Silvacure Plus

Uses

Allantoin is an ingredient used in skin care products to relieve irritation and protect minor cuts, scrapes, and burns.

Allantoin is commonly applied in a variety of topical vehicles or applications such as cosmetic creams, toothpastes, mouthwashes, shampoos, lipsticks, anti-acne products, and lotions for the purpose of moisturizing skin, enhancing the smoothness of skin, stimulating the healing of wounds, and soothing irritated skin .

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.

Silvacure Plus is also used to associated treatment for these conditions: Scarring, Dental cleaning, Skin Lightening, Skin protectionCatarrh 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 Infections

How Silvacure Plus works

There is no well controlled data that can formally substantiate the method of action . However, ongoing studies suggest that there may exist a histological wound healing profile induced by allantoin in rats that leads to the amelioration and fastening of the reestablishment of normal skin . This facilitation of wound healing is supported by observations that wounds inflicted to rat subjects to which topical allantoin preparations were applied histologically demonstrated increased vasodilation, presence of inflammatory exudates, number of inflammatory cells, angiogenesis, fibroblast proliferation, and increased collagen deposition when compared to rat subjects with wounds that did not receive any allantoin administration .

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.

Dosage

Silvacure Plus 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.

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.

Toxicity

No studies on repeated dose toxicity and reproductive toxicity have been submitted. Moreover, studies show that the tumor incidence in allantoin treated animals did not differ largely from that found in untreated controls. As a result, further or additional toxicity, mutagenicity, or carcinogenicity tests are not required in view of the endogenous nature of allantoin and the general lack of overall toxicity .

Finally, as allantoin is a normal component of the diet in humans and is a substance of endogenous origin present in the body of humans, it is generally recognized as being a safe substance for humans .

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.

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.

Interaction

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

Elimination Route

In studies on human subjects, a recovery of 19% and 34% of allantoin in the urine was observed but only in two individuals and only after the administration of massive doses of allantoin . After intravenous administration, recovery in the urine was practically quantitative with doses of 75 to 600 mgm in the human model . After 240 mgm, excretion continued for 72 hours in human subjects and the results were similar in regards to subcutaneous injection .

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.

Half Life

When studied in cattle, sheep, and horses, the half-life of allantoin is in the range of 1 to 2.5 hours .

Clearance

Some studies suggest that the average renal clearance of allantoin in normal, healthy human subjects is approximately 123 cc per minute . It is generally agreed upon that exogenously administered allantoin is rapidly excreted .

Elimination Route

Urinary clearance is the predominant excretion route .

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

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.

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

Special Warning

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

Storage Condition

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

Innovators Monograph

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