Brand name: Propofol-Lipuro

Active ingredient (generic name):Propofol

Manufacturer: B. Braun

Importer: Behestan Darou

Pharmacotherapeutic group: a short-acting general anesthetic

Pharmaceutical form: 20 ML ampoules and 50 & 100 ML vials

Pharmacodynamic:  

Propofol is a short-acting general anesthetic agent with a rapid onset of action of approximately 30 seconds. Recovery from anesthesia is usually rapid. The mechanism of action, like all general anesthetics, is poorly understood.

Pharmacokinetic:

The decline in propofol concentrations following a bolus dose or following the termination of an infusion can be described by a three compartment open model with very rapid distribution (half-life 2 –4 minutes), rapid elimination (half-life 30 – 60 minutes), and a slower final phase, representative of redistribution of propofol from poorly perfused tissue.

Propofol is extensively distributed and rapidly cleared from the body. Clearance occurs by metabolic processes, mainly in the liver where it is blood flow dependent, and to form inactive conjugates of propofol and its corresponding quinol, which are excreted in urine.

Therapeutic indication:

Propofol is a short-acting intravenous general anesthetic for:

• Induction and maintenance of general anesthesia

• Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anesthesia

• Sedation of ventilated patients in the intensive care unit.

 

Dosage and administration:

Induction of General Anesthesia

Adults: In unpremedicated and premedicated patients, it is recommended that Propofol 1% should be titrated (approximately 4 ml [40 mg] every 10 seconds in an average healthy adult by bolus injection or infusion) against the response of the patient until the clinical signs show the onset of anesthesia.

Children: For induction of anesthesia in children over 1 month of age, Propofol 1% should be titrated slowly until clinical signs show the onset of anesthesia. The dose should be adjusted according to age and/or body weight. Most patients over 8 years of age require approximately 2.5 mg/kg body weight of Propofol 1%for induction of anesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher (2.5–4 mg/kg body weight).

Maintenance of General Anesthesia

Adults: Anesthesia can be maintained by administering Propofol 1% either by continuous infusion or by repeat bolus injections to prevent the clinical signs of light anesthesia.

The required rate of administration varies considerably between patients, but rates in the region of 4–12 mg/kg/h usually maintain satisfactory anesthesia.

When Propofol 1% is used for maintenance of anesthesia the rate of infusion or 'target concentration' should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in the elderly as this may lead to cardio respiratory depression.

Children: Anesthesia can be maintained in children over 1 month of age by administering Propofol 1%by infusion or repeated bolus injection to maintain the depth of anesthesia required. The required rate of administration varies considerably between patients, but rates in the region of 9–15 mg/kg/h usually achieve satisfactory anesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher.

 

Adverse reaction:

Induction of anaesthesia is generally smooth with minimal evidence of excitation. The most commonly reported ADRs are pharmacologically predictable side effects of an anaesthetic agent, such as hypotension and respiratory depression.

Other common adverse reactions are: Local pain on induction, Bradycardia, Transient apnea during induction, Nausea and vomiting during recovery phase, Headache during recovery phase.

Thrombosis and phlebitis are the uncommon undesirable effect.

Accidental overdosage is likely to cause cardiorespiratory depression.

Contraindication:

Propofol 1% is contraindicated in patients with a known hypersensitivity to propofol or any of the excipients. Propofol 1% must not be used in patients of 16 years of age or younger for sedation in intensive care and it is not recommended in children aged less than 1 month.

Pharmacokinetic interactions:

Propofol 1% has been used in association with spinal and epidural anesthesia and with commonly used premedicants, neuromuscular blocking drugs, inhalational agents and analgesic agents; no pharmacological incompatibility has been encountered. Lower doses of Propofol may be required where general anesthesia is used as an adjunct to regional anesthetic techniques.

The concurrent administration of other CNS depressants such as pre-medication drugs, inhalation agents, analgesic agents may add to the sedative, anesthetic and cardio respiratory depressant effects of propofol .

Special warnings:

Appropriate care should be applied during Propofol-Lipuro administration. Pharmacokinetic interactions and contraindications should be considered carefully before administration. 

It should be prepared aseptically immediately before administration and must be used within 6 hours of preparation.

Pregnancy and lactation:

Propofol 1% crosses the placenta and may be associated with neonatal depression. Therefore it should not be used in pregnancy unless clearly necessary. Propofol 1% has been used, however, during termination of pregnancy in the first trimester.  

Studies in breast-feeding women showed that Propofol is excreted in small amounts into the milk so mothers should stop breast-feeding and discard breast milk for 24 hours after administration of Propofol.

Storage temperature:  

 Keep in temperature between 4 to 25 C. Do not freeze.

 

 

 

 

 

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