Instructions for use PARACETAMOL

Composition and release form

The medicine is available in the form of an oral solution. It can be flavored with vanilla, orange, cherry and strawberry. This hides the unpleasant taste of the medicine, making it easier for young children to treat. The solution has a yellowish tint. It is transparent, homogeneous, without suspended substances and sediment. The volume of the solution is 1 ml. The content of the active substance is 24 mg. The solution is poured into bottles. The kit includes a spoon for dosing the medicine.

Auxiliary components of the drug are:

• lemon acid;
• propylene glycol;
• vitamin B2 (riboflavin);
• sodium saccharinate;
• purified water;
• sodium citrate;
• sorbitol;
• sodium benzoate;
• flavoring

Compatibility

Using paracetamol alone for severe joint pain will not help. In such cases, it is recommended to combine this drug with tablets of the NSAID group, these include:

1. Diclofenac. This medicine is a universal drug that has a powerful analgesic and anti-inflammatory effect. It is used to eliminate pain of varying localization and severity. It is available in various forms - tablets, injection solution, ointments, aerosols and suppositories.
2. Ketoprofen. A non-steroidal drug with a powerful analgesic effect. In addition, Ketoprofen effectively relieves inflammation and swelling that forms during the development of knee disease. It is produced in the form of a gel, which is used externally.
3. Indometacid. These tablets have the most powerful anti-inflammatory effect. However, it is rarely used for the treatment of arthritis and arthrosis, since it has side effects on the digestive organs.
4. Movalis. This selective remedy perfectly eliminates pain and inflammation of moderate severity. It can be used over a long period of time, since Movalis has a selective effect on pain centers.
5. Piroxicam. This substance is used to treat pain syndromes in degenerative processes. Piroxicam is available in the form of suppositories and tablets. The drug is not selective and has a negative effect on the digestive tract, so it is used quite rarely for arthrosis of the knee joint.

pharmachologic effect

Paracetamol is an analgesic-antipyretic. This means that it reduces pain and reduces fever. The drug also has a weak anti-inflammatory effect. The active substance (paracetamol) suppresses the release of prostaglandins (they are responsible for the development of inflammation) and affects the thermoregulation center, which is located in the medulla oblongata.

Paracetamol is absorbed quickly. Distribution occurs in liquid media (blood, plasma, intercellular and cerebrospinal fluids). Metabolization (conversion of the drug) occurs in the liver. The half-life is 1-3 hours.

Pharmacokinetics

After intravenous administration, after a quarter of an hour, the highest concentration of the drug appears in the blood (30 mcg/ml), then it begins to decrease due to metabolism in the liver and excretion of breakdown products (glucuronides and sulfates) by the kidneys. This process in a healthy body ends within a day; for people with severe kidney problems, it takes three times longer. With massive intoxication, it is possible to form a large amount of a product from the paracetamol conversion chain - hepatotoxic N-acetylbenzoquinone imine, the danger of which is usually eliminated by mercaptopurine and cysteine. Half of the paracetamol that enters the adult body is eliminated after almost 3 hours; in children this period is somewhat shorter - up to 2 hours, and the excretion rate is about 18 liters per hour.

Directions for use and doses

When prescribing medication, the attending physician takes into account:

• indications;
• contraindications;
• individual tolerance;
• patient's age;
• body weight;
• interaction with other medications;
• physiological condition of the patient (presence of concomitant diseases, pregnancy, condition of the kidneys and liver);
• allergy history.

The dosage is determined individually. For adolescents and adults weighing more than 60 kg, a single dosage of Paracetamol is 500 mg. The medicine is taken orally up to 4 times a day. Intramuscular injections are not given. Paracetamol is not administered intravenously. The maximum single dose should not exceed 1000 mg (1 g), and the daily dose should not exceed 4000 mg (4 g).

For children under 12 years of age, dosage depends on age. Patients aged 6 to 12 years are prescribed 250-500 mg of Paracetamol at a time. When treating children from 1 to 5 years old, the medicine is used in a single dosage of 150-250 mg, from 3 to 12 months 60-100 mg is prescribed, and for children under 3 months the single dosage is 10 mg/kg body weight. The interval between taking the solution should be at least 4 hours. The maximum duration of therapy for adults is a week, and for children - 3 days.

Indications and contraindications for use

Indications for the use of Paracetamol in solution form are:

• mild or moderate headache of various etiologies (against the background of colds and acute respiratory viral diseases, bacterial infections);
• migraine;
• mild or moderate toothache;
• neuralgia (pain caused by damage to peripheral nerves);
• pain syndrome of mechanical origin (due to trauma and wounds);
• myalgia (muscle pain);
• algodismenorrhea (menstrual cycle disorder with severe pain);
• fever (temperatures above 38.5ºC).

Paracetamol is contraindicated for:

• chronic alcohol dependence (the drug is not compatible with alcoholic beverages);
• individual intolerance;
• allergies to drug components.

Side effects and overdose

When using Paracetamol in solution form, the following side effects are possible:

1. Dyspeptic disorders (bloating, abdominal pain, stool disturbances, loss of appetite) are rare.
2. Signs of liver damage in the form of pain in the right hypochondrium, jaundice, nausea, changes in blood counts (increased levels of liver enzymes). In high doses and long-term use, paracetamol has a hepatotoxic effect.
3. Thrombocytopenia (drop in platelet levels). This condition can lead to increased bleeding.
4. Leukopenia (drop in white blood cell count).
5. Pancytopenia (decrease in the number of all types of cells in the blood - leukocytes, platelets and red blood cells).
6. Neutropenia (decrease in the blood of a special type of leukocytes).
7. Agranulocytosis (absence of granulocytes in the blood - neutrophils, eosinophils and basophils).
8. Rash in the form of urticaria. Manifestation of an allergic reaction. The rash takes the form of round blisters raised above the skin. They are pink or red and very itchy.
9. Skin itching.
10. Exanthema-type rash.

Severe allergic reactions in the form of anaphylactic shock and Quincke's edema are not typical for Paracetamol.

An overdose can occur as a type of acute intoxication (liver failure). She has the following characteristics:

• increased AST and ALT in the blood;
• increased bilirubin concentration;
• vomit;
• diarrhea;
• nausea;
• yellowness of the skin and sclera;
• confusion;
• sleep disturbance;
• swelling;
• pain in the hypochondrium on the right;
• abdominal enlargement due to fluid accumulation (ascites);
• general malaise;
• decrease in diuresis.

After 3-4 days, the symptoms intensify and the person’s condition worsens. Characterized by bleeding, uncontrollable vomiting, and rapid heartbeat. A dangerous complication can be hepatic encephalopathy. It is manifested by a disorder of consciousness (delusions, hallucinations), changes in behavior, monotony of speech, arrhythmic muscle twitching (asterixis).

At the last stage, hepatic coma may develop. It is characterized by a decrease or complete disappearance of reactions to external stimuli, impaired urination and defecation, difficulty moving, pathological reflexes, areflexia, convulsions, liver odor and hemorrhages.

Symptoms of chronic Paracetamol overdose include:

• weakness;
• drowsiness;
• discomfort or pain in the hypochondrium on the right;
• dyspepsia;
• sweating;
• periodic bleeding.

Help for poisoning involves washing the stomach with warm water or weakly diluted potassium permanganate (when taking the solution orally), artificial evacuation of the stomach contents, avoiding Paracetamol, using sorbents, taking laxatives and hepatoprotectors (to improve liver function). Laboratory monitoring of the liver condition is mandatory.

Analogs

The pharmaceutical market offers a wide selection of Paracetamol analogues that are not inferior to it in therapeutic effectiveness.
Among the most popular products are the following: Apap Light

Available in the form of film-coated tablets. Apap Light is a direct analogue of Paracetamol and can be used as a substitute in the treatment of pain or reducing body temperature. It is distinguished by the presence of only one dosage of 500 mg of paracetamol per 1 tablet.

The drug contains paracetamol, ascorbic acid and chlorphenamine maleate. Available in the form of effervescent tablets. It is used as a means of symptomatic treatment of colds, as well as a drug to combat pain syndromes of various origins. Antigrippin has a wider range of contraindications compared to Paracetamol.

Askopar

It is an antipyretic and analgesic drug. Contains paracetamol, acetylsalicylic acid and caffeine. It is used primarily to reduce elevated temperature during infectious and inflammatory processes, as well as to eliminate pain of various etiologies. Along with Antigrippin, it has a long list of contraindications due to the combined composition.

Special instructions and precautions

When using Paracetamol you must:

• use caution when treating patients with benign hyperbilirubinemia;
• strictly observe the dosage and frequency of taking the solution;
• give up alcohol;
• monitor blood counts in case of long-term use.

Use in children and elderly patients

Paracetamol in solution form can be taken by young children according to the dosage regimen. Caution should be exercised when prescribing medication to the elderly.

Pregnancy and breastfeeding

There were no cases of negative effects of the drug on the fetus. Paracetamol can cross the placenta and be excreted in breast milk, so when prescribing the drug to pregnant and lactating women, the possible risks and benefits should be taken into account.

Interaction with other drugs

It is not recommended to use the following medications simultaneously with Paracetamol:

• medications that negatively affect liver tissue (Azithromycin, Azathioprine, Allopurinol, Amitriptyline, Amiodarone, Amoxiclav, Aspirin, Retabolil, Amphotericin B, Vincristine-Teva, Vilprafen, Doxycycline, Ibuprofen, Ketoprofen, Ketoconazole, etc.);
• anticoagulants (prothrombin time increases);
• Activated carbon;
• anticholinergics;
• oral contraceptives;
• Zidovudine;
• Diazepam;
• uricosuric drugs;
• Isoniazid.

The effectiveness of Paracetamol is reduced with simultaneous use of phenobarbital, phenytoin and carbamazepine.

Use for liver and kidney dysfunctions

Paracetamol is prescribed with caution to people with liver and kidney dysfunction.

What happens during an overdose?

Excessive amounts of the drug can cause death in the patient in case of acute liver damage. It is necessary to take into account the early or advanced age of the patient, the presence of chronic alcoholism, the risk of hepatotoxicity, as well as renal and protein failure.

Overdose markers that appear during the day:

1. nausea;
2. pallor;
3. vomit;
4. loss of appetite;
5. pain in the abdominal area.

Such cases require emergency hospitalization and the use of N-acetylcysteine, which inactivates the increased levels of paracetamol in plasma. The main thing is to have time to do all this within ten hours. In addition, symptomatic treatment is carried out and the activity of liver transaminases is checked once a day, the level of which usually returns to normal in one to two weeks.

Analogs

There are many analogues of Paracetamol, but for joint pain, several of the most powerful drugs should be highlighted. These include the following medications:

Nimid is the active component of nimisulide. Release form: tablets and suspension. It is used for fever, inflammation and severe pain. Panadol is a similar active substance, but the medicine also contains caffeine, which causes a number of side effects. Panadol is marketed in the form of tablets, syrup, and suspension. The suspension is used to treat children with viral and infectious diseases. Baralgetas is the active component of analgin, which acts on inflammation in the same way as paracetamol

It should be used carefully and only with careful adherence to the dosage, otherwise there is a high probability of developing more serious pathologies

Paracetamol intravenous for joint pain

In a clinical study of infusion use after minor surgical interventions on the knee joints, when paracetamol was administered at a dose of 1 g half an hour before the planned end of the operation, no side effects were observed. The combination with other analgesics was especially successful for joint pain.

Thus, for the relief of pain after knee surgery, paracetamol, used alone or in tandem, is quite effective and well tolerated by patients undergoing outpatient surgery. A properly selected dosage, taking into account all contraindications, is the key to the successful use of this antipyretic and analgesic in medical practice.

Paracetamol during pregnancy

Many women are accustomed to solving various ailments in the form of headaches and muscle pain, as well as elevated body temperature during a cold, with the help of the most popular medicine - paracetamol or drugs containing it.

Paracetamol during pregnancy is a very popular topic that is actively discussed by expectant mothers. They know very well that it is contraindicated to use any chemicals while carrying a child, and the thought of a possible illness simply throws them into panic and puts them in a hopeless situation. The disease definitely needs to be treated, but you can’t take medicine.

Paracetamol during pregnancy: instructions for use

Only a highly qualified doctor can recommend what a pregnant woman should do in this case, so at the first symptoms you should consult him. Self-treatment or simply inaction is strictly unacceptable. Paracetamol instructions for use for headaches is safe and helps very well, but it is not recommended for expectant mothers to use it, even in a child dosage.

Can I take paracetamol during pregnancy?

Paracetamol during pregnancy is prescribed as an analgesic and antipyretic due to the fact that it is considered the most harmless of similarly acting drugs (aspirin and analgin). However, the decision on the appropriateness of use and the permissible dosage should be made only by the attending physician.

Although the negative effect of the drug on the fetus has not been established (during experimental studies), it has been proven that Paracetamol penetrates the placental barrier, so it is necessary to carefully weigh the expected benefits of therapy for the mother and the potential risk for the child. It should be noted that high body temperature is too dangerous for both the mother and her unborn baby. This is when the need for Paracetamol often appears. By the way, it is best to take it after meals with plain water.

Instructions for use during pregnancy

Self-medication during pregnancy can lead to irreversible consequences. Paracetamol is prescribed during pregnancy to relieve pain and reduce fever. Studies have not revealed any negative effects on the fetus. However, it has been experimentally proven that the drug penetrates the placental barrier and is excreted in breast milk.

Paracetamol during pregnancy has less effect on the body of the mother and fetus than Aspirin or Analgin. The danger from high temperature during pregnancy exceeds the risks from taking the drug. If a pregnant woman's body temperature is below 38 degrees, taking medications is not advisable. At higher values, it is necessary to lower the temperature. To avoid the development of adverse reactions, it is necessary to start with 1/2 tablet, and the maximum dosage should not exceed 500-1000 mg. in 3-4 doses.

The dosage of the medicine for each pregnant woman is selected individually by the doctor. The duration of treatment is no more than 7 days. British scientists, after conducting research, found that children whose mothers took high doses of Paracetamol during pregnancy have an increased risk of developing:

• Bronchial asthma;
• Khripov;
• Respiratory diseases;
• Allergies.

It is believed that Paracetamol instructions for use during pregnancy can be prescribed when the risk associated with its use is justified by its high effectiveness and extreme necessity. It should be taken into account that a number of studies confirm the toxic effect on the fetus when using Paracetamol during pregnancy. Thus, cases of the development of cryptorchidism in boys whose mothers used it while pregnant are associated with this drug. Thus, the prescription of Paracetamol during pregnancy should occur exclusively with the participation of a doctor.

Drug interactions

When used simultaneously with inducers of microsomal liver enzymes and drugs with hepatotoxic effects, there is a risk of increasing the hepatotoxic effect of paracetamol.

When used simultaneously with anticoagulants, a slight or moderate increase in prothrombin time is possible.

When used simultaneously with anticholinergic drugs, the absorption of paracetamol may be reduced.

When used simultaneously with oral contraceptives, the elimination of paracetamol from the body is accelerated and its analgesic effect may be reduced.

When used simultaneously with uricosuric drugs, their effectiveness decreases.

With simultaneous use of activated carbon, the bioavailability of paracetamol decreases.

When used simultaneously with diazepam, the excretion of diazepam may be reduced.

There are reports of the possibility of enhancing the myelosuppressive effect of zidovudine when used simultaneously with paracetamol. A case of severe toxic liver damage has been described.

Cases of toxic effects of paracetamol have been described when used simultaneously with isoniazid.

When used simultaneously with carbamazepine, phenytoin, phenobarbital, primidone, the effectiveness of paracetamol decreases, which is due to an increase in its metabolism (glucuronidation and oxidation processes) and excretion from the body. Cases of hepatotoxicity have been described with the simultaneous use of paracetamol and phenobarbital.

When using cholestyramine for a period of less than 1 hour after taking paracetamol, the absorption of the latter may be reduced.

When used simultaneously with lamotrigine, the excretion of lamotrigine from the body moderately increases.

When used simultaneously with metoclopramide, it is possible to increase the absorption of paracetamol and increase its concentration in the blood plasma.

When used simultaneously with probenecid, the clearance of paracetamol may be reduced; with rifampicin, sulfinpyrazone - it is possible to increase the clearance of paracetamol due to an increase in its metabolism in the liver.

When used simultaneously with ethinyl estradiol, the absorption of paracetamol from the intestine increases.

Compatibility with other medications

Probenecid and salicylamide reduce the rate of excretion of paracetamol by the kidneys by almost 2 times; this fact makes it necessary to adjust the dose of the antipyretic

Due to the increased effect on liver transaminases, it should be used with caution in combination with enzyme-inducing drugs. Due to the use of oral coagulants and paracetamol, the level of INR (the main marker of blood clotting) may fluctuate, so it should be closely monitored for seven days after taking this combination

The effect of paracetamol can be reduced by barbiturates. In combination with ethyl alcohol, there is a risk of developing acute inflammation of the pancreas. High dosage and duration of use of paracetamol with salicylates increase the likelihood of developing cancer of the urinary system.

Efferalgan or Paracetamol

Manufacturer: UPSA (France)
Release form: rectal suppositories, effervescent tablets

Active ingredient: paracetamol

Both drugs have the same active ingredient, that is, they are analogues used to reduce temperature and relieve pain of various origins. Efferalgan, due to the additional ingredients included in the drug, gives a more pronounced effect due to rapid absorption in the intestine.

Paracetamol for children will be more preferable in the fight against fever and inflammation due to infections of viral or bacterial origin. Its dosage forms (suspension, rectal suppositories) allow the drug to be used by babies from 3 months of age.