Penstrep-400 Suspension for Injection

Country: Malaysia

Language: English

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

Active ingredient:

PROCAINE BENZYLPENICILLIN; DIHYDROSTREPTOMYCIN SULPHATE

Available from:

Danberg (m) Sdn Bhd

INN (International Name):

PROCAINE BENZYLPENICILLIN; DIHYDROSTREPTOMYCIN SULPHATE

Units in package:

50 ml; 100 ml

Manufactured by:

Interchemie Werken de Adelaar Eesti AS

Summary of Product characteristics

MANUFACTURED BY:
Interchemie Werken de Adelaar Eesti AS
Vanapere tee 14, Püünsi village, Viimsi municipality,
Harju country, 74013 ESTONIA
PHARMACOKINETICS: after intramuscular administration, benzylpenicillin
is released over a long period from the injection site, producing a
maximum concentration in the blood within 1-3 hours of administration
(depending on species). It is weakly bound to plasma proteins in a
production of 45 to 65% and therapeutic blood levels persist 24 hours.
Dihydrostreptomycin, however, is rapidly absorbed from the point of
inoculation, reaching the highest concentrations in the blood after
1 hour, being absorbed approximately 2 times faster than
benzylpenicillin, its biological half-life being half that of the
latter.
The optimal pH of activity of benzylpenicillin is slightly acidic, 5.5
to 6.5.
It is widely distributed throughout the body, but the concentration
in the different body tissues differs, reaching significant amounts of
the drug in the lung, kidney, liver, skin, and intestinal contents,
and
low concentrations are observed in poorly vascularized areas, such
as cornea, cartilage, and bones. The inflammatory state allows its
diffusion into pleural, pericardial, peritoneal, and synovial fluids,
as
well as into cerebrospinal fluid and abscesses. It crosses the
placenta
and slowly enters the fetal circulation from the mother. It is
partially
metabolized to peniciloic acid, but for the most part (90%) it is
excreted in the urine in unchanged form.
It also appears in small amounts in the milk of lactating females.
With respect to dihydrostreptimycin, it is preferentially distributed
in
the extracellular spaces of the body and is hardly bound to plasma
proteins (less than 10%), minimally penetrating most tissues except
the kidney (relatively small volume of distribution: 0, 35 L. 0.45
kg).
Good concentrations are obtained in the fluids of the body cavities,
especially if there is inflammation. It crosses the blood-brain and
placental barriers, as well as joints and the eyeball, but d