Revolade film-coated tablets PIL. Sign up to bookmark this SPC already have an account? Find medicines with the same active ingredients. Find medicines from the same company. Round, biconvex, white film-coated tablet approximately Round, biconvex, brown film-coated tablet approximately Round, biconvex, pink film-coated tablet approximately Revolade is indicated for chronic immune idiopathic thrombocytopenic purpura ITP patients aged 1 year and above who are refractory to other treatments e, was Petit Thrombophlebitis.
Revolade is indicated in adult patients with chronic hepatitis C virus HCV infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy see sections 4.
Revolade is indicated in adult patients with acquired severe aplastic anaemia SAA who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation see section 5.
Eltrombopag treatment should be initiated and remain under the supervision of a physician who is experienced in the treatment of was Petit Thrombophlebitis diseases or the management of chronic hepatitis C and its complications. Eltrombopag dosing requirements must be individualised based on the patient's platelet counts. The objective of treatment with eltrombopag should not be to normalise platelet counts. The powder for oral suspension may lead to higher eltrombopag exposure than the tablet formulation was Petit Thrombophlebitis section 5.
When switching between the tablet was Petit Thrombophlebitis powder for oral suspension formulations, platelet counts should be monitored weekly for 2 weeks. Dose adjustments are based upon the platelet count response, was Petit Thrombophlebitis. Eltrombopag must not be used to normalise platelet counts.
In clinical studies, platelet counts generally increased within 1 to 2 weeks after starting eltrombopag and decreased within 1 to 2 weeks was Petit Thrombophlebitis discontinuation.
The recommended starting dose of eltrombopag is 50 mg once daily. For patients of East Asian ancestry such as Chinese, Japanese, Taiwanese, Korean or Thaieltrombopag should be initiated at a reduced dose of 25 mg was Petit Thrombophlebitis daily see section 5, was Petit Thrombophlebitis.
A daily dose of 75 mg must not be exceeded. Clinical haematology and liver tests should be monitored regularly throughout therapy with eltrombopag and the dose regimen of eltrombopag modified based on platelet counts as outlined in Table 1. FBCs including platelet counts and peripheral blood smears should be obtained monthly thereafter.
Decrease the daily dose by 25 mg. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments. Eltrombopag can be administered in addition to other ITP medicinal products. The dose regimen of concomitant ITP medicinal products should be modified, as medically appropriate, to avoid excessive increases in platelet counts during therapy with eltrombopag.
It is necessary to wait for at least 2 weeks to see the effect of any dose adjustment on the patient's platelet response prior to considering another dose adjustment. The standard eltrombopag dose adjustment, either decrease or increase, would be 25 mg once daily. Treatment with eltrombopag should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of eltrombopag therapy at 75 mg once daily.
Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician. In non-splenectomised patients this should include evaluation relative to splenectomy.
The reoccurrence of thrombocytopenia is possible upon discontinuation of treatment see section 4. When eltrombopag is given in combination with antivirals reference should be made to the full summary of product characteristics of the respective coadministered medicinal products for comprehensive details of relevant safety information or contraindications.
In clinical studies, platelet counts generally began to increase within 1 week of starting eltrombopag. The aim of treatment with eltrombopag should be to achieve the minimum level of platelet counts needed to initiate antiviral therapy, in adherence to clinical practice recommendations. The lowest dose of eltrombopag needed to achieve the targets should be used, was Petit Thrombophlebitis. Eltrombopag should be initiated at a dose of 25 mg once daily, was Petit Thrombophlebitis.
No dosage adjustment is necessary for HCV patients of East Asian ancestry or patients with mild hepatic impairment see section 5, was Petit Thrombophlebitis. The dose of eltrombopag should be adjusted in 25 mg was Petit Thrombophlebitis every 2 weeks as necessary to achieve the target platelet count required to initiate anti-viral therapy. Platelet counts should be monitored every week prior to starting antiviral therapy.
On initiation of antiviral therapy the platelet count may fall, so immediate eltrombopag dose adjustments should be avoided see Table 2. During antiviral therapy, was Petit Thrombophlebitis, the dose of eltrombopag should be adjusted as necessary to avoid dose reductions of peginterferon due to decreasing platelet counts that may put patients at risk of bleeding see Table 2.
Dose reductions on the daily dose by 25 mg should be considered if platelet counts exceed the required target. It is recommended to wait for 2 weeks to assess the effects of this and any subsequent dose adjustments.
If after 2 weeks of eltrombopag therapy at mg the required platelet level to initiate antiviral therapy is not achieved, eltrombopag should be discontinued.
Eltrombopag treatment should be terminated when antiviral therapy is discontinued unless otherwise justified. Excessive platelet count responses or important liver test abnormalities also necessitate discontinuation.
Eltrombopag should be initiated at a dose of 50 mg once daily. For patients of East Asian ancestry, eltrombopag should be initiated at a reduced dose of 25 mg once daily see section 5. The treatment should not be initiated when the patients have existing cytogenetic abnormalities of chromosome 7. Haematological response requires dose titration, generally up to mg, and may take up to 16 weeks after starting eltrombopag see section 5.
For patients taking 25 mg once daily, was Petit Thrombophlebitis, the was Petit Thrombophlebitis should be increased to 50 mg daily before increasing the dose amount by 50 mg. A dose of mg daily must was Petit Thrombophlebitis be exceeded. Clinical haematology and liver tests should be monitored regularly throughout therapy with eltrombopag and the dosage regimen of eltrombopag was Petit Thrombophlebitis based on platelet counts as outlined in Table 3.
For patients taking 25 mg once daily, increase the dose to 50 mg daily before increasing the dose amount by 50 mg. Decrease the daily dose by 50 mg. Tapering for tri-lineage white blood cells, red blood cells, and platelets responders.
For patients who achieve Salbe mit trophischen Geschwüren Krampf response, including transfusion independence, lasting at least 8 weeks: Was Petit Thrombophlebitis counts remain stable after 8 weeks at the reduced dose, then eltrombopag must be discontinued and blood counts monitored.
If no haematological response has occurred after 16 weeks of therapy with eltrombopag, therapy should be discontinued. If new cytogenetic abnormalities are detected, it must be evaluated whether continuation of eltrombopag is appropriate see sections 4, was Petit Thrombophlebitis.
Excessive platelet count responses as outlined in Table 3 or important liver test abnormalities also necessitate discontinuation of eltrombopag see section 4. No dose adjustment is necessary was Petit Thrombophlebitis patients with renal impairment, was Petit Thrombophlebitis. If the use of eltrombopag is deemed necessary for ITP patients with hepatic impairment the starting dose must be 25 mg once daily. After initiating the dose of eltrombopag in patients with hepatic impairment an interval of 3 weeks should be observed before increasing the dose.
Chronic HCV patients and severe aplastic anaemia patients with hepatic impairment should initiate eltrombopag at a dose of 25 mg once daily see section 5. After initiating the dose of eltrombopag in patients with hepatic impairment an interval of 2 weeks should be observed before increasing the dose. There is an increased risk for adverse events, including hepatic decompensation and thromboembolic events, in thrombocytopenic patients with advanced chronic liver disease treated with eltrombopag, either in preparation for invasive procedure or in HCV patients undergoing antiviral therapy see sections 4.
There are limited data on the use of eltrombopag in ITP patients aged 65 years and older and no clinical experience in ITP patients aged over 85 years. In the clinical studies of eltrombopag, overall no clinically significant differences in safety of eltrombopag were observed between subjects aged at least 65 years and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out see section 5.
Caution should be exercised in these patients see section 4. For patients of East Asian ancestry such as Chinese, was Petit Thrombophlebitis, Japanese, Taiwanese, Korean or Thaiincluding those with hepatic impairment, eltrombopag should be initiated at a dose of 25 mg once daily see section 5.
Patient platelet count should continue to be monitored and the standard criteria for further dose modification followed. Revolade is not recommended for use in children under the age of one year with chronic ITP due to insufficient data on safety and efficacy.
No data are available. Wraps mit Apfelessig von Krampfadern tablets should be taken at least two hours before or four hours after any was Petit Thrombophlebitis such as antacids, dairy products or other calcium containing food products was Petit Thrombophlebitis,Besenbein mineral supplements containing polyvalent cations e.
Treatment with eltrombopag in was Petit Thrombophlebitis patients should be initiated only by physicians experienced in the management of advanced HCV, and only when the risks of thrombocytopenia or withholding antiviral therapy necessitate intervention.
If treatment is considered clinically indicated, was Petit Thrombophlebitis, close monitoring of these patients is required. Safety and efficacy have not been established in combination with direct acting antiviral agents approved for treatment of chronic hepatitis C infection.
Eltrombopag administration can cause abnormal liver function and severe hepatotoxicity, which might be life-threatening. In the controlled clinical was Petit Thrombophlebitis in chronic ITP with eltrombopag, increases in serum alanine aminotransferase ALTaspartate aminotransferase AST and bilirubin were observed see section 4.
These findings were mostly mild Gradereversible and not accompanied by clinically significant symptoms that would indicate an impaired liver function. Across the 3 placebo-controlled studies in adults with chronic ITP, 1 patient in the placebo group and 1 patient in the eltrombopag group experienced a Grade 4 liver test abnormality. Serum ALT, AST and was Petit Thrombophlebitis should be measured prior to initiation of eltrombopag, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose.
If bilirubin is elevated fractionation should be performed. Abnormal serum liver tests should be evaluated with repeat testing within 3 to 5 days. If the abnormalities are confirmed, serum liver tests should be monitored until the abnormalities resolve, stabilise, or was Petit Thrombophlebitis to baseline levels. Caution is required when administering eltrombopag to patients with hepatic disease.
Close monitoring is required when administering to patients with hepatic impairment see section 4. Hepatic decompensation in patients with chronic hepatitis C: Chronic HCV patients with cirrhosis may be at risk of hepatic decompensation when receiving alfa interferon therapy. Eltrombopag should only was Petit Thrombophlebitis administered to such patients after careful consideration of the expected benefits in comparison with the risks.
Patients with these characteristics should be closely monitored for signs and symptoms was Petit Thrombophlebitis hepatic decompensation, was Petit Thrombophlebitis.
The respective interferon summary of product characteristics should be referenced for discontinuation criteria. Eltrombopag should be terminated if antiviral therapy is discontinued for hepatic decompensation. The majority of TEEs were non-serious and resolved by the end of the study, was Petit Thrombophlebitis. No specific temporal relationship between start of treatment and event of TEE were observed.
/18 ICDCM Codes G40*: Epilepsy and recurrent seizures
Epitol, carbamazepine, USP, is an anticonvulsant and specific analgesic for trigeminal neuralgiaavailable for oral administration as tablets of mg. Its chemical name is 5 H -dibenz[ b,f ]azepine carboxamide, and its structural formula is:, was Petit Thrombophlebitis. Carbamazepine, USP is was Petit Thrombophlebitis white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone.
Epitol carbamazepine tablets USP mg contain the inactive ingredients colloidal silicon dioxide, was Petit Thrombophlebitis, croscarmellose sodium, ethylcellulose, glycerin, lactose monohydrate, magnesium stearate, and sodium starch glycolate.
Epitol carbamazepine tablets USP is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Epitol carbamazepine tablets USP as an anticonvulsant was derived from active drugcontrolled studies that enrolled patients with the following seizure types:.
Epitol carbamazepine tablets USP is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised.
As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals. Patients should be converted by administering the same number of mg per day in smaller, more frequent doses i.
Dosage generally should not exceed mg daily in children 12 to 15 years of age, and mg daily in patients was Petit Thrombophlebitis 15 years of age. Doses up to mg daily have been used in adults in rare instances. Adjust dosage to the minimum effective level, usually to mg daily.
Dosage generally should not exceed mg daily. Increase weekly to achieve optimal clinical response administered t. If satisfactory clinical was Petit Thrombophlebitis has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range.
Epitol carbamazepine tablets may be used alone or with other anticonvulsants. On the first day, mg b. Do not exceed mg daily. Control of pain can be maintained in most patients with to mg daily. However, some patients may be maintained on as little as mg daily, while others may require as much as mg daily. At least once every 3 months throughout the treatment period, attempts was Petit Thrombophlebitis be made to reduce the dose to the minimum effective level or even to discontinue the drug.
Increase weekly to achieve optimal clinical response, was Petit Thrombophlebitis, t. If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards.
The most frequently observed adverse reactions, particularly during the initial phases of therapy, was Petit Thrombophlebitis, are dizziness, drowsiness, unsteadinessnausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended. Aplastic anemiaagranulocytosispancytopeniabone marrow depression, thrombocytopenia was Petit Thrombophlebitis, leukopenialeukocytosiseosinophiliaacute intermittent porphyriavariegate porphyria, porphyria cutanea tarda.
In certain cases, discontinuation of therapy may be necessary. Congestive heart failureedema, aggravation of hypertensionhypotensionsyncope and collapse, aggravation of coronary artery diseasearrhythmias and AV block, thrombophlebitisthromboembolism was Petit Thrombophlebitis. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds. Abnormalities in liver function tests, cholestatic and hepatocellular jaundicehepatitisvery rare cases of hepatic failure.
Pulmonary hypersensitivity characterized by fever, dyspneapneumonitis, or pneumonia. Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemiarenal failure, and impotence. Was Petit Thrombophlebitisglycosuria, elevated BUNand microscopic deposits in the urine have also been reported.
Relevance of these findings to humans is unknown. Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopiaoculomotor disturbances, nystagmusspeech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitushyperacusis, neuroleptic malignant syndrome.
There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established. Isolated cases of neuroleptic malignant syndrome have been reported both with and without concomitant use of psychotropic drugs.
Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexiaand dryness of the mouth and pharynxincluding glossitis and stomatitis.
Although a direct causal relationship has not been established, many phenothiazines and related drugs have been shown to cause eye changes. Decreased levels of plasma calcium have been reported. Osteoporosis has been reported. Isolated cases of a lupus erythematosus-like syndrome have been reported.
There have been occasional reports of elevated levels of cholesterolHDL cholesterolwas Petit Thrombophlebitis, and triglycerides in patients taking anticonvulsants. A case of aseptic meningitisaccompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.
Clinically meaningful drug interactions have occurred with concomitant medications and include but are not limited to the following:. When carbamazepine is given with drugs that can increase or decrease carbamazepine levels, was Petit Thrombophlebitis, close monitoring of carbamazepine levels is indicated and dosage adjustment may be required.
CYP3A4 inhibitors inhibit carbamazepine metabolism and can thus increase plasma carbamazepine levels. Was Petit Thrombophlebitis that have been shown, was Petit Thrombophlebitis, or was Petit Thrombophlebitis be expected, to increase plasma carbamazepine levels include aprepitant, was Petit Thrombophlebitis, cimetidine, ciprofloxacin, danazol, diltiazem, was Petit Thrombophlebitis, macrolides, erythromycinwas Petit Thrombophlebitis, troleandomycin, clarithromycin, fluoxetine, fluvoxamine, trazodone, olanzapine, loratadine, terfenadine, omeprazole, oxybutynin, dantrolene, isoniazid, niacinamide, nicotinamide, ibuprofen, propoxyphene, azoles e.
Human microsomal epoxide hydrolase has been identified as the enzyme responsible for the formation of the 10,transdiol derivative from carbamazepine,11 epoxide. Coadministration of inhibitors of human microsomal epoxide hydrolase may result in increased carbamazepine,11 epoxide plasma concentrations.
CYP3A4 inducers can increase the rate of carbamazepine metabolism. Drugs that have been shown, was Petit Thrombophlebitis, or that would be expected, to decrease plasma carbamazepine levels include cisplatindoxorubicin HCl, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline.
When used concomitantly with carbamazepine, monitoring of concentrations or dosage adjustment of these agents may be necessary:. No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.
Serious and sometimes was Petit Thrombophlebitis dermatologic reactions, including toxic epidermal necrolysis TEN and Stevens-Johnson syndrome SJShave been reported with carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10, new users in countries was Petit Thrombophlebitis mainly Caucasian populations. However, the risk in some Asian countries is estimated to be about 10 times higher.
Carbamazepine should be discontinued at the first sign of a rash, unless the rash is clearly not was Petit Thrombophlebitis. The occurrence of higher rates of these reactions in countries with higher frequencies of this allele suggests that the risk may be increased in allele-positive individuals of any ethnicity. HLA-B is largely absent in individuals not of Asian origin e.
Prior to initiating carbamazepine therapy, testing for HLA-B should be performed in patients was Petit Thrombophlebitis ances try in populations in which HLA-B may be present, was Petit Thrombophlebitis.
In deciding which patients to screen, the rates provided above for the prevalence of HLA-B may offer a rough guide, keeping in mind the limitations of these figures due to wide variability in rates even within ethnic groups, the difficulty in ascertaining ethnic ancestry, and the likelihood of mixed ancestry.
Carbamazepine should not be used in patients positive for HLA-B unless the benefits clearly outweigh the risks. This information may be taken into consideration in determining the need for screening of genetically at-risk patients currently on carbamazepine. Retrospective case-control studies in patients of European, Korean, and Japanese ancestry have found a moderate association between the risk of developing hypersensitivity reactions and the presence of HLA-Aan inherited allelic variant of the HLA-A gene, was Petit Thrombophlebitis patients using carbamazepine.
The risks and benefits of carbamazepine therapy should be weighed before considering Epitol in patients known to be positive for HLA-A Application of HLA genotyping as a screening tool has important limitations and must never substitute for appropriate clinical vigilance and patient management. Patients with a history of adverse hematologic reaction to any drug may be particularly at risk of bone marrow depression.
Some of these events was Petit Thrombophlebitis been fatal or life-threatening. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved.
It is important to note that early manifestations of hypersensitivity e. If such signs or symptoms are present, the patient should be evaluated immediately. Epitol should be discontinued if an alternative etiology for the signs or symptoms cannot be established, was Petit Thrombophlebitis.
Hypersensitivity was Petit Thrombophlebitis to carbamazepine have been reported in patients who previously experienced this reaction to anticonvulsants including phenytoin, primidone, and phenobarbital.
If such history is present, was Petit Thrombophlebitis, benefits and risks should be carefully considered and, if carbamazepine is initiated, the signs and symptoms of hypersensitivity should be carefully monitored.
Patients should be informed that about a third of patients who have had hypersensitivity reactions to carbamazepine also experience hypersensitivity reactions with oxcarbazepine.
Antiepileptic was Petit Thrombophlebitis AEDsincluding Epitol, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication, was Petit Thrombophlebitis. Pooled analyses of placebo-controlled 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.
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 age 5 to years in the clinical trials analyzed. Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing Epitol or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed Varizen vaskuläre mesh themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.
Should suicidal thoughts blau Bein Thrombophlebitis behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.