Stalevo Dosage/Direction for Use

Each tablet is to be taken orally either with or without food (see Pharmacokinetics). One tablet contains 1 treatment dose. The tablets should always be swallowed whole.
The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using 1 of the 3 available tablet strengths (100/25/200 mg or 150/37.5/200 mg levodopa/carbidopa/entacapone).
Patients should be instructed to take only 1 Stalevo tab/dose administration. Patients receiving <70-100 mg carbidopa a day are more likely to experience nausea and vomiting. While the experience with total daily dosage >200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2000 mg and therefore the maximum Stalevo dose is 10 tabs/day.
Usually Stalevo is intended for use in patients already receiving treatment with corresponding doses of standard-release levodopa/DDC inhibitor and entacapone.
Starting Stalevo Therapy: As with levodopa/carbidopa, nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with Stalevo. These inhibitors must be discontinued at least 2 weeks prior to initiating therapy with Stalevo. Stalevo may be administered concomitantly with the manufacturer's recommended dose of MAO inhibitors with selectivity for MAO type B (eg, selegiline HCl).
Switching from Levodopa/DDC Inhibitor (Carbidopa or Benserazide) Preparations and Entacapone to Stalevo:
a. Patients who are currently receiving treatment with entacapone and standard-release levodopa/carbidopa in doses equal to Stalevo tablet strengths can be directly switched to the corresponding Stalevo tablets. For example, patients taking 1 tab of 100/25 mg levodopa/carbidopa with 1 tab of entacapone 200 mg 4 times daily can be switched to one 100/25/200 mg Stalevo tablet 4 times daily.
b. When initiating Stalevo therapy in patients currently receiving treatment with entacapone and levodopa/carbidopa in doses not equal to the available Stalevo tablet strengths (100/25/200 or 150/37.5/200 mg), Stalevo dosing should be carefully titrated for optimal clinical response. At the start of therapy, Stalevo should be adjusted to correspond as closely as possible to the total daily dose of levodopa currently used.
c. When initiating Stalevo in patients currently treated with entacapone and levodopa/benserazide in a standard-release formulation, treatment should be stopped for 1 night and Stalevo therapy started the next morning. The therapy should begin with a dosage of Stalevo that will provide either the same amount of levodopa or slightly (5-10%) more.
Switching in Patients not Currently Treated with Entacapone to Stalevo: Initiation of Stalevo at a dosage corresponding to current treatment may be considered in some patients with Parkinson's disease and end-of-dose motor fluctuations who are not stabilised on their current standard-release levodopa/DDC inhibitor treatment. However, a direct switch from levodopa/DDC inhibitor to Stalevo is not recommended for patients who have dyskinesias or whose daily levodopa dose is >800 mg. In such patients it is advisable to introduce entacapone treatment as a separate medication (entacapone tablets) 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 levodopa dosage by 10-30% within the 1st days to 1st weeks after initiating Stalevo treatment. The daily dose of levodopa can be reduced by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Dosage Adjustment During the Course of the Treatment: When more levodopa is required, an increase in the frequency of doses and/or the use of an alternative strength of Stalevo should be considered, within the dosage recommendations.
When less levodopa is required, the total daily dosage of Stalevo should be reduced either by decreasing the frequency of administration by extending the time between doses, or by decreasing the strength of Stalevo at an administration.
If other levodopa products are used concomitantly with a Stalevo tablet, the maximum dosage recommendations should be followed.
Discontinuation of Stalevo Therapy: If Stalevo treatment (levodopa/carbidopa/entacapone) is discontinued and the patient is switched to levodopa/DDC inhibitor therapy without entacapone, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms (see Rhabdomyolysis under Precautions).
Children and Adolescents: The safety and efficacy of Stalevo in patients <18 years have not been established. Therefore, the use of Stalevo in patients <18 years cannot be recommended.
Elderly: No adjustment of Stalevo dosage is necessary in elderly patients.
Hepatic Impairment: Caution is recommended when administering Stalevo to patients with mild to moderate hepatic impairment. Dose reduction may be necessary.
Renal Insufficiency: Renal insufficiency does not affect the pharmacokinetics of entacapone. No specific studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, and Stalevo should therefore be administered with caution in patients with severe renal impairment including those receiving dialysis therapy.