Prescription Information

• Description
• Uses
• Dosage and Administration
• Administration
• Contraindication
• Precaution
• How Supplied
• Shelf Life

 

 

Description

PROPOVAN (Propofol Inj.) is white, opaque liquid for intravenous injection contain-ing 10 mg Propofol per ml. The vehicle contains glycerol, purified egg lecithin, sodium hydroxide, soybean oil and water. PROPOVAN (Propofol Inj.) is an intrave-nous Anaesthetic agent which is chemically unrelated to other anesthetics. Induc-tion of anesthesia with PROPOVAN (Propofol Inj.) is rapid, and maintenance can be achieved by either continuous infusion or intermittent bolus injections, with either nitrous oxide or opioids used to provide analgesia.

 

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Uses

• PROPOVAN (Propofol Inj.) is a short-acting intravenous Anaesthetic agent suitable for induction and maintenance of general anesthesia.
• PROPOVAN (Propofol Inj.) may also be used for sedation of ventilated patients receiving intensive care for a period of upto three days.
• PROPOVAN (Propofol Inj.) may also be used for sedation for surgical and diag-nostic procedures.

 

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Dosage and Administration

1. Induction of general anesthesia

(a) Adults
In unpremedicated and in premedicated patients, it is recom-mended that PROPOVAN (Propofol Inj.) should be titrated [approximately 4 ml (40 mg) every 10 seconds in an average healthy adult] against the response of the patient until the clinical signs show the onset of anesthesia. Most adult patients aged less than 55 years are likely to require 2.0 to 2.5 mg/kg of PROPOVAN (Propo-fol Inj.). Above this age, the requirement will generally be less. In patients of ASA Grades 3 and 4, lower rates of administration should be used [approximately 2 ml (20 mg) every 10 seconds].

(b) Elderly Patients
PROPOVAN (Propofol Inj.) should be titrated against the response of the patients. Patients over the age of 55 years may require lower doses of PROPOVAN (Propofol Inj.) for induction of anesthesia.

(c) Children
PROPOVAN (Propofol Inj.) is not recommended for induction of anesthesia in children less than 3 years of age.

When used to induce anesthesia in children, it is recommended that PROPOVAN (Propofol Inj.) be given slowly until the clinical signs show the onset of anesthesia. The dose should be adjusted for age and/or weight. Most patients over 8 years of age are likely to require approximately 2.5 mg/kg of PROPOVAN (Propo-fol Inj.) for induction of anesthesia. Under this age the requirements may be more. Lower dosage is recommended for children of ASA grades 3 and 4.

2. Maintenance of general Anesthesia

Adults (Including Elderly Patients)
Anesthesia can be maintained by administering PROPOVAN (Propofol Inj.) either by continuous infusion or by repeat bolus injections to prevent the clinical signs of light anesthesia. Recovery from anesthesia is typically rapid and it is therefore important to maintain PROPOVAN (Propofol Inj.) administration until the end of the procedure.

(a) Continuous infusion
The average rate of administration varies considerably between patients, but rates in the region of 4 to 12 mg/kg/hr usually maintain satisfactory anesthesia. Slightly higher rates of administration may be required for 10 to 20 minutes after induction of anesthesia.

(b) Repeat bolus injections
If a technique involving repeat bolus injections is used, increments of 25 mg (2.5 ml) to 50 mg (5 ml) may be given according to clinical need.

PROPOVAN (Propofol Inj.) may be administered via a Y-piece close to the injection site into infusions of Dextrose 5%, Sodium Chloride 0.9%, or Dextrose 4% with Sodium Chloride 0.18%. Supplementary analgesic agents are generally re-quired in addition to PROPOVAN (Propofol Inj.). Nothing except Dextrose 5% should be used for dilution of PROPOVAN (Propofol Inj.).

(c) Children
PROPOVAN (Propofol Inj.) is not recommended for maintenance of anesthesia in children less than 3 years of age.

Anesthesia can be maintained by administering PROPOVAN (Propofol Inj.) by infusion of repeat bolus injection to prevent the clinical signs of light anesthesia. The required rate of administration varies considerably between patients, but rates in the region of 9 to 15 mg/kg/hour usually achieves satisfactory anesthesia.

3. Sedation during Intensive Care

(a) Adults (Including Elderly Patients)
When used to provide sedation for ventilated patients undergoing intensive care, it is recommended that PROPOVAN (Propofol Inj.) be given by continuous infusion. The infusion rate should be adjusted according to the depth of sedation required, but rates in the region of 0.3 to 4.0 mg/kg/hr should achieve satisfactory sedation. Rate of infusion greater than 4.0 mg/kg/hr is not recommended.

PROPOVAN (Propofol Inj.) may be diluted with 5% Dextrose (See Dilution and co-administration table below).

It is recommended that blood lipid level should be monitored when PROPOVAN (Propofol Inj.) is administered to patients who are at particular risk of fat overload. Administration of PROPOVAN (Propofol Inj.) should be adjusted appro-priately if the monitoring indicates that fat is being inadequately cleared from the body. If the patient is receiving other intravenous lipid concurrently, a reduction in quantity should be made in order to take account of the amount of lipid infused as part of PROPOVAN (Propofol Inj.) formulation. One ml of PROPOVAN contains approximately 0.1 g of fat.

Although no causal relationship has been established, serious adverse events (including fatalities) have been observed from spontaneous reports of unlicensed use. These events were seen most often in children with respiratory tract infections when doses given in excess of those recommended for adults.

(b) Children
PROPOVAN (Propofol Inj.) is not recommended for sedation in children as safety and efficacy have not been demonstrated.

4. Sedation For Surgical And Diagnostic Procedures

(a) Adults
To provide sedation for surgical and diagnostic procedures, rates of administration should be individualized and titrated to clinical response. Most patients would require 0.5 mg/kg to 1 mg/kg of PROPOVAN (Propofol Inj.) over 1 to 5 min. for onset of action.

Maintenance of sedation may be accomplished by titrating PROPOVAN (Propofol Inj.) infusion to the desired level of sedation. Most patients will require 1.5 to 4.5 mg/kg/hr. In addition to the infusion, bolus administration of 10 to 20 mg may be used if a rapid increase in the depth of sedation is required. In patients of ASA

Grade 3 and 4, the rate of administration and dosage may need to be reduced.

(b) Elderly Patients
PROPOVAN (Propofol Inj.) should be titrated against the response of the patients over the age of about 55 years, may require lower doses of PROPOVAN (Propofol Inj.) for sedation for surgical and diagnostic procedures.

(c) Children
PROPOVAN (Propofol Inj.) is not recommended for sedation in children as safety and efficacy have not been demonstrated.

 

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Administration

PROPOVAN (Propofol Inj.) should only be administered through a filter with a pore size of 5μ or greater.

PROPOVAN (Propofol Inj.) has no analgesic properties and therefore sup-plementary analgesic agents are generally required in addition to PROPOVAN (Propofol Inj.). PROPOVAN (Propofol Inj.) has been used in association with spinal and epidural anesthesia and with commonly used premedications, neuromuscular blocking drugs, inhalational agents and analgesic agents, no pharmacological incompatibility has been encountered. Lower dose of PROPOVAN (Propofol Inj.) may be required where general anesthesia is used as an adjunct to regional Anaesthetic technique.

PROPOVAN (Propofol Inj.) can be used for infusion undiluted from glass containers and plastic syringe, or diluted with 5% Dextrose intravenous infusion only, in PVC infusion bags or glass infusion bottles Dilutions, which must not exceed 1 in 5 (2 mg Propofol per ml) should be prepared aseptically immediately before admini-stration and must be used within 6 hours of preparation. It is recommended that, when using diluted PROPOVAN (Propofol Inj.) the volume of 5% Dextrose removed from the infusion bag during the dilution process is totally replaced in volume by PROPOVAN (Propofol Inj.) emulsion. The dilution may be used with a variety of infusion control techniques, but a given set used alone will not avoid the risk of accidental, uncontrolled infusion of large volumes of diluted PROPOVAN (Propofol Inj.). A burette, drop counter or volumetric pump must be included in the infusion line. The risk of uncontrolled infusion must be taken into account when deciding the maximum amount of PROPOVAN (Propofol Inj.) in the burette. When PROPOVAN (Propofol Inj.) is used undiluted to maintain anesthesia, it is recom-mended that equipments such as drop counters, syringe pumps or volumetric infusion pumps should always be used to control infusion rate.

In order to reduce pain on initial injection, PROPOVAN (Propofol Inj.) may be mixed with preservative free lignocaine injection 0.5% or 1% (See Dilution and Co-administration table below).

Dilution & Co-Administration Table

Co-administration Technique	Additive or diluent	Preparation	Precaution
Pre-mixing	Dextrose 5% Intravenous Infusion	Mix 1 part of PROPOVAN with up to 4 parts of Dextrose 5% Intravenous Infusion in either PVC infusion bags or glass infusion bottles. When diluted in PVC bags it is recom-mended that the bag should be full & that the dilution be prepared by with-drawing a volume of infusion fluid & replacing it with an equal volume of PROPOVAN.	Prepare asepti-cally just before Administration. The mixture is stable for Upto 6 hours.
	Lignocaine Hydrochloride Injection. (0.5% or 1% without preservatives)	Mix 20 parts of PROPOVAN with up to 1 part of either 0.5% or 1% Lignocaine Hydrochlo-ride injection	Prepare mixture aseptically immediately prior to administration, Use for induction only.
Co-administration via a Y-piece	Dextrose 5% intravenous	Co-administration via a Y-piece connector	Place the Y-piece connector close to the Injection site.
	Sodium Chloride 0.9% intravenous infusion	As above	As above
	Dextrose 4% with Sodium Chloride 0.18% intra-venous infusion	As above	As above

 

 

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Contraindication

Known allergy to PROPOVAN (Propofol Inj.).

 

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Precaution

A. PROPOVAN (Propofol Inj.) should be used cautiously for following patients

1. The epileptics (This medication may increase the risk of convulsions).
2. Patients with cardiac, respiratory, renal or hepatic impairment.
3. Hypovolaemic patients.
4. Debilitated patients.
5. Patients with disorders of fat metabolism and in other conditions where lipid emulsion must be used cautiously.

B. General Precautions

1. PROPOVAN (Propofol Inj.) should be given by those trained in anesthesia and facilities for maintenance of patient airway, artificial ventilation, and oxygen enrichment should be available.
2. PROPOVAN (Propofol Inj.) should not be administered by person conducting the diagnostic or surgical procedure.
3. When PROPOVAN (Propofol Inj.) is administered for sedation for surgical and diagnostic procedures, patients should be continuously monitored for early signs of hypotension, airway obstruction and oxygen desaturation.
4. As with other Anaesthetic agents, patients should be instructed to avoid alcohol before and for at least 8 hours after administration of PROPOVAN (Propofol Inj.).
5. Patients should be advised that their performance with skilled tasks, such as driving and operating machinery, may be impaired for some time after general anesthesia.
6. Sufficient recovering time is needed to patients after general anesthesia until the recovery is assured.
7. PROPOVAN (Propofol Inj.) lacks vagolytic activity and has been associated with reports of bradycardia, occasionally profound. The intravenous admini-stration of an anticholinergic agent before induction, or during maintenance of anesthesia should be considered, especially in situations where vagal tone is likely to predominate or when PROPOVAN (Propofol Inj.) is used in conjunction with other agents likely to cause bradycardia.
8. The local pain which may occur during intravenous injection of PROPOVAN (Propofol Inj.) can be minimized when the large veins of the forearm and an-tecubital fossa are used.

C. Drug Interactions

1. The combined treatment with the narcotics (morphine, meperidine, fen-tanyl) and narcotic tranquilizer (benzodiazepines, barbitals, chloral hydrate, droperidol etc.) is likely to decrease the inducting dosage of PROPOVAN (Propofol Inj.). These preparations are likely to increase Anaesthetic effect of PROPOVAN (Propofol Inj.) and to decrease systolic, diastolic, and average blood pressure and cardiac output.
2. The aids of anesthetics (nitrous oxide, opioids) can decrease the infusion rate of PROPOVAN (Propofol Inj.) during narcosis.
3. Inhalation anesthetics may increase the Anaesthetic effect to PROPOVAN (Propofol Inj.) and its effect on cardiac and respiratory system. So PROPOVAN (Propofol Inj.) is desirable not to be combined with inhalation anesthesia (isoflurane, enflurane, halothane).
4. PROPOVAN (Propofol Inj.) has not caused any clinical changes in the action, maintenance and degree of the neuromuscular blockers (succinyl choline and non-depolarizing muscle relaxants).

D. Usage In Pregnancy And Lactation:

1. PROPOVAN (Propofol Inj.) has been used during termination of pregnancy in the first trimester. It should not be used in pregnancy.
2. PROPOVAN (Propofol Inj.) crosses the placenta and may be associated with neonatal depression. It should not be used for obstetric anesthesia.
3. Safety to the neonate has not been established subsequent to the use of PROPOVAN (Propofol Inj.) in the mothers who are breast feeding.

E. Pediatric Usage
PROPOVAN (Propofol Inj.) should not be used for anesthesia in children less then 3 years of age and for sedation in the children.

F. Usage In Elderly Patients
PROPOVAN (Propofol Inj.) should be titrated against the response of the pa-tients. Patients over the age of about 55 years may require lower doses for induction of anesthesia (approximately 20% less).

G. Treatment In Case Of Overdosage

1. Accidental over dosage is likely to cause cardio-respiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen.
2. Cardiovascular depression would require lowering of the patients head and with severe use of plasma expanders and pressor agents.

H. Side Effects

1. Cardiovascular system: Hypotension, bradycardia, hypertension, tachycar-dia, premature ventricular contractions, premature atria contractions, syn-cope, ECG abnormal, ST segment depression.
2. Central nervous system: Movement, convulsion, headache, dizziness, twitch-ing, clonic/myoclonic movement, bucking/jerking/thrashing, amorous be-havior, somnolence, hypertonia/dystonia, paresthesia, tremor, excitation, hallucinations, delirium, euphoria, fatigue, moaning, rigidity.
3. Digestive system: Vomiting, nausea, abdominal cramping, hypersalivation, dry mouth, swallowing.
4. Respiratory system: Cough, hiccup, apnoea, upper airway obstruction, bronchospasm, dyspnea, wheezing decreased respiration, burning in throat, sneezing, tachypnea, hyperventilation, hypoxia.
5. Skin: Flushing, rash, pruritus, urticaria.
6. Injection site: Burning/stinging or pain, frigidity, hypersthesia, phlebitis, hives, itching, redness, discoloration.
7. Part of body: Fever, extremities pain, chest pain, neck rigidity stiffness.
8. Musculoskeletal system: Myalgia.
9. Urogenital system: Urine retention, green urine.
10. Others: Amblyopia, diplopia, eye pain, taste perversion, tinnitus, anaphylaxis, sexual discomfort.

Additional Precautions

1. PROPOVAN (Propofol Inj.) contains no antimicrobial preservatives and the vehicle supports growth of micro-organisms.
2. When PROPOVAN (Propofol Inj.) is to be aspirated, it must be drawn asepti-cally into a sterile syringe or giving set immediately after opening the con-tainer. Administration must commence without delay. Asepsis must be main-tained for both PROPOVAN (Propofol Inj.) and infusion equipment throughout the infusion period.
3. Any drugs or fluids added to the PROPOVAN (Propofol Inj.) line must be administered close to the cannula site.
4. PROPOVAN (Propofol Inj.) must not be administered via a microbiological filter as this filter restricts the flow of PROPOVAN (Propofol Inj.).
5. PROPOVAN (Propofol Inj.) and any syringe containing PROPOVAN (Propofol Inj.) are for single use in an individual patient.
6. According to the guide established in connection with the other fat emul-sions, an infusion period of this medication should not exceed 12 hours. After operation or 12 hour passage, any unused portion of PROPOVAN (Propofol Inj.) and the giving set must be discarded.
7. Any portion of the contents remaining after use should be discarded.
8. PROPOVAN (Propofol Inj.) should not be mixed prior to administration with injections or infusion other than 5% Dextrose and Lignocaine injection (See DOSAGE AND ADMINISTRATION).
9. Containers should be visually inspected for absence of signs of oil separa-tion.
10. Use of non-PVC (Polyvinyl Chloride) administration set (e.g. ethylene vinyl acetate, EVA) is recommended for continuous infusion.

 

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How Supplied

Each ml containing 10 mg Propofol B.P. in vials of 10 ml, 15 ml, 20 ml, 50 ml, 100 ml and ampoules of 10 ml, 15 ml & 20 ml. PROPOVAN (Propofol Inj.) should be stored below 250C. It should not be frozen.

 

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Shelf Life

Sealed & Unopened containers, when stored as recommended have a shelf life of 24 months from date of manufacturing.

Keep out of reach of children.

 

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