Irsuc Dosage & Drug Information

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

Concise Prescribing Info

Contents

Ferric hydroxide sucrose complex (equiv elemental Fe 20 mg)

Indications/Uses

Fe deficiency in patients who clinically need rapid Fe supply or cannot tolerate oral Fe therapy or non-compliant; in active inflammatory bowel disease or CKD where oral Fe prep is ineffective.

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Dosage/Direction for Use

Adult Individualized dosage. 5-10 mL (100-200 mg Fe) 1-3 times wkly. IV drip infusion 2.5 mL (50 mg Fe) diluted soln for at least 8 min infusion time, or 5 mL (100 mg Fe) diluted soln for at least 15 min infusion time, or 10 mL (200 mg Fe) diluted soln for at least 30 min infusion time. Slow IV inj Rate: 1 mL (20 mg Fe) undiluted soln/min not exceeding 10 mL (200 mg Fe)/inj.

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Overdosage

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Contraindications

Hypersensitivity to Fe sucrose or to other Fe parenteral products. Anemias not caused by Fe deficiency. Evidence of Fe overload or hereditary disturbances in utilisation of Fe.

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Warnings

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Special Precautions

For single use only. Risk of hypersensitivity reactions; increased risk in patients w/ history of severe asthma, eczema, other atopic allergy; SLE, RA. Discontinue administration in patients w/ bacteraemia. Avoid paravenous leakage. Use w/ caution in case of acute or chronic infection. Reports of hypotension related to rate & total dose administered in patients w/ CKD. Periodically monitor hematologic & hematinic parameters; w/hold therapy in patients w/ evidence of Fe overload. Perform careful risk/benefit assessment in patients w/ liver dysfunction. Avoid in patients w/ hepatic dysfunction where Fe overload is precipitating factor particularly porphyria cutanea tarda. No adequate & well-controlled studies in pregnancy & lactation. Not recommended for use in childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dysgeusia; hypotension, HTN; nausea; inj site pain. Chest pain, hypervolemia, CHF, cramps, musculoskeletal pain, diarrhea, vomiting, abdominal pain, elevated liver enzymes, skin irritation, pruritus, application site reaction, dizziness, dyspnea, pneumonia, cough, headache, fever, asthenia, malaise.

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Drug Interactions

Reduced absorption of oral Fe.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Vitamins & Minerals (Pre & Post Natal) / Antianemics

ATC Classification

B03AC - Iron, parenteral preparations ; Used in the treatment of anemia

Regulatory Classification

Presentation/Packing

Form

Irsuc soln for inj 20 mg/mL

Packing/Price

5 mL x 5 × 1's

Irsuc

iron sucrose

Manufacturer:

Alwin DMD

Distributor:

Afree Pharmaceutical

Marketer:

One Pharma