rivotril medicine ,Generic drug of the therapeutic class: Neurology–psychiatry
active ingredients: Clonazepam
- 1 When should Rivotril be taken?
- 2 Rivotril Dosage
- 3 How it works Rivotril
- 4 What is the side effect of Rivotril?
- 5 Rivotril Interactions
- 6 Rivotril Warnings and Precautions
- 7 Drive and use machines
- 8 Rivotril and PREGNANCY / BREAST FEEDING / FERTILITY
- 9 What should I do if I miss a dose?
- 10 rivotril overdose side effects
When should Rivotril be taken?
- This drug is recommended in some forms of convulsions of the adult and the child.
- In all cases, treatment will be initiated at the lowest effective dose and the maximum dose will not be exceeded.
Child from 1 to 15 years :
- · Very slow intravenous injection, 1/4 to 1/2 ampoule of Rivotril to be diluted with a vial of solvent.
From 15 years old and adults :
- · Slow intravenous injection, renewable intravenously or intramuscularly 4 to 6 times within 24 hours: 1 ampoule of Rivotril to be diluted with a vial of solvent.
Effective dose relationship – plasma levels of clonazepam
The studies undertaken showed a lack of rigorous correlation, not only between individuals, but also in the same subject, between plasma levels of clonazepam and effective therapeutic doses. In addition, depending on the methodologies used, the results may vary for the same plasma sample from one center to another.
One can simply consider that an antiepileptic activity of clonazepam is generally found for plasma concentrations ranging from 20 ng / ml to 70 ng / ml.
- At the time of use, the required amount of clonazepam (0.25 mg to 1 mg or 0.25 ml to 1 ml of solution) is to be diluted in a syringe with the contents of the ampoule of solvent (1 ml ).
Injectable route (IV and IM):
- State of convulsive illness: the effect of clonazepam, direct venous, is immediate in the majority of cases and its action can last three hours.
- Intravenous administration may be supplemented by an intramuscular injection of 1/4, 1/2 or 1 whole ampoule (after dilution), depending on the age and speed of the result obtained within one hour after intravenous injection.
- During intravenous administration, a vein of sufficient size should be selected and the injection should be performed slowly to avoid the risk of thrombophlebitis, under continuous monitoring of respiratory function and blood pressure.
How it works Rivotril
ATC Code: N03AE01 .
( N: central nervous system ).
Clonazepam belongs to the class of 1-4 benzodiazepines and has a pharmacodynamic activity qualitatively similar to that of other compounds of this class:
- · Muscle relaxant,
- · Anxiolytic,
- · Sedative,
- · Hypnotic,
- · Anticonvulsant,
- · Amnesia.
These effects are related to a specific agonist action on a central receptor belonging to the complex “GABA-OMEGA macromolecular receptors”, also called BZ1 and BZ2 and modulating the opening of the chlorine channel.
What is the side effect of Rivotril?
this medicine can cause side effects, although not everybody gets them.
The side effects depend on the dose used and the individual sensitivity of each person.
- Effects on the immune system: allergic reactions and very rare cases of anaphylaxis (severe allergic reaction with severe and sudden drop in blood pressure) and Quincke’s edema (sudden swelling of the face and feeling of suffocation).
- Psychiatric effects: disorders of concentration, agitation, confusion (loss of landmarks in time or space), disorientation, change of consciousness, behavioral disorders.
Depression can occur but it can also be associated with old depression.
The following paradoxical reactions (adverse reactions to the desired effect) were observed: excitability, irritability, aggression, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares and dreams of real appearance.
In rare cases, a decrease or change in libido (sexual desire) may occur.
Effects on the nervous system: drowsiness, slowed reactions, decreased muscle tone, dizziness, ataxia (equilibrium disorder).
Reversible disorders such as dysarthria (difficulty of speech), incoordination of movements, ataxia and nystagmus (involuntary movements of lil).
Anterograde memory disorders (no longer remembering recent events) and memory problems that may be associated with inappropriate behavior.
Increased seizure frequency in some forms of depilepsy.
Headaches (headaches) have been observed in rare cases.
Generalized seizures have been observed very rarely.
Ocular disorders : reversible vision disorders: double vision, blurred vision, frequent appearance of nystagmus (oscillatory movements of lil).
Cardiac disorders: heart failure (heart failure), cardiac arrest.
Chest and mediastinal respiratory disorders: respiratory depression (severe breathing difficulties), respiratory arrest.
- Gastrointestinal disorders: in rare cases: nausea and stomach upset, increased salivation.
- Liver disorders: a few cases of increased liver enzymes (substances produced in the liver).
- Effects on skin and subcutaneous tissue: in rare cases: urticaria (itchy red patches), itching, red patches on the skin, temporary hair loss, changes in skin color.
- Musculoskeletal and systemic disorders: decreased muscle tone (muscle weakness).
- Effect on kidney and urinary tract: In rare cases, urinary incontinence (difficulty retaining urine) or urinary retention (unable to cure) may occur.
- Effects on the reproductive organs and the breast: In rare cases, erectile dysfunction may occur.
General disorders and administration site conditions: fatigue, feeling tired.
- Injury, poisoning and procedural complications: An increased risk of falls and fractures has been reported in elderly patients treated with benzodiazepines.
Investigations: In rare cases, a decrease in the number of platelets, white blood cells or red blood cells can occur.
Additional side effects in children
- Effects on hormones: Reversible isolated cases of incomplete precocious puberty.
- Respiratory and thoracic effects: in infants and young children, increased production of saliva and bronchial secretion
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers – Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
rivotril and alcohol
- Alcohol enhancement of the sedative effect of benzodiazepines and the like. Impairment of alertness can make driving and using machines dangerous.
- Avoid taking alcoholic drinks and drugs containing alcohol.
- Associations subject to precautions for use
- Increased plasma concentrations of the active metabolite of carbamazepine. In addition, decreased plasma concentrations of clonazepam by increasing its hepatic metabolism by carbamazepine.
- Clinical monitoring, plasma dosages and possible adjustment of the dosages of the two anticonvulsants.
Associations to consider
Other sedative drugs : morphine derivatives (analgesics, antitussives and substitution treatments other than buprenorphine); neuroleptics; barbiturates; other anxiolytics; hypnotics; sedative antidepressants; sedative antihistamines H1; central antihypertensives; baclofen; thalidomide; pizotifene.
Increase of the central depression. Impairment of alertness can make driving and using machines dangerous.
- Increased risk of respiratory depression, which can be fatal in case of overdose.
- With buprenorphine used in substitution therapy: increased risk of respiratory depression, which can be fatal.
- Carefully evaluate the benefit / risk ratio of this combination. Inform the patient of the need to respect the prescribed doses.
- Increased risk of collapse with respiratory and / or cardiac arrest.
- Increased risk of respiratory depression, which can be fatal in case of overdose.
Rivotril Warnings and Precautions
- Suicidal thoughts and behaviors have been reported in patients treated with antiepileptic drugs in several indications. A meta-analysis of randomized, placebo-controlled trials of antiepileptic drugs also showed a slight increase in the risk of suicidal ideation and behavior. The causes of this risk are not known and the available data do not exclude the possibility of an increased risk with clonazepam.
- Therefore, patients should be closely monitored for signs of suicidal ideation and behavior and appropriate treatment should be considered. Patients and their families should be advised to seek medical advice if suicidal thoughts and behaviors occur. Patients with a history of depression and / or suicide attempts should be closely monitored.
- Like all medicines of this type, RIVOTRIL can, according to the dosage, the mode of administration and the individual sensitivity, modify the reactions of the patient (for example his ability to drive or his driving behavior) (see section Effects on the ability to drive and use machines ).
- The introduction of antiepileptic drug can rarely be followed by a recrudescence of seizures or the emergence of a new type of seizure in the patient, regardless of the fluctuations observed in certain epileptic diseases. In the case of benzodiazepines, the causes of these aggravations may be: an inappropriate choice of medication for seizures or epileptic syndrome of the patient, a modification of the concomitant antiepileptic treatment or a pharmacokinetic interaction with it, toxicity or overdose. There may be no other explanation than a paradoxical reaction.
- Clonazepam is considered to be probably non-porphyrinogenic, although there are some contradictory observations. Clonazepam should therefore be used with caution in patients with porphyria.
- This medicine contains 20% alcohol, ie up to 159 mg of alcohol per 1 mg / 1ml ampoule, equivalent to 4 ml of beer or 1.6 ml of wine per ampoule. The use of this drug is dangerous in alcoholic subjects and should be taken into account in pregnant or breastfeeding women, children and high-risk groups such as hepatic insufficiency.
- This medicine contains 30 mg / ml of benzyl alcohol. It can cause toxic reactions and anaphylactoid-like reactions in infants and children up to 3 years of age.
- The antiepileptic effect of clonazepam may decrease gradually despite the use of the same dose when administered for several weeks.
ABUSE AND DEPENDENCE
- The use of benzodiazepines may result in a state of physical and mental dependence, including therapeutic doses and / or in patients without individualized risk factors. In particular, long-term or high-dose treatment may result in reversible conditions such as dysarthria, motor incoordination and gait disturbance (ataxia), nystagmus and impaired vision (diplopia). In addition, the risk of anterograde amnesia, which may occur when using benzodiazepines at therapeutic dosages, may increase at higher dosages. Amnesic effects may be associated with inappropriate behavior. With some forms of epilepsy, an increase in seizure frequency (see section 4.8).) is possible during long-term treatment.
- The risk of dependence increases with the dose and duration of treatment. It is also higher in patients with a history of abuse or dependence on drugs, alcohol and / or drugs.
- Withdrawal symptoms may develop after prolonged use, especially at high doses or if the daily dosage is reduced rapidly or treatment is stopped abruptly. Symptoms, some of which may be commonplace, include tremor, sweating, agitation, sleep disturbance and anxiety, headache, muscle aches, extreme anxiety, tension, impatience, confusion, irritability and seizures that may be the consequence withdrawal from clonazepam. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact or hallucinations.
- The combination of several benzodiazepines may, at any indication, increase the risk of drug dependence. The risk of withdrawal symptoms is then increased when clonazepam or other benzodiazepines are used abruptly (cross-tolerance).
Cases of abuse have been reported.
- This transient syndrome may manifest itself in the form of an exacerbation of the disorders that motivated treatment with benzodiazepines and the like.
- AMNESIA AND ALTERATIONS OF PSYCHOMOTIC FUNCTIONS
- Anterograde amnesia and alterations of the psychomotor functions are likely to appear in the hours following the taking.
- In some subjects, benzodiazepines and related products may lead to a syndrome associating to varying degrees an alteration of the state of consciousness and behavioral and memory disorders.
Can be observed:
- · Worsening of insomnia, nightmares, agitation, nervousness,
- · Delusions, hallucinations, confuso-oniric state, psychotic type symptoms,
- · Disinhibition with impulsiveness,
- · Euphoria, irritability,
- · Anterograde amnesia,
- · Suggestibility.
This syndrome may be accompanied by potentially dangerous disorders for the patient or for others, such as:
- · Unusual behavior for the patient,
- · Self- or hetero-aggressive behavior, especially if the family is trying to interfere with the patient’s activity,
- · Automatic driving with post-event amnesia.
These events require the cessation of treatment.
RISK OF ACCUMULATION
Drive and use machines
Even if taken as directed, clonazepam may cause drowsiness and / or muscle hypotonia with a feeling of tiredness (see Warnings and Precautions ) and slow reactions to the point of impairing ability. driving vehicles or using machinery. These effects are aggravated by alcohol consumption and the combination with other sedating drugs should be discouraged or taken into account
Rivotril and PREGNANCY / BREAST FEEDING / FERTILITY
Risks related to epilepsy and antiepileptics
- For all antiepileptic drugs combined, it has been shown that in the offspring of treated epileptic women, the overall malformation rate is 2-3 times higher (about 3%) than that of the general population. Although there is an increase in the number of malformed children with combination therapy, the respective share of treatment and illness has not been established. The most commonly encountered malformations are cleft lip and cardiovascular malformations.
- Abrupt discontinuation of antiepileptic treatment may cause the mother to worsen the disease that is detrimental to the fetus.
Risks related to clonazepam
- In humans, the teratogenic risk, if any, is likely to be very low. A teratogenic effect has been reported for some benzodiazepines, but not confirmed following epidemiological studies. In these circumstances, it seems preferable to avoid the prescription of these substances during the first trimester of pregnancy.
- High doses should not be prescribed during the last trimester of pregnancy as there is a possibility of birth, hypotonia and respiratory distress in the newborn. After a few days to a few weeks of age may appear a withdrawal syndrome.
Given these data
- In an epileptic woman treated with clonazepam, it does not seem legitimate to discourage conception.
- If pregnancy is considered, this is an opportunity to weigh the indication of epileptic treatment again. During pregnancy, effective antiepileptic therapy with clonazepam should not be interrupted.
By analogy with other benzodiazepines, possibility of occurrence in the newborn:
- · Hypotonia and difficulty in sucking during prolonged use during pregnancy;
- · Respiratory depression and hypothermia (a rarer risk) in high doses and particularly parenterally, before delivery;
- · A withdrawal syndrome, which may appear after a few days to a few weeks of age.
- The use of this medicine during breastfeeding is not recommended.
What should I do if I miss a dose?
- If you notice it soon after the scheduled time, take the usual dose.
- If you notice a short time before the next dose, do not take the double dose to make up for the dose you forgot to take.
- If you have forgotten to take several doses, contact your doctor immediately.
rivotril overdose side effects
Notify a doctor urgently.
What is Forms and Composition Rivotril ?
- Clonazepam: 1 mg
- For a light bulb.
- Acetic acid, ethanol, benzyl alcohol, propylene glycol.
- Solvent: water for injections.
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