Rectal

Rectal

FormulationStrengths Available

Rectal enema (suspension)Hydrocortisone 100 mg/60 mL

Rectal foamHydrocortisone acetate 10% (limited availability — verify local supply)

Note: Foam formulations are not universally available across India; enema preparations are more commonly accessible.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

✦ Ulcerative Colitis — Distal Disease (Proctitis, Proctosigmoiditis, Left-sided Colitis)

Parameter Details

Starting dose 100 mg rectally (one enema) at bedtime

Titration Not applicable

Usual maintenance dose Not established for maintenance; therapy aimed at induction of remission followed by discontinuation or switch to 5-ASA maintenance

Maximum dose 100 mg/day (one enema daily)

Clinical Notes:

• Rectal corticosteroids are indicated for mild-to-moderate distal ulcerative colitis

• Enema reaches sigmoid and descending colon (up to splenic flexure); not effective for pancolitis

• Duration of therapy: typically 2–4 weeks; assess response at 2–3 weeks

• Instruct patient to retain enema overnight or for at least 1 hour for optimal mucosal contact

• May be used as adjunct to oral 5-ASA or oral/systemic corticosteroids

• Once remission achieved, transition to mesalamine rectal/oral for maintenance

• For isolated proctitis (disease limited to rectum), suppositories or foam may be preferred if available

✦ Radiation Proctitis

Parameter Details

Starting dose 100 mg rectally (one enema) at bedtime

Titration Not applicable

Usual maintenance dose Not applicable; short-term therapy

Maximum dose 100 mg/day

Clinical Notes:

• Duration: 2–4 weeks depending on symptom severity

• Typically prescribed by gastroenterologist or radiation oncologist

• May be combined with sucralfate enemas in refractory cases

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Notes

Solitary Rectal Ulcer Syndrome (SRUS) 100 mg rectally at bedtime 2–4 weeks; rarely extended OFF-LABEL — Specialist only; evidence limited to case series and expert opinion in refractory cases

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

✦ Ulcerative Colitis — Distal Disease (Proctitis, Left-sided Colitis)

Eligibility: Age ≥2 years; mandatory paediatric gastroenterology supervision

2–6 years 25–50 mg rectally once daily at bedtime Use smaller volume preparations if available; may require compounding

6–12 years 50 mg rectally once daily at bedtime Increase to 100 mg if inadequate response after 2 weeks

12 years 100 mg rectally once daily at bedtime Adult dosing applicable

Dosing Parameters:

Parameter Details

Starting dose 25–50 mg rectally at bedtime (age 2–12 years); 100 mg for adolescents

Titration Not typically required; reassess clinical response at 2–3 weeks

Usual maintenance dose Not established; aim for discontinuation after remission induction

Maximum dose 100 mg/day (should not exceed adult dose)

Monitoring Requirements:

• Height, weight, and growth velocity at baseline and during therapy

• Monitor for signs of systemic steroid absorption (cushingoid features, hyperglycaemia)

• Clinical response assessment at 2–3 weeks

Clinical Notes:

• Enema retention may be challenging in younger children; parental/caregiver instruction essential

• Duration: up to 4 weeks; taper or discontinue based on clinical improvement

• Transition to rectal mesalamine for maintenance once remission achieved

Secondary Indications — Paediatric Doses (Off-label, if any)

• No established off-label paediatric indications

Age Restriction Statement:

• Not recommended below 2 years of age except under specialist paediatric gastroenterology supervision with documented benefit-risk assessment

• No dose adjustment required

• Systemic absorption from rectal route is minimal with short-term use

• No specific concerns in patients with renal impairment

• Known hypersensitivity to hydrocortisone or any formulation component

• Untreated local infections of the rectum (tuberculosis, herpes simplex, amoebiasis, fungal infections)

• Systemic fungal infections

• Recent intestinal anastomosis or bowel perforation

• Obstruction, abscess, or fistula where enema administration is technically contraindicated

• Peritonitis

• Prolonged use (>4 weeks) may result in systemic corticosteroid effects including adrenal suppression

• Concurrent systemic corticosteroid use — increased risk of HPA axis suppression

• Diabetes mellitus — monitor blood glucose; systemic absorption may affect glycaemic control

• Hypertension — fluid retention possible with systemic absorption

• Osteoporosis — caution with prolonged use

• Peptic ulcer disease

• Immunocompromised patients — increased infection risk

• May delay healing of rectal/colonic mucosal lesions

• Elderly patients with multiple comorbiditi

Parameter Details

Safety Category Generally considered safe; rectal route has minimal systemic absorption

Preferred Alternative Hydrocortisone is preferred over fluorinated corticosteroids (betamethasone, dexamethasone) if systemic absorption anticipated

When May Be Used Use when benefit outweighs risk; appropriate for managing active distal UC in pregnancy

Monitoring Monitor fetal growth if prolonged use or significant systemic absorption suspected

Note: Uncontrolled IBD poses greater risk to pregnancy than short-term rectal corticosteroid use.

Parameter Details

Compatibility Compatible with breastfeeding

Drug Levels in Milk Low; minimal systemic absorption from rectal route

Preferred Alternative None required; hydrocortisone enema is acceptable during lactation

Infant Monitoring Monitor for rare signs of corticosteroid exposure (weight gain, GI upset, irritability) — unlikely with short-term rectal use

Parameter Recommendation

Starting Dose Standard adult dose (100 mg rectally at bedtime)

Titration Not applicable

Special Risks Slower mucosal healing; increased risk of local mucosal thinning with prolonged use; caution if comorbid diabetes, osteoporosis, or hypertension; monitor for systemic effects

Monitoring Blood glucose and blood pressure if prolonged therapy; assess skin and mucosal integrity

Interacting Drug Mechanism/Effect Recommendation

Systemic CYP3A4 inducers (rifampicin, phenytoin, carbamazepine) May reduce corticosteroid efficacy if systemic absorption occurs Clinical significance low with short-term rectal use; monitor for reduced efficacy in prolonged therapy

Strong CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir) May increase systemic hydrocortisone exposure Caution if concurrent systemic corticosteroid therapy; monitor for steroid excess

Note: Drug interactions are generally not clinically significant with short-term rectal hydrocortisone use due to minimal systemic absorption.

Interacting Drug Mechanism/Effect Recommendation

Potassium-depleting diuretics (furosemide, thiazides) Additive hypokalaemia risk if systemic absorption Monitor serum potassium with prolonged corticosteroid use

NSAIDs Additive risk of GI bleeding or ulceration Avoid concurrent use if possible; monitor for GI symptoms

Warfarin Variable effect on INR due to systemic corticosteroid absorption Monitor INR if prolonged rectal corticosteroid use

Oral hypoglycaemic agents / Insulin Corticosteroids may cause hyperglycaemia Monitor blood glucose; adjust antidiabetic therapy if needed

• Rectal discomfort, burning, or irritation at application site

• Tenesmus (feeling of incomplete evacuation)

• Flatulence

• Local pruritus

• Increased bowel movements during initial use

• Minor rectal bleeding (due to insertion technique)

• Headache

Adverse Effect Clinical Notes

Rectal mucosal thinning/ulceration May occur with prolonged use; discontinue if persistent local symptoms

Systemic corticosteroid effects Adrenal suppression, hyperglycaemia, cushingoid features, osteoporosis — with prolonged use (>4 weeks) or concurrent systemic steroids

Secondary infection Fungal overgrowth or bacterial superinfection; may require discontinuation

Hypersensitivity reaction Rare; discontinue immediately if occurs

Bowel perforation Risk increased if used in presence of severe colitis, diverticulitis, or recent anastomosis

Phase Parameters

Baseline Clinical assessment of rectal mucosa; blood glucose in diabetics; note concurrent steroid use

During Therapy (2–3 weeks) Assess clinical response (symptom improvement, endoscopic improvement if applicable); monitor for local adverse effects

Prolonged Use (>4 weeks) Monitor for systemic corticosteroid effects (blood glucose, blood pressure, signs of adrenal suppression); consider HPA axis assessment if extended use

Paediatric Growth velocity monitoring; watch for systemic steroid effects

Brand Name Manufacturer Formulation

Cortenema Torrent Pharmaceuticals Enema 100 mg/60 mL

Rectocort Macleods Enema (Hydrocortisone acetate)

Note: Availability of rectal foam formulations is limited in India; verify local supply before prescribing. Some centres may require compounding for paediatric doses.

Notes:

• Not included in NLEM 2022

• Available through private purchase only

• Price varies by brand and region

• Enema reaches sigmoid and descending colon only: Not effective for extensive or pancolitis; use oral/systemic therapy for disease beyond splenic flexure

• Combine with oral 5-ASA for optimal induction: Rectal corticosteroid + oral mesalamine is more effective than either alone in left-sided UC

• Patient counselling on retention is critical: Instruct patients to retain enema for at least 1 hour, preferably overnight; lie on left side during instillation to enhance distribution

• Avoid prolonged use beyond 4 weeks: Risk of systemic steroid effects and local mucosal atrophy increases with extended therapy; transition to rectal mesalamine for maintenance

• Foam formulations may improve adherence: If available, foam is easier to retain than liquid enema and may be preferred for isolated proctitis — but availability in India is limited

• Not a substitute for systemic therapy in moderate-severe disease: If inadequate response to rectal therapy within 2–3 weeks, escalate to oral/IV corticosteroids or biologics

hydrocortisone enema; rectal corticosteroid; ulcerative colitis; proctitis; distal colitis; IBD; local steroid therapy; radiation proctitis; paediatric IBD; gastroenterology

RxIndia v1.1 — 27 Jan 2026

• CDSCO Product Information

• Indian Pharmacopoeia / National Formulary of India (NFI)

• NLEM 2022 (National List of Essential Medicines) — noted absence

• API Textbook of Medicine

• AIIMS Gastroenterology Clinical Protocols

• Indian Society of Gastroenterology — IBD Management Recommendations

• IAP Guidelines for Paediatric IBD

• Goodman & Gilman's The Pharmacological Basis of Therapeutics