Almiral

Almiral

diclofenac

Manufacturer:

Medochemie

Distributor:

Medochemie
Concise Prescribing Info
Contents
Diclofenac Na
Indications/Uses
Treatment of inflammatory & degenerative forms of rheumatism; acute attacks of gout; post-traumatic & post-op pain, inflammation & swelling; painful &/or inflammatory conditions in gynaecology (eg primary dysmenorrhoea or adnexitis). Adjuvant in severe painful inflammatory infections of the ear, nose or throat.
Dosage/Direction for Use
Adult Initially 100-150 mg daily in 2-3 doses. Milder cases: 75-100 mg daily. Primary dysmenorrhoea Initially 50-150 mg. Max: 200 mg/day. Adolescent & childn ≥1 yr 0.5-2 mg/kg body wt daily in 2-3 divided doses. Juvenile RA Max: 3 mg/kg daily.
Administration
Should be taken with food: Take immediately after meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Active gastric/intestinal ulcer, bleeding or perforation. Hepatic, renal & severe cardiac failure. Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin &/or other drugs w/ prostaglandin-synthetase inhibitory activity. Treatment of peri-op pain in setting of CABG surgery. Patients w/ established CV disease (CHF, established ischemic heart & peripheral arterial disease) or uncontrolled HTN. Last trimester of pregnancy.
Special Precautions
Rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. GI bleeding, ulceration or perforation. Monitor blood count; patients w/ defects of haemostasis; asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (ie nasal polyps), COPD or chronic infections of the resp tract (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma exacerbations (so-called intolerance to analgesics/analgesics-asthma), Quincke's edema or urticaria. Hepatic porphyria & impairment. Discontinue use at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Impaired cardiac or renal function, history of HTN. Concomitant use w/ systemic NSAIDs including COX-2 selective inhibitors. Lactation. Elderly.
Adverse Reactions
Headache, dizziness; vertigo; nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, decreased appetite; increased transaminases; rash.
Drug Interactions
Increase Cmax & eposure w/ CYP2C9 inhibitors (eg voriconazole). Increased plasma conc of lithium & digoxin. Decreased effect w/ diuretic & antihypertensives (eg β-blockers, ACE inhibitors). Increased nephrotoxicity of ciclosporin. Increased serum K levels w/ drugs known to cause hyperkalemia (eg K-sparing diuretics, ciclosporin, tacrolimus, trimethoprim). Concomitant treatment w/ quinolones. Increase frequency of GI adverse reactions w/ other NSAIDs & corticosteroids. Increase risk of bleeding w/ anticoagulants; GI bleeding w/ SSRIs. Risk of hypo- & hyperglycemia w/ oral antidiabetics. Monitor plasma conc of phenytoin. Increase toxicity of methotrexate.
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
Almiral enteric-coated tab 25 mg
Packing/Price
100 × 10's
Form
Almiral enteric-coated tab 50 mg
Packing/Price
100 × 10's
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