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

Excipients: sorbitol solution, glycerol, xanthan gum, sodium benzoate, maltitol, liquid, Avicel RC-591 *, flavoring pineapple, citric acid, riboflavin, purified water.

* Avicel RC-591 - a mixture of microcrystalline cellulose and carmellose sodium.

Description:

Homogeneous suspension from light yellow to yellow with the smell of pineapple.

Pharmacotherapeutic group:Analgesic non-narcotic remedy

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.01 Paracetamol

Pharmacodynamics:Paracetamol has an analgesic and antipyretic effect. The drug blocks cyclooxygenase I and II 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 metabolism (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.

Pharmacokinetics:

Absorption is high. The time required to reach the maximum concentration (TCmah) - 0.5-2 hours; maximum concentration (Сmah) - 5-20 mcg / ml. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier. The volume of distribution varies from 0.8 to 1.36 l / kg body weight. Breast milk penetrates less than 1% of the accepted dose of paracetamol. 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 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 (T1/2) - 1.5-3 hours (mean value 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 decreases the clergyand increased T1 / 2.

Indications:

Daleron is used as:

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

- an anesthetic for acute pain (headache, dental);

- anesthetic for trauma, medical or dental interventions.

Contraindications:

- Hypersensitivity to paracetamol or other components of the drug;

- the period of newborns (up to 1 month);

- congenital insufficiency of glucose-6-phosphate dehydrogenase;

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

- congenital intolerance to fructose.

Carefully:Renal and hepatic insufficiency, children under 2 years of age (only on the recommendation of a doctor), congenital hyperbilirubinemia.

Pregnancy and lactation:

Daleron, a suspension for ingestion for children, contains paracetamol in doses recommended for children. Preclinical studies in animals have not revealed any adverse effect of paracetamol on pregnancy or fetal development. However, the risk can not be ruled out completely. During pregnancy, especially in the first trimester, and during lactation, the drug can be used only on the recommendation of a doctor for a short period of time, preferably once.

Dosing and Administration:Inside, the recommended single dose of paracetamol is 10-15 mg / kg of the child's body weight. Take with plenty of fluids, 1-2 hours after takinga food, 3-4 times a day, with an interval of 4-6 hours.A single dose for children depends on the age and body weight of the child. The recommended maximum daily dose is not more than 60 mg / kg of the child's body weight. Daleron, suspension for ingestion to children under 2 years of age is prescribed only on the advice of a doctor.

Recommended single doses of a suspension of Daleron:

Age of child	Single dose
1-3 months	1/3 syringe (1.7 ml) 40 mg
4-11 months	0.5 - 1 syringe (2.5-5 ml) 60-120 mg
1-2 years	1 syringe (5 ml) 120 mg
3-6 years old	1.5-2 syringe (7.5 - 10 ml) 180-240 mg
7-10 years old	2-3 syringes (10 - 15 ml) 240-360mg
11-12 years old	4 syringes (20 ml) 480 mg

Taking more than four doses of the drug per day is not recommended.

For accurate dosing of the drug, a dosing syringe is provided for oral administration of the drug. One complete dosing syringe (5 ml) contains 120 mg of paracetamol. The required amount of the drug should be slowly injected into the baby's mouth by a dosing syringe or can be transferred to a spoon; then the drug should be given to the baby with a spoon. Rinse the syringe with water after use. Before use, the contents of the bottle should be thoroughly shaken.

Duration of admission (without consulting a doctor) is no more than 5 days, with an appointment as an anesthetic and no more than 3 days - as an antipyretic.

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

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.

In recommended doses paracetamol rarely has a side effect.

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

On the part of the organs of hematopoiesis: very rarely - leukopenia, thrombocytopenia.

Allergic reactions: hypersensitivity reactions, incl. skin rash, itchy skin, bruisespivnitsa; angioedema.

Other: rarely - weakness.

If there are side effects, stop taking the medication and consult a doctor.

Overdose:

If a child receives a dose of the drug that exceeds the recommended dose, immediately consult a doctor even if the child is feeling well; signs of intoxication may appear only after a few days. In children, signs of an overdose appear when taking a dose exceeding 150 mg / kg body weight.

Symptoms Acute paracetamol poisoning develops within the first 24 hours and is manifested: nausea, vomiting, anorexia, pain in the stomach, sweating, pallor of the skin. Symptoms of liver dysfunction can occur after 1-2 days (soreness in the liver, increased activity of "liver" enzymes). In severe cases, it is possible to develop severe liver damage (hepatic insufficiency with progressive encephalopathy, hepatonecrosis, coma, death) and kidneys (acute renal failure with tubular necrosis); arrhythmia, pancreatitis.

Treatment: discontinue use and consult a doctor immediately; treatment is symptomatic. It is recommended to wash the stomach for the first four hours, taking enterosorbents (Activated carbon, polyphepan), intravenous donators SH-groups and precursors of the synthesis of glutathione-methionine for 8-9 hours after overdose and acetylcysteine-for 12 hours. The need for additional therapeutic measures (further introduction of methionine, intravenous injection of acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as by the time passed after its reception.

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 the 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.

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.

For children from 1 month to 2 years old, the suspension for oral ingestion can be taken only as directed by a doctor.

The drug Daleron, the suspension does not contain sugar, so it can be used by patients with diabetes mellitus.

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.

Duration of admission (without consultation with a physician) no more than 5 days for appointment at as an analgesic and not more than 3 days - at as an antipyretic. Further treatment with the drug is possible only after consulting a doctor.

Suspension Daleron contains sorbitol and maltitol, therefore the drug is not recommended for children with congenital intolerance to fructose.

Due to the fact that the preparation contains polyhydric alcohols (sorbitol, maltitol), large doses can cause gastrointestinal disorders (diarrhea).

Effect on the ability to drive transp. cf. and fur:Daleron, suspension for oral administration does not affect the ability to drive a car and work with technical means.

Form release / dosage:

Suspension for oral administration for children 120 mg / 5 ml.

Packaging:

100 ml of the suspension is placed in a vial of dark glass with a plastic lid with a control of the first opening. 1 bottle complete with a dispensing plastic syringe and instructions for use are placed in a cardboard pack.

Storage conditions:

Store in a dark place at a temperature of no higher than 30 ° C.

After opening the vial, the suspension can be used for 3 months, provided it is densely clogged after another use.

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 N011471 / 02

Date of registration:29.10.2009

Expiration Date:Unlimited

Date of cancellation:2016-12-07

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: & nbsp07.12.2016

Illustrated instructions

Instructions

Daleron (Daleron®)