Tovaxo

Indications

Tovaxo is indicated for the treatment of Glaucoma & ocular hypertension

Adverse Effects

The most common ocular adverse event observed in controlled clinical studies with Travoprost 0.004% was ocular hyperemia which was reported in 35 to 50% of patients. Approximately 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse events reported at an incidence of 5 to 10% included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. Ocular adverse events reported at an incidence of 1 to 4% included, abnormal vision, blepharitis, blurred vision, cataract, cells, conjunctivitis, dry eye, eye disorder, flare, iris discoloration, keratitis, lid margin crusting, photophobia, subconjunctival hemorrhage, and tearing. Nonocular adverse events reported at a rate of of 1 to 5% were accidental injury, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence, and urinary tract infection.

Mechanism of Action

Travoprost free acid, a prostaglandin analog is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow

Pharmacokinetics

The half life of Travoprost in Tovaxo is 45 minutes

Drug Use in Pregnancy

Pregnancy Category C Teratogenic effects:Tovaxo should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus Nursing Mothers A study in lactating rats demonstrated that radiolabeled travoprost and/or its metabolites were excreted in milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tovaxo is administered to a nursing woman.

Drug Use in Renal Impairment

Hepatic and Renal Impairment Travoprost ophthalmic solution has been studied in patients with hepatic impairment and also in patients with renal impairment. No clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients.

Drug Use in Hepatic Impairment

Drug Use in Pediatric Population

Pediatric Use Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.

Drug Use in Geriatric Population

Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.