TARONTAL 100mg/5ml Injection

Pentoxyfilline 100 mg / 5 ml

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COMPOSITIONS :

Tarontal® Injection 100 mg/5 ml, each ml contains : Pentoxifylline 20 mg.

 

DESCRIPTIONS :

Tarontal® containing Pentoxifylline as active ingredient is available in sugar coated tablet 100 mg, sugar coated caplet 400 mg, injection 20 mg/ml.

 

INDICATIONS :

  • Peripheral occlusive arterial disease and arteriovenous disorders of an arteriosclerotic or diabetic nature (e.g., arteriosclerosis with intermittent claudication or rest pain, diabetic angiopathy) and trophic disturbances (post-thrombotic syndrome, leg ulcer and gangrene).
  • Vascular disturbances of the eye (acute, sub-acute and chronic impairment of retinal and choroidal perfusion).
  • Cerebral circulatory disorders (sequelae of cerebral arteriosclerosis such as difficulties in concentration, vertigo, impairment of memory) ischaemic and post-apoplectic states.

 

DOSAGE AND ADMINISTRATIONS :

  • Tarontal® Injections :

Tarontal® may be administered as an IV infusion and may also be injected by the IV route. Extensive experience from clinical practice has shown IV infusion therapy to be the most effective and best tolerated form of parenteral administration.

  1. IV Infusion :

Depending on the severity of vascular disease, the patient’s body weight and tolerability factors, IV infusion therapy may be implemented using the following schedule :

    • One IV infusion in the morning and afternoon, each of 200 mg or 300 mg Pentoxifylline in 250 or 500 ml infusion fluid over a period of 120 – 180 minutes.

An additional oral administration of twice daily of one Tarontal® Sugar coated caplet 400 mg may be indicated after the afternoon infusion.

    • Where the two infusions are separated by a longer interval, the administration of one Tarontal® Sugar coated caplet 400 mg may be brought forward to around lunch time.
    • Where practical nursing considerations or tolerability factors permit only one IV infusion daily, additional oral administration of Tarontal® Sugar coated caplet 400 mg is recommended in a dose of 3 (2+1) sugar coated tablets spread throughout the day (midday and evening) after IV infusion.
    • A 24-hours parenteral IV drip infusion may be indicated in more advanced cases, especially in patients with severe rest pain and gangrene or ulceration (Fontaine Stage III and IV).
    • In general, the 24-hours dose of Tarontal® for parenteral administration should not exceed 1200 mg Pentoxifylline, and the individual dose may be based on the formula : 0.6 mg Pentoxifylline/kgBW/hour. The daily dose calculated in this way would be 1000 mg Pentoxifylline for a patient weighing 70 kg and 1150 mg Pentoxifylline for a patients weighing 80 kg.
    • The infusion volume should be established on the basis of underlying diseases and generally will be between 1000 ml – 1500 ml/24 hours.

2. IV Infusion :

The IV injection of 5 ml Tarontal® must given slowly over a 5 minutes period with the patient lying down.

An IV injection should, on no account, be repeated immediately after the first one.

Adjunctive and follow-up treatment :

The oral formulation of Tarontal® can be prescribed to supplement treatment by IV infusion or injection. After the onset of improvement, treatment may be continued with oral medication alone.

Adjunctive and follow-up treatment :

The oral formulation of Tarontal® can be prescribed to supplement treatment by IV infusion or injection. After the onset of improvement, treatment may be continued with oral medication alone.

Administrations of Tarontal® Injection :

  • For IV infusion administration, Tarontal® Injection can be diluted with NaCl solution and Glucose 5% solution. Compatibility with the solution to be used should be tested in each case before administration.
  • In patients with hypotension and circulatory instability, injection or infusion therapy should be introduced gradually, because all agents which promote blood flow may produce transient hypotension coupled with a tendency to collapse and in isolated cases, may result in anginal discomfort.
  • Patients with cardiac failure require appropriate treatment. Large volumes of fluid (infusion) should be avoided in such cases.
  • Dosage adjustment is necessary in-patients with impaired renal function.

 

CONTRAINDICATIONS :

  • Should not be administered to patient with hypersensitivity to Pentoxifylline, cerebral or extensive retinal haemorrhage or myocardial infarction.
  • Should not be used during pregnancy.
  • Severe coronary and cerebral sclerosis with hypertension and severe cardiac arrhythmias are relative contra-indications for a parenteral treatment.
  • Should not be administered to patients intolerance to Methylxanthine derivates such as Caffeine, Theophylline and Theobromine.

 

WARNINGS AND PRECAUTIONS :

  • Administration to nursing mothers is not recommended, stop nursing if the drug is needed.
  • Safety and effectiveness in children below the age of 18 years have not been decided.
  • If side effects persist at this lower dosage, the administration should be discontinued.
  • Periodic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy.

 

PRESENTATIONS :

Tarontal® Injection 100 mg/5 ml                                   Box, 5 ampoules @ 5 ml

Reg. No. DKL9302315343A1

 

STORAGE :

STORE BELOW 30ºC, PROTECT FROM LIGHT.

 

STORE THE PRODUCT ON THE BOX BEFORE USED.

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

PT. BERNOFARM

Sidoarjo – Indonesia

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