Hapacol 650 dhg effervescent tablets treat painful to medium intensity and fever (4 blisters x 4 tablets)

Paracetamol is a painkiller that also has antipyretic properties.

Paracetamol's exact mechanism of operation is not well known, although it is known that Paracetamol is operating at the level of the central nervous system and at a lower level, by preventing the creation of painful pulses at the peripheral level.

paracetamol is thought to increase pain threshold by inhibiting prostaglandin synthesis, by blocking cyclooxygenase in the central nervous system (specifically COX-3). However, Paracetamol does not significantly inhibit cyclooxygenase in peripherals.

Paracetamol stimulates the operation of serotonergic roads, preventing the transmission of sensitive signals to the spinal cord from peripherals. In this sense, some experimental data indicates that the use of antagonists of different Serotonergic receptors groups used in the spinal cord capable of losing the anti -cancer effect of paracetamol.

Antipator of fever related to PGE1 synthesis in the hypothalamus, physiological coordination organs of the thermal process.

Dynamic pharmacokinetics

When drinking, the bioavailability of paracetamol is 75 - 85%.

Paracetamol's absorption is fast and complete. The maximum concentration in plasma is achieved depending on the form of pharmaceutical products from 0.5 to 2 hours. The level of bonding with plasma protein is 10%.

time to promote the maximum effect is 1-3 hours, and the effect time is 3-4 hours. The metabolism of paracetamol undergoes the first impact in the liver, according to linear dynamics. However, this linear calculation disappears when the dose is greater than 2 g. Paracetamol is basically metabolized in the liver (90 - 95%), excreted mainly through urine in the form of a complex with glucuronic acid, and at a lower level with sulfuric and cysteine ​​acid; Under 5% is excreted in a constant form. The sale time of the drug is 1.5 - 3 hours (increasing when overdose and in patients with liver failure, the elderly and children). High doses can saturated the usual mechanisms of metabolism in the liver, resulting in the use of alternative metabolic paths that generate toxic metabolites to the liver and can be toxic to the kidneys due to glutathion exhaustion.

Special subjects

Renal failure: In case of severe renal failure (creatinine clearance below 10 ml/ min), the elimination of paracetamol and metabolites slows down.

Elderly: The ability to combine is not changed. Observed the increase in the sale time of paracetamol.

Patients with liver failure

In the case of liver failure, paracetamol does not use more than 2 g/24 hours and the minimum distance between the dose is 8 hours.

or as directed by the physician.

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? If overdose, patients need to be treated quickly at the medical center even if there are no significant symptoms or signs because although these substances may be fatal, they often do not manifest immediately after drinking but after the third day. Death may occur due to liver necrosis. Similarly, acute renal failure may appear.

Paracetamol overdose is evaluated in four stages, starting from the time of overdose:

1. Stage I (12 - 24 hours): Nausea, vomiting, sweating and anorexia. AST, ALT, Bilirubin and prothrombin concentrations begin to increase. The value of 20,000 can appear for AST.
2. Phase IV (7 - 8 days): Recovery. The minimum toxic dose, in a single dose, is more than 6 g in adults and more than 100 mg/kg of weight in children.

   The dose greater than 20 - 25 g is likely to cause death. Symptoms of liver poisoning include nausea, vomiting, anorexia, discomfort, sweating, abdominal pain and diarrhea. If the oral dosage is greater than 150 mg/kg or cannot determine the amount of oral, the serum paracetamol should be taken for 4 hours after drinking. In the case of liver toxicity, conducting liver function research and repeating this study is 24 hours apart. Hepatic failure can lead to brainstorming, coma and death.

   Paracetamol concentration in plasma is greater than 300 kg/ml, found 4 hours after drinking, related to liver damage in 90% of patients. This begins when the plasma paracetamol concentration at 4 hours is greater than 120 kg/ml or greater than 30 µg/ml at 12 hours after drinking.

   Take lasts at a dose of more than 4 g/day can lead to transient liver poisoning. The kidneys may have kidney necrosis, and the heart muscle may be injured.

   How to handle

   In all cases, gastric suction and lavage will be done, preferably within 4 hours after drinking.

   There is a specific antidote for paracetamol toxicity: N-acetylcysteine ​​can be injured or taken.

   Intravenous injection: 300 mg/kg N-acetylcystein should be used (equivalent to 1.5 ml/kg of 20%water solution; pH: 6.5), intravenous injection for 20 hours 15 minutes, according to the following diagram:

   Adults

   attack dose: 150 mg/kg (equivalent to 0.75 ml/kg of 20% N-acetylcystein water solution; pH 6.5) slow intravenous or diluted in 200 ml of 5% dextrose, for 15 minutes.

   Maintenance dose

   A) Initially: 50 mg/kg (equivalent to 0.25 ml/kg of 20% N-acetylcystein water solution; pH: 6.5) will be used in 500 ml of 5% dextrose in slow transmission for 4 hours.

   b) Then: 100 mg/kg (equivalent to 0.50 ml/kg of 20% N-acetylcysteine ​​water solution; pH: 6.5) will be transmitted in 1000 ml of 5% dextrose in slow transmission for 16 hours.

   Children

   The volume of 5% dextrose infusion must be adjusted based on the age and weight of children, to avoid pulmonary blood vessels.

   The effect of antidote is maximum if used within 4 hours after poisoning. The effectiveness gradually decreases after the eighth hour and ineffective after 15 hours of poisoning.

   The transmission of N-acetylcysteine ​​water solutions may be interrupted when blood test results show that the concentration of paracetamol in the blood is below 200 kg/ml.

   Side effects when using n-acetylcystein through intravenously rarely see the rash on the skin and anaphylaxis, usually within 15 minutes to 1 hour from the beginning of the transmission.

   Oral: N-acetylcysteine ​​antidote must be used within 10 hours after overdose.

   Adults

   Detoxifying dose recommended for adults is:

3. The initial dose is 140 mg/kg of body weight.
4. 17 dose 70 mg/kg body weight, every 4 hours. If vomiting within an hour after use, the dose should be repeated.

   If needed, detoxification (diluted in water) can be used by placing the colonial intubation.

   In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.

   What to do when you forget 1 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 doses to compensate for missed dose.

Notify the physician with unwanted effects when using the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Be cautious when using paracetamol, avoid long -term treatment in anemia, heart or lung disease, or severe liver and kidney dysfunction (in this case, the use of this drug is unacceptable, but long -term high doses may increase the risk of side effects affecting the kidneys).

The use of paracetamol in patients with alcohol drinks (from three or more alcoholic drinks per day) can cause liver damage.

In chronic alcoholics, do not use more than 2 g of paracetamol/day.

Caution is recommended in patients with acetylsalicylic acid asthma, because of a mild bronchospasm with paracetamol (cross -reaction) described in these patients, although only in a few patients, paracetamol can cause serious reactions in some cases, especially when using high doses.

Simultaneous use of more than one drug containing paracetamol can lead to poisoning.

Paracetamol -related toxic symptoms may be due to one overdose or due to many times with high doses of paracetamol.

There have been reports on cases of liver poisoning with daily dose below 4 g.

If the pain lasts more than 5 days or fever more than 3 days, or other symptoms that occur or worsen, it is necessary to re -evaluate the clinical condition.

Interventions with analytical tests

Paracetamol may change the analysis values ​​to identify uric acid and glucose.

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

related to excipients

This drug contains 19 mg of aspartam in each tablet. Aspartam is a source of phenylalanin, so it should not be used for patients with phenylketon urine, a rare genetic disorder, of which phenylalanin accumulates because the body cannot be removed properly.

Lactose anhydrous: Do not use in patients with galactose tolerance, lactase deficiency or glucose-Galactose absorption disorders.

This drug contains 55 mg of sodium benzoate in 1 tablet.

This drug contains 258.88 mg of sodium in each tablet, equivalent to 12.94 % of the maximum daily sodium recommended for adults to be 2 g.

The effect of the drug on the ability to drive and operate machinery

Paracetamol does not have or negatively affect the ability to drive and use machines and no effect is recorded.

Use drugs for women during pregnancy and lactation

Pregnant women

A large amount of data in pregnant women shows no second toxicity/newborn or birth defects. Epidemiological studies on children's neurological development in contact with paracetamol in the uterus shows that the results are not convincing. If clinically necessary, paracetamol may be used during pregnancy, but the lowest dose should be effective in the shortest possible and as often as possible.

breastfeeding women

Despite the maximum concentration of 10 to 15 kg/ml (66.2 to 99.3 umol/I), which was measured in breast milk for 1 to 2 hours after the mother took a single dose of 650 mg, paracetamol and non -metabolic substances were not detected in newborn urine. The sale time in breast milk is 1.35 to 3.5 hours. There is no report on side effects in children. Paracetamol can be used for breastfeeding women if not exceeded the recommended dose. Be cautious in case of long -term use.

Drug interaction

paracetamol is metabolized in the liver, causing the generation of toxic metabolites to the liver, so paracetamol can interact with drugs used in the same metabolic path. These drugs are: