Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
LOTEPREDNOL ETABONATE
ABIC MARKETING LTD, ISRAEL
S01BA14
OPHTHALMIC SUSPENSION
LOTEPREDNOL ETABONATE 5 MG / 1 ML
OCULAR
Required
BAUSCH & LOMB INCORPORATED, USA
LOTEPREDNOL
LOTEPREDNOL
Lotemax is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to otain an advisable diminution in edema and inflammation. Lotemax is less effective than prednisolone acetate 1 % in two 28 day controlled clinical studies in acute anterior uveitis, where 72 % of patients treated with Lotemax experienced resolution of anterior chamber cells, compared to 87 % of patients treated with prednisolone acetate 1 % . The incidence of patients with clinically significant increases in IOP (> or = 10 mmHg) was 1 % with Lotemax adn 6 % with prednisolone acetate 1 %. Lotemax should not be used in patients who require a more potent corticosteroid for this indication. Lotemax is also indicated for the treatment of post - operative inflammation following ocular surgery.
2014-10-31
Part # / SPEC#: 9633701 (L-500346) / 9632901 (L-500347) DESCRIPTION: Lotemax Israel Insert - COLORS: Black SPECIAL INSTRUCTIONS: Q SCANNER BAR LOCATION:NA QDIELINE DOES NOT PRINT QCOATING PER SPECIFICATION PRINTED BARCODES MUST BE VERIFIED READABLE AND ACCURATE BY VENDOR TO THE HUMAN READABLE INDICATED ON ARTWORK. BAUSCH & LOMB, 1400 N. GOODMAN ST. ROCHESTER,/:tFAX: 585-338-8959 This medicine is not intended for use in children and infants. DO NOT EXCEED THE RECOMMENDED DOSE. If there is no improvement in your condition within two days, refer to the doctor. The doctor may want to reevaluate your condition. If you are using Lotemax Suspension for 10 days or more, intraocular pressure should be monitored. Use this medicine at specified time intervals, as determined by the attending doctor. IF YOU ACCIDENTALLY TOOK A HIGHER DOSAGE OF THE MEDICINE, OR IF A CHILD ACCIDENTALLY SWALLOWED THE MEDICINE, immediately refer to a doctor or proceed to a hospital emergency room and bring the package of the medicine with you. IF YOU FORGOT TO TAKE THE MEDICINE If you forgot to take this medicine at the scheduled time, take a dose as soon as you remember, but never take two doses together. Adhere to the treatment as recommended by the doctor. Even if there is an improvement in your health condition, do not stop treatment before consulting a doctor. DO NOT TAKE MEDICINES IN THE DARK! CHECK THE LABEL AND DOSE EACH TIME YOU TAKE MEDICINE. WEAR GLASSES IF YOU NEED THEM. IF YOU HAVE FURTHER QUESTIONS REGARDING USE OF THE MEDICINE, CONSULT THE DOCTOR OR PHARMACIST. 4. SIDE EFFECTS As with any medicine, use of the preparation may cause side effects in some users. Do not be alarmed when reading the list of side effects. You may not suffer from any of them. REFER TO A DOCTOR IMMEDIATELY IF SOME OF THE FOLLOWING SIDE EFFECTS OCCUR: ∙ Blurred vision or any change in vision ∙ Redness or swelling of the eye ∙ Conjunctival edema (swelling of the membrane covering the white part of the eye) ∙ Ocular discharge Olvassa el a teljes dokumentumot
LOTEMAX Suspension – Ophthalmic Suspension - 0.5% - Minor Updates SPC – 10-2021 - ME PHYSICIANS’ PRESCRIBING INFORMATION LOTEMAX SUSPENSION Ophthalmic Suspension Rx only DESCRIPTION: LOTEMAX ® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti- inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula: C 24 H 31 ClO7 HO O C = O OCH 2 Cl OCO 2 C 2 H 5 Mol. Wt. 466.96 Chemical Name: chloromethyl 17 α -[(ethoxycarbonyl)oxy]-11 β -hydroxy-3-oxoandrosta-1,4-diene-17 β -carboxylate Each mL contains: ACTIVE: Loteprednol Etabonate 5 mg (0.5%); INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. CLINICAL PHARMACOLOGY: Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Corticosteroids are capable of producing a rise in intraocular pressure. Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone grou Olvassa el a teljes dokumentumot