Efferalgan bullets 150mg upsa sas analgesic, fever reduction (2 blisters x 5 tablets)

Dosage form Bullet
Specifications Box of 2 blisters x 5 tablets
Ingredient Acetaminophen

Ingredient

Composition information	Content
Acetaminophen	150mg

Uses

Indications

Efferalgan 150mg ordered for use in case of mild to medium analgesic and fever for children weighing from 10 - 15 kg.

Pharmacokinus

paracetamol is an analgesic and antipyretic with mild anti -inflammatory activity. Unlike traditional nonsteroidal anti -inflammatory drugs (NSAID), paracetamol does not inhibit platelet function at the dose of treatment.

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.

Dynamic pharmacokinetics

absorption: The absorption of paracetamol in the rectum is slower than oral. Peak concentration in plasma is reached about 2-4 hours after rectal use.

Distribution: Paracetamol is quickly distributed into most tissues. In adults, the distribution of Paracetamol's distribution is about 1-2 l/kg and in children between 0.7 - 1.0 l/kg. Paracetamol does not strongly connect with blood protein.

Metabolism:

Paracetamol is metabolized mainly in the liver in two main paths: in conjunction 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 glucoronide process appears only when the dose is higher, toxic to the liver. A small part (less than 4%) is metabolized by Cytochrom P450 to form a high reactive mediator (N-acetyl Benzoquinoneimin), under normal usage conditions, this intermediate will be detoxified by glutathion reduction and is reversed in urine after congestion with cystein and mercapturic acid.

However, when poisoning with high doses of paracetamol, the amount of toxic metabolites increases.

Era:

Paracetamol metabolites are mainly reversed in urine.

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

less than 5% are eliminated in constant form.

Selling time in plasma is about 2 hours.

Special patient groups

kidney failure:

When severe renal failure, the slightly slow paracetamol excretion. Gan:

Paracetamol has been studied in patients with liver failure. Some clinical trials have shown the average decline of paracetamol metabolism in patients with chronic liver failure, including alcoholic cirrhosis, as shown by the increase in plasma paracetamol levels and longer waste time. Therefore, be careful when using paracetamol in patients with liver failure.

Elderly people:

The elderly, pharmacokinetic and metabolic subjects of paracetamol change slightly, or unchanged.

Paracetamol pharmacokinetic parameters observed in young children and children are similar to observing in adults, except for the sale time in plasma slightly shorter (about 2 hours) compared to adults. Glucuronid is less than the plan and sulfate complex is significantly more significantly than adults.

Before taking Efferalgan bullets 150mg upsa sas analgesic, fever reduction (2 blisters x 5 tablets)

How to use

Efferalgan 150mg is prepared with rectal bullets.

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

Take off your children's clothes.

Give children more liquid.

Do not leave children in too hot.

If needed, bathing children with warm water, with a temperature lower than 2 ° C compared to the child's body temperature.

Frequency and time to use drugs:

Take the drug to avoid oscillations of pain or fever. In children, it is necessary to have a evenly gap between each drug, both day and night, so it is about 6 hours, or at least 4 hours.

kidney failure:

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

Creatinine clearance drug use distance Use

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

The appropriate age corresponds to the weight presented on the side for reference. To avoid the risk of overdose, check for oral medications at the same time (both prescribed and not prescribed drugs) must not contain paracetamol. Overdose due to unintentional can lead to severe liver damage and death.

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

Daily dose of paracetamol recommends is about 60 mg/kg/day, divided into 4 use, about 15 mg/kg every 6 hours. Because there is a risk of rectal irritation, the treatment with ammunition is shorter as possible, should not exceed 4 times/day and should be replaced as soon as possible by oral.

The form of ammunition is not suitable in the case of diarrhea.

See specific recommendations as the table below:

Weight (kg) appropriate age * 15 24 months to 3 years 150 mg 1

6 hours

600 mg (4 capsules) The use of age is based on local standard development curves.

Hepatic failure: In patients with chronic liver disease or liver disease, it is still active, especially in patients with liver cell impairment, prolonged malnutrition (poorly inferior glutathion reserves), and dehydration, dosage should not exceed 3 g/day. Therefore, Paracetamol should be used carefully in patients with liver failure and contraindicated when there is liver disease that is active, especially for alcohol hepatitis, due to CYP 2E1 induction, which increases the metabolitus of paracetamol toxic liver toxicity.

Older patients: Not related.

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 do

do when overdose? There is also the risk of overdose, especially in liver disease, in prolonged malnourished patients and enzyme -induced drug users. Especially overdose can lead to death in these cases.

Signs and symptoms: nausea, vomiting, anorexia, pale, abdominal pain, migraine and sweat often appear in the first 24 hours.

Overdose (one by more than 7.5 g in adults and 140 mg/kg body weight in children) will cause liver cell cancellation, which can cause complete necrosis and non -recovery, leading to liver cell failure, metabolic acidic infection, can lead to coma and death.

At the same time, there is an increase in liver transaminase, lactat dehydrogenase and bilirubin along with a decrease in prothrombin levels that can occur from 12 to 48 hours after taking the drug. The clinical symptoms of liver damage are usually pronounced at first after 1 to 2 days, and reach a maximum after 3-4 days.

Management:

Take it immediately to the hospital.

Take a blood tube as soon as possible to initially quantify the paracetamol concentration in plasma but not earlier 4 hours after taking paracetamol.

Quickly eliminate the amount of medicine used by gastrology.

The common treatment for paracetamol overdose includes an antidote as soon as possible, n-acetylcystein (oral or intravenous), if possible, before the 10th hour after overdose.

Symptomatic treatment.

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

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

Unwanted effects when using the Efferalgan 150mg that you may encounter.

Common, ADR> 1/100

No report.

rarely, 1/1000

No report.

There is no frequency

Blood and lymphatic system: reduced platelet amount.

Digestive: abdominal pain, diarrhea.

Liver: Hepatic failure, liver necrosis, hepatitis.

Immune: Anaphylactic reaction, hypersensitivity, eagles.

Clinical: Increase liver enzyme.

Skin and subcutaneous tissue: Red rash, itching, rash, urticaria, foreign-body syndrome, acute pustules, poisoned skin necrosis syndrome, Stevens-Johnson syndrome.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

contraindicated

Efferalgan 150mg contraindicated in the following cases:

allergies to paracetamol or with propacetamol hydrochloride (the precursor of paracetamol) or the ingredients of the drug.

Severe liver disease.

new anal inflammation, or rectal, or rectal bleeding.

Caution when using

To avoid the risk of overdose, choose other drugs (including prescription and non -prescribing drugs) without paracetamol.

Maximum recommendations:

For children weighing 10 - 15 kg, the total dose of paracetamol must not exceed 60 mg/kg per day.

Using bullets is at risk of local irritation, frequency and intensity increase over time, time of placement and dose.

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 usually observed after 3-4 days. Need to use antidote as soon as possible.

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

Use paracetamol carefully in the following cases:

Liver cell failure, including gilbert syndrome (hyperburin with family blood).

The glucose-6-phosphate-shotphat-dehydrogenase (G6PD) (G6PD) (can lead to hemolytic anemia).

Precautions: Bullets are not suitable in the case of diarrhea.

The ability to drive and operate machinery

The doctor may depend on the specific case that recommends whether or not recommend that patients take the drug when driving and operating machinery.

pregnancy

does not apply.

The period of breastfeeding

does not apply.

Drug interaction

Efferalgan's effect on other drugs:

Anticoagulant oral medication: Concomitant Paracetamol with coumarin including warfarin may change the Inr value slightly. In this case, it is necessary to strengthen the monitoring of the Inr value during the combination of use as well as within 1 week after stopping treatment with paracetamol.

Interaction with laboratory tests: using paracetamol can interact with blood uric acid tests by phosphotungstic acid method and with glucose-oxide-oxide-berroxidase test.

Effect of other drugs on Efferalgan:

Phenytoin: When used simultaneously, it can lead to reduced paracetamol effectiveness and increases the risk of toxicity to the liver. Patients who are being treated with phenytoin should avoid large and/or prolonged paracetamols. Patients need to be able to monitor the toxic signs of the liver.

Probenecid: can reduce nearly twice in paracetamol's clearance by inhibiting its combination with glucuronic acid. Should consider reducing the dose of paracetamoi when used simultaneously with probenecid.

salicylamid: can extend the waste time (1/4) of paracetamol.

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

Storage

Storage below 30 ° C.

Other drugs

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