Paracetamol 500mg Armepharco tablets treat pain and fever (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Acetaminophen

Ingredient

Composition information	Content
Acetaminophen	500mg

Uses

indications

Paracetamol 500mg Armepharco is indicated for use in cases of treatment of pain and fever from mild to medium:

Paracetamol is used temporarily in the treatment of mild and medium pain. The most effective drug is to relieve pain in low pain without organs.

Paracetamol is often used to reduce body temperature in patients with fever due to causes but do not reduce body temperature in normal people.

Do not use this drug for children under 10 years of age due to the inappropriate preparation content.

Pharmacokinus

paracetamol (acetaminophen or n-acetyi-p-amnophenol) is an active metabolic substance of phenacetin, an effective analgesic-antipyretic drug that can replace aspirin; However, unlike aspirin , paracetamol has no effect on inflammation treatment. With equal dose in grams, paracetamol has analgesic and antipyretic effects similar to Aspirin.

paracetamol reduces the body temperature, but rarely reduces the body temperature in normal people. The drug acts on the hypothalamus causing cooling, increasing heat due to vasodilation and increasing peripheral blood flow.

With treatment dose, paracetamol has little impact on the cardiovascular and respiratory system, does not change acid -base balance, does not cause ulcer irritation or stomach bleeding as when using Sallcylate. The effect of paracetamol on cycooxygenase activity is not fully known.

With a dose of 1 g/day, paracetamol is a weak cyclooxygenase inhibitor. The inhibitory effect of paracetamol on cyclooxygenase -1 is weak. Paracetamol is often chosen as an analgesic and antipyretic, especially in the elderly and in people with contraindicated use of salicylate or other NSAIDs, such as people with asthma, a history of peptic ulcer and children.

Paracetamol does not work on platelets or bleeding time.

Pharmacokinetics

absorption

Paracetamol is quickly absorbed and almost completely through the gastrointestinal tract. Carbohydrate -rich foods reduce the absorption rate of paracetamol.

Distribution

After drinking with treatment dose, peak plasma concentration reaches 30 to 60 minutes.

Paracetamol is distributed quickly and evenly in most body tissues. About 25% Paracetamol in the blood combined with plasma protein.

Metabolism

paracetamol is n -hydroxylation of cytochrom P -450 to create N - Acetyl - Benzoquinonimin (NAPQ), an intermediate reactive intermediate. This metabolic substance normally reacts with sulfhydryl groups in glutathion and is dimidated. However, if taking high doses of paracetamol, this passing substance is formed in sufficient amount to exhaust the glutathion of the liver; In that situation, NAPQ is not connected with glutathion toxic to liver cells, leading to inflammation and can lead to liver destruction.

Elimination

The half -life of paracetamol plasma is 1.25 - 3 hours, which can last for toxic doses or in patients with liver damage.

After the treatment dose, 90-100%of the urine can be found on the first day, mainly after the liver with glucuronic acid (about 60%), Add sulfuric (about 35%) or cysteine (about 3%); It also detects a small amount of hydroxyl metabolites - chemical and reducing acetyl. Children are less likely to glucuro than drugs than adults.

Before taking Paracetamol 500mg Armepharco tablets treat pain and fever (10 blisters x 10 tablets)

How to use

Paracetamol is often used by oral. Do not use paracetamol for children and children to treat high fever on their own (above 39.5 ° C), fever lasts for more than 3 days, or recurrent fever, unless it is instructed by a physician, because such a fever may be a sign of a serious illness that needs to be diagnosed quickly by a physician.

Dosage

People: 0.5 - 1 grams/time, 4 - 6 hours, maximum 4 grams/day.

Children 10 years and older: 0.5 grams/time, can repeat after 4-6 hours if needed, up to 4 doses/24 hours.

Patients with kidney failure: In case of severe renal failure (creatinine clearing coefficient below 10ml/minute); The minimum distance between 2 drinks is 8 hours.

Patients with hepatic impairment: use caution, use low doses. Avoid using scissors.

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

Paracetamol overdose can lead to severe liver damage and sometimes acute renal necrosis.

Paracetamol poisoning may be due to a single -dose, or due to a large dose of paracetamol (eg for 7.5 -10 g per day, for 1-2 days) or for long -term medication. Liver necrosis depends on the dose is the most serious toxic effect due to overdose and can be fatal.

Nausea, vomiting and abdominal pain usually occur within 2-3 hours after taking the poison of the drug. Blood methemoglobin leads to purple blue, mucosal and nails are a characteristic sign of acute poisoning P-aminophenol; A small amount of sulhemoglobin can also be produced. Children tend to create methemoglobin easier than people after taking paracetamol.

When severe poisoning, it is initially stimulated from the central nervous system, agitated, and delirium. Next can be inhibiting the central nervous system: dumbfounded, lower body temperature, tired, fast breathing, shallow; Fast, weak, irregular, low blood pressure and circulatory failure. Vascular collapse due to relative hypoxia and central inhibition effects, this effect only occurs with very doses. Shock may occur if a lot of vasodilation. The suffocating convulsions may occur. Often coma occurs before dying suddenly or after a few days of coma.

Clinical signs of liver damage becomes clearly in 2-4 days after taking toxic doses. Aminotransferase plasma increases (sometimes very high) and the concentration of bilirubin in plasma can also increase; In addition, when the liver lesions spread, the prothrombin time will last.

may be 10% of patients with untreated poisoning that have serious liver damage; Among them 10 - 20% finally died from liver failure. Acute renal failure can also occur in some patients. The liver biopsy detects the central necrosis of the lobe except the area around the door vein. In people who do not die, liver lesions recover after weeks or months.

Treatment

Early diagnosis is important in the paracetamol overdose. There are methods to quickly determine the concentration of drugs in plasma. However, do not postpone treatment while waiting for the test results if the history is suggested to overdose.

When severe poisoning, it is important to treat positive support.

Need to wash the stomach in any case, preferably within 4 hours after drinking.

The main detoxification is sulhydryl compounds, perhaps partly due to the addition of glutathion reserves in the liver. N-acetylcystein works when taken or intravenously. It must be used immediately, as soon as possible if less than 36 hours after taking paracetamol. Treatment with n-acetylcysteine is more effective when giving medication for less than 10 hours after taking paracetamol. When drinking, dilute N-acetylcystein solution with water or drink without alcohol to achieve a 5: 5 solution and must be taken within 1 hour after mixing.

Give N-acetylcystein oral at the first dose of 140mg/kg, then give 17 more doses, each dose 70mg/kg 4 hours apart. Termination of treatment if the paracetamol test in plasma shows a low risk of liver toxicity. N-acetylcysteine can also be used by intravenous line: The initial dose is 150mg/kg, mixed in 200ml of 5%glucose, intravenous injection for 15 minutes; Then intravenously 50mg/kg in 500ml glucose 5% in 4 hours, followed by 100mg/kg in 1 liter of solution within the next 16 hours.

If there is no 5% glucose solution, 0.9% sodium chloride solution may be used. N-acetylcystein's ADR includes skin rash (including urticaria, no need to stop the drug), nausea, vomiting, diarrhea, and anaphylactic reaction. Without n-acetylcysteine, methionine may be used. If you have used activated carbon before using methionin, you must remove activated carbon from the stomach first. Also can use activated carbon and/or salt bleach because they have the ability to reduce the absorption of paracetamol.

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. Do not drink twice as prescribed.

Side Effects

When using Paracetamol 500mg Armepharco, you may experience unwanted effects (ADR).

Common, ADR> 1/100

No information.

Uncommon, 1/1000

DA: DA

Stomach-intestine: Nausea, vomiting.

Hematology: Hemorrhagic disorders (neutropenia, all bloody, leukopenia), Anemia .

Kidney: Kidney disease, kidney toxicity when abusing for a long time.

Rare, ADR

Skin: Steven syndrome - Johnson, poisoned epidermal necrosis, lyell syndrome, acute foreign body pustules.

Systemic: Hypersensitivity reaction. People who are sensitive to Sallcylat rarely sensitivity to paracetamol and related drugs.

Instructions on how to handle ADR

Notify the doctor with unwanted effects when taking the drug.

Serious skin reactions such as Steven-Johnson syndrome, Lyell syndrome, poisoned epidermal necrotic, acne-based erythema pustules rarely occur, but likely to cause death. If you see a ban or other skin manifestations, you must stop the medicine and examine a physician.

Skin rash and other allergic reactions occur. Usually erythema or urticaria, but sometimes worse and may be accompanied by fever due to drugs and mucosal lesions. If you see a fever, bullies around the natural cavities, you should think of Steven-Johnson's witness immediately.

Warnings

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

Contraindicated

Paracetamol 500mg armepharco contraindicated in the following cases:

Hypersensitivity to paracetamol or any ingredient of the drug.

Patients with glucose deficiency - 6 - phosphate - dehydrogenase.

Severe liver failure.

Be cautious when used

paracetamol is usually non -toxic to the dose of treatment, and when used under the instructions of the physician. However, overdose of paracetamol is the main cause of acute liver failure. Using many preparations containing paracetamol (acetaminophen) and can lead to harmful consequences (such as paracetamol overdose).

Serious skin reaction, likely to cause death including the following syndrome:

Steven-Johnson syndrome (SJS): is a puffiness, puffiness allergy around the 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.

Poisoned skin necrosis syndrome (ten): is the most severe allergic drug, including diverse lesions in the skin (measles rash, thermal gap, rash or puffiness, damage quickly spread throughout the body), eye mucosa (corneal inflammation, pus inflammation, corneal ulcers), gastroentricular mucosa, stomach lesions) Genital, urinary tract. There are also serious systemic symptoms such as fever, gastrointestinal bleeding, pneumonia, glomerulonephritis, hepatitis ... The mortality rate is up to 15-30%.

Syndrome of the cable -body pustules (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, neutral leukemia tests.

When detecting signs of rash on the first skin or any other hypersensitive reactions, patients need to stop using the drug. People who have suffered from serious skin reactions caused by Paracetamol must not use the drug again and when visiting medical examination and treatment should notify health workers on this issue.

Sometimes skin reactions include itching and urticaria; Other sensitive reactions include larynx edema, angioedema, and anaphylactic reactions that may rarely occur. Platelet reduction, leukopenia, and all bloody hematuria have occurred with the use of p-aminophenol derivatives, especially when used for large doses. Neutral leukopenia and thrombocytopenic hemorrhage occur when using paracetamol. Rarely loss of granulocytes in patients using paracetamol.

Be cautious when using paracetamol for people with phenylceton-dermatology, liver failure, kidney failure, alcoholism, chronic malnutrition or dehydration. Avoid high doses, prolonged and intravenous use for people with liver failure.

Must use paracetamol carefully in patients with anemia before, because purple blue may not be clear, although high concentrations at a dangerous level of methemoglobin in the blood.

Drinking plenty of alcohol can cause toxicity to the liver of paracetamol, should avoid or limit drinking alcohol.

The ability to drive and operate machinery

has not seen any documents recorded about the impact of the drug when driving and operating machinery.

pregnancy

has not determined the safety of paracetamol related to unwanted effects that may be available to pregnancy development. Therefore, Paracetamol should only be used in pregnant women when needed.

The period of breastfeeding

Research in breastfeeding women using paracetamol, does not see unwanted effects in breastfed children.

Interactive drug

avoiding too much and long -term alcohol can increase the risk of paracetamol causing the liver.

Anti -convulsions (Phenytoin, Barbiturat, Carbamazepin) may increase the toxic liver toxic of paracetamol.

Isoniazid can lead to an increased risk of toxicity to the liver.

Probenecid may reduce paracetamol elimination and increase the half -life of plasma of paracetamol.

cholestyramin : reduces the absorption of paracetamol.

metoclopramide and domperidone: Increases the absorption of paracetamol.

chloramphenicol : Increases chloramphenicol levels in plasma.

Oral anticoagulants (warfarin, cooumarin ...): increase the effect of these drugs when using prolonged paracetamol, increasing the risk of bleeding.

Storage

Leave a dry place, the temperature does not exceed 30 ° C, avoiding light.

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