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Clofec Gel/Clofec Cool Gel/Clofec Spray

Clofec Gel/Clofec Cool Gel/Clofec Spray

diclofenac

Manufacturer:

Atlantic Lab

Distributor:

Atlantic Pharma
Concise Prescribing Info
Contents
Diclofenac diethylammonium
Indications/Uses
Clofec Gel/Clofec Cool Gel Symptomatic relief of muscle pain & inflammation of traumatic or rheumatic origin. OA. Clofec Spray Local symptomatic relief of pain & inflammation in musculoskeletal & joint disorders (eg, RA & OA); periarticular disorders (eg, bursitis & tendinitis); soft-tissue disorders (eg, sprains & strains).
Dosage/Direction for Use
Clofec Gel Apply to affected area bid to tid. Clofec Cool Gel Apply to affected site tid or qid. Clofec Spray Depending on size of affected area, spray 20-25 sprays tid up to max of 75 sprays daily.
Contraindications
Hypersensitivity to diclofenac, aspirin, or other NSAIDs. 3rd trimester pregnancy.
Special Precautions
Hypersensitivity reactions including anaphylaxis. Not to be used in patients allergic to diclofenac or those who had asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs. Not to be applied to broken skin, open wounds, infected areas, or exfoliative dermatitis. Avoid contact w/ eyes or areas close to the eyes. Avoid use in patients w/ ulcers or stomach & intestine bleeding or perforation. Increased risk of platelet dysfunction or fatal heart attack or stroke w/ long-term use. Lactation. Childn. Elderly. Clofec Cool Gel Skin allergies. May increase risk of UV light-induced skin tumors. Avoid use of occlusive dressings; sunscreens, cosmetics, lotions, moisturizers, insect repellents, or other topical medication on the same skin sites. Minimize or avoid sun exposure. Hepatic & renal impairment. Clofec Spray Discontinue treatment if skin rash or allergic skin reactions occur. Avoid use in severe renal or hepatic impairment. Avoid use in 3rd trimester & late pregnancy. Discontinue breastfeeding or treatment during lactation.
Adverse Reactions
Skin rash, contact dermatitis, paresthesia, edema. Clofec Cool Gel Pruritus, dry skin, pain, exfoliation. Clofec Spray Application site pain, rash, desquamation, erythema & induration, pruritus & xeroderma (application & non-application site); abdominal pain, constipation, diarrhea, dyspepsia, flatulence, halitosis, nausea; UTI; bruise; infection; sinus congestion, sinusitis.
Drug Interactions
Clofec Cool Gel Concomitant use w/ CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4 substrates. Inhibits CYP1A2 (moderate), 2C9, 2E1 & 3A4 (weak). Clofec Spray Concomitant use w/ oral NSAIDs including analgesic/anti-inflammatory doses of aspirin.
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.
Presentation/Packing
Form
Clofec Cool Gel 1.16% w/w
Packing/Price
30 g x 1's
Form
Clofec Gel 1% w/w
Packing/Price
10 g x 1's;15 g x 1's;30 g x 1's;50 g x 1's
Form
Clofec Spray 1.16% w/w
Packing/Price
60 mL x 1's
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