WHAT PENTOTHAL 500MG powder for solution for injection AND WHAT SHOULD IT USE?
Pharmacotherapeutic class GENERAL ANESTHESICS
(N: central nervous system)
2. BEFORE YOU USE PENTOTHAL 500MG powder for solution for injection?
List of information needed before taking the medication
Never use PENTOTHAL 500MG powder for solution injectableans the following cases:
· Respiratory obstruction
· Acute severe asthma, status asthmaticus
· Allergy to barbiturates,
Do not use PENTOTHAL 500 mg powder for solution for injection unless directed by your doctor in case of:
· Cardiovascular failure
· Hypotension, shock
· Addison’s disease (malfunction, adrenal glands)
· Severe kidney or liver disease
· Anemia (lack of red blood cells) severe
· Myxedema (malfunctioning, thyroid)
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR ANESTHESISTE.
Precautions for use; special warnings
Take special care with PENTOTHAL 500 mg powder for solution for injection:
Precautions for use
Tell your doctor before anesthesia, in case of high blood pressure, diabetes, asthma, respiratory diseases, reins, liver, endocrine glands, myopathy type Steinert’s disease.
· Thiopental injection should be performed intravenously strict, indeed
The passage of this product outside the vein resulting in tissue necrosis. If this occurs, give 10 ml of 1% procaine solution with hyaluronidase and apply a warm compress.
Intra-arterial injection of this product causes burning pain and can cause forearm pallor and hand pain with gangrene. In this case, a 1% procaine solution should be injected into the artery and immediate heparin treatment should be instituted to prevent thrombosis.
Doses of this drug will be decreased when combined with curare or analgesics, as well as in the elderly.
IF IN DOUBT DO NOT HESITATE TO ASK YOUR DOCTOR’S ADVICE.
Interactions with other drugs
Price or use of other drugs
If you have or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drinks
Interactions with herbal products or alternative therapies
Use during pregnancy and lactation
Pregnancy and breast feeding
As a precaution, it is best not to use thiopental during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
This medicine passes into breast milk. As a precaution, breastfeeding should be suspended for 24 hours after anesthesia.
Ask your doctor or pharmacist for advice before taking any medicine.
Effects on ability to drive or use machines
Driving and using machines
The injection of this product is incompatible with the transport of vehicles or the use of machines.
List of excipients with known effect
3. HOW TO USE PENTOTHAL 500MG powder for solution for injection?
Instructions for a good use
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
This product should not be administered by physicians specialized in anesthesia-resuscitation or emergency medicine and familiar with the use of anesthetics, or under their control, and all necessary anesthesia-resuscitation equipment.
The dosage of thiopental is individual, it is therefore necessary to find, by practicing the injection, the minimum anesthetic dose for each patient, which requires a very slow injection rate.
In certain resistant subjects, it is not necessary to insist on obtaining anesthesia in high doses, but to continue it with a volatile or gaseous anesthetic.
In the adult
· Induction: 3 to 5 mg / kg with the possibility of successive injections of 50 to 100 mg every 30 seconds until anesthesia is obtained.
Average total dose of 0.3 to 1 g.
· Maintenance: Re-injection of decreasing doses on demand. The total dose may range from 0.75 to 1 g for anesthesia of 40 to 60 minutes. As a general rule, the 1 g dose should not be exceeded to avoid delayed awakenings.
In the child
· Induction: A thiopental solution, diluted to 2.5% in water for injections is injected slowly at 30-second intervals for a dose of 4 to 5 mg / kg.
Average total dose of 0.1 to 0.5 g.
· Maintenance: Re-injection, on demand, of decreasing doses of thiopental diluted to 2.5%. For example, the maintenance dose for a child of 30 to 50 kg is 25 to 50 mg injected on demand.
In the elderly:
It is advisable to reduce the doses.
IN ALL CASES STRICTLY COMPLY WITH THE PRESCRIPTION OF YOUR DOCTOR
Method and route of administration
Intravenous injectable route.
Symptoms and instructions in case of overdose
If you take more PENTOTHAL 500 mg powder for solution for injection than you should:
· Clinical signs of overdose:
Overdose can occur as a result of too fast or repeated injections.
The clinical picture combines hypotension up to collapse, cough, laryngospasm and can worsen until coma calm, deep with respiratory depression.
Stop injecting thiopental, implement resuscitation measures.
Instructions for omitting one or more doses
Risk of withdrawal syndrome
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, PENTOTHAL 500 mg powder for solution for injection may have side effects, although not everybody gets them:
· Sometimes severe allergies
· Muscular movements
Coughing, sneezing, broncho-laryngospasm especially during the induction period
· Heart rhythm disorder
· Respiratory depression
· Nausea, vomiting, postoperative
· Dizziness, confusion, amnesia, headaches
· Moderate and transient disturbances of liver function. Exceptionally hepatitis.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PENTOTHAL 500 mg powder for solution for injection?
Keep out of the reach and sight of children.
Do not use PENTOTHAL 500 mg powder for solution for injection after the expiry date which is stated on the bottle.
No special storage conditions.
After reconstitution, the physico-chemical stability of the reconstituted solution was demonstrated for 8 hours at room temperature and 24 hours at a temperature of between 2 ° C and 8 ° C. However, from a microbiological point of view, the product should be used immediately.
If necessary, warn against some visible signs of deterioration
Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does PENTOTHAL 500 mg powder for solution for injection contain?
The active substance is:
Thiopental and sodium carbonate ……………………………………….530 mg
Corresponding amount of sodium thiopental at …………………….500 mg
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