Actimol Suspension

Actimol Suspension

paracetamol

Manufacturer:

Idaman Pharma

Distributor:

Pharmaniaga Logistics
Full Prescribing Info
Contents
Paracetamol.
Description
Each 5ml contains: Active Ingredient: Paracetamol 250 mg.
Preservatives: Methylparaben 9 mg and Propylparaben 1 mg.
Action
Pharmacology: Pharmacodynamics: Paracetamol is a centrally acting analgesic and antipyretic with minimal anti-inflammatory properties.
Analgesic: The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (specifically cyclooxygenase (COX)-2) and, to a lesser extent, through a peripheral action by blocking pain-impulse generation.
The peripheral action may also be due to inhibition of prostaglandin synthesis or inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation.
Antipyretic: Paracetamol act centrally on the hypothalamic heat-regulating centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. Paracetamol reduces fever by inhibiting the formulation and release of prostaglandins in the CNS and by inhibiting endogenous pyrogens at the hypothalamic thermoregulator centre.
Pharmacokinetics: Following oral administration, paracetamol is rapidly absorbed.
Paracetamol absorption takes place mainly in the small intestine and therefore the rate of absorption is depending on the rate of gastric emptying. It has been shown that drugs which delay gastric emptying also delay the absorption of paracetamol whereas metoclopramide (a drug which increases the rate of gastric emptying) accelerates absorption of the analgesic through the total amount absorbed.
The presence of food in the stomach has also been reported to reduce the rate of absorption of paracetamol. Alterations in gastric pH have no significant effect on paracetamol absorption. During absorption, the amount of paracetamol which is inactivated is negligible and it has been shown that paracetamol does not affect gastric mucosal permeability and does not produce mucosal bleeding.
Peak plasma concentrations reached 1 hour after absorption. The plasma half-life is 1 to 3 hours.
Paracetamol penetrates the brain and is present in breast milk of human. Paracetamol is metabolized by the microsomal enzyme system of the liver. This metabolism is mainly to the glucuronide and sulphate conjugates, accounting for approximately 49% and 26% of the ingested dose respectively. About 4% is excreted as free paracetamol. Other minor pathways include the production of catechol derivatives and cysteine conjugates (via glutathione). Paracetamol excretion is rapid and occurs via the urine.
Indications/Uses
Actimol is used for the relief of: Fever, Headache and symptoms of cold and flu, Toothache and discomfort of teething, Fever after vaccination.
Dosage/Direction for Use
Give in 6 hourly intervals; not more than 4 times a day. (See Table 1.)

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The previously mentioned table is based on the average weight-age grid of children. If the patient knows the body weight of their child, it's always more accurate to use the weight to arrive at the correct dose. Please refer as follows.
Using the body weight of your child, you can calculate the dose of ActiMol your child needs. Calculation is based on recommended dose of 15mg per body weight in kg (BW). (See equation.)

Click on icon to see table/diagram/image

Table 2 as follows provides the dose of ActiMol to be given, based on body weight. (See Table 2.)

Click on icon to see table/diagram/image

SHAKE WELL BEFORE USE.
Route of Administration: Oral.
Overdosage
Liver damage is possible in adults who have taken 10 g or more of Paracetamol. Ingestion of 5g or more of Paracetamol may lead to liver damage if the patient has risk factors.
Risk Factors: If the patient: 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: Toxic symptoms include vomiting, abdominal pain, hypotension, sweating, pallor, nausea, anorexia and abdominal pain. The most serious adverse effect of acute overdose of paracetamol is a dose-dependent, potentially fatal hepatic necrosis. Clinical and laboratory evidence of hepatoxicity may be delayed for up to one week. Major manifestations of liver failure such as jaundice, hypoglycaemia and metabolic acidosis may take at least 3 days to develop. 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.
Treatment: In cases of overdose, methods of reducing the absorption of ingested drug are important. Despite 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. Gastric lavage is essential even if several hours have elapsed. Prompt administration of 50g activated charcoal and 500ml iced mannitol 20% by mouth, may reduce absorption. Plasma paracetamol concentration should be measure at 4 hours or later after ingestion (earlier concentration is unreliable). If the history suggests that 15g Paracetamol or more has been ingested, administer one of the following antidotes: Acetylcysteine 20% I.V.: Administer intravenously, 20% acetylcysteine immediately without waiting for positive urine test or plasma level results: initial dose of 150mg/kg over 15 minutes, followed by continuous infusion of 50mg/kg in 500ml 5% glucose/dextrose over 4 hours and 100mg/kg in 1L 5% glucose/dextrose over 16 hours. OR; Oral Methionine: 2.5g immediately followed by three further doses of 2.5g at four hourly intervals. For a 3 years old child, 1g methionine every four hours for four doses has been used; OR; Oral Acetylcysteine 5%: 140mg/kg as a loading dose, then 70mg/kg every 4 hours for a total of 17 maintenance doses. If more than ten hours have elapsed since the overdosage was taken, the antidote may be in ineffective.
Contraindications
Hypersensitivity to paracetamol or any of the other ingredients/components of the product. Severe and active hepatic impairment.
Warnings
This preparation contains PARACETAMOL. Do not take any other paracetamol containing medicines at the same time.
Special Precautions
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash. These could be signs of serious conditions. If these reactions occur, stop use and seek medical assistance right away.
Do not take if allergic to paracetamol.
Patients should contact their health care provider if symptoms persist (if the pain lasts for more than 10 days, if there is redness or fever lasts more than 3 days).
Paracetamol should be given with care to patients with impaired kidney or liver function.
Large doses should be avoided in patients with hepatic impairment. Paracetamol overdose may harm the liver.
Do not exceed recommended dose. Leave at least 4 hours between doses.
Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed serious liver damage.
Paracetamol provides symptomatic relief only, additional therapy to treat the cause of the pain or fever should be instituted when necessary.
Never give medicine exceeding the recommended dosage.
Effects on Ability to Drive and Use Machines: It is unlikely to impair a patient's ability to drive or use machinery.
Use In Pregnancy & Lactation
Use in pregnancy: Considered to be the analgesic of choice in pregnancy patients.
Although it crosses placenta, paracetamol is considered to be safe in normal therapeutic doses for short-term use as a minor analgesic/antipyretic in pregnancy.
Use in lactation: Excreted in breast milk.
Maternal ingestion of paracetamol in normal therapeutic does not appear to present a risk to the nursing infant.
Adverse Reactions
(See Table 3.)

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Drug Interactions
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect
.The hepatotoxicity of paracetamol, particularly after overdosage, may be increased by drugs which induce liver microsomal enzymes such as barbiturates, tricyclic antidepressants and alcohol.
Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
Antivirals: Regular use of Paracetamol possibly reduces metabolism of Zidovudine (increased risk of neutropenia).
The use of drugs that induce hepatic microsomal enzymes such as anticonvulsants and oral steroid contraceptives may increase the extent of metabolism of paracetamol resulting in reduced plasma concentrations of the drug and a faster elimination rate.
Storage
Store below 30°C. Keep container tightly closed. Protect from light and moisture.
MIMS Class
Analgesics (Non-Opioid) & Antipyretics
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Presentation/Packing
Oral susp (orange suspension with a mentholated sweet and sourish orange taste) 250 mg/5 mL x 60 mL.
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