KAMAN

KAMAN
“250 mg hard capsules” 16 capsules
Paromomycin
COMPOSITION
Each capsule contains:
Active substance: Paromomycin sulfate 357.2 mg (equivalent to 250 mg of paromomycin)
Excipients: talc, gelatin, titanium dioxide.
PHARMACEUTICAL FORM AND PACKAGE
Pack containing 16 capsules.
PHARMACOTHERAPEUTIC CATEGORY
Intestinal antimicrobial antibiotic.
MARKETING AUTHORISATION HOLDER: I.B.N. Savio S.r.l., Via del Mare n° 36 – Pomezia (RM)
MANUFACTURED BY:
I.B.N. Savio S.r.l., Via E. Bazzano n° 14 – Ronco Scrivia (GE)
or
Segix Italia S.r.l., Via del Mare n° 36 – Pomezia (RM)
THERAPEUTIC INDICATIONS
Intestinal tract infections caused by sensitive microorganisms (E. coli, Shigella, Salmonella, excluding S. typhi, etc.). Intestinal content sterilization prior to intestinal surgery. Intestinal amoebiasis (acute and chronic). Adjunctive treatment in hepatic coma (for intestinal flora sterilization to reduce ammonia-producing bacteria).
CONTRAINDICATIONS
Hypersensitivity to the drug. Severe ulcerative lesions or intestinal obstruction (even partial), to avoid the risk of increased absorption. Do not administer this antibiotic concurrently with other potentially nephrotoxic agents such as: Neomycin, Kanamycin, Streptomycin, Colistin, Viomycin, Gentamicin, Cephalosporins, Polymyxin. Children under two years of age. Renal failure. Myasthenic syndromes. Malabsorption syndromes.
NECESSARY PRECAUTIONS FOR USE
Prolonged administration may lead to the development of non-sensitive microorganisms; in such cases, the patient must be closely monitored and appropriate therapy initiated. Paromomycin is normally not absorbed through the gastrointestinal tract, but abnormal and unpredictable absorption may occur at the level of intestinal mucosal lesions. Since the antibiotic is potentially ototoxic and nephrotoxic, periodic monitoring of renal function and audiometric testing are recommended, especially during long-term therapy. Concomitant use of anti-motion sickness drugs should be avoided, as they may mask early signs of ototoxicity. Particular caution is required when treating patients with renal disorders, even of mild severity, to detect possible accumulation of small amounts of absorbed antibiotic, especially through intestinal lesions. Similar caution is required in patients with liver disease.
WARNINGS
In pregnant women, this product should only be used when clearly needed and under direct medical supervision. It is advisable to discontinue therapy once symptoms related to the infection have resolved (treatment should not generally extend beyond 3–5 days).
The medicine is not contraindicated in patients with celiac disease.
Keep out of reach of children.
DOSAGE, ROUTE AND DURATION OF ADMINISTRATION (unless otherwise prescribed):
Dosages, expressed in mg of base paromomycin, for different indications are as follows:
Bacterial dysentery: 35–50 mg/kg body weight (in adults: 2–3 g). It is advisable to discontinue therapy once infection-related symptoms have resolved (treatment should generally not exceed 3–5 days).
Amoebiasis: 25–35 mg/kg body weight, administered in 3 divided doses with meals, for 5–10 days. In particularly resistant cases, the dose may be increased at the physician’s discretion.
Preoperative intestinal sterilization: 35 mg/kg body weight for 4 days.
Intestinal sterilization in hepatic coma: Adults: average dose 4 g per day, appropriately divided throughout the day, for 5–6 days.
UNDESIRABLE EFFECTS
When administered at high doses (exceeding 3 g per day), diarrhea, abdominal cramps, and nausea have been observed in some individuals.
Furthermore, in cases of abnormal absorption, especially with high or excessive doses, nephrotoxicity (oliguria, albuminuria, hematuria, etc.) or ototoxicity (dizziness, tinnitus, hearing loss) may occur. Hypersensitivity reactions, including skin rashes of various types or locations, have been rarely reported.
Inform your physician or pharmacist if any undesired effects occur that are not listed in this leaflet.
“WARNING: Do not use the medicine after the expiry date stated on the packaging.”