Sedalgin-Neo - Instructions For Use, Composition, Price, Reviews, Analogues

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

Sedalgin-Neo

Sedalgin-Neo: 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: Sedalgin-neo

ATX code: N02BB72

Active ingredient: codeine (Codeine) + caffeine (Caffeine) + metamizole sodium (Metamizole sodium) + paracetamol (Paracetamol) + phenobarbital (Phenobarbital)

Manufacturer: Balkanpharma-Dupnitsa AD (Bulgaria)

Description and photo updated: 2019-27-08

Prices in pharmacies: from 224 rubles.

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Sedalgin-Neo is a combined drug with antipyretic, analgesic, anti-migraine effects.

Release form and composition

Dosage form - tablets: from almost white to white, round, flat, with a double-sided bevel, on one side there is a dividing risk (5 or 10 pieces in a blister, 1 blister in a cardboard box and instructions for use of Sedalgin-Neo).

Content of active ingredients in 1 tablet:

• paracetamol: 0.3 g;
• phenobarbital: 0.015 g;
• metamizole sodium: 0.15 g;
• codeine phosphate hemihydrate: 0.01 g;
• caffeine: 0.05 g.

Auxiliary components: crospovidone, microcrystalline cellulose, wheat starch, povidone, sodium disulfite, magnesium stearate, talc.

Pharmacological properties

Pharmacodynamics

Sedalgin-Neo is a combination drug with analgesic, antipyretic, anti-migraine and vasodilatory efficacy. It has a symptomatic effect on colds and flu.

The effects of Sedalgin-Neo depend on the properties of its active ingredients:

• paracetamol: a non-narcotic analgesic that blocks cyclooxygenase 1 and 2 (COX1 and COX2) mainly in the central nervous system, thereby affecting the centers of thermoregulation and pain. It also has antipyretic and analgesic effects;
• metamizole sodium: refers to non-steroidal anti-inflammatory drugs. It has an antipyretic, analgesic and antispasmodic effect on the smooth muscles of the biliary and urinary tract;
• caffeine: a purine alkaloid, psychostimulant, has an analeptic effect, stimulates the psychomotor centers of the brain, increases mental and physical performance, eliminates the feeling of fatigue and drowsiness. Enhances the effect of analgesics;
• phenobarbital: a derivative of barbituric acid, an antiepileptic agent with sedative, hypnotic, muscle relaxant and antispasmodic effects;
• codeine: an alkaloid of opium, suppresses the excitability of the cough center, due to which it has a central antitussive effect. It also has an analgesic effect due to the ability to excite opiate receptors in various parts of the central nervous system, which leads to stimulation of the antinociceptive system and changes in the emotional perception of pain. Compared to morphine, it inhibits breathing less, and less often causes constipation, nausea, vomiting and miosis (due to the activation of opioid receptors in the intestine, smooth muscles relax, peristalsis and spasm of all sphincters decrease). Enhances the action of the analgesic.

The duration of action of Sedalgin-Neo is 4-6 hours.

Pharmacokinetics

Once in the gastrointestinal tract, the active components of Sedalgin-Neo are quickly and highly absorbed. They bind to plasma proteins slightly. They are metabolized rather quickly, which is carried out mainly in the liver.

Metamizole sodium, caffeine and phenobarbital are inducers of isoenzymes of the cytochrome P450 system, therefore, they can affect the metabolism and toxicity of some drugs. Excreted mainly by the kidneys.

The maximum plasma concentration of paracetamol is observed 2 hours after taking Sedalgin-Neo. It is metabolized mainly in the liver, resulting in the formation of glucuronides and sulfate metabolites.

The maximum plasma concentration of metamizole sodium is achieved in 60–90 minutes.

Metamizole sodium, caffeine and phenobarbital penetrate into the circulatory system of the fetus, are excreted in breast milk.

The half-life of paracetamol is 1.5-3 hours, metamizole sodium is 1-4 hours (up to 10 hours), caffeine is 3-6 hours, phenobarbital is 90-100 hours, codeine is 3-4 hours.

Indications for use

• adults: short-term symptomatic therapy of pain syndrome of various etiologies: migraine, headache and toothache, neuralgia, neuritis, pain in trauma, burns, postoperative, algomenorrhea (in the absence of a therapeutic effect in relieving pain syndrome with analgesics);
• children and adolescents over 12 years of age: the average intensity of acute pain syndrome, unresponsive to paracetamol or ibuprofen (analgesics of first choice for monotherapy of children).

Contraindications

• deficiency of glucose-6-phosphate dehydrogenase;
• hemorrhagic diathesis;
• aplastic anemia;
• leukopenia, agranulocytosis;
• aspirin bronchial asthma (bronchial asthma caused by hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs));
• severe liver and / or kidney dysfunction;
• hepatic porphyria;
• an indication in the medical history of the excessive use of tranquilizers (anxiolytics), opiates, sedatives;
• high activity of the isoenzyme CYP2D6;
• gluten enteropathy;
• exacerbation of gastric ulcer and duodenal ulcer;
• simultaneous consumption of alcohol;
• increased intracranial pressure;
• glaucoma;
• severe pathologies of the cardiovascular system (arterial hypertension, arrhythmia, acute myocardial infarction);
• age up to 12 years;
• the period of pregnancy and breastfeeding;
• hypersensitivity to the components in Sedalgin-Neo.

The drug is contraindicated in children and adolescents under 18 years of age after adenoidectomy and / or tonsillectomy due to sleep apnea syndrome (high risk of severe life-threatening side effects).

In addition, Sedalgin-Neo is contraindicated for the treatment of patients under the age of 18 with neuromuscular disorders, respiratory pathologies, infectious diseases of the upper respiratory tract or lungs, severe diseases of the respiratory system or heart, multiple injuries, after extensive surgical intervention.

It is recommended to prescribe with caution while taking paracetamol-containing drugs in old age.

Sedalgin-Neo, instructions for use: method and dosage

Sedalgin-Neo tablets are taken orally with meals, with plenty of liquid.

The drug should be used only as directed by a physician who determines the dosage regimen according to clinical indications.

Usually it is recommended to use 1 piece. 3-4 times a day.

The maximum daily dose is no more than 6 pcs., A single dose is 2 pcs.

The duration of the course of treatment should not exceed 3 days.

If there is no therapeutic effect after three days of taking Sedalgin-Neo, you should consult a doctor.

Side effects

• on the part of the cardiovascular system: a significant decrease in blood pressure (BP), extrasystole, palpitations, tachycardia;
• from the immune system: itching, rash, bronchospasm, an attack of bronchial asthma, urticaria, dyspnea; high risk of developing agranulocytosis and anaphylactic reactions (symptoms can occur at any stage of therapy, their appearance does not depend on the daily dose);
• from the nervous system: headache, drowsiness, irritability, anxiety, dizziness, a decrease in the speed of psychomotor reactions, impaired coordination, drug dependence (codeine), fatigue, tremors; against the background of uncontrolled long-term intake of high doses - addiction (decrease in analgesic effect);
• from the gastrointestinal tract (GIT): nausea, vomiting, dry mouth, loss of appetite, pain in the epigastric region, diarrhea, constipation;
• from the urinary system: it is possible (with prolonged therapy in high doses) - impaired renal function (renal failure, interstitial nephritis);
• dermatological reactions: very rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis;
• from the lymphatic system and the blood system: hemolytic anemia; very rarely - thrombocytopenia;
• laboratory indicators: increased activity of liver enzymes.

Most of the side effects are transient.

Overdose

An overdose of Sedalgin-Neo can manifest itself with the following symptoms: nausea, vomiting, gastralgia, a marked decrease in blood pressure, arrhythmia, tachycardia, bradycardia, depression of the central nervous system, accompanied by drowsiness, dizziness, respiratory depression, slowing of psychomotor reactions, significant weakness, up to loss of consciousness …

A dose of 7500 mg of paracetamol can cause liver dysfunction, up to the development of liver failure with a fatal outcome.

In case of taking a dose that is significantly higher than the recommended one, you should make a gastric lavage and take an adsorbent (for example, activated carbon). Further treatment is symptomatic. Until the complete elimination of the active substances of Sedalgin-Neo from the body, it is required to maintain adequate ventilation of the lungs and stable hemodynamic parameters. N-acetylcysteine is an effective antidote to paracetamol.

special instructions

Sedalgin-Neo should be prescribed after a careful assessment of the ratio of the benefits of therapy and the risk of the drug's effect on the body. If the potential risk prevails over the expected effect of the application, it is necessary to choose alternative methods of treatment.

The recommended dosage regimen should not be violated, as this can cause severe liver dysfunction.

In the event of a sudden appearance of severe forms of allergic reactions, accompanied by shortness of breath, skin rash, complaints from the cardiovascular system and gastrointestinal tract and are symptoms of an anaphylactic reaction, Sedalgin-Neo should be canceled immediately.

Discontinuation of pills is also required for agranulocytosis, the symptoms of which include a severe form of neutropenia and signs of infectious diseases (including fever, sepsis).

You can not prescribe Sedalgin-Neo to patients with a history of hypersensitivity to sodium metamizole.

With concomitant therapy with paracetamol drugs, the total dose of paracetamol taken should be determined in order to prevent overdose.

With frequent and prolonged use of Sedalgin-Neo, the patient needs to monitor the blood picture and indicators of kidney and liver function.

Drinking alcohol during the treatment period is strictly prohibited.

Taking the drug can cause the urine to turn red.

Since elderly patients are more susceptible to intoxication, Sedalgin-Neo should be taken with caution in this category of patients.

Long-term use of the drug can cause the development of codeine addiction.

After taking analgesics for three months or more in the regime every other day or more, headache may occur or worsen. To stop it, you cannot resort to increasing the dose of analgesics, you must stop taking them and consult a doctor.

In patients with high activity of the isoenzyme CYP2D6, the active metabolite of codeine, morphine, quickly reaches high plasma concentrations, therefore, the appointment of Sedalgin-Neo is contraindicated in this category of patients.

Common symptoms of opioid intoxication include drowsiness, nausea, vomiting, confusion, pupillary constriction, lack of appetite, shallow breathing, and constipation. In severe forms, life-threatening respiratory and circulatory collapse can develop, in very rare cases with a fatal outcome.

Taking the drug may affect the results of laboratory studies of doping control of athletes.

The preliminary reception of Sedalgin-Neo causes difficulty in establishing a diagnosis in acute abdominal pain syndrome.

With atopic bronchial asthma, pollinosis, the likelihood of developing hypersensitivity reactions increases.

Influence on the ability to drive vehicles and complex mechanisms

During the period of application of Sedalgin-Neo, patients should refrain from driving vehicles and mechanisms.

Application during pregnancy and lactation

The active substances in the composition of Sedalgin-Neo can have a damaging effect on the fetus, therefore, the drug is contraindicated during pregnancy.

Codeine is prohibited for women who are breastfeeding. At therapeutic doses, the substance and its active metabolites penetrate into the mother's milk in low doses, so it is unlikely that they will have a negative effect on the newborn. However, in the case of high activity in a woman of the isoenzyme CYP2D6, it is possible that higher concentrations of morphine (a metabolite of codeine) are formed in the body, which can cause the development of symptoms of opioid toxicity in a newborn, up to death. Metamizole sodium, caffeine and phenobarbital pass into breast milk. In this regard, Sedalgin-Neo is contraindicated during lactation.

Pediatric use

The appointment of the drug is contraindicated in children under 12 years of age.

Under 18 years of age, Sedalgin-Neo should not be used in children and adolescents if they have the following diseases / conditions: respiratory dysfunctions (including neuromuscular disorders), infectious diseases of the upper respiratory tract or lungs, severe heart and respiratory system diseases, extensive surgery or multiple trauma.

With impaired renal function

Sedalgin-Neo is prohibited for severe renal impairment.

For violations of liver function

Sedalgin-Neo is prohibited for severe liver dysfunction.

Use in the elderly

In elderly patients, Sedalgin-Neo should be used with caution.

Drug interactions

Due to the combined composition of the active ingredients of the drug with concomitant therapy with other agents, it is necessary to take into account the possible interaction of each of the components of Sedalgin-Neo.

With the simultaneous use of Sedalgin-Neo:

• paracetamol: aminophenazone can cause mutual amplification of the effects and increase the toxicity of each of the drugs; enhances the activity of indirect anticoagulants; being an inducer of liver microsomal enzymes, it accelerates the process of biotransformation of other drugs, reducing their therapeutic effect; its effect is weakened by oral contraceptives, rifampicin; cimetidine enhances its effect and reduces toxicity; chloramphenicol extends T ¹ / ₂, causing a risk of bone-marrow; hepatotoxic agents and ethanol increase the risk of liver dysfunction;
• phenobarbital: reduces serum concentration and dicumarol activity; accelerates the breakdown of quinidine, estrogens, griseofulvin, doxycycline, phenytoin, carbamazepine; alcohol, tricyclic antidepressants, phenothiazine, narcotic analgesics increase the depressing effect on the central nervous system; valproic acid, sodium valproate slow down the metabolism of phenobarbital;
• metamizole sodium: reduces the activity of indirect anticoagulants, the level of cyclosporine in the blood plasma; enhances the myelotoxic effect of bone marrow suppressants (including chloramphenicol); increases the activity of indirect anticoagulants, oral hypoglycemic agents, glucocorticosteroids, indomethacin; barbiturates, inducers of liver microsomal enzymes (including phenylbutazone) weaken the activity of metamizole sodium; tricyclic antidepressants, allopurinol, oral contraceptives enhance its effect;
• codeine: enhances the depressive effect on the central nervous system (CNS) of barbiturates, alcohol, benzodiazepines, sedatives and hypnotics; causes mutual enhancement of effects with monoamine oxidase inhibitors and tricyclic antidepressants; increases the risk of constipation, intestinal obstruction when taking drugs with anticholinergic activity;
• caffeine: reduces the effects of hypnotics; enhances the activity of NSAIDs.

Since the active substances of Sedalgin-Neo affect the metabolism of many drugs, it is recommended to avoid its combination with other drugs.

Analogs

The analogues of Sedalgin-Neo are Sedal-M, Santoralgin, Quintalgin, Pentabufen, Pentalgin-ICN, Zaldiar, Omnopon, Ramlepsa, Saridon, Tramaceta, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store in a dark, dry place at temperatures up to 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sedalgin-Neo

Reviews of Sedalgin-Neo are mostly positive: the drug effectively and quickly relieves pain syndrome of various etiologies, is inexpensive and well tolerated. Its disadvantages include a large list of contraindications, the poor effect of the drug on the liver, and prescription sales.

Price for Sedalgin-Neo in pharmacies

The price for Sedalgin-Neo is approximately 173-192 rubles. per pack of 10 tablets.

Sedalgin-Neo: prices in online pharmacies

Drug name Price Pharmacy

Sedalgin-Neo tablets 10 pcs. 224 r Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, 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!