ANTIPAR FILM COATED TABLET 150 MG/37.5 MG/200 MG [SIN16957P]

Product Info

ANTIPAR FILM COATED TABLET 150 MG/37.5 MG/200 MG

[SIN16957P]

Indication

5. Indications
ANTIPAR is indicated for the treatment of patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.

Dosing

6. Recommended Dosage
Unless otherwise advised by doctor;

The optimum daily ANTIPAR dose should be determined by careful titration of levodopa for each patient. The daily ANTIPAR dose should be optimized using one of the preferred tablet strengths (100 mg/25 mg/200 mg or 150 mg/37.5 mg/200 mg levodopa/carbidopa/entacapone). If the required dose could not be achieved by the 100mg/25mg/200mg or 150mg/37.5mg/200mg strengths other levodopa/carbidopa/entacapone products should be used.

Patients should be instructed to take only one ANTIPAR tablet per dose administration. While the experience with total daily dose greater than 200 mg of carbidopa is limited, but in patients receiving less than 70–100 mg carbidopa a day, possibility of nausea and vomiting are high. The maximum recommended daily dose of entacapone is 2000 mg and therefore the maximum ANTIPAR dose is 10 tablets per day for the ANTIPAR 100 mg/25 mg/200 mg, and 150 mg/37.5 mg/200 mg. Ten (10) tablets of ANTIPAR 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day. The maximum recommended daily dose of carbidopa is 375 mg.

The maximum daily levodopa dose to be administered during ANTIPAR treatment should not exceed 1500 mg.

Start to ANTIPAR treatment:

How to transfer patients taking levodopa/dopa decarboxylase (DDC) inhibitor (carbidopa or benserazide) preparations and entacapone tablets to ANTIPAR administration:

ANTIPAR is generally for use in patients treated with the equivalent standard release doses of levodopa/DDC inhibitor and entacapone.

Like with levodopa/carbidopa, non-selective monoamine oxidase (MAO) inhibitors are contraindicated for use with ANTIPAR. These inhibitors must be discontinued at least two weeks before starting ANTIPAR treatment. ANTIPAR can be administered concurrently with the manufacturer’s recommended doses of MAO inhibitors with selectivity for MAO type B (e.g. selegiline HCl).

a) Patients who are currently treated with entacapone and standard release levodopa/carbidopa equivalent to ANTIPAR tablet dose can be directly transferred to equivalent ANTIPAR tablet.

b) When initiating ANTIPAR treatment in patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Antipar 100 mg/25 mg/200 mg or 150mg/37.5 mg/200 mg, ANTIPAR dosing should be carefully titrated for optimal clinical response. At the initiation, ANTIPAR should be adjusted to correspond as closely as possible to the total daily dose of levodopa currently used.

c) When initiating ANTIPAR treatment in patients currently treated with entacapone and levodopa/benserazide in a standard release formulation, the dosing of levodopa/benserazide should be discontinued in the previous night, and ANTIPAR administration is started in the next morning. The starting dose of ANTIPAR should provide either the same amount of levodopa or slightly more (5%–10%).

d) There are no data on transferring patients from controlled-release formulations or standard release preparations with a 10:1 ratio of levodopa/DDC inhibitor to ANTIPAR.

How to transfer patients not currently treated with entacapone to ANTIPAR administration

Like with levodopa/carbidopa, concomitant use of non-selective monoamine oxidase (MAO) inhibitors with ANTIPAR is contraindicated. These inhibitors must be discontinued at least two weeks before starting ANTIPAR treatment. ANTIPAR can be administered concurrently with the manufacturer’s recommended doses of MAO inhibitors with selectivity for MAO type B (e.g. selegiline HCl).

Initiation of ANTIPAR may be considered at corresponding doses to current treatment in some patients with Parkinson disease and end-of-dose motor fluctuations, who are not stabilized on their current standard release levodopa/DDC inhibitor treatment. However, a direct switch from levodopa/DDC inhibitor to ANTIPAR is not recommended for patients who have dyskinesia or whose daily levodopa dose is above 600 mg. In such patients, entacapone treatment should be administered as a separate medication (entacapone tablet) and adjust the levodopa dose if necessary, before switching to ANTIPAR.

Entacapone enhances the effects of levodopa. Therefore, it may be necessary, particularly in patients with dyskinesia, to reduce levodopa dose by 10%–30% within the first days to first weeks after initiating ANTIPAR 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.

Dose 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 dosage of ANTIPAR should be considered, within the dose recommendations mentioned under Recommended Dosage section.

When less levodopa is required, the total daily dose of ANTIPAR should be reduced either by decreasing the frequency of administration by extending the time between doses, or by decreasing the strength of ANTIPAR at an administration.

If other levodopa products are used concomitantly with ANTIPAR tablet; the maximum dose recommendations should be followed.

Discontinuation of ANTIPAR treatment

If ANTIPAR (levodopa/carbidopa/entacapone) treatment is discontinued and the patient is transferred to levodopa/DDC inhibitor treatment without entacapone, it is necessary to adjust the dosing of other anti-parkinson treatments, especially levodopa, to achieve a sufficient level of control of the parkinson symptoms. (See section 9. Warnings and precautions, rhabdomyolysis – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Additional information on special populations:
Renal impairment:
No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency. Therefore, ANTIPAR treatment should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapies (See section 4.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment does not affect the pharmacokinetics of entacapone.

Pediatric population:
The safety and efficacy of ANTIPAR in children aged below 18 years (children and adolescents) have not been established. No other data are available. ANTIPAR is not recommended for use in children below age of 18.

Geriatric population
No dose adjustment of ANTIPAR is required for elder patients.

Contraindications

8. Contraindications

• Hypersensitivity to the levodopa, carbidopa and entacapone or any excipients in formulation,

• Liver impairment,

• Narrow-angle glaucoma,

• Pheochromocytoma,

• Co-administration of ANTIPAR with non-selective monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine).

• Co-administration with a selective MAO-A inhibitor and a selective MAO-B inhibitor (See section 10. Interaction with other medicines and other forms of interaction, other anti-parkinson drugs. – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) These inhibitors should be discontinued at least two weeks before starting ANTIPAR treatment.

• A previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.

• Because levodopa may activate malignant melanoma, ANTIPAR should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.