Levofenil 5ml Sol, Chloramphenicol, Dexamethasone, Phenylephrine
.Generic name: Chloramphenicol. Dexamethasone. Phenylephrine.
Dosage form and formulation: Solution. Each ml contains: 2.000 mg levorotatory chloramphenicol; 1.200 mg phenylephrine hydrochloride; 21-dexamethasone sodium phosphate, equivalent to 0.915 mg of dexamethasone phosphate. Vehicle qs 1000 ml.
Therapeutic Indications: Inflammatory diseases of the anterior segment of the eye associated infection by organisms susceptible to chloramphenicol as Staphylococcus aureus, Escherichia coli, H. influenzae, Klebsiella / Enterobacter, Moraxella locunata, Neisserias.
Pharmacokinetics: Dexamethasone is a glucocorticosteroid with antiinflammatory potency of 3 to 5 times that of hydrocortisone. This action is exerted directly on the protecting tissues from inflammatory insults, preventing its reaction to these, or is, a suppressive action; inhibiting edema, fibrin deposition, capillary dilation and macrophage migration to the site of inflammation, as well as the capillary and fibroblast proliferation, hung deposits and scar formation associated with inflammation. Dexamethasone also possesses antiallergic action it inhibits the action of histamine (without antagonizing her); by blocking the action of histidine decarboxylase, reduces the synthesis of prostaglandins and retards epithelial regeneration.
Glucocorticoids are absorbed by all routes; applied to the cornea, aqueous humor and passing adjacent structures and cause an increase in intraocular pressure. Chloramphenicol is a broad spectrum antibiotic, inhibits protein synthesis in the translation process, it binds to the 50s unit ribosomes and prevents binding of the amino-acid ribonucleic transfer ribosome, inhibiting the chain transfer nascent polypeptide to said amino acid; and training is indispensable for bacterial growth polypeptide is disrupted. It has been observed that substantial amounts reach Chloramphenicol aqueous humor when applied topically.
Chloramphenicol is excreted primarily in the urine and only 5 to 10% appears unchanged, the rest is inactivated by the liver. Approximately 3% is excreted in the bile and only 1% of the inactive form is excreted in the feces. Phenylephrine hydrochloride is an alpha-sympathomimetic stimulator produces constriction in dilated conjunctival vessels and elevated blood pressure by vasoconstriction.
Contraindications: Hypersensitivity to the components of the formula, ocular tuberculosis, epithelial keratitis, fungal diseases, purulent infections, viral keratoconjunctivitis, alkali burns, narrow-angle glaucoma.
Precautions: Chloramphenicol should not be used in patients with a history of hypersensitivity or toxic drug reactions; has to be used carefully in premature and newborn infants under medical supervision.
Restrictions on use during pregnancy and lactation: Studies in laboratory animals have shown that dexamethasone is teratogenic. No well-controlled studies in pregnant women, so its use is recommended only if absolutely necessary. It is not known whether these drugs are excreted in breast milk, so it should be used with caution in nursing. Chloramphenicol should be given in these conditions only if absolutely necessary, according to the doctor.
Adverse Reactions: Rarely slight burning, itching or perceived eye irritation after application of Cloran, which disappears in a few minutes. Dexamethasone may cause increased intraocular pressure with possible development of glaucoma, cataracts, secondary infections, delayed healing and globe perforation of the cornea or sclera is thinned. Chloramphenicol can cause hypersensitivity reactions, macular or vesicular rashes, transient irritation, blepharitis, allergy, punctate epithelial erosions in the cornea. Prolonged use of topical antibiotics may promote the overgrowth of non-susceptible organisms such as fungi. If this occurs or if the original condition is decrease unmanifest, the drug should be discontinued and seek medical advice. In prolonged or intermittent treatment, chloramphenicol can cause aplastic anemia rarely, death and after topical application.
Drug Interactions: Steroids decrease the action of antibiotics, so you must increase the dosage of these. Chloramphenicol may antagonize the action of bactericidal antibiotics like gentamicin, neomycin, bacitracin, polymyxin, tobramycin, cephalosporins, amikacin, etc..
Changes in the results of laboratory tests: Application of antibiotic ophthalmic use, prior to the taking of smear and culture, can give false negative results.
Precautions regarding effects of carcinogenicity, mutagenicity, teratogenicity and fertility: Studies in laboratory animals have shown that dexamethasone has teratogenic effects. There are no studies to evaluate their potential carcinogenicity, mutagenicity and effects on fertility. Not enough studies have been conducted in animals or in humans to evaluate the carcinogenic or chloramphenicol fertility potential. However, there is some clinical evidence that chloramphenicol can cause aplastic anemia and this can is associated with the subsequent development of leukemia. None established the potential of phenylephrine on these effects.
Dosage and administration: Route of administration: ophthalmic. Dose: applying 1 to 2 drops every 4 to 8 hours.
Manifestations and management of overdose or accidental ingestion: There is no risk at doses of this medicine. In any case, it can increase the secondary or adverse reactions. In case of accidental ingestion causing overdose, administer fluids to dilute.
Presentation (s): Retailing: box with 5 ml bottle with dropper. 15 ml bottle with dropper.
Storage Recommendations: Store at room temperature not exceeding 30 ° C and dry. Keep the bottle tightly closed. Protect from light.
Legends of protection: Exclusively for medical literature. Its sale requires a prescription. Keep out of reach of children. Prolonged use of corticosteroids in ophthalmic application is able to promote the development of glaucoma.
Name and address of laboratory: Grin Laboratorios SA de C.V.
Drug Name: LEVOFENIL
Comparable patent medicine: LEVOFENIL
Active substance: chloramphenicol DEXAMETHASONE PHENYLEPHRINE
Presentation: OPHTHALMIC SOLUTION
Concentration: 5 ML
Extended-release tablets: No
Lab: Grin Laboratorio, SA de CV