Paracetamol injections instructions for use. Paracetamol suspension for children

in glass bottles of 50 or 100 ml; V cardboard box 1 or 12 bottles.

Description of the dosage form

Transparent, colorless or slightly yellowish solution without visible mechanical inclusions.

Pharmacological action

Pharmacological action- antipyretic, analgesic.

Pharmacodynamics

It has a predominantly analgesic and antipyretic effect. Blocks cyclooxygenase I and II in the central nervous system, affects the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the lack of anti-inflammatory effect. Does not affect the synthesis of PG in peripheral tissues, therefore it has no effect negative influence on water-salt metabolism(sodium and water retention) and the gastrointestinal mucosa.

Pharmacokinetics

Cmax in blood plasma is reached after 15 minutes and is 15-30 mcg/ml. Volume of distribution - 1 l/kg. Weakly binds to plasma proteins. Passes through the BBB. Metabolized in the liver to form glucuronides and sulfates. A small portion (4%) is metabolized by cytochrome P450 to form an intermediate metabolite (N-acetylbenzoquinoneimine). IN normal conditions it is quickly detoxified by reduced glutathione and excreted in the urine after binding to cysteine ​​and mercaptopuric acid. With massive intoxication, the concentration of this toxic metabolite increases. T1/2 in adults is 2.7 hours, in children - 1.5-2 hours, in newborns - 3.5 hours. Total clearance - 18 l/hour. Excreted mainly in urine; 90% of the dose taken is within 24 hours in the form of glucuronide (60-80%) and sulfate (20-30%). Less than 5% is excreted unchanged. In severe renal failure (Cl creatinine below 10-30 ml/min), the excretion of paracetamol slows down somewhat, T1/2 is 2-5.3 hours. The rate of excretion of glucuronide and sulfate in patients with severe renal failure 3 times less than in healthy people.

Indications for the drug Perfalgan

pain of moderate intensity, especially after surgery;

febrile syndrome against the background infectious diseases. The drug is indicated for rapid pain relief, incl. when the oral route of administration is difficult.

Contraindications

hypersensitivity to paracetamol or propacetamol hydrochloride (prodrug of paracetamol) or any other component of the drug;

severe liver dysfunction;

children's age up to 1 year.

With caution:

when prescribing paracetamol to patients with severe renal failure (Cl creatinine<30 мл/мин);

benign hyperbilirubinemia (including Gilbert's syndrome, viral hepatitis, alcoholic liver damage);

alcoholism;

with glucose-6-phosphate dehydrogenase deficiency;

elderly patients.

Use during pregnancy and breastfeeding

Should be used with caution during pregnancy and breastfeeding. There were no adverse effects observed in children when using paracetamol during breastfeeding.

Side effects

From the skin: skin itching, rash on the skin and mucous membranes (usually erythematous or urticarial), Quincke's edema.

From the gastrointestinal tract: increased activity of liver enzymes (usually without the development of jaundice).

From the cardiovascular system: arterial hypotension.

From the hematopoietic organs: thrombocytopenia.

Interaction

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication even with a small overdose of paracetamol. Long-term use of barbiturates reduces the effectiveness of paracetamol. Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxicity.

Long-term combined use with other NSAIDs increases the risk of developing nephropathy, renal papillary necrosis and end-stage renal failure. Long-term combined use of high doses of paracetamol with salicylates increases the risk of developing kidney or bladder cancer.

Diflunisal increases the concentration of paracetamol in the blood plasma by 50% (risk of hepatotoxicity).

Directions for use and doses

IV, once, as an infusion over 15 minutes.

Opened and unused medication should be destroyed. Additional dilution with 0.9% sodium chloride solution is allowed, maximum 10 times. This diluted solution should be used within one hour of its preparation (including the time of infusion).

Children from 1 year to 11 years (with body weight up to 34 kg) - 15 mg/kg paracetamol per infusion, i.e. 1.5 ml solution per 1 kg of body weight up to 4 times a day. The minimum interval between administrations is 4 hours. The maximum daily dose is no more than 60 mg/kg.

Adults and adolescents (over 12 years old) with a body weight of 35-50 kg, 15 mg/kg per injection (1.5 ml/kg). The maximum daily dose is no more than 60 mg/kg body weight. The minimum interval between injections is 4 hours.

For adults and adolescents (over 12 years old) with a body weight of more than 50 kg, the maximum single dose is 1 g (1 vial 100 ml), the daily dose is 4 g. The interval between administrations of the drug is at least 4 hours.

In patients with impaired liver or kidney function, with Gilbert's syndrome and the elderly, the daily dose is reduced and administered at intervals of at least 8 hours.

Overdose

Symptoms acute overdose (develops within 24 hours after administration of paracetamol): gastrointestinal disorders (diarrhea, loss of appetite, nausea and vomiting, abdominal discomfort and/or abdominal pain), pallor of the skin. 12-13 hours after the administration of paracetamol, there is an increase in the activity of liver transaminases, lactate dehydrogenase and bilirubin levels, as well as a decrease in prothrombin levels. When administered simultaneously to adults of 7.5 g or more or to children of more than 140 mg/kg, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death.

Symptoms of chronic overdose (manifest 2-4 days after exceeding the dose of the drug): hepatotoxic effect, characterized by general (pain, weakness, adynamia, increased sweating) and specific (liver) symptoms. The hepatotoxic effect can lead to the development of hepatonecrosis and is complicated by the development of hepatic encephalopathy (impaired thinking, depression of higher nervous activity, agitation and stupor), convulsions, respiratory depression, coma, cerebral edema, bleeding disorders, development of disseminated intravascular coagulation syndrome, hypoglycemia, metabolic acidosis, arrhythmias, collapse.

Rarely, liver dysfunction develops at lightning speed and is complicated by renal failure (tubular necrosis).

Treatment acute overdose: administration of SH-group donors and precursors for glutathione synthesis - methionine (8-9 hours after overdose) and N-acetylcysteine ​​(12 hours). The need for further administration of methionine and N-acetylcysteine ​​is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration.

Special instructions

The risk of developing liver damage increases in patients with alcoholic hepatosis.

Distorts laboratory test results in the quantitative determination of glucose and uric acid in plasma.

During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

An open and unused bottle must be destroyed.

Storage conditions for the drug Perfalgan

At a temperature of 15-30 °C.

Keep out of the reach of children.

Shelf life of the drug Perfalgan

2 years.

Do not use after the expiration date stated on the package.

Synonyms of nosological groups

Category ICD-10	Synonyms of diseases according to ICD-10
M79.1 Myalgia	Pain syndrome in muscular and joint diseases
	Pain syndrome in chronic inflammatory diseases of the musculoskeletal system
	Muscle pain
	Muscle soreness
	Muscle soreness during heavy physical activity
	Painful conditions of the musculoskeletal system
	Pain in the musculoskeletal system
	Muscle pain
	Pain at rest
	Muscle pain
	Muscle pain
	Musculoskeletal pain
	Myalgia
	Myofascial pain syndromes
	Muscle pain
	Muscle pain at rest
	Muscle pain
	Muscle pain of non-rheumatic origin
	Muscle pain of rheumatic origin
	Acute muscle pain
	Rheumatic pain
	Rheumatic pains
	Myofascial syndrome
	Fibromyalgia
R50 Fever of unknown origin	Hyperthermia malignant
	Malignant hyperthermia
R52.2 Other persistent pain	Pain syndrome of non-rheumatic origin
	Pain syndrome with vertebrogenic lesions
	Pain syndrome with neuralgia
	Pain syndrome from burns
	Pain syndrome is mild or moderate
	Neuropathic pain
	Neuropathic pain
	Perioperative pain
	Moderate to severe pain
	Moderate or mild pain syndrome
	Moderate to severe pain syndrome
	Ear pain due to otitis media
Z100* CLASS XXII Surgical practice	Abdominal surgery
	Adenomectomy
	Amputation
	Angioplasty of coronary arteries
	Carotid angioplasty
	Antiseptic treatment of skin for wounds
	Antiseptic hand treatment
	Appendectomy
	Atherectomy
	Balloon coronary angioplasty
	Vaginal hysterectomy
	Corona bypass
	Interventions on the vagina and cervix
	Bladder interventions
	Intervention in the oral cavity
	Restorative and reconstructive operations
	Hand hygiene of medical personnel
	Gynecological surgery
	Gynecological interventions
	Gynecological surgeries
	Hypovolemic shock during surgery
	Disinfection of purulent wounds
	Disinfection of wound edges
	Diagnostic interventions
	Diagnostic procedures
	Diathermocoagulation of the cervix
	Long surgical operations
	Replacing fistula catheters
	Infection during orthopedic surgery
	Artificial heart valve
	Cystectomy
	Short-term outpatient surgery
	Short-term operations
	Short-term surgical procedures
	Cricothyroidotomy
	Blood loss during surgery
	Bleeding during surgery and in the postoperative period
	Culdocentesis
	Laser coagulation
	Laser coagulation
	Laser coagulation of the retina
	Laparoscopy
	Laparoscopy in gynecology
	CSF fistula
	Minor gynecological operations
	Minor surgical interventions
	Mastectomy and subsequent plastic surgery
	Mediastinotomy
	Microsurgical operations on the ear
	Mucogingival surgeries
	Stitching
	Minor surgeries
	Neurosurgical operation
	Immobilization of the eyeball in ophthalmic surgery
	Orchiectomy
	Complications after tooth extraction
	Pancreatectomy
	Pericardectomy
	Rehabilitation period after surgery
	The period of convalescence after surgical interventions
	Percutaneous transluminal coronary angioplasty
	Pleural thoracentesis
	Pneumonia postoperative and post-traumatic
	Preparing for surgical procedures
Preparing for surgery
Preparing the surgeon's hands before surgery
Preparing the colon for surgery
Postoperative aspiration pneumonia during neurosurgical and thoracic operations
Postoperative nausea
Postoperative bleeding
Postoperative granuloma
Postoperative shock
Early postoperative period
Myocardial revascularization
Resection of the apex of the tooth root
Gastric resection
Bowel resection
Resection of the uterus
Liver resection
Small bowel resection
Resection of part of the stomach
Reocclusion of the operated vessel
Bonding tissue during surgery
Removing stitches
Condition after eye surgery
Condition after surgery
Condition after surgical interventions in the nasal cavity
Condition after gastrectomy
Condition after resection of the small intestine
Condition after tonsillectomy
Condition after removal of the duodenum
Condition after phlebectomy
Vascular surgery
Splenectomy
Sterilization of surgical instruments
Sterilization of surgical instruments
Sternotomy
Dental operations
Dental intervention on periodontal tissues
Strumectomy
Tonsillectomy
Thoracic surgery
Thoracic operations
Total gastrectomy
Transdermal intravascular coronary angioplasty
Transurethral resection
Turbinectomy
Tooth extraction
Cataract removal
Cyst removal
Tonsil removal
Removal of fibroids
Removal of mobile baby teeth
Removal of polyps
Removing a broken tooth
Removal of the uterine body
Removing stitches
Urethrotomy
CSF duct fistula
Frontoethmoidohaymorotomy
Surgical infection
Surgical treatment of chronic limb ulcers
Surgery
Surgery in the anal area
Colon surgery
Surgical practice
Surgical procedure
Surgical interventions
Surgical interventions on the gastrointestinal tract
Surgical interventions on the urinary tract
Surgical interventions on the urinary system
Surgical interventions on the genitourinary system
Heart surgery
Surgical procedures
Surgical operations
Vein surgery
Surgical intervention
Vascular surgery
Surgical treatment of thrombosis
Surgery
Cholecystectomy
Partial gastrectomy
Transperitoneal hysterectomy
Percutaneous transluminal coronary angioplasty
Percutaneous transluminal angioplasty
Coronary artery bypass surgery
Tooth extraction
Extirpation of baby teeth
Pulp extirpation
Extracorporeal circulation
Tooth extraction
Tooth extraction
Cataract extraction
Electrocoagulation
Endourological interventions
Episiotomy
Ethmoidotomy

Analgesic-antipyretic

Active ingredient

Release form, composition and packaging

Solution for infusion

Excipients: cysteine ​​hydrochloride monohydrate, disodium phosphate dihydrate, sodium hydroxide, concentrated hydrochloric acid, water, nitrogen.

50 ml - bottles (1) - cardboard boxes.
50 ml - bottles (12) - cardboard boxes.

Solution for infusion transparent, colorless or slightly yellowish, without visible mechanical inclusions.

Excipients: mannitol, cysteine ​​hydrochloride monohydrate, disodium phosphate dihydrate, sodium hydroxide, concentrated hydrochloric acid, water, nitrogen.

100 ml - bottles (1) - cardboard boxes.
100 ml - bottles (12) - cardboard boxes.

Pharmacological action

Analgesic-antipyretic for infusion administration. It has an analgesic and antipyretic effect, the mechanism of which is due to the blocking of COX-1 and COX-2 in the central nervous system (mainly) and the effect on the centers of pain and thermoregulation. In areas of inflammation, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains its almost complete lack of anti-inflammatory effect.

The drug does not affect the synthesis of prostaglandins in peripheral tissues, which means there is no negative effect on the water-electrolyte balance (does not cause sodium and water retention) and on the gastrointestinal mucosa.

Pharmacokinetics

Suction and distribution

Cmax in the blood is reached after 15 minutes and is 15-30 mcg/ml. Vd is 1 l/kg. Penetrates through the BBB. Paracetamol is weakly bound to plasma proteins.

Metabolism and excretion

Paracetamol is biotransformed in the liver to form glucuronides and sulfates. A small part (about 4%) is metabolized with the participation of isoenzymes of the cytochrome P 450 system with the formation of an intermediate metabolite (N-acetylbenzoquinoneimine), which under normal conditions is quickly neutralized by reduced glutathione and excreted in the urine after binding to cysteine ​​and mercaptopuric acid. However, with massive intoxication, the amount of this toxic metabolite increases.

T 1/2 is 2.7 hours, total clearance is 18 l/hour.

Paracetamol is excreted mainly in the urine; while 90% of the dose taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide (60-80%) and sulfate (20-30%), less than 5% is excreted unchanged.

Pharmacokinetics in special clinical situations

T1/2 in children – 1.5-2 hours, in newborns – 3.5 hours.

In case of severe renal failure (creatinine clearance 10-30 ml/min), the excretion of paracetamol slows down somewhat, and T1/2 is 2-5.3 hours. The rate of excretion of glucuronide and sulfate in patients with severe renal failure is 3 times lower than in healthy patients.

Indications

— pain of moderate intensity, especially after surgical interventions;

— febrile syndrome against the background of infectious and inflammatory diseases.

The drug is indicated for rapid relief of pain and fever (including when it is impossible to take paracetamol orally).

Contraindications

- severe liver dysfunction;

- children under 1 year of age;

- hypersensitivity to paracetamol or propacetamol hydrochloride (prodrug of paracetamol) or any other component of the drug.

WITH caution the drug is prescribed for severe renal failure (creatinine clearance less than 30 ml/min), benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, patients with chronic alcoholism (including alcoholic liver damage), elderly people age, with deficiency of glucose-6-phosphate dehydrogenase.

Dosage

The drug is used as an intravenous infusion over 15 minutes. The minimum interval between administrations should be 4 hours.

Adolescents over 12 years of age and adults weighing more than 50 kg the maximum single dose is 1 g of paracetamol, i.e. 1 bottle (100 ml). The maximum daily dose is 4 g.

Adolescents over 12 years of age and adults weighing from 35 to 50 kg the drug is prescribed at the rate of 15 mg/kg of paracetamol per administration (i.e. 1.5 ml of solution per 1 kg of body weight). The maximum daily dose is 60 mg/kg.

Children aged 1 to 11 years weighing up to 34 kg Prescribe 15 mg/kg of paracetamol per infusion, that is, 1.5 ml of solution per kg, up to 4 times a day. The minimum interval between administrations is 4 hours. The maximum daily dose is 60 mg/ct.

U patients with impaired liver or kidney function, Gilbert's syndrome and the elderly the interval between administrations of the drug should be at least 8 hours, and the daily dose should be reduced.

Side effects

From the digestive system: increased activity of liver enzymes (usually without the development of jaundice).

From the cardiovascular system: arterial hypotension.

From the hematopoietic system: thrombocytopenia.

Dermatological reactions: itching, rash on the skin and mucous membranes (usually erythematous or urticarial).

Allergic reactions: Quincke's edema.

Overdose

The clinical picture of acute overdose develops in the first 24 hours after taking paracetamol in a high dose. Symptoms of chronic overdose appear 2-4 days after increasing the dose of the drug.

Symptoms of acute overdose: diarrhea, loss of appetite, nausea, vomiting, discomfort and/or abdominal pain, pale skin. With the simultaneous administration of paracetamol to adults at a dose of 7.5 g or more, and to children - more than 140 mg/kg, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death. 12.8 hours after the administration of paracetamol, there is an increase in the activity of liver transaminases, LDH and bilirubin levels and a decrease in prothrombin levels.

Symptoms of chronic overdose: a hepatotoxic effect develops, characterized by general symptoms (pain, weakness, adynamia, increased sweating) and specific ones characterizing liver damage. As a result, hepatonecrosis may develop. The hepatotoxic effect of paracetamol can be complicated by the development of hepatic encephalopathy (thought disturbances, central nervous system depression, agitation and stupor), the occurrence of convulsions, respiratory depression, coma, cerebral edema, bleeding disorders, development of disseminated intravascular coagulation syndrome, hypoglycemia, metabolic acidosis, arrhythmia, collapse. Rarely, liver dysfunction develops at lightning speed and can be complicated by renal failure (tubular necrosis).

Treatment: administration of SH-group donors and precursors for glutathione synthesis 8-9 hours after an overdose and N-acetylcysteine ​​- after 12 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as the time elapsed since its introduction.

Drug interactions

When used together, inducers of microsomal liver enzymes (phenytoin, ethanol, barbiturates, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which makes it possible to develop severe intoxications with a slight excess of the dose.

When used together with paracetamol, ethanol increases the likelihood of developing acute pancreatitis.

When used together, inhibitors of microsomal liver enzymes (including) reduce the risk of hepatotoxicity.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Long-term combined use of paracetamol and NSAIDs increases the risk of developing analgesic nephropathy and renal papillary necrosis, and the onset of end-stage renal failure.

Simultaneous long-term use of paracetamol in high doses and salicylates increases the risk of kidney or bladder cancer.

When used together, diflunisal increases the plasma concentration of paracetamol by 50% and increases the risk of developing hepatotoxic reactions.

Special instructions

The risk of developing liver damage increases in patients with alcoholic hepatosis.

When using Perfalgan, laboratory test results for the quantitative determination of uric acid in plasma are distorted.

The use of the drug is contraindicated in cases of severe liver dysfunction.

WITH caution the drug is prescribed for benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, and patients with chronic alcoholism (including alcoholic liver damage).

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature of 15° to 30°C. Shelf life – 2 years.

This instruction is provided for informational purposes only. On its basis, you cannot carry out independent treatment with the drug, but only after consulting a doctor.

Paracetamol is one of the most famous and popular NSAIDs for fever and pain relief. It is a non-narcotic analgesic recognized by WHO as the most important medicine.

Description of the drug

The drug is named after the active substance (paracetamol), which is a derivative of phenacetin. The substance acts by inhibiting the production of prostaglandins, which are chemical compounds that are formed during the development of the inflammatory process and are responsible for the occurrence of symptoms (fever, pain).

Paracetamol has an analgesic effect by influencing neurons of the central nervous system and blocking pain impulses. The drug has a mild anti-inflammatory effect without irritating the mucous membrane of the digestive system. Paracetamol is quickly absorbed by the body and penetrates all tissues. The final destruction of the substance occurs in the liver, forming metabolites (intermediate metabolic products), some of them (para-aminophenol) are toxic. In connection with this fact, in case of kidney and liver diseases, the use of this medication should be limited.

After breakdown, the substance passes through the kidney filters and is excreted in the urine. When taking paracetamol orally, the maximum concentration in the blood reaches half an hour after taking the medicine. After another hour, the full effect of the drug is observed.

Release form:

1. Tablets (active substance content -200 and 500 mg).
2. Gelatin-coated capsules (500 mg).
3. Effervescent tablets for dissolution in water (500 mg).
4. Solution in ampoules for injections and infusions (15 mg in one gram of solution).
5. Children's syrup and suspension.
6. Rectal suppositories (suppositories).

Indications

The main indications are:

• increased body temperature in infectious and inflammatory diseases;
• fever and teething pain;
• relieving inflammation for back pain.

The drug is effective for symptomatic treatment of:

• myalgia;
• arthralgia;
• headache;
• neuralgia;
• toothache;
• wandering pain of unknown etiology.

Attention! When used as an anti-inflammatory agent for back pain caused by sciatica or neuralgia, it is undoubtedly very effective. However, you should be careful when relieving such pain by taking Paracetamol on your own, since the pain may hide a serious disease not related to the musculoskeletal system (impaired functioning of the kidneys, gall bladder). By taking the remedy without the knowledge of the doctor, you can suppress the true cause and waste time.

Instructions for use

According to the instructions for the medication, the dose for adults is 500-1000 mg, for children over 12 years of age the dose is similar. The maximum permissible limit for this category is no more than 4000 mg of the active substance.

For children under 12 years of age, the dose is calculated individually, taking into account the child’s weight, on average 125-250 mg per dose.

In any case, regardless of the prescribed form of the medicine, the daily dose should be divided into 3-4 times with an interval of 4 hours or no less.

Side effects

Paracetamol is one of the safest drugs and, if the treatment regimen is followed, usually does not cause side effects. However, there is information about some adverse reactions associated with hypersensitivity to the substance or with existing hidden diseases. All possible manifestations of adverse reactions should be considered.

1. Digestive system – liver dysfunction, dyspepsia.
2. Blood – anemia, methemoglobinemia, thrombocytopenia, agranulocytosis.
3. CCC – intracardiac blockade.
4. Immunity – allergies, anaphylactic shock (extremely rare).
5. Urinary system – renal dysfunction, nephritis, polyuria.

Contraindications

The use of the drug is contraindicated under the following factors:

• individual sensitivity;
• liver dysfunction;
• kidney diseases;
• deterioration of blood condition;
• during pregnancy;
• when breastfeeding.

The question often arises: can children take paracetamol? Although the instructions give dosages for children, the medicine should not be given to children unless absolutely necessary.

What to replace it with?

Paracetamol is a very well-known and often used drug in practice, which is produced by all pharmaceutical companies and each has a different name. Analogues of Paracetamol:

• Abesanil;
• Actazol;
• AkamolTeva;
• Acetophene;
• Alvedon;
• Aminodol;
• Aminophen;
• Algo rushed;
• Amphenol;
• Apamid;
• Apagan;
• Acelifen;
• Apanol;
• Acetalgin;
• Acemol;
• Acetaminophenol;
• Acetaminophen;
• Bindard;
• Biocetamol;
• Valorin;
• Valadol;
• Vinadol;
• Valgesik;
• Dapirex;
• Volpan;
• Dafalgan;
• Datril;
• Deminofen;
• Dexamol;
• Dolamin;
• Dimindol;
• Dolipram;
• Dolanex;
• Calpol;
• Ifimol;
• Metamol;
• Meksalen;
• Mialgin;
• Minoset;
• Naprinol;
• Napamol;
• Nisacetol;
• Nasprin;
• Opradol;
• NEP;
• Panadol Soluble;
• Panadol;
• Paramol;
• Paracetamol 325;
• Paracetamol 200;
• Panadol junior;
• Pyremol;
• Pacimol;
• Rolocin;
• Pyrinazine;
• Tempramol;
• Tylenol;
• Tilemin;
• Tylenol;
• Ushamol;
• Tralgon;
• Febrinil;
• Febridol;
• Febricet;
• Febrinol;
• Chemcetafen;
• Fendon;
• Celifen;
• Cetanyl;
• Cetadol;
• Efferoglan;
• Efferalgan;
• Erocetamol.

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REGISTRATION NUMBER - P No. 016008/01
TRADE NAME OF THE DRUG: Perfalgan
INTERNATIONAL NON-PROPENTED NAME - Paracetamol
DOSAGE FORM - solution for infusion

Compound:

One ppm solution contains:

Active ingredients: Paracetamol - 10 mg;

Excipients: mannitol, cysteine ​​hydrochloride monohydrate, disodium phosphate dihydrate, sodium hydroxide, concentrated hydrochloric acid, water for injection, nitrogen.

DESCRIPTION. A transparent, colorless or slightly yellowish solution without visible mechanical inclusions.

PHARMACOTHERAPEUTIC GROUP - analgesic non-narcotic drug.

ATX code.

Pharmacological properties

Pharmacodynamics

Perfalgan (paracetamol) has analgesic and antipyretic effects. The drug blocks cyclooxygenase I and II mainly in the central nervous system, affecting the centers of pain and thermoregulation. The lack of influence on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.

Pharmacokinetics

The maximum concentration in blood plasma is reached after IS min and is 15-30 mcg/ml. The volume of distribution is I l/kg. Paracetamol weakly binds to plasma proteins and penetrates the blood-brain barrier.

Metabolized in the liver to form glucuronides and sulfates. A small part (4%) of the drug is metabolized by cytochrome P450 to form an intermediate metabolite (N-acetylbenzoquinoneimine), which under normal conditions is quickly neutralized by reduced glutathione and excreted in the urine after binding to cysteine ​​and mercaptopuric acid. However, with massive intoxication, the amount of this toxic metabolite increases. The half-life in adults is 2.7 hours, in children - 1.5-2 hours, in newborns - 3.5 hours, total clearance 18 l/hour. Paracetamol is excreted mainly in the urine; 90% of the dose taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide (60-80%) and sulfate (20-30%). Less than 5% is excreted unchanged. In severe renal failure (creatinine clearance below 10-30 ml/min), the elimination of paracetamol slows down slightly, and the half-life is 2-5.3 hours. The rate of excretion of hayucuronide and sulfate in patients with severe renal failure is 3 times less than in healthy people patients.

Indications for use

• Pain syndrome of moderate intensity, especially after surgical interventions.
• Feverish syndrome against the background of infectious and inflammatory diseases.
• The drug is indicated for rapid relief of pain and fever, including when the oral route of administration is difficult.

Contraindications

• Hypersensitivity to paracetamol or propacetamol hydrochloride (prodrug of paracetamol) or any other component of the drug.
• Severe liver dysfunction.
• Children's age up to 12 years.

With caution - severe renal failure (creatinine clearance< 30 мл/мин), доброкачественные гипербилирубинемии (в т.ч. синдром Жильбера, вирусный гепатит, алкогольное поражение печени), алкоголизм, пожилой возраст, дефицит глюкозо-6-фосфатдегидрогеназы.

Pregnancy and lactation

The drug should be used with caution during pregnancy and breastfeeding.

Directions for use and doses

Intravenous single infusion over 15 minutes. Opened and unused medication must be destroyed. Additional dilution with 0.9% sodium chloride solution is allowed, up to a maximum of ten times. This diluted solution should be used within one hour of its preparation (including the time of infusion).

• Adolescents (over 12 years old) and adults weighing from 35 to 50 kg: 15 mg/kg paracetamol per injection, i.e. 1.5 ml/kg. The maximum daily dose should not exceed 60 mg/kg body weight. The minimum interval between administrations should be 4 hours.
• Adolescents (over 12 years old) and adults weighing more than 50 kg: the maximum single dose is 1 g of paracetamol, i.e. I bottle (100 ml). The maximum daily dose is 4 g. The interval between administrations of the drug should be at least 4 hours.

Side effect

See instructions

Storage conditions:

At a temperature of 15 - 30 "C.

KEEP OUT OF REACH OF CHILDREN!

Best before date

2 years. Do not use the drug after the expiration date indicated on the packaging.

Conditions for dispensing from pharmacies:

FROM PHARMACIES - ACCORDING TO A PRESCRIPTION

Manufacturer:

Bristol-Myers Squibb, France
304, avenue du Doctor Jean Bra 47000 AGEN-France
For more information, contact your Bristol-Myers Squibb Representative.
Moscow, Trekhprudny lane, 9, αρ. 16.

Solution for infusion.

Pharmacotherapeutic group

Analgesics and antipyretics. ATC code N02B E01.

Indications

Adults: short-term treatment of pain of moderate intensity, especially in the postoperative period.

Short-term treatment of hyperthermic reactions.

Children: symptomatic treatment of pain and hyperthermia in postoperative patients.

Contraindications

Hypersensitivity to paracetamol and other components of the drug.

Severe hepatocellular failure.

Directions for use and doses

The drug is used for rapid relief of pain and/or hyperthermic syndrome, when an exclusively intravenous route of drug administration is required.

The duration of the intravenous infusion should be 15 minutes.

Adults and children weighing 50 kg or more.

The maximum single dose is 1 g of paracetamol, i.e. 1 bottle (100 ml). The maximum daily dose is 4 g. The interval between administration of the drug should be at least 4 hours. Typically, 1 to 4 infusions are used during the first day from the onset of pain (postoperative period), if necessary, the duration of treatment can be increased, but it should not exceed 72 hours (3 days) and a total of 12 infusions.

Children weighing from 33 kg to 50 kg.

Children weighing from 10 kg to 33 kg.

15 mg/kg of paracetamol per injection, that is, 1.5 ml/kg. The maximum daily dose should not exceed 60 mg/kg body weight. The minimum interval between administrations should be 4 hours. The duration of treatment usually does not exceed 4 infusions over one day.

When using the drug in children, before starting the infusion, remove excess drug from the bottle and leave a volume of solution that corresponds to a single dose.

In adult patients with renal failure (creatinine clearance £ 30 ml/min), the interval between doses should increase to 6 hours. The duration of treatment should not exceed 48 hours.

Adverse reactions

From the cardiovascular system: rarely – arterial hypotension.

From the liver: rarely - increased levels of liver transaminases.

From the blood: rarely - thrombocytopenia, leukopenia, neutropenia.

General: rarely – malaise; very rarely - hypersensitivity reactions; isolated cases - anaphylactic shock.

Isolated cases of simple or urticarial skin rashes have been reported.

Overdose

The risk of toxic effects of the drug increases in the elderly, in children, patients with liver failure, in cases of chronic alcoholism, in the presence of nutritional dystrophy and in people with reduced enzymatic activity. In these cases, overdose can be fatal.

Symptoms appear within the first 24 hours and include nausea, vomiting, anorexia, pallor, and abdominal pain.

An overdose in adults can occur with a single dose of 7.5 g or more, in children - 140 mg/kg body weight. In this case, liver cytolysis, liver failure, metabolic acidosis, and encephalopathy develop, which can lead to coma and death of the patient. Within hours, the level of liver transaminases (AST, ALT), lactate dehydrogenase, bilirubin increases and the level of prothrombin decreases. Clinical symptoms of liver damage appear after two days and reach a maximum of the latter.

Treatment: administration of SH-group donors and precursors for the synthesis of glutathione-methionine an hour after an overdose and N-acetylcysteine ​​- after 12 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration.

Use during pregnancy or breastfeeding

There is no data regarding the negative impact of paracetamol for intravenous use on fetal development or fetotoxic effects, however, before using the drug, the benefit/risk ratio should be carefully assessed and the pregnant woman should be closely monitored during the use of the drug.

Paracetamol can pass into breast milk. During treatment with the drug, you should stop breastfeeding.

Do not use in children under 1 year of age and weighing less than 10 kg.

Used in children over 1 year of age weighing more than 10 kg only for the symptomatic treatment of pain and hyperthermia in postoperative patients.

Features of application

When using the solution, you should not simultaneously use oral forms of paracetamol due to the risk of overdose.

Use the drug with caution if the patient has:

• hepatocellular failure;
• with severe renal failure (creatinine clearance less than 30 ml/min);
• chronic alcoholism;
• nutritional depletion (decreased glutathione reserve in the liver);
• dehydration.

Exceeding recommended doses may cause serious liver dysfunction. Clinical signs of liver damage may not appear for two days, maximum 4-6 days after the drug is prescribed. It is necessary to apply antidote therapy as soon as possible.

The risk of developing liver damage during treatment with Paracetamol Farka increases in patients with alcoholic hepatosis.

The use of the drug may adversely affect the results of laboratory tests when quantitatively determining the content of glucose and uric acid in blood plasma.

The ability to influence reaction speed when driving vehicles or operating other mechanisms

Interaction with other drugs and other types of interactions

Probenecid halves the clearance of paracetamol by blocking its binding to glucuronic acid, therefore, when combined therapy with probenecid, the dose of paracetamol should be reduced.

Salicylates may increase the half-life of paracetamol from the body.

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) can contribute to the development of severe intoxication even with a slight overdose.

Pharmacological properties

Pharmacodynamics. Paracetamol has an analgesic and antipyretic effect, blocks cyclooxygenase (COX) I and II only in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete absence of anti-inflammatory effect. The lack of influence on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on water-salt metabolism (sodium and water retention) and the mucous membrane of the digestive tract.

Pharmacokinetics. The time of maximum concentration in blood plasma is reached after 15 minutes; maximum concentration – µg/ml. The volume of distribution is 1 l/kg. Paracetamol is weakly bound to plasma proteins. Penetrates the blood-brain barrier. Metabolized in the liver to form glucuronides and sulfates. A small part (4%) is metabolized by cytochrome P450 to form an intermediate metabolite (N-acetylbenzoquinoneimine), which under normal conditions is quickly neutralized by reduced glutathione and excreted in the urine after binding to cysteine ​​and mercaptopuric acid. However, with massive poisoning, the amount of this toxic metabolite increases. The half-life in adults is 2.7 hours, in children - 1.5-2 hours, in newborns - 3.5 hours, total clearance - 18 l/hour. Paracetamol is excreted mainly in the urine; 90% of the dose taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide (%) and sulfate (%). Less than 5% is excreted unchanged. In severe renal failure (creatinine clearance below ml/min), the elimination of paracetamol slows down slightly, and the half-life is 2-5.3 hours. The rate of excretion of glucuronide and sulfate in patients with severe renal failure is 3 times less than in healthy individuals. Pharmacokinetics in children is practically no different from adults, with the exception of a short half-life from the blood plasma (1.5-2 hours). In children under 10 years of age, conjugation with glucuronic acid is significantly reduced and more increased with sulfates compared to adults.

Basic physical and chemical properties

transparent colorless liquid with a yellowish tint.

Best before date

The drug is used in one dose, the remainder is poured out.

Storage conditions

In a place protected from light at a temperature not exceeding +25 °C.

Keep out of the reach of children.

Package

100 ml of solution (10 mg/ml) in a bottle. 12 bottles in a cardboard box.

Vacation category

Manufacturer

Amriya Pharmaceutical Industries, Arab Republic of Egypt (ARE).

Location

Amriya, 25 km, Alex Cairo Desert Road, Alexandria, Arab Republic of Egypt (ARE).

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PARACETAMOL

Analgesic-antipyretic. It has analgesic, antipyretic and weak anti-inflammatory effects. The mechanism of action is associated with inhibition of prostaglandin synthesis, with a predominant effect on the thermoregulation center in the hypothalamus.

After oral administration, paracetamol is rapidly absorbed from the gastrointestinal tract, mainly in the small intestine, mainly by passive transport. After a single dose of 500 mg, Cmax in blood plasma is reached after a minute and is about 6 μg/ml, then gradually decreases and after 6 hours it is μg/ml.

Widely distributed in tissues and mainly in body fluids, with the exception of adipose tissue and cerebrospinal fluid.

Protein binding is less than 10% and increases slightly with overdose. Sulfate and glucuronide metabolites do not bind to plasma proteins even at relatively high concentrations.

Paracetamol is metabolized primarily in the liver by conjugation with glucuronide, conjugation with sulfate and oxidation with the participation of mixed liver oxidases and cytochrome P450.

The negatively acting hydroxylated metabolite N-acetyl-p-benzoquinoneimine, which is formed in very small quantities in the liver and kidneys by mixed oxidases and is usually detoxified by binding to glutathione, can escalate with paracetamol overdose and cause tissue damage.

In adults, most paracetamol is bound to glucuronic acid and, to a lesser extent, to sulfuric acid. These conjugated metabolites do not have biological activity. In premature infants, newborns and in the first year of life, the sulfate metabolite predominates.

T1/2 is 1-3 hours. In patients with liver cirrhosis, T1/2 is slightly longer. The renal clearance of paracetamol is 5%.

It is excreted in the urine mainly in the form of glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol.

Orally or rectally in adults and adolescents weighing more than 60 kg, use a single dose of 500 mg, frequency of administration - up to 4 times a day. Maximum duration of treatment days.

Maximum doses: one-time - 1 g, daily - 4 g.

Single doses for oral administration for children aged 6-12 years mg, 1-5 years mg, from 3 months to 1 year mg, up to 3 months - 10 mg/kg. Single doses for rectal use in children aged 6-12 years mg, 1-5 years mg.

The frequency of use is 4 times a day with an interval of at least 4 hours. The maximum duration of treatment is 3 days.

Maximum dose: 4 single doses per day.

From the digestive system: rarely - dyspeptic symptoms; with long-term use in high doses - hepatotoxic effects.

From the hematopoietic system: rarely - thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis.

Allergic reactions: rarely - skin rash, itching, urticaria.

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.

Use with caution in patients with impaired liver and kidney function, with benign hyperbilirubinemia, as well as in elderly patients.

With long-term use of paracetamol, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

It is used to treat premenstrual tension syndrome in combination with pamabrom (a diuretic, a xanthine derivative) and mepiramine (a histamine H1 receptor blocker).

Paracetamol penetrates the placental barrier. To date, there have been no negative effects of paracetamol on the fetus in humans.

Paracetamol is excreted in breast milk: the content in milk is 0.04-0.23% of the dose taken by the mother.

If it is necessary to use paracetamol during pregnancy and lactation (breastfeeding), you should carefully weigh the expected benefits of therapy for the mother and the potential risk to the fetus or child.

IN experimental studies The embryotoxic, teratogenic and mutagenic effects of paracetamol have not been established.

Perfalgan (brief) - official instructions for use

REGISTRATION NUMBER - P No. 016008/01

TRADE NAME OF THE DRUG: Perfalgan

INTERNATIONAL NON-PROPENTED NAME - Paracetamol

DOSAGE FORM - solution for infusion

Compound:

One ppm solution contains:

Active ingredients: Paracetamol - 10 mg;

Excipients: mannitol, cysteine ​​hydrochloride monohydrate, disodium phosphate dihydrate, sodium hydroxide, concentrated hydrochloric acid, water for injection, nitrogen.

DESCRIPTION. A transparent, colorless or slightly yellowish solution without visible mechanical inclusions.

PHARMACOTHERAPEUTIC GROUP - analgesic non-narcotic drug.

ATX code.

Pharmacological properties

Perfalgan (paracetamol) has analgesic and antipyretic effects. The drug blocks cyclooxygenase I and II mainly in the central nervous system, affecting the centers of pain and thermoregulation. The lack of influence on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.

The maximum concentration in blood plasma is reached after IS min and is µg/ml. The volume of distribution is I l/kg. Paracetamol weakly binds to plasma proteins and penetrates the blood-brain barrier.

Metabolized in the liver to form glucuronides and sulfates. A small part (4%) of the drug is metabolized by cytochrome P450 to form an intermediate metabolite (N-acetylbenzoquinoneimine), which under normal conditions is quickly neutralized by reduced glutathione and excreted in the urine after binding to cysteine ​​and mercaptopuric acid. However, with massive intoxication, the amount of this toxic metabolite increases. The half-life in adults is 2.7 hours, in children - 1.5-2 hours, in newborns - 3.5 hours, total clearance 18 l/hour. Paracetamol is excreted mainly in the urine; 90% of the dose taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide (60-80%) and sulfate (20-30%). Less than 5% is excreted unchanged. In severe renal failure (creatinine clearance below ml/min), the excretion of paracetamol slows down somewhat, and the half-life is 2-5.3 hours. The rate of excretion of hayucuronide and sulfate in patients with severe renal failure is 3 times less than in healthy patients.

Indications for use

• Pain syndrome of moderate intensity, especially after surgical interventions.
• Feverish syndrome against the background of infectious and inflammatory diseases.
• The drug is indicated for rapid relief of pain and fever, including when the oral route of administration is difficult.

Contraindications

• Hypersensitivity to paracetamol or propacetamol hydrochloride (prodrug of paracetamol) or any other component of the drug.
• Severe liver dysfunction.
• Children's age up to 12 years.

With caution - severe renal failure (creatinine clearance< 30 мл/мин), доброкачественные гипербилирубинемии (в т.ч. синдром Жильбера, вирусный гепатит, алкогольное поражение печени), алкоголизм, пожилой возраст, дефицит глюкозо-6-фосфатдегидрогеназы.

Pregnancy and lactation

The drug should be used with caution during pregnancy and breastfeeding.

Directions for use and doses

Side effect

Storage conditions:

At a temperature of "C.

KEEP OUT OF REACH OF CHILDREN!

Best before date

Conditions for dispensing from pharmacies:

Manufacturer:

Bristol-Myers Squibb, France

304, avenue du Doctor Jean BraAGEN-France

For more information, contact your Bristol-Myers Squibb Representative.

Perfalgan

Active ingredient:

Pharmacological group

Nosological classification (ICD-10)

Composition and release form

in glass bottles of 50 or 100 ml; in a cardboard box 1 or 12 bottles.

Description of the dosage form

Transparent, colorless or slightly yellowish solution without visible mechanical inclusions.

Pharmacological action

Pharmacodynamics

It has a predominantly analgesic and antipyretic effect. Blocks cyclooxygenase I and II in the central nervous system, affects the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the lack of anti-inflammatory effect. It does not affect the synthesis of PG in peripheral tissues, therefore it does not have a negative effect on water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa.

Pharmacokinetics

Cmax in blood plasma is reached after 15 minutes and is 15–30 µg/ml. Volume of distribution - 1 l/kg. Weakly binds to plasma proteins. Passes through the BBB. Metabolized in the liver to form glucuronides and sulfates. A small portion (4%) is metabolized by cytochrome P450 to form an intermediate metabolite (N-acetylbenzoquinone imine). Under normal conditions, it is quickly detoxified by reduced glutathione and excreted in the urine after binding to cysteine ​​and mercaptopuric acid. With massive intoxication, the concentration of this toxic metabolite increases. T1/2 in adults is 2.7 hours, in children - 1.5–2 hours, in newborns - 3.5 hours. Total clearance - 18 l/hour. Excreted mainly in urine; 90% of the dose taken is within 24 hours in the form of glucuronide (60–80%) and sulfate (20–30%). Less than 5% is excreted unchanged. In severe renal failure (Cl creatinine below 10–30 ml/min), the excretion of paracetamol slows down somewhat, T1/2 is 2–5.3 hours. The rate of excretion of glucuronide and sulfate in patients with severe renal failure is 3 times less than in healthy.

Indications for the drug Perfalgan

pain of moderate intensity, especially after surgery;

febrile syndrome due to infectious diseases. The drug is indicated for rapid pain relief, incl. when the oral route of administration is difficult.

Contraindications

hypersensitivity to paracetamol or propacetamol hydrochloride (prodrug of paracetamol) or any other component of the drug;

severe liver dysfunction;

children's age up to 1 year.

when prescribing paracetamol to patients with severe renal failure (Cl creatinine<30 мл/мин);

benign hyperbilirubinemia (including Gilbert's syndrome, viral hepatitis, alcoholic liver damage);

with glucose-6-phosphate dehydrogenase deficiency;

elderly patients.

Use during pregnancy and breastfeeding

Should be used with caution during pregnancy and breastfeeding. There were no adverse effects observed in children when using paracetamol during breastfeeding.

Side effects

From the skin: skin itching, rash on the skin and mucous membranes (usually erythematous or urticarial), Quincke's edema.

From the gastrointestinal tract: increased activity of liver enzymes (usually without the development of jaundice).

From the cardiovascular system: arterial hypotension.

From the hematopoietic organs: thrombocytopenia.

Interaction

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication even with a small overdose of paracetamol. Long-term use of barbiturates reduces the effectiveness of paracetamol. Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxicity.

Long-term combined use with other NSAIDs increases the risk of developing nephropathy, renal papillary necrosis and end-stage renal failure. Long-term combined use of high doses of paracetamol with salicylates increases the risk of developing kidney or bladder cancer.

Diflunisal increases the concentration of paracetamol in the blood plasma by 50% (risk of hepatotoxicity).

Directions for use and doses

IV, once, as an infusion over 15 minutes.

Opened and unused medication should be destroyed. Additional dilution with 0.9% sodium chloride solution is allowed, maximum 10 times. This diluted solution should be used within one hour of its preparation (including the time of infusion).

Children from 1 year to 11 years (with body weight up to 34 kg) - 15 mg/kg paracetamol per infusion, i.e. 1.5 ml solution per 1 kg of body weight up to 4 times a day. The minimum interval between administrations is 4 hours. The maximum daily dose is no more than 60 mg/kg.

Adults and adolescents (over 12 years of age) weighing 35–50 kg, 15 mg/kg per injection (1.5 ml/kg). The maximum daily dose is no more than 60 mg/kg body weight. The minimum interval between injections is 4 hours.

For adults and adolescents (over 12 years old) with a body weight of more than 50 kg, the maximum single dose is 1 g (1 vial 100 ml), daily dose is 4 g. The interval between administrations of the drug is at least 4 hours.

In patients with impaired liver or kidney function, with Gilbert's syndrome and the elderly, the daily dose is reduced and administered at intervals of at least 8 hours.

Overdose

Symptoms acute overdose (develops within 24 hours after administration of paracetamol): gastrointestinal disorders (diarrhea, loss of appetite, nausea and vomiting, abdominal discomfort and/or abdominal pain), pallor of the skin. 12–13 hours after the administration of paracetamol, there is an increase in the activity of liver transaminases, lactate dehydrogenase and bilirubin levels, as well as a decrease in prothrombin levels. When administered simultaneously to adults of 7.5 g or more or to children of more than 140 mg/kg, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death.

Symptoms of chronic overdose (manifest 2–4 days after exceeding the dose of the drug): hepatotoxic effect, characterized by general (pain, weakness, adynamia, increased sweating) and specific (liver) symptoms. The hepatotoxic effect can lead to the development of hepatonecrosis and is complicated by the development of hepatic encephalopathy (impaired thinking, depression of higher nervous activity, agitation and stupor), convulsions, respiratory depression, coma, cerebral edema, bleeding disorders, development of disseminated intravascular coagulation syndrome, hypoglycemia, metabolic acidosis, arrhythmias, collapse.

Rarely, liver dysfunction develops at lightning speed and is complicated by renal failure (tubular necrosis).

Treatment acute overdose: administration of SH-group donors and precursors for glutathione synthesis - methionine (8–9 hours after overdose) and N-acetylcysteine ​​(12 hours). The need for further administration of methionine and N-acetylcysteine ​​is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration.

Special instructions

The risk of developing liver damage increases in patients with alcoholic hepatosis.

Distorts laboratory test results in the quantitative determination of glucose and uric acid in plasma.

During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

An open and unused bottle must be destroyed.

Storage conditions for the drug Perfalgan

Keep out of the reach of children.

Shelf life of the drug Perfalgan

Do not use after the expiration date stated on the package.

Paracetamol, solution for infusion 10 mg/ml

Paracetamol, solution for infusion 10 mg/ml

Chemical name: N-(4-hydroxyphenyl) acetamide

The drug is transparent, colorless or slightly yellowish

active ingredient – ​​paracetamol;

100 ml of solution contains 1 g of paracetamol;

excipients: anhydrous glucose, sodium citrate for injection, sodium acetate

trihydrate, diluted acetic acid, water for injection

Solution for infusion 10 mg/ml

Anilides. Analgesics, antipyretics. PBX code N02BE01

Paracetamol has analgesic and antipyretic effects. Preparation

blocks cyclooxygenase I and II mainly in the central nervous system, affects pain centers and

thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effects of

paracetamol on cyclooxygenase, which explains the almost complete absence

anti-inflammatory effect. There is no effect on the synthesis of prostaglandins in

peripheral tissues, therefore does not have a negative effect on water-salt

metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.

The time of maximum concentration in blood plasma is reached 15 minutes after

intravenous infusion and is 30 mcg/ml. The volume of distribution is 1 l/kg.

Paracetamol is weakly bound to plasma proteins. Penetrates through the blood-brain

barrier, 20 minutes after intravenous infusion of 1 g in the cerebrospinal fluid

a significant concentration of paracetamol is detected (about 1.5 µm/ml).

Metabolized in the liver to form glucuronides and sulfates. Small part

(4%) of the drug is metabolized by cytochrome P450 with the formation of an intermediate

metabolite (N-acetylbenzoquinoneimine), which under normal conditions quickly

is neutralized by reduced glutathione and excreted in the urine after binding to

cysteine ​​and mercaptopuric acid. However, with massive intoxication, the amount

of this toxic metabolite increases. The half-life in adults is 2.7 hours,

in children - 1.5 - 2 hours, in newborns - 3.5 hours, total clearance 18 l/hour. Paracetamol is eliminated

mainly in the urine, 90% of the dose taken is excreted by the kidneys within 24 hours, in

mainly in the form of glucuronide (%) and sulfate (%). Less than 5% is excreted into

unchanged. In severe renal failure (creatinine clearance below 10-

30 ml/min) the elimination of paracetamol slows down somewhat, and the half-life

is 2 - 5.3 hours. The rate of excretion of glucuronide and sulfate in patients with severe

renal failure is 3 times less than in healthy patients.

Intravenously. Paracetamol infusion is indicated for the short-term treatment of moderate

pain, especially after surgery and for short-term treatment of fever when

intravenous administration is clinically justified or there is an urgent need for

analgesic treatment or in the relief of hyperthermia and/or when administered during

using other routes of administration is not possible.

Paracetamol for infusion is used to quickly relieve pain and/or

hyperthermic syndrome, when exclusively intravenous administration is required

drug. The duration of the intravenous infusion should be 15 minutes.

infusion (10 mg/ml)

to the reception, which

based on the top

≤ 10 kg* 7.5 mg/kg 0.75 ml/kg 7.5 ml 30 mg/kg

> 10 kg to ≤ 33 kg 15 mg/kg 1.5 ml/kg 49.5 ml 60 mg/kg not more than 2 g

> 33 kg to ≤ 50 kg 15 mg/kg 1.5 ml/kg 75 ml 60 mg/kg not more than 3 g

1 g 100 ml 100 ml 3 g

1 g 100 ml 100 ml 4 g

**Maximum daily dose. Maximum daily dose as indicated in the table

higher, for patients not receiving other drugs containing paracetamol or dose

should be adjusted accordingly to take paracetamol

***Patients with lower body weight will require smaller volumes.

The minimum interval between each dose should be at least 4 hours.

Minimum interval between each dose in patients with severe renal impairment

insufficiency must be at least 6 hours.

No more than 4 doses should be administered within 24 hours.

(creatinine clearance< 30 мл / мин), увеличить минимальный интервал между каждым

administration up to 6 hours.

In adults with hepatocellular insufficiency, chronic alcoholism,

chronic malnutrition (low liver glutathione reserves), dehydration

the maximum daily dose should not exceed 3 g.

Patients weighing ≤10 kg: ready-made solution for infusion 100 mg/ml in polymer

containers is not suitable for administration to this group of patients, since it does not provide

15 minute introduction.

The volume of solution of 10 mg/ml required for administration must be drawn from the container

polymer and diluted in 0.9% sodium chloride solution or 5% glucose solution until

one tenth (one volume of paracetamol solution 10 mg/ml per nine volumes of diluent)

and administered within 15 minutes. 5 or 10 ml syringes should be used for measurement

doses as needed for baby's weight and desired volume. However, never

should exceed 7.5 ml per administration.

The user should refer to the product information for guidelines

As with all solutions for infusion presented in polymer containers, you should

remember that careful monitoring is necessary especially at the end of infusions, regardless of

routes of administration. This monitoring at the end of perfusion is necessary to avoid air leakage.

Features of use Be careful when prescribing and administering

paracetamol for infusion to avoid dosing errors due to confusion between

and death. Take care to ensure proper dose. When filling out prescriptions

It is necessary to include both the total dose in mg and the total volume of solution prescribed.

It is necessary to monitor the accuracy of the dosage.

As with all paracetamol drugs, adverse reactions are rare (> 1/10000,

<1/1000) и очень редко (<1/10000), они описаны ниже:

General Discomfort Reactions

Liver Level Up

tests (pain and burning).

Very rare cases of hypersensitivity reactions ranging from simple skin rash or

urticaria prior to anaphylactic shock have been reported and require cessation

There have been no reports of cases of erythema, redness, itching, or tachycardia.

Paracetamol solution for infusion is contraindicated:

In patients with hypersensitivity to paracetamol or proparacetamol

hydrochloride (a prodrug of paracetamol) or one of the excipients.

In cases of severe hepatocellular failure.

There is a risk of liver damage (including fulminant hepatitis, hepatic

failure, cholestatic hepatitis, cytolytic hepatitis), especially in the elderly

patients, young children, patients with liver diseases, chronic

alcoholism, in patients with chronic malnutrition and in patients receiving

enzyme inducers. Overdose can lead to death in these cases.

Symptoms usually appear within the first 24 hours and include: nausea,

vomiting, anorexia, pallor, abdominal pain. Overdose of 7.5 g or more of paracetamol with

a single dose in adults and 140 mg/kg body weight as a single dose in children

may cause hepatic cytolysis, which can lead to complete and

irreversible necrosis, as a result of hepatocellular failure to

metabolic acidosis and encephalopathy, which can lead to coma and death.

At the same time, an increase in the level of liver transaminases (AST, ALT),

lactate dehydrogenase and bilirubin are observed together with a decrease in prothrombin levels,

which may appear 12 to 48 hours after administration.

Clinical symptoms of liver damage usually first appear through

two days and reaches a maximum after 4 to 6 days.

Before starting treatment, you need to take a blood test to measure levels

Treatment includes administration of the antidote N-acetylcysteine ​​(NAC), if possible.

intravenously or orally, if possible, before the 10th hour. NAC, however, can give

some degree of protection even after 10 hours, but in these cases a long

Liver tests should be performed at the start of treatment and repeated every 24 hours. IN

In most cases, liver transaminases return to normal levels within

within one to two weeks with complete restitution of liver function. In very severe cases

A liver transplant may be necessary.

Paracetamol should be used with caution in the following cases:

For hepatocellular insufficiency;

In severe renal failure (creatinine clearance< 30 мл / мин);

For chronic alcoholism;

For chronic malnutrition (low liver reserves, glutathione);

Risk of medical errors

Be careful to avoid dosing errors due to confusion between

milligrams (mg) and milliliters (ml), which may lead to accidental overdose

To avoid the risk of overdose, make sure that other drugs you take

the medicines do not contain paracetamol or proparacetamol.

Clinical symptoms and signs of liver damage (including fulminant hepatitis,

liver failure, cholestatic hepatitis, cytolytic hepatitis), such as

As a rule, they are first recorded after two days of taking the drug with a peak manifestation, as

usually put it on. Antidote treatment should be started as soon as possible.

Probenecid causes an almost 2-fold decrease in the clearance of paracetamol by

inhibition of conjugation with glucuronic acid. Reducing the dose of paracetamol should

be considered for concomitant treatment with probenecid.

Salicylamide may prolong the elimination half-life of paracetamol.

Attention should be paid to the concomitant use of enzyme-inducing substances.

Concomitant use of paracetamol (4 g per day for 4 days) with oral

anticoagulants may lead to slight variations in MHO. In this case should

enhanced monitoring of MHO should be carried out during concomitant use

paracetamol and anticoagulants, as well as for 1 week after stopping treatment

Clinical experience with intravenous paracetamol is limited. Nevertheless,

epidemiological data on the use of oral therapeutic doses

paracetamol indicate the absence of undesirable effects on the course of pregnancy

or on fetal/newborn health.

Prospective data on overdosed pregnant women have not shown

increased risk of developmental defects.

Reproduction studies with intravenous paracetamol have not been conducted in

animals. However, studies using the oral route have not shown any effect

developmental defects or fetotoxic effects.

However, paracetamol infusion should be used during pregnancy

only after a careful assessment of benefits and risks. In this case, the recommended dosage and

duration must be strictly observed.

After oral administration, paracetamol is excreted into breast milk in small quantities.

There are no reports of adverse effects in infants.

Therefore, paracetamol for infusion can be used by women who are breastfeeding.

Impact on the ability to drive a car and operate machinery

In a place protected from light at a temperature not exceeding 25 ° C. Keep out of reach of

2 years. Do not use after the expiration date stated on the package.

By doctor's prescription.

100 ml in polymer containers for infusion solutions in package No. 1.

For hospitals: 100 ml in polymer containers for infusion solutions in

packaging No. 80, 100.

Belarusian-Dutch joint venture company with

limited liability company "Farmland", Republic of Belarus,

222603, Minsk region, Nesvizh, st. Leninskaya, 124-3

Tel/fax, tel. 8(01770)63939

Paracetamol

Manufacturer: Sintez OJSC Russia

PBX code: N02BE01

Release form: Liquid dosage forms. Oral suspension.

General characteristics. Compound:

Active substance: paracetamol - 2.4 g. Excipients: methyl parahydroxybenzoate (nipagin or methylparaben), liquid sorbitol, glycerol (distilled glycerin), xanthan gum, azorubine dye (acid red 2C), strawberry flavor (food flavor "Strawberry"), sucrose (refined sugar), purified water - up to 100 ml.

Pharmacological properties:

A non-narcotic analgesic, it blocks cyclooxygenase (COX) 1 and COX 2 mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete absence of anti-inflammatory effect. The absence of a blocking effect on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.

Pharmacokinetics. Absorption - high, time to reach maximum concentration (TCmax) - 0.5-2 hours; maximum concentration (Cmax) µg/ml. Communication with plasma proteins - 15%. Penetrates the blood-brain barrier. The therapeutically effective concentration of paracetamol in plasma is achieved when administered in dosemg/kg. Metabolized in the liver (90-95%): 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites, which conjugate with glutathione to form inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP2E1 isoenzyme is also involved in the metabolism of the drug. Half-life (T1/2) h. Excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged.

Indications for use:

Used in children from 1 month (in children 1-3 months of age, use for all indications is possible only as prescribed by a pediatrician) as:

Antipyretic - for acute respiratory diseases, influenza and childhood infectious diseases (chicken pox, mumps, measles, rubella, scarlet fever);

Anesthetic (analgesic) agent - for pain of mild to moderate intensity, including: headache and toothache, myalgia, arthralgia, ear pain with otitis media, sore throat, neuralgia, pain from injuries and burns.

Directions for use and dosage:

Orally, before meals, undiluted, with water, 3-4 times a day with an interval of 4-6 hours. Before use, the contents of the bottle should be shaken well. For convenience and accuracy of dosing, we recommend using a double-sided spoon: a large spoon contains 5 ml (120 mg of paracetamol), a small spoon - 2.5 ml (60 mg of paracetamol), or a spoon that has two marks: the lower one corresponds to 2.5 ml (60 mg of paracetamol ) and top - 5 ml (120 mg paracetamol). The dose of the drug depends on the age and body weight of the child. A single dose of the drug is mg/kg body weight. The maximum daily dose is no more than 60 mg/kg of the child’s body weight. Depending on age, the drug is prescribed in the following single doses: from 1 to 3 months - about 2 ml of suspension (about 50 mg of paracetamol), from 3 months to 1 year - 2.5-5 ml of suspension (mg of paracetamol), from 1 year up to 6 letml suspension (mg paracetamol), from 6 to 14 letml suspension (mg paracetamol).

The maximum duration of treatment without consulting a doctor is no more than 3 days as an antipyretic and no more than 5 days as an analgesic.

Continue treatment with the drug after consulting a doctor.

Features of application:

The simultaneous use of paracetamol with other paracetamol-containing drugs should be avoided, as this may cause an overdose of paracetamol.

If the febrile syndrome continues during the use of paracetamol for more than 3 days and pain syndrome for more than 5 days, a doctor’s consultation is required.

Distorts laboratory test results in the quantitative determination of glucose and uric acid in plasma.

During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

The risk of developing liver damage increases in patients with alcoholic liver disease. Concomitant use with ethanol is not recommended.

The suspension contains 0.04 XE of sucrose per 1 ml, which should be taken into account when treating patients with diabetes.

Side effects:

Allergic reactions (including skin rash).

Interaction with other drugs:

Reduces the effectiveness of uricosuric drugs.

Concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (decreased synthesis of procoagulant factors in the liver).

Inducers of microsomal oxidation in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications even with a slight overdose.

Ethanol contributes to the development of acute pancreatitis.

Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxicity.

Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Long-term combined use of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of developing “analgesic” nephropathy and renal papillary necrosis, and the onset of end-stage renal failure.

Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Contraindications:

Hypersensitivity to paracetamol or other components of the drug;

Severe dysfunction of the liver and kidneys;

Diseases of the blood system;

Genetic absence of glucose-6-phosphate dehydrogenase;

Newborn period (up to 1 month).

Overdose:

Symptoms: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; impaired glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear one hour after an overdose. In case of severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis.

Treatment: gastric lavage no later than 4 hours after poisoning, taking adsorbents (activated carbon, Polyphepan (hydrolytic lignin)). Administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after an overdose and acetylcysteine ​​- after 12 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, and also on the time elapsed after taking it.

Storage conditions:

In a place protected from light at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children.

Shelf life: 2 years. Do not use after expiration date.

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Paracetamol Routek solution for infusion

PRESCRIPTION MEDICINES ARE PRESCRIBED TO THE PATIENT ONLY BY A DOCTOR. THIS INSTRUCTION IS FOR MEDICAL PROFESSIONALS ONLY.

INSTRUCTIONS for the use of the drug for medical use Paracetamol Routek

Registration number LP1213

Trade name: Paracetamol Routek

International nonproprietary name: Paracetamol

Dosage form: solution for infusion

1.0 ml of solution contains:

Paracetamol 10.0 mg

Excipients: mannitol 50.0 mg, sodium hydrogen phosphate 0.25 mg, sodium hydroxide to pH from 4.5 to 6.5, hydrochloric acid to pH from 4.5 to 6.5, water for injection up to 1.0 ml .

Description: Transparent colorless or light yellow solution.

Pharmacotherapeutic group: non-narcotic analgesic.

PHARMACOLOGICAL PROPERTIES

Paracetamol has analgesic, antipyretic and weak anti-inflammatory effects.

The analgesic effect of paracetamol occurs within 5 to 10 minutes after the start of the infusion and reaches a maximum after 1 hour; duration of action - 4 - 6 hours.

The antipyretic effect of paracetamol occurs within 30 minutes after the start of the infusion; duration of action is at least 6 hours.

The exact mechanism of the analgesic and antipyretic effect of paracetamol has not been established. Apparently, it includes central and peripheral components.

It is known that paracetamol inhibits cyclooxygenase I and II mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains its almost complete lack of anti-inflammatory effect. The lack of influence on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.

With single and repeated administration of paracetamol over 24 hours in doses of up to 2 g, its pharmacokinetics is linear.

The bioavailability of paracetamol when administered as an infusion at a dose of 1 g does not differ from the bioavailability of 2 g of propacetamol (contains 1 g of paracetamol). The maximum concentration of paracetamol in the blood plasma is reached 15 minutes after intravenous infusion at a dose of 1 g and is 30 mcg/ml. The volume of distribution in adults is 1 l/kg. Paracetamol is weakly bound to plasma proteins. Penetrates the blood-brain barrier; 20 minutes after intravenous infusion of 1 g of the drug, a high concentration of paracetamol (about 1.5 µmol/ml) is detected in the cerebrospinal fluid.

In adults, paracetamol is metabolized mainly in the liver to form glucuronides and sulfates. A small part (4%) of paracetamol is metabolized by cytochrome P450 to form an active intermediate metabolite (N-acetylbenzoquinoneimine), which under normal conditions is quickly neutralized by reduced glutathione and excreted in the urine after binding to cysteine ​​and mercapturic acid. However, with a massive overdose, the amount of this toxic metabolite increases. The half-life in adults is 2.7 hours, in children 1.5 - 2 hours, total clearance is 18 l/h. Paracetamol is excreted mainly in the urine; 90% of the dose taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide (60 - 80%) and sulfate (20 - 30%). Less than 5% is excreted unchanged. In severe renal failure (creatinine clearance) The rate of excretion of glucuronide and sulfate in patients with severe renal failure is 3 times lower than in healthy volunteers.

The pharmacokinetics of paracetamol in elderly patients does not change; in children, only the plasma half-life differs, which is slightly shorter compared to adults (1.5 - 2 hours). In addition, in children under 10 years of age, paracetamol is largely excreted in the form of sulfate rather than glucuronide, which is typical for adult patients. At the same time, the total clearance of paracetamol and its metabolites in patients of all age groups is the same.

Indications for use

Short-term treatment of moderate pain (especially in the postoperative period) and short-term relief of fever when intravenous administration is clinically justified or administration by other routes is not possible.

Contraindications

Hypersensitivity to paracetamol or propacetamol hydrochloride (a prodrug of paracetamol) or any other component of the drug.

Severe liver failure.

Children's age up to 3 months.

With caution

Severe renal failure (creatinine clearance

Use during pregnancy and breastfeeding

Clinical experience with intravenous paracetamol is limited. However, according to epidemiological data on the ingestion of paracetamol in therapeutic doses, no undesirable effects on the course of pregnancy or the health of the fetus and newborn have been identified.

Overdose of paracetamol during pregnancy does not increase the risk of congenital malformations.

Animal reproductive toxicity studies have not been conducted with intravenous paracetamol formulations. Studies with oral paracetamol have not demonstrated teratogenic or fetotoxic potential.

In this regard, the drug should be used during pregnancy only if the expected benefit outweighs the possible risk to the mother and fetus, strictly observing the dosage regimen and the timing of treatment.

After taking paracetamol orally, it passes into breast milk in small quantities. No adverse effects on the child were reported. Paracetamol can be used during breastfeeding if the expected benefit to the mother outweighs the risk to the baby.

Directions for use and doses

Inadvertently exceeding recommended doses may result in serious impairment of liver function, including death. When determining the dose, the individual risk factors for hepatotoxicity present in the patient should also be taken into account, including liver failure, chronic alcoholism, chronic malnutrition, and dehydration.