Pharmacology: Pharmacodynamics: Pharmacological actions: Acetaminophen is the active metabolic of phenacetin and has antipyretic and analgesic activities. In peripheral tissue, acetaminophen is a weak COX-1 and COX-2 inhibitor. Acetaminophen appears to an equivalent to aspirin as an analgesic and antipyretic agent. However, acetaminophen lacks antiinflammatory properties, does not affect uric acid levels and does not inhibit platelet function.
Pharmacokinetics: Absorption/Distribution: Immediate-release acetaminophen is absorbed rapidly, and peak plasma levels are reached in 30 to 60 minutes. Acetaminophen is distributed throughout most body fluids and is slightly bound to plasma proteins.
Metabolism/Distribution: Approximately 90% of acetaminophen usually undergoes hepatic conjugation with glucuronide (40% to 67%) and sulfate (20% to 46%) to from inactive metabolites that are excreted in the urine. A small amout (5% to 15%) of acetaminophen is metabolized to N-acetyl-p-benzoquinoneimine (NAPQI), and the resulting complex is rendered harmless and excreted. After a large ingestion of acetaminophen, these pathways become satured, and glutathione stores become depleted. Therefore, NAPQI concentrations increase, which may cause hepatotoxicity. The elimination half-life of acetaminophen is about 2 to 3 hours. Less than 5% of acetaminophen is excreted unchanged.
Special populations: Hepatic function impairment: the half-life may increase 2 fold or more in patients with liver disease.
Relieves fever, aches and pain of flu, discomfort of teething and fever after vaccination.
Recommended Dosage: Maximum daily dose: 60 mg /kg presented in divided doses of 10 - 15 mg/kg throughout the 24 hour period.
Minimum dosing interval: 4 hours.
No more than four doses in any 24-hour period. Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.
Maximum duration of continued use without medical advice: 3 days.
For children under 3 months, if fever persists for more than 24 hours (4 doses), seek medical advice. This is to ensure that fever that may be due to a serious infection is quickly diagnosed.
Not recommended in children under 1 month.
Instruction for Use: Shake the bottle well before use.
Measure out the right amount using a measuring cup, oral syringe or medical spoon.
Do not exceed recommended dose.
Drink water after swallow LOTEMP KIDS.
Mode of Administration: Oral.
Liver damage is possible in adults who have taken 10 g or more of Paracetamol. Ingestion of 5 g or more of Paracetamol may lead to liver damage if the patient has risk factors.
Risk Factors: If the patient: a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes.
or b, Regularly consumes ethanol in excess of recommended amounts.
or c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms: Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management: Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma Paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 h from ingestion should be discussed with the NPIS or a liver unit.
When used for self-medication, do not use with other drug products containing acetaminophen or if allergic to acetaminophen or any of the inactive ingredients.
This preparation contains PARACETAMOL.
Do not take any other paracetamol containing medicines at the same time.
Ethanol use: Use with caution in patients with alcoholic liver disease; consuming 2 or more alcoholic drinks/day may increase the risk of liver damage.
Hepatotoxicity: Hepatotoxicity is usually associated with excessive acetaminophen intake and often involves more than one product that contains acetaminophen.
Self-medication: When used for self-medication, patients should be instructed to contact health care provider if symptoms get worse or new symptoms appear, redness or swelling is present in the painful area, fever lasts longer than 3 days (all ages), or pain lasts longer than 5 days for children and adolescent, if sore throat is severe, persists for longer than 2 days, or is followed by fever, rash, headache, nausea, or vomiting, consult health care provider immediately.
Glucose-6-phosphate dehydrogenase deficiency: Use with caution in patients with known glucose-6-phosphate dehydrogenase deficiency.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash.
These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.
Effects on Ability to Drive and Use Machines: This medicine does not affect ability to drive and use machine.
Pregnancy and Lactation: Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.
Dermatologic - Acute generalized exanthematous pustulosis (intravenous); severe dermatological reaction (intravenous); skin/rash (oral/rectal); Stevens-Johnson syndrome (intravenous); toxic epidermal necrolysis (intravenous).
Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.
Endocrine & Metabolic - Decreased serum bicarbonate (oral/rectal) decreased serum calcium (oral/rectal) decrease serum sodium (oral/rectal) hyperammonemia (oral/rectal); hyperchloremia (oral/rectal); hyperuricemia (oral/rectal); increased serum glucose (oral/rectal).
Hematologic & Oncologic - Anemia (oral/rectal); leukopenia (oral/rectal) ; neutropenia (oral/rectal); pancytopenia (oral/rectal).
Hepatic - Increased serum alkaline phosphatase (oral/rectal); increased serum bilirubin (oral/rectal).
Hypersensitivity – Hypersensitivity reaction (rare) (oral/rectal).
Renal - Renal disease (analgesic) (oral/rectal).
Genitourinary - Nephrotoxicity (with chronic overdose) (oral/rectal).
Hepatic - Hepatic injury (dose related).
Hypersensitivity - Anaphylaxis (intravenous); hypersensitivity reaction (intravenous).
Concurrent use of Paracetamol and Barbiturates (eg, phenobarbital): The potential hepatotoxicity of acetaminophen may be increased when large or chronic dose of barbiturates are coadministered. The therapeutic effects of acetaminophen may be reduced with barbiturate therapy.
Charcoal, activated: Charcoal can reduce the GI absorption of acetaminophen when administered as soon as possible after overdose.
Hydantoins (eg. phenytoin): The potential hepatotoxicity of acetaminophen may be increased when coadministered with sulfinperazone. The therapeutic effects of acetaminophen may be reduced with sulfinpyrazone therapy.
Isoniazid: May increase the risk of liver toxicity. Administer acetaminophen with caution to patients receiving isoniazid.
Lamotrigine: Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects. A clinically important interaction is unlikely to occur with a single dose or several doses of acetaminophen, if an interaction is suspected adjust the dose of lamotrigine if needed.
Sulfinpyrazone: the potential hepatotoxicity of acetaminophen may be increased when coadministered with sulfinpyrazone. The therapeutic effects of acetaminophen may be reduced with sulfinpyrazone therapy.
Store in the original package.
Store in a cool and dry place below 30°C. Protect from light. Do not refrigerate or freeze.
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Lotemp Kids oral susp 120 mg/5 mL
(bubblegum flavour) 60 mL x 1's
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