- PRESCRIBING INFORMATION - PRODUCT MONOGRAPH - HUMATIN
(Paromomycin Sulfate Capsules MANUFACTURER STANDARD)
250 mg Capsules
- THERAPEUTIC CLASSIFICATION
- ACTION AND CLINICAL PHARMACOLOGY
HUMATIN* (Paromomycin Sulfate) is a broad spectrum aminoglycoside antibiotic produced by Streptomyces rimosus var. paromomycinus. The drug is structurally related to neomycin, streptomycin and kanamycin.
It is poorly absorbed after oral administration with almost 100% of the drug recoverable in the stool.
Paromomycin sulfate is considered a luminal or contact amebicide since it acts principally in the intestinal lumen.
Unlike tetracyclines, paromomycin is a direct-acting amebicide and is effective either in the presence or absence of bacteria.
Like other aminoglycosides, paromomycin is bactericidal and appears to inhibit protein synthesis in susceptible bacteria at the 30S segment of the ribosome.
Paromomycin sulfate has a broad spectrum of activity, including activity against protozoa, bacteria and cestodes.
Paromomycin sulfate is active against protozoa, especially E. histolytica. The drug is believed to act against both the trophozoite and encysted forms of Entamoeba.
Paromomycin sulfate has an antibacterial spectrum quite similar to that of neomycin and is bactericidal to many normal and pathogenic organisms in the gastrointestinal tract. Almost complete cross-resistance exists between paromomycin and kanamycin, neomycin and streptomycin.
- INDICATIONS 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.
Individuals with a history of previous hypersensitivity reactions to HUMATIN (Paromomycin Sulfate). It is also contraindicated in intestinal obstruction.
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.
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.
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
- 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).
- Empirical Formula: C23H45N5O14 .xH2SO4
- Molecular Weight: 615.64 (Base)
- Structural Formula:
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.
- PATIENT MEDICAL INFORMATION
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
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*.
If you think you have used too much HUMATIN*, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
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 possible side effects from using HUMATIN*?
These are not all the possible side effects you may feel when taking HUMATIN*. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
• Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Store HUMATIN* at room temperature (15 to 30°C). Protect from moisture.
Keep out of reach and sight of children.
If you want more information about HUMATIN*:
Talk to your healthcare professional
Find the full prescribing information that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer's website (www.eci2012.net), or by calling 1-800-931-3133.
This leaflet was prepared by ERFA Canada 2012 Inc.
Last revision date: 25-Jan-2019
- What is HUMATIN* used for?
Please note that an error occurred on the label of Humatin 250mg 100’s lot 11K04. The generic name should read: Paromomycin (not paramomycin) sulfate. Thank you.