Never administer Rivotril drops directly into the mouth from the bottle. After each opening, make sure that dropper is secured within the neck of the bottle.
Each tablet contains: Clonazepam (USP).-. 0.5 mg
Each tablet contains: Clonazepam (USP).,…. 2 mg
Each 1 ml contains: Clonazepam (USP)…. 2.5 mg
The tablets are cylindrical, bi planar and of a while to slightly yellowish color (2 mg) or of a pale orange color (0.5 mg). The drops are a viscous liquid, blue in color.
Properties and Effects
In animals, Clonazepam has pronounced anticoagulant properties. Animal experiments and electroencephalography studies in man have shown that Clonazepam brings about direct inhibition of the cortical and sub cortical epiteptogenic focus and prevents generalization of convulsive activity- Rivotril therefore has a beneficial effect on focal epilepsy and primary generalized seizures. Clonazepam potentiates the pre and post synaptic inhibitory action of gamma-amaino-butyric acid in the CNS. Over compensatory excitation processes are thereby reduced via negative feedback without substantial disturbance of other physiological neuronal activity.
Pharmacol Kinetics Absorption
The active ingredient Clonazepam is quickly and completely absorbed after oral administration of Rivotril. Peak plasma concentrations are reached in most cases within 1 -4 hours after an oral dose. Bio availability is 90% on average.
The mean volume of distribution of Clonazepam is estimated at about 3 I/kg. At a daily dose of 6 mg. steady-state plasma concentrations are 25-75 mg/ml. The plasma protein binding rate of Clonazepam is 85%. Steady-state plasma concentrations following repeat doses may be four times higher than those observed after a single dose. Clonazepam crosses the placental barrier and can be assumed to pass into the maternal milk.
The plasma concentrations of active ingredient which achieve the optimum effect are between 20 and 70 ng/ml (on average about 55 mg/ml). A single oral dose of 2 mg Rivotril begins to take effect within 30-60 minutes and remains effective for 6-8 hours in children and 8-12 hours in adults. Metabolism
The bio transformation pathway of Clonazepam encompasses oxidative hydroxylation and reduction 01 the 7-nitro group, with formation of . 7-amino or 7-acetyl amino compounds. The main metabolite is 7-amino-Clonazepam, which in experiments has shown only slight aniicon-vulsant activity. Four other metabolites present in very small proportions have also been identified.
The elimination half-life of the terminal phase is between 20 and 60 hours. Within 4-10 days 50-70% of an oral dose of Clonazepam is excreted in the urine and 10-30% in the feces, almost exclusively in Hie form of unbound or conjugated metabolites. Less than 0.5% appears as unchanged Clonazepam in the urine.
Pharmacol kinetics in special clinical situations
As with other benzodiazepines, plasma elimination of Clonazepam may be slower in neonates, the elderly and patients with renal or hepatic dysfunction, and this must be taken into account when dosing Rivotril.
Most clinical forms of epilepsy in infants and children, in particular typical and atypical absences (Lennon syndrome), nodding spasms, primary or secondary generalized tonic-clonic spasms. Rivotril may also be used in adult epilepsy and focal seizures.
Dosage and Administration
The dosage of Rivotril must be individually adjusted according to the patient’s clinical response, tolerance of the drug and the patient’s age. To ensure optimum dosage adjustment, infants should be given the drops and children the 0.5 mg tablets- The cross-scored 0,5 mg tablets facilitate the administration of lower daily doses to adults in the initial stages of treatment. As a general rule, Rivotril is given as low-dose, single-drug therapy in new, non-therapy-resistant cases. A single oral dose of Rivotril begins to take effect within 30-60 minutes and remains effective for 6-8 hours in children and 8-12 hours in adults.
To avoid adverse reactions at the beginning of therapy, it is essential to increase the daily dose progressively until the maintenance dose suited to the individual patient has been reached.
The initial dose for infants and children up to the age of 10 years (or up to 30 kg body weight) is 0.01-0.03 mg/kg daily. For children over 10 years (or over 30 kg) and for adults, the recommended initial dose is 1-2 mg daily. The maintenance dose for infants and children up to the age of 10 years (or up to 30 kg body weight) is 0-05-0.1 mgAg daily. For children 10-16 years (or over 30 kg), a dose of 1.5-3 mg daily and for adults a dose of 2-4 mg daily is recommended.
Once the maintenance dose level has been reached, the daily amount may be given in a single dose in the evening. Should several doses be necessary. the largest should be taken in the evening. The maintenance dose level Is best attained after 1 -3 weeks oi treatment To ensure optimum dosage adjustment, infants should be given the drops and children the 0.5 mg tablets. The cross-scored 0.5 mg tablets facilitate the administration of lower daily doses to adults in the initial stages of treatment. The maximum therapeutic dose (or adults is 20 mg daily-
Before adding Rivotril to an existing anti convuisant regimen, it should be considered that the use of multiple anti convulsants may result in an increase of undesired effects.
Special Dosage Instructions
Rivotril can be administered concurrently with one or several other anti epileptic agents, in which case the dosage of each drug must be adjusted to achieve the optimum affect.
As with all antiseptically agents, treatment with Rivotril must not be stopped abruptly, but must be reduced in a step wise fashion (sea Undesirable effects).
Correct Method of Administration
The drops should be mixed with water, tea or fruit juice and administered with a spoon.
Rivotril must not be used in patients with known hypersensitivity to Donazepam or any of the drug’s recipients, or those with severe respiratory insufficiency.
Rivotril may be used only with particular caution in patients with spinal or cerebellar ataxia, in the event of acute intoxication with’alcohol, other antiseptic drugs, hypnotics, analgesics, neurotic agents, antidepressants or Lithium, in patients with severe liver damage (e.g. cirrhosis of the liver) or in patients suffering from sleep apnea. Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining potency of the airways.
The dosage of Rivotril must be carefully adjusted to individual requirements in patients with pre-existing disease of the respiratory system (e.g. chronic obstructive pulmonary disease), liver or kidneys, and in patients undergoing treatment with other centrally acting medications or anti convulsani (anti epileptic) agents (see Interactions).
Like all drugs of this type, Rivotril may. depending on dosage, administration and individual susceptibility. modify the patient’s reactions (e.g. driving ability, behavior in traffic).
Anfconvuteant drugs including Rivotril should not be discontinued abruptly in epileptic patients as frils may precipitate status epileptics. When, in the Judgement of the clinician, the need for dosage reduction or discontinuation arises, this should be done gradually.
Patients with a history of depression and /or suicide attempts should be kept under doss supervision.
Pregnancy, Nursing Mothers
From pre clinical studies it cannot be excluded that donazepam possesses the possibility of producing congenital malformations. From epidemic-logical evaluations there is evidence that anti convulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists in other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth detects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the fetus.
During pregnancy, Rivotril may be administered only if there is a compelling indication.
Administration of high doses in the last trimester of pregnancy or during labor can cause irregularities in the heartbeat of the unborn child, and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. it should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy.
Although the active ingredient of Rivotril has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breast-feed, it there is a compelling indication for Rivotril, breast-feeding should be discontinued.
Rivotril does not have any harmful effect on the blood, kidneys or liver, and is well tolerated gastro intestinal. It has no toxic effects on the organs, even when given for long periods.
The following undesirable effects occur relatively frequently: tiredness, sleepiness, lassitude . muscular hypotonia, muscle weakness, dizziness, light neadedness, ataxia, slowed reaction. These effects are usually transient and generally disappear spontaneously in the course of the treatment or on reduction of the ‘dosage. They can be partially prevented by increasing the dose slowly at the start of treatment.
Poor concentration, restlessness, confusion, agitation, excitability, irritability and disorientation have been observed. Anterograde amnesia may occur using benzodiazepines at therapeutic dosages, the’ risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behavior.
With certain forms of epilepsy, an increase in the frequency of seizures during long-term treatment is possible. Depression may occur in patients treated with Rivotril, but it may be also associated with the underlying disease-
The following paradoxical reactions have been observed: excitability, irritability, aggressive behavior, agitation, nen/ousness, hostility, anxiety, steep disturbances, nightmares and vivid dreams.
In rare cases, urticaria, prurient, rash, angioedema, pharyngeal eczema, transient hair loss, pigmentation changes, nausea, epigastric symptoms. headache, chest pain, reduction in blood platelets (thromhocytopenia). decrease in soxual drive (loss of libido), impotence and urinary incontinence may occur. Isolated cases of reversible development of premature secondary sex characteristics in children (incomplete precocious puberty) and anaphylactic shock have been reported. Allergic reactions and a very few cases of anaphylaxis have been reported to occur with benzodiazapines.
Particularly in long-term or high-dose treatment, reversible disorders such as a slowing or slurring of speech (dysarthria), reduced coordination of movements and gait (ataxia) and disorders of vision (double vision, nystagmus) may occur.
In infants and young children, Rivotril may cause increased production of saliva or of bronchial secretion. Particular attention should therefore be paid to maintaining potency of the airways.
Use of benzodiazepinas may lead to the development of physical and psychological dependence upon these products. The risk of dependence increases with dose and duration of treatment and is particularly pronounced in predisposed patients with a history of alcoholism or drug abuse.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms- During long-term treatment, withdrawal symptoms may develop after a lengthy period of use, especially with high doses or if the daily dose is reduced rapidly or abruptly discontinued.
The symptoms include tremor, sweating, agitation, sleep disturbances and anxiety, headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, Irritability and epileptic seizures which may be associated with the underlying disease. In severe cases the following symptoms may occur derealization, depersonalfzation. hyperacusis, numbness and tingling of the extremities, hyper sensitivity to light, noise and physical contact or hallucination.
Since the risk of withdrawal symptoms is greater after abrupt discontinuation of treatment, abrupt withdrawal of the drug should therefore be avoided and treatment even if only of short duration should be terminated by gradually reducing the daily dose.
Effects on Ability to Drive and Use Machines
Even if taken as directed, Clonazepam can slow reactions to such an extent that the ability to drive a vehicle or operate machinery is seriously impaired. This effect is aggravated by consumption of alcohol. Driving, operating machinery and other hazardous activities should therefore be avoided altogether or at least during the first few days of treatment- The decision on this question rests with the patients physician and should be based on the patient’s response’to treatment and the dosage involved.
Rivotril can be administered concurrently with one or more anti epileptic agents. But adding an extra drug to the patient’s regimen should involve a careful evaluation of the response to the treatment, because unwanted effects, such as sedation and apathy are more likely to occur. In such cases, the dosage of each drug must be adjusted to achieve the optimum desired effect
Concurrent administration of liver enzyme inducers such as barbiturates or hydantoins or carbamazepine, may accelerate the biolranslormation of Clonazepam without affecting its protein binding. By contrast, Clonazepam itself does not appear to induce the enzymes responsible for its own metabolism. In concurrent treatment with phenytoin or primidone. a rise in the serum concentration of these two substances has been observed in isolated cases.
The combination of Clonazepam with valproic acid may occasionally cause petit mal status epileptics.
Concurrent use of Rivotril and other centrally acting medications, e.g. other anti convulsant (antiseptically) agents, anesthetics, hypnotics, psychoactive drugs and some analgesics as well as muscle-relaxants, may result in mutual potentiate of drug effects. This is especially true in the presence of alcohol.
In combination therapy with centrally-acting medications, the dosage of each drug must be adjusted to achieve the optimum effect.
Epileptic patients being treated with Rivotril must under no circumstances consume alcohol since it may after the effect of the drug, reduce the effrcacy of treatment or produce unexpected -side effects.
The symptoms of over dosage or intoxication vary greatly from person to person depending on age. bodywstght and individual response.
They range from drowsiness and light-headedness to ataxia, somnolence and stupor, and finally to coma with respiratory depression and circulatory collapse. Serious sequel are rare unless other drugs or alcohol have been taken concomitantly.
In the management of overdose it should be borne in mind, that multiple agents may have been taken. In addition to monitoring of respiralion, pulse rate and blood pressure, .gastric lavage, i.v. fluid replacement with general supportive measures and the provision of emergency facilities to deal with possible airways obstruction are indicated. Hypo tension may be treated with sympathetic agents.
The bonzodfazeplne antagonist Anexate (active ingredient: flumazenil) (s not Indicated In patients with epilepsy who have been treated with benzodiazeplne. Antagonism of the benzodlazepine effect in such patients may provoke seizures.
This medicine should not be used after the expiry date (EXP) shown on the pack-
Drops 2.5 mg/ml (1 drop = 0.1 mg active ingredient) 10 ml
Tablets (cross-scored) 0.5 mg 50’s
Tablets (cross-scored) 2 mg____^_____________________________________________30’s
, . :-^
Keep all medicines out of the reach of children.
Protect from light, haat and moisture.
Store below 30°C.
To be sold on prescription of a registered medical practitioner only.
Keep bottle upright,
Tablets: Roche Farma, S.A.. Leganes, Spain.
Drops: Roche S.p.A. Milan, prodiKtIon site Segrate, Italy.
Martin Dow Limited.
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