Drugs List

Therapeutic Indications

Uses

For painful inflammatory conditions of the oropharynx, including: sore throat, mouth ulcers, sore gums, pharyngitis following tonsillectomy or the use of a naso-gastric tube, mucositis or oral ulceration due to radiation therapy, gingivostomatitis associated with herpetic infection or erythema multiforme, dental pain and pain following dental surgery.

Administration

For oromucosal administration.

Contraindications

Third trimester of pregnancy - see 'Pregnancy' section

Precautions and Warnings

First and second trimesters of pregnancy - see 'Pregnancy' section

Breastfeeding - see 'Lactation' section

Maximum treatment 7 days unless on doctor's advice.

Avoid contact with eyes.

Not all formulations are licensed for all age groups (see Dosage - Children ).

Do not swallow oral rinse - expel from mouth after use.

Pregnancy and Lactation

Pregnancy

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).

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 14-17 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 ).

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. Small amounts may be systemically absorbed into the mother. There are no known studies on its effects when used topically on the oral mucosa 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.

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

Side Effects

Numbness
Stinging
Hypersensitivity reactions
Pruritus
Rash
Urticaria
Photoallergic reactions
Laryngospasm
Bronchospasm

Presentation

Oral rinse containing 0.15% w/v benzydamine hydrochloride

Throat spray containing 0.15% w/v benzydamine hydrochloride in a metered dose pump spray delivering 175 microlitres per actuation.

Drugs List

Therapeutic Indications

Uses

For painful inflammatory conditions of the oropharynx, including: sore throat, mouth ulcers, sore gums, pharyngitis following tonsillectomy or the use of a naso-gastric tube, mucositis or oral ulceration due to radiation therapy, gingivostomatitis associated with herpetic infection or erythema multiforme, dental pain and pain following dental surgery.

Dosage

Adults

Elderly

Children

Additional Dosage Information

Administration

For oromucosal administration.

Contraindications

Third trimester of pregnancy - see 'Pregnancy' section

Precautions and Warnings

First and second trimesters of pregnancy - see 'Pregnancy' section

Breastfeeding - see 'Lactation' section

Maximum treatment 7 days unless on doctor's advice.

Avoid contact with eyes.

Not all formulations are licensed for all age groups (see Dosage - Children ).

Do not swallow oral rinse - expel from mouth after use.

Pregnancy and Lactation

Pregnancy

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).

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 14-17 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 ).

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. Small amounts may be systemically absorbed into the mother. There are no known studies on its effects when used topically on the oral mucosa 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.

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

Counselling

The treatment duration should not exceed 7 days, unless on doctor's advice.

The oral rinse should generally be used undiluted, but may be diluted with an equal volume of water if 'stinging' occurs.

Advise patients that the oral rinse should not be swallowed but expelled from the mouth after use.

Advise patients to avoid contact with eyes.

Side Effects

Numbness
Stinging
Hypersensitivity reactions
Pruritus
Rash
Urticaria
Photoallergic reactions
Laryngospasm
Bronchospasm

Overdosage

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 (https://www.toxbase.org/).

Shelf Life and Storage

Metered Dose Oromucosal Spray
Do not store above 30 degrees C.
Do not refrigerate or freeze.

Oral Rinse
Store between 5 and 30 degrees C.
Do not freeze.
Protect from direct sunlight.

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

BNF for Children (2012-2013) 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 Spray. Meda Pharmaceuticals. Revised June 2011.

Summary of Product Characteristics: Difflam Oral Rinse. Meda Pharmaceuticals. Revised June 2011.

Summary of Product Characteristics: Difflam Sore Throat Rinse. Meda Pharmaceuticals. Revised November 2012.