Paromomycin is an active pharmaceutical ingredient in the Antibiotics group (A07AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised March 22, 2025[1]
AND USAGE HUMATIN* (Paromomycin Sulfate) is indicated for the treatment of intestinal amebiasis, acute and chronic. (NOTE--It is not effective in extraintestinal amebiasis). To reduce the development of drug-resistant microorganisms and maintain the effectiveness of HUMATIN* and other antimicrobial drugs, HUMATIN* should be used only to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms.
When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
CONTRAINDICATIONS Individuals with a history of previous hypersensitivity reactions to HUMATIN* (Paromomycin Sulfate). It is also contraindicated in intestinal obstruction. PRECAUTIONS Susceptibility/Resistance Development of Drug Resistant Organisms Prescribing HUMATIN* in the absence of a proven or strongly suspected microbial infection is unlikely to provide benefit to the patient and risks the development of resistant organisms.
Drug interactions
Known interactions involving Paromomycin. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]Health Canada (DPD) · 02078759 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
The use of HUMATIN* (Paromomycin Sulfate), as with other antibiotics, may result in an overgrowth of nonsusceptible organisms, including fungi. Constant observation of the patient is essential. If new infections caused by nonsusceptible organisms appear during therapy, appropriate measures should be taken.
The drug should be used with caution in individuals with ulcerative lesions of the bowel to avoid renal toxicity through inadvertent absorption. ADVERSE REACTIONS Nausea, abdominal cramps and diarrhea have been reported in patients using HUMATIN* (Paromomycin Sulfate), on doses over 3 g daily.
DOSAGE AND ADMINISTRATION Adults and Children:
Usual dose of HUMATIN* (Paromomycin Sulfate) is 25 to 35 mg/kg body weight daily, administered in 3 doses with meals, for 5 to 10 days. 4 Capsule Composition Each HUMATIN* (Paromomycin Sulfate) capsule contains: paromomycin sulfate equivalent to paromomycin 250 mg.
Non-medicinal ingredients:
Each capsule contains: colloidal silica, magnesium stearate. Capsule shell: yellow iron oxide, black iron oxide, red iron oxide, gelatin and titanium dioxide. Stability and Storage Recommendations Store HUMATIN* (Paromomycin Sulfate) at controlled room temperature 15 - 30°C.
Protect from moisture. AVAILABILITY OF DOSAGE FORMS HUMATIN* (Paromomycin Sulfate) capsules are available in the dosage strength of 250 mg per capsule. Each capsule has a coni-snap No1 brown cap and a yellow body with no print. Available in bottles of 100.
PHARMACEUTICAL INFORMATION Drug Substance Proper Name:
Paromomycin Sulfate Chemical Name: O-2-amino-2-deoxy--D-glucopyranosyl-(14)-O-[O-2,6-diamino-2,6-dideoxy--L- idopyranosyl-(13)--D-ribofuranosyl-(15)]-2-deoxy-D-streptamine sulfate(salt). 64 (Base) Structural Formula: 5 Description: It is a white, amorphous, stable water-soluble product.
Paromomycin Sulfate is the sulfate salt of an antibiotic substance or substances produced by the growth of Streptomyces rimosus var. paromomycinus, or a mixture of two or more such salts. It has a potency equivalent to not less than 675 g of paromomycin (C23H45N5O14) per mg, calculated on the dried basis.
6 Patient Medication Information Pr HUMATIN* Paromomycin Sulfate Capsules Read this carefully before you start using HUMATIN*. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about HUMATIN*.
What is HUMATIN* used for? HUMATIN* is used to treat infections of intestines that are caused by certain parasites. Drugs like HUMATIN* only treat certain infections. They do not treat viral infections. How does HUMATIN* work? HUMATIN* contain an antibiotic.
It works by killing or stopping the growth of parasites that cause disease. What are the ingredients in HUMATIN*? Medicinal ingredients: paromomycin sulfate Non-medicinal ingredients: black iron oxide, colloidal silica, gelatin, magnesium stearate, red iron oxide, titanium dioxide, yellow iron oxide.
HUMATIN* come in the following dosage form:
As capsules containing paromomycin sulfate equivalent to 250 mg paromomycin. Do not use HUMATIN* if you: are allergic to paromomycin sulphate have an intestinal blockage 7 To help avoid side effects and ensure proper use, talk to your healthcare professional before you use HUMATIN*.
Talk about any health conditions or problems you may have, including if you: are allergic to any other antibiotic have ulcers in your bowels are pregnant or planning to become pregnant are breastfeeding or planning to breastfeed Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take HUMATIN*: Swallow HUMATIN* capsules with water. Take HUMATIN* with your meals. Follow all instructions given to you by your healthcare professional. Although you may feel better early in treatment, HUMATIN* should be used exactly as directed.
Misuse or overuse of HUMATIN* could lead to the growth of microorganisms that will not be killed by HUMATIN* (resistance). This means that HUMATIN* may not work for you in the future. Do not share your medicine. Usual dose of HUMATIN*: Your healthcare professional will decide how much HUMATIN* you will be given.
The dose you are given will be based on your body weight. You will take it three times a day with your meals. Your healthcare professional will tell you for how long you should take HUMATIN*. 8 Overdose: Missed dose: If you miss a dose of HUMATIN*, take it as soon as you remember.
If it is almost time for your next dose, skip the missed dose and take your next scheduled dose. Never take a double dose to make up for a missed dose. What are […]