Product Information
Registration Status: ActiveAPO-NAPROXEN TABLET 250mg is approved to be sold in Singapore with effective from 1991-08-01. It is marketed by PHARMAFORTE SINGAPORE PTE LTD, with the registration number of SIN05295P.
This product contains Naproxen 250mg in the form of TABLET. It is approved for ORAL use.
This product is manufactured by APOTEX INC in CANADA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
Indication
For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, and acute gout. Also for the relief of mild to moderate pain and the treatment of primary dysmenorrhea.
Mechanism of Action
The mechanism of action of naproxen, like that of other NSAIDs, is believed to be associated with the inhibition of cyclooxygenase activity. Two unique cyclooxygenases have been described in mammals. The constitutive cyclooxygenase, COX-1, synthesizes prostaglandins necessary for normal gastrointestinal and renal function. The inducible cyclooxygenase, COX-2, generates prostaglandins involved in inflammation. Inhibition of COX-1 is thought to be associated with gastrointestinal and renal toxicity while inhibition of COX-2 provides anti-inflammatory activity.
Pharmacokinetics
- Absorption
- Naproxen itself is rapidly and completely absorbed from the GI tract with an in vivo bioavailability of 95%. Although naproxen itself is well absorbed, the sodium salt form is more rapidly absorbed resulting in higher peak plasma levels for a given dose. Food causes a slight decrease in the rate absorption.
- Distribution
- Metabolism
- Naproxen is extensively metabolized to 6-0-desmethyl naproxen and both parent and metabolites do not induce metabolizing enzymes.
- Elimination
Toxicity
ORAL (LD50): Acute: 248 mg/kg [Rat]. 360 mg/kg [Mouse]. Symptoms of overdose include drowsiness, heartburn, indigestion, nausea, and vomiting.
Active Ingredient/Synonyms
(+)-(S)-6-Methoxy-α-methyl-2-naphthaleneacetic acid | (+)-(S)-Naproxen | (+)-2-(6-Methoxy-2-naphthyl)propionic acid | (+)-2-(Methoxy-2-naphthyl)-propionic acid | (+)-2-(Methoxy-2-naphthyl)-propionsäure | (+)-Naproxen | (S)-(+)-2-(6-Methoxy-2-naphthyl)propionic acid | (S)-(+)-Naproxen | (S)-2-(6-Methoxy-2-naphthyl)propanoic acid | (S)-2-(6-Methoxy-2-naphthyl)propionic acid | (S)-6-Methoxy-alpha-methyl-2-naphthaleneacetic acid | (S)-Naproxen | Naprolag | Naproxen | Naproxène | Naproxeno | Naproxenum | Naproxen |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.