Benzydamine
Topical NSAID for mouth and throat complaints
Benzydamine is a topically active non steroidal anti inflammatory drug of the indazole class. Angelini introduced the substance in the 1960s under the brand name Tantum, and in Germany it is available without prescription as Tantum Verde, Tantum Spray and as generics in the form of oral rinse, spray, lozenges and vaginal irrigation. Benzydamine is one of the most widely used locally active NSAIDs for inflammation of the oral cavity, throat and genital mucosa.
In contrast to classic systemically used NSAIDs, benzydamine remains locally effective. Limited systemic absorption and a limited spectrum of effects make the substance particularly attractive for mucosal irritation in sore throat, aphthae, oral thrush or after dental procedures. In addition to its anti inflammatory action, benzydamine shows antiseptic and mild local anaesthetic properties, which strengthens symptomatic relief.
Mechanism of Action
The anti inflammatory effect of benzydamine is based on stabilisation of cell membranes and on inhibition of prostaglandin synthesis and leukocyte migration at the site of inflammation. Unlike classic NSAIDs benzydamine inhibits cyclooxygenase only weakly; instead it acts on lipoxygenase signalling pathways and on the release of pro inflammatory mediators from mast cells and neutrophils.
At the local level benzydamine also acts as a mild local anaesthetic and antiseptic. The analgesic component explains the rapid onset of action in difficulty swallowing, and the antimicrobial activity is directed mainly against Gram positive cocci and Candida. The substance accumulates in inflamed tissue and reaches higher concentrations there than in healthy mucosa, which accounts for the topical efficacy with low systemic exposure.
With an oral rinse, less than 5 percent of the dose is absorbed. Systemic exposure is low, yet small amounts are detectable in plasma and urine. Elimination takes place hepatically via glucuronidation; the half life is about 7 to 13 hours. Relevant systemic NSAID side effects do not occur with use as directed.
Indications
- Acute pharyngitis and tonsillitis for relief of difficulty swallowing and sore throat
- Inflammatory disease of the oral mucosa such as stomatitis, gingivitis, aphthae
- Radiation and chemotherapy induced mucositis for symptomatic relief
- After dental and maxillofacial procedures to support healing
- After tonsillectomy or adenoidectomy for postoperative pain relief
- Non specific vaginitis as an irrigation solution
- Oral thrush as an adjunct to antifungal therapy
Dosage and Administration
Oral rinse: 15 ml undiluted 2 to 3 times daily, gargle for about 30 seconds and then spit out. Do not swallow. Spray: 4 to 8 sprays every 1.5 to 3 hours, maximum 6 to 8 applications daily, directly onto the affected mucosa. Lozenges: 1 lozenge 3 to 4 times daily, allow to dissolve slowly in the mouth, do not chew or swallow.
Children: from 6 years rinse with 10 ml, from 12 years adult dose. Spray from 6 years at half dose, lozenges from 6 to 12 years 1 lozenge 2 to 3 times daily. Children under 6 years should not receive rinse or spray, and lozenges are only intended from 6 years because of choking risk.
Vaginal irrigation: 140 ml once daily for 3 to 5 days, on medical advice. As a rule the duration of use should not exceed 7 days; if there is no improvement, medical assessment is necessary because a more serious underlying condition must not be overlooked.
Side Effects
Common and uncommon: local burning in the mouth or throat, numbness of the tongue, dry mouth, transient taste disturbance, mild cough reflex.
Rare: allergic reactions from contact eczema to urticaria, bronchospasm especially in asthmatic patients, laryngospasm in sensitive children, photosensitisation on topically treated skin.
Very rare: anaphylactic reactions, Stevens Johnson syndrome has been described in isolated case reports, angioedematous reactions, dyspnoea after spray use.
Important: Accidental oral ingestion of large amounts (for example by children) can cause central nervous system symptoms such as restlessness, tremor, dizziness, hallucinations or seizures. If suspected, contact the poison control centre immediately. Individual sprays or lozenges are harmless in this respect.
Interactions
- Other NSAIDs, acetylsalicylic acid: no clinically relevant interactions with topical use, systemic combination theoretically additive
- Antiseptic mouth rinses with chlorhexidine: keep an interval of at least 30 minutes to avoid mutual inactivation
- Antifungals: no negative interactions, combination common in oral thrush
- Toothpastes containing sodium lauryl sulfate: may impair local tolerance, keep an interval
- Other locally irritating substances: avoid alcohol containing mouthwashes, hot drinks and spicy food directly after use
Special Notes
Contraindications: known hypersensitivity to benzydamine or any of the excipients, hypersensitivity to acetylsalicylic acid and other NSAIDs, asthmatic reactions to NSAIDs (analgesic induced asthma).
Pregnancy: topical use under recommended conditions is usually acceptable because systemic absorption is low. In the third trimester use should be avoided as a precaution in order to avoid theoretical NSAID effects on the ductus arteriosus. Breastfeeding: topical use is possible; after a rinse the mouth should be well cleaned and spray use directly before a breastfeeding interval should be avoided.
Children: spray and rinse only from 6 years, lozenges from 6 years because of choking risk. Observe age appropriate dosing, supervision by adults is sensible, especially on first use.
Discolouration: benzydamine may cause tooth discolouration that is reversible with normal dental hygiene. Blue discolouration of the tongue is rare, usually harmless and disappears within a few days after end of treatment.
Duration of treatment: self medication for sore throat should be limited to 7 days; for vaginitis or after surgery it follows medical advice. In case of fever, severe difficulty swallowing, unilaterally enlarged lymph nodes or skin rash medical evaluation is necessary.
You may also be interested in
- Chlorhexidine, antiseptic mouth rinse
- Dexpanthenol, mucosal care for irritation
- Ambroxol, sore throat lozenges with local analgesic effect
- Tyrothricin, topical antibiotic for mouth and throat
- Mesalazine, locally active agent in chronic bowel inflammation
Frequently Asked Questions
Am I allowed to swallow Tantum Verde?
No. The oral rinse and the spray are intended for local application. After gargling the fluid should be spat out to keep systemic uptake minimal. Accidental swallowing of small amounts is usually harmless; with larger amounts, and especially in children, the poison control centre should be contacted.
How quickly does benzydamine relieve sore throat?
Relief of symptoms often occurs within a few minutes, while the anti inflammatory effect develops over the day. Application may be repeated up to 6 times daily. If there is no improvement after 3 days or if symptoms worsen, a medical evaluation is advisable.
Which age groups is benzydamine suitable for?
Spray and rinse are approved from 6 years, below this they are not recommended because of swallowing risks. Lozenges are suitable from 6 years, not before because of choking risk. In children use should take place under supervision. For infants and toddlers other local therapy options are available.
What to do about numbness of the tongue?
The mild numbness arises from the local anaesthetic component and subsides within 10 to 20 minutes. It is harmless. Hot food or drinks should be avoided during this time to prevent unintentional burns. In case of persistent or severe symptoms, medical evaluation is advised.
Sources
- EMA, European Medicines Agency
- AWMF, guidelines on acute pharyngitis and mucositis
- Gelbe Liste, benzydamine active substance profile
- BfArM, Federal Institute for Drugs and Medical Devices
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The information provided on this page is for general informational purposes only and does not constitute medical advice, diagnosis or treatment recommendation. It does not replace consultation with a licensed physician or pharmacist. Medicines should only be taken on medical prescription or via a pharmacy. All information is based on product information and recognised scientific sources published at the time of creation; the manufacturer's current summary of product characteristics is always authoritative. Sanoliste assumes no liability for the completeness, timeliness or accuracy of the information presented. In a medical emergency, call the emergency number 112.