Daleron C - instructions for use, dose, side effects, contraindications

Excipients: sodium saccharinate, sodium cyclamate, flavoring grapefruit, lemon flavor, corn starch, quinoline yellow color (E104), povidone, citric acid, anhydrous, sucrose.

Description:

Finely chopped granules of light yellow color with a characteristic fruity smell of grapefruit and lemon.A solution prepared from 1 sachet and 150 ml of hot water, muddy yellow-green color with a smell and taste of grapefruit and lemon.

Pharmacotherapeutic group:Analgesic combined (analgesic non-narcotic remedy + vitamin)

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.51 Paracetamol in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Daleron C is a combination of paracetamol and ascorbic acid.

Paracetamol has an analgesic and antipyretic effect. The drug blocks cyclooxygenase 1 and 2 mainly in the central nervous system (CNS), affecting the centers of pain and thermoregulation. In inflamed tissues cellular peroxidase neutralize the effect of paracetamol on the cyclo-oxygenase, which explains the almost complete absence of his anti-inflammatory effect. The drug has no adverse effect on the water-salt exchange (sodium and water retention) and the mucosa of the gastrointestinal tract (GIT) due to lack of effect on prostaglandin synthesis in peripheral tissues. The possibility of methaemoglobin formation is unlikely.

Ascorbic acid (vitamin C) plays an important role in the regulation of oxidation-reduction processes, carbohydrate metabolism; increases the resistance of the body, which is associated with the stimulation of the immune system. Ascorbic acid is a cofactor of many enzymes and protects the cell from the harmful effects of oxidative processes (antioxidant action). It improves paracetamol tolerance and extends its action (slowing its excretion).

Pharmacokinetics:Paracetamol. Absorption is high. The time required to reach the maximum concentration (TCmax) is 0.5-2 h; the maximum concentration (Cmax) is 5-20 μg / ml. Connectivity with plasma proteins -15%. Penetrates through the blood-brain barrier (BBB). The volume of distribution varies from 0.8 to 1.36 l / kg body weight. Less than 1% of the dose of paracetamol taken by the lactating mother penetrates into breast milk. The therapeutically effective concentration of paracetamol in plasma is achieved when it is administered at a dose of 10-15 mg / kg. Metabolised in the liver (90-95%): 80% enters the conjugation reaction with glucuronic acid and sulfates with the formation of inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites.With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. In the metabolism of the drug is also involved isoenzyme CYP2E1. The half-life (Tm) - 1.5-3 hours (mean T1 / 2 is 2.3 hours). It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% - in unchanged form. In elderly patients, clearance clearance decreasesAta and increases T1 / 2.

Ascorbic acid. After oral administration ascorbic acid quickly absorbed from the digestive tract. Absorption depends on the dose and improves with increasing dose. After suction ascorbic acid distributed in tissues, penetrates the placental barrier and is secreted into breast milk. It accumulates in phagocytes and lymphocytes in amounts that are up to 100 times higher than plasma concentrations, which proves the role of this vitamin in the functioning of the cells of the immune system. Connection with plasma proteins - 25%. At a dose of 90 to 150 mg / day plasma concentrations of vitamin C are increasing. Ascorbic acid reversibly oxidized to dehydroascorbic acid, which is partially metabolized to form oxalic acid and ascorbate-2 sulfate, which are excreted by the kidneys. Excess ascorbic acid is excreted by the kidneys unchanged.

Indications:

Daleron C, pellets for the preparation of oral solution, used in adults and children over 12 years old as:

- antipyretic agents for infectious-inflammatory (bacterial, viral) diseases;

- anesthetic for pain in muscles and joints;

- anesthetic for mild to moderate pain syndrome (headache, toothache) of non-inflammatory origin, with neuralgia, algodismenorea;

- an anesthetic for trauma, medical interventions.

The drug in the form of a hot drink is especially suitable for patients who, due to the inflamed mucosa of the oral cavity and pharynx, hardly accept conventional dosage forms.

Contraindications:

- Hypersensitivity to paracetamol, ascorbic acid or other components of the drug;

- Children under 12 years of age (for this drug at the specified dose);

- congenital insufficiency of glucose-6-phosphate dehydrogenase;

- marked violations of the liver and kidneys (creatinine clearance (CK) less than 30 ml / min), viral hepatitis;

- diabetes;

- congenital fructose intolerance, glucose-galactose malabsorption syndrome, or isochlorase-isomaltase deficiency.

Carefully:

Renal and hepatic insufficiency, congenital hyperbilirubinemia, alcoholism, elderly patients.

Pregnancy and lactation:

Data on the efficacy and safety studies of the combination of paracetamol and ascorbic acid in pregnant and lactating women are not available. Thus, it is not possible to assess the possible relationship between risk and benefit, and therefore the use of the drug in these categories of patients is not recommended.

Dosing and Administration:

Inside. Adults and children over 12 years are recommended to take 1 sachet (sachet) 4-6 times a day at intervals of not less than 4 hours.

The contents of one sachet should be poured into a glass and pour 150 ml of warm water or tea, mix thoroughly until completely dissolved and ingested in the form of a warm drink. The solution is unclear, yellowish green in color with the smell and taste of grapefruit and lemon.

The maximum single dose for adults or children over 12 years old is 2 packets (1 g for paracetamol).

The maximum daily dose is 8 bags (sachets) (4 grams of paracetamol).

With renal and / or liver failure, the daily dose is reduced by reducing the single dose and / or the frequency of intake (not less than 8 hours). Duration of admission is not more than 5 days when prescribed as an anesthetic and 3 days - as an antipyretic.

Further treatment with the drug is possible only after consulting a doctor.

Do not exceed the indicated dose.

In case of an overdose, seek medical help immediately, because there is a risk of delayed signs of serious liver damage.

Side effects:

Classification of the incidence of adverse events (WHO):

very often> 1/10

often from> 1/100 to <1/10

infrequently from> 1/1000 to <1/100

rarely from> 1/10000 to <1/1000

very rarely from <1/10000, including individual messages.

From the digestive system: rarely - nausea; very rarely - vomiting, diarrhea, epigastric pain, jaundice, pancreatitis and increased activity of "liver" enzymes.

Allergic reactions: rarely - skin rash, itching, hives, angioedema.

From the organs of hematopoiesis and lymphatic system: very rarely - anemia, leukopenia, thrombocytopenia, agranulocytosis.

Other: rarely - weakness.

Overdose:

Symptoms:

Paracetamol: symptoms of acute overdose develop within the first 24 hours and are manifested: nausea, vomiting, increased sweating, pale skin, anorexia,abdominal pain; a violation of glucose metabolism, metabolic acidosis. At a significant excess of recommended doses (more than 150 mg / kg body weight) severe liver and kidney damage, arrhythmia, pancreatitis can develop. A detailed clinical picture of liver damage occurs after 2-4 days after an overdose. Rarely, liver function abnormalities develop with lightning speed and can be complicated by renal failure (tubular necrosis).

Ascorbic acid: very high doses (more than 10 g / day) can cause the formation of oxalate stones. The amount of ascorbic acid in the granules of the preparation Daleron C practically excludes the development of an overdose.

Treatment: symptomatic. It is necessary to stop taking the drug, rinse the stomach, take Activated carbon. Further therapeutic measures should be carried out in the setting of a medical institution: the appointment of donators SH - groups and precursors of the synthesis of glutathione - methionine for 8-9 hours after an overdose and acetylcysteine - during the first 12 hours. The need for additional therapeutic measures (further introduction of methionine,intravenous injection of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:

If you are taking other medications at the same time, you should consult your doctor.

Reduces efficiency uricosuric drugs.

For prolonged and regular use paracetamol potentiates the action warfarin and other coumarin derivatives and increases the risk of bleeding.

Simultaneous reception colestyramine leads to a decrease in the absorption of paracetamol (and weakening effects of paracetamol).

Metoclopramide and domperidone increase the absorption of paracetamol.

Simultaneous use of paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of developing "analgesic" neuropathy and renal papillary necrosis, the terminal stage of renal failure.

Simultaneous application of paracetamol and chloramphenicol can be accompanied by an increase in T1/2 chloramphenicol up to 5 times.

Stimulants of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which causes the possibility of severe intoxication even with small overdoses.

Salicylamide increases T1 / 2 paracetamol, which leads to the accumulation of paracetamol and, accordingly, increased formation of its toxic metabolites.

Simultaneous application of paracetamol and ethanol can enhance hepatotoxicity of paracetamol, and also promote the development of acute pancreatitis.

Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

High doses ascorbic acid can affect the results of laboratory studies (determination of glucose, uric acid, creatinine and inorganic phosphate).

Special instructions:

Patients with mild to moderate renal impairment (QC 30 ml / min or more) and liver are recommended to administer paracetamol under medical supervision.

Do not take with other drugs containing paracetamol (risk of increased side effects).

Do not exceed the recommended dose. If there is no therapeutic effect, discontinue treatment and consult your doctor.

Patients with congenital hyperbilirubinemia drug should be used in lower doses and with a longer interval between doses.

Patients suffering from alcohol dependence during the treatment with the drug should be strictly under medical supervision.

The granules of Daleron C contain sucrose, so the drug is not recommended for patients with congenital fructose intolerance, glucose-galactose malabsorption syndrome, or iso-maltase sucrose deficiency.

The drug should not be taken by people with diabetes, because it contains sucrose (about 3.88 g of sucrose is contained in one sachet).

Effect on the ability to drive transp. cf. and fur:The pellets of Daleron C do not affect the ability to drive and work with complex technical devices.

Form release / dosage:

Granules for solution for oral administration, 500 mg + 20 mg.

Packaging:

For 5 g of the drug in bags (sachets). For 10 bags are placed in a pack of cardboard along with instructions for use.

Storage conditions:

Store in a dry place, at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N011483 / 01

Date of registration:03.11.2009

Expiration Date:Unlimited

Date of cancellation:2018-04-12

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp12.04.2018

Illustrated instructions

Instructions

Daleron C (Daleron® C)