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Zipropol

Zipropol

propofol

Manufacturer:

Celon Laboratories

Distributor:

Zyre Pharma
Full Prescribing Info
Contents
Propofol.
Description
Each vial (1 mL) contains: Propofol USP 10 mg, excipients q.s.
Propofol (Zipropol injectable emulsion) is a sterile, nonpyrogenic emulsion, containing 10 mg/mL of Propofol suitable for intravenous administration. It is slightly soluble in water and thus is formulated in a white, oil-in-water emulsion. It is isotonic and has a pH of 7-8.5.
Indications/Uses
Propofol Injectable Emulsion is an IV sedative-hypnotic agent for induction and maintenance of general anesthesia, initiation and maintenance of Monitored Anesthesia Care (MAC) Sedation and initiation and maintenance of ICU Sedation in Intubated, Mechanically Ventilated.
Dosage/Direction for Use
Induction of general anesthesia: Healthy adults less than 55 years of age: 40 mg every 10 seconds until induction onset (2 to 2.5 mg/kg).
Elderly Debilitated or ASA-PS III or IV patients: 20 mg every 10 seconds until induction onset (1 to 1.5 mg/kg).
Cardiac Anesthesia: 20 mg every 10 secs until induction onset (0.5 to 1.5 mg/kg).
Neurosurgical Patients: 20 mg every 10 secs until induction onset (1 to 2 mg/kg).
Pediatric Patients, healthy from 3 years to 16 years of age: 2.5 to 3.5 mg/kg administered over 20-30 seconds.
Maintenance of General Anesthesia: Healthy Adults less than 55 years of age: 100 to 200 mcg/kg/min (6 to 12 mg/kg/h).
Elderly Debilitated or ASA-PS III or IV Patients: 50 to 100 mcg/kg/min (3 to 6 mg/kg/h).
Cardiac Anesthesia: Most patients require: Primary HYPRO injectable emulsion with secondary opioid 100-150 mcg/kg/min; low dose HYPRO with primary opioid 50-100 mcg/kg/min.
Neurological patients: 100-200 mcg/kg/min (6 to 12 mg/kg/h).
Pediatric Patients: Healthy from 2 months of age to 16 years of age: 125 to 300 mcg/kg/min (7.5 to 18 mg/kg/h) following the first half hour of maintenance, if clinical signs of light anesthesia are not present, the infusion rate should be decreased.
Maintenance of General Anesthesia: Intermittent Bolus, Healthy Adults less than 55 years of age: Increments of 20 to 50 mg as needed.
Initiation of MAC Sedation: Healthy Adults less than 55 years of age: Slow infusion or slow injection techniques are recommended to avoid apnea or hypotension. Most patients require an infusion of 100 to 150 mcg/kg/min (6 to 9 mg/kg/h) for 3 to 5 minutes or a slow injection of 0.5 mg/kg over 3 to 5 minutes followed immediately by a maintenance infusion.
Elderly, Debilitated, Neurological, or ASA-PS III or IV Patients: Most patients require dosages similar to healthy adults. Rapid boluses are to be avoided.
Maintenance of MAC Sedation: Healthy adults less than 55 years of age: A variable rate infusion technique is preferable over an intermittent bolus technique. Most patients require an infusion of 25 to 75 mcg/kg/min (1.5 to 4.5 mg/kg/h) or incremental bolus doses of 10 mg or 20 mg.
Elderly, Debilitated, Neurological or ASA-PS III or IV Patients: Most patients require 80% of the usual adult dose.
A rapid (single or repeated) bolus dose should not be used.
Initiation and Maintenance of ICU Sedation in Intubated, Mechanically Ventilated: Adult Patients: Because of the residual effects of previous anesthetic or sedative agents, in most patients, the initial infusion should be 5 mcg/kg/min (0.3 mg/kg/h) for at least 5 minutes. Subsequent increments of 5-10 mcg/kg/min (0.3 to 0.6 mg/kg/h) over 5-10 minutes may be used until desired clinical effect is achieved.
Maintenance rates of 5 to 50 mcg/kg/min (0.3 to 3 mg/kg/h) or higher may be required.
Evaluation of clinical effect and assessment of CNS function should be carried our daily throughout maintenance to determine the minimum dose of HYPRO required for sedation. The tubing and unused portions of HYPRO injectable emulsion should be discarded after 12 hours because it contains no preservatives and is capable of supporting growth of microorganisms.
Contraindications
It is contraindicated in patients with a known hypersensitivity to propofol injectable emulsion or any of its components. It is contraindicated to patients with allergies to eggs, egg products, soybeans and soy products. It is also contraindicated to pregnant and lactating women and to patients with history of epilepsy and seizure.
Storage
Store at temperature not exceeding 30°C.
Diluted Solution: Stored at temperature 2-8°C.
Shake well before use.
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01AX10 - propofol ; Belongs to the class of other general anesthetics.
Presentation/Packing
Form
Zipropol emulsion for inj
Packing/Price
10 mL x 1's;20 mL x 1's
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