COMPOSITIONS :
Thiopental Sodium Powder for Injection 1 g, each vial contains : Thiopental sodium and sodium carbonate equivalent to Thiopental sodium 1 g.
DESCRIPTIONS :
Thiopental Sodium contains Thiopental sodium and sodium carbonate (equivalent to Thiopental sodium) as active ingredient available in powder for injection 0.5 g and 1 g.
INDICATIONS :
- As the sole anesthetic agent for brief (15 minutes) procedures.
- For induction of anesthesia prior to administration of other anesthetic agents.
- To supplement regional anesthesia.
- To provide hypnosis during balanced anesthesia with other agents for analgesia or muscle relaxation.
- For the control of convulsive states during or following inhalation anesthesia, local anesthesia or other causes.
- In neurosurgical patients with increased intracranial pressure, if adequate ventilation is provided.
- For narcoanalysis and narcosynthesis in psychiatric disorders.
DOSAGE AND ADMINISTRATIONS :
Thiopental Sodium is administered by the intravenous route only. Individual response to the drug is so varied that there can be no fixed dosage. The drug should be titrated against patient requirements as governed by age, sex and body weight.
- Premedication :
Premedication usually consists of Atropine or Scopolamine to suppress vagal reflexes and inhibit secretions. In addition, a Barbiturate or an Opiate is often given. Pentobarbital sodium injection is suggested because it provides a preliminary indication of how the patient will react to Barbiturate anesthesia. Ideally, the peak effect of these medications should be reached shortly before the time of induction.
- Test dose :
It is advisable to inject a small “test” dose of 25 to 75 mg (1 to 3 ml of a 2.5% solution) of Thiopental Sodium for injection to assess tolerance or unusual sensitivity to Thiopental sodium, and pausing to observe patient reaction for at least 60 seconds. If unexpectedly deep anesthesia develops or if respiratory depression occurs, consider these possibilities : (1) the patient may be unusually sensitive to Thiopental sodium, (2) the solution may be more concentrated than had been assumed or (3) the patient may have received too much premedication.
- Use in anesthesia :
Moderately slow induction can usually be accomplished in the “average” adult by injection of 50 to 75 mg (2 to 3 ml of a 2.5% solution) at intervals of 20 to 40 seconds, depending on the reaction of the patient. Once anesthesia is established, additional injections of 25 to 50 mg can be given whenever the patient moves.
When Thiopental Sodium for injection is used for induction in balanced anesthesia with a skeletal muscle relaxant and an inhalation agent, the total dose of Thiopental Sodium can be estimated and then injected in two to four fractional doses. With this technique, brief periods of apnea may occur which may require assisted or controlled pulmonary ventilation. As an initial dose, 210 to 280 mg (3 to 4 mg/kg) of Thiopental Sodium is usually required for rapid induction in the average adult (70 kg).
- Use in convulsive states :
For the control of convulsive states following anesthesia (inhalation or local) or other causes, 75 to 125 mg (3 to 5 ml of a 2.5% solution) should be given as soon as possible after the convulsion begins. Convulsions following the use of a local anesthetic may require 125 to 250 mg of Thiopental Sodium given over a ten minute period. If the convulsion is caused by a local anesthetic, the required dose of Thiopental Sodium will depend upon the amount of local anesthetic given and its convulsant properties.
- Use in neurosurgical patients with increased intracranial pressure :
In neurosurgical patients, intermittent bolus injections of 1.5 to 3.5 mg/kgBW may be given to reduce intraoperative elevations of intracranial pressure, if adequate ventilation is provided.
- Use in psychiatric disorders :
For narcoanalysis and narcosynthesis in psychiatric disorders, premedication with an anticholinergic agent may precede administration of Thiopental Sodium. After a test dose, Thiopental Sodium for injection is injected at a slow rate of 100 mg/minute (4 ml/minute of a 2.5% solution) with the patient counting backwards from 100. Shortly after counting becomes confused but before actual sleep is produced, the injection is discontinued. Allow the patient to return to a semi-drowsy state when a conversation is ongoing.
Preparation of solutions :
Solutions should be prepared aseptically with sterile water for injection.
Reconstitutions :
Thiopental Sodium 1 g : Powder for injection 1 g dissolved in 40 ml of sterile water for injection
After reconstitution with steril water for injection, Thiopental Sodium can be stored for up to 24 hours at temperatures below 25C.
OVERDOSAGE :
Overdosage may occur from too rapid or repeated injections. Too rapid injection may be followed by an alarming fall in blood pressure even to shock levels. Apnea, occasional laryngospasm, coughing and other respiratory difficulties with excessive or too rapid injections may occur. In the event of suspected or apparent overdosage, the drug should be discontinued, a patent airway established (intubate if necessary) or maintained and oxygen should be administered, with assisted ventilation if necessary.
The lethal dose of Barbiturates varies and cannot be stated with certainty. Lethal blood levels may be as low as 1 mg/100 ml for short-acting Barbiturates; less if other depressant drugs or alcohol are also present.
CONTRAINDICATIONS :
Absolute contraindications :
- Absence of suitable veins for intravenous administration.
- Hypersensitivity (allergy) to Barbiturates.
- Latent or manifest porphyria.
Relative contraindications :
- Severe cardiovascular disease.
- Hypotension or shock.
- Conditions in which the hypnotic effect may be prolonged or potentiated – excessive premedication, Addison’s disease, hepatic or renal dysfunction, myxedema, increased blood urea, severe anemia, asthma, myasthenia gravis.
- Status asthmaticus.
WARNINGS AND PRECAUTIONS :
- Keep resuscitative and endotracheal intubation equipment and oxygen readily available. Maintain patency of the airway at all times.
- This drug should be administered only by persons qualified in the use of intravenous anesthetics.
- Avoid extravasation or intra-arterial injection.
- Administer only clear reconstituted solutions.
- Use within 24 hours after reconstitution. Discard unused portions.
- If used in conditions involving relative contraindications, reduce dosage and administer slowly.
- Care should be taken in administering the drug to patients with advanced cardiac disease, increased intracranial pressure, ophthalmoplegia plus, asthma, myasthenia gravis and endocrine insufficiency (pituitary, thyroid, adrenal, pancreas).
- Thiopental sodium readily crosses the placental barrier and small amounts may appear in the milk of nursing mothers following administration of large doses.
- Thiopental sodium should be given to a pregnant woman only if clearly needed (category C).
- Observe aseptic precautions at all times in preparation and handling of Thiopental sodium solutions.
DRUG INTERACTIONS :
- Probenecid : Prolonged action of Thiopental sodium.
- Diazoxide : Hypotension.
- Zimelidine : Thiopental sodium antagonism.
- Opioid analgesics : Decreased antinociceptive action.
- Aminophylline : Thiopental sodium antagonism.
- Midazolam : Synergism.
ADVERSE REACTIONS :
Respiratory depression, myocardial depression, cardiac arrhythmias, prolonged somnolence and recovery, sneezing, coughing, bronchospasm, laryngospasm, shivering, anaphylactic and anaphylactoid reactions.
Rarely immune hemolytic anemia with renal failure and radial nerve palsy have been reported.
PRESENTATIONS :
Thiopental Sodium Powder for Injection 1 g Box, 10 vials @ 1 g
Reg. No. GKL1302348244B1
STORAGE :
STORE BELOW 25ºC AND DRY PLACE
After reconstitution with sterile water for injection, Thiopental Sodium can be stored for up to 24 hours at temperatures below 25ºC.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
