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VIGAMOX is a brand name for Moxifloxacin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Recommended Dose The recommended dosage regimen for patients one year of age and older is one drop in the affected eye(s) 3 times a day for 7 days. Missed Dose If a dose is missed, the missed dose should be administered as soon as possible.
Treatment should then be continued with the next dose as planned. Administration To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
OVERDOSAGE No information is available on overdose of VIGAMOX in humans. A topical overdose of VIGAMOX may be flushed from the eye(s) with warm tap water. In an oral (gavage) monkey study, doses of moxifloxacin hydrochloride up to 15 mg/kg/day did not produce any toxicity.
This dose is at least 10 times higher than the accidental ingestion of the contents of a 3 mL bottle of VIGAMOX by a 10 kg child. No toxic effects are expected with an ocular overdose of the product, or in the event of accidental ingestion of the contents of one bottle.
For management of a suspected drug overdose, contact your regional Poison Control Centre. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Moxifloxacin is a synthetic fluoroquinolone antibacterial agent active in vitro against a broad spectrum of Gram-positive and Gram-negative ocular pathogens, atypical microorganisms and anaerobes.
The antibacterial action of moxifloxacin results from inhibition of topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA.
Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division (see MICROBIOLOGY). VIGAMOX® Product Monograph Page 9 of 27 Pharmacodynamics/Pharmacokinetics Following topical ocular administration of VIGAMOX, moxifloxacin was absorbed into the systemic circulation.
Plasma concentrations of moxifloxacin were measured in 21 male and female adult subjects who received bilateral topical ocular doses of VIGAMOX every 8 hours for a total of 13 doses. 9 ng•hr/mL, respectively. These systemic exposure values were at least 1,600 and 1,000 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of moxifloxacin.
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The plasma half-life of moxifloxacin was estimated to be 13 hours. Moxifloxacin is widely distributed in the body and is excreted in feces or urine either unchanged or as glucuronide or sulfate conjugates. Tear film concentrations were studied in 31 healthy male and female adult volunteers who were administered 1 drop of VIGAMOX to both eyes every 8 hours for a total of 10 doses.
2mcg/mL, respectively. Thereafter, they decline rapidly in a biphasic manner with the means ranging approximately 1 to 4 mcg/mL over the 1 to 8 hour sampling period. Pre-dose morning tear concentrations on Days 2 to 4 averaged over 4 mcg/mL.
Studies conducted in animals indicate penetration into the conjunctiva and ocular tissues with prolonged binding to melanin.
Special Populations and Conditions Geriatrics:
The effects of age on the pharmacokinetic parameters of oral moxifloxacin have been studied. Plasma levels were 24 to 29% higher in the elderly than in young subjects. But, when normalized for body weight, the differences were minimized.
Gender:
Gender differences in the steady-state Cmax and AUC were seen. However, when adjusted for body weight, the differences were minimized and not clinically relevant (see DETAILED PHARMACOLOGY, Human Pharmacokinetics).
Race:
Subgroup analysis by race (Caucasian, Asian) showed no meaningful differences in the mean steady-state pharmacokinetic parameters of moxifloxacin (see DETAILED PHARMACOLOGY, Human Pharmacokinetics).
Hepatic Insufficiency:
The pharmacokinetic parameters of oral moxifloxacin were not significantly altered in patients with mild to moderate hepatic insufficiency (see DETAILED PHARMACOLOGY, Special Populations).
Renal Insufficiency:
The pharmacokinetic parameters of oral moxifloxacin were not significantly altered by mild, moderate or severe renal impairment (see DETAILED PHARMACOLOGY, Special Populations). STORAGE AND STABILITY Store at 4C - 25 C. Discard 28 days after opening.
Keep out of the reach and sight of children. VIGAMOX® Product Monograph Page 10 of