Efferalgan effervescent 500mg upsa sas analgesic, reducing fever (4 blisters x 4 tablets)

Dosage form Effervescent tablet
Specifications Box of 4 blisters x 4 tablets
Ingredient Paracetamol

Ingredient

Composition information	Content
Paracetamol	500mg

Uses

Indications

Efferalgan 500mg is indicated for treatment of pain and/or fever such as headache, flu, toothache, muscle aches, dysmenorrhea.

Pharmacokological

paracetamol is an analgesic, antipyretic, anti -inflammatory drug that has a weak anti -inflammatory effect. Unlike traditional nonsteroidal anti -inflammatory drugs (NSAID), paracetamol does not inhibit platelet function at the dose of treatment.

Mechanism of action

The exact mechanism of pain relief and fever effects of paracetamol has not been determined. The mechanism of action can be related to the effects at the central and peripheral.

pharmacokinetic

absorption

Paracetamol absorption when taken will be completely and completely. The peak concentration of plasma is about 10-60 minutes after drinking.

Distribution

paracetamol is quickly distributed into most tissues.

In adults, the distribution of Paracetamol's distribution is about 1-2 liters/kg and in children between 0.7-1.0 liters/kg. Paracetamol is not strongly connected to plasma proteins.

Metabolism

Paracetamol is metabolized mainly in the liver in two main paths in the liver: associated with glucuronic acid and associated with sulfuric acid; Combined with sulfuric acid quickly saturated when taking a higher dose but still within the scope of treatment. The saturation of the glucoronid process appears only when the dose is higher, toxic to the liver.

A small part (less than 4%) is metabolized by Cytochrom P450 forming a high reaction mediator (N-acetyl Benzoquinoneimin), under normal usage conditions, this intermediate will be detoxified with glutathion and eliminated in urine after conjugation with cystein and mercapturic acid. However, when poisoning with high doses of paracetamol, the amount of metabolites has this toxicity increases.

Elimination

Paracetamol metabolites are mainly eliminated in the urine. In adults, about 90%of the dose is excreted for 24 hours, mainly in the form of glucuronid complex (about 60%) and sulfate complex (about 30%).

less than 5% are eliminated in constant form.

Selling time in plasma is about 2 hours.

Special patient groups

kidney failure

When the renal failure is severe, the slightly slow paracetamol excretion. For glucuronid and sulfate combinations, the elimination speed is slower in people with severe renal failure than healthy people. The minimum time between each medication is 6 hours or 8 hours when taking paracetamol for these patients.

Hepatic failure

Paracetamol has been studied in patients with liver failure. In one study, Paracetamol 4G/day for 5 days used for 6 subjects with chronic liver disease stable. Paracetamol levels in plasma are determined between the third dose and the order per day between 4.5 ng/ml to 26.7 mg/ml, much lower than the dose level. There is no significant paracetamol accumulation and no change in the patient's clinical condition or testing. The average selling time is 3.4 hours.

In this study, 20 subjects with chronic chronic liver disease have been randomly selected in a cross -study, two stages. They used paracetamol or placebo 4 g/day for 13 days and then crossed through replacement treatment. An object with increased values of liver function tests (LFTS) but after recovery from that stage, this male patient did not show any abnormalities in the next two tests. This concludes that the increase of liver function tests are not related to the drug and there is no contraindication to the use of paracetamol at the dose of treatment for patients with chronic liver disease.

Some clinical trials have shown the average decline of paracetamol metabolism in patients with chronic liver failure, including alcoholic cirrhosis, as shown by an increase in plasma paracetamol levels and longer selling time.

In these reports, paracetamol's disposal time is associated with reducing the synthesis of the liver. Therefore, it is advisable to use paracetamol in patients with liver failure and contraindicated when there is a liver disease that still works, especially alcoholic hepatitis, due to CYP2E1 induction, leading to an increase in the formation of toxic metabolites for the liver of paracetamol.

Elderly

In the elderly, the pharmacokinetics and metabolism of paracetamol changes slightly, or unchanged. No dose adjustment in this patient group.

infants, children and children

Paracetamol pharmacokinetics parameters observed in young children and children are similar to observing in adults, except for the half -blooding time in plasma (about 2 hours) compared to adults. In infants, the sale time in plasma is longer than in young children (about 3.5 hours).

Before taking Efferalgan effervescent 500mg upsa sas analgesic, reducing fever (4 blisters x 4 tablets)

How to use

Take oral use.

Completely dissolve the pill in a large glass of water and drink.

If a child has a fever of 38.5 ° C, take the following steps to increase the effectiveness of the drug:

Remove children's clothes.

Give children more liquid.

up to 5 days in pain cases.

up to 3 days in fever cases.

If the pain lasts more than 5 days or the fever lasts more than 3 days and if this condition occurs more seriously or there is any other symptoms, do not continue to use the drug without the consent of your doctor or pharmacist.

Dosage

Dosage must be calculated according to the child's weight. The appropriate age corresponds to the weight presented below just for reference. To avoid the risk of overdose, it is necessary to check and confirm the accompanying drugs (including prescription and non -prescribing drugs) without paracetamol. This type of drug is only for adults and children weighing over 17kg (about 5 years or older).

For children

daily paracetamol dose is calculated according to the weight of children and children's age for reference and instructions. If you do not know your weight, you need to weigh the most appropriate dose.

Paracetamol has many different types of dose for appropriate treatment depending on the weight of each child.

The daily dosage of paracetamol depends on the child's weight: about 60mg/kg/day, divided into 4 times or 6 times, equivalent to about 15mg/kg every 6 hours, or 10mg/kg every 4 hours. The maximum daily dose must not exceed 3G.

Do not take the whole pill. Completely dissolve the tablet in a glass of water before drinking.

Weight (kg)

appropriate age*

(year)

Paracetamol/dose The number of Effervescent pills/dose The minimum distance between the drug use (hours) The maximum dose of each day (tablet) 7 250 0.5

(1000mg)

(1500mg)

(2000mg)

(3000mg)

Normally, it is not necessary to exceed 3000mg of paracetamol a day (about 6 tablets a day). However, in the case of a lot of pain and as recommended by the doctor, in the dose of the drug can increase to 4000mg a day (about 8 tablets a day).

However:

The dose higher than 3000mg of paracetamol one day must have a doctor's opinion.

In patients with severe renal failure, the minimum distance between each drug should be adjusted according to the following table:

Creatinine clearance

Medication distance ml/minute

8 hours

In patients with chronic liver disease or liver disease, it is still possible to work, especially in patients with liver cell insufficiency, chronic alcoholism, prolonged malnutrition (poor liver glutathione reserves), and dehydration, dosage should not exceed 3G/day.

Older patients

No dose adjustment requirements in older patients.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Signs and symptoms

may be at risk of poisoning, especially in people with liver disease, chronic alcoholism, prolonged malnourished patients and enzyme users. In particular, overdose can lead to death in these cases.

Symptoms of poisoning usually appear in the first 24 hours, including nausea, vomiting, anorexia, re -skin, uncomfortable and sweating.

Overdose when taking a dose higher than 7.5g of paracetamol in adults, or 140mg/kg body weight in children will cause inflammation and cancel of liver cells, which can cause complete and non -recovery liver necrosis, leading to liver cell failure, metabolic acid infection and brain disease leading to coma and death.

At the same time, there is an increase in liver transaminase levels (AST, ALT), lactate dehydrogenase and bilirubin along with decreased prothrombin levels, which can occur from 12 to 48 hours after taking the drug.

Clinical symptoms of liver damage often become pronounced at first after 2 days, and reach a maximum after 4-6 days.

Management:

Take it immediately to the hospital.

Before starting treatment, taking a blood tube as soon as possible to quantify the concentration of paracetamol in plasma but not earlier 4 hours after taking paracetamol.

Overdose treatment includes antidote, n-acetylcystein (NAC), by taking or intravenously, if possible, within 8 hours after taking the drug. NAC may have a protective level even after 16 hours.

Symptomatic treatment.

Quickly eliminate the amount of medicine used by gastrology.

Must conduct a liver test at the beginning of treatment and repeat every 24 hours. In most cases, the liver transaminase returns to normal after 1-2 weeks with the full recovery of the liver function. In case of being too heavy, liver transplant may need.

What to do when forgetting a dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using the drug, you may experience unwanted effects (ADR).

As well as for all drugs, this drug can cause, in some people, reactions to severe or mild degrees.

The following side effects have been reported in after -sales monitoring but the rate of appearance (frequency) is not known.

liver disorders liver enzyme INR Man)

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Efferalgan medicine 500mg contraindicated in the following cases:

allergies to paracetamol or with propacetamol hydrocloride (paracetamol's precursor) or other ingredients of the drug.

Severe liver disease.

Precautions when using

Read the instructions carefully before use. If you need more information, please consult your doctor.

Warning

must immediately notify the doctor when overdose, or miss too high.

This drug contains paracetamol. Other drugs also contain this active ingredient. Do not use such combination of drugs to avoid exceeding the daily dose appointed (see the dose section).

Paracetamol dose is higher than the recommended dose that causes very serious risk of liver damage. Clinical symptoms of liver damage are usually first recorded after 1 to 2 days of paracetamol overdose. Maximum symptoms of liver damage are often observed after 3-4 days, need to use antidote as soon as possible.

Use paracetamol carefully in the following cases:

Hepatic cell failure. Eat, incorrect or worn, prolonged malnutrition (ie inferior to glutathione reserves in the liver).

Doctors need to warn the patient about signs of serious skin reactions such as Stevens-Johnson syndrome (SJS), toxic skin necrosis syndrome (Ten) or Lyell syndrome, acute pustules syndrome (AGEP).

Be cautious when using

If symptoms of pain persist for more than 5 days or a fever for more than 3 days, or the drug is not effective enough, or seeing other symptoms, no treatment without treatment without consulting your doctor.

In case of a diet of salt or light (reducing salt), remember that each pill contains 412.4mg of Na to calculate the daily diet.

Do not use this drug in non -tolerated patients with fructose (a rare disease).

Note:

Serious side effects on the skin, although the incidence is not high but serious, even life -threatening including Steven -Johnson syndrome (SJS), Poisoned Skin necrotic syndrome: Toxic Epidermal Necrolysis (Ten) or Lyell syndrome, Surgery syndrome - Acute body pustular syndrome: Acute Generized Exanthematousisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisisish (AGEP).

Symptoms of the above -mentioned syndrome are described as follows:

Steven-Johnson syndrome (SJS): is a puffiness, puffiness allergy, localized puffiness around natural cavities: eyes, nose, mouth, ears, genitals and anus. In addition, it may be accompanied by high fever, pneumonia, liver dysfunction. Diagnosis of Steven - Johnson syndrome (SJS) when at least two natural cavities are damaged.

Symptoms of toxic skin necrosis (ten): is the most severe allergic, including:

Diverse lesions in the skin: measles, pink, pink or puffiness, damage quickly spread throughout the body.

Eye mucosa lesions: corneal inflammation, blind conjunctivitis, corneal ulcer.

Damage to the gastrointestinal tract: stomatitis, mouth mucosa, pharyngeal ulcer, esophagus throat, stomach, intestines;

Damage to the mucosa of genital tract, urinary tract.

There are also serious systemic symptoms such as fever, gastrointestinal bleeding, pneumonia, glomerulonephritis, hepatitis ... high mortality rate 15 - 30%.

Excellent pustules syndrome (AGEP): Small sterile pustules arise on the spreading background. Damage often appears in folds such as armpits, groin and face, then can spread the whole body. Systemic symptoms are often fever, high neutrophilic blood test.

When detecting signs of rash on the first skin or any other hypersensitive reactions, patients need to stop using the drug. Those who have suffered from serious skin reactions caused by paracetamol must not be used again and when visiting medical examination and treatment, they need to notify medical staff on this issue.

The ability to drive and operate machinery

has no effect of the drug on the ability to drive and operate machines.

Pregnancy

Epidemic data from the use of Paracetamol treatment dose by oral, showing no unwanted effect on pregnant women or on embryo or infant health.

Studies on reproductive function with oral paracetamol have not shown any deformities or toxicity to the embryo. Later data on pregnant women overdose Paracetamol shows no increased risk of deformities.

However, Efferalgan should only be used for pregnant women after being carefully evaluated between treatment benefits and risks. In pregnant patients, recommended doses and drug use time must be closely monitored.

Breastfeeding period

After drinking, a small amount of paracetamol is secreted into breast milk. There have been reports on the rash in breastfeeding. Although Paracetamol is considered to be suitable for nursing women, it is necessary to be cautious when using Efferalgan for women during breastfeeding.

If the doctor prescribes the measurement of uric acid or blood sugar levels, you need to report that you are taking this medication.

Drug interaction

Efferalgan may increase the likelihood of unwanted effects when used with other drugs.

anticoagulants

Simultaneous use of paracetamol with cooumarin including warfarin may slightly change the INR. In this case, it is necessary to strengthen the monitoring of the INR index during the combination as well as within 1 week after stopping treatment with Paracetamol.

Effect of other drugs on Efferalgan

Concentrated use with phenytoin can lead to reduced paracetamol effectiveness and increase the risk of toxicity to the liver. Patients who are undergoing phenytoirin should avoid large doses of paracetamol and/or prolonged. Need to monitor patients on signs of toxicity for the liver.

Probenecid may reduce nearly twice in paracetamol's clearance by inhibiting its conjugate with glucuronic acid. Paracetamol dose should be considered when used simultaneously with probenecid. Salicylamide can extend the disposal time (t ½) of paracetamol.

Enzyme induction substances: Be careful when using paracetamol with enzyme induction substances. These substances include but unlimited barbiturate, isoniazid, carbamazepine, rifampin and ethanol.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children.

Other drugs

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