Pharmacological properties
Pharmacodynamics. Bilobil is a herbal preparation that normalizes cell metabolism, rheological properties of blood and microcirculation. Improves cerebral blood circulation and delivery of oxygen and glucose to the brain, prevents erythrocyte aggregation, inhibits platelet activation factor. Has a dose-dependent regulatory effect on the vascular system, stimulates the synthesis of endothelium-dependent dilating factor (nitric oxide - NO), dilates small arteries, increases venous tone, thereby regulating blood supply to the vessels. Reduces the permeability of the vascular wall (anti-edema effect - both at the brain and peripheral levels). Has an antithrombotic effect (due to stabilization of platelet and erythrocyte membranes, influence on the synthesis of prostaglandins, reduction of the action of biologically active substances and platelet-activating factor). Bilobil prevents the formation of free radicals and peroxidation of lipids of cell membranes. normalizes the release, reabsorption and catabolism of neurotransmitters (norepinephrine, dopamine, acetylcholine) and their ability to bind to receptors. Bilobil has an antihypoxic effect, improves metabolism in organs and tissues, promotes the accumulation of macroergs in cells, increases the utilization of oxygen and glucose, normalizes mediator processes in the CNS.
Pharmacokinetics. Active ingredient - standardized dry extract of ginkgo biloba: 24% heterosides and 6% ginkgolides-bilobalides (ginkgolides A, B and bilobalide C).
When administered orally, the bioavailability of ginkgolide A, B and bilobalide C is 80-90%. Cmax is reached 1-2 hours after taking the drug. T½ is about 4 hours (bilobalide, ginkgolide A) and 10 hours (ginkgolide B).
These substances do not break down in the body, are almost completely excreted in the urine, and a small amount is excreted in the feces.
Indication
Symptomatic treatment of cognitive disorders in elderly patients, with the exception of patients with confirmed dementia, Parkinson's disease, cognitive disorders of iatrogenic origin or arising as a result of complications of depression, vascular disorders, metabolic disorders.
Concomitant treatment of vertigo of vestibular origin together with vestibular rehabilitation.
Symptomatic treatment of ringing in the ears.
Application
In adults, the drug is used 1 capsule 3 times a day.
The capsules are swallowed with ½ glass of water. The average duration of the treatment course is 3 months.
Contraindication
Hypersensitivity to ginkgo biloba extract or any inactive component of the drug.
Side effects
The following reactions are occasionally observed:
Digestive system: indigestion; dyspepsia, diarrhea, abdominal pain, nausea, vomiting; immune system: hypersensitivity reactions, including angioedema, urticaria, shortness of breath; skin: skin inflammation, hyperemia, edema, rash, itching, eczema; nervous system: headache, dizziness, syncope (including vasovagal).
If severe side effects occur, treatment should be discontinued.
Special instructions
Before starting treatment with Bilobil, you should make sure that the symptoms are not the result of another disease that requires specialized treatment.
If hypersensitivity is detected, the capsules should be discontinued.
Before surgery, patients should inform their doctor that they are taking Bilobil capsules.
Patients with an increased tendency to bleed (hemorrhagic diathesis) and patients taking anticoagulants should consult a doctor before starting treatment with Bilobil.
Patients taking antidiabetic or antihypertensive medications should consult a doctor before starting treatment with Bilobil.
It is recommended to closely monitor patients who are taking drugs that are metabolized by cytochrome P450 3A4. There is no information on the abuse of ginkgo biloba. Based on the pharmacological characteristics of the drug, ginkgo biloba has no potential for abuse.
Special information about some of the ingredients. Bilobil contains lactose and glucose. Patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bilobil capsules contain the azo dye azorubine (E122), which may cause allergic reactions.
Pregnancy and breastfeeding. Given the lack of relevant clinical data, the use of this product is not recommended during pregnancy and breastfeeding.
Children. Bilobil capsules are not recommended for use in children due to the lack of data on the safety of the drug in this group of patients.
Ability to influence the reaction speed when driving vehicles or working with other mechanisms. Studies assessing the effect on the reaction speed when driving vehicles or working with other mechanisms have not been conducted. However, dizziness may impair the ability to drive a car or work with other mechanisms.
Interactions
When used simultaneously with drugs that inhibit blood coagulation (such as phenprocoumon and acetylsalicylic acid), the effect of the latter may be enhanced - the risk of bleeding increases.
The simultaneous use of ginkgo biloba extract with the following drugs requires special supervision:
Ginkgo biloba increases the metabolism of antiepileptic drugs, metabolized through the CYP 2C enzyme system. When used simultaneously, antiepileptic drugs (valproate, phenytoin) can lower the seizure threshold, increase the possibility of epileptic seizures; the interaction of Ginkgo biloba extract with drugs metabolized by the cytochrome P450 enzyme system cannot be completely excluded (in some cases, there is a possibility of inhibition or induction of some isoenzymes).
Based on the results obtained in other interaction studies with Ginkgo biloba, potentiation or inhibition of cytochrome P450 isoenzymes has been demonstrated. Midazolam concentrations were altered after concomitant administration of Ginkgo biloba, suggesting an interaction via CYP 3A4. Therefore, drugs that are primarily metabolized by CYP 3A4 and have a narrow therapeutic index should be used with caution.
Overdose
No cases of overdose have been reported.
There are currently no reports of any cases of intoxication with Ginkgo biloba extract caused by ingestion of standardized amounts of extract. Intoxication is possible with the use of large quantities of Ginkgo seeds or improperly purified Ginkgo biloba extract.
Storage conditions
In the original packaging to protect from moisture at a temperature not exceeding 25 °C.
