Description
Latin name
Sedalgin Plus
Release form
Tablets.
packaging 10 pcs
Pharmacological action
Combined drug, has analgesic, antipyretic and anti-inflammatory effects.
Pharmacokinetics
Pharmacokinetic properties of the drug Sedalgin Plus depend on the pharmacokinetics of the components included in its composition.
Metamizole sodium
After oral administration, metamizole sodium is rapidly and completely absorbed from the digestive tract. Cmax in plasma is achieved on average 60-90 minutes after administration. It binds to plasma proteins and is metabolized in the liver. Along the path of non-enzymatic hydrolysis, it is cleaved to 4-methylaminoantipyrine with further metabolism through active 4-aminoantipyrine to 4-acetylaminoantipyrine – the main metabolite, 90% of which is excreted by the kidneys and 10% – with bile. T1 / 2 is about 10 hours.
Caffeine
Caffeine, which is part of the drug, is almost completely absorbed from the digestive tract. Cmax in plasma is determined after 30-40 minutes. It passes quickly through the BBB and the placental barrier. Penetrates into breast milk. It is excreted mainly by the kidneys unchanged and in the form of metabolites.
Thiamine
After oral administration, thiamine absorption is high and occurs throughout the small intestine. Before absorption, thiamine hydrochloride is released from the bound state by digestive enzymes. In the blood, the concentration of thiamine hydrochloride is relatively low. Mostly free thiamine is found in plasma, and phosphorus esters are found in erythrocytes and leukocytes. Half of the total amount is found in striated muscles (including the myocardium) and about 40% – in the internal organs. Phosphorylation occurs in the liver. The most active phosphorus ester is thiamine diphosphate, which has coenzyme activity. It accumulates mainly in the liver, heart, brain, kidneys, spleen. It is excreted through the intestines and kidneys.
Indications
Moderate or mild pain syndrome of various origins: headache (including migraine),
toothache, neuralgia,
muscle pain (myalgia),
joint pain (arthralgia), radicular syndrome, s pain (algodismenorea).
Feverish syndrome in colds and other infectious and inflammatory diseases (with an established diagnosis).
Contraindications
Hypersensitivity to the drug.
Hypersensitivity to other pyrazolone derivatives – phenylbutazone.
Severe hepatic and / or renal failure.
Bronchospasm.
Deficiency of glucose-6-phosphate dehydrogenase (a syndrome of congenital insufficiency of the enzyme glucose-6-phosphate dehydrogenase).
Diseases of the blood system.
Insomnia.
Uncontrolled hypertension. Severe atherosclerosis. Increased intraocular pressure.
Children’s age (up to 12 years).
Caution – impaired liver and / or kidney function.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Composition
1 tablet contains: active substances: metamizole sodium 500 mg, caffeine 50 mg, thiamine hydrochloride 38, 75 mg
excipients: microcrystalline cellulose 45.75 mg, wheat starch 11.00 mg, gelatin 4.00 mg, colloidal silicon dioxide 2.50 mg, talc 12.00 mg, magnesium stearate 6.00 mg.
Dosage and administration of
The drug is taken orally after meals, 1 tab. 2-3 times in the morning.
Adults and teenagers 16 years of age and older: the maximum single dose is 2 tablets, the maximum daily dose is 6 tablets. within no more than 1-2 days.
For children aged 12 to 16 years: 1/2 tab. or 1 tab. 2-3 times / day. The maximum daily dose is 4 tablets.
Duration of admission is no more than 5 days when prescribed as an anesthetic and 3 days as an antipyretic.
If symptoms persist or worsen, seek medical attention.
An increase in the daily dose of the drug or the duration of treatment is possible only under the supervision of a doctor.
Side effects of
From the gastrointestinal tract: loss of appetite, nausea, vomiting, cholestasis, jaundice
From the blood: thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, purpura
From the central nervous system: insomnia, dizziness, increased irritability
From the cardiovascular system: palpitations, cardiac arrhythmias
Allergic reactions: rash, rash, rash, rash anaphylactic shock bronchospasm.
All side effects should be reported to your healthcare provider.
Drug Interaction
Co-administration of metamizole sodium (analgin) with other non-narcotic analgesics, non-steroidal anti-inflammatory drugs, can lead to mutual enhancement of toxic effects.
Tricyclic antidepressants, oral contraceptives, allopurinol interfere with the metabolism of sodium metamizole in the liver and increase its toxicity.
Barbiturates, phenylbutazone (butadion) and other inducers of microsomal liver enzymes attenuate the action of sodium metamizole. Concomitant use of sodium metamizole with cyclosporine reduces the latter’s concentration in the blood.
Sedatives and tranquilizers enhance the analgesic action of sodium metamizole.
Overdose
Symptoms: nausea and vomiting sometimes with blood, stomach pain, mental and motor excitement, tachycardia, heart rhythm disorders, possible decrease or increase in diuresis, convulsions, anxiety, confusion, confusion, confusion, confusion headache, increased tactile or pain sensitivity, tremor or muscular twitching of tinnitus, seizures (with acute overdose – tonic-clonic).
Treatment: You should seek immediate medical attention. The victim should do a gastric lavage, prescribe adsorbents (eg activated carbon), laxatives.
If necessary, carry out symptomatic treatment (with hemorrhagic gastritis – the introduction of antacid drugs and gastric lavage with ice 0.9% sodium chloride solution maintenance of lung ventilation and oxygenation in epileptic seizures – intravenous diazepam, phenobarbitostin.
Storage conditions
In a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children!
Expiration
2 years.
Active substance
Metamizole Nat Ia, caffeine, thiamine
pharmacy terms and conditions without a prescription
tablet dosage form
dosage form
tablets
Balkanfarma, Bulgaria
