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OverviewMechanism of ActionHow To UseUsesBenfitsIndicationsMethod of AdministrationDosage StrengthsDosage FormsDietary RestrictionsContraindicationsWarnings and Precautions for usingAdverse ReactionsSide EffectsUse of Benzydamine in Specific PopulationsClinical Pharmacology Clinical StudiesAuthored by Reviewed by References
Benzydamine

Benzydamine

Indications, Uses, Dosage, Drugs Interactions, Side effects
Benzydamine
Medicine Type :
Allopathy
Prescription Type:
Prescription Required
Approval :
DCGI (Drugs Controller General of India)
Schedule
Schedule H
Pharmacological Class:
Nonsteroidal Anti-inflammatory Drugs (NSAIDs),
Therapy Class:
Anti-inflammatory Agent, Local Anesthetic,

Benzydamine is a Non-steroidal anti-inflammatory drugs (NSAIDs)belonging to Anti-inflammatory / Local Anesthetic.

Benzydamine is a locally-acting NSAID indicated for the symptomatic relief of pain in acute sore throat and for the symptomatic relief of oropharyngeal mucositis caused by radiation therapy.

Absorption of Benzydamine takes place via oral mucosa during oral rinse.Time taken to reach Peak plasma concentration is 2 hrs.The volume of distribution of benzydamine is 10 L. Benzydamine exhibits < 20% plasma protein binding after oral administration.Benzydamine is primarily metabolized by oxidation, dealkylation, and conjugation into hydroxy, dealkylated, and N-oxide metabolites. Excretion occurs mainly through Urine (primarily as unchanged drug).

Benzydamine shows common side effects like Numbness of mouth, Stinging feeling in mouth, Nausea and vomiting, Irritation of throat.

Benzydamine is available in the form of Mouth wash and Liquids.

Benzydamine is available in India, Canada,Philippines, Australia, Japan, Malaysia, Singapore, and China.

Benzydamine is an Anti-inflammatory / Local Anestheticbelonging to the class Non-steroidal anti-inflammatory drugs (NSAIDs).

Despite being categorized as a non-steroidal anti-inflammatory drug (NSAID), benzydamine demonstrates various mechanisms of action that differ from those of traditional aspirin-like NSAIDs. Benzydamine predominantly acts by inhibiting the synthesis of pro inflammatory cytokines like tumor necrosis factor-alpha (TNF-α) and interleukin-1β (IL-1β) without largely affecting other pro inflammatory cytokines (ie. such as IL-6 and IL-8) or anti-inflammatory cytokines (ie. like IL-10 or IL-1 receptor antagonist).

The amount of time required for Benzydamine to show its action and its duration of action is not clinically established.

Time to peak plasma concentration is approximately 2-4 hours (oral).

Benzydamine is available in the form of Mouth wash and liquid.

Gargle or rinse 15 mL in mouth (for 30 seconds, followed by expulsion from mouth) 3-4 times per day. Do not swallow.

Benzydamine is a painkiller medicine containing Benzydamine. This medicine is used to relieve pain and swelling associated with conditions of the mouth and throat such as sore throat, mouth ulcers, pain after dental surgery, sore tongue or gums, radiation therapy-induced dry mouth or mouth sores, etc.

Benzydamine is a Non-steroidal anti-inflammatory drugs (NSAIDs)belonging to Anti-inflammatory / Local Anesthetic.

Benzydamine works by inhibiting the production of certain substances in your body that cause pain and swelling.

Benzydamine is approved for use in the following clinical indications

  • Mucositis, due to radiation therapy
  • Pharyngitis

  • Mucositis, due to radiation therapy

Adult Dose: Oral rinse: 15 mL (undiluted solution) as a gargle or rinse 3 or 4 times daily (depending on mucositis severity).

Children ≥6 years and Adolescents: Oral rinse: Refer to adult dosing.

  • Pharyngitis

Adult Dose: Oral rinse: Gargle with 15 mL (undiluted solution) every 11/2 to 3 hours until symptoms resolve.

Children ≥6 years and Adolescents: Oral rinse: Refer to adult dosing.

Benzydamine is available in various strengths as 0.15%.

Benzydamine is available in the form of Mouth wash and liquid.

Benzydamine is contraindicated in patients with

  • Hypersensitivity to benzydamine or any component of the formulation.
  • Irritation/burning: May cause local irritation and/or burning sensation in patients with altered mucosal integrity; dilution (1:1 in lukewarm water) may attenuate this effect.
  • Renal impairment: Use with caution in patients with renal impairment (may be absorbed from oral mucosa).

Alcohol Warning

Alcohol should not be taken while you are taking Benzydamineas it may lead to unpleasant side effects.

Breast Feeding Warning

The safety and efficacy of Benzydamine are not studied in breastfeeding women.

Pregnancy Warning

The safety and efficacy of Benzydamine are not studied in pregnant women.

Common

Localized numbness, drowsiness, headache, burning sensation of skin, stinging of the skin, Nausea, vomiting, xerostomia, Cough, pharyngitis.

Benzydamine have interactions with medicines to treat alcohol addiction (disulfiram), to asthma (theophylline, salbutamol), painkillers (naproxen, ibuprofen).

The common side effects of Benzydamine include the following

Common side effects

Numbness of mouth, Stinging feeling in mouth, Nausea and vomiting, Irritation of throat.

  • Pregnancy

Pregnancy Category

The safety and efficacy of Benzydamine are not studied in pregnant women.

  • Nursing Mothers

The safety and efficacy of Benzydamine are not studied in breastfeeding women.

  • Pediatric Use

Benzydamineis not recommended for children under the age of 12 years.

  • Pharmacodynamic

Benzydamine is a non-steroidal anti-inflammatory drug (NSAID) designed to elicit local anesthetic and analgesic effects mainly for the mouth and throat. It specifically acts on the local mechanisms of inflammation such as pain, oedema, or granuloma. Typically applied topically, the drug demonstrates anti-inflammatory activity reducing oedema as well as exudate and granuloma formation. Moreover, benzydamine exhibits analgesic properties and local anaesthetic activity if pain is caused by an inflammatory condition. Benzydamine can be absorbed into the oral mucosa and intact skin. Once absorbed in the local area of pain or inflammation, benzydamine binds selectively to local inflamed tissues, usually allowing it to act with few adverse systemic effects. On average a period of 2 to 4 hours is necessary for the substance to reach peak plasma concentration.

  • Pharmacokinetics

Absorption

Absorption of Benzydamine takes place via oral mucosa during oral rinse.Time taken to reach Peak plasma concentration is 2 hrs.

Distribution

The volume of distribution of benzydamine is 10 L. Benzydamine exhibits < 20% plasma protein binding after oral administration.

Metabolism and Excretion

Benzydamine is primarily metabolized by oxidation, dealkylation, and conjugation into hydroxy, dealkylated, and N-oxide metabolites. Excretion occurs mainly through Urine (primarily as unchanged drug).

There are some clinical studies of the drug Benzydamine mentioned below:
  1. Kim JH, Chu F, Lakshmi V, Houde R. A clinical study of benzydamine for the treatment of radiotherapy-induced mucositis of the oropharynx. International journal of tissue reactions. 1985 Jan 1;7(3):215-8.
  2. Epstein JB, Stevenson-Moore P, Jackson S, Mohamed JH, Spinelli JJ. Prevention of oral mucositis in radiation therapy: a controlled study with benzydamine hydrochloride rinse. International Journal of Radiation Oncology* Biology* Physics. 1989 Jun 1;16(6):1571-5.
  3. Maamer M, Aurousseau M, Colau JC. Concentration of benzydamine in vaginal mucosa following local application: an experimental and clinical study. International Journal of Tissue Reactions. 1987 Jan 1;9(2):135-45.

  • https://go.drugbank.com/drugs/DB09084
  • https://reference.medscape.com/drug/tantum-benzydamine-343305#4
  • https://www.apollopharmacy.in/salt/BENZYDAMINE
  • https://www.uptodate.com/contents/benzydamine-united-states-not-available-drug-information?search=benzydamine&source=panel_search_result&selectedTitle=1~6&usage_type=panel&kp_tab=drug_general&display_rank=1
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Jyoti Suthar
Jyoti is a Post graduate in Pharmaceutics ( M Pharm) She did her graduation ( B Pharm) From SSR COLLEGE OF PHARMACY And thereafter did her M Pharm specialized in Pharmaceutics from SSR COLLEGE OF PHARMACY
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Dr JUHI SINGLA
Dr JUHI SINGLA has completed her MBBS from Era’s Lucknow Medical college and done MD pharmacology from SGT UNIVERSITY Gurgaon. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
Published on: 8 Jun 2023 9:30 AM GMT
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