DYNA-PENTOXIFYLLINE SR 400 mg - Pharma Dynamics

SCHEDULING STATUS:
S2
DYNA-PENTOXIFYLLINE SR 400 mg
PROPRIETARY NAME AND DOSAGE FORM:
DYNA- PENTOXIFYLLINE SR 400 mg Slow Release Tablets
COMPOSITION:
Each slow release tablet contains Pentoxifylline 400 mg
PHARMACOLOGICAL CLASSIFICATION:
A. 8. Medicines acting on the blood and haemopoietic system.
PHARMACOLOGICAL ACTION:
Pentoxifylline improves erythrocyte flexibility, microcirculatory flow, tissue oxygen
concentrations and reduces viscosity.
Pharmacokinetics:
Pentoxifylline is readily absorbed from the gastrointestinal tract but undergoes first-pass
hepatic metabolism. Some metabolites are active. The apparent plasma half-life of
pentoxifylline is reported to be 0,4 to 0,8 hours; that of the metabolites varies from 1,0 to
1,6 hours. In 24 hours most of a dose is excreted in the urine mainly as metabolites, and
less than 4% is recovered as unchanged drug in the faeces. Elimination of pentoxifylline
is decreased in elderly patients and patients with hepatic disease. Pentoxifylline and its
metabolites cross into breast milk.
INDICATIONS:
Symptomatic relief of intermittent claudication, associated with chronic occlusive arterial
disorders of the limbs and trophic ulcers. Pentoxifylline may improve function as well as
provide symptomatic relief. Raynaud’s syndrome.
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CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Pentoxifylline should be avoided in cerebral haemorrhage, extensive retinal
haemorrhage, and acute myocardial infarction. It should be used with caution in patients
with ischaemic heart disease or hypotension. Pentoxifylline may potentiate the effect of
antihypertensive agents. High parenteral doses of Pentoxifylline may enhance the
hypoglycaemic action of insulin in diabetic patients. Pentoxifylline should not be given
concomitantly with ketorolac as there is reported to be an increased risk of bleeding
and/or prolongation of the prothrombin time. The dose of Pentoxifylline may need to be
adjusted in renal failure.
Pregnancy and lactation:
The safety in pregnancy and lactation has not been established.
WARNINGS:
Use with caution in patients with cirrhosis.
DOSAGE AND DIRECTIONS FOR USE:
Unless otherwise prescribed by a physician, the average dose is one DYNA-
PENTOXIFYLLINE SR 400 mg taken two to three times daily after meals, swallowed
whole with sufficient amounts of liquid (approximately half a glass). In patients with
impairment of renal function (creatinine clearance below 30 ml/min) a dose reduction of
approximately 30% to 50% may be necessary. A dose reduction is necessary in patients
with severely impaired liver function.
A dose reduction is also advised in hypotensive patients or patients whose circulation is
unstable as well as in patients, who would be at particular risk from a reduction in blood
pressure (e.g. patients with severe coronary heart disease or relevant stenoses of blood
vessels supplying the brain); in such cases, the dose must only be increased gradually.
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SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Pentoxifylline can cause nausea, gastrointestinal disturbances, dizziness and headache.
Flushing, angina, palpitations, cardiac arrhythmias and hypersensitivity reactions may
also occur. Bleeding events have been reported rarely, usually in association with
bleeding risk factors.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage with Pentoxifylline may be associated with fever, faintness, flushing,
hypotension, drowsiness, agitation and seizures.
Treatment is symptomatic and supportive.
IDENTIFICATION:
Pink-violet oval film coated tablets.
PRESENTATION:
30 and 100 tablets in white securitainers.
STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
36/8/0282
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NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Marketed by Pharma Dynamics (Pty) Ltd for:
CompuPharm (Pty) Ltd
476 Kings Highway
Lynnwood
Pretoria
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11 December 2004
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SKEDULERINGSTATUS:
S2
EIENDOMSNAAM EN DOSEERVORM:
DYNA-PENTOXIFYLLINE SR 400 mg
DYNA-PENTOXIFYLLINE SR 400 mg Stadige-vrystelling Tablette
SAMESTELLING:
Elke stadige-vrystelling tablet bevat 400 mg Pentoksifillien.
FARMAKOLOGIESE KLASSIFISERING:
A 8 Medisyne wat op die bloed- en hemopoïetiese sisteem werk.
FARMAKOLOGIESE WERKING:
Pentoksifillien verbeter die soepelheid van eritrosiete, mikrosirkulatoriese vloei, en
weefselsuurstofkonsentrasies, en verminder viskositeit.
Farmakokinetika:
Pentoksifillien word maklik uit die spysverteringskanaal geabsorbeer, maar ondergaan
presistemiese hepatiese metabolisme. Sommige van die metaboliete is aktief. Daar word
berig dat die skynbare plasmahalfleeftyd van pentoksifillien 0,4 tot 0,8 uur is; dié van die
metaboliete varieer van 1,0 tot 1,6 uur. In 24 uur word die grootste deel van 'n dosis in
die urine hoofsaaklik as metaboliete uitgeskei, en minder as 4% word as onveranderde
geneesmiddel in die faeces herwin. Eliminasie van pentoksifillien is verminder in
bejaarde pasiënte en pasiënte met hepatiese siekte. Pentoksifillien en sy metaboliete
word in borsmelk uitgeskei.
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INDIKASIES:
Simptomatiese verligting van intermitterende kloudikasie, geassosieer met chroniese
okklusiewe arteriële versteurings van die ledemate en trofiese ulkusse. Pentoksifillien
mag die funksie verbeter en ook simptomatiese verligting verskaf. Raynaud se sindroom.
KONTRA-INDIKASIES:
Hipersensitiwiteit teenoor enigeen van die bestanddele.
Pentoksifillien moet vermy word in serebrale bloeding, ekstensiewe retinale bloeding, en
akute miokardiale infarksie. Dit moet met omsigtigheid gebruik word by pasiënte met
iskemiese hartsiekte of hipotensie. Pentoksifillien mag die uitwerking van
antihipertensiemiddels versterk. Hoë parenterale dosisse Pentoksifillien mag die
hipoglisemiese werking van insulien by diabetiese pasiënte verhoog. Pentoksifillien moet
nie saam met ketorolak toegedien word nie, omdat berigte van 'n verhoogde risiko van
bloeding en/of verlenging van die protrombientyd ontvang is. Die dosis Pentoksifillien
moet moontlik in nierversaking aangepas word.
Swangerskap en laktasie:
Die veiligheid tydens swangerskap en laktasie is nie vasgestel nie.
WAARSKUWINGS:
Gebruik met omsigtigheid by pasiënte met sirrose.
DOSERING EN GEBRUIKSAANWYSINGS:
Tensy andersins deur 'n geneesheer voorgeskryf, is die gemiddelde dosis een DYNA-
PENTOXIFYLLINE SR 400 mg wat twee tot drie keer per dag na maaltye geneem word.
Dit moet heel ingesluk word met toereikende hoeveelhede vloeistof (ongeveer 'n halwe
glas). By pasiënte met inkorting van nierfunksie (kreatinienopruiming onder 30 ml/min)
mag 'n dosisvermindering van ongeveer 30% tot 50% noodsaaklik wees. 'n
Dosisvermindering is noodsaaklik by pasiënte met ernstig ingekorte lewerfunksie.
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'n Dosisvermindering is ook aanbeveel by hipotensiewe pasiënte of pasiënte by wie die
sirkulasie onstabiel is, asook in pasiënte wat aan 'n besondere risiko as gevolg van 'n
verlaging in bloeddruk sou blootgestel wees (bv. pasiënte met ernstige koronêre
hartsiekte of relevante stenoses van bloedvate wat die brein versorg); in sulke gevalle
moet die dosis slegs geleidelik verhoog word.
NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS:
Pentoksifillien kan naarheid, gastroïntestinale versteurings, duiseligheid en hoofpyn
veroorsaak.
Blosing, angina, hartkloppings, kardiale aritmieë en hipersensitiwiteitsreaksies mag ook
voorkom. Insidente van bloeding is in seldsame gevalle aangemeld, gewoonlik in
assosiasie met bloedingsrisikofaktore.
BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE
BEHANDELING DAARVAN:
Oordosering met Pentoksifillien mag met koors, floutes, blosing, hipotensie, slaperigheid,
agitasie en konvulsies geassosieer wees.
Behandeling is simptomaties en ondersteunend.
IDENTIFIKASIE:
Pienk-pers ovale filmbedekte tablette.
AANBIEDING:
30 en 100 tablette in wit veiligheidshouers.
BERGINGSAANWYSINGS:
Bewaar onder 25 o C.
HOU BUITE BEREIK VAN KINDERS.
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REGISTRASIENOMMER:
36/8/0282
NAAM EN BESIGHEIDSADRES VAN DIE APPLIKANT:
Bemark deur Pharma Dynamics (Edms) Bpk vir:
CompuPharm (Edms) Bpk
Kings Highway 476
Lynnwood
Pretoria
DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:
11 Desember 2004
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