Ciprofloxacin Injection USP 200 mg/10Oml

 

CLINICAL PHARMACOLOGY

Pharmacological effects: Halogens such as lodine are rapidly bactericidal, fungicidal, virucidal and sporicidal. Lodine on coming into contact with water releases nascent Oxygen, which damages the nuclei of the pathogens. Because of this unique mode of action, development of resistance has not been a clinical problem with the use of lodine. Although lodine is considered as one of the best all-round antiseptics, its use is associated with irritation and excessive staining in a significant number of patients. In addition, aqueous solutions of lodine are unstable.

To overcome these problems, iodophors were developed (lodine carriers or lodine - releasing agents). Iodophors are complexes of lodine and a solubilizing agent or carrier, which acts as a reservoir for the active iodine. The most widely used iodophor throughout the world is iodinated. Although iodophors such as iodinated-Povidone have good germicidal activity, iodophors are less effective against anaerobic bacteria. This dissuades many physicians from prescribing iodinated-Povidone preparations.

Metronidazole is a member of the Imidazole class of anti-bacterial agents and is effective against a wide variety of anaerobic bacteria such as Bacteroides spp., Fusobacterium, Pepto coccus and Pepto streptococcus spp. that are commonly found in contaminated wounds. In malodorous skin lesions (primarily fungating tumors and decubitus ulcers) the offending bacteria appear to be anaerobes, specifically the Bacteroides species. Topical Metronidazole has shown promise for odor control without the cost or side effects of a systemic drug.

Mode of action: The microbicidal activity of Povidone lodine is due to the strong oxidant effects of free lodine on functional groups of Amino acids, Nucleotides and double bonds of unsaturated fatty acids. Rimer while elucidating the effect of Povidone lodine on cell ultra structure by electron microscopy and to monitor changes in enzymes activity and Nucleotide efflux, rapid partitioning of the cytoplasm and pronounced coagulation of nuclear material of Staph aureus and E.coli was noted. A rapid and dose dependent loss of cellular Beta Galactosidase was also found. These studies indicate that Povidone lodine interacts with cell walls of microorganisms cause pore formation or generating solid liquid interfaces at the lipid membrane level which lead to loss of Cytosol material in addition to enzyme denaturation.

Metronidazole is a prototype Nitroimidazole and has broad spectrum cidal activity against protozoa and many anaerobic bacteria. After entering the cell by diffusion its Nitro group is reduced by certain redox proteins operative only in anaerobic microbes by highly reactive nitro radical exerts cytotoxicity by damaging DNA and other critical biomolecules. It has been found to inhibit mediated immunity, to induce mutagenesis and to cause radio sensitization.

CLINICAL PHARMACOKINETICS

Only very small quantities of lodine are absorbed through an intact skin, (Reynolds, 1989). Iodine can be absorbed by wounds and abrasions Enhanced absorption occurs through denuded skin, decubitus ulcers, mucosal surfaces with high absorptive capacity (vagina), or large areas of intact skin. Distribution is poor due to low absorption through intact skin. Enhanced distribution occurs through denuded skin.

Serum Metronidazole levels have been shown to be below detection limits (<25 ng/mL) at the majority of time points after administration of topical Metronidazole. At the time points that it could be detected, topical Metronidazole produced blood levels (C approximately 80% less than a similar dose administered orally (C212 ng/mL). Therefore, with 40.6 ng/mL) that were normal usage, topical Metronidazole results in minimal blood levels of Metronidazole.

INDICATIONS

As a dressing medicament for exudative wounds as in, immediate post-operative wounds, umbilical cord dressing, pressure ulcers, venous ulcers, diabetic ulcers etc.

DOSAGE AND ADMINISTRATION

Adults: Drez Powder is FOR EXTERNAL USE ONLY. Areas to be treated should be cleansed before application of Drez Powder. Apply and rub a thin film of sufficient quantity of Drez Powder three to four times daily to entire affected area(s).

Children: Dosage recommendations and indications for the use of Drez Powder in children have not been established.

CONTRAINDICATIONS

Drez Powder is contra indicated in those patients who are hypersensitive to lodine or other ingredients of the preparation.

WARNINGS AND PRECAUTIONS

Application of Drez Powder to large areas of the body is to be done under medical supervision. Hypothyroidism may occur following ingestion of large quantities of Drez Powder.

Use this medicine as directed by the Physician. Do not use expired medicines. Do not exceed maximum recommended period of use.

ADVERSE EFFECTS

Occasionally local side effects such as skin rash, itching and redness may be associated with the use of Drez Powder.

DRUG INTERACTIONS

Can interact with Lithium therapy.

STORAGE

Do not store above 30° C. Protect from light. Keep out of reach of children.

PRESENTATIONS

10g in a container packed in a carton with Package Insert.

SHELF LIFE:36 months.

Manufactured by:

STEDMAN PHARMACEUTICALS PVT. LTD. C-4, SIDCO Pharmaceutical Complex, Alathur, Thiruporur-603 110. Tamil Nadu, India.

Date of Publication: April 2007, last Revised: July 2019