Maxtra Gargle

Benzydamine Mouthwash BP 0.15% w/v

Benzydamine Hydrochloride BP 0.15% w/v

Hydrochloric flavoured vehicle containing Ethanol IP 10% q.s.

Liquid external (Mouthwash)

0.15% w/v

4.1. Therapeutic indication

Benzydamine Mouthwash is a locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the mouth and throat including:

• Traumatic Conditions: Pharyngitis following tonsillectomy or the use of a naso-gastric tube;
• Inflammatory Conditions: Pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy;
• Dentistry: For use after dental operations.

4.2. Posology and method of administration

Rinse or gargle with 15 mL solution for 20-30 seconds every 1.5 to 3 hours as required for pain relief. The solution should be expelled from the mouth after use. Benzydamine Mouthwash should generally be used undiluted, but if ‘stinging’ occurs the rinse may be diluted with water.

4.3. Contraindications

Use in patients with a known hypersensitivity to the active ingredient, benzydamine hydrochloride, or to any of the other ingredients.

4.4. Special warnings and precautions for use

• Benzydamine Mouthwash is for oromucosal use only and should not be swallowed.
• Benzydamine use is not advisable in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.
• Avoid contact with eyes.
• Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients.

4.5. Drugs interactions

No interaction studies have been performed.

4.6. Use in special populations

There is no information as regards use of benzydamine in pregnancy. Benzydamine Mouthwash should not be used in pregnancy or lactation unless considered essential by the physician.

4.7. Effects on ability to drive and use machines

Benzydamine Mouthwash has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

The most common side effects are numbness and a stinging feeling in the mouth. The adverse reactions reported are classified by system organ class.

Respiratory, thoracic and mediastinal disorders

Laryngospasm or bronchospasm.

Gastrointestinal disorders

Oral numbness (hypoesthesia) and a stinging feeling in the mouth (oral pain), dryness of mouth

Skin and subcutaneous tissue disorders

Hypersensitivity reactions which may be associated with pruritus, urticaria, photosensitivity reaction and rash, Angioedema

Immune system disorders

Anaphylactic reactions (which can be potentially life-threatening), hypersensitivity reactions

The small amount of alcohol in this medicine will not have any noticeable effects.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com.

Website: http://www.zuventus.co.in/safety.aspx

4.9. Overdose

Intoxication is only expected in case of accidental ingestion of large quantities of benzydamine (> 300 mg).

Very rarely symptoms of overdosing such as excitation, convulsions, sweating, ataxia, tremor and vomiting have been reported after the oral administration of benzydamine dosages much larger than recommended. In the event of acute overdose only symptomatic treatment is possible; the stomach should be emptied by inducing vomiting or by gastric lavage, and the patient carefully observed and given supportive treatment. Adequate hydration must be maintained.

5.1. Mechanism of Action

The indazole analogue benzydamine has physicochemical properties and pharmacological activities which differ from those of the aspirin-like NSAIDs. Unlike aspirin-like NSAIDs which are acids or metabolised to acids, benzydamine is a weak base. In further contrast, benzydamine is a weak inhibitor of the prostaglandin synthesis. Only at concentration of 1 mM and above benzydamine effectively inhibits cyclooxygenase and lipooxygenase enzyme activity. It mostly exerts its effects through inhibition of the synthesis of pro-inflammatory cytokines including tumor necrosis factor-alpha (TNF-α) and Interleukin-1β (IL-1β) without significantly affecting other pro-inflammatory (IL-6 and 8) or anti-inflammatory cytokines (IL-10, IL-1 receptor antagonist). Further mechanisms of action are hypothesised including the inhibition of the oxidative burst of neutrophils as well as membrane stabilisation as demonstrated by the inhibition of granule release from neutrophils and the stabilisation of lysosomes. The local anaesthetic activity of the compound has been related to an interaction with cationic channels.

5.2. Pharmacodynamic properties

Benzydamine specifically acts on the local mechanisms of inflammation such as pain, oedema or granuloma. Benzydamine topically applied demonstrates antiinflammatory activity reducing oedema as well as exudate and granuloma formation. Further, it exhibits analgesic properties if pain is caused by an inflammatory condition and local anaesthetic activity. Hyperthermia, which is indicative of systemic functional involvement, is poorly affected by benzydamine.

5.3. Pharmacokinetic properties

Oral doses of benzydamine are well absorbed and plasma drug concentrations reach a peak fairly rapidly and then decline with a half-life of about 13 hours. Less than 20% of the drug is bound to plasma proteins. Although local drug concentrations are relatively large, the systemic absorption of mouthwash-gargle doses of benzydamine is relatively low compared to oral doses. This low absorption should greatly diminish the potential for any systemic drug side-effects when benzydamine is administered by this route. Benzydamine is metabolized primarily by oxidation, conjugation and dealkylation.

6.1. Animal Toxicology or Pharmacology

Non-Clinical Data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated toxicity, genotoxicity, cardiogenic potential, and toxicity to reproduction.

Benzydamine belongs to the group of nonsteroidal anti-inflammatory drugs.

Molecular Formula: C19H23N3O·HCl

Molecular Weight: 345.87 g/mol

8.1. Incompatibilities

Not Applicable

8.2. Shelf-life

24 months

8.3. Packaging information

PET clear 120 mL bottle with silver cap and 15 mL measuring cup

8.4. Storage and handing instructions

Store in cool place. Do not refrigerate or freeze.

FOR MOUTHWASH USE ONLY.

DO NOT SWALLOW.

SHAKE WELL BEFORE USE.

FOR EXTERNAL USE ONLY

Instruct patients on the following points when administering the drug.

• If a dose of this medication is missed, it is not necessary to make up the missed dose. Skip the missed dose and continue with the next scheduled dose. Do not double doses.
• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• Instruct patients to this medicine is for oromucosal use only and should not be swallowed.
• Remind patient to tell about asthmatic condition
• Remind patient to tell about allergic condition to acetylsalicylic acid or to other anti-inflammatory painkillers called NSAIDs