Megatrum
Megatrum Uses, Dosage, Side Effects, Food Interaction and all others data.
Ornidazole is a 5-nitroimidazole derivative active against protozoa and anaerobic bacteria. It is converted to reduction products that interact with DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms.
Povidone-iodine is an iodophore with a powerful broad-spectrum germicidal activity against a wide range of bacteria, viruses, fungi, protozoa and spores. Microbicidal; oxidizes cell constituents; iodinates proteins and inactivates them.
Povidone iodine is a kind of iodine disinfectant which directly cause in vivo protein denaturation, precipitation of bacteria, and further resulting in the death of pathogenic microorganisms. Therefore, it is effective in disinfection and sterilization. It can kill viruses, bacteria, spores, fungi, and protozoa with low toxicity to human. Povidone-iodine aqueous solution has strong pharmacological activity against Staphylococcus aureus, Neisseria gonorrhoeae, Pseudomonas aeruginosa, syphilis, hepatitis B virus, HIV, and Trichomonas vaginalis.Povidone iodine gel is a gynecological topical semi-mobile colloidal agent made by povidone iodine and hydrophilic matrix. It is a system for maintaining its sustained release. Owing to the continuous release of free iodine, it can enable the skin and mucous membranes to maintain a certain effective concentration of iodine for killing bacteria. It is mainly used for gynecological vaginal infection. It exerted its effect through being miscible with vaginal secretions and further killing the inside pathogenic microorganisms, and thus blocking the spread of sexually transmitted diseases and invasion, as well as treating other infected vaginal diseases caused by other kinds of bacteria.
Published reports on the in vitro antimicrobial efficacy of iodophors demonstrate that iodophors are bactericidal, mycobactericidal, and virucidal but can require prolonged contact times to kill certain fungi and bacterial spores. Three brands of povidone-iodine solution have demonstrated more rapid kill (seconds to minutes) of S. aureus and M. chelonae at a 1:100 dilution than did the stock solution. The virucidal activity of 75–150 ppm available iodine was demonstrated against seven viruses. Other investigators have questioned the efficacy of iodophors against poliovirus in the presence of organic matter and rotavirus in distilled or tapwater. Manufacturers' data demonstrate that commercial iodophors are not sporicidal, but they are tuberculocidal, fungicidal, virucidal, and bactericidal at their recommended use-dilution.
Trade Name | Megatrum |
Generic | Ornidazole + Povidone-iodine |
Weight | 1% |
Type | Ointment |
Therapeutic Class | |
Manufacturer | Group Pharmaceuticals Ltd |
Available Country | India |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Ornidazole is used for Amoebiasis (Intestinal and hepatic), Giardiasis, Trichomoniasis, Bacterial vaginosis, Treatment of susceptible anaerobic infections
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
Megatrum is also used to associated treatment for these conditions: Amebiasis, Anaerobic Bacterial Infection, Chlamydial Infections, Gastrointestinal Infections caused by entamoeba histolytica, Giardiasis, Mixed Vaginal Infections, Surgical Site Infections, Trichomonal Vaginitis, TrichomoniasisSkin Infections, Skin disinfection, Irrigation of the ocular surface therapy, Prepping of the periocular region, Prophylaxis of bacterial skin infections
How Megatrum 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 .
Dosage
Megatrum dosage
Amoebiasis:
- Adults: 500 mg twice a day for 5 days.
- Children: 10-25 mg per kg body weight in two divided doses.
Amoebic dysentery:
- Adults: 1.5 gm once a day for 3 days.
- Children: 40 mg per kg body weight, once a day for 3 days.
Giardiasis:
- Adults: 1.5 gm once daily for 1-2 days.
- Children: 40 mg per kg body weight for 2 days.
Trichomoniasis: 1.5 gm once or 500 mg twice a day for 5 days. Sexual partner should also be treated at the same time.
Bacterial vaginosis: 3 tablets of 500 mg each as a single dose or one tablet of 500 mg once daily for 5-7 days.
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.
Side Effects
Side effects of Ornidazole have been mainly limited to the gastrointestinal tract (nausea, vomiting, epigastric pain) and central nervous system (dizziness, headache, lassitude). Unlike other nitroimidazoles, Ornidazole does not interact with alcohol, although this requires further study.
Leukopenia has been described occasionally during therapy. Adverse central nervous system (CNS) effects of Ornidazole have mainly included headache, dizziness, lassitude or somnolence, fatigue and weakness. Adverse CNS effects of Ornidazole may be less than that happens with metronidazole. Seizures have not been reported with Ornidazole in studies available to date.
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.
Toxicity
ORAL (LD50): Acute: 8000 mg/kg [Rat]. 8100 mg/kg [Mouse]
Precaution
In patient with ataxia, vertigo, and mental confusion, Ornidazole should be prescribed with caution. During prolonged treatment with Ornidazole, blood dyscrasia namely mild leukopenia have been reported rarely. In case leukopenia occurs, the decision to discontinue the therapy should depend upon the gravity of infection.
Avoid contact with eyes; should not be used under occlusive dressing. Pregnancy, lactation
Interaction
Like other imidazoles, Ornidazole has a mild potential to cause disulfiramlike reactions. Concomitant administration of oral anticoagulants may increase the risk of haemorrhage due to diminished hepatic metabolism. Ornidazole has been reported to decrease the clearance of 5-fluorouracil.
Volume of Distribution
Povidone-Iodine is intended for topical application and has no volume of distribution.
Elimination Route
Povidone-Iodine is intended for topical application and is not absorbed.
Half Life
Povidone-Iodine is intended for topical application and is not eliminated.
Clearance
Povidone-Iodine is intended for topical application and is not eliminated.
Elimination Route
Povidone-Iodine is intended for topical application and is not eliminated.
Pregnancy & Breastfeeding use
Adequate clinical trials have not been conducted. Ornidazole should be prescribed only if the potential benefit justifies the potential risk to fetus/neonate.
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.
Contraindication
Previous hypersensitivity to Ornidazole and to other nitroimidazoles. Ornidazole is contraindicated in central nervous system disorders, particularly in epilepsy or in peripheral neuropathy.
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.
Acute Overdose
Renal Impairment Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic Impairment Severe: Double the interval between doses.
Storage Condition
Store at room temperature and protect from light and moisture.
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