Recommended Topic Related To:

Stalevo

"Jan. 8, 2013 -- Parkinson's disease itself doesn't seem to raise a person's risk for compulsive addictions to things like gambling, shopping, or sex, a new study shows.

Compulsive behaviors affect about 14% of Parkinson's patients tre"...

Stalevo

Stalevo

INDICATIONS

Stalevo® (carbidopa, levodopa and entacapone) is indicated to treat patients with idiopathic Parkinson's disease:

  1. To substitute (with equivalent strength of each of the three components) for immediate-release carbidopa/levodopa and entacapone previously administered as individual products.
  2. To replace immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off' (only for patients taking a total daily dose of levodopa of 600 mg or less and not experiencing dyskinesias, see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

Individual tablets should not be fractionated and only one tablet should be administered at each dosing interval.

Generally speaking, Stalevo® (carbidopa, levodopa and entacapone) should be used as a substitute for patients already stabilized on equivalent doses of carbidopa-levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa-levodopa may be treated with Stalevo (carbidopa, levodopa and entacapone) ® if a decision has been made to add entacapone (see below).

The optimum daily dosage of Stalevo (carbidopa, levodopa and entacapone) ® must be determined by careful titration in each patient. Stalevo (carbidopa, levodopa and entacapone) ® tablets are available in six strengths, each in a 1:4 ratio of carbidopa to levodopa and combined with 200 mg of entacapone in a standard release formulation (Stalevo (carbidopa, levodopa and entacapone) ® 50 containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone; Stalevo (carbidopa, levodopa and entacapone) ® 75, containing 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone; Stalevo (carbidopa, levodopa and entacapone) ® 100 containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone; Stalevo (carbidopa, levodopa and entacapone) ® 125, containing 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone; Stalevo (carbidopa, levodopa and entacapone) ® 150 containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone; and Stalevo (carbidopa, levodopa and entacapone) ® 200 containing 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone).

Therapy should be individualized and adjusted according to the desired therapeutic response.

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

Clinical experience with daily doses above 1600 mg of entacapone is limited. It is recommended that no more than one Stalevo (carbidopa, levodopa and entacapone) ® tablet be taken at each dosing administration.

Thus the maximum recommended daily dose of Stalevo (carbidopa, levodopa and entacapone) ® 50, Stalevo (carbidopa, levodopa and entacapone) ® 75, Stalevo (carbidopa, levodopa and entacapone) ® 100, Stalevo (carbidopa, levodopa and entacapone) ® 125 and Stalevo (carbidopa, levodopa and entacapone) ® 150, defined by the maximum daily dose of entacapone, is eight tablets per day. Because there is limited experience with total daily doses of carbidopa greater than 300mg, the maximum recommended daily dose of Stalevo (carbidopa, levodopa and entacapone) ® 200 is six tablets per day.

How to transfer patients taking carbidopa-levodopa preparations and Comtan® (entacapone) tablets to Stalevo® (carbidopa, levodopa and entacapone) tablets

There is no experience in transferring patients currently treated with formulations of carbidopa-levodopa other than immediate-release carbidopa-levodopa with a 1:4 ratio (controlled-release formulations, or standard-release presentations with a 1:10 ratio of carbidopa-levodopa) and entacapone to Stalevo (carbidopa, levodopa and entacapone) ® .

Patients who are currently treated with Comtan 200 mg tablet with each dose of standard-release carbidopa-levodopa, can be directly switched to the corresponding strength of Stalevo (carbidopa, levodopa and entacapone) ® containing the same amounts of levodopa and carbidopa. For example, patients receiving one tablet of standard-release carbidopa-levodopa 25/100 mg and one tablet of Comtan 200 mg at each administration can be switched to a single Stalevo (carbidopa, levodopa and entacapone) ® 100 tablet (containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone).

How to transfer patients not currently treated with Comtan® (entacapone) tablets from carbidopa-levodopa to Stalevo® (carbidopa, levodopa and entacapone) tablets

In patients with Parkinson's disease who experience the signs and symptoms of end-of-dose "wearing-off" on their current standard-release carbidopa-levodopa treatment, clinical experience shows that patients with a history of moderate or severe dyskinesias or taking more than 600 mg of levodopa per day are likely to require a reduction in daily levodopa dose when entacapone is added to their treatment. Since dose adjustment of the individual components is impossible with fixed-dose products, it is recommended that patients first be titrated individually with a carbidopa-levodopa product (ratio 1:4) and an entacapone product, and then transferred to a corresponding dose of Stalevo (carbidopa, levodopa and entacapone) ® once the patient's status has stabilized.

In patients who take a total daily levodopa dose up to 600 mg, and who do not have dyskinesias, an attempt can be made to transfer to the corresponding daily dose of Stalevo (carbidopa, levodopa and entacapone) ® . Even in these patients, a reduction of carbidopa-levodopa or entacapone may be necessary however, the provider is reminded that this may not be possible with Stalevo (carbidopa, levodopa and entacapone) ® . Since entacapone prolongs and enhances the effects of levodopa, therapy should be individualized and adjusted if necessary according to the desired therapeutic response.

Maintenance of Stalevo (carbidopa, levodopa and entacapone) ® Treatment

Therapy should be individualized and adjusted for each patient according to the desired therapeutic response.

When less levodopa is required, the total daily dosage of carbidopa-levodopa should be reduced by either decreasing the strength of Stalevo (carbidopa, levodopa and entacapone) ® at each administration or by decreasing the frequency of administration by extending the time between doses.

When more levodopa is required, the next higher strength of Stalevo (carbidopa, levodopa and entacapone) ® should be taken and/or the frequency of doses should be increased, up to a maximum of 8 times daily of Stalevo (carbidopa, levodopa and entacapone) ® 50, Stalevo (carbidopa, levodopa and entacapone) ® 75, Stalevo (carbidopa, levodopa and entacapone) ® 100, Stalevo (carbidopa, levodopa and entacapone) ® 125 and Stalevo (carbidopa, levodopa and entacapone) ® 150, and maximum of 6 times daily of Stalevo (carbidopa, levodopa and entacapone) ® 200.

Addition of Other Antiparkinsonian Medications

Standard drugs for Parkinson's disease may be used concomitantly while Stalevo (carbidopa, levodopa and entacapone) ® 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 levodopa preparations. Patients should be observed carefully if abrupt reduction or discontinuation of Stalevo (carbidopa, levodopa and entacapone) ® is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

If general anesthesia is required, Stalevo (carbidopa, levodopa and entacapone) ® 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.

Special Populations

Patients With Impaired Hepatic Function

Patients with hepatic impairment should be treated with caution. The AUC and Cmax of entacapone approximately doubled in patients with documented liver disease, compared to controls. However, these studies were conducted with single-dose entacapone without levodopa/dopa decarboxylase inhibitor coadministration, and therefore the effects of liver disease on the kinetics of chronically administered entacapone have not been evaluated (see CLINICAL PHARMACOLOGY, Pharmacokinetics of Entacapone).

HOW SUPPLIED

Stalevo® (carbidopa, levodopa and entacapone) is supplied as film-coated tablets for oral administration in the following six strengths:

Stalevo (carbidopa, levodopa and entacapone) ® 50 film-coated tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone.

The round, bi-convex shaped tablets are brownish- or greyish-red, unscored, and embossed "LCE 50" on one side.

HDPE bottle of 100 tablets...............................................................NDC 0078-0407-05
HDPE bottle of 250 tablets...............................................................NDC 0078-0407-28

Stalevo (carbidopa, levodopa and entacapone) ® 75 film-coated tablets containing 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone.

The oval-shaped tablets are light brownish red, unscored and embossed with code "LCE 75" on one side.

HDPE bottle of 100 tablets...............................................................NDC 0078-0544-05

Stalevo (carbidopa, levodopa and entacapone) ® 100 film-coated tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone.

The oval-shaped tablets are brownish- or greyish-red, unscored, and embossed "LCE 100" on one side.

HDPE bottle of 100 tablets...............................................................NDC 0078-0408-05
HDPE bottle of 250 tablets...............................................................NDC 0078-0408-28

Stalevo (carbidopa, levodopa and entacapone) ® 125 film-coated tablets containing 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone.

The oval-shaped tablets are light brownish red, unscored and embossed with code "LCE 125" on one side.

HDPE bottle of 100 tablets...............................................................NDC 0078-0545-05

Stalevo (carbidopa, levodopa and entacapone) ® 150 film-coated tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone

The elongated-ellipse shaped tablets are brownish- or greyish-red, unscored, and embossed "LCE 150" on one side.

HDPE bottle of 100 tablets...............................................................NDC 0078-0409-05
HDPE bottle of 250 tablets...............................................................NDC 0078-0409-28

Stalevo (carbidopa, levodopa and entacapone) ® 200 film-coated tablets containing 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone

The oval shaped tablets are dark brownish red, unscored, and embossed "LCE 200" on one side.

HDPE bottle of 100 tablets...............................................................NDC 0078-0527-05

Store at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F). [see USP Controlled Room Temperature.]

Dispense in tight container (USP).

Manufactured by: Orion Corporation, Orion Pharma, Orionintie 1, FIN-02200 Espoo, Finland. Marketed by: Novartis Pharmaceuticals Corporation., East Hanover, New Jersey 07936. Rev: Sep 2010.

Last reviewed on RxList: 11/8/2010
This monograph has been modified to include the generic and brand name in many instances.

A A A

Stalevo - User Reviews

Stalevo User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Stalevo sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


WebMD Daily

Get breaking medical news.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations