Naldebain 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 Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Dinalbuphine sebacate

Indications/Uses

Relief of moderate to severe acute post-op pain.

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Dosage/Direction for Use

150 mg single dose slow IM inj.

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Overdosage

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Contraindications

Hypersensitivity to nalbuphine, sesame oil or benzoyl benzoate. IV administration.

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Special Precautions

Discontinue use if serotonin syndrome is suspected. Not adequate for administration in patients w/ urgent analgesics need. Adrenal insufficiency; presence of head injury, intracranial lesions or preexisting increased intracranial pressure; sexual function/reproduction disorders; androgen deficiency. May be habit-forming on prolonged repeated use. Emergency procedures. Ambulatory patients. Concomitant use w/ benzodiazepines, serotonergic drugs. May affect ability to drive or operate machinery. Hepatic dysfunction/impairment. May cause reduced fertility in females & males of reproductive potential. Labor & delivery. Pregnancy & lactation. Monitor newborn for resp depression, apnea, bradycardia & arrhythmias if used.

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Use In Pregnancy & Lactation

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Adverse Reactions

Nausea, vomiting, inj site reaction, pyrexia, dizziness.

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Drug Interactions

Additive effect w/ opioid analgesic, general anesth, phenothiazines, other tranquilizers, sedatives, hypnotics or other CNS depressants. Increased risk of resp depression, profound sedation, coma & death w/ benzodiazepines. Serotonin syndrome w/ SSRIs, SNRIs, TCAs, triptans, 5-HT₃ antagonists, drugs affecting serotonin neurotransmitter system, MAOIs.

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Storage

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Description

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Action

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MIMS Class

Analgesics (Opioid)

ATC Classification

N02AF - Morphinan derivatives ; Used to relieve pain.

Regulatory Classification

Presentation/Packing

Form

Naldebain ER inj 75 mg/mL

Packing/Price

2 mL x 1's

Naldebain

nalbuphine

Manufacturer:

Lumosa Therapeutics

Distributor:

DKSH