Anupco


SULTRIM 240

Solution for injection

COMPOSITION

Sulfamethoxazole 200 mg

Trimethoprim 40 mg

Excipients up to 1 ml

PHARMACOLOGICAL PROPERTIES

SULTRIM 240 contains an established combination of trimethoprim and sulphamethoxazole in a ratio of 1:5. Sulphonamides inhibit the bacterial synthesis of dihydrofolic acid from p-aminobenzoic acid by competitive inhibition. Trimethoprim inhibits the enzyme dihydrofolate reductase that reduces dihydrofolic acid to tetrahydrofolic acid. Since both active components interfere at two sequential steps of the folic acid metabolism of bacteria , this results in a synergistic and a rapid bactericidal effect against a wide range of gram-positive and gram-negative bacteria. Resistance against sulphonamides and trimethoprim mainly develops by transmission of R-plasmides. However, development of resistance is slowed down using the combination. Cross-resistance exists among sulphonamides, but also between trimethoprim and other dihydrofolate reductase inhibitors.

Both components are very well absorbed from parenteral injection sites, providing therapeutically active plasma concentrations for 12-24 hours. Sulphamethoxazole is mainly distributed over extracellular fluids. Plasma protein binding is 60-70%. The lipophylic trimethoprim is very well distributed with higher concentrations found in tissues than in plasma. Plasma protein binding of trimethoprim is about 50%. Both substances are extensively metabolised and excreted mainly with urine.

INDICATIONS

Infections of the respiratory tract, gastro-intestinal tract, and urogenital tract, infections of skin, soft tissues and wounds and septicaemia, caused by sulphamethoxazole/ trimethoprim susceptible bacteria.

CONTRA-INDICATIONS

Haematopoietic, renal and hepatic disturbances. The intravenous route of administration if contra-indicated in the case of previous or concurrent administration of central nervous system depressants (eg. anaesthetics, neuroleptics).

DOSAGE AND MODE OF ADMINISTRATION

By deep intramuscular, subcutaneous or slow intravenous injection, 24 mg/kg b.w. or 1 ml/ 10 kg b.w. once daily or divided over 2 administrations with 12 hour intervals. Treatment should be continued up to 1-2 days after disappearance of clinical symptoms.

UNDESIRABLE EFFECTS

Transient local reactions (swelling, pain) at the site of injection may occur. Allergic reaction (eg. polyarthritis, keratoconjunctivitis sicca, erythrema in dogs) seldom occur. Cardiac and respiratory shock have been observed after intravenous administration (particularly in horses).

SPECIAL PRECAUTIONS FOR USE AND WARNINGS

SULTRIM 240 may be used in pregnant animals, only if it is therapeutically justified. Cardiac and respiratory shock have been observed mostly in horses after intravenous administration. The intravenous route therefore should only be used if therapeutically justified and after the injectable solution is brought approximately to body temperature. The intravenous route of administration is contra-indicated in the case of previous or concurrent administration of central nervous system depressants (eg. anaesthetics, neuroleptics). At the first sign ofáintolerance, the intravenous injection should be interrupted and shock treatment should be initiated if necessary. To avoid sulfonamide mediated renal toxic effects, always supply sufficient amounts of drinking water.

PACK SIZE

50 ml, 100 ml and 250 ml vials.

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