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5.1 Hypoglycemia . The exact mechanism of action is unknown at this time. 0000094171 00000 n
Ocular adverse reactions reported at an incidence of 5% to 10% in these clinical trials included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus.Ocular adverse reactions reported at an incidence of 1% to 4% in clinical trials with TRAVATAN or TRAVATAN Z included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage, and tearing.Non-ocular adverse reactions reported at an incidence of 1% to 5% in these clinical studies were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence, and urinary tract infections.Additional adverse reactions have been identified during post approval use of TRAVATAN or TRAVATAN Z in clinical practice. Inform the patient about the possibility of eyelid skin darkening, which may be reversible after discontinuation of TRAVATAN Z Inform the patient about the possibility of eyelash and vellus hair changes in the treated eye during treatment with TRAVATAN Z. 0000094483 00000 n
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All glinides, including PRANDIN, can cause hypoglycemia [see Adverse Reactions (6.1)] 0000012792 00000 n
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Peak blood concentrations of travoprost free acid (<= 25 pg/ml) are achieved within 30 minutes and … 0000016671 00000 n
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Tamper evidence is provided with a shrink band around the closure and neck area of the package.After opening, TRAVATAN Z can be used until the expiration date on the bottle.Advise the patient about the potential for increased brown pigmentation of the iris, which may be permanent. 0000012942 00000 n
Following ophthalmic administration, travoprost is absorbed primarily through the cornea, where it is hydrolyzed by esterases to the biologically active travoprost free acid. 0000013777 00000 n
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TRAVATAN Z should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.TRAVATAN Z has not been evaluated for the treatment of angle-closure, inflammatory or neovascular glaucoma.There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. 0000015336 00000 n
4 CONTRAINDICATIONS . The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to TRAVATAN or TRAVATAN Z, or a combination of these factors, include: arrhythmia, vomiting, epistaxis, tachycardia, and insomnia.In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.There are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk.In animal reproduction studies, subcutaneous (SC) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses.Advise pregnant women of a potential risk to a fetus. 0000098368 00000 n
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For patients whose A1C is greater than 8%, the initial dose is 1 or 2 mg given within 30 minutes prior to each meal, 2, 3, or 4 times a day. WebMD provides common contraindications for Prandin Oral. 0000094343 00000 n
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Pediatric use: Safety and effectiveness in pediatric patients have not been established. 0000014201 00000 n
Repaglinide is a white to off-white powder with molecular formula C 27 H 36 N 2 O 4 and a molecular weight of 452.6. 0000014878 00000 n
Pigmentation 0000013127 00000 n
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Its chemical name is [1Travoprost is a clear, colorless to slightly yellow oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. 0000012867 00000 n
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However, at 100 mcg/kg/day, male rats were only treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. 5 WARNINGS AND PRECAUTIONS 5.1 Pigmentation Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. 0000008901 00000 n
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4 CONTRAINDICATIONS None. 0000094919 00000 n
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See full prescribing information for TRAVATAN Z.To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or