دواعي استعمال رومالكس 100مجم 5 اقماع لبوس

Diclofenac sodium 100 mg rectal suppositories, pack of 5, by Alexandria Company for Pharmaceuticals (Egypt).

• Adults: relief of pain and inflammation in rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, acute musculoskeletal disorders (periarthritis, tendinitis, tenosynovitis, bursitis) and painful conditions from trauma, fractures, low back pain, sprains, strains, dislocations, orthopaedic, dental and minor surgery.electronic medicines compendium (emc)

• Common: headache, dizziness, vertigo, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia, raised transaminases, rash.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Rare/very rare: GI haemorrhage or ulcer with perforation, hepatitis, hypersensitivity/anaphylaxis, asthma, blood dyscrasias, severe skin reactions, acute renal failure; uncommon (long-term high dose): myocardial infarction, cardiac failure.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

• Hypersensitivity to diclofenac or any excipient; active gastric or intestinal ulcer, bleeding or perforation; history of NSAID-related GI bleeding or perforation; active or recurrent peptic ulcer/haemorrhage; last trimester of pregnancy; hepatic failure; renal failure; established congestive heart failure (NYHA II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease; asthma, angioedema, urticaria or acute rhinitis precipitated by ibuprofen, aspirin or other NSAIDs.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Proctitis (suppositories).نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

• Use the lowest effective dose for the shortest duration; avoid combination with other systemic NSAIDs including COX-2 inhibitors.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Gastrointestinal bleeding, ulceration or perforation, which can be fatal, may occur at any time; consider gastroprotection (misoprostol or PPI) in high-risk patients and stop treatment if GI bleeding occurs.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Increased risk of arterial thrombotic events (myocardial infarction, stroke), particularly at 150 mg/day and with long-term use; treat patients with cardiovascular risk factors only after careful consideration.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Hepatic effects (raised liver enzymes, hepatitis) and renal effects (fluid retention, oedema); monitor hepatic and renal function in at-risk patients and during prolonged treatment.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Serious skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) occur very rarely; stop at first sign of rash or mucosal lesions. Anaphylactic reactions and Kounis syndrome can occur.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• May impair female fertility; not recommended in women attempting to conceive.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

• LithiumDiclofenac may increase plasma lithium; monitor serum lithium.electronic medicines compendium (emc)
• DigoxinDiclofenac may raise plasma digoxin; monitor serum digoxin.electronic medicines compendium (emc)
• Diuretics and antihypertensives (ACE inhibitors, beta-blockers)Reduced antihypertensive effect and increased nephrotoxicity risk; monitor blood pressure and renal function, keep patients hydrated.electronic medicines compendium (emc)
• Anticoagulants and antiplatelet agentsIncreased bleeding risk; close monitoring required.electronic medicines compendium (emc)
• Other NSAIDs and corticosteroidsIncreased risk of GI bleeding or ulceration; avoid two or more NSAIDs.electronic medicines compendium (emc)
• SSRIsIncreased risk of GI bleeding.electronic medicines compendium (emc)
• MethotrexateRaised methotrexate levels and toxicity when given within 24 hours of an NSAID.electronic medicines compendium (emc)
• Ciclosporin / tacrolimusIncreased nephrotoxicity.electronic medicines compendium (emc)
• Quinolone antibacterialsPossible convulsions.electronic medicines compendium (emc)
• Potent CYP2C9 inhibitors (e.g. voriconazole)Increased diclofenac exposure.electronic medicines compendium (emc)

• Diclofenac passes into breast milk in small amounts; should not be administered during breast-feeding.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

• Monitor hepatic function, blood count and renal function during prolonged treatment; monitor blood pressure with antihypertensives and blood glucose with antidiabetics as a precaution.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

• Inhibits prostaglandin synthetase (cyclo-oxygenase).