Cloisone Dosage

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Dosage of Cloisone in details

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Dosage in Patients Naïve to Levodopa (Cloisone) Therapy

The recommended starting dosage of Cloisone in Levodopa (Cloisone)-naïve patients is 23.75 mg / 95 mg taken orally three times a day for the first 3 days. On the fourth day of treatment, the dosage of Cloisone may be increased to 36.25 mg / 145 mg taken three times a day.

Based upon individual patient clinical response and tolerability, the Cloisone dose may be increased up to a maximum recommended dose of 97.5 mg / 390 mg taken three times a day. The dosing frequency may be changed from three times a day to a maximum of five times a day if more frequent dosing is needed and if tolerated. The maximum recommended daily dose of Cloisone is 612.5 mg / 2450 mg.

Maintain patients on the lowest dosage required to achieve symptomatic control and to minimize adverse reactions such as dyskinesia and nausea.

Converting from Immediate-Release Carbidopa (Cloisone)-Levodopa (Cloisone) to Cloisone

To convert patients from immediate-release Carbidopa (Cloisone)-Levodopa (Cloisone) to Cloisone, determine the recommended starting dosage of Cloisone using Table 1.

The dosages of other Carbidopa (Cloisone) and Levodopa (Cloisone) products are not interchangeable with the dosages of Cloisone.

Adjust the dose to maintain patient tolerance and sufficient symptomatic control. The dosing frequency may be changed from three times a day to a maximum of five times a day if more frequent dosing is needed and if tolerated. The maximum recommended daily dose of Cloisone is 612.5 mg / 2450 mg.

For patients currently treated with Carbidopa (Cloisone) and Levodopa (Cloisone) plus catechol-O-methyl transferase (COMT) inhibitors (such as entacapone), the initial total daily dose of Levodopa (Cloisone) in Cloisone described in Table 1 may need to be increased.

Use of Cloisone in combination with other Levodopa (Cloisone) products has not been studied.

Table 1: Conversion from Immediate-Release Carbidopa (Cloisone)-Levodopa (Cloisone) to Cloisone
Total Daily Dose of Levodopa (Cloisone) in Immediate-Release Carbidopa (Cloisone)-Levodopa (Cloisone) Recommended Starting Dosage of Cloisone
Total Daily Dose of Levodopa (Cloisone) in Cloisone Cloisone Dosing Regimen
*
TID: three times a day
400 mg to 549 mg 855 mg 3 capsules Cloisone 23.75 mg / 95 mg taken TID*
550 mg to 749 mg 1140 mg 4 capsules Cloisone 23.75 mg / 95 mg taken TID
750 mg to 949 mg 1305 mg 3 capsules Cloisone 36.25 mg / 145 mg taken TID
950 mg to 1249 mg 1755 mg 3 capsules Cloisone 48.75 mg / 195 mg taken TID
Equal to or greater than 1250 mg 2340 mg or 4 capsules Cloisone 48.75 mg / 195 mg taken TID or
2205 mg 3 capsules Cloisone 61.25 mg / 245 mg taken TID

Discontinuation of Cloisone

Avoid sudden discontinuation or rapid dose reduction of Cloisone. The daily dose of Cloisone should be tapered at the time of treatment discontinuation.

Administration Information

Swallow Cloisone whole with or without food. A high-fat, high-calorie meal may delay the absorption of Levodopa (Cloisone) by about 2 hours.

Do not chew, divide or crush Cloisone capsules. For patients who have difficulty swallowing intact capsules, administer Cloisone by carefully opening the capsule, sprinkling the entire contents on a small amount of applesauce (1 to 2 tablespoons), and consuming immediately. Do not store the drug/food mixture for future use.

What other drugs will affect Cloisone?

Taking Cloisone with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Cloisone with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete. Other drugs may interact with Carbidopa (Cloisone) and Levodopa (Cloisone), including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Cloisone drug interactions (more detail)

Cloisone interactions

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Caution should be exercised when the following drugs are administered concomitantly with Cloisone.

Symptomatic postural hypotension occurred when Cloisone was added to the treatment of a patient receiving antihypertensive drugs. Therefore, when therapy with Cloisone is started, dosage adjustment of the antihypertensive drug may be required.

For patients receiving MAO inhibitors (Type A or B), see CONTRAINDICATIONS. Concomitant therapy with selegiline and Carbidopa (Cloisone) Levodopa (Cloisone) may be associated with severe orthostatic hypotension not attributable to Carbidopa (Cloisone) Levodopa (Cloisone) alone.

There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and Cloisone.

Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of Levodopa (Cloisone). In addition, the beneficial effects of Levodopa (Cloisone) in Parkinson's disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with Cloisone should be carefully observed for loss of therapeutic response.

Use of Cloisone with dopamine-depleting agents (e.g., reserpine and tetrabenazine) or other drugs known to deplete monoamine stores is not recommended.

Cloisone and iron salts or multivitamins containing iron salts should be coadministered with caution. Iron salts can form chelates with Levodopa (Cloisone) and Carbidopa (Cloisone) and consequently reduce the bioavailability of Carbidopa (Cloisone) and Levodopa (Cloisone).

Although metoclopramide may increase the bioavailability of Levodopa (Cloisone) by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties.


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References

  1. DailyMed. "CARBIDOPA; ENTACAPONE; LEVODOPA: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. FDA/SPL Indexing Data. "KR87B45RGH: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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