Drug withdrawn from the market on 07/15/2011
propofan drug Uses and indication
- Symptomatic treatment of pain of moderate to intense intensity, or not responding to the use of peripheral analgesics alone.
Reserved for adults and adolescents from 15 years old.
- The tablets should be swallowed as is, with a large glass of water, during a meal.
- 1 to 2 tablets per dose. On average 4 tablets a day divided into 2 to 4 doses.
- Do not exceed 6 tablets a day.
- The catches must be spaced at least 4 hours apart, at best 8 to 12 hours.
- In cases of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between 2 doses will be at least 8 hours.
- Paracetamol allergy
- Dextropropoxyphene allergy
- Hepatocellular insufficiency
- Severe renal failure
- Child under 15
- Feeding with milk
- CONTRA-INDICATEDThis medicinal product is contraindicated in the following situations:
- allergy to paracetamol, dextropropoxyphene or to another component of the medicinal product,
- hepatocellular insufficiency,
- severe renal insufficiency,
- children under 15 years old,
- breast-feeding: this medicine passes into breast milk; a few cases of hypotonia and respiratory pauses have been described in infants after maternal ingestion of dextropropoxyphene at therapeutic doses. If breastfeeding, taking this medication is contraindicated,
- combination with buprenorphine, nalbuphine and pentazocine (see interactions).
- Combinations not recommended: alcohol, carbamazepine, enoxacin.
how does propofan work
Pharmacotherapeutic group: DEXTROPROPOXYPHENE IN ASSOCIATION.
ATC Code: N02AC54.
(N: Central nervous system).
propofan drug is a combination of 3 active ingredients:
- paracetamol : ANALGESIC AND ANTIPYRETIC,
- dextropropoxyphene : ANALGESIC OPIOID,
- caffeine : PSYCHOSTIMULANT.
What are the side effects of propofan ?
PARACETAMOL RELATED :
- Few cases of hypersensitivity reactions such as anaphylactic shock, angioedema, erythema, urticaria, skin rash have been reported. Their occurrence requires the definitive discontinuation of this drug and related drugs.
- Very exceptional cases of thrombocytopenia, leukopenia and neutropenia have been reported.
RELATED TO DEXTROPROPOXYPHENE :
- The most common: nausea, vomiting.
- More rarely: constipation, abdominal pain, rash, headache, asthenia, euphoria, minor vision disorders, disorientation, somnolence, dizziness, severe hypoglycemia, cholestatic or mixed hepatitis.
CAFEIN RELATED :
- rare cases of insomnia,
- possibility of palpitations.
INTERACTIONS WITH PARACLINICAL EXAMINATIONS :
- Paracetamol may interfere with the glucose-oxidase-peroxidase assay at abnormally high concentrations.
- Taking paracetamol may interfere with the determination of blood uric acid by the phosphotungstic acid method.
ASSOCIATIONS WITH PRECAUTIONS FOR USE :
Oral anticoagulants :
- Risk of an increase in the effect of oral anticoagulant and haemorrhagic risk when taking paracetamol at maximum doses (4 g / d) for at least 4 days.
- More frequent control of the INR. Possible adaptation of oral anticoagulant dosage during paracetamol treatment and after discontinuation.
RELATED TO DEXTROPROPOXYPHENE :
CONTRAINDICATED ASSOCIATION :
Morphine agonists-antagonists (buprenorphine, nalbuphine, pentazocine) :
- Decrease of the analgesic effect by competitive blocking of the receptors, with the risk of appearance of a withdrawal syndrome.
ASSOCIATIONS DEVOTED :
- Increase by alcohol of sedative effect of opioid analgesics.
- Impairment of alertness can make driving and using machines dangerous.
How long after propofol Can I drink alcohol?
- Avoid taking alcoholic drinks and drugs containing alcohol.
– Carbamazepine :
- Increased plasma concentrations of carbamazepine with signs of overdose by inhibition of its hepatic metabolism.
- Clinical surveillance and possible reduction of the dosage of carbamazepine.
ASSOCIATIONS TO BE TAKEN INTO ACCOUNT :
– Other morphine derivatives (including antitussives and substitution treatments), benzodiazepines, barbiturates:
Increased risk of respiratory depression, which can be fatal in case of overdose.
– Other central nervous system depressants, such as other morphine derivatives (including antitussives and substitution treatments), sedative antidepressants, sedative antihistamines H1, anxiolytics, hypnotics, neuroleptics, central antihypertensives, thalidomide, baclofen :
Increased central depression. Altered alertness can make driving and using machines dangerous.
RELATED CAFFEINE :
ASSOCIATION NOT RECOMMENDED :
- Significant increase in caffeine levels in the body that can lead to excitement and hallucinations (decreased hepatic metabolism of caffeine).
ASSOCIATIONS TO BE TAKEN INTO ACCOUNT :
Ciprofloxacin, norfloxacin :
warnings and Precautions :
- The risk of predominantly psychological dependence appears only for higher dosages than recommended and for long-term treatments.
– Related to the presence of dextropropoxyphene :
- Alcohol absorption during treatment is not recommended.
- Propofan should be avoided in patients with suicidal tendencies, in patients treated with tranquilizers,
- antidepressants or central nervous system depressants.
– Related to the presence of paracetamol :
- Interactions of paracetamol with paraclinical examinations: taking paracetamol may interfere with the determination of blood uric acid by the phosphotungstic acid method and the determination of glucose by the
- glucose oxidase-peroxidase method.
– Pregnancy: A prospective epidemiological study, involving a few hundred women, did not show any teratogenic effect of dextropropoxyphene and paracetamol administered alone.
- Paracetamol, an analgesic that has no anti
-inflammatory properties, does not appear to pose a fetal risk when used during the 2nd and 3rd trimesters.
- In clinical studies, the analysis of a high number of exposed pregnancies apparently did not reveal any particular malformative or fetotoxic effect of caffeine.
- Although similar to morphinomimetics, the occasional administration of dextropropoxyphene, under common prescribing conditions, does not pose a risk of neonatal withdrawal.
- Caffeine abuse can cause fetal and neonatal tachycardia.
However, compared to a normal population, no increase in spontaneous miscarriages, prematurity and number of children with hypotrophy has been reported
. As a result, this medication can be prescribed during pregnancy if needed, in short treatment and at the recommended doses.
Drive and use machines:
PROPOFAN has an important influence on the ability to drive and use machines.
Driving or using machines is contraindicated during the day of propofol anesthesia. If other medications have been combined, driving may be discouraged for a longer period.
The effects of propofol usually disappear after 12 hours.
PREGNANCY / BREAST FEEDING / FERTILITY:
- Studies in animals have not shown any teratogenic effect.
- In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected.
- Indeed, to date, the substances responsible for malformations in humans have been teratogenic in animals in well-conducted studies on two species.
- In clinical practice, there are currently no data of sufficient relevance to evaluate the possible malformative or fetotoxic effect of propofol when administered during pregnancy.
Therefore, as a precaution, it is best not to use propofol during pregnancy (except of course in case of termination of pregnancy) unless absolutely necessary.
Propofol passes through the placenta and can cause neonatal depression.
- The use of propofol in nursing women is not recommended.
- Studies have shown that small amounts of propofol are excreted in the milk of lactating women.
- Therefore, women should not breastfeed for 24 hours after taking propofol. The milk produced during this period will have to be discarded.
propofan overdose side effects
Poisoning is to be feared in the elderly and young children (therapeutic overdose or accidental intoxication frequent in toddlers) where it can be dramatic or even fatal.
– Paracetamol Overdose Symptoms :
- Nausea, vomiting, anorexia, pallor, abdominal pain usually appear within the first 24 hours.
- Overdose, starting with 10 g of paracetamol in a single dose in adults and 150 mg / kg of body weight in a single dose in children, causes hepatic cytolysis which may result in complete and irreversible necrosis Hepatocellular insufficiency, metabolic acidosis, encephalopathy that can lead to coma and death.
- At the same time, there is an increase in hepatic transaminases, lactic dehydrogenase, bilirubin and a decrease in the prothrombin level that may occur 12 to 48 hours after ingestion.
– Dextropropoxyphene overdose symptoms :
- Disorders of consciousness ranging from somnolence to coma.
- Nausea, vomiting, abdominal pain, respiratory depression ranging from simple dyspnea to apnea.
- Myosis, convulsions, delirium, cyanosis, collapse, death by cardiac arrest.
– Emergency Driving :
- Immediate transfer to hospital.
- Rapid evacuation of the product ingested by gastric lavage and activated charcoalper os .
- Before beginning treatment, draw a tube of blood for plasma determination of paracetamol and dextropropoxyphene.
- Treatment of overdose includes the early administration of the paracetamol antidote, N-acetylcysteine IV or oral, if possible before the tenth hour and the administration of naloxone, antidote for dextropropoxyphene.
- Respiratory support.
- Do not use analeptics or central nervous system stimulants as they may precipitate fatal convulsions.
What is Forms and Composition ?
|FORMS and PRESENTATIONS|
- IV Injectable Emulsion 20 mg / ml: Pre-filled 50 ml syringe.
|A pre-filled syringe of 50 ml contains 1 g of propofol|
- Excipients: refined soybean oil, purified egg phosphatides, glycerol, sodium hydroxide, disodium edetate, water for injections.
- Excipients with known effect: refined soybean oil, sodium.
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