Hemorrhoids - Guidelines for Prescribing Rectal Hydrocortisone Combination Products

Description of Hemorrhoids
  • Hemorrhoids are vascular cushions in the anal canal and are a normal part of human anatomy
  • These cushions or plexus normally help to seal the upper anal canal and contribute to continence
  • Become medical problems only if they become enlarged, inflamed, thrombosed, or prolapsed
  • Mistakenly described as varicose veins in the anal canal
  • Symptoms are often self-limiting, usually resolving without treatment within two weeks
  • For more information, go to

Classification: Classified as internal and external hemorrhoids based on location above or below the dentate line, respectively. The dentate line occurs where the anal epithelium meets the rectal epithelium. (See illustration)

  • Internal hemorrhoids originate above the dentate line and are further classified into four stages
    • 1st degree:  Hemorrhoids swell in the anal cushion with straining and are usually painless
    • 2nd degree:  Prolapse through the anus on straining but spontaneously return to normal position
    • 3rd degree: Remain in the prolapsed position after straining and require manual replacement
    • 4th degree:  Cannot be replaced after a bowel movement.  Create a permanent bulge at the anus.  This stage is quite painful.  Fourth-degree hemorrhoids are at risk of thrombosis and gangrene.
  • External hemorrhoids originate and are located below the dentate line and can be painful.
  • Mixed hemorrhoids - combination of internal and external hemorrhoids

Contributing Causes:

  • Chronic constipation
  • Straining
  • Diarrhea (due to frequent bowel movements)
  • Pregnancy
  • Old age
  • Certain physical exertion (lifting heavy objects with poor technique)
  • Prolonged sitting on the toilet
Signs and Symptoms
  • All Classes:
    • Bleeding from the rectum that appears as bright red blood.  The bleeding may vary from light spotting on the toilet paper to copious amounts in the toilet bowl
    • Constipation or diarrhea
    • Straining with defecation
  • External hemorrhoids
    • Rarely painful unless thrombosed
    • Rarely bleeding (except for clot eroding through skin)
    • A palpable “lump” can be felt often when the hemorrhoid has thrombosed
  • Internal hemorrhoids
    • Usually painless
    • More severe internal hemorrhoids may result in feeling of fullness and incomplete evacuation after defecation
    • Protruding hemorrhoids present as a mass with more prominent bleeding
    • If 4th degree internal hemorrhoid, increased risk of strangulation and/or thrombosis with acute pain
    • Individuals often have fecal soiling --> pruritus and irritation
Differential Assessment

Hemorrhoids are diagnosed based on the presence of the typical signs and symptoms listed above. Rule out the following conditions that may present with similar signs and symptoms:

  • Colorectal Cancer - Symptoms:
    • Large amounts of blood
    • Blood is dark in colour
    • Bleeding is recurrent
    • Change in bowel habits (stool consistency, frequency)
  • Upper GI tract bleeding - black, tarry stools not typical of hemorrhoids
  • Inflammatory bowel disease - rectal bleeding common, associated with changes in bowel habits, abdominal cramping
  • Anal fissure - severe sharp pain which always occurs during defecation; small amounts of red blood can be seen on tissue or in stool.
  • Pinworms – consider if predominant symptom is prurutis and there is a child in the household
When to Refer

Patients with typical signs / symptoms of hemorrhoids often do not require further investigation, however a physician assessment should be recommended in the following situations:

  • Child under 12 years of age ( congenital abnormality, sexual abuse)
  • Patient has risk factors for colorectal cancer:
    • Over 50 years of age with new onset of symptoms not diagnosed by physician
    • History of inflammatory bowel disease
    • Personal history of colorectal cancer or adenomatous polyposis
    • Strong family history (either cancer or polyps in a first-degree relative less than 60 years old or two first-degree relatives of any age
  • Rectal bleeding persisting for 6 weeks or more with or without a change in stool consistency and / or frequency
  • Frequent recurrent episodes of bleeding hemorrhoids. Refer to rule out colorectal cancer
  • Hemorrhoids causing severe discomfort in pregnant patients
  • 3rd or 4th degree internal hemorrhoids  unless 3rd degree are small.
  • Unable to confirm patient self-diagnosis - symptoms require further evaluation and /or physician-supervised treatment. (See Differential Assessment above)
  • Symptoms have not improved despite 7 days of pharmacological treatment
Treatment

Goals of Therapy

  • Symptom relief
  • Prevent future episodes
  • Proper use of products

Non-pharmacological General Measures

  • Mild hemorrhoids may be treated solely with changes in diet and by resolving underlying constipation.
  • Increase fibre and fluid intake to avoid constipation and straining.  This may include recommending a fibre supplement, aiming for 20-30g of fiber per day through diet and supplements.  Increase daily fibre intake slowly to avoid bloating and constipation.
  • Do not sit on the toilet for long periods of time.
  • Regular exercise.
  • Sitz baths or Epsom salt baths (1 cup per 2 litres of water) to relieve irritation and itch (poor evidence).  15 minutes BID to TID.
  • Cleanse anal area with unscented moistened towelettes or unscented baby wipes and pat area dry.

Over-the-Counter Drug Options

  • For constipation, recommend a bulk-forming laxative or an osmotic laxative such as lactulose. Stimulant laxatives without stool softener (eg. Senna) may worsen hemorrhoid symptoms.
  • A stool softener such as docusate sodium may also be recommended to reduce straining.
  • Analgesics such as acetaminophen or ibuprofen can be used for pain relief.  Avoid ibuprofen if bleeding is present.  Opioids of any kind should not be recommended, as they may cause constipation and worsen the hemorrhoids.
  • Combination Topical OTC Agents
    • Zinc sulfate +/- topical anaesthetics (e.g.Anusol® and Anusol Plus®, Rectogel®)
      • Zinc sulfate has astringent, antipruritic and skin protectant properties.
      • Pramoxine and benzocaine are topical anaesthetics used in hemorrhoid preparations for relief of pain and itching.
      • Ointment Dosage:  Bathe and dry the affected anal area.  Apply ointment freely to the affected area every 4 hours or as needed and after each bowel movement.
      • Suppository Dosage:  Bathe and dry the affected anal area.  Insert 1 suppository in the morning,at bedtime and after each bowel movement.
    • Shark liver oil 3%, yeast 1% (e.g. Preparation H®, Preparation H-PE®)
      • H-PE® cooling gel contains hamamelis 50%, phenylephrine hydrochloride 0.25%.
      • Shark liver oil works as a dermatological protectant topically and is of value as a lubricant to ease painful bowel movements.
      • H-PE® cooling gel contains hamamelis 50%, phenylephrine hydrochloride 0.25%.
      • Phenylephrine causes vasoconstriction which may relieve inflammation and stop bleeding.
      • Cooling Gel, Cream, and Ointment dosage:  Apply freely morning, night, after each bowel movement and when symptoms occur.
  • Topical hydrocortisone
    • Only use if infection is excluded
    • Insufficient evidence that it reduces swelling, bleeding or protrusion
    • Long term use may cause mucosla atrophy
  • Protectants, such as white petrolatum or glycerin, provide a physical barrier to prevent irritation of perianal area.

Prescription Drug Options

  • Indicated for short term use for symptomatic relief of hemorrhoid symptoms.
  • Hydrocortisone 1% in various combinations with zinc sulfate and / or local anaesthetics are available.
    • Hydrocortisone may relieve inflammation but there is no evidence that it reduces swelling, bleeding or protrusion.
    • Local anaesthetics are used to treat pain associated with hemorrhoids but evidence of effectiveness is lacking.
    • Recommended maximum duration of treatment is 7 days, but up to 14 days may be appropriate if significant improvement is occuring.
  • There is insufficient evidence to recommend one product over another.
  • Choice of product is based on patient's symptoms:
    • Pain
      • Hydrocortisone 0.5 -1 %
      • Local anaesthetics such as benzocaine, cinchocaine (=dibucaine), pramoxine
    • Pruritus
      • Hydrocortisone 0.5 - 1 %
      • Zinc sulfate
      • Local anaesthetics
    • Bleeding
      • Astringents such as zinc sulfate, esculin
    • Inflammation
      • Hydrocortisone 0.5-1%

  • Choice of formulation depends on hemorrhoid type:
    • External hemorrhoids - ointment formulations
    • Internal hemorrhoids - ointment applied manually using a finger cot (preferred to rectal tubes or suppositories)
    • Suppositories likely to slip into rectum and bypass anal canal; likely less effective than ointments (low evidence).
  • Pregnancy:Recommend general measures - treating constipation, hygiene, cold packs, etc first.  Oral acetaminophen can also be given for pain relief.  Consider anesthetics and steroids applied sparingly and externally.  If patient is very uncomfortable, refer to physician.
  • Lactation: rectal use of topical products containing hydrocortisone is not likely to pose a risk to the infant.  Topical products containing astringents or anesthetics also pose minimal risk due to low absorption.
Advice / Monitoring
  • Provide information on appropriate non-drug measures to all patients.
  • Provide verbal instruction on use of ointments or suppositories.
    • Clean and pat dry area before applying product
    • Apply morning, night and after each bowel movement until acute pain and discomfort passes, up to 7 days
    • For internal hemorrhoids, apply manually using finger cot (as opposed to tube applicators)
    • If using suppositories, do not insert far; lie down on side for few minutes after insertion
  • Advise patients that no medication can cure hemorrhoids - drug therapy provides symptomatic relief only.
  • Advise patients to expect improvement in symptoms within 48 hours.
  • Education about:
    • Prevention of constipation (fibre, fluid, activity) to reduce recurrences
    • Anal hygiene

Assess benefit in 7 days

  • If no relief and product is being used appropriately, refer to MD for further evaluation.
  • If improvement, advise patient to continue therapy until symptoms are resolved (Maximum duration for hydrocortisone is 14 days).
  • Expect recurrence; have patient begin preventative measures - fibre and fluid to avoid constipation, regular physical activity, avoiding prolonged sitting and straining on the toilet.
  • Treating recurrences with prescription products is appropriate provided bleeding and pain resolve between each recurrence.

Assess adverse effects

  • Local anaesthetics can cause sensitization - if excessive or persistent burning, discontinue products.
  • Products containing hydrocortisone should be used for maximum of 14 days to prevent skin atrophy and steroid-induced dermatitis
Products

Detailed information on contraindications, cautions, adverse effects and interactions is available in individual drug monographs in the CPS (e-CPS), Lexi-Comp, AHFS, www.drugs.com or other reliable drug monograph references. For comprehensive drug comparisons, see RxFiles charts (www.rxfiles.ca).
This information should be routinely consulted before prescribing.

Table 1: Prescription Hemorrhoid Products: Ointments
Product Active Ingredients Adult Dose

Anodan-HC®
Anusol-HC®
Egozinc-HC®
Jampzinc-HC®
Ratio-Hemcort®
Riva-Sol HC®
Sandoz Anuzinc HC®

HC 0.5%
Zinc sulfate 0.5%
Administer in the morning, at bedtime, and after each
bowel movement.  Continue treatment until the acute
phase of pain and discomfort passes and inflammation subsides.
Anugesic-HC®
Proctodan-HC®
Sandoz Anuzin HC Plus®
HC 0.5%
Pramoxine 1%
Zinc Sulfate 0.5%
As above.
Proctol®
Proctosedyl®
Ratio-Proctosone®
Sandoz Proctomyxin HC®
HC 0.5%
Dibucaine 0.5%
Esculin 1%
Framycetin SO4 1%
As above.
HC = hydrocortisone acetate; SO4 - sulfate

Table 2: Prescription Hemorrhoid Products: Suppositories and Foam
Product Active Ingredients Adult Dose
Anodan-HC®
Anusol-HC®
Egozinc-HC®
Jampzinc-HC®
Ratio-Hemcort®
Riva-Sol HC®
Sandoz Anuzinc HC®
HC 10 mg
Zinc sulfate 10 mg
Insert in the morning, at bedime, and after each bowel
movement.  Continue treatment until the acute phase
of pain and discomfort passes and inflammation subsides. 
Anugesic-HC®
Proctodan-HC®
Sandoz Anuzin HC Plus®
HC 10 mg
Pramoxine 20 mg
Zinc sulfate 10 mg
As above
Proctol®
Proctosedyl®
Ratio-Proctosone®
Sandoz Proctomyxin HC®
HC 5 mg
Dibucaine 5 mg
Esculin 10 mg
Framycetin SO4 10 mg
As above
Proctofoam HC® HC 1%
Pramoxine 1%
As above

HC = hydrocortisone; SO4 = sulfate



TABLE 3: OTC Hemorrhoid Products

Product

Anesthetic

Astringent

Protectant

Other

Anusol

Anuzinc

Zn oxide 5%

Anusol Plus

Pramoxine

20 mg

Zn sulfate

monohydrate 10 mg

Preparation H

Yeast 22 mg

Preparation H Soothing Wipes

Tucks Cleansing Wipes

+Various Manufacturers

Hamamelis 50%

Glycerin 10%

Anusol Ointment

Zn sulfate monohydrate 0.5%

Anusol Plus Ointment
+Various manufacturer
Pramoxine 1% Zn sulfate monohydrate 0.5%
Hemoclin Gel Aloe barbadensis 40$
Preparation H PE Cooling Gel Hamamelis 50% Phenylephrine 0.25%
Preparation H Cream Shark liver oil 3% Yeast 1%

Prescribing and Billing Details
  • pseudoDIN: 00951098
    • Max of 3 claims per 365 days per patient

  • May prescribe sufficient quantity to treat up to 14 days.
    • Give 7 days at a time.  If significant improvement after the 7 day follow-up, refill for another 7 days.

  • The products in the "product" section are NOT on the drug plan and will not be covered for the patient.  The assessment fee will still be covered.
Treatment Flowchart
Pharmacist Assessment Documents
References / Suggested Reading
  1. Carruthers-Czyzewski P. Hemorrhoids. In: Jovaisas B, ed. Compendium of Therapeutics for Minor Ailments. Ottawa, ON: Canadian Pharmacists Association; 2014. Available from: https://www.e-therapeutics.ca. Subscription required.
  2. Thornton S. Hemorrhoids. Medscape. http://emedicine.medscape.com/article/775407-overview. Updated November 3, 2014. Accessed September 1, 2015.
  3. Altomare DF, Giannini I.  Pharmacological treatment of hemorrhoids: a narrative review. Expert Opin Pharmacother. 2013;14(17):2343-9. doi:10.1517/14656566.2013.836181.
  4. Buntzen S, Christensen P, Khalid A, et al.  Diagnosis and treatment of haemorrhoids. Dan Med J. 2013;60(12):C4754. http://www.danmedj.dk/portal/pls/portal/!PORTAL.wwpob_page.show?_docname=10485054.PDF. Published December 2013. Accessed September 1, 2015.
  5. Hall JF.  Modern management of hemorrhoidal disease. Gastroenterol Clin North Am. 2013;42(4):759-72. doi:10.1016/j.gtc.2013.09.001.
  6. Ganz RA.  The evaluation and treatment of hemorrhoids: a guide for the gastroenterologist. Clin Gastroenterol Hepatol. 2013;11(6):593-603. doi:10.1016/j.cgh.2012.12.020.

Prepared by medSask.
Reviewed by Dr. Dr D. G. Bishop, Family Physician and Dr. Brenda Schuster, Pharm D.
Funded by the Saskatchewan College of Pharmacists.
Posted May 2010. Updated March 2016.