Parcopa (Carbidopa / Levodopa) - Indications and Dosage

INDICATIONS AND USAGE

PARCOPA™ is indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. PARCOPA™ is indicated in these conditions to permit the administration of lower doses of levodopa with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response, and with supplemental pyridoxine (vitamin B₆).

In some patients, a somewhat smoother antiparkinsonian effect results from therapy with carbidopa-levodopa than with levodopa. However, patients with markedly irregular ("on-off") responses to levodopa have not been shown to benefit from carbidopa-levodopa therapy.

Although the administration of carbidopa permits control of parkinsonism and Parkinson's disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa.

Certain patients who responded poorly to levodopa have improved when carbidopa-levodopa was substituted. This is most likely due to decreased peripheral decarboxylation of levodopa which results from administration of carbidopa rather than to a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa in parkinsonian syndromes.

In considering whether to give PARCOPA™ to patients already on levodopa who have nausea and/or vomiting, the practitioner should be aware that, while many patients may be expected to improve, some do not. Since one cannot predict which patients are likely to improve, this can only be determined by a trial of therapy. It should be further noted that in controlled trials comparing carbidopa-levodopa with levodopa, about half of the patients with nausea and/or vomiting on levodopa improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial.

INSTRUCTIONS FOR USE/HANDLING PARCOPA™ TABLETS

Just prior to administration, GENTLY remove the tablet from the bottle with dry hands. IMMEDIATELY place the PARCOPA™ Tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

The optimum daily dosage of PARCOPA™ must be determined by careful titration in each patient. PARCOPA™ is available in a 1:4 ratio of carbidopa to levodopa (PARCOPA™ 25/100) as well as 1:10 ratio (PARCOPA™ 25/250 and PARCOPA™ 10/100). Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage.

Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.

DOSAGE AND ADMINISTRATION

USUAL INITIAL DOSAGE

Dosage is best initiated with one tablet of PARCOPA™ 25/100 three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight tablets of PARCOPA™ 25/100 a day is reached.

If PARCOPA™ 10/100 is used, dosage may be initiated with one tablet three or four times a day. However, this will not provide an adequate amount of carbidopa for many patients. Dosage may be increased by one tablet every day or every other day until a total of eight tablets (2 tablets q.i.d.) is reached.

HOW TO TRANSFER PATIENTS FROM LEVODOPA

Levodopa must be discontinued at least twelve hours before starting PARCOPA™ (carbidopa-levodopa orally disintegrating tablets). A daily dosage of PARCOPA™ should be chosen that will provide approximately 25 percent of the previous levodopa dosage. Patients who are taking less than 1500 mg of levodopa a day should be started on one tablet of PARCOPA™ 25/100 three or four times a day. The suggested starting dosage for most patients taking more than 1500 mg of levodopa is one tablet of PARCOPA™ 25/250 three or four times a day.

MAINTENANCE

Therapy should be individualized and adjusted according to the desired therapeutic response. At least 70 to 100 mg of carbidopa per day should be provided. When a greater proportion of carbidopa is required, one tablet of PARCOPA™ 25/100 may be substituted for each tablet of PARCOPA™ 10/100. When more levodopa is required, PARCOPA™ 25/250 should be substituted for PARCOPA™ 25/100 or PARCOPA™ 10/100. If necessary, the dosage of PARCOPA™ 25/250 may be increased by one-half or one tablet every day or every other day to a maximum of eight tablets a day. Experience with total daily dosages of carbidopa greater than 200 mg is limited.

Because both therapeutic and adverse responses occur more rapidly with PARCOPA™ than with levodopa alone, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with PARCOPA™ than with levodopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.

ADDITION OF OTHER ANTIPARKINSONIAN MEDICATIONS

Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while PARCOPA™ is being administered, although dosage adjustments may be required.

INTERRUPTION OF THERAPY

Sporadic cases of a symptom complex resembling Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of carbidopa-levodopa. Patients should be observed carefully if abrupt reduction or discontinuation of PARCOPA™ is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

If general anesthesia is required, PARCOPA™ may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.

HOW SUPPLIED

PARCOPA™ (carbidopa-levodopa orally disintegrating tablets) 25/100 are yellow, round, flat-faced, mint-flavored, scored and engraved "25/100" on the unscored side and "SP" above and "342" below the score on the other side. They are supplied as follows:

   Bottles of 100      NDC 0091-3342-01

PARCOPA™ (carbidopa-levodopa orally disintegrating tablets) 10/100 are blue, round, flat-faced, mint-flavored, scored and engraved "10/100" on the unscored side and "SP" above and "341" below the score on the other side. They are supplied as follows:

   Bottles of 100      NDC 0091-3341-01

PARCOPA™ (carbidopa-levodopa orally disintegrating tablets) 25/250 are blue, round, flat-faced, mint-flavored, scored, and engraved "25/250" on the unscored side and "SP" above and "343" below the score on the other side. They are supplied as follows:

   Bottles of 100      NDC 0091-3343-01

STORAGE

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture and light.

Dispense in a tight, light-resistant container as defined in the USP/NF.

Manufactured for:

SCHWARZ PHARMA

Milwaukee, WI 53201, USA

By:

CIMA LABS INC.®

Eden Prairie, MN 55344, USA

PARCOPA™ uses CIMA® U.S. Patent Nos. 6,024,981 and 6,221,392.

PC4578

Rev. 01/03