Medicine Overview of Ferromax 30mg Capsule
Pregnancy Not absorbed systemically as an intact complex following oral administration Maternal use is not expected to result in fetal exposure to the drug Animal data In animal reproduction studies, oral administration of ferric or ferrous compounds to gravid CD1-mice and Wistar rats during organogenesis at doses 13-32 times the recommended human dose resulted in no adverse developmental outcomes Overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes, and fetal malformation Clinical considerations Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as postpartum anemia Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight Lactation There are no data on the presence of ferric maltol in human milk, the effects on the breastfed child, or the effects on milk production
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There are no empirical data on avoiding drug interactions between ferric maltol and concomitant oral medication Concomitant use of some oral drugs may reduce bioavailability of iron after ferric maltol administration Separate the administration of ferric maltol from these drugs; duration of separation may depend on the absorption characteristics of the medication concomitantly administered, such as time to peak concentration or whether the drug is an immediate- or extended-release product; monitor clinical response to ferric maltol Coadministration of ferric maltol with some oral medications may also decrease the bioavailability of some drugs For oral drugs for which reductions in bioavailability may cause clinically significant effects on its safety or efficacy, separate ferric maltol administration by at least 4 hr; monitor clinical responses to concomitant drugs as appropriate Dimercaprol Coadministration of iron products with dimercaprol may increase the risk of nephrotoxicity Avoid use with dimercaprol
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Ferric Maltol capsule should be taken in oral route, preferably on an empty stomach, at least 1 hour before or 2 hours after meals. Do not open, break or chew Ferric Maltol capsule. The recommended dosage of Ferric Maltol is 30 mg twice daily. Treatment duration will depend on the severity of iron deficiency but generally at least 12 weeks of treatment is required. The treatment should be continued as long as necessary until ferritin levels are within the normal range.
Use in children and adolescents: Safety and effectiveness of ferric maltol have not been established in pediatric patients.
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Drug interaction with medication: Concomitant use of iron products with dimercaprol may increase the risk of nephrotoxicity. Avoid concomitant use of ferric maltol with dimercaprol. Concomitant use of ferric maltol may decrease the bioavailability of some drugs, including mycophenolate, ethynyl estradiol, ciprofloxacin and doxycycline. For oral drugs where reductions in bioavailability may cause clinically significant effects on its safety or efficacy, separate the administration of ferric maltol by at least 4 hours.
Drug interaction with food and others: Food has been shown to decrease the bioavailability of iron after administration of ferric maltol.
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