PRAXILENE

Country: Indónesía

Tungumál: indónesíska

Heimild: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Vara einkenni Vara einkenni (SPC)
26-03-2021

Virkt innihaldsefni:

NAFTIDROFURYL OXALATE

Fáanlegur frá:

MERCK TBK - Indonesia

INN (Alþjóðlegt nafn):

NAFTIDROFURYL OXALATE

Skammtar:

200 MG

Lyfjaform:

TABLET SALUT SELAPUT

Einingar í pakka:

DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT

Framleitt af:

MERCK - Indonesia

Leyfisdagur:

2019-10-09

Vara einkenni

                                149 mm
197 mm
COMPOSITIONS
Each film-coated tablet contains Naftidrofuryl Oxalate 200 mg
MODE OF ACTION
Praxilene has been shown to exert a direct effect on intracellular
metabolism.
Thus it has been demonstrated in men and animals that it produces an
increase ATP levels and a decrease of lactic acid levels in ischaemic
conditions,
evidence for an enhancement of cellular oxidative capacity.
Furthermore, Praxilene is a powerful spasmolytic agent.
Naftidrofuryl possesses 5-HT2 blocking activity and counteracts both
the
vasoconstrictor effects in animals and the effects promoting platelet
aggregation in animals and in man due to Serotonin.
INDICATIONS
Peripheral vascular disorders - painful symptoms of arteritis,
intermittent
claudication, night cramps, rest pain, incipient gangrene, trophic
ulcers,
Raynaud’s syndrome, diabetic arteriopathy and acrocyanosis.
DOSAGE AND ADMINISTRATION
Adult and the elderly :
1 tablet 3 times daily for a minimum of 3 months, or at the discretion
of
the Physician.
Children :
The drug is not indicated for use in children
PRECAUTIONS
Caution should be exercised in patients with severe cardiac
insufficiency,
conduction disorders and renal or hepatic insufficiency. The
possibility of
an additive effect occurring between Praxilene and anti-arrhythmic and
beta adrenergic blocking drugs should be considered.
The administration of Praxilene may modify the composition of the
urine,
promoting the formation of calcium oxalate kidney stones.
Indeed, the oxalate content is 19 mg per 100 mg of active ingredient.
Therefore, a sufficient amount of liquid should be taken during
treatment
to maintain an adequate level of diuresis.
The administration of Praxilene without liquid before going to bed may
cause local oesophagitis. Therefore, it is essential to always take
Praxilene
with a large glass of water.
Cases of liver damage have been reported. In case of symptoms
suggesting
liver damage, naftidrofuryl must be discontinued
DRUG INTERACTIONS
Although naftidrofuryl inhibited in vitro metabolic reactio
                                
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