Almiral

Almiral

diclofenac

Manufacturer:

Medochemie

Distributor:

Medochemie
Concise Prescribing Info
Contents
Diclofenac Na
Indications/Uses
Inflammatory & degenerative forms of rheumatism. Acute attacks of gout. Post-traumatic & post-op pain, inflammation & swelling (eg, following dental or orthopaedic surgery). Painful &/or inflammatory conditions in gynaecology (eg, primary dysmenorrhoea or adnexitis). Adjuvant in severe painful inflammatory infections of the ear, nose or throat (eg, pharyngotonsillitis, otitis).
Dosage/Direction for Use
Adult Initially 100-150 mg daily in 2-3 divided doses. Milder cases: 75-100 mg daily. Max: 150 mg daily. Primary dysmenorrhoea Initially 50-150 mg daily. Max: 200 mg daily. 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 or intestinal ulcer, bleeding or perforation. Severe cardiac failure. Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid &/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. Hepatic & renal impairment. Last trimester of pregnancy.
Special Precautions
Discontinue use at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; possible serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Not recommended for patients w/ rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. GI bleeding, ulceration or perforation. Risk of serious CV thrombotic events (including MI & stroke). Monitor blood count; patients w/ defects of haemostasis. Asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (ie, nasal polyps), COPD or chronic resp tract infections (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma exacerbations (analgesics/analgesics-asthma intolerance), Quincke's edema or urticaria. May mask the signs & symptoms of infection. Concomitant use w/ systemic NSAIDs including cyclooxygenase-2 selective inhibitors. Regularly monitor hepatic function during prolonged treatment; discontinue use if abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent w/ liver disease develop or if other manifestations (eg, eosinophilia, rash) occurs. Hepatic porphyria. Impaired cardiac or renal functions, history of HTN. Mild to moderate renal & hepatic impairment. Pregnancy (1st & 2nd trimesters). Not to be administered during breast feeding. Elderly ≥65 yr.
Adverse Reactions
Headache, dizziness; vertigo; nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, decreased appetite; increased transaminases; rash. Stevens-Johnson syndrome, toxic epidermal necrolysis.
Drug Interactions
May significantly increase peak plasma conc & exposure w/ potent CYP2C9 inhibitors (eg voriconazole). Increased plasma conc of lithium & digoxin. May decrease effects of diuretics & antihypertensives (eg β-blockers, ACE inhibitors). May increase nephrotoxicity of ciclosporin. May increase serum K levels w/ known hyperkalemia-causing drugs (eg K-sparing diuretics, ciclosporin, tacrolimus, trimethoprim). Concomitant use w/ quinolones may possibly lead to convulsions. May increase frequency of GI undesirable effects w/ other NSAIDs & corticosteroids. Increased risk of bleeding w/ anticoagulants & anti-platelet agents; GI bleeding w/ SSRIs. Monitor blood glucose level when used concomitantly w/ antidiabetics. Monitor plasma conc of phenytoin. May increase toxicity of methotrexate.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
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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