Expiration date: 10/2026
The composition and form of issue:
Trental
Tablets coated with enteric film cover. 1 tablet contains:
pentoxifylline 100 mg
excipients: lactose starch talc silica colloidal anhydrous magnesium stearate
shell: methacrylic acid copolymer sodium hydroxide macrogol (polyethylene glycol) 8000 talc titanium dioxide (E171)
blistere in 10 PCs in a cartons of 6 blister packs.
Concentrate for solution for infusion. 1 ml contains:
pentoxifylline 20 mg
excipients: sodium chloride water for injections
in ampoules of 5 ml in a cardboard pack of 5 ampoules.
Trental 400
Tablets prolonged action, film-coated. 1 tablet contains:
pentoxifylline 400 mg
auxiliary substances: povidone (PVP) giallone (hydroxyethyl cellulose) talc magnesium stearate
the shell: polymer (hydroxypropyl methylcellulose) benzyl alcohol titanium dioxide talc macrogol (polyethylene glycol) 6000
blistere in 10 PCs in the paper cartons 2 blister.
Description pharmaceutical form:
Trental
Tablets 100 mg: round biconvex coated white.
Solution for infusion: almost clear, colorless.
Trental 400
Extended-release tablets: oblong, biconvex, film-coated white color. On one side of the tablet is engraved "ATA"
Pharmacokinetics:
Tablets 100 400 mg
After oral administration, pentoxifylline is rapidly and almost completely absorbed.
After almost complete absorption of pentoxifylline is metabolized. The absolute bioavailability of the original substance is (19±13)%. The main active metabolite 1-(5-hydroxyhexyl)-3,7-dimethylxanthine (metabolite-1) has a concentration in the blood plasma, in 2 times exceeding the original concentration of pentoxifylline.
T1/2 pentoxifylline after oral administration, is 1.6 h.
Pentoxifylline is completely metabolized more than 90% is excreted via the kidneys in the form of a non-conjugated water-soluble metabolites. Excretion of metabolites is delayed in patients with impaired renal function.
In patients with impaired liver function T1/2 pentoxifylline is extended and the absolute bioavailability increases.
Solution for infusion
Pentoxifylline is extensively metabolized in erythrocytes and liver. Among the most prominent metabolites — metabolite-1 (M-1 gidroksitamoksifen) is formed by cleavage, and metabolite 4 (M-IV) and metabolite 5 (M-V carboxypenicillins) is due to the oxidation of the base material. M-l has the same pharmacological activity as pentoxifylline. More than 90% of the dose of pentoxifylline is excreted through the kidneys and 3-4% in the feces.
T1/2 pentoxifylline after I/V administration of 100 mg was approximately 1.1 hours in patients with severely impaired liver function of T1/2 pentoxifylline increases. Pentoxifylline has a large volume of distribution (168 l after 30 min of infusion 200 mg) and high ground clearance of approximately 4500-5100 ml/min. Pentoxifylline and its metabolites are not associated with blood plasma proteins. In case of severe violation of the kidney excretion of metabolites is slow.
Description pharmacological action:
Trental improves blood rheology (fluidity) due to the impact on pathologically changed erythrocyte deformability, inhibiting platelet aggregation and reducing high blood viscosity. Trental improves microcirculation in the areas disturbed blood circulation.
As the active active substance Trental contains xanthine derivative is pentoxifylline. Its mechanism of action is associated with inhibition of phosphodiesterase and cyclic amp accumulation in the cells smooth muscles receptacles and uniform elements of blood.
Providing weak myotropic vasodilating action, pentoxifylline slightly reduces round and slightly increases coronary vessels.
Trental treatment leads to improvement of symptoms in cerebrovascular disease.
The success of treatment of occlusive lesions of peripheral arteries (e.g. intermittent claudication) is manifested in the elongation of the distance of the walk, the elimination of night cramps in the calf muscles and the disappearance of pain at rest.
Indications:
- violations of peripheral blood circulation of atherosclerotic Genesis (e.g., "intermittent" claudication, diabetic angiopathy), trophic disorders (e.g. trophic ulcers drumsticks, gangrene) frostbite, post-thrombotic syndrome, etc. (when applying the solution for infusion)
- violations of cerebral circulation (effects of cerebral atherosclerosis, as, for example, impaired concentration, dizziness, memory impairment), ischemic and post-stroke status
- circulatory disorders in the retina and choroid
- otosclerosis, degenerative changes on the background of vascular pathology of the inner ear and hearing loss.
Contraindications:
Tablets 100 mg and 400 mg
- hypersensitivity to pentoxifylline, others metilksantina or to any component of the drug
- massive bleeding, extensive bleeding in the retina, bleeding in the brain
- acute myocardial infarction
- pregnancy
- breastfeeding
- children up to age 18 years.
With caution:
- severe cardiac arrhythmias (risk of worsening of arrhythmia)
- hypotension (risk for further blood pressure reduction, see "Method of application and dosage")
- chronic heart failure
- ulcers disease stomach and duodenal ulcers
- impaired renal function (Cl creatinine below 30 ml/min) (risk of accumulation and increased risk of side effects, see the section "Method of application and dosage")
- severe violations of liver function (risk of accumulation and increased risk of side effects, see the section "Method of application and dosage")
- after recently migrated surgical interventions
- an increased tendency to bleeding, for example as a result of using anticoagulants or in case of disturbances in blood coagulation system (risk of more severe bleeding).
Solution for infusion
- hypersensitivity to pentoxifylline, others metilksantina or to any component of the drug
- massive bleeding, extensive bleeding in the retina, bleeding in the brain
- acute myocardial infarction
- severe arrhythmia
- severe atherosclerotic lesions of the coronary or cerebral arteries
- uncontrolled hypotension
- pregnancy
- breastfeeding
- children up to age 18 years.
With caution:
- hypotension (risk reducing actions)
- chronic heart failure
- impaired renal function (Cl creatinine below 30 ml/min) (risk cumulation and an increased risk of side effects)
- severe violations of the liver (risk cumulation and an increased risk of side effects)
- an increased tendency to bleeding, including the use of anticoagulants or in case of disturbances in blood coagulation system (risk of more severe bleeding)
- after recently migrated surgical interventions.
Application of pregnancy and breast-feeding:
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.
Side effects:
For all dosage forms:
In cases where Trental is used in large doses or at high speed of infusion, sometimes you may experience the following side effects:
From the nervous system: headache, dizziness, anxiety, sleep disturbances, seizures.
On the part of the skin and subcutaneous fat: hyperemia skin, tides of blood to the face and upper chest, edema, increased nail fragility.
From the digestive system: xerostomia, anorexia, atony bowel.
From the side of cardiovascular system: tachycardia, arrhythmia, cardialgia, progression of angina, decrease in blood pressure.
From the hemostatic system and organs of hematopoiesis: leukopenia, thrombocytopenia, pancytopenia, bleeding from the blood vessels of the skin, mucous membranes, stomach, intestines, hypofibrinogenemia.
From the sensory organs: impaired vision, scotoma.
Allergic reactions: itching, hyperemia of skin, urticaria, angioneurotic edema, anaphylactic shock.
Very rare cases of aseptic meningitis, intrahepatic cholestasis and increased activity of "liver" transaminases, alkaline phosphatase.
For tablets more:
From the digestive system: a feeling of pressure and overflow in the stomach, nausea, vomiting, diarrhea.
Drug interactions:
For all dosage forms
Pentoxifylline is able to increase the effects of means of reducing blood pressure (ACE inhibitors, nitrates).
Pentoxifylline may exacerbate the effects of drugs that affect blood coagulation system (indirect and direct anticoagulants, thrombolytics), antibiotics (including cephalosporins).
Cimetidine increases the concentration of pentoxifylline in plasma (the risk of side effects).
Joint appointment with other xanthine can lead to excessive nerve stimulation.
The hypoglycemic action of insulin or oral antidiabetic drugs can be increased when taking pentoxifylline (increased risk of hypoglycemia). Need for close monitoring of these patients.
In some patients, simultaneous administration of pentoxifylline and theophylline may increase theophylline level. This can lead to increases or increased side effects associated with theophylline.
Method of application and dose:
Trental
Trental 400
Tablets 100 400 mg
The dosage set by the physician in accordance with individual characteristics of the patient.
Inside, swallowing whole, during or immediately after a meal, squeezed enough water.
Usual dose — 1 table. Trental® is 100 mg 3 times a day with subsequent slow-dose escalation up to 200 mg 2-3 times per day. The maximum single dose of 400 mg.
Usual dose — 1 table. Trental 400 mg 2-3 times a day.
Maximum daily dose of 1200 mg. in patients with impaired renal function (Cl creatinine <30 1="" 2="" p="">
Trental
Solution for infusion
The dosage set by the physician in accordance with individual characteristics of the patient.
In/in, drip, dose and route of administration are determined by the severity of circulatory disorders, as well as based on individual tolerability.
The usual dose is two in/in infusion a day (morning and afternoon), each of which contains 200 mg pentoxifylline (2 amp. 5 ml) or 300 mg pentoxifylline (3 amp. 5 ml) in a 250 ml or 500 ml of 0.9% sodium chloride solution or ringer's solution. Compatibility with other infusion solutions should be tested separately to use only transparent solutions.
Pentoxifylline (100 mg) should be administered at least within 60 min, depending on comorbidities (heart failure) may be necessary to reduce injection volumes. In such cases it is recommended to use special investor for controlled infusion.
After a day of infusion may be appointed in addition 2 table. Trental 400 mg If 2 infusion separated by a longer interval, 1 table. Trental 400 mg from is additionally assigned two may be taken earlier (approximately at noon).
If, due to clinical conditions the on/in infusion is only possible 1 time a day, additionally after it can be assigned to 3 tables. Trental 400 mg (noon — 2 table. and evening 1 tab.). Long in/in infusion Trental for 24 h are shown in more severe cases, especially in patients with severe pain at rest, gangrene, or trophic ulcers (stage III–IV by Fontaine).
Trental dose, administered parenterally for 24 h, as a rule, should not exceed 1200 mg pentoxifylline, the individual dose can be calculated by the formula: 0.6 mg pentoxifylline per kg per hour. Daily dose, calculated thus, will be 1000 mg of pentoxifylline — for a patient weighing 70 kg and 1150 mg of pentoxifylline — for a patient weighing 80 kg. in patients with renal insufficiency (Cl creatinine <30 30="" 50="" p="">
For all dosage forms the dosage set by the physician in accordance with individual characteristics of the patient. Decrease dose based on individual tolerability, it is necessary in patients with severe hepatic impairment. Treatment may be initiated with low doses in patients with low blood pressure, as well as in individuals who are at risk due to the possible reduction of HELL (patients with severe ischemic heart disease or with hemodynamically significant stenosis of cerebral vessels). In these cases, the dose may be increased only gradually.
Overdose:
Tablets 100 400 mg
Symptoms: dizziness, retching, falling blood pressure, tachycardia, arrhythmia, skin reddening, loss of consciousness, vomiting, areflexia, tonic-clonic seizures.
Solution for infusion
Symptoms: weakness, sweating, nausea, cyanosis, dizziness, reducing AD, tachycardia, fainting, drowsiness or agitation, arrhythmia, hyperthermia, areflexia, loss of consciousness, tonic-clonic seizures, signs of gastrointestinal bleeding (vomiting type of coffee grounds).
Treatment: symptomatic, particular attention should be directed to the maintenance of blood pressure and respiratory function. Seizures removed with an injection of diazepam.
When the first signs of an overdose (excessive sweating, nausea, cyanosis) immediately stop taking the drug. Provide a lower position of the head and upper torso. Watch free airway.
Special instructions:
Treatment should be under the control of AD.
Diabetic patients taking hypoglycemic drugs, the appointment of high doses can cause gipoglikemia (require dose adjustment).
When administered in conjunction with anticoagulants should be carefully monitored indicators of blood coagulation.
Patients who recently had surgery, requires systematic monitoring of hemoglobin and hematocrit.
The administered dose should be reduced in patients with low and unstable HELL.
The elderly may require dose reduction (increase bioavailability and decrease elimination rates).
The safety and efficacy of pentoxifylline in children has not been studied.
Smoking may reduce the therapeutic efficacy of the drug.
The compatibility of the solution with pentoxifylline infusion solution should be checked in each case.
When the on/in infusion, the patient should be in supine position.
