Regulatory Information
DKSH SINGAPORE PTE. LTD.
DKSH SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**Dosage and administration** _General_ Although naproxen and naproxen-sodium-containing products all circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking naproxen sodium and within 1 hour in patients taking naproxen. The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients. Synflex is not recommended in patients with baseline creatinine clearance less than 20 ml/minute because accumulation of naproxen metabolites has been seen in such patients. _Recommended formulations_ Because the sodium salt of naproxen is more rapidly absorbed, Synflex is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. Synflex may be given orally either in fasting state or with meals and/or antacids. _Dose in adults_ Analgesia / Dysmenorrhea / Acute musculoskeletal conditions/ Acute pain states in which there is an inflammatory component: Because the sodium salt of naproxen is more rapidly absorbed, Synflex is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. The recommended starting dose is Synflex 550 mg followed by Synflex 275 mg every 6–8 hours as required. The total daily dose should not exceed 1375 mg. _Acute gout:_ The recommended starting dose is 825 mg of Synflex followed by 275 mg every 8 hours as needed. _Migraine:_ For treatment of acute migraine headache, the dose is Synflex 825 mg at the first symptom of an impending attack. An additional dose of Synflex 275 mg to 550 mg can be taken throughout the day, if necessary, but not before half an hour after the initial dose. The total daily dose should not exceed 1375 mg. For prophylaxis of migraine headache, the dose of Synflex is 550 mg twice daily. If no improvement is seen within 4–6 weeks, the drug should be discontinued. _**Dose in children**_ Synflex is not recommended for use in children under 16 years of age.
ORAL
Medical Information
**Indications** Synflex (naproxen sodium) is indicated in the relief of mild to moderate pain including post partum pain, pain following IUD insertion, post-operative pain and pain due to orthopedic surgery, for the treatment of primary dysmenorrhea and for the relief (prophylaxis) of migraine headache. It is also indicated for the treatment of the signs and symptoms of mild to moderately severe, acute or chronic, musculoskeletal and soft tissue inflammation and acute gout.
**Contraindications** All naproxen products are contraindicated in patients who have had allergic reactions to prescription as well as to over-the-counter products containing naproxen or naproxen sodium. It is also contraindicated in patients in whom aspirin or other nonsteroidal anti-inflammatory/ analgesic drugs induce the syndrome of asthma, rhinitis and nasal polyps. Both types of reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients. All products containing naproxen or naproxen sodium are CONTRAINDICATED in patients with active peptic ulceration or active gastrointestinal bleeding. Products containing naproxen or naproxen sodium are contraindicated in children under 2 years of age since safety in this age group has not been established.
M01AE02
naproxen
Manufacturer Information
DKSH SINGAPORE PTE. LTD.
RECIPHARM LEGANES S.L.U
Fourrts India Laboratories Private Limited
Active Ingredients
Documents
Package Inserts
Synflex 275mg 100 tabs 766-3867 SG PIL - clean revised.pdf
Approved: May 7, 2021