Remitch 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 Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Nalfurafine HCl

Indications/Uses

Cutaneous pruritus in hemodialysis patients when sufficient efficacy is not obtained w/ existing therapies or treatments.

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Dosage/Direction for Use

Adult 2.5 mcg once daily after evening meal or before bedtime. Max: 5 mcg once daily.

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Overdosage

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Administration

May be taken with or without food. Place on the tongue & allow it to disintegrate. Swallow w/ saliva or water.

Contraindications

History of hypersensitivity.

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Special Precautions

Endocrine dysfunction eg, prolactin elevation. Not to be used for long term if no efficacy is observed. May affect ability to drive & use machine. Renal impairment. Moderate (Child-Pugh grade B) & severe (Child-Pugh grade C) hepatic dysfunction. Not recommended in pregnant or possibly pregnant female patients. Lactation. Premature, neonates, nursing infants, infants & childn. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Insomnia; constipation; pollakiuria/nocturia; increased prolactin. Sleepiness, dizziness, headache; thirst, nausea, diarrhoea; aggravated itching, eczema, rash; increased total bile acids; polyuria; decreased testosterone, increased antidiuretic hormone, decreased/increased TSH; presence of blood & protein urine; malaise.

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Drug Interactions

Increased plasma conc w/ CYP3A4 inhibitors eg, azole antifungals (itraconazole), midecamycin, ritonavir, ciclosporin, nifedipine, cimetidine, grapefruit juice. Enhanced CNS adverse reactions w/ hypnotics, anxiolytics, antidepressants, antipsychotics, antiepileptics. Reinforced or decreased effect w/ opioids. Inhibited P-gp-mediated transport w/ ketoconazole, verapamil HCl, cyclosporine, tacrolimus, cetirizine HCl.

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Caution For Usage

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

Storage

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Description

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

Action

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MIMS Class

Other Therapeutic Products

ATC Classification

V03AX02 - nalfurafine ; Belongs to the class of other therapeutic products. Used in the management of pruritus in haemodialysis patients.

Thai FDA Category

Presentation/Packing

Form

Remitch orodispersible tab 2.5 mcg

Packing/Price

10 × 14's

Remitch

Manufacturer:

Bushu Pharmaceuticals

Distributor:

DKSH

Marketer:

Meiji