Paracetamol (paracetamol) rectal suppositories 150 mg. №10

Description

Paracetamol composition
active substance: paracetamol;
1 rectal suppository contains 150 mg of paracetamol;
excipient: solid fat.

Dosage form
Rectal suppositories.

Pharmacological properties
It has analgesic, antipyretic and weak anti-inflammatory effects. The mechanism of action is due to the inhibition of the synthesis of prostaglandins and the predominant effect on the center of thermoregulation in the hypothalamus.

Indications
Symptomatic treatment of diseases accompanied by mild to moderate pain and / or fever.

Contraindications
Hypersensitivity to paracetamol or other components of the drug.
Children up to 1 month old (child’s body weight up to 4 kg).
Severe renal and / or liver dysfunction, congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood diseases, severe anemia, leukopenia.
Inflammation of the rectal mucosa and dysfunction of the anus.
Do not use the drug for diarrhea.

Children
Apply the drug to children from 6 month.

Application during pregnancy or lactation
The drug in this dosage form should be used only for children.

Method of administration and dosage
The drug should be used under close medical supervision, with extreme caution – for children under 1 year old.
Apply rectally. Suppositories cannot be divided to obtain the required dosage. If the required single dose is less than the contents of one suppository, then after consulting a doctor, it is recommended to use other dosage forms of paracetamol (for example, oral solution).
When treating children, the dose should be calculated in accordance with the child’s body weight, and depending on this, the appropriate dosage form should be chosen. The approximate age of children based on body weight is given as a guideline only.
Paracetamol, rectal suppositories, 80 mg is intended for children weighing 4 to 6 kg (approximately from 1 to 4 months).
Paracetamol, rectal suppositories, 150 mg is intended for children weighing from 8 to 12 kg (approximately from 6 months to 2 years).
Apply from 3 to 4 suppositories per day with an interval between injections of 6 hours, depending on the child’s body weight at the rate of 60 mg / kg / day.
When treating children, the dosage regimen should be followed in accordance with the child’s body weight, and depending on this, the appropriate dosage form must be selected.

Overdose
To avoid overdose, do not use other medicines containing paracetamol.
There is a risk of overdose in young children (drug overdose and accidental poisoning are common). This can be fatal.
For children weighing less than 37 kg, the maximum daily dose of paracetamol should not exceed 80 mg / kg of body weight / day.
For children weighing from 38 kg to 50 kg, the maximum daily dose of paracetamol should not exceed 3 g / day.
For children weighing more than 50 kg, the maximum daily dose of paracetamol should not exceed 4 g / day.
With a single dose of 150 mg / kg of the child’s body weight, the drug can cause hepatocellular insufficiency, impaired glucose metabolism, metabolic acidosis, hemorrhages, hypoglycemia, encephalopathy, and coma and be fatal. At the same time, the level of hepatic transaminase, lactate dehydrogenase and bilirubin increases, the level of prothrombin decreases within 12-48 hours. Acute renal failure with acute tubular necrosis can present with severe lumbar pain, hematuria, proteinuria, and develop even in the absence of severe liver damage. Arrhythmia and pancreatitis have also been reported. With long-term use of the drug in large doses on the part of the hematopoietic organs, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, and thrombocytopenia may develop. When taking large doses from the central nervous system (central nervous system) – dizziness, psychomotor agitation and disorientation; from the urinary system – nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis); from the digestive system – hepatonecrosis. In patients with risk factors (long-term use of carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort or other drugs that induce liver enzymes; alcohol abuse; glutathione system deficiency, such as malnutrition, AIDS, starvation, cystic fibrosis, cachexia), use 5 g or more paracetamol can lead to liver damage. Liver damage can occur 12-48 hours after overdose. In case of an overdose, the patient should be immediately taken to the hospital, even if there are no early symptoms of an overdose. Overdose symptoms appear within the first 24 hours: nausea, vomiting, loss of appetite, pallor, abdominal pain. Symptoms may not reflect the severity of the overdose or the risk of injury.
Urgent measures:

• immediate hospitalization;
• determination of the level of paracetamol in blood plasma;
• gastric lavage;
• intravenous administration of the antidote N-acetylcysteine ​​or oral methionine during the first 10 hours;
• symptomatic therapy.

Side effects:

• Allergic reactions: anaphylaxis, anaphylactic shock, Quincke’s edema, erythema, urticaria, pruritus, rash on the skin and mucous membranes, exudative erythema multiforme, toxic epidermal necrolysis.
• From the side of hematopoiesis: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia, thrombocytopenia, leukopenia and neutropenia.
• From the respiratory system: bronchospasm in patients sensitive to aspirin and other NSAIDs (non-steroidal anti-inflammatory drugs).
• On the part of the digestive system: nausea, epigastric pain, abnormal liver function, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).
• From the endocrine system: hypoglycemia, up to hypoglycemic coma.
• Associated with the dosage form: irritation of the rectum and anus.

If any adverse reactions occur, you should stop using the drug and always consult a doctor.

Shelf life
3 years.

Storage conditions
Store in its original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.