Panadol Extend

Panadol Extend

paracetamol

Manufacturer:

GlaxoSmithKline Consumer Healthcare

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Paracetamol.
Action
Pharmacology: Pain is a very common experience and analgesic drugs such as paracetamol plays an important role in providing general pain relief for both acute and chronic pain. Paracetamol is widely recommended as the initial drug of choice for the treatment of mild to moderate musculoskeletal pain and symptomatic osteoarthritis as it is regarded as having a more acceptable safety profile in chronic use than nonsteroidal anti-inflammatory drugs (NSAIDs).
Panadol Extend provides analgesic action via its inhibition activity on the central prostaglandin synthetase and its antipyretic action is thought to be due to selective inhibition of prostaglandin synthesis in the central nervous system (CNS).
Panadol Extend is readily absorbed from the upper small intestine, has absolute oral bioavailability (70-90%) and is extensively metabolized in the liver.
Pharmacokinetics: Panadol Extend formulation consists of a bilayer tablet containing 665 mg of paracetamol: One layer containing an immediate-release (IR) formulation and providing 31% of the total dose and a 2nd layer containing a sustained release (SR) formulation that provides the remaining 69% of the total dose.
Pharmacokinetics of Panadol Extend have been investigated in 2 pivotal biostudies. In the First study, Panadol Extend and Panadol tablets were compared in fed and fasted volunteers. Both were bioequivalent with respect to dose-corrected AUC(0-t) and AUC(0-inf) in both fed and fasted states. The bioavailability of paracetamol from Panadol Extend is not affected by food thus indicating that the formulation can be taken with or without food.
In the Second study, where Panadol Extend was again compared with Panadol; Panadol Extend showed a clear pattern of controlled release of paracetamol, and the formulations were bioequivalent based on the comparison of AUCs for the final 24 hours of the 48-hour dosing period. This shows that there is no additional accumulation of paracetamol from the Panadol Extend formulation. Besides that, steadier concentrations of paracetamol were achieved with Panadol Extend. Thus, Panadol Extend may be particularly appropriate for patients who require repeat doses as it maintains a continuous therapeutic effect when taken every 8 hours (2 x 665 mg tablets per dose).
Indications/Uses
For treatment of mild to moderate pain, in particular pain associated with osteoarthritis (OA) and the relief of muscular aches and pain eg, backache. Suitable for headaches, migraine, dysmenorrhea, toothache and pain after dental procedures. For relieving pain and fever after vaccinations, for treating symptoms associated with the common cold (eg, sore throat) and relief of fever.
Dosage/Direction for Use
For oral use. Panadol Extend can be administered 3 times daily, at an adult dose of 2 tablets at each dosing. Maximum of 6 tablets in 24 hours. Providing a total dose of 4 g of paracetamol every 24 hours.
Overdosage
Panadol Extend is less likely to cause overdose incidents. Immediate medical attention is required in the event of overdose, even if the symptoms of overdose are not present. Paracetamol overdose may cause liver failure. Administration of N-acetylcysteine or methionine may be required.
Contraindications
Panadol Extend is contraindicated in patients with a previous history of hypersensitivity to paracetamol or excipients.
Warnings
If symptoms persist, consult the doctor or pharmacist. Panadol Extend contains sustained-release acetaminophen (paracetamol). Do not take any other acetaminophen (paracetamol)-containing medicines at the same time.
Special Precautions
Renal and hepatic failure.
Use in pregnancy & lactation: Human and animal studies have not identified any risk to pregnancy or embryo-foetal development.
Human studies have not identified any risk to lactation or the breastfed offspring.
Paracetamol crosses the placental barrier and is excreted in breast milk.
Use in children: Not suitable for use in children under 12 years of age.
Side Effects
When taken in recommended doses, Panadol Extend is virtually free from side effects. Skin rashes and other allergic reactions are rare.
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.
Storage
Store at room temperature (under 30°C).
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Presentation/Packing
SR caplet 665 mg x 12's, 48's.
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