Profenac 1% Gel
Diclofenac Sodium 1% Topical
1 gm/100 gm
Popular Pharmaceuticals Ltd.
| Pack size | 10gm Tube |
|---|---|
| Unite Price | 12.95 BDT |
Indications
Profenac 1% Gel is used for:
Rheumatoid arthritis, Osteoarthritis, Joint and muscular pains
Adult Dose
Topical/Cutaneous
Osteoarthritis
Adult: Apply 2 g (upper extremities)/4 g (lower extremities) q6hr
Not to exceed 8 g/day to any single joint of (upper) extremities; 16 g/day to any single joint of (lower extremities)
Local symptomatic relief of pain and inflammation
Adult: As diclofenac Na (1% gel): Apply onto affected area 3 or 4 times daily.
Child Dose
Safety and efficacy not established
Renal Dose
Administration
Apply to clean, dry skin
Avoid showering/bathing until gel/solution is dry for at least 30 min
Wash hands after use
Avoid clothing on knees until gel/solution is dry
Contra Indications
Contraindicated to the patients hypersensitive to any ingredient of the products. Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor.
Gel should not be used under occlusive airtight dressings.
Precautions
In rare instances where peptic ulceration or gastro-intestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation.
Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.
Lactation: Excretion in milk unknown/not recommended
Pregnancy-Lactation
Pregnancy
Published literature reports that use of NSAIDs after 30 weeks’ gestation increases the risk of premature closure of the fetal ductus arteriosus
Data from observational studies regarding potential embryofetal risks of NSAID use, including diclofenac, in women in the first or second trimester of pregnancy are inconclusive
Clinical considerations
Avoid use of NSAIDs in pregnant women after 30 weeks’ gestation because NSAIDs can cause premature closure of the fetal ductus arteriosus
Lactation
Data from published literature reports with oral preparations of diclofenac indicate the presence of small amounts of diclofenac in human milk
There are no data on the effects on the breastfed infant or the effects on milk production
Interactions
May increase serum levels of methotrexate. Concomitant use w/ other NSAIDs or anticoagulants (e.g. warfarin) is associated w/ higher risk of GI bleeding. Increased risk of nephrotoxicity w/ ciclosporin or triamterene. May increase the risk of developing corneal complications in patients w/ significant pre-existing corneal inflammation when use concomitantly w/ ophth preparation containing corticosteroids. Colestyramine and colestipol reduce the bioavailability of diclofenac. Decreased plasma concentration when administered after sucralfate. Ophth application of diclofenac may reduce the efficacy of ophth acetylcholine and carbachol. May increase serum levels of lithium and digoxin.
Side Effects
Side effects of Diclofenac Sodium 1% Topical :
>10%
Dry skin (25-27%), Rash (20-35%), Contact dermatitis (19-33%), Pain (15-26%), Paresthesia (<20%), Pruritus (52%), Exfoliation (6-24%)
1-10%
Hypertension, Chest pain, Skin ulcer, Diarrhea, Dyspepsia, Alepesia, Photosensitivity, Edema, Conjunctivitis, Hematuria, Asthma
Mode of Action
Diclofenac, a phenylacetic acid derivative is a prototypical NSAID. It has potent anti-inflammatory, analgesic and antipyretic actions. Inhibits cyclooxygenase (COX)-1 and COX-2, thereby inhibiting prostaglandin synthesis. May also inhibit neutrophil aggregation/activation, inhibit chemotaxis, decrease proinflammatory cytokine level, and alter lymphocyte activity.
Note
Profenac 1% 1 gm/100 gm Gel generic name is Diclofenac Sodium 1% Topical. Profenac 1% 1 gm/100 gm Gel is manufactured by Popular Pharmaceuticals Ltd.Profenac 1% is availble in all over Bangladesh.
Mes BD drug index information on Profenac 1% Gel is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.