Schwarz Pharma
Manufacturer Details
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Schwarz Pharma Drugs
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![Parcopa (Carbidopa And Levodopa) Tablet, Orally Disintegrating [Schwarz Pharma]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
Parcopa
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.
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.
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Dilatrate-sr
As noted above (CLINICAL PHARMACOLOGY), multiple studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for organic nitrates including dilatrate®-SR must provide a daily nitrate-free interval to avoid the development of tolerance. To achieve the necessary nitrate-free interval with immediate-release oral ISDN, it appears that at least one of the daily interdose intervals must be at least 14 hours long. The necessary interdose interval for dilatrate®-SR has not been clearly identified, but it must be greater than 18 hours.
As noted under Clinical Pharmacology, only one trial has ever studied the use of extended-release isosorbide dinitrate for more than one dose. In that trial, 40 mg of dilatrate®-SR was administered twice daily in doses given 6 hours apart. After 4 weeks, dilatrate®-SR could not be distinguished from placebo.
Large controlled studies with other nitrates suggest that no dosing regimen with dilatrate®-SR should be expected to provide more than about 12 hours of continuous antianginal efficacy per day.
In clinical trials, immediate-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 30 to 480 mg.
Do not exceed 160 mg (4 capsules) per day.
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Proctofoam Hc
Apply to affected area 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal use, transfer a small quantity to a tissue and rub in gently.
Directions for Use
Place cap on top of container. Shake foam container vigorously for 5-10 seconds before each use. Do not remove container cap during use of the product. Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. CONTAINER MUST BE HELD UPRIGHT TO OBTAIN PROPER FLOW OF MEDICATION. Pull plunger past the fill line on the applicator barrel. Hold the container and applicator at eye level. Place the index and middle fingers on the container cap flanges and the thumb beneath the container. Support the applicator with your other hand. Prime the container by pressing down firmly on flanges and then release. With initial priming, a burst of air may come out of the container. It usually requires 1-2 pumps for foam to appear. To fill applicator barrel, press down firmly on cap flanges, hold for 1-2 seconds, and release. Wait 5-10 seconds to allow foam to expand in applicator barrel. Repeat until foam reaches fill line. It usually requires 3-4 pumps for foam to reach fill line. Remove applicator from container cap. Note: If foam goes beyond fill line, it will continue to expand and flow backwards resulting in foam build-up under cap. Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator. CAUTION: Do not insert any part of the aerosol container directly into the anus. Apply to anus only with enclosed applicator. Do not insert any part of the applicator past the anus into rectum. After each use, applicator parts should be pulled apart for thorough cleaning with warm water. Since some foam will appear under the cap, the cap and underlying tip should be pulled apart and rinsed to help prevent build-up of foam and possible blockage.
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