Progesic Tablet 375mg+20mg

PRESENTATION

Progesic 375 Tablet: Each tablet contains delayed release Naproxen BP 375 mg and immediate release Esomeprazole Magnesium

Trihydrate BP equivalent to Esomeprazole 20 mg.

Progesic 500 Tablet: Each tablet contains delayed release Naproxen BP 500 mg and immediate release Esomeprazole Magnesium

Trihydrate BP equivalent to Esomeprazole 20 mg.

DESCRIPTION

Progesic consists of an immediate release Esomeprazole magnesium layer and an enteric coated Naproxen core. As a result

Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine.

Naproxen is a NSAID with analgesic and antipyretic properties. The mechanism of action of Naproxen is to inhibition of the

prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of

the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Esomeprazole blocks the final step in

acid production, thus reducing gastric acidity

INDICATIONS

It is indicated for the relief of signs and symptoms of osteoarthritis, rehumatoid arthritis and ankylosing spondylitis,

dysmenorrhoea and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric

ulcers.

DOSAGE & ADMINISTRATION

Carefully consider the potential benefits and risks of Progesic and other treatment options before deciding to use Progesic. Use

the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole

lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.

Rheumatoid Arthritis, Osteoarthritis, Alkylosing Spondylitis, and dysmenorrhoea: Progesic 375 or 500 one tablet twice daily as

directed by the physician.

• Do not split, chew, crush, or dissolve the tablet. Progesic is to be taken at least 30 minutes before meals.

Elderly patients

Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is

increased in the elderly. Use caution when high doses are required and some adjustment of dosage may be required in elderly

patients. As with other drugs used in the elderly use the lowest effective dose.

Patients With Moderate to Severe Renal Impairment

Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment

(creatinine clearance <30 mL/min).

Hepatic Insufficiency

Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen

component of Progesic. Progesic is not recommended in patients with severe hepatic impairment because esomeprazole dosage should

not exceed 20 mg daily in these patients.

Children

Dosage in children less than 18 years has not been established.

SIDE EFFECTS

In general, Progesic is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia,

gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.

Contraindications

• Known hypersensitivity to any component of Progesic or substituted benzimidazoles

• History of asthma, 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

• Late pregnancy

PRECAUTIONS

Patients with known CV disease/risk factors may be at greater risk. Progesic should be used with caution in patients with fluid

retention or heart failure.

USE IN PREGNANCY & LACTATION

In pregnancy: Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus

arteriosus.

In lactation: Progesic should not be used in nursing mothers due to the naproxen component.

DRUG INTERACTION

• Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE Inhibitors, diuretics, and beta-blockers

• Concomitant use of Progesic and warfarin may result in increased risk of bleeding complications.

• Esomeprazole inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important

determinant of bioavailability (eg, ketoconazole, iron salts and digoxin).

OVER DOSE

There is no clinical data on overdosage with Progesic.

Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal

discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction,

metabolic acidosis, apnea, vomiting etc.

Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor

and intermittent clonic convulsions etc

COMMERCIAL PACK

Progesic 375 Tablet: Each box contains 3 Alu-Alu blister strips of 10 tablets.

Progesic 500 Tablet: Each box contains 7 Alu-Alu blister strips of 4 tablets.