Powder for solution for injection thiopental
sodium
What Pentocur is and what it is used for
Pentocur contains the active substance thiopental sodium. It is a fast-acting thiobarbiturate given intravenously ( injection into a vein).
Pentocur is used:
- to initiate general anesthesia (a condition of deep sleep during, for example, surgery )
- for hypnosis (you are sleepy but not completely asleep) during anesthesia with other anesthetics
- as part of the treatment for seizures (including those caused by local anesthetics)
- to lower the pressure in the skull ( intracranial pressure ) in patients where the pressure is elevated (if controlled ventilation is given)
Thiopental sodium contained in Pentocur may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Pentocur
Do not use Pentocur
You should not receive Pentocur :
- if you are allergic to thiopental, barbiturates, or any of the other ingredients of this medicine (listed in section 6)
- if you have airway obstruction which prevents airflow ( respiratory obstruction )
- if you have acute asthma (severe asthma attack)
- if you suffer from hereditary muscle disease that breaks down the muscles (myotonic dystrophy)
- if you are in severe shock
- if you have porphyria
Warnings and cautions
If possible, talk to your doctor or nurse before receiving Pentocur. The healthcare professional must take extra care and may need to adjust your dose if you have/are:
- elevated pressure in your skull
- asthma or another serious respiratory disease
- inflammation of the mouth, jaw, or throat – this can lead to breathing problems during the use of Pentocur
- any cardiovascular disease or high blood pressure
- inflammation of the pericardium
- low fluid volume in the body ( hypovolemia ) or if you are dehydrated
- severe bleeding or burns
- myasthenia gravis (a disease that weakens muscles)
- impaired function of the adrenal cortex, even if treated with cortisone
- general malaise, malnutrition, or weight loss
- high levels of urea, toxins, or potassium in the blood
- severe anemia ( anemia )
- shock
- impaired liver or kidney function
- any metabolic disease (such as thyrotoxicosis, myxedema, and diabetes )
- alcohol dependence or drug abuse
Other medicines and Pentocur
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
The following medicines may affect or be affected by this injection and may need to be adjusted before or after you receive this injection:
- aminophylline and theophylline (for the treatment of asthma )
- midazolam (a sedative)
- opioid analgesics (strong painkillers)
- probenecid (anti-gout medicine )
- sufentanil (painkiller)
- chloral hydrate (sleeping pills)
- muscle relaxants
- MAO inhibitors and tricyclic antidepressants (for the treatment of depression) eg citalopram, amitriptyline
- drugs that suppress the activity of the central nervous system
- metoclopramide and droperidol (medicines for nausea and vomiting)
- an herbal medicine containing St. John’s wort ( Hypericum perforatum )
- androgen er (for the treatment of male infertility )
- antiepileptic drugs
- glucocorticoids (anti-inflammatory drugs)
- drugs for the treatment of bacterial infections such as metronidazole, sulfafurazole, isoniazid, vancomycin
- estrogen (for the treatment of menopause)
- drugs for the treatment of diabetes taken by mouth
- drugs for the treatment of high blood pressure eg captopril, enalapril, terazosin, felodipine, hydralazine, losartan, methyldopa, moxonidine, and diuretics ( diuretics )
- acetylsalicylic acid and other painkillers
- antipsychotic drugs such as promethazine or quetiapine; lithium
- diazoxide (for the treatment of hypoglycemia)
- tablets or sprays used to treat angina pectoris (angina)
- blood thinners ( oral anticoagulants )
Pentocur with alcohol
Dose one of Pentocur may need to be increased if you are addicted to or regularly consume large amounts of alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pentocur should only be given to pregnant women if your doctor thinks it is necessary.
Thiopental is excreted in breast milk. Breast-feeding should be temporarily discontinued (for at least 12 hours after thiopental use) or breast milk should be pumped out before using Pentocur.
Driving and using machines
Pentocur has a significant effect on the ability to drive and use machines. Even if waking up is relatively fast, you may experience dizziness (feeling dizzy), confusion, and dullness. Therefore, patients should not drive or use machines 24-36 hours after using Pentocur.
You are responsible for assessing whether you are in a position to perform or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Pentocur contains sodium
One vial Pentocur 500 mg contains 51-56 mg (or 2.2 – 2.4 mmol) sodium , one vial Pentocur 1000 mg contains 102-112 mg (4.4-4.9 mmol) sodium (the main ingredient in table salt / table salt ). This corresponds to 2.8% (500 mg vial ) and 5.6% (1000 mg vial ) of the highest recommended daily intake of sodium for adults.
How to use Pentocur
Pentocur will be given to you by anesthesiologists who will be available at all times when you receive Pentocur. Resuscitation equipment will also be available.
Pentocur will be given directly into one of your blood vessels, a vein ( intravenously ).
A test dose will be given to adjusting the dose to your needs.
Anesthesia
Your doctor will determine your dose and it will be based on your age, gender, body weight, and general health. You will be given a dose to initiate anesthesia and additional injections to maintain anesthesia.
Cramps
Injection of Pentocur should be given as soon as possible after the onset of seizures. An additional dose may be needed to keep the seizures under control.
Elevated pressure in the skull
You will be given a dose, based on your body weight, to lower the pressure in your head (controlled ventilation is given at the same time).
Impaired liver and kidney function
Your doctor will reduce the dose one if you have impaired liver or kidney function.
If you are given too much Pentocur
It is unlikely that you will receive an overdose, as healthcare professionals will take care of administering one of Pentocur.
Overdose may occur with too many injections or if Pentocur is administered too quickly. In case of suspected or obvious overdose, the drug should be discontinued. Symptoms of overdose include an alarming drop in blood pressure and medical shock. In addition, respiratory arrest, coughing, and other breathing difficulties may occur (however, this may also be a sign of underdosing).
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms – you may need urgent medical attention:
- Difficulty breathing, wheezing, rash, itching, hives, and dizziness. This can be a severe allergic reaction (has been reported, occurs in an unknown number of users).
- Swelling of the face, tongue, or throat; difficulty swallowing, and drops in blood pressure ( angioedema and anaphylactoid reactions) are rare side effects and may affect up to 1 in 1,000 people.
Other side effects that may occur:
Common side effects (may affect up to 1 in 10 people)
- heart rhythm disorders
- heart disease
- low blood pressure
- somnolence
- prolonged awakening from anesthesia
- breathing difficulties
- hyperventilation (rapid breathing)
- difficulty swallowing
- cough
- snoring
- overindulge
Has been reported (occurs in an unknown number of users)
- the increased amount of potassium in the blood (hyperkalemia)
- decreased amount of potassium in the blood ( hypokalaemia )
- loss of appetite
- general malaise, weakness
- fatigue (exhaustion)
- headache
- dizziness
- allergic reactions, skin reactions, hypersensitivity
When Pentocur is given, there may initially be cramps in the larynx, cough, or sneezing. Vomiting after surgery and use of Pentocur is less common but persistent drowsiness, confusion, memory loss, and chills may occur.
How to store Pentocur
| Unopened vial: | No special storage instructions. |
| After reconstitution: | Store in a refrigerator (2-8 ° C) for a maximum of 24 hours.Store at room temperature for a maximum of 6 hours. |
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is thiopental sodium.
- Each vial of Pentocur 0.5 g powder for solution for injection contains 500 mg of thiopental sodium (as thiopental sodium and sodium carbonate).
- Each vial of Pentocur 1 g powder for solution for injection contains 1000 mg of thiopental sodium (as thiopental sodium and sodium carbonate).
- The other ingredient is sodium carbonate
What the medicine looks like and the contents of the pack
Glass vial with bromobutyl rubber cap, aluminum seal, in cardboard.
Pack sizes:
Pentocur powder for solution for injection 0.5 g: 1 x 1 vial ,
10 x 1 vial , 20 x 1 vial or 50 x 1 vial .
Pentocur powder for solution for injection 1 g: 1 x 1 vial,
10 x 1 vial , 20 x 1 vial or 50 x 1 vial .
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
VUAB Pharma as, Vltavska 53, 25263 Roztoky, Czech Republic.