Composition
Per capsule:
active ingredient: dry ginkgo bilabial extract, standardized with flavonol glycosides content of 22.0-27.0% and terpene lactones content of 5.0-12.0% – 120.0 mg;
excipients: cellulose microcrystalline – of 144.6 mg, calcium stearate – 2.7 mg, silicon dioxide colloid – 2.7 mg;
capsules hard gelatin (capsules: titanium dioxide E 171 – 1.00%, iron dye red oxide E 172 – 0.50%, dye iron oxide black E 172 – 0,39%, dye iron oxide yellow E 172 – 0,27%, gelatin – up to 100%).
Pharmacological action
Pharmacotherapy group
Angioprotective agent of plant origin
ATX Code: N06DX02
Pharmacodynamics :
Increases the body’s resistance to hypoxia especially brain tissue inhibits the development of traumatic or toxic brain edema improves cerebral and peripheral blood circulation improves blood rheology.
It has a dose-dependent regulating effect on the vascular wall expands small arteries increases vein tone.
Prevents the formation of free radicals and lipid peroxidation of cell membranes.
Normalizes the release, reabsorption, and catabolism of neurotransmitters (norepinephrine, dopamine, and acetylcholine) and their ability to bind to receptors.
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 central nervous system.
Pharmacokinetics:
Suction
The bioavailability of terpenlactones (ginkgolide A, ginkgolide B, and bilobalide) after oral use is 100% (98%) for ginkgolide A,93% (79%) for ginkgolide B, and 72% for bilobalide.
Distribution
The maximum plasma concentrations are: 15 ng / ml for ginkgolide A,4 ng / ml for ginkgolide B, and approximately 12 ng / ml for bilobalide. Binding to plasma proteins is: 43% for ginkgolide A,47% for ginkgolide B, and 67% for bilobalide.
Deduction
The elimination half-lives are 39 hours (ginkgolide A),7 hours (ginkgolide B) and 32 hours (bilobalide).
Indications
-Symptomatic treatment of cognitive disorders in adults (memory impairment, decreased concentration of attention and intellectual abilities).
– Auxiliary treatment of vertigo of vestibular origin.
– Symptomatic treatment of tinnitus (ringing or tinnitus).
Use during pregnancy and lactation
Due to the lack of sufficient clinical data, the use of the drug during pregnancy and lactation is contraindicated.
If it is necessary to prescribe the drug during breastfeeding, you should decide whether to stop it.
Contraindications
Hypersensitivity to the components of the drug reduced blood clotting erosive gastritis acute peptic ulcer of the stomach and duodenum acute cerebral circulatory disorders acute myocardial infarction pregnancy and lactation age up to 18 years (efficacy and safety have not been studied).
With caution:
Use in patients with epilepsy; hypotension.
Side effects
Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO): very common (≥1/10) common (≥1/100 <1/10) uncommon (≥1/1000 <1/100) rare (≥1/10000 <1/1000) very rare (
Skin and subcutaneous tissue disorders
frequency unknown: allergic reactions (skin hyperemia, edema, pruritus, rash).
Gastrointestinal disorders
common: nausea vomiting diarrhea abdominal pain.
Disorders of the blood and lymphatic system
frequency unknown: decreased blood clotting bleeding (nasal gastrointestinal hemorrhage in the eye brain) (with prolonged use in patients simultaneously taking drugs that reduce blood clotting).
Immune system disorders
frequency unknown: hypersensitivity reactions (anaphylactic shock).
Nervous system disorders
very common: headache;
common: dizziness;
very rare: hearing impairment insomnia irritability.
Visual disturbances
are very rare: accommodation disorders photopsia.
Interaction
It is not recommended to use the drug in patients who are constantly taking acetylsalicylic acid anticoagulants (direct and indirect action) as well as thiazide diuretics tricyclic antidepressants anticonvulsants gentamicin.
There may be isolated cases of bleeding in patients simultaneously taking medications that reduce blood clotting.
When used concomitantly with anticoagulants and antiplatelet agents, their therapeutic effect may change.
In patients with a tendency to abnormal bleeding (hemorrhagic diathesis) and with concomitant therapy with anticoagulants and antiplatelet agents, this drug should be taken only after consulting a doctor.
According to studies, there was no interaction between warfarin and preparations containing ginkgo bilobate leaf extract; despite this, it is necessary to monitor blood clotting indicators before and after treatment, as well as when changing the drug.
Concomitant use of preparations containing ginkgo bilabial leaf extract with efavirenz is not recommended, as it is possible to reduce its concentration in blood plasma due to the induction of cytochrome CYP3A4 under the influence of ginkgo bilabial.
A study of the interaction with talinolol showed that ginkgo bilobate leaf extract can inhibit P-glycoprotein at the intestinal level. This can lead to an increase in the plasma concentration of drugs that are substrates of P-glycoprotein at the intestinal level, including dabigatran. Caution should be exercised when using such combinations of drugs.
In one study, it was shown that ginkgo bilobate leaf extract increases the Cmax of nifedipine and in some cases up to 100% with the development of dizziness and increased severity of hot flashes.
How to take, course of use and dosage
Inside.
Capsules should be swallowed whole with a small amount of water, regardless of food intake.
For the symptomatic treatment of cognitive impairment in adults (memory impairment decreased concentration and intellectual abilities) 120 mg 1-2 times a day.
For the treatment of vertigo of vestibular origin and tinnitus (ringing or tinnitus) the daily dose is 120 mg per day.
Duration of therapy up to 3 months if it is necessary to continue therapy, consult your doctor.
With a double dosage regimen, take in the morning and evening with a single one-preferably in the morning.
If the drug was missed or an insufficient amount of it was taken, its subsequent use should be carried out as indicated in these instructions without any changes.
Overdose
No cases of overdose of the drug have been reported so far.
Special instructions
Do not exceed the recommended dose of the drug.
If a hypersensitivity reaction develops, the drug should be discontinued.
Before surgery, it is necessary to inform the doctor in advance about the use of the drug.
If you often experience dizziness and tinnitus, you should consult your doctor. In case of sudden deterioration or loss of hearing, you should immediately consult a doctor.
Patients with bleeding disorders (hemorrhagic diathesis) and patients receiving anticoagulant therapy should consult a doctor before starting therapy with the drug.
It is not recommended to take the drug together with ethanol.
Against the background of the use of the drug in patients suffering from epilepsy, epileptic seizures may occur.
Influence on the ability to drive vehicles and fur. :
During the period of taking the drug, care should be taken when performing potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles and working with moving mechanisms).
Storage conditions
At a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf
life is 3 years.
Do not use after the expiration date.
Conditions of release from pharmacies
Over-the-counter
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Side effects of Ginkoum capsules 120mg, 30pcs.
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