017, so it is not currently available there. We could not confirm any current or historical authorisation in Canada, and it is not FDA-approved in the United States. (1) (3) (5) (6) (7) (8)

What is the mechanism of action of fluocortolone pivalate and fluocortolone hexanoate with cinchocaine hydrochloride?

Fluocortolone hexanoate and fluocortolone pivalate are two esters of the corticosteroid fluocortolone with different onset/duration profiles (pivalate: rapid-onset; hexanoate: slower-onset, more prolonged), giving a fast-and-lasting anti-inflammatory, antiallergic, and antipruritic effect. Cinchocaine (or, in some markets, lidocaine) is a local anaesthetic providing additional pain relief. Rectal absorption of fluocortolone pivalate is low (roughly 5-15% of the applied dose per the sources reviewed); systemic anaesthetic absorption is low enough, when used as directed, that systemic effects are not expected. (1) (5)

What is the generic name of Ultraproct?

The generic name is fluocortolone pivalate and fluocortolone hexanoate with cinchocaine hydrochloride. (1) (5)

What class of drug is fluocortolone pivalate and fluocortolone hexanoate with cinchocaine hydrochloride?

Ultraproct is classed as: Topical (rectal) corticosteroid combined with a local anaesthetic. (1) (5)

References

  1. Ultraproct Ointment -- Summary of Product CharacteristicsMedicines and Healthcare products Regulatory Agency (MHRA), United Kingdom -- official product SmPC · United Kingdom · accessed 2026-07-29 · source 1
  2. Ultraproct Suppositories -- Summary of Product CharacteristicsMedicines and Healthcare products Regulatory Agency (MHRA), United Kingdom -- official product SmPC · United Kingdom · accessed 2026-07-29 · source 2
  3. Ultraproct, creme rectal / supositorio -- Resumo das Caracteristicas do MedicamentoBayer Portugal, Lda. -- official EU national SmPC (Resumo das Caracteristicas do Medicamento), hosted on bayer.com · European Union · accessed 2026-07-29 · source 3
  4. Ultraproct Salbe / Zaepfchen (fluocortolone pivalate/hexanoate + cinchocaine hydrochloride)Bayer Vital GmbH (Germany) and German consumer pharmaceutical reference sites, citing the German-marketed Ultraproct Salbe/Zaepfchen · European Union (Germany) · accessed 2026-07-29 · source 4
  5. Ultraproct (ointment and suppositories) -- New Zealand Data SheetMedsafe (New Zealand Medicines and Medical Devices Safety Authority) -- official data sheet · New Zealand · accessed 2026-07-29 · source 5
  6. ULTRAPROCT cinchocaine hydrochloride / fluocortolone hexanoate / fluocortolone pivalate ointment tube -- Cancelled under s30(1)(c) of the ActTherapeutic Goods Administration (TGA), Australia -- ARTG cancellation notice · Australia · accessed 2026-07-29 · source 6
  7. Search for an Ultraproct-branded product or fluocortolone-containing product in the Health Canada drug product listingsHealth Canada Drug Product Database / product monograph search · Canada · accessed 2026-07-29 · source 7
  8. Search for an Ultraproct-branded or fluocortolone-containing product on DailyMedDailyMed (NIH) / FDA product search · United States · accessed 2026-07-29 · source 8

Brand names by country

Single-ingredient fluocortolone pivalate and fluocortolone hexanoate with cinchocaine hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United Kingdom

  • Ultraproct Ointment (1)MHRA licensed direct smpc confirmed PL 19115 0008 · 0.92 mg/g fluocortolone pivalate + 0.95 mg/g fluocortolone hexanoate + 5 mg/g cinchocaine hydrochloride · Meadow Laboratories Limited
  • Ultraproct Suppositories (2)MHRA licensed direct smpc confirmed PL 19115 0009 · 0.61 mg fluocortolone pivalate + 0.63 mg fluocortolone hexanoate + 1 mg cinchocaine hydrochloride per suppository · Meadow Laboratories Limited

Australia

  • Ultraproct (ointment, ARTG 70064; suppositories) (6)real historical TGA registration sponsor cancelled 2017-11-21 · not specified in fetched source · Bayer Australia Ltd

New Zealand

  • Ultraproct (ointment and suppositories) (5)Medsafe approved direct data sheet confirmed first approved 1969 · 0.92 mg/g fluocortolone pivalate + 0.95 mg/g fluocortolone hexanoate + 5 mg/g cinchocaine hydrochloride (ointment); 0.61 mg + 0.63 mg + 1 mg (suppository) · AFT Pharmaceuticals Ltd
View brands in additional countries.

European Union

Ultraproct creme rectal / supositorio (Portugal) (3), Ultraproct Salbe / Zaepfchen (Germany) (4)

This page provides general reference information about Ultraproct and is not a substitute for advice from the prescriber managing your treatment. All treatment decisions, including how long to use this medicine, should be made with your prescriber.

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