Sumatriptan Canon - Instructions For Use, Price Of Tablets, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sumatriptan Canon

Sumatriptan Canon: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Sumatriptan Canon

ATX code: N02CC01

Active ingredient: Sumatriptan (Sumatriptan)

Producer: CJSC "Kanonfarma Production" (Russia)

Description and photo update: 2020-17-01

Prices in pharmacies: from 441 rubles.

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Sumatriptan Canon is an anti-migraine agent.

Release form and composition

The drug is produced in the form of film-coated tablets: round, biconvex, white or almost white (in a cardboard box 1 blister containing 2, 4, 6 or 10 tablets, or 3 blister packs containing 2 tablets each, and instructions for use of Sumatriptan Canon).

The composition of the drug for 1 tablet:

• active substance: sumatriptan - 50 or 100 mg (in the form of sumatriptan succinate - 70 or 140 mg, respectively);
• auxiliary components: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, mannitol, magnesium stearate, croscarmellose sodium, calcium stearate, hyprolose (hydroxypropyl cellulose Klucel LF);
• film sheath: Selecoat AQ-02003 [titanium dioxide, hypromellose (hydroxypropyl methylcellulose), macrogol (polyethylene glycol 6000)].

Pharmacological properties

Pharmacodynamics

The active substance of Sumatriptan Canon - sumatriptan, is a selective agonist of vascular 5-hydroxytryptamine-1-receptors (5-HT1D). The predominant location of these receptors is the cranial blood vessels of the brain, which narrow when stimulated. The drug has no effect on other subtypes of 5-HT receptors (5-HT2-5-HT7).

In animal studies, sumatriptan selectively caused a narrowing of the lumen of the branches of the carotid artery without affecting blood flow in the vessels of the brain. The vascular basin of the carotid artery provides blood supply to the extracranial and intracranial tissues (including the meningeal membranes), and the main mechanism for the development of migraine in humans is considered to be edema and / or vasodilation of the meninges.

According to experimental data, sumatriptan also reduces the sensitivity of the trigeminal nerve.

It is assumed that the anti-migraine effect of Sumatriptan Canon is due to two described properties.

The effectiveness of sumatriptan has been confirmed in the treatment of migraine attacks, including menstrual-associated migraine (MAM).

The drug develops within 30 minutes after taking a dose of 100 mg.

The recommended dose is 50 mg. However, the severity of migraine attacks can vary from person to person or from person to person at different times, so a 100 mg dose may be required.

In clinical trials, sumatriptan in the dose range from 25 to 100 mg has shown significantly greater efficacy compared to placebo. However, according to statistics, the 25 mg dose is less effective than the 50 and 100 mg doses.

Pharmacokinetics

The pharmacokinetics of orally administered sumatriptan is independent of migraine attacks.

Basic pharmacokinetic parameters of Sumatriptan Canon:

• absorption: Sumatriptan is rapidly absorbed after oral administration. Its plasma concentration in 45 minutes reaches 70% of the maximum level. The maximum plasma concentration (C _max) after taking a dose of 100 mg is 54 ng / ml. The absolute bioavailability averages 14%, partly due to incomplete absorption, partly due to presystemic metabolism;
• distribution: the average total volume of distribution (V _d) of sumatriptan is 170 l, from 14 to 21% of the dose binds to plasma proteins;
• metabolism: as a result of biotransformation of sumatriptan (under the action of monoamine oxidase A), an indoleacetic analog of sumatriptan is formed, which is excreted mainly in the urine in the form of a glucuronide conjugate and free acid. It does not show activity at 5-HT1 and 5-HT2-serotonin receptors. No minor metabolites were found;
• elimination: the average renal clearance of sumatriptan is 260 ml / min, the total plasma clearance is on average 1160 ml / min, and the extrarenal clearance is approximately 80% of the total clearance. The half-life is about 2 hours.

With a functional disorder of the liver, the presystemic clearance of sumatriptan decreases, which leads to an increase in its plasma concentration and, as a result, an increase in bioavailability.

The effect on the pharmacokinetics of the drug of moderate hepatic dysfunction (class B on the Child-Pugh scale) was assessed after subcutaneous administration. No significant differences were found with healthy patients.

Indications for use

Sumatriptan Canon is used to relieve migraine attacks, including those with aura (including MAM).

The drug is not intended for the prevention of migraine.

Contraindications

Absolute:

• migraine of ophthalmoplegic, basilar and hemiplegic forms;
• peripheral arterial occlusive disease;
• moderate and severe arterial hypertension;
• mild arterial hypertension, not amenable to adequate control;
• transient ischemic attack, stroke (including data in anamnesis);
• angina pectoris (including vasospastic);
• ischemic heart disease (CHD) or the presence of symptoms that cause suspicion of its development;
• myocardial infarction (including data in anamnesis), postinfarction cardiosclerosis;
• severe impairment of kidney and / or liver function;
• age under 18 and after 65 years;
• simultaneous use of monoamine oxidase inhibitors (MAO) and a period of 14 days after their cancellation;
• co-administration of other tryptamines / 5-nt1-receptor agonists, ergotamine or its derivatives (including methysergide);
• hypersensitivity to any component of the drug.

Relative (Sumatriptan Canon tablets should be used with caution):

• arterial hypertension, amenable to control;
• epilepsy and conditions characterized by a decreased epileptic threshold;
• diseases that can affect the absorption, metabolism or excretion of sumatriptan, including functional disorders of the liver and kidneys;
• hypersensitivity to sulfonamides (taking sumatriptan can cause the development of hypersensitivity reactions, the severity of which varies from skin manifestations to anaphylaxis);
• mild to moderate liver dysfunction (class A or B on the Child-Pugh scale);
• pregnancy and breastfeeding.

Sumatriptan Canon, instructions for use: method and dosage

Despite the fact that Sumatriptan Canon is effective at any stage of a migraine attack, it is recommended to start taking it immediately when the first symptoms appear.

The tablets are taken orally, swallowed whole and washed down with water.

The recommended dose is 50 mg, but some patients may need a dose of 100 mg.

If the patient feels improvement after the first dose, but the symptoms have resumed, the second dose is allowed, provided that at least 2 hours have passed, and during the previous 24 hours the total dose taken did not exceed 300 mg.

In cases where it is not possible to stop the migraine attack by taking the first dose, the second should not be taken. Further, it is allowed to take acetylsalicylic acid, paracetamol or a non-steroidal anti-inflammatory drug. For the relief of subsequent attacks, taking Sumatriptan Canon is allowed.

Side effects

Adverse reactions are classified as follows: ≥ 1/10 - very often, from ≥ 1 100 to <1/10 - often, from ≥ 1 1000 to <1/100 - infrequently, from ≥ 1/10 000 to <14 000 - rarely, <1/10 000 - very rare.

According to clinical studies, Sumatriptan Canon can cause the following side effects from different organs and body systems:

• on the part of the vessels: often - hot flashes, a temporary increase in blood pressure (usually occurs soon after taking the pill);
• from the respiratory system: often - shortness of breath;
• from the nervous system: often - drowsiness, dizziness, sensory disturbances (including paresthesia);
• from the musculoskeletal tissue: often - a feeling of heaviness in any part of the body, including the throat and chest (usually transient, may be intense);
• from the gastrointestinal tract: often - nausea, vomiting (their causal relationship with taking the drug has not been established);
• others: often - weakness and fatigue (usually transient, mild or moderate), a feeling of constriction or pressure in any part of the body, including the throat and chest (usually transient, may be intense), a feeling of heat or cold, painful prolapse;
• laboratory data: very rarely - slight deviations in liver function tests.

According to post-registration observations, Sumatriptan Canon can cause the following side effects (the frequency of their development has not been established due to insufficient data):

• from the side of the psyche: anxiety;
• from the immune system: hypersensitivity reactions (including skin manifestations, anaphylaxis);
• from the heart and blood vessels: arterial hypotension, palpitations, arrhythmias, angina pectoris, tachycardia, coronary vasospasm, bradycardia, Raynaud's syndrome, signs of transient myocardial ischemia on the electrocardiogram, myocardial infarction;
• on the part of musculoskeletal tissue: arthralgia, stiff neck;
• from the skin and subcutaneous tissues: hyperhidrosis;
• from the gastrointestinal tract: diarrhea, ischemic colitis;
• from the nervous system: nystagmus, dystonia, tremor, scotoma, seizures (in most cases occurred in patients with predisposing conditions and patients with a history of seizures);
• on the part of the organ of vision *: decreased visual acuity, diplopia, flickering, blindness (usually transient).

* It should be borne in mind that visual impairments can be directly caused by a migraine attack.

Overdose

When taking a dose of the drug up to 400 mg, side effects may develop, which can be observed with the usual use of Sumatriptan Canon.

In case of an overdose for at least 10 hours, the patient should be under close medical supervision. Treatment is symptomatic. There are no data on the effectiveness of hemodialysis or peritoneal dialysis in removing the drug from the body.

special instructions

Sumatriptan Canon can only be prescribed with accurate confidence in the diagnosis of migraine. In patients with atypical conditions, potentially dangerous neurological pathologies, for example, transient ischemic attacks or stroke, must be excluded.

In some cases, transient symptoms, including tightness and chest pain, occur. They can be intense and spread to the neck. If you suspect the development of ischemic heart disease, a diagnostic examination should be carried out.

Patients who have any risk factors for the development of coronary artery disease, as well as heavy smokers and persons receiving nicotine replacement therapy, can not use Sumatriptan Canon without a preliminary examination of the cardiovascular system. This is especially true for men over the age of 40 and women in the postmenopausal period. It is important to bear in mind that not every patient has heart disease during examination.

In very rare cases, serious cardiovascular disorders occur in patients with no history.

In controlled arterial hypertension, Sumatriptan Canon should be used with caution, since there is a danger of a transient increase in blood pressure and peripheral vascular resistance.

It is not recommended to use Sumatriptan Canon in combination with any triptans (5-HT1 agonists).

The risk of allergic reactions (up to anaphylactic shock) increases with hypersensitivity to sulfonamides.

During the simultaneous use of drugs containing St. John's wort with triptans, the likelihood of side effects increases.

In sensitive patients, headaches may worsen as a result of abuse of drugs for acute headache relief. In this case, you may need to cancel the Sumatriptan Canon.

Influence on the ability to drive vehicles and complex mechanisms

Due to the frequent development of drowsiness, which is possible not only as a result of taking the drug, but also because of the migraine itself, patients are advised to be careful when engaging in potentially hazardous activities.

Application during pregnancy and lactation

In preclinical studies on animals, no direct teratogenic effect of sumatriptan on the fetus of rats, a negative effect on the prenatal and postnatal development of their embryo / fetus was revealed. However, there is some evidence that the drug affects the viability of the embryo and fetus in rabbits.

Studies of more than 1000 women who took sumatriptan in the first trimester of pregnancy do not provide sufficient information about the risk of intrauterine formation of congenital malformations in the fetus. The experience of using the drug in the II and III trimesters of pregnancy is also limited.

In connection with the above, during pregnancy, Sumatriptan Canon tablets can be used only in exceptional cases, when the benefits to the woman are higher than the risks to the fetus.

In studies, sumatriptan, administered subcutaneously, was excreted in breast milk. For this reason, women should refrain from breastfeeding for at least 12 hours after taking Sumatriptan Canon.

Pediatric use

Sumatriptan Canon is contraindicated in patients under 18 years of age, since its effectiveness and safety in this age group have not been established.

With impaired renal function

Do not use the drug in patients with severe functional impairment of the kidneys.

With caution Sumatriptan Canon should be used for mild to moderate renal impairment.

For violations of liver function

Do not use the drug in patients with severe functional liver disorders.

With caution Sumatriptan Canon should be used for mild to moderate liver dysfunction (class A or B on the Child-Pugh scale).

Use in the elderly

In patients over 65 years of age, experience with sumatriptan is limited. According to observations, the pharmacokinetics in this age population does not differ from that in younger patients. However, Sumatriptan Canon is not recommended for elderly patients until additional data from clinical trials are available.

Drug interactions

In healthy volunteers, there was no interaction of sumatriptan with pizotifen, flunarizine, propranolol, ethyl alcohol.

Ergotamine, when taken simultaneously, causes prolonged vasospasm. According to limited data, the use of sumatriptan with ergotamine or other triptans / 5-HT1 receptor agonists increases the risk of coronary vasospasm, therefore it is contraindicated to use them together. The exact period of time between their doses has not been established, it depends on the type of drugs prescribed and their dose. The action can be additive. The minimum recommended interval between taking these drugs and Sumatriptan Canon is 24 hours. After taking the anti-migraine drug, ergotamine can be taken no earlier than 6 hours, other triptans / 5-HT1 receptor agonists - after 24 hours.

There is a risk of drug interaction between sumatriptan and MAO inhibitors, therefore it is contraindicated to use them simultaneously.

In the course of post-marketing studies, rare reports of the occurrence of serotonin syndrome (including neuromuscular disorders, autonomic lability and mental status disorders) have been received in patients who took sumatriptan while on therapy with selective serotonin reuptake inhibitors (SSRIs). There are also known cases of the development of this syndrome with the simultaneous use of selective serotonin and norepinephrine reuptake inhibitors (SSRIs) and triptans. In this regard, the patient should be carefully monitored during the period of joint administration of Sumatriptan Canon and drugs from the SSRI or SSRI group.

Analogs

Analogues of Sumatriptan Canon are Amigrenin, Sumatriptan-Pfizer, Imigran, Kofetamin, Sumatriptan-OBL, Nomigren, Migrepam, Relpax, Sumatriptan-Teva, Rapimed, Sumamigren, Synapton, Sumatriptan, Sumarin, Sumatriptan, Famigran, etc.

Terms and conditions of storage

Store in the manufacturer's packaging at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life is 4 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Sumatriptan Canon

According to most reviews, Sumatriptan Canon is an effective anti-migraine drug that is well tolerated, sold in many pharmacies, and affordable.

Side effects include minor stomach discomfort, dry mouth, chest tightness, increased blood pressure, and drowsiness. The bitter taste of the tablets is also noted.

Price for Sumatriptan Canon in pharmacies

Approximate prices for Sumatriptan Canon in the form of film-coated tablets:

• dosage 50 mg: 10 pcs. in the package - 436-590 rubles;
• dosage 100 mg: 2 pcs. in the package - 115–210 rubles, 10 pcs. in the package - 685–755 rubles.

Sumatriptan Canon: prices in online pharmacies

Drug name Price Pharmacy

Sumatriptan Canon tab. p.p. 50 mg 10 Pcs. 441 r Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!