Description overdue on 06/19/2014
- Latin name: Sermion
- ATC code: C04AE02
- Active substance: Nicergoline (Nicergoline)
- Manufacturer: Pfizer Italia S.r.L. (Italy)
- Composition
- Product form
- Pharmacological action
- Indications Sermion
- Pharmacodynamics and pharmacokinetics
- Contraindications
- Side effects
- Instructions for use Sirmione (method and dosage)
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
Composition medication Sermion slightly different depending on the amount of active substance in the composition and on the form of preparation.
- Active ingredient: nicergoline 5 mg.
Excipients: 100 mg of calcium hydrogen phosphate dihydrate, 1, 3 mg of sodium carboxymethylcellulose, 1 3mg magnesium stearate 22, 4 mg of MCC.
Sugar-coated tablets: 10, 9mg of talc, 33, 35mg sucrose , 1mg tar sandarac, 0, 7 mg magnesium carbonate 0, 06mg carnauba wax, 0, 6mg rosin, 2, 7 mg Acacia gum, 0, 7 mg titanium dioxide (E171), 0, 05mg Sunset Yellow (E110). - Active ingredient: 10 mg of nicergoline.
Excipients: 94 3mg calcium hydrogenphosphate dihydrate , 1, 3 mg of sodium carboxymethyl cellulose, 2 mg magnesium stearate, 22, 4mg MCC.
Sugar-coated tablets 10, talc 9mg, 33, 35mg sucrose, 1mg sandarac resin, 0, 7 mg of magnesium carbonate, 0, 06mg carnauba wax, 0, 6mg rosin, 2, 7 mg Acacia gum, 0, 7 mg titanium dioxide (E171) . - Active ingredient: nicergoline 30 mg.
Excipients: 72, 69mg calcium hydrogen phosphate dihydrate, 1, 3 mg carboxymethylcellulose sodium, 3, 61mg of magnesium stearate, 22, 4mg MCC.
Film-coated tablets: 0, 7246mg titanium dioxide (E171), 0, 0145mg silicone 0 2899mg polyethylene glycol 600 2, 8985mg hypromellose 0, 0725mg yellow iron oxide (E172). - Lyophilisate or powder white mass to prepare injectable solutions. Also attached solvent - a colorless transparent liquid.
Active ingredient: 4ml nicergoline.
Other ingredients: tartaric acid, lactose monohydrate .
The composition of the solvent: benzalkonium chloride . sodium chloride Water for injections (to 4 mL).
Product form
- Tablets 5mg : Convex round tablets with an orange shell in blister packs of 15pcs. The cardboard package contains 2 blisters.
- Tablets of 10 mg : Convex round tablets with a white shell in blister packs of 25 pcs. The cardboard package contains 2 blisters.
- The tablets of 30mg : Biconvex round tablets with a yellow envelope in blister packs of 15pcs. The cardboard package contains 2 blisters.
- Lyophilizate for the preparation of injection solutions contained in colorless glass vials. Also included are the ampoule with solvent. One carton box contains 4 vials and 4 ampoules freeze-dried product with a solvent.
Pharmacological action
The drug improves peripheral and cerebral circulation, and an alpha-blocker. The main active ingredient of the drug (nicergoline) is derived ergoline and improves hemodynamic and metabolic processes Occurring in the brain.
The drug reduces platelet aggregation and improves rheology Other than that it accelerates the blood flow in the lower and upper extremities. Improving blood flow due to alpha1-adrenoceptor blocking action.
Sermion directly affects of cerebral neurotransmitters - dopaminergic . noradrenrergicheskuyu and acetylcholinergic , Which favorably affects the cognitive processes . With prolonged use of the drug in patients showed a decrease in the severity of dementia-related behavioral disturbances and improves cognitive function of the body.
Indications Sermion
The drug is indicated for:
- chronic and acute cerebral vascular and metabolic disorders (occurring as a result of hypertension . atherosclerosis . embolism or thrombosis brain Including vascular dementia , Acute transient cerebral circulatory problems and headaches that caused vasospasm );
- chronic and acute cardiovascular and metabolic disorders (functional and organic limb arteriopathy Syndrome, which emerged as a result of peripheral blood flow, as well as Raynaud's disease );
- as an adjunct in the treatment of hypertensive crisis .
Pharmacodynamics and pharmacokinetics
Suction (for tablets)
Getting in the human body, nicergoline It is absorbed very quickly and almost without a trace. The rate and extent of absorbability Nicergoline practically does not depend on the dosage form, any of the meal. When using the dosage to 60 mg of nicergoline pharmacokinetics is linear, not changing according to age to take the drug.
Distribution and metabolism
Nicergoline substance binds to more than 90% protein plasma While its degree of affinity for serum albumin is smaller than α-acid glycoprotein. Nicergoline and its metabolites can be spread in the blood cells.
The main products of the metabolism of the substance nicergoline are: 6-methyl-8β-hydroxymethyl-10α-metoksiergolin (MDL, result demethylation occurring under the action of the isoenzyme CYP2D6) and 1, 6-dimethyl-8β-hydroxymethyl-10α-metoksiergolin (MMDL, the product formed by hydrolysis).
When administered intravenously, nicergoline or receiving it inside the ratio of values of the AUC for MDL and MMDL points to clear the metabolism during the "first pass" through the liver. When receiving the 30mg formulation Cmax MMDL (21 ± 14 ng / ml) MDL (41 ± 14 ng / ml) were achieved after 1 and 4 hours, respectively, after which the concentration of MDL decreased with a half-life of 13-20 hours. Also during studies have confirmed the absence of accumulation of other metabolites in blood (including MMDL).
Withdrawal
Nicergoline substance excreted from the body in the form metabolites for the most part in the urine (about 80%) and the feces (about 10-20% of the total dose).
Pharmacokinetics manifested in special clinical situations
Those patients who were suffering from renal failure severe, isolated metabolic products in the urine is considerably less than the patients who have had a normal renal function.
Contraindications
The drug is contraindicated in:
- orthostatic abuse regulation;
- migrated in recent times myocardial infarction ;
- expressed bradycardia ;
- acute bleeding ;
- hypersensitivity to those substances which are contained in a preparation.
The drug should be used with caution if the history is observed gout or hyperuricemia and / or if the drug must combine with medications that violate uric acid excretion and / or metabolism.
In addition to the above, the indications for use Sermion tablets have additional restrictions:
- the patient's age under 18 years;
- during pregnancy and lactation;
- isomaltase deficiency in the body / sucrase, glucose-galactose malabsorption and fructose intolerance.
Side effects
Nervous system: occasionally manifested insomnia or drowsiness.
For the cardiovascular system: occasionally seen marked reduction of blood pressure (especially with parenteral administration of the drug), fever, dizziness.
For metabolism: might increase blood concentrations of uric acid. This has no effect depending on the dosage and duration of treatment.
Other side effects: occasionally appear and skin rashes dyspepsia .
Usually, the side effects of the drug expressed moderately.
Instructions for use Sirmione (method and dosage)
Tablets Sermion
The drug is given inside.
When post-stroke conditions, cognitive and chronic vascular disorders circulatory disorders of the brain Sermion tablets should be taken three times a day for 10 mg. Minimum course of treatment - 3 months, since the therapeutic effect of the drug is gradually.
When vascular dementia Sermion medication should be taken twice a day for 30 mg. It is recommended to consult with your doctor every 6 months on the subject of whether to continue treatment.
In ischemic stroke, caused by thrombosis, atherosclerosis and cerebral vascular embolism, acute and transient circulatory disorders of the brain (in hypertensive cerebral crises and transistor ischemic attacks) treatment is best to begin with parenteral administration Nicergoline Then take Sermion inside.
When violations of peripheral blood circulation the drug should be taken three times a day for 10 mg at a time over a long period of time (several months).
Patients who have been impaired renal function (serum creatinine greater than 2 mg / dL), you need to take a smaller dose of a therapeutic drug Sermion.
Instructions for use of the lyophilizate Sermion
Intramuscular: 2-4ml drug administered by twice daily (2-4mg).
Intravenous: the drug is administered in a dosage of 4-8mg slowly into 100ml 5-10% dextrose, or 0 9% sodium chloride solution. The dosage of such drug injections can produce up to several times per day.
Intraarterially: for 2 minutes in preparation administered 4 mg 10ml 0 9% sodium chloride solution.
It is recommended to use the reconstituted solution immediately after its preparation.
The duration of therapy, the dosage and mode of administration of the drug in the body depend on the disease. Sometimes it is better to start with parenteral drug administration, and then move to the intake for the purpose of maintenance treatment.
Patients who have been impairment of renal function (serum creatinine greater than 2 mg / dL) Sermion medication you need to take in at a therapeutic dosage.
Overdose
Symptoms of overdose drug is expressed by a transient decrease in blood pressure.
As a rule, special treatment in cases of overdose Sermion not needed, just lie down for a few minutes. Very rarely can occur circulatory disorders of the heart and brain. In this case, it is recommended to enter sympathomimetic agents, constantly monitoring blood pressure.
Cooperation
Taking Sermion with antiholinoliticheskimi and antihypertensive agents , The last action can be strengthened.
If you take the drug at the same time Cholestyramine or nonabsorbable antacids , The absorption of Sirmione is slower.
Metabolism of drugs produced by direct enzyme, CYP 2D6, therefore, it is possible interaction with other drugs that are also biotransformed by this enzyme ( Risperidone . Rinidin As well as other antipsychotics).
Terms of sale
The product is available for purchase in pharmacies only with a prescription.
Storage conditions
Keep out of access to children at temperature not exceeding 25 ° C.
Shelf life
3 years.
Cautions
Typically Sermion as used in therapeutic doses has no effect on blood pressure. However, those patients in whom there is hypertension, can experience a gradual reduction in blood pressure caused by the action of the drug.
If use is made of the drug parenterally, patients are encouraged to lie down for a few minutes immediately after the injection because it may cause hypotension . This is especially true for those patients who have just started a course of treatment.
The action of the drug is gradually Sermion so you need to take for a long time. During the course of treatment the physician should periodically assess the effect of treatment, and the feasibility of the treatment to be continued in the future.
Effects on ability to drive machinery and driving vehicles has not been studied. Therefore, despite the property of the drug improves concentration, patients are advised to exercise extreme caution when driving or operating machinery, especially given the nature inherent in the underlying disease.
Analogs Sermion
Nicergoline
Vazobral
Sergolin . Nicergoline . Nitserium . It is worth noting that the price is significantly lower than peers.
During pregnancy and lactation
Studies of the drug when Sermion pregnancy not carried out, it should be taken only under medical supervision under strict indications.
While receiving the drug should refrain from breast-feeding children, as nicergoline and products that are formed by metabolism It stands out, along with breast milk.
Reviews Sirmione
The network can find a lot of reviews about the drug Sermion, with almost all of them are positive. Patients taking the drug, talk about its high efficiency. They had returned to normal pressure, gradually there was a decrease of migraine attacks and headaches ceased. Many reviews of Sirmione contain messages about patients increase concentration and improve cognitive functions organism.
Forum also includes warnings patients taking tablets that this medication should be taken for a long time, because it starts to act only as it accumulates in the body. In this regard, there were a few patient testimonials about Sirmione in a negative context - taking medication, without waiting for the effect of throwing a course of treatment.
There is also a warning that this drug is not suitable for children. It can not take the children and adolescents, whose age has not reached 18 years old.
Price Sermion where to buy
Depending on the margins of pharmacies and the form of the drug, tablets Sermion price can vary greatly:
- Tablets 5mg are from 274 to 419r for 30shtuk in the package (in Donetsk cost of the drug starts from 79grn);
- Tablets 10mg It can be found from 378 to 515r per pack, which contains 50 tablets;
- cost 30mg tablets It ranges from 556r per pack of 30 pieces to 776r;
- price Sirmione in ampoules - From 698 to 828r per pack.
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