- 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).
Individuals with a history of previous hypersensitivity reactions to HUMATIN (Paromomycin Sulfate). It is also contraindicated in intestinal obstruction.
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.
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.