Nupovel

Nupovel

propofol

Manufacturer:

Novell Pharma

Distributor:

DKLL

Marketer:

Genemax Healthcare
Concise Prescribing Info
Contents
Propofol
Indications/Uses
Short-acting anesth in adults & childn >1 mth for induction & maintenance of general anesth; sedation for diagnostic & surgical procedures, alone or in combination w/ local or regional anesth; ventilated patients >16 yr in the ICU.
Dosage/Direction for Use
IV Individualized dosage. Induction of anesth Adult Titrate 20-40 mg every 10 sec until clinical signs show onset of anesth. <55 yr 1.5-2.5 mg/kg. Elderly & in patients of American Society of Anesthesiologist (ASA) grades III & IV, especially w/ impaired cardiac function Total dose may be reduced to ≤1 mg/kg at approx (2 mL) 20 mg every 10 sec. Childn >8 yr 2.5 mg/kg, 3 yr-1 mth 2.5-4 mg/kg. Maintenance of anesth Administer as continuous infusion or repeat bolus inj. Adult Repeat bolus inj: 25-50 mg increments (equiv to 2.5-5 mL). Continuous infusion: 4-12 mg/kg/hr. Elderly, patients of poor general condition, patients of ASA grades III & IV, hypovolaemic Reduce dose according to severity of condition & anesth technique. Childn 3 yr - 1 mth May require higher dose, >1 mth 9-15 mg/kg/hr. ASA III & IV patients Lower doses. Sedation for diagnostic & surgical procedures Adult Onset of sedation: 0.5-1 mg/kg over 1-5 min. Maintenance: 1.5-4.5 mg/kg/hr. Titrate infusion to the desired level of sedation. May be supplemented by 10-20 mg bolus infusion for rapid increase of sedation. Childn >1 mth Onset of sedation: 1-2 mg/kg. Maintenance: 1.5-9 mg/kg/hr. Titrate infusion to the desired level of sedation. May be supplemented by 1 mg/kg bolus infusion for rapid increase of sedation. Patients >55 yr & of ASA grades III & IV Lower doses may be required & reduce rate of administration. Sedation of ventilated patients in the ICU 0.3-4 mg/kg/hr by continuous infusion. Determine infusion rate by the required depth of sedative.
Contraindications
Hypersensitivity. Patients allergic to peanut or soya. Not to be used in patient ≤16 yr for sedation in intensive care. Not recommended in childn <1 mth for anesth induction.
Special Precautions
Not to be administered by the person conducting the diagnostic or surgical procedure. Cardiac, resp impairment; hypovolaemic or debilitated patient. Risk of convulsion in epileptic patient; abuse & dependence. Hypotension, airway obstruction & O2 desaturation; bradycardia (occasionally profound) & asystole. Involuntary movements during operative procedures. Induced impairment not generally detectable beyond 12 hr. Patients w/ disorders of fat metabolism. Constantly monitor patients; facilities for maintenance of a patent airway, artificial ventilation, O2 enrichment & other resuscitative facilities should be readily available at all times. Ensure adequate period prior to discharge of the patient. Accompany patients when leaving the place of administration. Concomitant use w/ other sedating agents (eg, benzodiazepines, opiates, alcohol. Consider IV anticholinergics before induction, or during maintenance of anesth. Reduced clearance w/ concomitant use of medications that reduce cardiac output. Advise patients on timing of recommencement of skilled or hazardous tasks eg, driving. Neonatal CNS & resp depression during pregnancy. Not recommended in obstet, including caesarean section deliveries. Not recommended during breastfeeding.
Adverse Reactions
During anesth: Inj site pain. Low BP; changes in breathing pattern; slow heartbeat. After anesth: Nausea, vomiting, headache. Childn in intensive care (when propofol has been stopped suddenly): W/drawal symptoms including unusual behavior, sweating, shaking & feeling anxious; flushing of the skin.
Drug Interactions
Profound hypotension following anesth induction w/ rifampicin. Additive sedative, anesth & cardioresp depressant effects w/ CNS depressants eg, pre-medication drugs, inhalation & analgesic agents. Consider dose reduction when used concomitantly w/ valproate.
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01AX10 - propofol ; Belongs to the class of other general anesthetics.
Presentation/Packing
Form
Nupovel emulsion for inj/infusion 10 mg/mL
Packing/Price
20 mL x 5 × 1's
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