Progesic 500 mg+20 mg (Tablet (Delayed Release))
Unit Price: ৳ 15.00 (7 x 4: ৳ 420.00)
Strip Price: ৳ 60.00
Medicine Details
Category | Details |
---|---|
Generic | Naproxen sodium esomeprazole magnesium |
Company | Incepta pharmaceuticals ltd |
Also available as |
Indications
- Relief of signs and symptoms of osteoarthritis
- Relief of signs and symptoms of rheumatoid arthritis
- Relief of signs and symptoms of ankylosing spondylitis
- Decreasing the risk of developing gastric ulcers in patients at risk of NSAID-associated gastric ulcers
Pharmacology
- Consists of immediate release Esomeprazole Magnesium layer & enteric-coated Naproxen core
- Esomeprazole released first into the stomach before dissolution of Naproxen in the small intestine
- Naproxen is a NSAID with analgesic & antipyretic properties
- Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell
Dosage
- Use lowest effective dose for the shortest duration consistent with individual patient treatment goals
- Adults: One tablet twice daily of either - 375 mg naproxen/20 mg esomeprazole; or 500 mg naproxen/20 mg esomeprazole
- Adolescent Patients 12 Years of Age & Older: 375 mg naproxen/20 mg esomeprazole; or 500 mg naproxen/20 mg esomeprazole for weight greater than 50 kg
- Adolescent Patients 12 Years of Age & Older: One tablet twice daily of 375 mg naproxen/20 mg esomeprazole for weight 38 kg to less than 50 kg
Administration
- Tablet is to be taken at least 30 minutes before meals
- Do not split, chew, crush or dissolve the tablet
Interaction
- Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
- Concomitant use of tablet and warfarin may result in an increased risk of a bleeding complication
- Esomeprazole inhibits gastric acid secretion & may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts & digoxin)
- Administration of Naproxen & Esomeprazole together with high-fat food in healthy volunteers does not affect the extent of absorption of naproxen but significantly prolongs tmax by 10 hours and decreases peak plasma concentration (Cmax) by about 12%
Contraindications
- Known hypersensitivity to any component of the tablet or substituted benzimidazoles
- History of asthmay urticaria or other allergic-type reactions after taking aspirin or other NSAIDs
- Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
Side Effects
- Immediate release esomeprazole included in the tablet formulation to decrease the incidence of gastrointestinal side effects from Naproxen
- Tablet shown to significantly decrease occurrence of gastric ulcers and NSAID associated upper gastrointestinal adverse events compared to Naproxen alone
- Gastrointestinal adverse events such as peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in older people, may occur
- Oedema, hypertension, and cardiac failure reported in association with NSAID treatment
Pregnancy & Lactation
- In women attempting to conceive or during the first and second trimester of pregnancy, tablet should not be given unless the potential benefit to the patient outweighs the potential risk to the foetus
- Tablet contraindicated during the third trimester of pregnancy
- Tablet should not be used during breastfeeding
- Use of NSAIDs like Naproxen may impair female fertility
Precautions & Warnings
- Combination of tablet and NSAIDs should be avoided due to the cumulative risks of inducing serious NSAID-related adverse events
- Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms
- Elderly people have an increased frequency of adverse reactions especially gastrointestinal bleeding and perforation
- Patients with a history of gastrointestinal disease should use caution when receiving NSAIDs
Use in Special Populations
- Elderly patients: Use caution when high doses are required & some adjustment of dosage may be required
- Patients with Moderate to Severe Renal impairment: Not recommended for use
- Hepatic insufficiency: Monitor patients closely & consider possible dose reduction based on the Naproxen component
Overdose Effects
- Related to Naproxen overdose: Symptoms may include lethargy, dizziness, drowsiness, epigastric pain, gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression, and coma
- Related to esomeprazole overdose: The symptoms described in connection with deliberate esomeprazole overdose (limited experience of doses in excess of 240 mg/day) are transient
Therapeutic Class
- Drugs for Osteoarthritis
- Drugs used for Rheumatoid Arthritis
- Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Storage Conditions
- Store at temperature of below 30°C, protect from light & moisture
- Keep out of reach of children
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