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

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 peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the almost complete absence of anti-inflammatory effect. The drug does not adversely affect the water-salt exchange (sodium and water retention) and the mucous membrane of the gastrointestinal tract (GIT), due to the lack of influence on the synthesis of prostaglandins 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).

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.

Pharmacokinetics:

Paracetamol

Absorption is high. The time required to reach the maximum concentration (TFROM_max) - 0.5-2 hours; maximum concentration (FROM_max) - 5-20 mcg / ml. Connection 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. Half-life (T_1/2) - 1.5-3 hours (mean value T_1/2 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, the clearance of the drug decreases and increases T_1/2.

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® Since junior is indicated for admission in childhood as:

- antipyretic agents for infectious-inflammatory (bacterial, viral) diseases, as well as after vaccination;

- anesthetic for acute pain (headache, toothache), pain in muscles and joints with infectious-inflammatory (bacterial, viral) diseases;

- anesthetic for trauma, medical or dental interventions.

Contraindications:

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

- children under 2 years;

- congenital insufficiency of glucose-6-phosphate dehydrogenase;

- expressed 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.

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, the recommended single dose of paracetamol is 10-15 mg / kg body weight.

Each sachet (5 g) contains 120 mg of paracetamol.

The drug is given to children in accordance with the dosing schedule, depending on the age and / or the estimated average body weight of the child.

The contents of one sachet should be poured into a glass and poured with warm water or tea, thoroughly stirred until completely dissolved and taken inside as a warm drink. The solution is unclear, orange, with the smell and taste of orange.

Scheme of application of the drug Daleron® From Junior:

Age of child (years)	Single dose
2-3	1 bag of granules (sachets) / 50 ml of liquid
4-6	2 bags of granules (sachets) / 100 ml of liquid
7-10	2-3 bags of granules (sachets) / 100-150 ml of liquid
10-12	3-4 packets of granules (sachets) / 150 ml of liquid

The interval between taking the drug should be at least 4 hours. During the day should not be given more than 4 doses of the drug.

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 no more than 5 days when prescribed as an anesthetic and no more than 3 days as an antipyretic agent.

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

Do not exceed the recommended 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 side effects, recommended by the World Health Organization (WHO):

Often	≥ 1/10
often	from ≥ 1/100 to <1/10
infrequently	from ≥ 1/1000 to <1/100
rarely	from ≥ 1/10000 to <1/1000
rarely	< 1/10000
frequency unknown	can not be estimated from the available data.

In each frequency group, undesirable effects are presented in descending order of severity of side effects.

If the preparation Daleron® C junior, granules for the preparation of a solution for ingestion, taken at recommended doses, side effects are rarely seen and are mild.

The frequency of side effects from individual systems and organs

Violations of the blood and lymphatic system:

very rarely: anemia, leukopenia, thrombocytopenia.

Immune system disorders:

very rarely: anaphylaxis, angioedema;

rarely: reaction sensitivity, especially skin rash, itching, hives.

Disturbances from the nervous system:

rarely: increased fatigue.

Disturbances from the respiratory system, chest and mediastinal organs:

very rarely: bronchospasm.

Violations from the digestive system:

rarely: nausea;

very rarely: vomiting, diarrhea, abdominal pain, pancreatitis.

Disturbances from the liver and bile ducts:

rarely: jaundice activity of "liver" enzymes.

With prolonged use in large doses, hepatotoxic and nephrotoxic effects are possible.

Disturbances from the skin and subcutaneous tissues:

Very rarely: cases of severe skin reactions (toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, acute generalized exanthematous pustulosis) have been reported.

With the development of severe adverse reactions, treatment should be discontinued.

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 drug Daleron® C junior 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 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 may be accompanied by an increase T_1/2 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 the T_1/2 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.

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

It is not recommended to use paracetamol with other drugs containing paracetamol.

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

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 paracetamol-containing drugs.

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.

Azole color (coloring sunset yellow (E 110)) can cause allergic reactions.

Granules of Daleron® Since junior contain sucrose, therefore the drug is not recommended for patients with congenital fructose intolerance, glucose-galactose malabsorption syndrome or isomaltase deficiency.

The drug should not be taken by people with diabetes, because it contains sucrose (one packet contains 4.561 g of sucrose).

Effect on the ability to drive transp. cf. and fur:Daleron® With a junior does not affect the ability to drive a car and work with complex technical devices.

Form release / dosage:

Granules for solution for oral administration, 120 mg + 10 mg.

Packaging:

For 5 g of the drug in bags (sachets) from laminated three-layer foil: Paper / Al / PE.

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 N011482 / 01

Date of registration:03.11.2009 / 22.12.2015

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 Junior (Daleron® C junior)