INSTRUCTION for medical use of the drug
PENTALGINE FC®
Tradename.
PENTALGINE FC®
Latin name.
PENTALGIN FC
General characteristics:
basic physical and chemical properties: white or white tablets with a yellowish tint of color, with a facet and a risk; on the surface of one side of the tablet, the trademark of the enterprise is marked;
1 tablet contains 0.3 g of metamizole sodium (analgin), 0.3 g of paracetamol 0.05 g of caffeine, 0.01 g of phenobarbital, 0.008 g of codeine;
potato starch, calcium stearate, food gelatin
Form of issue.
Pills.
Pharmacological group.
Analgesics and antipyretics. ATS code N02B B72.
Pharmacological properties.
Combined drug, has analgesic, anti-inflammatory, as well as antipyretic effect.
Pharmacodynamics.
Metamizole sodium (analgin) - a non-steroidal anti-inflammatory drug, has analgesic, spasmolytic effect on the biliary tract and smooth muscles, which displays urine.
The action occurs in 20-40 minutes. and reaches a maximum after 2:00. Paracetamol, a non-narcotic analgesic that blocks cyclooxygenase (COX), predominantly in the central nervous system, affects pain centers and thermoregulation; has analgesic and antipyretic effect.
Caffeine stimulates the psychomotor centers of the brain, has an analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, increases physical and mental performance.
Phenobarbital - an antiepileptic agent, has a sedative, spasmolytic and miorelaksiruyuschee effect.
Codeine - antitussive drug of central action; alkaloid of the phenanthrene series; belongs to the group of narcotic analgesics, the agonist of opioid receptors, reduces the excitability of the cough center. Activation of opioid receptors in the intestine causes relaxation of smooth muscles, a decrease in peristalsis and spasm of all sphincters.
Has analgesic effect, to a lesser extent than morphine, depresses breathing, rarely causes miosis, nausea and constipation. In small doses does not cause depression of the respiratory center, does not violate the function of ciliated epithelium and does not reduce bronchial secretion, enhances the action of analgesics, hypnotics and sedatives. Frequent unreasonable use of codeine and its use in large doses causes the development of side effects from the gastrointestinal tract.
Pharmacokinetics.
Metamizole sodium (analgin) is well and quickly absorbed in the gastrointestinal tract (GIT). In the intestinal wall it hydrolyzes with the formation of an active metabolite - there is no unchanged drug in the blood. The association of the active metabolite with proteins is 50-60%. Metabolized in the liver, excreted by the kidneys.
Paracetamol is rapidly absorbed into the digestive tract, binds to plasma proteins. Half-life (T?) From plasma 1-4 hours Metabolised in the liver with the formation of glucuronide and paracetamol sulfate. It is excreted by the kidneys mainly in the form of conjugation products, less than 5% is excreted unchanged. Caffeine is well absorbed along the entire intestine. Metabolised in the liver. It is excreted in urine (10% unchanged).
Phenobarbital is absorbed completely, slowly. Metabolized in the liver, induces microsomal enzymes of the liver. Cumulates. The half-life period is 3-4 days. It is excreted by the kidneys in the form of inactive metabolites, 25-50% unchanged. It penetrates well through the placenta.
Codeine is well absorbed into the digestive tract. Due to its lipophilicity it quickly penetrates the blood-brain barrier, accumulates in adipose tissue and less in tissues with a high level of perfusion, such as lungs, liver, kidneys and spleen. Codeine in the body is first hydrolyzed by tissue esterases - there is a cleavage of the methyl group, and then in the liver it is easily conjugated to glucuronic acid. Metabolites of codeine also have analgesic and other types of activity.
Metabolites of codeine are excreted mainly in the urine, a much smaller proportion of metabolites associated with glucuronic acid is excreted with bile. In patients with renal insufficiency, these active metabolites can accumulate, leading to a longer action of the drug.
Indications.
The drug is used in severe pain syndrome of various genesis.
It is especially effective for pains in joints, muscles, radiculitis, menstrual pains, neuralgia, and is also effective for headache and dental pain, migraine.
Pentalgin FC® can be used for colds and fever, accompanied by pain symptoms and inflammation.
Method of administration and dose.
Assign Pentalgin FC® inside 1 tablet 1-3 times a day.
The maximum single dose - 2 tablets, daily - 6 tablets. The course of treatment is 5 days.
The drug should not be taken for more than 5 days as an anesthetic without prescribing and monitoring the doctor.
Side effect.
Sometimes skin allergic reactions (rash, itching, urticaria) are possible, a decrease in the speed of psychomotor reactions, dizziness, drowsiness, palpitation, tachycardia, nausea and vomiting, constipation.
Rarely - a violation of the blood system (leukopenia, granulocytopenia, agranulocytosis).
With prolonged use in large doses, addiction (weakening of the analgesic effect), hospital dependence (codeine), impaired liver and kidney function is possible.
Contraindications.
Hypersensitivity to the components of the drug. Pronounced disorders of kidney and liver function, peptic ulcer of the stomach and duodenum, bronchospasm, conditions accompanied by respiratory depression, blood diseases (leukopenia, thrombocytopenia, hemolytic anemia).
Increased intracranial pressure, craniocerebral trauma, acute myocardial infarction, cardiac rhythm disturbances, high blood pressure, deficiency of glucose-6-phosphate dehydrogenase, glaucoma, pregnancy and lactation.
Children under 12 years.
Interaction with other drugs.
Simultaneous administration 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).
Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium (analgin). Simultaneous reception of analgin with cyclosporine reduces the level of the latter in blood plasma. Sedatives and tranquilizers increase the analgesic effect of Pentalgin IC®.
Overdose.
Symptoms: nausea, vomiting, tachycardia, arrhythmia, oppression of the respiratory center.
Features of application.
With long-term administration of Pentalgina FC® (more than 1 week), it is necessary to monitor the morphological composition of the blood and the liver function.
The use of the drug may alter the results of doping control tests in athletes.
It is difficult to establish a diagnosis for acute abdominal pain syndrome.
In patients with atopic bronchial asthma, pollinosis, there is an increased risk of developing hypersensitivity reactions.
It is necessary to refrain from potentially dangerous activities requiring increased concentration of attention (management of vehicles, machines and mechanisms).
With caution should be taken to patients with impaired renal and hepatic function, peptic ulcer of the stomach and duodenal ulcer in the remission stage, to the elderly.
Storage conditions.
Keep out of the reach of children, dry, protected from light, at a temperature of 15 to 25 ° C.
Shelf life - 3 years.
Terms of leave.
Without recipe.
Packaging.
10 tablets in a planar cell package; 1 contour pack in a pack of cardboard or 10 tablets in a planar cell package.
Manufacturer.
Acino, Switzerland
Producer. Acino, Switzerland.
Subdivision Acino Ukraine.
