Sublimax Injection

Sublimax Injection

fentanyl

Manufacturer:

Yichang Humanwell

Distributor:

Endure Medical
Concise Prescribing Info
Contents
Fentanyl citrate
Indications/Uses
Short term duration analgesia during premed induction & maintenance of anaesth, in immediate post-op period & resp depressant in the management of mechanically ventilated patients under intensive care.
Dosage/Direction for Use
Individualized dosage. Adult Premed 50-100 mcg (1-2 mL) via IM 30-60 min prior to surgery. Patient w/ spontaneous resp Initially 50-200 mcg w/ supplements of 50 mcg. Significant resp depression follow doses of >200 mcg. Patient where ventilation is assisted Initially 300-3,500 mcg (up to 50 mcg/kg) w/ supplements of 100-200 mcg or higher depending on the response. Adjunct to general anaesth Initial induction of 50-100 mcg (1-2 mL) via IV, repeat at 2-3 min intervals until desired effect is achieved. Elderly & poor risk patient Reduce dose of 25-50 mcg (0.5-1 mL). Maintenance: 25-50 mcg (0.5-1 mL) IM/IV when movement &/or changes in vital signs indicate surgical stress or lightening of analgesia. Adjunct to regional anaesth 50-100 mcg (1-2 mL) via IM for the control of pain, tachypnoea & emergence delirium. May be repeated in 1-2 hr as needed. Post-op 50-100 mcg (1-2 mL) via IM for the control of pain, tachypnoea & emergence delirium. May be repeated in 1-2 hr as needed. Childn 2-12 yr Induction & maintenance: Reduced dose of 20-30 mcg (0.4-0.6 mL) per 10 kg.
Contraindications
Hypersensitivity. Bronchial asthma; head injuries & increased intracranial pressure; patients susceptible to resp depression eg, comatose patient who may have head injuries or brain tumour; myasthenia gravis.
Special Precautions
Patients w/ severe impairment of pulmonary function due to possibility of resp depression (eg, COPD, patients w/ decreased resp reserve or any patient w/ potentially compensated resp). Maintain appropriate surveillance because the duration of resp depression is usually longer than the duration of narcotic antagonist action. Patients w/ liver & kidney dysfunction. May produce bradycardia; caution in patients w/ cardiac bradyarrhythmias. Episodes suggestive of Oddi spasm may occur. Concomitant use w/ nitrous oxide. Altered BP & hypotension w/ neuroleptics ie, droperidol. Post-op narcotics should be used initially in reduced doses. Muscle rigidity. Drug dependence. Pregnancy.
Adverse Reactions
Resp depression (high dose); transient hypotension following IV; muscle rigidity. Nausea, vomiting, constipation, drowsiness, & confusion. Difficult micturition, ureteric or biliary spasm; alterations in liver enzyme values. Antidiuretic effect. Dry mouth, dizziness, sweating, facial flushing, headache, vertigo, bradycardia, tachycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, mood changes, decreased libido or potency, hallucinations, & miosis. Raised intracranial pressure. Convulsions especially in infant & childn. Rhabdomyolysis progressing to renal failure in overdosage. Contact dermatitis, inj site pain & irritation.
Drug Interactions
May increase plasma conc w/ CYP3A4 potent inhibitors eg, ritonavir & other HIV PIs. Prolonged induced resp depression, decreased plasma clearance & increased elimination t½ & AUC w/ ritonavir. Additive sedative effect w/ benzodiazepines eg, diazepam, lorazepam, & midazolam. Severe resp depression & sudden hypotension w/ midazolam or sufentanil, respectively. Reduced clearance of midazolam. Higher mean blood conc of propofol. Severe & unpredictable potentiation by MAOIs.
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01AH01 - fentanyl ; Belongs to the class of opioid anesthetics. Used as general anesthetics.
Presentation/Packing
Form
Sublimax Injection soln for inj 50 mcg/mL
Packing/Price
2 mL x 10 × 1's
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