Velphoro Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Sucroferric oxyhydroxide

Indications/Uses

Control of serum P levels in adult CKD patients on haemodialysis or peritoneal dialysis.

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Dosage/Direction for Use

Divide total daily dose across the meals of the day to maximise adsorption of dietary phosphate. Starting dose: 1,500 mg Fe (3 tab) daily. Titration & maintenance: Monitor serum P levels & up- or down-titrate dose in increments of 500 mg Fe (1 tab) daily every 2-4 wk until acceptable serum P level is reached, w/ regular monitoring afterwards. Patients who respond usually achieve optimal serum P levels at doses of 1,500-2,000 mg Fe (3-4 tab) daily. Resume regular dose w/ next meal if missed. Max dose: 3,000 mg Fe (6 tab) daily.

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Overdosage

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Administration

Should be taken with food: Must be chewed or crushed. Must not be swallowed whole.

Contraindications

Hypersensitivity. Haemochromatosis & any other Fe accumulation disorders.

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Special Precautions

Should only be used following careful benefit/risk assessment in patients w/ recent history of peritonitis (w/in last 3 mth), significant gastric or hepatic disorders, & patients w/ major GI surgery. Can cause discoloured (black) stool. Contains sucrose. Should not be taken by patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Contains potato starch & pregelatinised maize starch. Patients w/ diabetes should take notice that 1 tab is equiv to approx 1.4 g of carbohydrates. No clinical data available in patients w/ earlier stages of renal impairment. Should only be used by pregnant women if clearly needed following careful benefit/risk assessment. Decide whether to continue breastfeeding or to continue therapy. Safety & efficacy in childn & adolescents <18 yr have not yet been established.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhoea, discoloured faeces. Nausea, constipation, vomiting, dyspepsia, abdominal pain, flatulence, tooth discolouration; abnormal product taste.

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Drug Interactions

For concomitant treatment w/ medicinal products w/ narrow therapeutic window, monitor clinical effect & adverse events on initiation or dose adjustment of either Velphoro or the concomitant medicinal product. When administering any medicinal product that is already known to interact w/ Fe (eg, alendronate & doxycycline) or has the potential to interact w/ sucroferric oxyhydroxide (eg, levothyroxine), administer medicinal product at least 1 hr before or 2 hr after Velphoro.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Velphoro detailed prescribing information

Storage

View Velphoro storage conditions for details to ensure optimal shelf-life.

Description

View Velphoro description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Antidotes & Detoxifying Agents

ATC Classification

V03AE05 - sucroferric oxyhydroxide ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.

Regulatory Classification

P₁S₁S₃

Presentation/Packing

Form

Velphoro chewable tab 500 mg

Packing/Price

90's

Velphoro

sucroferric oxyhydroxide

Manufacturer:

Rxilient

Distributor:

KLN Pharma