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Trenlin 400
PRODUCT
Trenlin 400MG S.R. Tablet
DESCRIPTION
Pink, caplet shaped, film coated tablet, "CCM" embossed on one side and
plain on the other side.
NAME(S) AND STRENGTH(S) OF ACTIVE INGREDIENT(S)
Active Ingredient: Pentoxifylline 400mg
Preservatives: None
ACTIONS AND MODE OR MECHANISMS OF ACTION
Pentoxifylline is 3,7-dimethyl-1-(5-oxo-hexyl)xanthine. It is a water-and
lipid-soluble xanthine derivative. It reduces blood viscosity and improves
erythrocyte flexibility, and tissue oxygen concentrations. Improvement in
erythrocyte flexibility appears to be due to inhibition of phosphodiesterase
and a resultant increased in cyclic AMP in red blood cells. Reduction of
blood viscosity may be the result of decreased plasma fibrinogen
concentrations and inhibition of red blood cell and platelet aggregation.
One important feature of Trenlin is the continuous release of the active
substance resulting in constant absorption and long lasting blood level.
PHARMACOLOGY / PHARMACOKINETICS
Pentoxifylline is readily absorbed from the gastro-intestinal tract but
undergoes extensive first-pass hepatic metabolism. Pentoxifylline is
metabolised by erythrocytes and in the liver. The 5-hydroxy-methyl
metabolite and 3-carboxypropyl metabolite 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 the dose is
excreted in the urine mainly as metabolites and less than 4% is recovered 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
Pentoxifylline is used in the treatment of peripheral occlusive arterial
disease and arteriovenous disorders (e.g. intermittent claudication or rest
pain) and trophic disturbances (e.g. gangrene and leg ulcers). It is also
used in cerebrovascular disorders (sequel to cerebral arteriosclerosis such
as difficulties in concentration, vertigo, impairment of memory).
CONTRAINDICATIONS
Trenlin 400 should be avoided in patients who are hypersensitive or
intolerant to the active ingredient, pentoxifylline and other xanthine
derivatives such as caffeine, theophylline or theobromine.
Pentoxifylline is also contraindicated in cases where patients suffer from
acute myocardial infarction.
Risk-benefit should be considered when there is a risk of bleeding,
especially recent cerebral or retinal hemorrhage or active bleeding (may
cause or exacerbate bleeding).
In accordance with general principle, pentoxifylline should not be given
during pregnancy.
DRUG INTERACTIONS
Concurrent use of anticoagulants, platelet aggregation inhibitors and
thrombolytic agents may increase the risk of bleeding because of additive
interference with blood clotting. Antihypertensive effects may be
potentiated when antihypertensive medications are used concurrently with
pentoxifylline.
Smoking may interfere with the therapeutic effect because nicotine
constricts blood vessels, which may worsen the condition for which
pentoxifylline is being used.
High parenteral doses of pentoxifylline, in rare cases, have been shown to
enhance the hypoglycaemic action or insulin and oral antidiabetic drugs.
Ketorolac and pentoxifylline should not be given concomitantly as there is
increased risk of bleeding and/or prolongation of prothrombin time .
SIDE EFFECTS / ADVERSE REACTIONS
Pentoxifylline can cause nausea, gastro-intestinal disturbances, dizziness
and headache. Flushing, angina, palpitation, cardiac arrhythmia and
hypersensitivity reaction may also occur, particularly under high doses of
pentoxifylline. In such cases, a reduction of the daily dosage or a
discontinuation of the preparation is to be considered.
PRECAUTIONS / WARNINGS
Pentoxifylline should be used with caution in patients with severe coronary
artery disease or hypotension, cerebrovascular disease, hepatic function
impairment or renal function impairment.
It has been used safely for treatment of peripheral arterial disease in
patients with concurrent coronary artery and cerebrovascular disease but
there have been occasional reports of angina, hypotension and arrhythmia.
When concomitantly administered with antihypertensive agents, dosage
adjustment is required.
Avoidance of smoking is recommended.
Nursing mother: Pentoxifylline and its metabolites are distributed into
breast milk. The use of pentoxifylline during breast-feeding is not
recommended due to lack of information.
Paediatric use: Safety and effectiveness in children below the age of 18
years have not been established.
Geriatrics: Bioavailability of pentoxifylline may be increased due to
decrease in excretion as well as age-related renal function impairment in
the elderly. This may result in increased potential for toxicity.
RECOMMENDED DOSAGE, DOSAGE SCHEDULE AND ROUTE OF ADMINISTRATION
Usual dose
is one tablet two or three times daily with meals and swallow whole with
some liquid.
Impaired renal function creatinine clearance below 10ml/min, may be
necessary to reduce the dose to 800mg or 400mg daily.
SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND ANTIDOTE(S)
The signs of overdosage include flushing, loss of consciousness,
"coffee-ground" vomit, absent reflexes, tonic-clonic convulsions.
Recommended treatment consists of the following:
• Immediate evacuation of the stomach.
• Symptomatic and supportive treatment, including respiratory support,
maintenance of blood pressure, and control of convulsions.
PACKING / PACK SIZE
Packed in a well-closed, amber glass bottle.
Pack sizes: 30's x 400 mg, 100's x 400 mg tablets.
STORAGE CONDITIONS, USER INSTRUCTIONS AND PHARMACEUTICAL PRECAUTIONS
Keep container tightly closed.
Store below 30°C in a cool dry place.
Keep medicines out of reach of children.
SHELF LIFE
Please refer to label or unit carton
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