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Anestho (Thiopental Sodium)
Therapeutic Group: Anesthetic / Critical Care » I.V Induction Agents
Presentation

Anestho 500 IV Injection: Each vial contains Thiopental Sodium for Injection USP 500 mg (a sterile mixture of Thiopental Sodium and anhydrous Sodium Carbonate as a buffer).

Anestho 1 gm IV Injection: Each vial contains Thiopental Sodium for Injection USP 1 gm (a sterile mixture of Thiopental Sodium and anhydrous Sodium Carbonate as a buffer).

Descriptions
Thiopental Sodium for Injection is a thiobarbiturate, the sulfur analogue of Sodium Pentobarbital. The drug is prepared as a sterile powder and after reconstitution with an appropriate diluent is administered by the intravenous route. Thiopental Sodium is an ultra short-acting depressant of the central nervous system, which induces hypnosis and anesthesia, but not analgesia. It produces hypnosis within 30 to 40 seconds of intravenous injection. Recovery after a small dose is rapid, with some somnolence and retrograde amnesia. Repeated intravenous doses lead to prolonged anesthesia because fatty tissues act as reservoir; they accumulate Thiopental Sodium in concentrations 6 to 12 times greater than the plasma concentration, and then release the drug slowly to cause prolonged anesthesia. The half-life of the elimination phase after a single intravenous dose is three to eight hours.

Approximately 80% of the drug in the blood is bound to plasma protein. Thiopental Sodium is largely degraded in the liver and to a smaller extent in other tissues, especially the kidney and brain. It has a pKa of 7.4; Biotransformation products of Thiopental are pharmacologically inactive and mostly excreted in the urine.
Indications
Thiopental Sodium for Injection is indicated (1) as the sole anesthetic agent for brief (15 minutes) procedures, (2) for induction of anesthesia prior to administration of other anesthetic agents, (3) to supplement regional anesthesia, (4) to provide hypnosis during balanced anesthesia with other agents for analgesia or muscle relaxation, (5) for the control of convulsive states during or following inhalation anesthesia, local anesthesia, or other causes, (6) in neurosurgical patients with increased intracranial pressure, if adequate ventilation is provided, and (7) for narcoanalysis and narcosynthesis in psychiatric disorders.
Dosage & Administration
Thiopental Injection is administered intravenously normally as a 2.5% w/v solution. On occasions it may be administered as a 5% w/v solution (500 mg in 10 ml). The intravenous injection preparation should be used after reconstitution of the sterile powder with Water for Injections, usually to produce a 2.5% w/v solution.

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. 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 mg to 75 mg of Thiopental Sodium for Injection to assess tolerance or unusual sensitivity to Thiopental Sodium for Injection, 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 for Injection, (2) the solution may be more concentrated than had been assumed, or (3) the patient may have received too much.

Use in anaesthesia
Normal dosage for the induction of anesthesia is 100 mg to 150 mg injected over 10 to 15 seconds. If necessary, a repeat dose of 100 mg to 150 mg may be given after one minute. No fixed dosage recommendations for the intravenous injection can be given, since the dosage will need to be carefully adjusted according to the patient's response. Factors such as age, sex, and weight of the patient should be taken into consideration. Thiopental Sodium reaches effective concentrations in the brain within 30 seconds and anesthesia is normally produced within one minute of an intravenous dose.

Adult
100 mg to 150 mg intravenously over 10 to 15 seconds, normally as a 2.5% w/v solution.
A repeat dose of 100 mg to 150 mg may be given after one minute. The intravenous injection should be given slowly and the amount given titrated against the patient's response to minimize the risk of respiratory depression or the possibility of over dosage. The average dose for an adult of 70 kg is roughly 200 mg to 300 mg (8 mls to 12 mls of a 2.5% w/v solution) with a maximum of 500 mg.

Children
2 mg/kg to 7 mg/kg bodyweight, intravenously over 10 to 15 seconds, normally as a 2.5% w/v solution. A repeat dose of 2 mg/kg to 7 mg/kg may be given after one minute. The dose is 2 mg/kg to 7 mg/kg based on the patient's response. The dose for children should not exceed 7 mg/kg.

Elderly
Smaller adult doses are advisable.

Use in convulsive states
75 mg to 125 mg (3 mls to 5 mls of a 2.5% w/v solution) should be given as soon as possible after the convulsion begins. Further doses may be required to control convulsion following the use of a local anesthetic. Other regimens, such as the use of intravenous or rectal diazepam, may be used to control convulsive states.
Side Effects
Hypersensitivity reactions have been reported. Other adverse reactions to thiopental sodium include the followings: respiratory depression, myocardial depression, cardiac arrhythmias, prolonged somnolence and recovery, hypotension, tachycardia, sneezing, coughing, bronchospasm, laryngospasm and shivering. Anaphylactic reactions have been reported. Symptoms, e.g., urticaria, bronchospasm, vasodilation and edema.
Precautions
A person competent in anesthesia management should be in constant attendance and adequate facilities for support of respiration and circulation should be available when Thiopental Sodium for injection is being used. Thiopental Sodium for Injection should be administered with caution to patients with preexisting hypotension or in conditions where the hypnotic effect may be prolonged or intensified, such as in the presence of liver disease and renal disease.

Warnings
This product may be habit forming. Keep resuscitative and endotracheal intubation equipment and oxygen readily available. Maintain patency of the airway at all times. Only persons qualified in the use of anesthetics should administer this drug. Avoid extravasations or intra-arterial injection.
Contraindications
Thiopental Sodium for Injection is contraindicated in patients with severe respiratory embarrassment, hypersensitivity to barbiturates, status asthmaticus, variegate or acute intermittent porphyria, and inflammatory conditions of the mouth, jaw, and neck and in the absence of suitable veins for intravenous administration. Thiopental Sodium for Injection is also relatively contraindicated in severe cardiovascular disease, hypotension or shock, and conditions in which the hypnotic effect may be prolonged or potentiated, i.e. excessive premedication, Addison's disease, hepatic or renal dysfunction, myxedema, increased blood urea, severe anemia and myasthenia gravis.
Use in Pregnancy & Lactation
Thiopental readily crosses the placental barrier and also appears in breast milk. Therefore, breast-feeding should be temporarily suspended or breast milk expressed before the induction of anaesthesia. It has been shown that Thiopental can be used without adverse effects during pregnancy although the total dose should not exceed 250mg. However, when considering use of Thiopental the clinician should only use the drug when the expected benefits outweigh any potential risks.
Overdose
Overdosage may occur from too rapid or repeated administration. Too rapid injection may be followed by an alarming fall in blood pressure even to shock levels. Apnoea, occasional laryngospasm, coughing and other respiratory difficulties with excessive or too rapid injections may occur. In the event of suspected or apparent overdosage, the agent should be discontinued.
Storage
Store at controlled room temperature of 15o C to 30o C (59o F to 86o F).
Solutions should be freshly prepared and used immediately. Any portion of the contents remaining should be discarded.
Commercial Packaging
Anestho 500 mg injection: Each box contains 1 vial of 500 mg Thiopental Sodium USP for Injection (a sterile mixture of Thiopental Sodium and anhydrous Sodium Carbonate as a buffer) & 1 ampoule of 10 ml Water for Injection BP.
Anestho 1 gm injection: Each box contains 1 vial of 1 gm Thiopental Sodium USP for Injection (a sterile mixture of Thiopental Sodium and anhydrous Sodium Carbonate as a buffer) & 2 ampoules of 10 ml Water for Injection BP.
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