API’s

PAROMOMYCIN SULPHATE

Molecular formula: C23H46N5O14 . X H2SO4 Molecular weight: 615,64 (base)

CAS registry No: 1263-89-4

Presentation: Powder

Category: Aminoglycoside antibiotic PAROMOMYCIN SULPHATE PAROMOMYCIN For human and veterinary use Application: For production of pharmaceutical products Quality: USP

CONTENT Not less than 675 µg/mg.

Pharmacological action Paromomycin sulphate is a broad-spectrum Aminoglycoside antibiotic, produced by Streptomyces Chrestomyceticus. The antibiotic is structurally related to Neomycin, Streptomycin and Kanamycin. Paromomycin sulphate is used for the preparation of drug forms for oral, parenteral and topical use. The antibiotic is administered in the form of solution for injection, capsules, creams, and oral solutions.

Paromomycin has a broad spectrum of activity, including activity against protozoa, bacteria and cestodes. The drug has an antibacterial spectrum similar to that of neomycin but it is also active against some protozoa, including Leishmania spp., Entamoeba histolytica and Cryptosporidium spp., and has anthelmintic properties against tapeworms. Paromomycin is believed to act against both the trophozoite and encysted forms of Entamoeba histolytica. The antibiotic is active against Mycobacterium tuberculosis, including multi-drug resistant strains and Mycobacterium avium complex.

Paromomycin is bactericidal to many normal and pathogenic organisms in the gastrointestinal tract. Like other aminoglycosides, Paromomycin appears to inhibit the protein synthesis in susceptible bacteria at the 30S subunit of the ribosome.

Paromomycin is considered a luminal or contact amebicide since it acts principally in the intestinal lumen. Unlike tetracycline, Paromomycin is a direct-acting amebicide and is effective either in the presence or absence of bacteria. Almost complete cross-resistance exists between Paromomycin and Kanamycin, Framycetin, Neomycin, and Streptomycin. Paromomycin is poorly absorbed after oral administration with almost 100 % of the drug recoverable in the stool. The antibiotic is ineffective against systemic infections when given perorally.

Paromomycin is an Aminoglycoside antibiotic that has been administered by mouth as sulphate in the treatment of intestinal protozoal infections, including acute and chronic amoebiasis, cryptosporidiosis in patients with AIDS, and giardiasis. The antibiotic is not effective in extraintestinal amoebiasis. API’s

Paromomycin has also been tried parenterally for visceral, and topically for cutaneous leishmaniasis. It has also been used in the treatment of tapeworm infection, but it is not the treatment of choice, and similarly to neomycin is used in the suppression of intestinal flora both pre-operative treatment and management of hepatic encephalopathy.

Paromomycin is used as a single oral dose to eliminate Taenia saginata, Taenia solium and Diphyllobothrium latum, and repeated doses are necessary to eliminate Hymenolepis nana.

PAROMOMYCIN SULPHATE PAROMOMYCIN Re-test period Two (2) years from manufacturing date.

Storage In a dry place, protected from light.

Packing 20 kg in a fiber drum.