Prosp. lotesoft ingles.indd

drops of LOTESOFT® in the conjunctival sac of the affected eye(s) four times dosage, go to the nearest hospital or toxicology centers.
a day. During the initial treatment in the first week, if necessary, dosage may The product is manufactured under sterile conditions. Patients should avoid LOTESOFT ®
be increased up to 1 drop per hour. Treatment should not be interrupted contact of the dropper tip with any surface, since this may contaminate the How supplied:
before the term indicated by the physician. If the signs and symptoms do not Packages with one 5-ml dropper bottle.
improve after two days of treatment, the patient should be examined and the In case of pain or redness, itching or inflammation worsening, the patient should consult the physician. As with all ophthalmologic products containing Storage conditions:
Postsurgical ocular inflammation: Apply one or two drops of LOTESOFT benzalkonium chloride, patients should not use soft contact lens during the conjunctival sac of the operated eye(s) four times a day, starting the applica- tion 24 hours after the surgery and continuing for 2 weeks afterwards.
Carcinogenesis - Mutagenesis - Impairment of fertility
Once the container is opened for the first time, it should be used within 4 Shake suspension well before instilling.
Long-term studies in animals to evaluate the carcinogenic potential of If you are using LOTESOFT®, the use of contact lens during the treatment STERILE OPHTHALMIC SUSPENSION
Loteprednol Etabonate have not been performed. The substance was not genotoxic in vitro and in vivo studies (Ames test, murine tk lymphoma test, Keep drugs out of reach of children.
In order to avoid product contamination, the dropper tip should not be in chromosome aberration test in human lymphocytes, murine micronucleus Delicate use product. To be administered under prescription and medical In case the patient forgets to apply a dose, he/she should apply it immedi- The treatment of male and female rats with doses of up to 50 mg/kg/day Formula:
ately after perceiving the omission, but he/she should not do so if the next and 25 mg/kg/day of Loteprednol Etabonate, respectively (equivalent to 600 Each 100 ml of ophthalmic suspension contains: application hour is coming soon. Doses should not be duplicated.
and 300 times the maximum clinical dose, respectively) before and during The product is manufactured under sterile conditions. Patients should avoid copulation phase did not modify fertility in either sex.
LABORATORIOS POEN S.A.C.I.F.I.
Preservative: Benzalkonium chloride 10.0 mg; Inactive ingredients: contact of the dropper tip with any surface, since this may contaminate the Pregnancy
Bermúdez 1004 - C1407BDR Buenos Aires, Argentina Glycerin; Disodium edetate 2H2O; Polyvinylpyrrolidone; Tyloxapol; HCl Studies performed in female rabbits treated with Loteprednol etabonate in 1N/HONa 1N q.s. pH 5.0-6.0; Purified Water, q.s. In case of pain or redness, itching or inflammation worsening, the patient oral doses of 3 mg/kg/day (85 and 35 times the maximum daily clinical dose of ophthalmic suspension 0.2% and 0.5%, respectively) during the period of Therapeutical action:
As with all ophthalmologic products containing benzalkonium chlo- organogenesis showed that Loteprednol is embryotoxic and teratogenic. The Ophthalmic anti-inflammatory steroid.
ride, patients should not use soft contact lens during the application of same results were observed in studies with rats.
The oral administration of 50 mg/kg/day (a toxic dose for the mother) to Indications:
rats since the beginning of the fetal period until the end of lactation caused a LOTESOFT® is indicated for the treatment of inflammatory ocular affec- Contraindications:
decrease in the growth and survival of the offspring and a retarded develop- tions in the eyelids and bulbar conjunctiva, cornea and eyeball anterior LOTESOFT® is contraindicated for viral diseases affecting the cornea and segment, including allergic conjunctivitis, rosacea acne, superficial punc- conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), Lactation
tata keratitis, herpes zoster keratitis, iritis, cyclitis, and cases of infectious vaccinia and varicella, as well as for eye microbacterial infections and mycosis It is unknown whether the topical ophthalmic administration of corticoste- conjunctivitis in which a reduction of the edema and inflammation would roids may produce enough systemic absorption to detect the substance in be beneficial and in which the risk of using corticosteroid agents would be LOTESOFT® is contraindicated for subjects with known or suspected hyper- human milk. Steroids administered systemically are detected in human milk justified. Furthermore, it is indicated for the treatment of the inflammation sensitivity to any of the components of the formula and other corticosteroids.
and may suppress growth, interfere with the endogenous production of corticosteroids or cause other undesirable effects in the infant.
Warnings:
Extreme precautions should be taken when indicating LOTESOFT® to nursing Pharmacological characteristics:
The long-term use of corticosteroids may cause glaucoma with damage to Pharmacological action
the optic nerve, defects in visual acuity and field, as well as formation of Pediatric use
Corticosteroids suppress the inflammatory reaction to a variety of causal posterior subcapsular cataract. Steroids should be used with caution in cases The safety and effectiveness of LOTESOFT® have not been established in agents and probably delay cicatrization. They inhibit edema, fibrin deposit, capillary dilatation, leukocyte migration, capillary proliferation, The long-term use of corticosteroids may suppress the host immune response, fibroblast proliferation, collagen deposit, and the formation of scars, all thus increasing the risk of secondary ocular infections.
Adverse reactions:
of which are phenomena associated with inflammation. Although the In those pathologies causing corneal o scleral thinning, perforations caused Reactions related to the topical ophthalmic use of steroids include increased mechanism of action of corticosteroids is not known in detail, it is believed by the use of topical steroids have been observed. intraocular pressure possibly associated with optic nerve damage, defects in that they act by induction of the phospholipase A2 -inhibiting proteins In acute purulent affections of the eye, steroids may mask an infection or visual acuity and field, formation of posterior subcapsular cataract, second- -called lipocortins-, which would control the biosynthesis of potent inflam- ary ocular infection, and eyeball perforation when there is corneal or scleral mation mediators, such as prostaglandins and leukotrienes, by inhibiting The use of ocular steroids may prolong the course and exacerbate the sever- the release of their common precursor, the arachidonic acid.
ity of many viral infections of the eye (including herpes simplex). The use of Ocular adverse reactions observed in 5 to 15% of the patients treated with Pharmacokinetics
a corticosteroid in the treatment of patients with a history of herpes simplex Loteprednol Etabonate ophthalmic suspension in clinical studies included Loteprednol Etabonate is structurally similar to other corticosteroids but abnormal/ blurry eyesight, burning feeling after instillation, chemosis (con- does not have the ketone group at position 20. It is highly soluble in The use of steroids after cataract surgery may delay cicatrization.
junctival edema), secretion, dry eyes, epiphora (lacrimation), foreign body Iipids, which favors its penetration in cells. The synthesis of Loteprednol It is recommended to determine intraocular pressure if LOTESOFT® is admin- feeling, itching, reddening, and photophobia.
Etabonate is achieved by means of structural modifications of compounds istered for 10 days or longer. Before continuing the treatment for more than Other ocular adverse reactions reported in less than 5% of the patients related to prednisolone so that it may suffer a predictable biotransforma- 14 days, an ophthalmologic study is recommended, including biomicroscopic include conjunctivitis, cornea abnormalities, palpebral erythema, keratocon- test with cleft lamp and fluorescein dye, if appropriate.
junctivitis, ocular irritation / pain / malaise, papillas, and uveitis. Some of Based on pre-clinical in vivo and in vitro biotransformation studies, these events were similar to the underlying ocular disease that was being Loteprednol Etabonate undergoes an extensive metabolism forming inac- Precautions:
If the signs and symptoms do not improve after two days of treatment In less than 15% of the patients there were non-ocular adverse reactions, The bioavailability study of the administration of a drop of Loteprednol with LOTESOFT®, the patient should be examined and the case should be among which headache, rhinitis, and pharyngitis were reported.
0.5% in each eye eight times a day for 2 days or four times a day for 42 In a group of randomized controlled studies carried out in patients treated days showed that plasma concentrations of Loteprednol Etabonate and its If the product is applied for 10 days or longer, intraocular pressure should be with Loteprednol etabonate for 28 days or longer, the incidence of a signifi- primary inactive metabolite were below the quantifiable detection limit at checked even if it proves to be a difficult procedure in children or uncoopera- cant increase in intraocular pressure (≥ 10 mmHg) was 2% among patients all determination instances, which suggests a limited systemic absorption treated with Loteprednol etabonate, 7% among patients treated with pred- Fungi infections of the cornea are particularly likely to develop coinciding nisolone acetate 1%, and 0.5% among patients treated with placebo.
with the long-term use of local steroid agents. The possibility of fungi infec- Dosage and administration:
tion should be taken into account in case of any persistent corneal ulceration Overdosage:
Treatment of steroid-sensitive inflammatory affections: Apply one or two when a steroid has been or is being used. If considered appropriate, a fungi No overdosage cases have been reported with LOTESOFT®. In case of over- Laboratorio/Laboratory: LABORATORIOS POEN Elemento/Item: PROSPECTO (FRENTE Y DORSO)

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