Benzydamine hydrochloride topical
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Cream formulations of benzydamine hydrochloride
Painful inflammation of musculoskeletal system - short term treatment
Short term symptomatic treatment of painful inflammatory conditions of the musculoskeletal system, including:
Acute inflammatory disorders such as bursitis and myalgia.
Traumatic conditions such as sprains, strains, contusions and the after effects of fractures.
Apply 1 g to 2 g (35 mm to 85 mm) 3 times daily dependent on the size of the area to be treated.
Maximum frequency is up to 6 times daily in more severe conditions.
Treatment should not exceed 10 days duration.
(See Dosage; Adult)
Third trimester of pregnancy
Precautions and Warnings
Children under 18 years
First trimester of pregnancy
Second trimester of pregnancy
Advise patient to wash hands after use
Avoid contact with eyes
Avoid contact with mucous membranes
Do not apply to broken or denuded skin
Length of treatment should not exceed 10 days
Advise patient to avoid exposure to direct sunlight
Pregnancy and Lactation
Benzydamine hydrochloride is a nonsteroidal anti-inflammatory agent that acts as an anti-inflammatory and analgesic by stabilising cell membranes and inhibiting prostaglandin synthesis. It may be absorbed when used topically. There are no known studies on its effects when used topically during pregnancy.
The manufacturer reports that animal studies have not revealed any evidence of teratogenic effects.
In the absence of evidence of safety the manufacturer advises that use during pregnancy should be restricted to when considered essential by a physician. Schaefer considers that if topically applied nonsteroidal anti-inflammatory agents are used, their use should be restricted to small areas after the 30th week of pregnancy (Schaefer, 2007). Application to inflamed, abraded or broken skin should be avoided.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Benzydamine hydrochloride is a nonsteroidal anti-inflammatory agent that acts as an anti-inflammatory and analgesic by stabilising cell membranes and inhibiting prostaglandin synthesis. Small amounts may be systemically absorbed into the mother. There are no known studies on its effects when used topically in a breastfeeding mother. It is not known if it crosses into breast milk.
In the absence of evidence of safety the manufacturer advises that use during breastfeeding should be restricted to when use is considered essential by a physician. Benzydamine cream should not be applied to the breast area.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
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: August 2013
British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Summary of Product Characteristics: Difflam Cream. Meda Pharmaceuticals. Revised May 2013.
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