Navigation Links
Prasco® Launches Authorized Generic of Shire's Carbatrol®
Date:1/12/2012

CINCINNATI, Jan. 12, 2012 /PRNewswire/ -- Prasco® Laboratories announced today it has entered into an agreement with Shire (NASDAQ: SHPGY) for the distribution in the U.S. of the Authorized Generic version of Carbatrol® (Carbamazepine) Extended-Release Capsules in 100 mg, 200 mg and 300 mg strengths.

Carbamazepine Extended-Release Capsules are AB-rated, therapeutically equivalent and substitutable for the brand Carbatrol®. The product will be distributed in the U.S. under the Prasco label. Financial terms of the agreement were not disclosed.

"We are pleased to provide Carbamazepine Extended-Release Capsules to pharmacists and consumers," said Prasco chief executive officer Christopher H. Arington. "As a Prasco Authorized Generic, Carbamazepine Extended-Release Capsules will provide patients with a therapeutically equivalent product to the brand."

Indications

Carbatrol is a medicine used to treat:

  • certain types of seizures (partial, tonic-clonic, mixed).
  • certain types of nerve pain (trigeminal and glossopharyngeal neuralgia).

Carbatrol is not a regular pain medicine and should not be used for aches or pains.

Important Safety Information

Do not stop taking Carbatrol without first talking to your doctor. Stopping Carbatrol suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

WARNING

SERIOUS SKIN REACTIONS

Carbatrol may cause rare but serious rashes that may lead to death. These serious skin reactions are more likely to happen within the first four months of Carbatrol treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent you may need a genetic blood test before you take Carbatrol to see if you are at a higher risk for serious skin reactions with this medicine.  Symptoms may include:

  • skin rash
  • hives
  • sores in your mouth
  • blistering or peeling of the skin

SERIOUS BLOOD PROBLEMS

Carbatrol may cause rare but serious blood problems.  Symptoms may include:

  • fever, sore throat or other infections that come and go or do not go away
  • easy bruising
  • red or purple spots on your body
  • bleeding gums or nose bleeds
  • severe fatigue or weakness

Carbamazepine extended-release capsules, 100 mg, 200 mg and 300 mg, represent the latest product from Prasco in its expanding Authorized Generics portfolio. Carbatrol is registered in the United States Patent and Trademark Office. For additional important information, click  here to see the Full Prescribing Information, INCLUDING BOXED WARNING, or visit  www.prasco.com.

About Prasco Laboratories – Prasco, the Authorized Generics company, is a privately-held pharmaceutical company located in Mason, Ohio that specializes in Authorized Generics. Prasco authorized Generics provide patients with the identical brand drug experience at a price that competes with generics. Prasco Authorized Generics also simplify interactions between pharmacists and consumers because they are identical to branded drugs. Moreover, Prasco Authorized Generics offer brand pharmaceutical companies a strategic lifecycle management solution. For more information, visit  www.prasco.com.

About Carbatrol

Indications

Carbatrol is a medicine used to treat:

  • certain types of seizures (partial, tonic-clonic, mixed).
  • certain types of nerve pain (trigeminal and glossopharyngeal neuralgia).

Carbatrol is not a regular pain medicine and should not be used for aches or pains.

Additional Important Safety Information

Do not take Carbatrol if you:

  • Have a history of bone marrow depression.
  • Are allergic to carbamazepine or any of the ingredients in Carbatrol.
  • Take nefazodone.
  • Are allergic to antidepressant medications called tricyclic (TCAs).
  • Have taken a medicine called Monoamine Oxidase Inhibitor (MAOI) in the last 14 days.

Call your doctor right away at the first sign of a skin rash while taking Carbatrol.

Carbatrol may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you:  thoughts about suicide or dying; attempt to commit suicide; new or worse depression, anxiety or irritability; feeling agitated or restless; panic attacks; trouble sleeping; acting aggressive, being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking; or other unusual changes in behavior or mood.

Tell your doctor right away if you become pregnant while taking Carbatrol.  Carbatrol may harm your unborn baby and can pass into breast milk. You and your doctor should decide if you should take Carbatrol while you are pregnant or plan to breastfeed.

  • If you become pregnant while taking Carbatrol, talk to your doctor about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll- free number at 1-888-233-2334.

Carbatrol may make your birth control less effective.  Discuss your birth control options with your doctor.

Tell your doctor if you have a history of seizures; a history of heart, blood problems, liver, or kidney problems; have any other medical conditions; or have previously started and stopped therapy with Carbatrol.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Carbatrol may cause serious side effects such as irregular heartbeat (such as pounding heartbeat or shortness of breath) and liver problems (such as yellowing of your skin).

The most common side effects of Carbatrol include dizziness, drowsiness, unsteadiness, nausea and vomiting.

Do not crush, chew or break Carbatrol capsules or the beads inside of the capsules.

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Full Prescribing Information and Medication Guide, including Boxed WARNING regarding Serious Skin Reactions and Serious Blood Problems.

 


'/>"/>
SOURCE Prasco Laboratories
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Prasco® Selected as Eli Lilly and Companys Authorized Generics Partner
2. Prasco® Launches Authorized Generic with Shionogi Inc.
3. Prasco® Announces Authorized Generic Agreement with Shionogi Inc.
4. MX.com Launches Pelvic Health Program Model to Help Hospitals Rapidly Expand Key Services
5. Shopko Launches Mobile Pharmacy App to Maximize Customer Convenience
6. QIAGEN Launches QIAensemble Decapper Sample Preparation Automation System
7. Revation Systems Launches an Accessible Virtual Care Solution for Healthcare Organizations
8. Verenium Launches Second Enzyme Product for Oilfield Services
9. Successful Diabetes Product Launches Balance Digital & Traditional Public Relations Tools
10. Actavis Launches Generic Equivalent of Ritalin LA® in the US, With 180-Day Exclusivity
11. theVisualMD Launches a Revolutionary New Visual Path to Wellness
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... , Feb. 5, 2016  Syneron Medical Ltd. ... device company, announced today that William Griffing ... America, is scheduled to participate in the Leerink ... on February 11, 2016 in New ... institutional investors to meet with the Mr. Griffing ...
(Date:2/5/2016)... 2016 http://www.researchandmarkets.com/research/jsc97m/global ... "Global Musculoskeletal Partnering 2010-2016: Deal trends, ... their offering. --> http://www.researchandmarkets.com/research/jsc97m/global ... "Global Musculoskeletal Partnering 2010-2016: Deal trends, ... their offering. --> Research ...
(Date:2/5/2016)... , Feb. 5, 2016  Zimmer Biomet Holdings, Inc. ... the previously announced underwritten secondary offering of 11,027,558 shares ... consisting of affiliates of Blackstone and Goldman Sachs.  The ... initial price of $96.45 per share. The selling stockholders ...  Neither Zimmer Biomet nor any of its directors, officers ...
Breaking Medicine Technology:
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... ... ranked #3 in the 2015 Best in KLAS: Software & Services for HIT ... annual Best in KLAS report independently ranks vendor performance by healthcare executives, managers ...
(Date:2/5/2016)... , ... February 05, 2016 , ... Stuart Bentkover, ... technology, the PicoSure. Designed to provide the most effective tattoo removal today, Dr. Bentkover ... unmatched results. , Developed by Cynosure, the PicoSure has been approved by the Food ...
(Date:2/5/2016)... ... 05, 2016 , ... In sleep, when the defenses of the day are ... of patients with eating disorders is significant self-criticism, and consequently these patients experience this ... regarded as maladaptive means for coping with this unease, but also leads to a ...
(Date:2/5/2016)... ... February 05, 2016 , ... On June 9-10, Las ... continuing medical education (CME) event presented by the Association for Comprehensive Care in ... for ACCORD, whose mission is to provide education, tools, and resources to primary ...
(Date:2/5/2016)... ... ... –This week, Atascadero water heater company First Call Plumbing has ... the report, click here or see below. , There are two ... cons, the type chosen is almost entirely up to personal preference. However, tankless water ...
Breaking Medicine News(10 mins):