Planil 2X Gel: Dosing, Side Effect & Interaction

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Diclofenac diethylamine

Indications/Uses

Relief of pain, inflammation & swelling in soft-tissue injuries eg, trauma of tendons, ligaments, muscles & joints [eg, due to sprains, strains, bruises & backache (sports injuries)]; localized forms of soft tissue rheumatism eg, tendonitis (eg, tennis elbow), bursitis, shoulder-hand syndrome & periarthropathy. Relief of pain of non-serious arthritis of knees or fingers; localized forms of degenerative rheumatism eg, OA of peripheral joints & of vertebral column.

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Dosage/Direction for Use

Adult & adolescent ≥12 yr Apply to affected area bid. Max treatment duration: Soft-tissue injuries & rheumatism 14 days. Arthritis pain 21 days.

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Overdosage

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Contraindications

Hypersensitivity. History of hypersensitivity reactions (eg, asthma, bronchospasm, urticaria, acute rhinitis or angioedema) in response to ASA or NSAIDs. Non-intact or damaged skin, including exudative dermatitis, eczema, infected lesions, burns or wounds. Last trimester of pregnancy. Childn & adolescents <12 yr.

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Special Precautions

Discontinue treatment immediately if skin rash develops. Not to be applied on skin wounds or open injuries; breasts or large areas of skin. Avoid contact w/ eyes or mucous membranes; occlusive dressings &/or heat application to the treated area; airtight occlusive dressing. Possibility of systemic adverse events when used on large skin areas over prolonged period. Patients w/ reduced renal, heart & liver function, including those w/ active peptic ulcer in stomach & duodenum. Concomitant use w/ oral NSAIDs. Not recommended in advanced renal disease. Avoid during last trimester of pregnancy. Pregnancy (1st & 2nd trimester) & lactation. Not to be applied on breasts or to large areas of skin, nor use for prolonged period during lactation. Not recommended in childn <12 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Application site pain, rash, pruritus, erythema, paresthesia, dryness, vesicles, irritation, or papules.

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Storage

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Description

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Action

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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.

Thai FDA Category

NDD

Presentation/Packing

Form

Planil 2X Gel gel 2% w/w

Packing/Price

30 g x 1's

Planil 2X Gel

diclofenac

Manufacturer:

Biolab

Distributor:

Biopharm

Marketer:

Biopharm