STALEVO 50MG TAB; entacapone, levodopa, carbidopa, antiparkinson agents .
ACTIVE-INGREDIENT OF STALEVO 50MG TAB
Film-coated tablets containing 50 mg levodopa, 12.5 mg carbidopa and 200 mg entacapone.
INDICATION OF STALEVO 50MG TAB
Stalevo is indicated for the treatment of adult patients with Parkinson’s disease who have motor fluctuations (Known as “end-of-dose” or “on-off” symptoms) that are not stabilized on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
DOSAGE OF STALEVO 50MG TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Each Stalevo film-coated tablet should be swallowed whole. The tablet may be taken with or without food. The optimum daily dose must be determined for each patient by careful titration. The daily dose should preferably be optimized using one of the available tablet strengths. Patients should be instructed to always take only one Stalevo tablet per dose administration. Experience with daily doses greater than 200 mg carbidopa is limited. The maximum recommended daily dose of entacapone is 2,000 mg. This corresponds to a maximum daily dose of 10 Stalevo filn-coated tablets for the tablet strengths up to 150 mg/3.75 mg/200 mg, and a maximum daily dose of 7 Stalevo film-coated tablets for the tablet strength 200 mg/50 mg/200 mg. Nausea and vomiting are more likely to occur in patients receiving leass than 70-100 mg carbidopa per day. Switching patients from levodopa/DDC (dopa decarboxylase) inhibitors (carbidopa or benserazide) and entacapone to Stalevo: a. Patients who are currently receiving treatment with entacapone and standard-release levodopa/carbidopa in doses that correspond to a Stalevo tablet strength can be directly switched to the corresponding. Stalevo film-coated tablets, For example, a patient who has been taking one 50 mg/12.5 mg levodopa/carbidopa tablet with one 200 mg entacapone tablet four times daily can switch to one 50 mg/12.5 mg/200 mg Stalevo film-coated tablet four times daily. b. In patients who are currently receiving treatment with entacapone and levodopa/carbidopa at doses not equivalent to one of the available tablet strengths of Stalevo film-coated tablets, the dose of Stalevo should be carefully titrated to achieve optimum clinical efficacy. At the start of treatment, the dose of Stalevo should be adjusted to correspond as closely as possible to the total daily dose of levodopa being used at the time of the changeover. c. When starting treatment with Stalevo in patients being treated with entacapone and levodopa/benserazide in a standard-release formulation, levodopa/benserazide should be discontinued the previous evening and treatment with Stalevo film-coated tablets initiated the next morning. Initially, a dosage of Stalevo should be chosen that provides either the same amount of levodopa, or slightly more (5-10% more). Switching patients not currently treated with entacapone to Stalevo: Initiation of Stalevo – at doses corresponding to the ones already in use in treatment – should be considered in patients with Parkinson’s disease who have motor fluctuations (Known as “end-of-dose” or “on-off” symptoms) that are not stabilized on levodopa/dopa decarboxylase (DDC) inhibitor. Note: If there is no improvement in clinical symptoms after three months, treatment with Stalevo should be discontinued in these patients, bearing in mind the relevant recommendations and precautions. A direct switch from levodopa/DDC inhibitor treatment to Stalevo is not recommended in patients with pre-existing dyskinesias or whose daily levodopa dose is above 800 mg. In such patients it is advisable to introduce entacapone treatment as a separate medication and adjust the levodopa dose if necessary before switching to Stalevo. Entacapone enhances the effects of levodopa, It may therefore be necessary, particularly in patients with dyskinesia, to reduce the levodopa dosage by 10-30% during the first days or weeks following the start of treatment. The daily dose of levodopa can be reduced by extending the dosing intervals and/or by reducing the individual dose of levodopa, depending on the clinical condition of the patient. Dosage adjustment during the course of treatment: If a higher dose of levodopa is required, an increase in the frequency of administration and/or an internative tablet strength should be considered, taking the dosage recommendations into account. If less levopoda is required, The total daily dose of Stalevo should be lowered either by reducing the frequency of administration (i.e. extending the intervals between doses) or using a different tablet strength of Stalevo. If other levodopa products are used concomitantly with Stalevo, the maximum recommended doses must be adhered to . Discontinuation of Stalevo therapy: If treatment with Stalevo (levodopa/carbidopa/entacapone) is discontinued and the patient is being switched to levodopa/DDC-inhibitor therapy without entacapone, It is necessary to adjust the doses of the other antiparkinsonian drugs, especially levodopa, to ensure sufficient control of the parkinsonian symptoms. Dosage in special patient populations: Children and adolescents: The safety and efficacy of Stalevo have not been studied in children and adolescents below the age of 18. No date are available. Stalevo is contraindicated in children and adolescents. Elderly patients : No adjustment in the dosage of Stalevo is required in elderly patients. Patients with hepatic impairment: Stalevo is contraindicated in patients with hepatic impairment. Patients with renal impairment does not affect the pharmacokinetics of entacapone. No particular studies are available on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Stalevo therapy should be administered with special caution to patients with severe renal impairment including those receiving dialysis therapy.
OVER-DOSAGE OF STALEVO 50MG TAB
Since market launch, isolated cases of overdose have been reported in which the highest daily doses have been at least 10.000 mg of levodopa and at least 40.000 mg of entacapone. The acute signs and symptoms in these cases of overdose included agitation, confusional states , coma, bradycardia, ventricular tachycardia, Cheyne-Stokes respiration, discolorations of skin, tongue and conjunctiva, and chromaturia. Management of acute overdosage with Stalevo is largely similar to management of acute overdosage with levodopa. Pyridoxine, however, cannot reverse the effect of Stalevo. Hospitalization is advised and general supportive measures with immediate gastric lavage and repeated administration of activated charcoal should also be undertaken. Thses measures can promote the elimination of entacapone from the body, particularly by decreasing its absorption/reabsorptiom from the gastrointestinal tract. The adequate functioning of the respiratory, circulatory and renal systems should be closely monitored and appropriate supportive measures employes. ECG monitoring should be carried out and the patient shopuld be watched for potential development of arrhythmias. If required, appropriate antiarrhythmic treatment should be given. It should be kept in mind that the patient might have taken other drugs in addition to Stalevo. The value of dialysis in the treatment of an overdose is not known.
CONTRA-INDICATION OF STALEVO 50MG TAB
Known hypersensitivity to lvodopa, carbidopa, entacapone or any of the other components of the medicinal product. Hepatic impairment. Narrow-angle glaucoma. Suspicious, previously undiagnosed skin lesion or history of melanoma. Phaeochromosytoma (due to the increased risk of hypertensive crisis). Concomitant use of Stalevo with a non-selective monoamine oxidase (MAO-A and MAO-B) inhibitor, such as phenelzine or tranylcypromine, is contraindicated. Similar;y, concomitant use of Stalevo with a selective MAO-A and a selective MAO-B inhibitor is contraindicated. Stalevo may, however, be used in combination with selegiline ( a selective MAO-B inhibitor ) but the daily dose of selegiline should not exceed 10 mg. History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis. Use in children and adolescents under 18 years of age.
STORAGE OF STALEVO 50MG TAB
Do not store above 30 °C. Keep out of the reach and sight of children.
PACK OF STALEVO 50MG TAB
30 Film-Coated tablets .
STALEVO 50MG TAB MANUFACTURED BY
Orion Corporation, Espoo, Finland for Novartis Pharma AG, Basle, Switzerland.