SULFOLAN POWDER

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

SULFADIMIDINE/SULFAMETHAZINE; TYLOSIN TARTRATE

Available from:

Y.S.P. INDUSTRIES (M) SDN. BHD.

INN (International Name):

SULFADIMIDINE/SULFAMETHAZINE; TYLOSIN TARTRATE

Units in package:

100 gm; 1 kg; 20 kg

Manufactured by:

Y.S.P. INDUSTRIES VIETNAM CO., LTD

Summary of Product characteristics

SULFOLAN
POWDER
INGREDIENT(S):
Tylosin (as Tylosin tartrate)
....................................................................................
88mg/g
Sulfamethazine
....................................................................................................
88mg/g
PHARMACOLOGY (SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS):
PHARMACODYNAMICS
Tylosin –
Tylosin is thought to have the same mechanism of action as
erythromycin (binds to 50S ribosome and
inhibits protein synthesis). It is a bacteriostatic antibiotic.
Sulfamethazine –
Sulfonamides interfere with the biosynthesis of folic acid in
bacterial cells; they compete with
para-aminobenzoic acid (PABA) for incorporation in the folic acid
molecule. By replacing the PABA
molecule and preventing the folic acid formation required for DNA
synthesis, the sulfonamides prevent
multiplication of the bacterial cell. Only organisms that synthesize
their own folic acid are susceptible;
mammalian cells use preformed folic acid and, therefore, are not
susceptible. Cells that produce excess
PABA or environments with PABA, such as necrotic tissues, allow for
resistance by competition with the
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PHARMACOKINETICS
Tylosin –
Tylosin tartrate is well absorbed from the GI tract, primarily from
the intestine. Tylosin is well distributed
in the body after systemic absorption, with the exception of
penetration into the CSF. The volume of
distribution of tylosin is reportedly 1.7L/kg in small animals and
1~2.3L/kg in cattle. In lactating dairy
cattle, the milk to plasma ratio is reported to be between 1 and 5.4.
Tylosin is eliminated in the urine
and bile apparently as unchanged drug. The elimination half-life of
tylosin is reportedly 54 minutes in
small animals, 139 minutes in newborn calves, and 64 minutes in calves
2 months of age or older.
Sulfamethazine –
Most sulfonamides are well absorbed orally. Delays in absorption may
occur in adult ruminants or when
sulfonamides are administered with food to monogastric animals. The
oral bioa