Betasym S

Uses

Abrasion, Bed sore, Burns, Cuts, Decubitus or stasis ulcers, Leg ulcers and pressure sores, Pre-operative and post-operative skin cleansing, Pre-operative scrubbing & washing, Pre-operative skin disinfection, Pressure sores, Skin infections, Vaginitis, Wound and burn dressing, Wound and ulcer cleansing, Wound cleansing, Wound infection, Wound sepsis, Wounds

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.

Betasym S is also used to associated treatment for these conditions: Skin Infections, Skin disinfection, Irrigation of the ocular surface therapy, Prepping of the periocular region, Prophylaxis of bacterial skin infectionsDyspepsia, Gastric Ulcer, Gastritis, Gastro-esophageal Reflux Disease (GERD), Healing, Mucositis, Peptic Ulcer, Stress Ulcers, Active Duodenal ulcer, Antiplatelet Therapy

How Betasym S works

Povidone-iodine is called iodophore which means povidone acts as a carrier of iodine. Iodine is considered as the active moiety that mediates microbicidal actions. When released from the complex, free iodine (I2) penetrates the cell wall of microorganisms quickly, and the lethal effects are believed to result from disruption of protein and nucleic acid structure and synthesis. While the full mechanism of action is not fully elucidated, iodine is thought to inhibit vital bacterial cellular mechanisms and structures, and oxidizes nucleotides fatty or amino acids in bacterial cell membranes . Additionally, free iodine disrupts the function of the cytosolic enzymes involved in the respiratory chain, causing them to become denatured and deactivated . In vitro evidence suggests that iodine also counteracts inflammation elicited by both pathogens and the host response via multifactorial effects. In hosts, povidone-iodine was demonstrated to modulate the redox potential, inhibit the release of inflammatory mediators such as TNF-α and β-galactosidase, inhibit metalloproteinase production, and potentiate the healing signals from pro-inflammatory cytokines by activation of monocytes, T-lymphocytes, and macrophages, in vitro .

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

Betasym S dosage

Pre-operative scrubbing & washing: Wet hands with water, then pour 5 ml of solution onto the palm and spread over both the hands, rub the scrub over the entire area for about 2 mintues, add water to develope copious suds, rinse throughly under running water.

Pre- and post-operative skin cleansing: After the skin is shaved and wet with water, apply surgical scrub & rub throughly for minimum 2 mintues, rinse of with the sterile gauze saturated with water.

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

Local skin irritation and sensitivity. Application to large areas of denuded skin may produce systemic effects due to iodine absorption.The application of povidone iodine to large wounds or severe burns may producesystemic adverse effectssuch as metabolic acidosis, hypernatraemia and impairment of renal function.

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

Toxicity

ORAL (LD50): Acute: 8000 mg/kg [Rat]. 8100 mg/kg [Mouse]

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

Avoid contact with eyes; should not be used under occlusive dressing. Pregnancy, lactation

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

Interaction

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

Povidone-Iodine is intended for topical application and has no volume of distribution.

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

Elimination Route

Povidone-Iodine is intended for topical application and is not absorbed.

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

Povidone-Iodine is intended for topical application and is not eliminated.

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

Povidone-Iodine is intended for topical application and is not eliminated.

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

Povidone-Iodine is intended for topical application and is not eliminated.

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

Pregnancy & Breastfeeding use

Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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; prolonged use in patients with thyroid disorders or on lithium therapy. Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.

There are no known contraindications

Acute Overdose

There is no experience in human with overdosage

Storage Condition

Store at 20-25° C.

Innovators Monograph

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