Occttal

Uses

Benzydamine Hydrochloride mouthwash is used to treat many painful conditions affecting the throat or mouth including: Sore throat, Sore tongue or gums, Mouth ulcers, Discomfort caused by dentures, Pain after dental surgery etc.

For antisepsis of clean and surgical hand to prevent infections

Occttal is also used to associated treatment for these conditions: Acute Sore Throat, Gingivitis, Inflammation of Mouth, Laryngitis, Mouth irritation, Mucositis of the oro-pharyngeal, Orofacial Pain, Pain, Pharyngitis, Sore gums, Throat irritation, Traumatic Injuries caused by Dental Prosthesis, Gum irritation, Oral Hygiene, Tooth Extractions, Oral antisepsisCatarrh of the throat, Chemotherapy Induced Mucositis, Chronic Wounds, Decubitus Ulcer, Dental Cavity, Dysphagia, Eczema infected, Foeter Ex Ore, Gingival Bleeding, Gingival disorders NEC, Gingivitis, Glossitis, Hoarseness, Infection, Infectious Periodontal Diseases, Injury Throat, Mild to Moderate Inflammatory Reaction of the Oral Cavity, Mild to Moderate Inflammatory Reaction of the Pharynx, Mouth injury, Mucositis, Neurodermatitis, Ocular Inflammation, Ocular Irritation, Oral Aphthous Ulcer, Oral Infection, Pain, Periodontitis, Pharyngitis, Plaque, Dental, Postoperative Wound Infection, Purulent Gingivitis, Radiation Mucositis, Red eye, Ringworm, Skin Infections, Skin Infections, Bacterial, Sore Throat, Stomatitis, Surgical Wound, Tissue Damage, Tonsillitis, Ulcer, Aphthous, Ulcers, Leg, Wound Infections, Dry, cracked skin, Gum disorder, Gum pain, Moderate Gingivitis, Oral lesions, Recurrent Oral fungal infection, Severe Gingivitis, Superficial Wounds, Throat disinfection, Tongue inflammation, Anesthesia of Mucous Membrane, Antimicrobial Therapy, Contact Lens Care, Disinfection, Disinfection of External Genitalia, Disinfection of the Urethra, Disinfection of the Vaginal Mucosa, Irrigation therapy, Lubrication of the Urethra, Oral Care, Oral Hygiene, Oropharyngeal antisepsis, Skin disinfection, Surgical Scrubbing, Topical Antisepsis, Urethral Anesthesia, Wound Cleansing, Wound Healing, Oral antisepsis, Oral disinfection

How Occttal works

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. In particular, benzydamine predominantly acts by inhibiting the synthesis of pro inflammatory cytokines like tumour 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).

Moreover, benzydamine is largely a weak inhibitor of prostaglandin synthesis as it has been shown to effectively inhibit cyclooxygenase (COX) and lipoxygenase enzyme activity only at concentrations of 1mM or greater. Considering most contemporary usages of benzydamine are topical applications that are generally not well absorbed through the skin and/or non-specialized mucosae, benzydamine does not often achieve the kind of absorption or blood concentrations necessary to cause any extraneous distant systemic effects or COX inhibition, allowing it to localize its action.

Additionally, it is also hypothesized that benzydamine is capable of inhibiting the oxidative burst of neutrophils and membrane stabilization. These actions are exhibited by the substance’s ability to inhibit the release of granules from neutrophils and to stabilize lysosomes.

Furthermore, benzydamine is capable of a local anaesthetic effect that may be related to its capability for inhibiting the release of inflammatory mediators like substance P and calcitonin gene related peptide from sensory nerve endings. Since substance P is capable of causing the release of histamine from mast cells, benzydamine’s prevention of substance P release further contributes to an anti-inflammatory effect.

Benzydamine also demonstrates a non-specific antibacterial activity against various bacterial strains that are resistant to broad-spectrum antibiotics such as ampicillin, chloramphenicol, and tetracycline at concentrations of about 3 mmol/L. Combinatorial use of benzydamine and other antibiotics like tetracycline and chloramphenicol are also synergistic against antibiotic resistant strains of Staphylococcus aureus and Pseudomonas aeruginosa.

Chlorhexidine’s broad-spectrum antimicrobial effects are due to its ability to disrupt microbial cell membranes. The positively charged chlorhexidine molecule reacts with negatively charged phosphate groups on microbial cell surfaces - this reaction both destroys the integrity of the cell, allowing leakage of intracellular material, and allows chlorhexidine to enter the cell, causing precipitation of cytoplasmic components and ultimately cell death. The specific means of cell death is dependent on the concentration of chlorhexidine - lower concentrations are bacteriostatic and result in leakage of intracellular substances such as potassium and phosphorous, whereas higher concentrations are bactericidal and cause cytoplasmic precipitation.

Dosage

Occttal dosage

15 ml of Benzydamine mouthwash should be rinsed or gargled every 1.5-3 hours or as required, for 20-30 seconds. If stinging occurs, it can be diluted with an equal volume of water.

To sterilize clean hand: Take adequate amount (about 3 ml) of Sanityza on the palm of the both hands and wrists; rub until full drying as if every part is sterilized effectivelyBefore surgery: Apply about 5 ml of Sanityza following above mentioned method; apply upto the elbow

Side Effects

Benzydamine Hydrochloride mouthwash can cause side effects, although not everybody gets them. Side effects are generally minor.

• Severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects throat and makes breathing difficult and swallowing difficult, patients should be hospitalized
• Itchy rash, sometimes with pale, raised areas of skin with red edges (urticaria).
• A feeling of numbness in mouth.
• A stinging feeling in mouth- the mouthwash may be diluted with water if you experience stinging. This should help to reduce the stinging effect.

Skin sensitivity; mucosal irritation; reversible brown staining of the teeth; tongue discoloration and burning sensation; transient taste disturbance; parotid gland swelling.

Toxicity

A possible adverse reaction associated with the use of the mouthwash or oromucosal spray formulations of benzymadine is potential numbness and/or stinging in the mouth and/or throat .

Some possible adverse reactions that tend to be associated more with topical cream formulations of benzymadine include increased sensitivity to sunlight, and localized itching, skin rash, redness, or swelling .

The prescribing information for all formulations of benzymadine however, warn against the possibility of severe allergic reaction (anaphylaxis) associated with swelling of the throat and mouth, difficulty in swallowing, speaking, and breathing, or wheezing .

As benzydamine is a non-steroidal anti-inflammatory drug (NSAID), it is necessary to determine if a patient is allergic to NSAIDs before considering its use .

Intoxication is expected as a consequence of accidental ingestion of large quantities of benzydamine (over 300 mg ingestion). Other symptoms associated with overdose of ingested benzydamine include gastrointestinal and central nervous system symptoms like nausea, vomiting, abdominal pain, oesophageal irritation, dizziness, hallucinations, agitation, anxiety, and irritability .

The official prescribing information for benzydamine generally suggest that benzydamine mouthwashes and sprays should not be used in pregnancy . Similarly, the official prescribing information for benzydamine also generally suggest that benzydamine mouthwashes and sprays should not be used during lactation unless considered essential by a physician .

The prescribing information for topical cream formulations of benzydamine note that benzydamine cream should not be used in pregnancy or lactation unless considered necessary by the physician .

Overall, 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 . Additionally, there is no evidence of teratogenic effects in animal studies .

The LD₅₀ of subcutaneously administered chlorhexidine in mice is >5 g/kg.

Small children are likely to be more susceptible to chlorhexidine overdose - ingestion of 1-2 ounces by a small child may result in gastric distress, nausea, and intoxication. Treatment should consist of symptomatic and supportive measures. Seek medical attention if a child ingests >4 ounces of chlorhexidine solution or if symptoms of intoxication develop post-exposure.

Precaution

• Keep away from the reach of children

• If the solution comes in contact with eyes, wash your eyes with water immediately ·

• 3. Keep away from light and keep at room temperature• Keep away from combustible material and fire

Interaction

Soaps, other anionic agents, borates, bicarbonates, carbonates, chlorides, citrates, nitrates, phosphates & sulfates.

Volume of Distribution

The volume of distribution of benzydamine is 10 L .

Elimination Route

Oral doses of benzydamine are well absorbed and plasma drug concentrations reach a peak fairly rapidly and then decline with a half-life of approximately 13 hours. When applied topically, although the local drug concentrations are relatively large, the systemic absorption of topically applied benzydamine is relatively low compared to oral doses. This low topical absorption contributes to a decreased potential for any systemic drug side-effects when benzydamine is administered in this way.

Topically, chlorhexidine is unlikely to undergo any degree of systemic absorption. Orally administered chlorhexidine, such as that found in oral rinses for dental purposes, is very poorly absorbed from the gastrointestinal tract - the C_max in human subjects following an oral dose of 300mg was 0.206 µg/g and occurred approximately 30 minutes after ingestion (T_max). Following the insertion of 4 PerioChips in 18 adult patients, no detectable plasma or urine chlorhexidine levels were observed.

Half Life

Approximately 13 h after oral administration , with a terminal half life of about 7.7 h .

Clearance

Benzydamine demonstrateas a systemic clearance of 170 ml/min .

Elimination Route

The relatively high lipid solubility of the weak base benzydamine is thought to be associated with considerable passive resorption within the renal tubule, which suggests that only approximately 5% of benzydamine is excreted unchanged in the urine . At the same time however, other studies have suggested that considerably larger amounts (50-65%) of the drug is excreted unchanged in urine .

While several inactive oxidized metabolites of benzydamine are excreted in urine, the benzydamine N-oxide metabolite can remain in plasma and demonstrate a half-life that is longer than the parent benzydamine compound .

Nevertheless, it is generally believed that excretion occurs mainly through urine and is mostly in the form of inactive metabolites or conjugation products .

Excretion of chlorhexidine gluconate occurs almost exclusively via the feces, with less than 1% of an ingested dose excreted in the urine.

Pregnancy & Breastfeeding use

The safety of Benzydamine has not been established in pregnant patients. Risk to benefit ratio should be established if this drug is to be used in these patients.

Pregnancy Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Contraindication

Patients allergic (hypersensitive) to Benzydamine or other component of mouthwash should not use the preparation. Contact with eye should be avoided. If accidentally get into eyes, they should be immediately washed with cold water.

Hypersensitivity.

Storage Condition

Keep away from light, store in cool and dry place under 30º C. Keep out of reach of children.

Store in a cool and dry place, protected from light.

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