Amidex Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Drug Interactions MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Dexketoprofen trometamol

Indications/Uses

Symptomatic treatment of mild to moderate pain intensity eg, acute musculoskeletal pain, dysmenorrhea, toothache, & post-op pain. Inj: Symptomatic treatment of acute pain intensity in situations where oral administration is not possible eg, post-op pain.

Click to view Amidex detailed prescribing information

Dosage/Direction for Use

FC tab 12.5 mg every 4-6 hr or 25 mg every 8 hr. Post-op pain 25 mg every 8 hr. Total daily dose: 75 mg. Liver or kidney dysfunction, elderly Total daily dose: 50 mg. Inj Adult 50 mg every 8-12 hr. May repeat dose every 6 hr, if needed. Total daily dose: 150 mg. Mild to moderate liver disease, kidney dysfunction Reduce to total daily dose of 50 mg.

Click to view Amidex detailed prescribing information

Administration

Should be taken on an empty stomach: FC tab: Take 30 min before meals, especially in case of acute pain.

Contraindications

Hypersensitivity. Patients w/ history of or active or suspected gastric ulcer, or chronic dyspepsia, gastric bleeding or other active bleeding, Crohn's disease or ulcerative colitis. History of asthma attack, bronchospasm, acute rhinitis or nasal polyp, urticaria or angioneurotic edema which are triggered by other medication w/ similar mode of action (eg, aspirin or other NSAIDs); bronchial asthma. Patients w/ haemorrhagic diathesis & other blood coagulation disorders; receiving anticoagulant therapy. Severe heart failure, moderate to severe kidney dysfunction, severe liver function impairment. Pregnancy & lactation.

Click to view Amidex detailed prescribing information

Special Precautions

Discontinue medication if GI bleeding or increased SGPT & SGOT occurs. Patients w/ haematologic changes, SLE, or mixed connective tissue disease. History of esophagitis &/or peptic ulcer, drug allergy, gastritis. May increase risk of nephrotoxicity in patients receiving diuretic therapy or in hypovolemic condition. May impair ability to drive or operate machinery. Impaired liver, kidney or heart function & other conditions causing fluid retention. Elderly.

Click to view Amidex detailed prescribing information

Adverse Reactions

Nausea, vomiting, abdominal pain, diarrhea, dyspepsia. SJS, Lyell syndrome; angioedema.

Click to view Amidex detailed prescribing information

Drug Interactions

Concomitant use w/ other NSAIDs, heparin anticoagulants, lithium, MTX, hydantoin, sulphonamide, diuretics, β-blockers, pentoxifylline, thrombolytic agents, zidovudine, sulfonylurea, cyclosporin, tacrolimus, probenecid, cardiac glycoside, mifepristone, quinolone.

Click to view Amidex detailed prescribing information

MIMS Class

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

ATC Classification

M01AE17 - dexketoprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

Regulatory Classification

Presentation/Packing

Form

Amidex FC tab 25 mg

Packing/Price

3 × 10's

Form

Amidex inj 25 mg/mL

Packing/Price

2 mL x 5 × 1's

Amidex

dexketoprofen

Manufacturer:

Gracia Pharmindo