Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: Chemically, clonazepam is 5- 2-chlorophenyl -1,3-dihydronitro-2 H -1,4- benzodiazepinone.
It is a light yellow crystalline powder. It has a molecular weight of Get emergency medical help if you have any of these signs Thrombophlebitis Petit an allergic reaction: Report any new or worsening symptoms to your doctor, such as: Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome petit mal variantakineticand myoclonic seizures.
In patients with absence seizures petit mal who have failed to respond to succinimides, Klonopin may be useful. Klonopin is indicated for the treatment of panic disorderwith or without agoraphobiaas defined in DSM -V. The efficacy of Klonopin was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded Thrombophlebitis Petit the DSM-IIIR category of panic Thrombophlebitis Petit see Clinical Trials, Thrombophlebitis Petit.
Panic disorder DSM-V is characterized by recurrent unexpected panic attacks, i. The effectiveness of Klonopin in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials.
Clonazepam is available as a tablet. The Thrombophlebitis Petit should be administered with water by swallowing the tablet whole. The use of multiple anticonvulsants may result in an increase of CNS depressant adverse effects. This should be considered before adding Klonopin to an existing anticonvulsant regimen. The initial dose for adults with seizure disorders should not exceed 1.
Dosage may be increased in increments of 0. Maintenance dosage must be individualized for each patient depending upon response, Thrombophlebitis Petit. Maximum recommended daily dose is 20 mg. Klonopin is administered orally. In order to minimize drowsiness, the initial dose for infants and children up to 10 years Thrombophlebitis Petit age Thrombophlebitis Petit 30 kg of body weight should be between 0.
Dosage should be increased by no more than 0. Whenever Thrombophlebitis Petit, the daily dose should be divided into three equal doses. If doses are not equally divided, the largest dose should be given before retiring. There is no clinical trial experience with Klonopin in seizure disorder patients 65 years of age and older.
The initial dose for adults with panic disorder is 0. To reduce the inconvenience of somnolenceadministration of one dose at bedtime may be desirable. Treatment should be discontinued gradually, with a decrease of 0. There is no body of evidence available Thrombophlebitis Petit answer the question of how long the patient treated with clonazepam should remain on it. Therefore, the physician who elects to use Klonopin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient, Thrombophlebitis Petit.
There is no clinical trial experience with Klonopin in panic disorder patients under 18 years of age, Thrombophlebitis Petit. There is no clinical trial experience with Klonopin in panic disorder patients 65 years of age and older. Klonopin tablets are available as scored tablets with a K-shaped perforation - 0.
The adverse experiences for Klonopin are provided separately for patients with seizure disorders and with panic disorder. The most frequently occurring side effects of Klonopin are referable to CNS depression. Others, listed by system, including those identified during postapproval use of Klonopin are:.
Hair loss, hirsutismskin rash, ankle and facial edema, Thrombophlebitis Petit. Anorexiacoated tongue, constipation, diarrhea, dry mouthencopresisgastritisincreased appetite, nausea, sore gums.
Dysuriaenuresisnocturiaurinary retention. AnemialeukopeniaThrombophlebitis Petit, thrombocytopeniaeosinophilia. Hepatomegalytransient elevations of serum transaminases and alkaline phosphatase. Dehydration, general deterioration, fever, lymphadenopathyweight loss or gain. Confusion, Thrombophlebitis Petit, depression, amnesiahysteria, increased libidoinsomnia, psychosis the behavior effects are more likely to occur in patients with a history of psychiatric disturbances.
The following paradoxical reactions have been observed: Chest congestionrhinorrheashortness of breath, Thrombophlebitis Petit, hypersecretion in upper respiratory passages, Thrombophlebitis Petit. Adverse events during exposure to Klonopin were obtained by spontaneous report and recorded by clinical investigators using terminology of their own choosing.
Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories.
In the tables and tabulations that follow, CIGY dictionary terminology has been used to classify reported adverse events, except in certain cases in which redundant terms were collapsed into more meaningful terms, as noted below. The stated frequencies of adverse events represent the proportion Thrombophlebitis Petit individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Table 3 enumerates the incidence, rounded to the nearest percent, Thrombophlebitis Petit, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6- to 9-week trials, Thrombophlebitis Petit.
The prescriber should be aware that the figures in Table 3 cannot be used to predict the incidence Thrombophlebitis Petit side effects in the course of usual medical practice where patient characteristics and other factors differ from Thrombophlebitis Petit that Thrombophlebitis Petit in the clinical trials.
Similarly, the cited frequencies cannot be compared with figures obtained from other Thrombophlebitis Petit investigations involving different treatments, uses and investigators, Thrombophlebitis Petit.
The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied. While these findings are noteworthy, Hamilton Depression Rating Scale HAM-D data collected in these trials revealed a larger decline in HAM-D scores in the clonazepam group than the placebo group suggesting that clonazepamtreated patients were not experiencing a worsening or emergence of clinical depression.
Following is a list of modified CIGY terms that reflect treatment-emergent adverse events reported by patients treated with Klonopin at multiple doses during clinical trials. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and events reported only once and which did not have a substantial probability of being acutely life-threatening.
It is important to emphasize that, although the events occurred during treatment with Klonopin, Thrombophlebitis Petit were not necessarily caused by it. Events are further categorized by body system and listed in order of decreasing frequency.
Body as a Whole: Central and Peripheral Nervous System Disorders: Hearing and Vestibular Disorders: Metabolic and Nutritional Disorders: Skin and Appendages Disorders: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression Thrombophlebitis Petit of actions at different receptor sites in the CNS that control respiration. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid -related respiratory depression exists.
Limit dosage and duration of concomitant use of benzodiazepines and opioids, Thrombophlebitis Petit, and follow patients closely for respiratory depression and sedation. Clonazepam does not appear to alter the pharmacokinetics of carbamazepine or phenobarbital. Clonazepam has the potential to influence concentrations of phenytoin.
Monitoring of phenytoin concentration is recommended when clonazepam is co-administrated with phenytoin. The effect of clonazepam on the metabolism of other drugs has not been investigated, Thrombophlebitis Petit.
Literature reports suggest that ranitidinean agent that decreases stomach acidity, does not greatly alter clonazepam pharmacokinetics.
Although clinical studies have not been performed, Thrombophlebitis Petit, based on the involvement of the cytochrome P 3A family in clonazepam metabolism, inhibitors of this enzyme system, notably oral antifungal agents e, Thrombophlebitis Petit.
The CNS-depressant action of the benzodiazepine class of Thrombophlebitis Petit may be potentiated by alcohol, narcotics, barbiturates, nonbarbiturate hypnotics, antianxiety agents, the phenothiazines, thioxanthene and butyrophenone classes of antipsychotic agents, monoamine oxidase inhibitors and the tricyclic antidepressantsand by other anticonvulsant drugs.
Withdrawal symptomssimilar in character to those noted with barbiturates and alcohol e, Thrombophlebitis Petit. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms e. Addiction- prone individuals such as drug addicts or alcoholics should be under careful surveillance when receiving clonazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence.
Following the short-term treatment of patients with panic disorder in Studies 1 and 2 see Clinical Trialspatients were gradually withdrawn during a 7-week downward-titration discontinuance period. Overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon.
However, there are not sufficient data from adequate and well-controlled long-term clonazepam studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be Thrombophlebitis Petit with such use. Concomitant use of benzodiazepinesincluding Klonopin, and opioids may result in profound sedation, respiratory Thrombophlebitis Petitcoma, and death, Thrombophlebitis Petit.
Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.
If a decision is made to prescribe Klonopin concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation, Thrombophlebitis Petit.
Since Klonopin produces CNS depression, patients receiving this drug should be cautioned against engaging in hazardous occupations requiring Thrombophlebitis Petit alertness, such as operating machinery or driving a motor vehicle.
Antiepileptic drugs AEDsincluding Klonopin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Pooled analyses of Thrombophlebitis Petit clinical trials mono- and adjunctive therapy of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk adjusted Relative Risk 1. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27, AED-treated patients was 0.
There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide, Thrombophlebitis Petit.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed.
Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by Thrombophlebitis Petit 5— years in the clinical trials analyzed.
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials Thrombophlebitis Petit psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing Klonopin or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness.
Sign up to bookmark this SPC already have an account? Find medicines with the same active ingredients. Find medicines from the same company. Qualitative and quantitative composition The active ingredient is 5H-dibenzo[b,f]azepinecarboxamide. Each coated tablet contains mg or mg carbamazepine Ph. Pharmaceutical form Prolonged Release Tablet, Thrombophlebitis Petit. The mg tablets are beige-orange, oval, slightly biconvex, Thrombophlebitis Petit, coated tablets with Thrombophlebitis Petit score on each side.
The mg tablets are brownish-orange, oval, slightly biconvex coated tablets with a score on each side. Tegretol Prolonged Release is indicated Thrombophlebitis Fotos und Behandlung newly diagnosed patients with epilepsy and in those patients who are uncontrolled or unable to tolerate their current anti-convulsant therapy. Carbamazepine is not usually effective in absences petit mal and myoclonic seizures.
Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences. The paroxysmal pain of trigeminal neuralgia. For the prophylaxis of manic-depressive psychoses in patients unresponsive to lithium Tinktur aus Rosskastanie von Krampfadern an den Beinen. In a few patients when changing from other oral dosage forms of Tegretol to Tegretol Prolonged Release the total daily dose may need to be increased, particularly when it is used in polytherapy.
When starting treatment with Tegretol Prolonged Release in monotherapy, mg once or twice daily is recommended, Thrombophlebitis Petit. This may be followed by a slow increase in dosage until the best response is obtained, often mg daily. In some instances, mg or even mg daily may Thrombophlebitis Petit necessary. Tegretol Prolonged Release either the whole or half divisible tablet as prescribedshould not be chewed but should be swallowed with a little liquid, before, during or between meals.
The divisible tablet presentation enables flexibility of dosing Thrombophlebitis Petit be achieved. The dose of carbamazepine detraleks Varizen be adjusted to the needs of the individual patient to achieve adequate control of seizures, Thrombophlebitis Petit.
Determination of plasma levels may help in establishing the optimum dosage. It is advised that with all formulations of Tegretol, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual Thrombophlebitis Petit. Due to the potential for drug interactions, the dosage of Tegretol should be selected with caution in elderly patients. Age up to 5 years: Tegretol Prolonged Release Tablets are not recommended mg daily mg to mg Thrombophlebitis Petit same as adult dose, Thrombophlebitis Petit.
Maximum recommended dose Up to 6 years of age: Wherever possible, Tegretol Prolonged Release should be used as the sole drug anti-epileptic agent but if used in polytherapy, the same incremental dosage pattern is advised. When Tegretol is added to existing antiepileptic therapy, Thrombophlebitis Petit should be done gradually while maintaining or, if necessary, adapting the dosage of the other antiepileptic s see 4.
Slowly raise the initial dosage of mg daily until freedom from pain is achieved normally at mg times daily. In the majority of patients a dosage of mg 3 or 4 times a day is sufficient to maintain a pain free state.
In some instances, doses of mg Tegretol daily may be needed. However, once the pain is in remission, the dosage should be gradually reduced to Thrombophlebitis Petit lowest possible maintenance level, Thrombophlebitis Petit. When pain relief has been obtained, attempts should Thrombophlebitis Petit made to gradually discontinue therapy, until another attack occurs. Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Tegretol should be selected with caution in elderly patients.
In elderly patients, an initial dose of mg twice daily is recommended. The initial dosage of mg twice daily should be slowly raised daily until freedom from pain is achieved normally at mg 3 to 4 times daily.
The dosage should then be gradually reduced to the lowest possible maintenance level. For the prophylaxis of manic depressive psychosis in patients unresponsive to lithium therapy: Initial starting dose of mg daily, in divided doses, increasing gradually until symptoms are controlled or a total of mg given in divided doses is Thrombophlebitis Petit. The usual dosage range is mg daily, given in divided doses.
No data are available on the pharmacokinetics Thrombophlebitis Petit carbamazepine in patients with impaired hepatic or renal function. Patients with atrioventricular block, a history of bone marrow depression or Thrombophlebitis Petit history of hepatic porphyrias e.
The use of Tegretol is contraindicated in combination with monoamine oxidase inhibitors MAOIs see section 4. Agranulocytosis and aplastic anaemia have been associated with Tegretol; however, due to the very low incidence of these conditions, meaningful risk estimates for Tegretol are difficult to obtain. The overall risk in the general untreated population has been estimated Thrombophlebitis Petit 4. Decreased platelet or white blood cell counts occur occasionally to frequently Thrombophlebitis Petit association with the use of Tegretol.
Nonetheless, complete pre-treatment blood counts, including platelets and possibly reticulocytes and serum iron, should be obtained as a baseline, and periodically thereafter. Patients and their relatives should be made aware of early toxic signs and symptoms indicative of a potential haematological problem, as well as symptoms of dermatological or hepatic reactions.
If reactions such as fever, sore throat, rash, ulcers in the mouth, Thrombophlebitis Petit, easy bruising, petechial or purpuric haemorrhage appear, the patient should be advised to consult his physician immediately.
If the white blood cell or platelet count is definitely low or decreased during treatment, the patient and the complete blood count should be closely monitored see Thrombophlebitis Petit 4. However, Thrombophlebitis Petit, treatment with Tegretol should be discontinued if the patient develops leucopenia which is severe, progressive or accompanied Thrombophlebitis Petit clinical manifestations, e. Tegretol should also be discontinued if any evidence of significant bone marrow Thrombophlebitis Petit appears.
Liver function tests should also be performed before commencing treatment and periodically thereafter, particularly in patients with a history of liver disease and in elderly patients.
The drug should be withdrawn immediately in cases Thrombophlebitis Petit aggravated liver dysfunction or acute liver disease, Thrombophlebitis Petit. Some liver function tests in patients receiving carbamazepine may be found to be abnormal, particularly gamma glutamyl transferase.
This is probably due to hepatic enzyme induction. Enzyme induction may also produce modest elevations in alkaline phosphatase. These enhancements of hepatic metabolising capacity are not an indication for the withdrawal of carbamazepine, Thrombophlebitis Petit. Severe hepatic reactions to carbamazepine occur very rarely, Thrombophlebitis Petit.
The development of signs and symptoms of liver dysfunction or active liver disease should be urgently evaluated and treatment with Tegretol Thrombophlebitis Petit pending the outcome of the evaluation. Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications.
A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour, Thrombophlebitis Petit.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for carbamazepine, Thrombophlebitis Petit. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients and caregivers of patients should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Serious dermatological reactions, including toxic epidermal necrolysis TEN: Patients with serious dermatological reactions may require hospitalization, as these conditions may be life-threatening and may be fatal. These reactions are estimated to occur in 1 to Thrombophlebitis Petit per 10, new users in countries with mainly Caucasian populations. If signs and symptoms suggestive of severe skin reactions e, Thrombophlebitis Petit. Serious and sometimes fatal cutaneous Thrombophlebitis Petit including toxic epidermal necrolysis TEN and Stevens-Johnson syndrome SJS have been reported during treatment with carbamazepine, Thrombophlebitis Petit.
These reactions Berlin Varison estimated to occur in per 10 new users in countries with mainly Caucasian populations, but the risk in some Asian countries is estimated to be about 10 times higher.
There is growing evidence of the role of different HLA alleles in Thrombophlebitis Petit patients to immune-mediated adverse reactions see section 4. Whenever possible, these individuals should be screened for this allele before starting treatment Thrombophlebitis Petit carbamazepine see section 4.
If these individuals test positive, carbamazepine should not be started unless there is no other therapeutic option. Because of the prevalence of this allele in other Asian populations e, Thrombophlebitis Petit. Mild skin reactions e. They usually disappear within a few days or weeks, either during the continued course of treatment or following a decrease in dosage. However, since it may be difficult Thrombophlebitis Petit differentiate the early signs of more serious skin reactions from Thrombophlebitis Petit transient reactions, the patient should be kept under close surveillance with consideration given to immediately withdrawing the drug Thrombophlebitis Petit the reaction worsen with continued use.
Tegretol may trigger hypersensitivity reactions, including Drug Rash with Eosinophilia and Systemic Symptoms DRESSreactivation of HHV6 associated with DRESS, a delayed multi-organ hypersensitivity disorder with fever, rash, Thrombophlebitis Petit, vasculitis, lymphadenopathy, pseudo lymphoma, arthralgia, leukopenia, eosinophilia, hepato-splenomegaly, abnormal liver function tests and vanishing bile duct syndrome destruction and disappearance of the intrahepatic bile ductsthat may occur in various combinations.
Other organs may also be affected e. In general, Thrombophlebitis Petit, if signs and symptoms suggestive of hypersensitivity reactions occur, Tegretol should be withdrawn immediately.
Cross-hypersensitivity can occur between carbamazepine and phenytoin. Tegretol should be used with caution in patients with mixed seizures which include absences, either typical or atypical. In all these conditions, Tegretol may exacerbate seizures. In case of exacerbation Thrombophlebitis Petit seizures, Tegretol should be discontinued. An increase in seizure frequency may occur during switchover from an oral formulation to suppositories.
Dose reduction and withdrawal effects. Abrupt withdrawal of Thrombophlebitis Petit may precipitate Thrombophlebitis und tiefe Venenthrombose Behandlung therefore carbamazepine withdrawal should be gradual, Thrombophlebitis Petit.
If treatment with Tegretol has to be withdrawn abruptly in a patient with epilepsy, the changeover to another anti-epileptic drug should if necessary be effected under the cover of a suitable drug.
Endocrinological effects Breakthrough bleeding has been reported in women taking Tegretol while using hormonal contraceptives. The reliability of hormonal contraceptives may Thrombophlebitis Petit adversely affected by Tegretol and women of childbearing potential should be advised to consider using alternative forms of birth control while taking Tegretol. Monitoring of plasma levels. Although correlations between dosages and plasma levels of carbamazepine, Thrombophlebitis Petit, and between plasma levels and clinical efficacy or tolerability are rather tenuousmonitoring of the plasma levels may be useful in the following conditions: Tegretol should be prescribed only after a critical benefit-risk appraisal and under close monitoring in patients with a history of cardiac, hepatic or renal damage, adverse haematological reactions to other drugs, or interrupted courses of therapy with Tegretol.
Baseline and periodic complete urinalysis and BUN determinations are recommended. Hyponatremia is known to occur with carbamazepine. In patients with pre-existing renal conditions associated with low sodium or in patients treated concomitantly with sodium-lowering medicinal products e.
Thereafter, serum sodium levels should be measured after approximately two weeks and then at monthly intervals for the first three months during therapy, or according to clinical need, Thrombophlebitis Petit. These risk factors may apply especially to elderly patients.
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