Burnosaf

Uses

For antisepsis of clean and surgical hand to prevent infections

Prophylaxis and treatment of infection in burn wounds-

As an adjunct to short-term treatment of infection in

• Leg ulcers
• Pressure sores

As an adjunct to prophylaxis of infection in

• Skin graft donor sites
• Extensive abrasions

Conservative management of Finger-tip injuries

Silver Sulphadiazine is a local chemotherapeutic agent for prevention and treatment of burn wound infections. Silver Sulphadiazine disintegrates in the burn wound, thereby causing a slow and sustained release of silver ions. Silver ions bind to bacterial Deoxyribonucleic acid (DNA), thus inhibiting the growth and multiplication of bacterial cells without affecting the cells of the skin and subcutaneous tissue. Silver Sulfadiazine cream has a broad antibacterial spectrum including virtually all microbial species likely to infect the burn wound: Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, strains of Proteus and Klebsiella. It is also an effective agent against Candida albicans and other fungi. Silver Sulfadiazine penetrates into the necrotic tissue and exudate. This effect is very important in view of the fact that systemic antibiotics are not effective against the bacterial flora of vascular burn necrosis.

Sucralfate tablet is used for the treatment of acute, nonmalignant gastric and duodenal ulcers. Maintenance therapy to prevent the recurrence of duodenal ulcers.

Sucralfate suspension is used for the short-term (up to 8 weeks) treatment of active duodenal ulcer.

Burnosaf is also used to associated treatment for these conditions: Catarrh 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 disinfectionWound InfectionsDyspepsia, Gastric Ulcer, Gastritis, Gastro-esophageal Reflux Disease (GERD), Healing, Mucositis, Peptic Ulcer, Stress Ulcers, Active Duodenal ulcer, Antiplatelet Therapy

How Burnosaf works

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.

Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. Silver sulfadiazine acts only on the cell membrane and cell wall to produce its bactericidal effect. A specific mechanism of action has not been determined, but silver sulfadiazine's effectiveness may possibly be from a synergistic interaction, or the action of each component. Silver is a biocide, which binds to a broad range of targets. Silver ions bind to nucleophilic amino acids, as well as sulfhydryl, amino, imidazole, phosphate, and carboxyl groups in proteins, causing protein denaturation and enzyme inhibition. Silver binds to surface membranes and proteins, causing proton leaks in the membrane, leading to cell death. Sulfadiazine is a competitive inhibitor of bacterial para-aminobenzoic acid (PABA), a substrate of the enzyme dihydropteroate synthetase. The inhibited reaction is necessary in these organisms for the synthesis of folic acid.

The mechanism of action of this drug in the healing duodenal ulcers is not yet completely defined, however, there are several probable mechanisms that adequately describe the healing activity of sucralfate. There is evidence that sucralfate acts locally to aid in tissue healing, and not systemically .

Studies in both humans and animals have indicated that sucralfate forms a complex that binds to protein-rich exudate found on the surface of ulcers. It binds to albumin and fibrinogen preventing blood clot lysis by stomach acid (hydrochloric acid). Sucralfate increases the tissue levels of fibroblast growth factors and epidermal growth factors , leading to an increase in prostaglandins at the gastrointestinal tract lining, which promote the healing of gastrointestinal ulcers .

In the laboratory setting, a sucralfate-albumin film provides a barrier against the entry of hydrogen ions, which are a component of gastric acid. In humans, sucralfate, given at therapeutic doses for ulcers, decreases pepsin activity in gastric fluids by 32% . Pepsin has been shown to be damaging to tissues, further aggravating ulcer lesion inflammation . Bile salts have been implicated in mucosal injury to the gastrointestinal tract . Sucralfate has also been shown to adsorb bile salts in the laboratory, setting, which could further contribute to its beneficial effects in ulcer healing .

Dosage

Burnosaf dosage

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

Burns: Keep the burn wound in clean condition and apply Burnsil over the affected area to a depth of 3 to 5 mm. This application is best achieved with a sterile gloved hand and/or a sterile spatula. Where necessary, the cream should be re-applied to any area from which it has been removed by patient activity. In burns, Burnsil should be re-applied at least every 24 hours, or more frequently if the volume of exudate is large.

Hand burns: Apply Burnsil to the burn area and enclose with a clean plastic bag or glove upto wrist. The patient should be encouraged to move the hand and fingers. The dressing should be changed when an excessive amount of exudate has accumulated in the bag.

Leg ulcers/pressure sores: The cavity of ulcer should be filled with Burnsil to a depth of at least 3-5 mm. As Burnsil can cause maceration of normal skin on prolonged contact, care should be taken to prevent spread on the non-ulcerated areas. Application of Burnsil should be followed by an absorbed pad or gauze dressing, with further application of pressure bandaging as appropriate for the ulcer. The dressings should normally be changed daily but for wounds which are less exudative, less frequent changes (every 48 hours) may be acceptable. Cleanings and debriding should be performed before application of Burnsil. Burnsil is not recommended for use in leg or pressure ulcer that is very exudative.

Fingertip injuries: Haemostasis of the injury should be achieved prior to the application of a 3-5 mm layer of Burnsil . A conventional finger dressing may be used. Alternatively waterproof adhesive tape can be used on finger covered by a plastic or surgical glove. Dressings should be changed every 2-3 days.

Adult: Usual dose 1 gm 4 times daily to be taken 1 hour before meals and at bed time. Maximum daily dose is 8 gm. Four to six weeks treatment is usually needed for ulcer healing but upto twelve weeks may be necessary in resistant cases. Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Gastalfet.

Elderly: There are no special dosage requirements for elderly patients but as with all medicines the lowest effective dose should be used.

children: Safety and efficacy in children have not been established

Side Effects

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

In prolonged treatment of burn wounds involving extensive areas of the body the serum Sulphonamide concentrations may approach the levels equal to those in systemic treatment.

The incidence and severity of side effects from sucralfate are very low. Mild side effect like constipation has been reported in some patients.

Toxicity

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.

Acute oral toxicity (LD50) in rat is 10001 mg/kg.

Overdose

Overdosage has never been observed with sucralfate . It is unlikely, as administering a maximum dose of up to 12 g/kg/body weight in several animal species did not result in death. The lethal dose could not be determined in these studies . It is likely that overdose of sucralfate in humans would result in constipation, and supportive treatment would be advised .

Use in pregnancy

This drug is considered a pregnancy Category B drug. Studies have been performed in rodents and rabbits at doses up to 50 times the recommended human dose. No harm to the fetus has been observed in the abovementioned studies. Sufficient and well-controlled clinical trials have not been performed in pregnant women. Due to the fact that the results of animal studies are not always relevant to human response, sucralfate should be used during pregnancy only if it is deemed essential for the mother's health .

Use in nursing

Whether this drug is excreted in human milk is currently unknown. Many drugs are excreted in breast milk, therefore, if sucralfate is administered to a lactating and nursing woman, caution should be observed .

Carcinogenesis

24 month toxicity studies were performed in rodents, and the dose of sucralfate reached up to 1 g/kg (equivalent to 12 times the recommended human dose). No signs of sucralfate-related tumors were noted.

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

Precautions: Caution is required in the presence of hypersensitivity to Sulphonamides because of possible allergic reactions, in patients with inborn glucose-6-phosphate dehydrogenase deficiency, as haemolysis may occur after the application of the cream to the large body surface area; as well as in the presence of hepatic and renal dysfunction.When treatment with Burnsil cream involves prolonged administration or large burn surfaces, the white blood cell count should be monitored, as leukopenia may occur.

Warning: Elevation of body temperature occurring in children during the first days of treatment is unrelated to Burnsil administration and should not lead to the discontinuation of therapy.

The product should only be used with caution in patients with renal dysfunction

Interaction

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

Concomitant use of sucralfate may reduce the bioavailability of certain drugs as has been observed in animal studies with tetracycline, phenytoin and cimetidine and in human studies with digoxin. Administration of sucralfate with any of these drugs should be separated by two hours. Since sucralfate may hinder warfarin absorption, caution should be exercised when these two drugs are used together.

Volume of Distribution

This drug is absorbed in a very small quantity, and normally localizes to inflamed gastrointestinal lesions .

Elimination Route

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.

Very limited penetration through the skin. Only when applied to very large area burns is absorption into the body generally an issue.

This drug is absorbed from the gastrointestinal tract in very minimal quantities . The adsorbed sulfated disaccharide is excreted in the urine . This drug contains aluminum and after the administration of 1 g of sucralfate 4 times per day, about 0.001% to 0.017% of this aluminum content is absorbed in patients with normal renal function . This number is expected to increase in those with impaired renal function .

Half Life

The half-life is not known. In animals, the elimination half-life of the sucrose component of this drug is from 6-20 h .

Clearance

Sucralfate contains aluminum. The administration of sucralfate in non-dialyzed chronic renal failure patients warrants careful consideration from the treating physician as the excretion of absorbed aluminum may be decreased, causing possible aluminum toxicity .

In dialyzed patients diagnosed with chronic renal failure, aluminum toxicity related to sucralfate has been observed and reported. The daily amount of aluminum ingestion (including sucralfate) should be carefully examined before administering sucralfate in combination with other drugs also containing aluminum, including various antacids .

Elimination Route

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

The negligible amount of this drug that is absorbed is excreted mainly in the urine within 48 hours .

Pregnancy & Breastfeeding use

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.

As Sulphonamide therapy is known to increase the possibility of kernicterus, Silver Sulphadiazine 1% cream should not be used on pregnant women approaching or at term.

Although animal studies show no evidence of foetal malformation, safety in pregnant women has not been established and Sucralfate should be used in pregnancy only if clearly needed.

It is not known whether this drug is excreted in human milk. Caution should be exercised when sucralfate is administered to nursing mothers.

Contraindication

Hypersensitivity.

The use of Burnsil is contraindicated in premature infants and neonates because of possible kernicterus. It should not be used in pregnancy, except in cases when the potentially life-saving benefits of the medication outweigh possible hazards to the foetus

There are no known contraindications

Special Warning

Infant: The cream should not be used on premature infants, or on newborn infants during the first 2 months of life.

Acute Overdose

There is no experience in human with overdosage

Storage Condition

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

Store at 20-25° C.

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