Instruction for use: Santotitralgin

Dosage form

Pills.

Composition

Each tablet contains:

codeine monohydrate 8 mg,

caffeine 50 mg,

metamizole sodium monohydrate 300 mg,

phenobarbital 10 mg,

excipients: calcium stearate,

starch,

talc.

Description of dosage form

Tablets are white or white with a yellowish tint of color, flat-cylindrical shape. On one side of the tablet there is a chamfer and risk, on the other side - a bevel and a corporate logo in the form of a cross.

Pharmacological group

Analgesic agent (analgesic opioid + analgesic non-narcotic + psychostimulating + barbiturate).

Pharmacodynamics

Santotitralgin has analgesic, antipyretic, anti-inflammatory, antispasmodic, sedative effect. Combined drug that combines the properties of active ingredients. Metamizol sodium has a pronounced anti-inflammatory, antipyretic effect, analgesic activity, which is enhanced by codeine (blocks opiate receptors, stimulates the antinociceptive system and changes the emotional perception of pain). Phenobarbital has a sedative effect. Caffeine causes the expansion of the blood vessels of skeletal muscles, brain, heart, kidneys; increases mental and physical performance, helps to eliminate fatigue and drowsiness; increases blood pressure in hypotension; increases the permeability of histohematological barriers and increases the bioavailability of non-narcotic analgesics, thereby contributing to the enhancement of the therapeutic effect.

Pharmacokinetics

The components of the drug are well absorbed in the gastrointestinal tract.

Metamizol sodium:

In the intestinal wall, it hydrolyses to form an active metabolite, 4-methyl-amino-antipyrine, which in turn is metabolized to 4-formyl-amino-antipyrine and other metabolites. The level of binding of the active metabolite with proteins is 50-60%. Excretion of metabolites passes through the kidneys. In addition, they are excreted in breast milk.

Caffeine:

Well absorbed in the intestine, half-life - 5 hours (sometimes - up to 10 hours). It is excreted mainly by kidneys in the form of metabolites, about 10% - in unchanged form.

Codeine: Slightly binds to plasma proteins. It is exposed to biotransformation in current (10% by demethylation passes into morphine). Excreted by the kidneys (5-15% - unchanged).

Phenobarbital:

Bioavailability is 80%. In plasma it binds to proteins by 50%, it penetrates well through the placenta. Biotransformatsya in the liver. The main metabolite does not have pharmacological activity. It is excreted by the kidneys, including 20-25% unchanged.

Indications

Accept with a weak and moderately pronounced pain syndrome of different genesis. It is especially effective for pains in the joints, muscles, radiculitis, menstrual pains, neuralgia, as well as headache, migraine, toothache. Can be used for fever, colds and other diseases, accompanied by pain syndrome and inflammation.

Contraindications

Hypersensitivity to the components of the drug. Pronounced impairment of liver or kidney function. Stomach ulcer and duodenal ulcer in the stage of exacerbation. Bronchospasm. Bronchial asthma. Conditions accompanied by respiratory depression. Increased intracranial pressure, craniocerebral injury. Acute myocardial infarction. Violation of the heart rate. High blood pressure. Alcoholic intoxication. Glaucoma. Pregnancy and the period of breastfeeding. Child age - up to 12 years, deficiency of glucose-6-phosphate dehydrogenase; anemia, and leukopenia.

Carefully

Applied in patients with impaired liver or kidney function, with gastric ulcer and duodenal ulcer in remission, in the elderly, with prolonged alcohol history.

pregnancy and lactation

The drug is contraindicated for use in pregnancy.

If it is necessary to use the drug during lactation, it is necessary to solve the problem of stopping breastfeeding.

Dosing and Administration

The drug is usually taken 1 tablet 1-3 times a day. The maximum daily dose is 4 tablets.

The drug should not be used for more than 5 days as an anesthetic without prescribing a doctor.

Side effects

Dyspeptic disorders (nausea, vomiting, constipation), skin allergic reactions (rash, itching, urticaria), epigastric pain, dizziness, drowsiness, decreased speed of the psychomotor reaction, palpitations are possible. Rarely - the oppression of hematopoiesis, in high doses, it is possible that the liver and kidneys are impaired. With prolonged uncontrolled admission in high doses - addiction (weakening analgesic effect).

Overdose

Symptoms:

Nausea, vomiting, stomach pain, tachycardia, cardiac arrhythmias, weakness, drowsiness, delirium, respiratory depression.

Treatment: induction of vomiting, gastric lavage, the appointment of adsorbents (activated charcoal), symptomatic therapy aimed at maintaining vital functions.

Interaction

Simultaneous use of the drug with other non-narcotic analgesics may lead to an increase in toxic effects. Tricyclic antidepressants, oral contraceptives, allopurinol increase the toxicity of metamizole sodium (analgin), which is part of the drug. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium (analgin). Simultaneous use of metamizole sodium (analgin) with cyclosporine reduces the level of the latter in the blood. Sedatives and tranquilizers increase the analgesic effect of the drug.

special instructions

It may complicate the performance of work that requires high speed of mental and physical reactions (driving vehicles, controlling mechanisms, instruments, etc.). The patient should be informed that with prolonged use of the drug without appropriate medical control, it is possible to develop addiction and the formation of drug dependence.

During the treatment it is necessary to refrain from drinking alcohol.

When using the drug for more than 5 days, it is necessary to monitor the pattern of peripheral blood and the functional state of the liver.

Taking the drug may make it difficult to diagnose an acute pain syndrome in the abdomen.

Form of issue

Pills.

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil. On 1 contour acheikova packing together with the instruction on application place in a pack from a cardboard.

Storage conditions

In a dry, dark place at a temperature of +2 ° C to + 30 ° C. Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiration date printed on the package.

Conditions of leave from pharmacies

Without recipe.