$16.50
Manufacturer: Poland
For the symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute diseases of the musculoskeletal system and dysmenorrhea in patients aged 16 years and older.
Description
Ingredients
active ingredient : naproxen;
1 enteric tablet contains naproxen 250 mg or 500 mg
excipients : K 90, croscarmellose sodium, magnesium stearate enteric coating (methacrylate copolymer dispersion, triethyl citrate, micronized talc, simethicone emulsion).
Dosage form
Enteric tablets.
Basic physical and chemical properties : white or almost white, round, biconvex.
Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs. Derivatives of propionic acid. Naproxen. ATX code M01A E02.
Pharmacodynamics
In animal studies using classical research systems, naproxen has been proven to have anti-inflammatory, analgesic and hypothermic properties. The drug shows its anti-inflammatory effect even in animals with removed adrenal glands, and this indicates that its action is not due to the pituitary-adrenal-adrenal axis. The drug, like other non-steroidal anti-inflammatory drugs, inhibits prostaglandin synthetase. However, the exact mechanism of the anti-inflammatory action of naproxen (as well as other drugs in this group) is not known.
Pharmacokinetics
Naproxen is completely absorbed from the gastrointestinal tract, the maximum plasma concentration is reached within 2-4 hours. Naproxen is present in the blood predominantly unchanged and actively binds to plasma proteins. The half-life is from 12 to 15 hours, due to which the equilibrium state is reached within 3 days from the start of therapy with a twice daily regimen. The degree of absorption is practically independent of food intake and most antacids. Excretion occurs almost entirely in the urine, predominantly as conjugated naproxen with some unchanged form. Metabolism in children is similar to that in adults. In chronic alcoholic hepatitis, the total plasma concentration of naproxen decreases, but the concentration of unbound naproxen increases.
When naproxen is taken in enteric form, peak plasma concentrations are reached later than after conventional tablets. However, the average area under the curve “plasma concentration – time”, and hence the bioavailability is the same. So, as you might expect, the tablets do not disintegrate until they enter the small intestine, where they quickly and completely dissolve.
Indications
For the symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute diseases of the musculoskeletal system and dysmenorrhea in patients aged 16 years and older.
Contraindications
- Hypersensitivity to naproxen and naproxen sodium or any of the excipients.
- Contraindicated in patients in whom aspirin or other non-steroidal anti-inflammatory / analgesic drugs cause asthma attacks, rhinitis, nasal polyps or urticaria.
- Active ulcer or history of ulcer, active gastrointestinal bleeding (two or more separate episodes of confirmed ulceration or bleeding).
- History of gastrointestinal bleeding or perforation associated with previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
- Severe renal, hepatic or heart failure.
- Pregnancy and lactation period.
Dosage and administration
Side effects can be minimized by using the lowest effective dose for the shortest period of time needed to relieve symptoms.
Therapy should be started at a low recommended dose, especially in elderly patients.
For oral use.
Preferably taken with or after meals.
Anapran (naproxen) tablets should be swallowed whole, not divided or crushed.
Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
The usual dose is from 500 mg to 1 g per day and is taken in 2 doses with a 12-hour interval. If a 1 g dose is required, it is recommended to take either one 500 mg tablet twice a day, or two 500 mg tablets at a time (morning or evening). A loading dose of 750 mg or 1 g per day is recommended for treatment in the acute phase in the following cases:
- patients who have severe nocturnal pain or severe stiffness in the morning;
- patients who switched to taking Anapran EC from high doses of other antirheumatic drugs;
- with osteoarthritis, if pain is the main symptom.
Acute diseases of the musculoskeletal system and dysmenorrhea
Anapran (naproxen) is started with 500 mg and then taken, if necessary, 250 mg at intervals of 6-8 hours; the maximum daily dose after the first day is 1250 mg.
Elderly patients
Studies show that although the total plasma concentration of naproxen does not change with age, the unbound plasma fraction of naproxen increases in the elderly. The significance of these data for the dosing of Anapran EC is unknown. As with other drugs, it is advisable for the elderly to use the lowest effective dose possible for the shortest time possible, since such patients are more likely to develop adverse events. Patients need constant monitoring for gastrointestinal bleeding during treatment with NSAIDs (NSAIDs).
Impaired kidney or liver function
In patients with impaired renal or hepatic function, the drug should be used at a low dose. Anapran EC is contraindicated in patients with baseline creatinine clearance below 30 ml/min, as accumulation of metabolites of naproxen is observed in patients with severe renal insufficiency or those receiving dialysis.
Treatment should be regularly reevaluated and discontinued if it is not effective enough.
Recent Reviews