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Short –acting IV anesthetic agent.

PropofolPropofol BP

Product Profile:

• Brand Name: Propofol

• Generic Name: Propofol

• Therapeutic Class : Anesthesia

• Strength : 20 ml IV injection (10 mg/ml )

Description:

• Propofol® Injectable Emulsion is a sterile, non pyrogenic emulsion containing 10 mg/ml of propofol suitable for intravenous administration. Propofol is slightly soluble in water and, thus, is formulated in a white to light yellow, oil-in-water emulsion. In addition to the active component, Propofol®, the formulation also contains soybean oil (100 mg/ml), glycerol (22.5 mg/ml), egg lecithin (12 mg/ml) and disodium edetate (0.005%) with sodium hydroxide to adjust pH.

Pharmacology:Propofol® Injectable Emulsion is an IV sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. IV injection of a therapeutic dose of propofol induces hypnosis, with minimal excitation, usually within 40 seconds from the start of injection (the time for one arm-brain circulation). As with other rapidly acting IV anesthetic agents, the half-time of the blood-brain equilibration is approximately 1 to 3 minutes, accounting for the rate of induction of anesthesia.

Mechanism of action:

When GABAA receptors are activated, trans membrane chloride conductance increases, resulting in hyperpolarization of the postsynaptic cell membrane and functional inhibition of the postsynaptic neuron.

Indications:Propofol® is a short-acting intravenous anesthetic agent suitable for

• Induction and maintenance of general anesthesia.

• Sedation of ventilated patients receiving intensive care.

• Monitored anesthesia care sedation for surgical and diagnostic procedures.

Dosage & Administration:Induction of General Anesthesia Healthy Adults Less Than 55 Years of Age: 40 mg every 10 seconds until induction onset (2-2.5 mg/kg).Elderly, Debilitated, or ASA III/IV Patients: 20 mg every 10 seconds until induction onset (1-1.5 mg/kg).Cardiac Anesthesia: 20 mg every 10 seconds until induction onset (0.5-1.5 mg/kg).Neurosurgical Patients: 20 mg every 10 seconds until induction onset (1-2 mg/kg).Pediatric Patients - healthy, from 3-16 years of age: 2.5-3.5 mg/kg administered over 20-30 seconds.

Maintenance of General Anesthesia

Healthy Adults Less Than 55 Years of Age: 100-200 μg/kg/min (6-12 mg/kg/h).

Elderly, Debilitated, ASA III/IV Patients: 50-100 μg/kg/min (3-6 mg/kg/h).

Pediatric Patients - healthy, 3 years to 16 years of age: 125-300 μg/kg/min (7.5-18 mg/kg/h)

Cardiac Anesthesia, Most Patients Require:Primary propofol injectable emulsion with secondary opioid: 100-150 μg/kg/min. Low-dose propofol injectable emulsion with primary opioid: 50-100 μg/kg/min.

Neurosurgical Patients: 100-200 μg/kg/min (6-12 mg/kg/h).

Contraindication:• Absolute contraindications: Patients with a

known hypersensitivity to propofol or any of its components; allergies to eggs, egg products, soybeans or soy products; disorders of fat metabolism.

• Relative contraindications: Patients undergoing stereotactic neurosurgery such as pallidotomy, as it temporary abolishes tremors in patients with Parkinsonism; Known case of Epilepsy; Untreated hypertensive, compromised Left ventricle function; Hepatic or Renal impairment; Pregnant and lactating mother; Paediatric patients age < 3 years.

Advantages of propofol:

1. Rapid & smooth Recovery.

2. Completed eliminated from body in 4 hours so patient is ambulatory early.

3. Anti-Emetic.

4. Anti-Pruritic.

5. Bronchodilator.

Competitors:

Brand Name Contains Dosage Form

Manufacturer Price(Tk.)

FRESOFOL Propofol 10mg/ml Injection

Fresenius Kabi/Hye Impex

20ml amp x 5s pack: 1758.00 MRP; 50ml bot x 1s pack: 779.00 MRP

POFOL I.V Propofol 10mg/ml i.v Injection

Popular Pharmaceuticals Ltd.

20ml amp x 1s pack: 200.00 MRP

RECOFOL Propofol 10mg/ml Injection

Bayer Schering Oy/ Tajarat

20ml amp x 1s pack: MRP; 50ml vial x 1s pack:

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