Prasco has Begun Distribution of Doxercalciferol Capsules
CINCINNATI, OH March 11, 2014 — Prasco Laboratories announced today it has begun shipping Doxercalciferol 0.5, 1.0 & 2.5 mcg capsules, each in 50-count bottles under the Prasco label. Prasco entered into a distribution and supply agreement with Genzyme Corporation, a Sanofi company, for doxercalciferol capsules, the Authorized Generic (AG) version of Hectorol® 0.5, 1.0 & 2.5 mcg capsules. This is the latest Authorized Generic offering by Prasco.
“By expanding our AG line to include doxercalciferol capsules, patients will receive the identical ingredients with Prasco’s Authorized Generic as they do with the Hectorol brand,” stated Prasco chief executive officer, Chris Arington. “We look forward to continuing to enhance our product portfolio for our customers and their patients.”
Please click here for full Prescribing Information for Doxercalciferol capsules 0.5 mcg and 1.0 mcg
?Please click here for full Prescribing Information for Doxercalciferol capsules 2.5 mcg
Hectorol capsules are indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease not on dialysis and patients with chronic kidney disease on dialysis.
Important Safety Information About Hectorol®
• You should not take Hectorol if you have a history of abnormally high calcium blood levels (hypercalcemia) or if you have very high vitamin D levels.
• Overdosage of any form of vitamin D is dangerous and may require emergency attention.
• Before taking Hectorol, tell your doctor if you have ever had an irregular heartbeat or seizure, or if you are taking any digitalis drugs, or cholestyramine.
• Do not take other vitamin D related drugs if you are currently taking Hectorol.
• It is important for anyone taking Hectorol to talk to their doctor before taking any non-prescription drugs or magnesium-containing antacids, supplements and herbal preparations and to adhere to instructions about following a low phosphorus diet and calcium supplementation.
• Your doctor should monitor your calcium, phosphorus and PTH levels.
• Tell your doctor if you experience symptoms of hypercalcemia such as weakness, headache, drowsiness, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste and loss of appetite.
• Your doctor should check and treat you for nutritional vitamin D deficiency before starting you on Hectorol (doxercalciferol).
• The main side effects of treatment with Hectorol are hypercalcemia, hyperphosphatemia, hypercalciuria, and oversuppression of PTH. Your doctor may ask you questions to see if you are experiencing any symptoms related to these conditions.
• During treatment, your doctor may change your dose of Hectorol as well as the dose of your phosphate binder.
• Common side effects seen in Hectorol-treated patients on dialysis were swelling, headache, ill feeling, nausea/vomiting, dizziness, shortness of breath, itching and slow heartbeat.
• Common side effects seen in patients taking Hectorol capsules with Stage 3 or Stage 4 chronic kidney disease were infection, chest pain, constipation, indigestion, anemia, dehydration, depression, muscle stiffness, insomnia, tingling, increased cough, shortness of breath and runny/stuffy nose.
• Tell your doctor if you are pregnant or nursing.
• This drug should be used with caution if you have impaired liver function.
Please click here for full Prescribing Information for Hectorol capsules.
Hectorol® is a registered trademark of Genzyme Corporation, a Sanofi company. All rights reserved.
About Prasco Laboratories
Prasco, the Authorized Generic Company, is a privately held healthcare company located in Mason, Ohio. The leader in Authorized Generics, Prasco has more AG partnerships than any other company. Established brand companies rely on Prasco to bring their brand products to the generic marketplace as Authorized Generics, which offers alternatives to consumers and pharmacists. For more information, visit prasco.com.