Diclofenac sodium topical
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Gel formulation of diclofenac.
Relief of pain and inflammation due to trauma
Depending on the size of the affected site to be treated, 2 to 4g of gel (a circular shaped mass approximately 2 to 2.5cm in diameter) should be applied three to four times daily, with four hours between applications (maximum 4 doses in 24 hours).
(See Dosage; Adult)
Children 14 years and over
(See Dosage; Adult)
Administration site infection
Children under 14 years
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Third trimester of pregnancy
Precautions and Warnings
First trimester of pregnancy
History of asthma
History of peptic ulcer
Inflammatory bowel disease
Second trimester of pregnancy
NSAIDs may provoke or exacerbate asthma
Contains propylene glycol: may cause irritation
Some preps contain methyl & propylparaben; may cause allergic reactions
Some products may contain soya or soya derivative
Advise patient to wash hands after use
Avoid contact with diseased or inflamed skin
Avoid contact with eyes
Avoid contact with mucous membranes
Breastfeeding: Wash product off breasts prior to breastfeeding infant
For topical use only
Prolonged use over a large area may cause systemic absorption
Discontinue if patient is attempting to conceive
Discontinue treatment if rash occurs
Advise patient to minimise exposure of treated areas to sunlight/sunlamps
Discontinue and consult a doctor if there is no improvement within 3 days
Serious skin reactions, including exfoliative dermatitis, Stevens Johnson syndrome and epidermal necrolysis have been associated with the administration of NSAIDs. The risk of occurrence is highest during the first month of treatment. Concomitant use of oral NSAID's should be cautioned.
Pregnancy and Lactation
Diclofenac sodium is contraindicated during pregnancy.
The manufacturer does not recommend using diclofenac sodium during the first and second trimesters of pregnancy unless clearly necessary. The dose should be low and the duration as short as possible.
Use of diclofenac sodium during the third trimester of pregnancy is contraindicated by the manufacturer. There is an increased risk of developmental effects including cardiopulmonary toxicity and renal dysfunction.
Use diclofenac sodium with caution during breastfeeding.
The manufacturer does not recommend breastfeeding whilst using diclofenac sodium unless advised by a healthcare professional. Avoid application to the breast area.
Application site reaction
Burning sensation (local)
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: November 2019
Summary of Product Characteristics: Diclofenac 1% Gel. Typharm Ltd. Revised November 2019.
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