| Dose | Size & Price | Qty |
|---|
| 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.
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.
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.
Before using this medication, you may want to consult a healthcare provider about the following:
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.
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.
Anusol Plus suppositories are generally well tolerated. Reported side effects can include:
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.
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (e.g., different shape or color), as trademark laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.