Dosanac

Dosanac

diclofenac

Manufacturer:

Siam Pharm

Distributor:

Pharmaforte
Concise Prescribing Info
Contents
Diclofenac Na
Indications/Uses
Emulsion gel Local relief of pain & inflammation in traumatic inflammation of the tendons, ligaments, muscles & joints; localized forms of soft-tissue rheumatism (eg, tendinitis) & painful joint diseases. Inj Inflammatory & degenerative forms of rheumatism (eg, RA & ankylosing spondylitis); OA & spondylarthritis; painful vertebral column syndromes; renal & biliary colic; painful post-op & post-traumatic inflammation & swelling; non-articular rheumatism; acute gout attacks.
Dosage/Direction for Use
Emulsion gel Apply 2-4 g (3-6 cm) tds-qds to the affected parts & rub in gently. Inj Adult 1 amp daily. Severe cases (eg, colic) 2 inj daily separated by few hr interval. Established CV disease or significant CV risk factor Initially ≤100 mg daily.
Contraindications
Emulsion gel Hypersensitivity to diclofenac, acetylsalicylic acid (aspirin) & other NSAIDs, isopropanol or propylene glycol. Inj Hypersensitivity. Peptic ulcer; asthmatic patients, urticaria or acute rhinitis precipitated by acetylsalicylic acid or other drugs w/ prostaglandin-synthetase inhibiting activity; high dose (150 mg daily) for >4 wk in patients w/ established CV disease (CHF, established ischemic heart disease, peripheral arterial disease) or uncontrolled HTN. Childn <2 yr.
Special Precautions
Pregnancy & lactation. Emulsion gel Avoid contact to eyes or mucous membranes. Do not apply to skin wounds or open injuries. Severe cutaneous reactions including Stevens-Johnson syndrome & toxic epidermal necrolysis (Lyell's syndrome). Monitor for sign of hypersensitivity reaction. Discontinue use if rash occurs. Childn. Inj Small increased risk of serious CV thrombotic events (including MI & stroke) particularly at high dose & in long-term treatment. Periodically re-evaluate patient's need for symptomatic relief & response to therapy especially when initial inj treatment continues w/ diclofenac tab or supp for >4 wk. Advise patients to remain alert for signs & symptoms of serious arteriothrombotic events (eg, chest pain, shortness of breath, weakness, speech slurring). Patients w/ symptoms of GI disease, history suggestive of GI ulcerative colitis, Crohn's disease, pre-existing dyshaemopoiesis or blood coagulation disorders; severe hepatic, cardiac or renal impairment. W/draw treatment if peptic ulceration or GI bleeding occurs. Monitor hepatic & renal function of elderly during prolonged treatment.
Adverse Reactions
Emulsion gel Rashes or skin eruptions. Inj GI distress, occult GI bleeding & gastric ulceration.
Drug Interactions
Inj Increased blood conc of lithium. Lowered plasma conc w/ acetylsalicylic acid.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Dosanac emulsion gel 1 g/100 g
Packing/Price
25 g x 1's
Form
Dosanac inj 25 mg/mL
Packing/Price
3 mL x 100 × 1's
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