BUSTON INJECTION 20MGML

Land: Malaysia

Sprache: Englisch

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

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18-10-2021
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18-10-2022

Wirkstoff:

Hyoscine-N-Butylbromide

Verfügbar ab:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Internationale Bezeichnung):

Hyoscine-N-Butylbromide

Einheiten im Paket:

1 ml 10 Units mL; 1 ml 100 Units mL

Hergestellt von:

SIU GUAN CHEM. IND.CO.,LTD.

Fachinformation

                                BUSTON INJECTION 20MG/ML
HYOSCINE-N-BUTYLBROMIDE 20MG/ML SOLUTION FOR INJECTION
DESCRIPTION
A colourless to slightly yellow clear sterile solution in amber glass
ampoules.
COMPOSITION
Each 1 ml contains 20mg of Hyoscine-N-butylbromide.
MODE OF ACTION
Hyoscine and related compounds are competitive antagonists of the
actions of acetylcholine and
other muscarinic agonist; they compete with such agonists for a common
binding site on the
muscarinic receptor. The receptors affected are those of peripheral
structures that are either
stimulated or inhibited by muscarine, which are exocrine glands and
smooth and cardiac muscle.
SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS
Buston is an antispasmodic agent which relaxes smooth muscle of the
organs of the abdominal
and pelvic cavities. It is believed to act predominantly on the
intramural parasympathetic ganglia
of these organs.
After intravenous administration hyoscine-N-butylbromide is rapidly
distributed into the tissues.
The volume of distribution (Vss) is 128 l. The half-life of the
terminal elimination phase (t½γ) is
approximately 5 hours. The total clearance is 1.2 l/min, approximately
half of the clearance is
renal.
In
rat,
highest
concentrations
of
hyoscine-N-butylbromide
are
found
in
the
tissue
of
the
gastrointestinal tract, liver and kidneys. Plasma protein binding of
hyoscine-N-butylbromide is
low.
Hyoscine-N-butylbromide does not readily pass the blood-brain barrier.
INDICATIONS
Buston Injection is indicated in acute spasm, as in renal or biliary
chronic, in radiology for
differential diagnosis of obstruction. It also indicated to reduce
spasm and pain in pyelography,
and in other diagnostic procedures where spasm may be a problem.
ADVERSE REACTIONS/SIDE EFFECTS
Side effects of Buston are dryness of the mouth, increased viscosity
of bronchial secretions,
accomodation disorders, diminution of lacrymal secretion, tachycardia,
palpitations, constipations,
urinary retention, excitement, irritability, mental confusion of the
elderly.
PRECAUTIONS/WARNINGS
In pro
                                
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