Povimed 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.

Trichomoniasis: Tinidazole is used for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection.

Giardiasis: Tinidazole is used for the treatment of giardiasis caused by Giardia duodenalis in both adults and pediatric patients older than three years of age. Sections or subsections omitted from the full prescribing information are not listed.

Amebiasis: Tinidazole is used for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not used for the treatment of asymptomatic cystpassage.

Bacterial Vaginosis: Tinidazole is used for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women.

Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole and other antibacterialdrugs, Tinidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Povimed 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 TherapyAmebiasis, Bacterial Vaginosis (BV), Candidal Vulvovaginitis, Giardiasis, Mixed Vaginal Infections, Nongonococcal urethritis, Sexually Transmitted Disease (STD), Trichomonas Vaginalis Infection, Trichomoniasis

How Povimed 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 .

Tinidazole is a prodrug and antiprotozoal agent. The nitro group of tinidazole is reduced in Trichomonas by a ferredoxin-mediated electron transport system. The free nitro radical generated as a result of this reduction is believed to be responsible for the antiprotozoal activity. It is suggested that the toxic free radicals covalently bind to DNA, causing DNA damage and leading to cell death. The mechanism by which tinidazole exhibits activity against Giardia and Entamoeba species is not known, though it is probably similar.

Dosage

Povimed 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

Prevention of Postoperative Infections :

• Adult: A single oral dose of 2g approximately 12 hours before surgery.
• Children less than 12 years: Data are not available to allow dosage recommendations for children below the age of 12 years in the prophylaxis of anaerobic infections.

Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time Giardiasis:

• Adults: a single 2 g dose taken with food.
• Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food

Amebiasis, Intestinal:

• Adults: 2 g per day for 3 days with food.
• Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3 days with food

Amebic liver abscess:

• Adults: 2 g per day for 3-5 days with food.
• Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3-5 days with food

Bacterial vaginosis: Non-pregnant, adult women: 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food.

Should be taken with food. Take during or immediately after meals.

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.

Reported side effects have generally been infrequent, mild and self-limiting. Side effects from the gastrointestinal tract include nausea, vomiting, anorexia, diarrhoea and metallic taste. Hypersensitivity reactions, occasionally severe, may occur in rare cases in the form of skin rash, pruritis, urticaria and angioneurotic oedema. As with related compounds, tinidazole may produce transient leukopenia. Other rarely reported side-effects are headache, tiredness, furry tongue and dark urine.

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.

There are no reported overdoses with tinidazole in humans. In acute studies with mice and rats, the LD 50 for mice was generally > 3,600 mg/kg for oral administration and was > 2,300 mg/kg for intraperitoneal administration. In rats, the LD 50 was > 2,000 mg/kg for both oral and intraperitoneal administration.

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

Compounds of similar chemical structure have produced various neurological disturbances such as dizziness, vertigo, uncoordination, and ataxia. If, during therapy with tinidazole, abnormal neurological signs develop, therapy should be discontinued. Use in Pregnancy & Lactation: Tinidazole is contraindicated during the first trimester of pregnancy. While there is no evidence that tinidazole is harmful during the late stages of pregnancy, its use during the last two trimesters requires that the potential benefits outweigh the possible risk to mother and foetus. Tinidazole is excreted in breast milk in concentrations similar to those seen in serum. Tinidazole can be detected in breast milk for up to 72 hours following administration. Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose.

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.

The following interactions were reported with metronidazole, which is chemically-related to tinidazole.

Alcohol, disulfiram: Avoid during tinidazole use and for 3 days afterward because cramps, nausea, vomiting, headaches, and flushing may occur.

Anticoagulants, oral (eg, warfarin): Anticoagulant effects may be increased. Anticoagulant dose may need to be adjusted during coadministration and for up to 8 days after discontinuation.

Cholestyramine: Bioavailability of tinidazole may be decreased. Cyclosporine, lithium, tacrolimus: Levels may be elevated by tinidazole, increasing the risk of toxicity.

Drugs that induce CYP3A4 (eg, fosphenytoin, phenobarbital, phenytoin, rifampin): May increase metabolism of tinidazole, decreasing plasma levels and therapeutic effect.

Drugs that inhibit CYP3A4 (eg, cimetidine, ketoconazole): May prolong t½ and decrease tinidazole Cl, increasing plasma levels and risk of adverse reactions.

Fluorouracil: Cl may be decreased by tinidazole, increasing the risk of adverse reactions

Fosphenytoin, phenytoin: The t½ may be prolonged and Cl reduced by tinidazole, increasing the risk of adverse reactions.

Oxytetracycline: Therapeutic effect of tinidazole may be decreased.

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 .

• 50 L

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 .

Rapidly and completely absorbed under fasting conditions. Administration with food results in a delay in T_max of approximately 2 hours and a decline in C_max of approximately 10% and an AUC of 901.6 ± 126.5 mcg hr/mL.

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 .

The elimination half-life is 13.2±1.4 hours and the plasma half-life is 12 to 14 hours.

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 .

Tinidazole crosses the placental barrier and is secreted in breast milk. Tinidazole is excreted by the liver and the kidneys. Tinidazole is excreted in the urine mainly as unchanged drug (approximately 20-25% of the administered dose). Approximately 12% of the drug is excreted in the feces.

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.

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

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

As with other compounds of similar structure, tinidazole, is contraindicated in patients having, or with a history of, blood dyscrasias although no persistent haematological abnormalities have been noted in clinical or animal studies. Tinidazole should be avoided in patients with organic neurological disorders. Tinidazole should not be administered to patients with known hypersensitivity to the compound.

Special Warning

Renal Impairment: Haemodialysis: Additional dose equal to half the usual dose at the end of haemodialysis.

Acute Overdose

There is no experience in human with overdosage

Storage Condition

Store at 20-25° C.

Store at room temperature & protected from light.

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