دواعي استعمال رومالكس 75مجم/3مل 6 امبولات

Diclofenac sodium 75 mg/3 ml intramuscular injection, pack of 6 ampoules, by Alexandria Company for Pharmaceuticals (Egypt).

• Intramuscular: acute forms of pain, including renal colic, exacerbations of osteo- and rheumatoid arthritis, acute back pain, acute gout, acute trauma and fractures, and post-operative pain.electronic medicines compendium (emc)

• Common: headache, dizziness, vertigo, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia, raised transaminases, rash, injection-site reaction/pain/induration.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)
• Additionally for intravenous use: concomitant NSAID or anticoagulant use, haemorrhagic diathesis or cerebrovascular bleeding, high-bleeding-risk operations, asthma history, moderate or severe renal impairment, hypovolaemia or dehydration.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)
• Follow the intramuscular injection technique strictly (deep intragluteal injection) to avoid injection-site reactions including necrosis and embolia cutis medicamentosa (Nicolau syndrome). Ampoules contain propylene glycol, benzyl alcohol and sodium metabisulphite (may rarely cause severe hypersensitivity and bronchospasm).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).