Diclofenac we care

Diclofenac we care

diclofenac

Manufacturer:

Mega Lifesciences

Distributor:

Maxxcare
Concise Prescribing Info
Contents
Diclofenac Na
Indications/Uses
Acute forms of pain, including renal colic, exacerbations of OA & RA; acute back pain, gout, trauma & fractures; post-op pain.
Dosage/Direction for Use
IM Adult 75 mg once daily or bd in severe cases for max of 2 days. Renal colic Initially 75 mg, followed by further 75 mg after 30 min if necessary.
Contraindications
Hypersensitivity. Active, gastric or intestinal ulcer, bleeding or perforation. History of GI bleeding or perforation, relating to previous NSAID therapy. Active history of recurrent peptic ulcer/haemorrhage (≥2 distinct episodes of proven ulceration or bleeding). Severe hepatic, renal or cardiac failure. Patients in whom attacks of asthma, angioedema, urticaria or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other NSAIDs. Pregnancy (last timester) & lactation. Childn <12 yr.
Special Precautions
Anaphylactic/anaphylactoid reactions can occur. May mask infection-signs &-symptoms. Na metabisulphate content may lead to isolated severe hypersensitivity reactions & bronchospasm. Potentially fatal, GI bleeding (haematemesis, melaena), ulceration or perforation; w/draw therapy if GI bleeding or ulceration occurs. Consider combination therapy w/ protective agents (eg, misoprostol or proton pump inhibitors) in patients w/ history of ulcer (particularly if complicated w/ haemorrhage or perforation, in the elderly, required of concomitant therapy w/ low-dose aspirin or agents increasing GI risk. Report any unusual abdominal symptoms (especially GI bleeding) in patients w/ GI toxicity history (particularly in the elderly). Close medical surveillance in patients w/ ulcerative colitis, or w/ Crohn's disease; patients w/ hepatic impairment. Liver enzymes may increase. Discontinue if abnormal liver function tests persist or worsen, clinical signs or symptoms consistent w/ liver disease develop or if other manifestations occur (eosinophilia, rash). Potential hepatitis w/o prodromal symptoms. Attacks may be triggered in patients w/ hepatic porphyria. Fluid retention & oedema in patients w/ cardiac or renal impairment, history of HTN, elderly, receiving concomitant treatment w/ diuretics or agents w/ significant renal-function impact, w/ substantial extracellular vol depletion from any course eg, pre- & post-op; monitor renal function. Very rare but potentially fatal, serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis; highest risk appears during early course of therapy. Discontinue at 1st appearance of skin rash, mucosal lesions or any other hypersensitivity signs. Increased risk of aseptic meningitis in patients w/ SLE & mixed connective tissue disorders. Monitor patients w/ history of HTN &/or mild to moderate CHF for potential fluid retention & oedema. Increased risk of arterial thrombotic events w/ high-dose & long term therapy; treat only after careful consideration. Patients w/ uncontrolled HTN, CHF, established ischaemic heart disease peripheral arterial disease, &/or cerebrovascular disease; prior to initiation, patients w/ CV events risk factors (eg, HTN, hyperlipidaemia, DM, smoking). Monitor blood count during prolonged treatment. May reversibly inhibit platelet aggregation; carefully monitor patients w/ defects of haemostasis, bleeding diathesis or haematological abnormalities. Patients w/ asthma, seasonal allergic rhinitis, swelling of nasal mucosa (eg, nasal polyps), COPD or chronic resp tract infections (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs eg, asthma exacerbations, Quincke's oedema or urticaria; w/ allergy to other substances eg, w/ skin reactions, pruritus or urticaria. May precipitate bronchospasm in patients suffering from or w/ previous history of bronchial asthma. Avoid concomitant use w/ systemic NSAIDs including cyclooxygenase-2 selective inhibitors. Concomitant therapy w/ medications which could increase risk of ulceration or bleeding eg, systemic corticosteroids, anticoagulants (eg, warfarin), SSRIs or anti-platelet agents. Not recommended in women attempting to conceive as it may impair fertility. Patients w/ low body wt. Elderly.
Adverse Reactions
Headache, dizziness; vertigo; nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia; increased transaminases; rash; inj site reaction, pain, & induration. Stevens-Johnson syndrome, toxic epidermal necrolysis.
Drug Interactions
May increase lithium, & digoxin plasma conc. May decrease antihypertensive effects in concomitant use w/ diuretics & antihypertensive agents (eg, β-blockers, ACE inhibitors); periodically monitor BP especially in the elderly. Increased risk of nephrotoxicity particularly for diuretics & ACE inhibitors; hydrate adequately & consider renal function monitoring after initiation of concomitant therapy periodically. Increased serum K levels in concomitant administration of K-sparing diuretics. May increase risk of bleeding in concomitant use w/ anticoagulants & anti-platelet agents. Risk of GI bleeding or ulceration may be increased w/ other systemic NSAIDS. Risk of GI bleeding may be increased by SSRIs. Possible hypoglycaemic & hyperglycaemic effects in concomitant use of antidiabetic agents. Increased methotrexate levels. May increase nephrotoxicity of ciclosporin. Possible increased nephrotoxicity risk w/ tacrolimus. Convulsions may occur in concomitant use w/ quinolones. Expected increased phenytoin exposure. Absorption may be delayed or decreased w/ colestipol & cholestyramine. May exacerbate cardiac failure, reduce GFR & increase plasma glycoside levels w/ concomitant use of cardiac glycosides. May reduce mifepristone effect. Peak plasma conc & exposure may be increased significantly by potent CYP2C9 inhibitors (eg, sulfinpyrazone & voriconazole).
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Diclofenac we care soln for inj 25 mg/mL
Packing/Price
3 mL x 10 × 1's
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