Amidex

Amidex

dexketoprofen

Manufacturer:

Gracia Pharmindo
Full Prescribing Info
Contents
Dexketoprofen trometamol.
Indications/Uses
Symptomatic treatment of mild to moderate pain intensity, ie. Acute musculoskeletal pain, dysmenorrhea, toothache and post-operative pain.
Injection: Symptomatic treatment for acute pain intensity in situations where oral administration is not possible, such as pain after surgery.
Dosage/Direction for Use
FC tablet: 12.5 mg 4-6 hourly or 25 mg 8 hourly.
Post-operative pain: 25 mg 8 hourly. Total daily dose: 75 mg.
Total daily dose in elderly patients, patients with liver or kidney dysfunction: 50 mg. To be taken 30 minutes before meals, especially in acute pain case.
Injection: Adults: 50 mg 8-12 hourly. Doses may be repeated 6 hourly, if needed. Total daily dose: 150 mg.
Patients with mild to moderate liver disease, kidney dysfunction: Reduce dose to total daily dose of 50 mg.
Contraindications
Hypersensitivity. Patients with a history of asthma attacks, bronchospasm, acute rhinitis or nasal polyps, urticaria, or angioneurotic edema which are triggered by other medication with a similar mode of action (eg. Aspirin or other NSAIDs). Patients with a history or (active or suspected) gastric ulcer, or chronic dyspepsia, gastric bleeding or other active bleeding, Crohn's disease or ulcerative colitis, a history of bronchial asthma, severe heart failure, moderate to severe kidney dysfunction, severe impaired liver function. Patients with haemorrhagic diathesis and other blood coagulation disorders or receiving anticoagulant therapy. Pregnancy and lactation.
Special Precautions
A history of esophagitis and/or peptic ulcer, drug allergic, gastritis. Discontinue medication if gastrointestinal bleeding or increased SGPT & SGOT occur. Patients with haematologic changes, systemic lupus erythematosus, or mixed connective tissue disease. Patients with impaired liver, kidney or heart function and other conditions causing fluid retention. Patients receiving diuretic therapy or in hypovolemic conditions may increased the risk of nephrotoxicity. May impair the ability to drive or operate the machinery. Elderly.
Adverse Reactions
Common (1-10%): nausea, vomiting, abdominal pain, diarrhea, dyspepsia.
Uncommon (0.1-1%): sleep disturbances, dizziness, vertigo, palpitation, gastritis, constipation, dry mouth, flatulence, skin rash, fatigue, hot flushes, pain, asthenia, stiffness, malaise.
Rarely (0.01-0.1%): paresthesia, hypertension, peripheral edema, bradypnea, peptic ulcer, gastrointestinal bleeding or perforation, anorexia, increased liver enzyme, urticaria, acne, hyperhidrosis, polyuria, menstrual disorders, prostate disorders, back pain, syncope.
Very rare (<0.01%): neutropenia, thrombocytopenia, blurred vision, tinnitus, tachycardia, hypotension, bronchospasm, dyspnea, pancreatic damage, liver damage, severe mucocutaneous reactions (Steven-Johnson's syndrome, Lyell syndrome), angioedema, dermatology reactions, photosensitivity reactions, pruritus, kidney damage (nephritis or nephrotic syndrome), anaphylaxis, facial edema.
Drug Interactions
Concomitant use with other NSAIDs, heparin anticoagulants, lithium, methotrexate, hydantoin, sulphonamide, diuretics, beta-blockers, pentoxifylline, thrombolytic agents, zidovudine, sulfonylurea, cyclosporin, tacrolimus, probenecid, cardiac glycoside, mifepristone, quinolone.
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.
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
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