ZOLMIGREN ZOLMITRIPTANUM tablets 2.5mg №2

ZOLMIGREN ZOLMITRIPTANUM tablets 2.5mg №2

Product Code: 7163
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Composition

active substance:zolmitriptan;

1 tablet contains zolmitriptan in terms of 100% substance 2.5 mg

excipients:lactose, microcrystalline cellulose 102, starch sodium (type A), magnesium stearate

shell composition: Sepifilm 752 Blanc (hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol (macrogol 40), titanium dioxide (E 171)), iron oxide yellow (e 172).

The

Dosage form

Tablet, film-coated.

basic physico-chemical properties:circular tablets with a biconvex surface, covered with a film shell, pale brownish-yellow.

The

drug description

drugs used in migraine. Selective agonists 5НТ1serotonin receptor. Zolmitriptan. ATC code N02C C03.

The

Pharmacological properties

Pharmacodynamics.

Zolmitriptan is a selective agonist of recombinant 5-HT1B/1Dserotonin receptors of the vessels. Has a moderate relationship with serotonin 5-NT1Areceptors, has no significant affinity or pharmacological activity for 5NT2-, 5NT3-, 5NT4- serotonin receptors, a1-, a2-, b- 1, SUB>adrenergic receptors, H1- H2-histamine receptors, M-Choline receptors, D1-, D2-dopaminergic receptors. The drug causes vasoconstriction mainly cranial vessels, blocks the release of neuropeptides, in particular vasoactive intestinal peptide, which is the main effector of reflex excitation, causes vasodilation, which is the basis of migraine pathogenesis. Suspends the development of a migraine attack without direct analgesic action. Together with the relief of migraine attacks, it weakens nausea, vomiting (especially with left - sided attacks), photo-and phonophobia. In addition to the peripheral action, it affects the centers of the brain stem associated with migraine, which explains the steady repeated effect in the treatment of a series of several migraine attacks in one patient. Highly effective in complex treatment of migraine status (series of several severe, following each other, migraine attacks lasting 2-5 days). Eliminates migraine associated with menstruation. High doses have a sedative effect and cause drowsiness.

the effect of the drug occurs after 15-20 minutes and reaches a maximum of 1:00 after administration. The maximum effect is observed when taken in a period of development of the attack.

Pharmacokinetics.

after taking well absorbed in the digestive tract. Absorption of the drug does not depend on food intake. The average bioavailability is about 40%. The plasma protein binding is 25%. The time to reach the maximum concentration is 1: 00, the therapeutic concentration in plasma is maintained for the next 4-6 hours. When re-admission cumulation of the drug is not observed. Subject to intense biotransformation in the liver with the formation of N-demetilirovannogo that is 2-6 times more pharmacological activity than the parent compound, and several inactive metabolites. It is excreted from the body mainly by the kidneys as metabolites, about 30% - by the intestine unchanged. There are three main metabolite of zolmitriptan: endolith acid (the main metabolite in plasma and urine), N-oxide and N-dermatolology. N-desmetilirovaniya metabolite is active, and two other metabolita inactive. The elimination half-life (T1/2) of zolmitriptan is 2.5-3 hours. In women, the maximum concentration and bioavailability of the drug is higher, and the total clearance is lower than in men. In patients with moderate and severe renal failure, renal clearance of zolmitriptan and its metabolites is 7-8 times less than in healthy volunteers, the half-life period increases by an hour (up to 3-3.5 hours), while the bioavailability of zolmitriptan and its active metabolite increases by only 16% and 35%. In hepatic insufficiency, the metabolism of zolmitriptan decreases proportionally to its degree.

Reading

Relief of migraine attack with aura and without aura.

Contra

hypersensitivity to the components of the drug.

Moderate or severe hypertension, poorly marked and uncontrolled increase in pressure. Coronary heart disease or similar symptoms, including a history of myocardial infarction. Angiospasticescoy angina (Prinzmetal's angina). Cerebrovascular and transient ischemic attack (TIA) in anamnesis. CC below 15 ml/min concomitant use of ergotamine, derivatives of ergotamine (including methysergide), sumatriptan, Naratriptan or other agonists of the receptor 5HT1B/1D. Of peripheral vascular disease. Do not use in elderly patients (over 65 years).

The

Interaction with other medicinal products and other forms of interaction

a Valid combination of the drug with caffeine, paracetamol, metoclopramide, pizotifen, fluoxetine, rifampicin and propranolol.

based on data obtained with the participation of healthy volunteers, there is no interaction between Zolmitriptan and ergotamine in terms of pharmacokinetics or any interaction should be of clinical significance. Because theoretically may increase the risk of koronarospazm, Soligranit is recommended to make not earlier than 24 hours after application of preparations containing ergotamine. Conversely, medication containing ergotamine, it is recommended to make not earlier than 6:00 after the application Soligran.

After ingestion of moclobemide, a specific inhibitor of MAO-A, there was a slight increase (26%) and the AUC (area under the curve) for zolmitriptan and a three-fold increase in AUC for the active metabolite. Therefore, patients, MAO-a inhibitors, take zolmitriptan at a dose of no more than 5 mg per day. Drugs should not be used simultaneously while taking moclobemide in doses more than 150 mg twice a day.

after taking cimetidine, the total inhibitor P450, the half - life of zolmitriptan grew by 44%, and AUC-by 48%. In addition, cimetidine has doubled the half-life and AUC period of the active N-dimethylated metabolite (183C91). Patients taking cimetidine, zolmitriptan recommended dose of not more than 5 mg per day.

Based on the General profile of interaction, it is impossible to exclude the possibility of interaction with specific inhibitors of CYP 1A2. Therefore, when using similar compounds such as fluvoxamine and quinolones (eg, ciprofloxacin) dosage is also recommended to reduce.

From the point of view of pharmacokinetics, selegiline (an inhibitor of MAO-B) and fluoxetine (SSRI) with Zolmitriptan do not interact.

After the simultaneous application of triptans and selective inhibitors of serotonin reuptake (SSRI) inhibitors or reverse takeover serotonin and noradrenalina (Issen) reported the emergence of serotonin syndrome (including altered mental status, autonomic instability, neuromuscular abnormalities).

like other 5HT1B/1Dreceptor agonists , zolmitriptan may slow the absorption of other drugs.

avoid the simultaneous application of zolmitriptan with other 5-HT1B/1Dagonists within 24 hours and Vice versa.

application Features

the Preparation should be used only in cases where migraine diagnosis is accurately established. Before starting the treatment of headache, other neurological conditions should be excluded in patients who have previously been diagnosed with migraine, and those who have atypical symptoms with an established diagnosis of migraine.

the Drug should not be used in hemiplegic, basilar and ophthalmoplegic migraines.

you May experience stroke and other cerebrovascular disorders in patients receiving agonists of 5HT1B/1D. It should be noted that patients suffering from migraine have an increased risk of cerebrovascular disorders.

Soligranshould not be administered to patients with symptoms of the syndrome of Wolff-Parkinson-white or arrhythmias associated with other cardiac additional conductive paths.

in rare cases, as well as in the application of other agonists 5HT1B/1D, possible coronarospasm, angina pectoris and myocardial infarction. Soligranshould not be used in patients with risk factors of coronary heart disease (e.g., Smoking, hypertension, hyperlipidemia, diabetes mellitus, heredity) without prior examination for the presence of diseases of the cardiovascular system. Particular attention should be paid to postmenopausal women and men over 40 years of age with such risk factors. However, the examination does not reveal each patient with heart disease, so there were isolated cases of serious heart events in patients without cardiovascular disorders in the history.

As the use of other agonists of 5HT1B/1Dafter taking zolmitriptan may be feeling of heaviness, pressure or squeezing in the heart region. The appearance of chest pain or symptoms characteristic of a coronary heart disease, the use of Soligranshould stop and conduct a survey of the patient.

as with other 5HT1B/1D agonists,a transient increase in blood pressure is possible in patients with both a history of higher blood pressure and normal blood pressure. Very rarely this increase in blood pressure was combined with serious clinical manifestations. The recommended dose Soligranshould not be exceeded.

While the use of triptanov and trav annih Assembly containing St. John's wort, adverse reactions may increase.

Reported occurrence of serotonin syndrome (including altered mental status, autonomic instability, neuromuscular abnormalities) following the simultaneous application of triptans and selective inhibitors of serotonin reuptake (SSRI) inhibitors or reverse takeover serotonin and noradrenalina (Issen). These reactions can be difficult. If concomitant use of SSRIs and zolmitriptan and Issen clinically appropriate, it is recommended to undertake an appropriate examination of the patient, especially at the beginning of treatment, when increasing the dose or use another serotonergic tool.

Prolonged use of any painkiller for headache can increase pain. In such a situation, it is necessary to stop treatment and consult a doctor. Diagnosis of headache caused by excessive treatment should be suspected in patients with frequent or daily headaches, do not decrease the regular use of drugs.

the Drug contains lactose, so patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.

Use in pregnancy and lactation

pregnancy

Safety of use of zolmitriptan during pregnancy is not established. Studies on animals did not reveal a direct teratogenic effect. However, some research data indicate embryotoxicity decreased viability of the embryo. During pregnancy Soligrancan be used only if the possible therapeutic effect for the mother outweighs the potential risk to the fetus/baby.

breast-feeding

Studies have shown that zolmitriptan penetrates the milk of animals that feed. There is no data on the penetration of zolmitriptan into human breast milk. Therefore, women during breastfeeding should use the drug with caution. Influence on the infant should be minimized, which feed it should be not earlier than 24 hours after taking the drug.

The

Ability to influence the reaction rate when driving motor transport or operating other mechanisms

during the administration of the drug by a small group of healthy volunteers at a dosage of up to 20 mg, there was no significant impact on the results of psychomotor tests.

but drivers of vehicles and persons whose work is associated with increased concentration of attention, it should be noted that in the event of a migraine attack, drowsiness and other symptoms may develop.

Method of application and doses

the Drug is not intended for use in order to prevent an attack of migraine. Soligranit is recommended to apply as early as possible after the occurrence of a migraine attack.

Adults appoint 1 tablet (2.5 mg zolmitriptan). In the absence of effect or with a relapse of pain, it is possible to re-take 1 tablet. If necessary a second dose can be taken no earlier than 2:00 after the first dose.

With the lack of effectiveness of a dose of 2.5 mg may increase dose to 5 mg (maximum single dose). The maximum daily dose-10 mg.

for patients with mild to moderate hepatic impairment dose adjustment is not required. For patients with severe liver dysfunction daily dose should not exceed 5 mg.

with CC more than 15 ml/min dose does not need to be adjusted.

do not use in elderly patients (over 65 years).

The

Children

do not use this Medicine for children.

Overdose

the volunteers, who once zolmitriptan at a dose of 50 mg was observed sedative effect.

the half-life of zolmitriptan is from 2.5 to 3:00, so you should observe the patient after an overdose of less than 15 hours or until symptoms resolve. There is no specific antidote.

intensive care procedures are recommended in case of severe intoxication, including ensuring airway patency, adequate oxygenation and ventilation, monitoring and maintenance of the cardiovascular system.

it is Unknown how hemodialysis and peritoneal dialysis affects the concentration of zolmitriptan in the serum.

Side effects

Side effects are usually mild in nature, usually are transient, appear within 4 hours after taking the drug rather than becoming more frequent after re-administration and disappear spontaneously without any additional treatment.

from the immune system:hypersensitivity reactions, including urticaria, angioedema and anaphylactic reactions.

heart:heartbeat, tachycardia, myocardial infarction, angina, coronarospasm.

on the part of vessels:a slight increase in blood pressure, temporary increase in blood pressure.

from nervous system:sensitivity disorders, dizziness, headache, hyperesthesia, paresthesia, drowsiness, feeling of heat.

from the gastrointestinal tract:abdominal pain, nausea, vomiting, dry mouth, dysphagia, ischemia or heart attack (e.g., intestinal ischemia, intestinal infarction, spleen infarction), which can manifest as diarrhea mixed with blood or abdominal pain .

from the kidneys and urinary system:polyuria, increased urination, imperative urge to urinate.

on the part of the musculoskeletal system and connective tissue:muscle weakness, muscle pain.

Common disorders:asthenia, a feeling of heaviness, compression, pain or pressure in the throat, neck, chest and limbs.

Some symptoms may belong to the migraine itself.

The

shelf Life

3 years.

do not use after the expiry date indicated on the package

storage Conditions

Store in its original packaging at a temperature not exceeding 25° CC.

keep out of reach of children.

The

Packaging

2 or 10 tablets in a blister. 1 blister in a pack.

The

Category vacation

According to the recipe.

The

Manufacturer

JSC "Farmak".

location of the manufacturer and address of the place of business

Ukraine, 04080, g.. Kyiv, Frunze str., 74.

SOLIGEN 2.5 MG No. 2

Soligran is a drug used for the treatment of migraine. Due to the possession of analgesic and vasoconstrictor properties, it quickly eliminates the onset of the disease and prevents the disease from developing. Soligran usually used in the complex therapy with other drugs against migraine, however, the selection of combinations of drugs should be undertaken with caution. 

the drug Soligran

    The
  1. over the course of treatment accumulate in the body, due to which gives a strong re effect.
  2. The
  3. is Not used in Pediatrics, is not assigned to elderly patients. 
  4. The
  5. If during the course Samigina become pregnant, should consult a doctor for the selection of another therapy tool. 
  6. The
  7. for Patients taking MAO inhibitors, you should finish the course, wait 14 days and then start therapy Saligramam. 
  8. The
  9. Treatment Saligramam should not be combined with taking the herb St. John's wort and medicines on its basis. 

Application

Welcome Saligrama can be performed on an empty or on a full stomach – on the perception of the drug is not affected. The total daily dose of the drug for adults should not exceed 6 tablets.

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