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FORMULA INGREDIENTS
Each 5ml contains:
Acitive ingredient: Paracetamol 150mg
Excipients: q.s
DOSAGE FORM
Oral suspension
Description: The suspension has a sweet aroma and is easy to drink.
INDICATIONS
Symptomatic treatment of fever and pain of mild or moderate intensity.
ADMINISTRATION AND DOSAGE
Dosage:
Children:
Because of the severity of hepatotoxicity and death that has occurred in children with paracetamol overdose, dosage should be based on weight and calibrated measuring devices should be used.
Parents should also be warned that the risk of overdose and serious liver damage is increased when multiple medicines containing Paracetamol are taken simultaneously.
It is necessary to adhere to the dosage determined based on weight. The child's age based on weight is given for reference.
The recommended daily dose of Paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e. 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
Dosage for children under 2 years of age will be established in consultation with your doctor.
For administration of 15 mg/kg every 6 hours, the regimen is as follows, in which doses may be repeated at minimum intervals of 6 hours, without exceeding a total of 4 doses in 24 hours.
|
Child's weight (age range) |
Maximum dose (per dose)/6 hours |
|
|
2,7 - 5 kg (from 0 - 3 months) |
40 – 75 mg |
1,7 – 3 ml |
|
5 - 8 kg (from 4 to 11 months) |
80 – 120 mg |
3 – 5,0 ml |
|
8 - 10,5 kg (from 12 to 23 months) |
120 – 160 mg |
5 – 6,5 ml |
|
10,5 - 13 kg (from 2 - 3 years) |
160 – 195 mg |
6,5 – 8 ml |
|
13 - 18,5 kg kg (from 4 – 5 years) |
195 - 280 mg |
8 – 11,5 ml |
|
18,5 - 24 kg (from 6 – 8 years) |
280 – 360 mg |
11,5 –15 ml |
|
24 - 32 kg (from 9 – 10 years) |
360 – 480 mg |
15 – 20 ml |
If the desired effect is not achieved after 3-4 hours of administration, the dose may be increased every 4 hours, in which case a dose of 10 mg/kg should be used.
Always use the lowest effective dose.
Adults and adolescents over 15 years old:
The recommended dose is 20 - 40 ml per dose as needed every 4 - 6 hours. Dosing sessions must be at least 4 hours apart. Do not exceed 120 ml (3 g paracetamol) per day.
Patients with kidney failure
The dose should be reduced according to glomerular filtration rate (not to exceed 500 mg per dose in adults and adolescents) and the dosing interval should be increased according to the following table:
|
Glomerular filtration rate |
Frequency of administration |
|
10-50 ml/phút |
1 dose every 6 hours |
|
< 10 ml/phút |
1 dose every 8 hours |
Patients with liver failur
In case of hepatic impairment, the dose should be reduced (not to exceed 2 g/24 hours in adults and adolescents) and the minimum interval between doses should be 8 hours (see Warnings and Precautions).
Elderly:
In elderly patients, an increased half-life of paracetamol has been observed, therefore the dose in adults should be reduced by 25%.
Maximum recommended dose
In case of hepatic impairment, the dose should be reduced (not to exceed 2 g/24 hours in adults and adolescents) and the minimum interval between doses should be 8 hours (see Warnings and Precautions). In elderly patients, an increased half-life of paracetamol has been observed, therefore the dose in adults should be reduc
The total dose of paracetamol should not exceed 80 mg/kg/day for children weighing less than 37 kg and 3 g per day for adults and children weighing more than 38 kg. (See Overdose and treatment).
Frequency of taking medication
Systematic use allows you to avoid fluctuations in pain or fever.
In children, it should be given at regular intervals, including at night, preferably every 6 hours, and maintain a minimum interval of 4 hours between doses.
Concomitant use of paracetamol and food increases the absorption time of paracetamol because food reduces motility and transit time through the digestive tract. For quick relief, take the medication without food, especially if the food is high in carbohydrates.
In the event of high fever, or signs of secondary infection, or symptoms lasting more than three days, treatment should be reassessed. If symptoms worsen or if fever lasts more than 3 days or pain lasts more than 3 days in children or 5 days in adults (2 days for sore throat), treatment should be stopped and a doctor should be consulted. doctor.
Administration
Oral.
The medicine is taken directly or diluted with water or other liquid, or mixed with milk or porridge
Shake well before use
CONTRAINDICATIONSS
Hypersensitivity to paracetamol or any ingredient of the drug.
CẢNH BÁO VÀ THẬN TRỌNG KHI DÙNG THUỐC
Paracetamol should be administered with caution under the following circumstances
· Hepatic impairment
· Chronic alcoholism
· Renal impairment (GFR≤50ml/min)
· Gilbert's Syndrome (familial non-haemolytic jaundice)
· Concomitant treatment with medicinal products affecting hepatic function
· Glucose-6-phosphate dehydrogenase deficiency
· Haemolytic anaemia
· Glutathione deficiency
· Dehydration
· Chronic malnutrition
· Patients who are underweight (for adults, those under 50 kg)
· Elderly
In general, medicinal products containing paracetamol should be taken for only a few days without the advice of a physician or dentist and not at high doses.
If high fever or signs of secondary infection occur or if symptoms persist for longer than 3 days, a physician should be consulted.
Prolonged or frequent use is discouraged. Patients should be advised not to take other paracetamol containing products concurrently. Taking multiple daily doses in one administration can severely damage the liver; in such case medical assistance should be sought immediately.
Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported very rarely in patients receiving paracetamol. Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Excipient warning
This medicine contains sucrose. Patients with hereditary fructose intolerance, glucose or galactose malabsorption or sucrase-isomaltase deficiency should not take this medicine. This medicine contains 0.4 g/ ml, which should be taken into account when treating diabetic patients.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-217).
This medication may cause allergic reactions because it contains azorubine (carmosine) (E-122). It may cause asthma, especially in patients allergic to acetylsalicylic acid
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest possible dose, for the shortest possible time at the lowest possible frequency.
When given to the mother in labelled doses, paracetamol crosses the placenta into the foetal circulation as early as 30 minutes after ingestion and is effectively metabolised by foetal sulphate conjugation.
Breastfeeding
Paracetamol is excreted in breast milk in low concentrations (0.1% to 1.85% of the ingested maternal dose). Maternal ingestion of paracetamol at the recommended dose is not considered to present a risk to the nursing infant.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Drug has no or negligible influence on the ability to drive and use machines.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS
Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual’s ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.
The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks factors
UNDESIRABLE EFFECTS
As with all medicines containing paracetamol, adverse reactions due to paracetamol are rare or very rare.
The most commonly reported unwanted effects during paracetamol use are: hepatotoxicity, nephrotoxicity, changes in blood formula, hypoglycemia and allergic dermatitis.
The conventional frequency is: Rare (>1/10,000 to
<1/1,000); very rare (><1/10,000).>
Adverse reactions are listed in order of decreasing severity within each frequency range:
General disorders and local conditions
Rare: Discomfort.
Immune system disorders
Very rare: Hypersensitivity reactions ranging from skin rash or hives to anaphylactic shock.
Hepatobiliary disorders
Rare: Increased liver transaminase levels
Very rare: Hepatotoxicity (jaundice).
Metabolic and nutritional disorders
Very rare: Hypoglycemia.
Blood and lymphatic system disorders
Very rare: Thrombocytopenia, agranulocytosis, leukopenia, neutropenia, hemolytic anemia.
Vascular disorders
Rare: Hypotension.
Skin and subcutaneous tissue disorders:
Very rare: Serious skin reactions have been reported.
Renal and urinary disorders
Very rare: Aseptic pyuria (cloudy urine), renal side effects (see Warnings and Precautions).
OVERDOSE
Symptoms and signs
Hepatic necrosis is a dose-related complication of paracetamol overdose. In adults and adolescents (> 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. ><12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity.
Early symptoms following a potentially hepatotoxic overdose may include: anorexia, nausea, vomiting, diaphoresis, pallor and general malaise.
If a paracetamol extended release product is involved, it may be appropriate to obtain an additional plasma paracetamol level 4-6 hours following the initial paracetamol level.
Serious toxicity or fatalities have been extremely infrequent following an acute paracetamol overdose in young children, possibly because of differences in the way they metabolize paracetamol.
The following are clinical events associated with paracetamol overdose that if seen with overdose are considered expected, including fatal events due to fulminant hepatic failure or its sequelae.
Adverse Drug Reactions Identified with Overdose of Paracetamol
Metabolism and Nutrition Disorders:
Anorexia
Gastrointestinal Disorders:
Vomiting, Nausea, Abdominal discomfort
Hepatobiliary Disorders:
Hepatic necrosis, Acute (fulminant) hepatic failure, Jaundice, Hepatomegaly, Liver tenderness General Disorders and Administration Site Conditions:
Pallor, Hyperhidrosis, Malaise
Investigations:
Blood bilirubin increased, Hepatic enzymes increased, International normalised ratio increased, Prothrombin time prolonged, Blood phosphate increased, Blood lactate increased
The following clinical events are sequelae to acute hepatic failure and may be fatal. If these events occur in the setting of acute hepatic failure associated with paracetamol overdose (adults and adolescents: ≥12 years of age: >7.5 g within 8 hours; children <12 years of age: >150 mg/kg within 8 hours), they are considered expected.
Expected Sequelae to Acute Hepatic Failure Associated with Paracetamol Overdose
Infections and Infestations:
Sepsis, Fungal infection, Bacterial infection
Blood and Lymphatic System Disorders:
Disseminated intravascular coagulation, Coagulopathy, Thrombocytopenia
Metabolism and Nutrition Disorders:
Hypoglycaemia, Hypophosphatemia, Metabolic Acidosis, Lactic Acidosis
Nervous System Disorders:
Coma (with massive paracetamol overdose or multiple drug overdose), Encephalopathy, Brain oedema
Cardiac Disorders:
Cardiomyopathy, Cardiac arrhythmias
Vascular Disorders:
Hypotension
Respiratory, Thoracic and Mediastinal Disorders:
Respiratory failure
Gastrointestinal Disorders:
Pancreatitis, Gastrointestinal haemorrhage
Renal and Urinary Disorders:
Acute renal failure with acute tubular necrosis
General Disorders and Administration Site Conditions:
Multi-organ failure.
Treatment
To protect the patient against delayed hepatotoxicity, paracetamol overdosage should be treated promptly by gastric lavage followed by intravenous N-acetylcysteine or oral methionine. Additional therapy (further methionine or intravenous cysteamine or intravenous N-acetylcysteine) is normally considered in the light of blood paracetamol content and the time elapsed since ingestion. Fulminant hepatic failure which may follow paracetamol overdosage requires specialised management.
In paracetamol overdosage with liver cell damage, paracetamol half-life is often prolonged from around 2 hours in normal adults to 4 hours or longer.
However liver cell damage has been found in patients with a paracetamol half life less than 4 hours. Diminution of 14CO2 excretion after 14C-aminopyrine has been reported to correlate better with liver cell damage in paracetamol overdosage than do either plasma paracetamol concentration or half-life, or conventional liver function test measurements.
PHARMACODYNAMIC PROPERTIES
Pharmacological group:Other analgesics and antipyretics
ATC Code: N02BE01
Paracetamol is a centrally acting, non-opiate, non-salicylate analgesic. Paracetamol is a clinically proven analgesic/antipyretic, and it is thought to produce analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating centre. Single-dose studies (12.5 mg/kg) of paracetamol in febrile children showed an onset of fever reduction within 15 to 30 minutes.
Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.
PACKING
Box of 20 sachets x 5 ml with instruction for use
Box of 1 bottle 60 ml with instruction for use
STORAGE
Dry place, away from light, temperature not exceeding 30°C.
SHELF LIFE
36 months from date of manufacture
SPECIFICATIONS: In-house
NAME, ADDRESS OF DRUG MANUFACTURE
EURO SANTÉ PHARMACEUTICAL JOINT STOCK COMPANY
Song Cung Industrial Site, Dong Thap Commune, Dan Phuong District, Hanoi City, Vietnam
