Anusol Plus Hemorrhoidal Suppositories (Pramoxine HCl / Zinc Sulfate Monohydrate)

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12-Pack
24-pack
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Fact Table

Fact Table
Formula C17H28ClNO3 (pramoxine hydrochloride); H2O5SZn / ZnSO4·H2O (zinc sulfate monohydrate)
License Health Canada marketed, DIN 01945904; original market date 1992-12-31; company: Church & Dwight Canada Corp. No FDA NDA identified for Anusol Plus suppositories
Bioavailability Not established for rectal suppository use; intended mainly for local anorectal action with limited systemic exposure expected
Legal status Non-prescription / over-the-counter in Canada
Chemical Name Pramoxine hydrochloride: 4-[3-(4-butoxyphenoxy)propyl]morpholine hydrochloride; Zinc sulfate monohydrate: zinc(2+) hydrate sulfate / zinc sulfate hydrate
Elimination half-life Not established for this rectal topical combination; pramoxine topical pharmacokinetic half-life not well characterized; zinc has complex physiological homeostasis rather than a product-specific half-life
Dosage (Strength) Suppositories: pramoxine hydrochloride 20 mg / zinc sulfate 10 mg per suppository; use rectally as directed for hemorrhoidal pain, itching, swelling and discomfort
Pregnancy Consult a doctor or pharmacist before use during pregnancy or breastfeeding
Brands Anusol Plus Hemorrhoidal Suppositories; Anusol Plus Ointment; generic pramoxine/zinc sulfate hemorrhoidal preparations where available
Protein binding Not established for pramoxine in rectal/topical use; circulating zinc is largely protein-bound, mainly to albumin, alpha-2-macroglobulin and amino acids
PubChem CID 73957 (pramoxine hydrochloride); 62639 (zinc sulfate monohydrate); 24424 (zinc sulfate)
MedlinePlus a682429 (pramoxine); no specific MedlinePlus monograph identified for Anusol Plus combination
ChEBI Not assigned/identified for pramoxine hydrochloride; 35176 (zinc sulfate)
ATC code C05AD07 and D04AB07 (pramoxine); A12CB01 and B05XA18 (zinc sulfate); no specific combination ATC identified
DrugBank DB09345 / DBSALT001353 (pramoxine/pramoxine hydrochloride); DB09322 / DBSALT001304 (zinc sulfate/zinc sulfate monohydrate)
KEGG D00739 (pramoxine hydrochloride); D06371 (zinc sulfate)
Routes of administration Rectal administration as suppositories; related Anusol Plus ointment may be used rectally/topically

Anusol Plus Hemorrhoidal Suppositories are used for short-term relief of pain, burning, itching, and discomfort from hemorrhoids and other minor irritations of the anus. They contain two medicines: pramoxine hydrochloride, which numbs the area, and zinc sulfate monohydrate, which helps protect irritated skin and reduce swelling. The suppository is inserted into the rectum so the medicine can work directly where it is needed.

Directions

Before using Anusol Plus suppositories, gently wash and dry the anal area, then wash your hands.

Remove the foil wrapper and insert 1 suppository into the rectum in the morning, in the evening, and after each bowel movement.

Use the bathroom first if you can.

Do not use more than 5 suppositories in 24 hours.

Wash your hands after each use, and store the suppositories in a cool place below 22°C (72°F) so they do not soften.

Stop using this product and talk to a healthcare provider if symptoms do not improve within 7 days, get worse, or come back.

Ingredients

The active ingredients in each suppository are pramoxine hydrochloride and zinc sulfate monohydrate. The non-medicinal ingredients may include calcium phosphate, magnesium stearate, parabens, and vegetable oil.

Cautions

Before using this medication, you may want to consult a healthcare provider about the following:

  • Any existing health conditions
  • Any allergies
  • A list of all medications currently being taken

Stop using Anusol Plus and consult a healthcare provider if you notice rectal bleeding. While occasional minor spotting can happen with hemorrhoids, ongoing or unexplained rectal bleeding should always be checked to rule out other causes.

Anusol Plus is meant for short-term use. If symptoms do not improve within 7 days, get worse, or come back after treatment, stop using the suppositories and see a healthcare provider.

Do not use Anusol Plus suppositories in the eyes, mouth, or vagina.

Do not insert into broken or open skin or use over a large skin area.

Stop using Anusol Plus if irritation, swelling, rash, or other signs of sensitivity develop. The pramoxine, zinc sulfate, or paraben components may cause skin reactions.

Talk to a pediatrician before using Anusol Plus in children. It is generally intended for adult use.

Keep the suppositories tightly closed in their original packaging, stored under 22°C, and out of reach of children.

Contraindications

Avoid taking or using this medication if you have a known allergy or hypersensitivity to pramoxine, zinc sulfate, parabens, or any of the other ingredients in Anusol Plus suppositories.

Side Effects

Anusol Plus suppositories are generally well tolerated. Reported side effects can include:

  • Occasional burning or stinging at the application site
  • Mild irritation or itching
  • Skin redness around the anal area
  • Dryness of the skin in the treated area

Stop using Anusol Plus and get medical care if you develop signs of a serious allergic reaction such as widespread rash, swelling of the lips, tongue, or throat, trouble breathing, or severe swelling.

Stop using the suppositories and contact a healthcare provider for rectal bleeding that is more than minor spotting, severe pain that doesn’t improve, signs of infection (such as fever or pus), or any other unusual reaction.

References

  • Anusol Plus Patient Information Leaflet. Folkestone, Kent, UK: Church & Dwight UK Limited.
  • Anusol Plus Summary of Product Characteristics. Folkestone, Kent, UK: Church & Dwight UK Limited.

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