Pentoxifylline

• Occlusive disease of peripheral arteries of atherosclerotic or diabetic origin (for example, "intermittent" claudication, diabetic angiopathy).

• Cerebral circulation disorders (consequences of cerebral atherosclerosis, such as impaired concentration, dizziness, memory impairment), ischemic and post-stroke conditions.

• Trophic tissue disorders due to impaired arterial or venous microcirculation (trophic ulcers, post-thrombophlebitic syndrome, frostbite, gangrene).

• Circulatory disorders in the vessels of the eye (acute and chronic circulatory failure in the mesh or in the choroid).

• Dysfunction of the middle ear of vascular origin, accompanied by hearing loss.

• Hypersensitivity to pentoxifylline, other methylxanthine derivatives or other components that make up the drug.
• Acute myocardial infarction.
• Massive bleeding (risk of increased bleeding).
• Retinal hemorrhage (risk of increased bleeding).
• Acute hemorrhagic stroke.
• Pregnancy.
• Breastfeeding period.
• Age up to 18 years (efficacy and safety have not been established).
• Intolerance to fructose, lactose, lactase deficiency, sucrase / isomaltase. glucose-galactose malabsorption (the drug contains lactose and sucrose).

Carefully

Use with caution in patients with a pronounced decrease in blood pressure (BP) (risk of further lowering blood pressure) and hemodynamically significant heart rhythm disturbances; chronic heart failure (CHF); severe liver dysfunction (risk of cumulation and an increased risk of side effects); impaired renal function (creatinine clearance (CC) less than 30 ml / min) (risk of cumulation and increased risk of side effects); peptic ulcer of the stomach and duodenum; with an increased tendency to bleeding, for example, as a result of the use of indirect anticoagulants [vitamin K antagonists] or in case of disorders in the blood coagulation system (the risk of more severe bleeding); after a recent surgery (risk of bleeding);

Caution should be exercised while using the drug Pentoxifylline Sanofi with platelet aggregation inhibitors (clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs [except for selective inhibitors of cyclooxygenase-2], acetylsaliclopiriclopidine drugs), acetylsaliclopirinyl and hypoglycemic agents for oral administration), ciprofloxacin and theophylline.

When using the drug Pentoxifylline Sanofi, the following side effects may occur, which are divided into systemic organ classes in accordance with the classification of the Medical Dictionary of Regulatory Activities (MedDRA). To indicate the frequency of occurrence of side effects, the WHO classification was used: very frequent (≥10%); frequent (≥1% and <10%); infrequent (≥0.1% and <1%); rare (≥0.01% and <0.1%); very rare (<0.01%); the frequency is unknown (according to the available data, it is not possible to determine the frequency of occurrence of the side effect).

Nervous system disorders: frequency unknown - headache, dizziness, convulsions, aseptic meningitis.

Mental disorders: frequency unknown - agitation, sleep disturbances, anxiety.

Cardiac disorders: the frequency is unknown - tachycardia, arrhythmia, angina pectoris, decreased blood pressure.

Vascular disorders: the frequency is unknown - "hot flushes" of blood to the skin, bleeding (including bleeding from the vessels of the skin, mucous membranes, gastrointestinal bleeding, nosebleeds).

Disorders from the skin and subcutaneous tissues: the frequency is unknown - itching, skin rash, erythema (redness of the skin), urticaria, edema, increased fragility of the nails.

Disturbances from the gastrointestinal tract: frequency unknown - anorexia, intestinal atony, epigastric discomfort, bloating (feeling of fullness in the stomach), vomiting, diarrhea, dry mouth, constipation, hypersalivation (increased salivation).

Violations of the organ of vision: the frequency is unknown - visual impairment, scotoma.

Disturbances from the blood and lymphatic system: frequency unknown - thrombocytopenia, leukopenia / neutropenia, pancytopenia, hypofibrinogenemia.

Immune system disorders: frequency unknown - anaphylactic / anaphylactoid reactions, angioedema, anaphylactic shock, bronchospasm.

Disturbances from the liver and biliary tract: the frequency is unknown - intrahepatic cholestasis, increased activity of alanine aminotransferase (ALT) and aspartate aminotransferase (ACT), increased activity of alkaline phosphatase.

With antihypertensive drugs
The drug Pentoxifylline Sanofi can increase the decrease in blood pressure when used simultaneously with antihypertensive drugs (for example, ACE inhibitors) or other drugs with a potential antihypertensive effect (for example, nitrates).

With drugs that affect the blood coagulation system
Pentoxifylline Sanofi can enhance the action of drugs that affect the blood coagulation system (direct and indirect anticoagulants, thrombolytics, antibiotics such as cephalosporins).

With the combined use of pentoxifylline and indirect anticoagulants (vitamin K antagonists) in post-marketing studies, cases of increased anticoagulant action (risk of bleeding) have been reported. Therefore, at the beginning of taking the drug Pentoxifylline Sanofi or changing its dose, it is recommended to control the severity of the anticoagulant effect in patients taking this combination of drugs (for example, to regularly monitor the international normalized ratio (INR)).

With cimetidine,
cimetidine can increase the concentration of pentoxifylline and active metabolite I in the blood plasma (the risk of adverse reactions).

With other xanthines
Co-administration with other xanthines can lead to excessive nervous excitement.

With hypoglycemic agents (insulin and hypoglycemic agents for oral administration) The
hypoglycemic effect of insulin or hypoglycemic agents for oral administration may be enhanced with simultaneous use with Pentoxifylline Sanofi (increased risk of hypoglycemia). Strict monitoring of the condition of such patients is required, including regular glycemic control.

With theophylline
In some patients, while the drug Pentoxifylline Sanofi and theophylline, there is an increase in the concentration of theophylline in the blood plasma. In the future, this may lead to an increase in the incidence of adverse reactions associated with theophylline.

With ciprofloxacin
In some patients, with the simultaneous use of the drug Pentoxifylline Sanofi and ciprofloxacin, there is an increase in the concentration of pentoxifylline in the blood plasma. In the future, this can lead to an increase or increase in side reactions associated with the use of this combination.

With valproic acid
When used together, the drug Pentoxifylline Sanofi can enhance the effect of valproic acid.

With inhibitors of platelet aggregation
With the simultaneous use of pentoxifylline with inhibitors of platelet aggregation (clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs [except for selective inhibitors of cyclooxygenase, the development of potential tsalypitivide), acetylidin increasing the risk of bleeding. Therefore, due to the risk of bleeding, the drug Pentoxifylline Sanofi should be used with caution along with the above platelet aggregation inhibitors.

The tablets are taken orally, without chewing, regularly, at the same time, preferably during or after meals, with plenty of water and without chewing.

The drug is taken at 200 mg (2 tablets) 3 times a day during the first week. With a sharp decrease in blood pressure and symptoms of irritation from the gastrointestinal tract or central nervous system, the initial dose is reduced to 100 mg (1 tablet) 3 times a day.

During the course of treatment, 100 mg (1 tablet) is prescribed 3 times a day.

The maximum daily dose is 1200 mg per day.

Patients with low blood pressure, as well as those at risk due to a possible sharp decrease in blood pressure (patients with severe coronary artery disease or with hemodynamically significant cerebral vascular stenosis), treatment with Pentoxifylline Sanofi should be started with low doses, followed by a gradual increase in the daily dose.

Stage II peripheral arterial occlusive disease ("intermittent claudication")
The daily dose for this category of patients is 1200 mg per day, preferably in the form of sustained-release tablets 400 mg 3 times a day or 600 mg 2 times a day.

Patients with impaired liver function
When using the drug Pentoxifylline Sanofi in patients with impaired liver function of severe severity, care should be taken, a possible dose reduction should be carried out taking into account the individual tolerance of the drug.

Patients with impaired renal function
When using the drug Pentoxifylline Sanofi in patients with a CC value below 30 ml / min, caution should be exercised. The dose of Pentoxifylline Sanofi can be reduced by 50-70%.

Children and adolescents
The use of the drug Pentoxifylline Sanofi in patients under the age of 18 is contraindicated. The safety and efficacy of using the drug Pentoxifylline Sanofi in this age group has not been established.

Symptoms: dizziness, nausea, vomiting of the "coffee grounds" type, marked decrease in blood pressure, tachycardia, arrhythmia, redness of the skin, loss of consciousness, chills, areflaxia, tonic-clonic seizures.
In the event of the above violations, you must immediately consult a doctor.

Treatment: symptomatic treatment. When the first signs of an overdose appear (sweating, nausea, cyanosis), immediately stop taking the drug. If the drug is recently taken, measures should be taken to prevent further absorption of the drug by removing it (gastric lavage) or slowing down absorption (for example, taking activated charcoal). Particular attention should be paid to maintaining blood pressure and respiratory function. For convulsive seizures, diazepam is administered.

The specific antidote is unknown.

Treatment should be carried out under the control of blood pressure.

In patients with diabetes mellitus taking hypoglycemic agents, the appointment of large doses of Pentoxifylline Sanofi can cause severe hypoglycemia (dose adjustment is required).

When prescribing the drug Pentoxifylline Sanofi simultaneously with anticoagulants, it is necessary to carefully monitor the indicators of the blood coagulation system.

In patients who have recently undergone surgery, systematic monitoring of hemoglobin and hematocrit is necessary.

Patients with low and unstable blood pressure need to select the dose of Pentoxifylline Sanofi individually.

In elderly patients, a dose reduction of Pentoxifylline Sanofi may be required (increased bioavailability and decreased elimination rate).

The safety and efficacy of the drug Pentoxifylline Sanofi in children has not been adequately studied. When using the drug Pentoxifylline Sanofi in patients with severe liver dysfunction, caution should be exercised. Given the risk of drug accumulation and the increased risk of side effects, dose reduction should be carried out taking into account individual tolerance. Patients with severe renal impairment (CC below 30 ml / min) when taking Pentoxifylline Sanofi require careful medical supervision.

If during the period of use of the drug in patients there are hemorrhages in the retina of the eye, the drug is immediately canceled.

Smoking can reduce the therapeutic efficacy of Pentoxifylline Sanofi.

The drug Pentoxifylline Sanofi contains lactose and sucrose, therefore, patients with fructose, lactose intolerance, lactase, sucrase / isomaltase deficiency, glucose-galactose malabsorption are contraindicated in taking the drug.

Influence on the ability to drive vehicles and mechanisms

There was no negative effect of the drug Pentoxifylline Sanofi on the ability to drive vehicles and mechanisms. However, care should be taken when driving vehicles and during classes that require increased concentration of attention and speed of psychomotor reactions, due to the possibility of dizziness and visual impairment when using Pentoxifylline Sanofi.