ScripNet » Rx Updates

Endo Pharmaceuticals Announces Potential for Short Supply of Pain Medicines

DKoldras — Mon, 30 Jan 2012 22:54:33 +0000

January 30, 2012 – Endo Pharmaceuticals Announces Potential for Short Supply of Pain Medicines Endo Pharmaceuticals back on January 9th, as a result of a temporary shut-down of Novartis Consumer Health Inc.’s Lincoln, Neb., manufacturing facility, there will be a short-term supply constraint of OPANA® ER. The company also announced certain other Endo analgesic products manufactured at this facility may experience short-term supply disruptions. Endo is working closely with the U.S. Food and Drug Administration (FDA) and Novartis to minimize patient disruptions and promptly resume production of Endo’s products at the Lincoln facility.

As a result of the Novartis facility shutdown, Endo will be expediting the production of products at alternative manufacturing facilities. Endo has initiated the manufacturing of PERCOCET® and ENDOCET® at its Huntsville, Ala., facility and expects minimal disruption to patients on these products.

The possibility of short-term disruption in supply is expected to affect the following products and possibly all strengths:

• Opana ER®/Opana® (oxymorphone hydrochloride)
• Percocet®/Endocet® (oxycodone/acetaminophen)
• Percodan®/Endodan® (oxycodone/aspirin)
• Zydone® (hydrocodone/acetaminophen)
• oxymorphone hydrochloride
• morphine sulfate ER

Generic Version of Long-Acting Morphine, Kadian® Approved by FDA

DKoldras — Fri, 02 Dec 2011 08:00:10 +0000

November 22, 2011 – Watson Pharmaceuticals, a company based in Corona, CA, announced on November 11^th that the U.S. Food and Drug Administration (FDA) has approved their Abbreviated New Drug Application (ANDA) for a generic version of Kadian. This long-acting morphine sulfate preparation is indicated for the management of moderate to severe pain requiring around-the-clock relief for an extended period of time. The AB rated generic morphine sulfate extended release capsules are available in 20, 30, 50, 60, 80, and 100mg strengths, some of which are already available for shipment from wholesalers.

As with other opioids, morphine sulfate extended release carries the risk for dependence and abuse, respiratory depression, sedation, constipation and other side effects and must be titrated to a sufficient dose over time. It is not indicated for use in the 12 to 24 hours following surgery, for breakthrough pain on an “as needed” basis, for mild pain or pain which is expected to last for a short period of time. Morphine sulfate extended release capsules should not be chewed, crushed or dissolved. For patients who have difficulty swallowing oral solid medication, the capsules may be opened and sprinkled on applesauce but care must be taken not to chew the pellets to avoid consuming a potentially fatal dose of morphine.

Additionally, morphine sulfate extended release capsules should not be used by patients having an asthma attack, with severe asthma, trouble breathing, lung problems, or have a bowel blockage called paralytic ileus. This medication should not be taken with alcohol and caution must be used if it is to be taken with any other medications which may cause drowsiness.

For more information and the complete prescribing information , please go to: http://www.watson.com/products/product-database-detail.asp

Generic Version of Keppra XR® (Levetiracetam) Launched

DKoldras — Tue, 22 Nov 2011 18:31:56 +0000

September 15, 2011 – Generic versions of the brand name drug, Keppra XR, are being launched this month by both Watson Laboratories and Lupin Ltd. And both companies have begun shipping their products. Both companies are producing AB rated versions of levetiracetam in 500mg and 750mg strengths. Levetiracetam is indicate for the adjunctive therapy to treat partial onset seizures with epilepsy who are 16 years of age or older with epilepsy.

Treatment should be initiated with a dose of 1000mg once daily which can then be titrated upward by 1000mg every 2 weeks to a maximum dose of 3000mg per day. Dose adjustments are recommended in patients with impaired renal function. Should therapy need to stop, the dose should be gradually reduced in order to prevent withdrawal seizures. Common side effects include somnolence, dizziness and irritability. Patients and caretakers should be aware of the risk of suicidal ideation and contact the prescriber should this or other behavioral abnormalities be noted.

For more information, please go to Watson Laboratories: http://www.watson.com/products/product-database-detail.asp?group=alpha&c=L

Or Lupin, Ltd.: http://www.lupinpharmaceuticals.com/productlist.htm

Nucynta ER® (tapentadol extended release) Approved by FDA

DKoldras — Thu, 15 Sep 2011 18:20:59 +0000

September 15, 2011 – Johnson & Johnson obtained approval from the US Food & Drug Administration (FDA) for the long-acting version of tapentadol, Nucynta ER. The medication is designed to be taken twice daily for the control of moderate to severe chronic pain in adults when a continuous, 24-hour opioid analgesic is needed for an extended period of time. Nucynta ER is available in 50mg, 100mg, 150mg, 200mg and 250mg strengths and is currently available at wholesalers.

As with other opioid drugs, patients run the risk of becoming physically and psychologically dependent on this medication. Nucynta ER is available with a risk evaluation and mitigation strategy, or REMS, designed to educate providers about the potential for abuse, misuse, overdose and addiction from exposure to the drug.

Nucynta ER is contradicted for use in individuals with paralytic ileus, acute or severe bronchial asthma, hypercapnia in unmonitored settings or where there is no resuscitative equipment, and those with significant respiratory depression. Use of MAOI antidepressants must stop taking them for at least 14 days prior to initiating therapy with Nucynta ER to avoid the risk of serious cardiovascular events.

For more information, please go to:
http://www.jnj.com/connect/news/all/nucynta-er-tapentadol-extended-release-tablets-receives-fda-approval-for-the-management-of-moderate-to-severe-chronic-pain

FDA Issues Warning for doses of Celexa® (citalopram) over 40mg/day

DKoldras — Thu, 15 Sep 2011 17:35:13 +0000

September 15, 2011 – The US FDA has issued a warning stating that citalopram hydrobromide, an antidepressant sold generically and under the brand name Celexa, should not be administered at doses over 40 mg per day, because it can trigger abnormal electrical activity in the heart, leading to potentially fatal heart rhythm problems (including Torsade de Pointes). Additionally, the FDA stated that doses above 40mg per day do not appear to provide greater benefit in the treatment of depression than doses lower than 40mg per day. Formerly, citalopram dosage and administration guidelines from the manufacturer stated that some patients may need 60mg per day. Citalopram is available in 10mg, 20mg and 40mg tablets as well as a 10mg/5ml oral solution.

Alterations in the heart’s electrical activity (prolongation of the QT interval) may especially affect those with existing heart conditions, as well as patients who are prone to low levels of blood potassium and magnesium. The drug label for citalopram has been modified to include usage recommendations in line with the new drug dosage guidelines, as well as details on the risk for QT interval prolongation and Torsade de Pointes.

Patients taking doses of citalopram greater than 40mg per day should be instructed not the stop taking it or to change their dose without consulting their prescriber, but should be encouraged to contact their prescriber as soon as possible. Patients experiencing shortness of breath, dizziness, fainting or irregular heartbeat while taking citalopram should get immediate medical attention. Patients taking citalopram should also be instructed to read the drug’s medication guide and be encouraged to discuss questions with their prescriber. Patients with congenital long QT syndrome should not be prescribed citalopram. Patients with bradyarrhythmias, heart failure, or predisposition to hypomagnesemia or hypokalemia because of concomitant illness or medications, have a greater chance of developing Torsade de Pointes. Hypomagnesemia and hypokalemia should be effectively treated before prescribing citalopram. Test for electrolytes as clinically indicated. For patients with bradyarrhythmias, congestive heart failure, or those on concomitant drugs that prolong QT interval, considers ECG monitoring more frequently. For those with hepatic impairment, aged 60+ years, who are CYP 2C19 poor metabolizers, or who are taking concomitant Tagamet (Cimetidine) – the maximum recommended dose is 20 mg per day.

For more information please go to:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm