SOUTH BELOIT, Ill., April 10, 2012 (GLOBE NEWSWIRE) -- TAGI Pharma, Inc., a subsidiary of Precision Dose, Inc., announced today the signing of an exclusive marketing rights agreement to market and sell the approved NDA product, Codeine Sulfate Oral Solution CII, 30mg/5mL in the United States and its territories, possessions and protectorates.
Codeine Sulfate Oral Solution CII, 30 mg/5mL is the only FDA approved codeine sulfate liquid product which does not include acetaminophen as an ingredient of the product. Codeine sulfate is an opioid analgesic indicated for the management of mild to moderately severe pain where the use of an opioid analgesic is appropriate. Codeine sulfate is contraindicated in patients with known hypersensitivity to codeine or any components of the product. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine. Codeine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. Codeine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. Codeine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus. (See the accompanying prescribing information for additional safety and product information)
Thomas Anderson, Executive President and responsible for TAGI's Business Development activities said, "This agreement represents a significant step forward in the implementation of TAGI Pharma's business plan to bring differentiated products to the marketplace, utilizing an aggressive business development initiative to license, acquire and co-develop products." Robert Koopman, President and CEO of TAGI Pharma, said "We are particularly pleased to have this product in our portfolio, which provides patients with an alternative to medicines that contain acetaminophen."
About TAGI Pharma, Inc. and Precision Dose, Inc.
TAGI Pharma, Inc. is a specialty pharmaceutical company, established to target the generic retail market. Thomas Anderson said, "Our product selection for TAGI Pharma is focused on higher barriers to entry and limited competition, with an emphasis on controlled substances, where there are market expansion opportunities in the retail market, as well as the non-retail sector being serviced by Precision Dose."
Precision Dose was established in 2003, and continues to work with the products of prescription and non-prescription liquid manufacturers, as well as its own products, to add value through its unique unit dose delivery systems, servicing the hospital and long term care markets. "With its unique line of liquid unit dose products, Precision Dose continues to expand market share by meeting customers' needs to eliminate dispensing errors, improve inventory control and achieve cost containment. We are uniquely positioned in the marketplace, leveraging the customer relationships of both companies, and thereby optimizing the market opportunities for our products," said Kenny Harrington, Vice President of Sales and Marketing for both TAGI Pharma and Precision Dose, Inc.
Codeine Sulfate Oral Solution CII Important Information:
BRIEF SUMMARY
This brief summary does not include all the information needed to use CODEINE SULFATE ORAL SOLUTION safely and effectively. Please see package insert for full prescribing information for CODEINE SULFATE ORAL SOLUTION.
CODEINE SULFATE ORAL SOLUTION CII
(Codeine Sulfate Oral Solution, USP) 30 mg per 5 mL
DESCRIPTION
Each 5 mL of Codeine Sulfate Oral Solution contains codeine sulfate, USP 30 mg. The concentration of the 30 mg per 5 mL solution is 6 mg/mL.
INDICATIONS AND USAGE
Codeine sulfate is an opioid analgesic indicated for the management of mild to moderately severe pain where the use of an opioid analgesic is appropriate.
DOSAGE AND ADMINISTRATION
Usual adult dosage: 15 to 60 mg up to every 4 hours as needed.
Doses above 60 mg may fail to give commensurate pain relief, and may be associated with an increased incidence of undesirable side effects.
CONTRAINDICATIONS
Codeine sulfate is contraindicated in:
- Patients with known hypersensitivity to codeine or any components of the product. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine.
- Patients with respiratory depression in the absence of resuscitative equipment.
- Patients with acute or severe bronchial asthma or hypercarbia.
- Patients who have or are suspected of having paralytic ileus.
WARNINGS AND PRECAUTIONS
Respiratory Depression
Increased risk in elderly, debilitated patients, those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction.
Controlled Substance
Codeine sulfate is a Schedule II controlled substance with an abuse liability similar to other opioids.
CNS Effects
Additive CNS depressive effects, including respiratory depression, hypotension, profound sedation, coma, or death when used in conjunction with alcohol, other opioids, or illicit drugs.
Elevation of Intracranial Pressure
May be markedly exaggerated in the presence of head injury, other intracranial lesions.
Hypotensive Effect
Increased risk with compromised ability to maintain blood pressure.
Prolonged Gastric Obstruction
Codeine sulfate should not be administered to patients with gastrointestinal obstruction, especially paralytic ileus.
Pancreatic/Biliary Tract Disease
May cause spasm of the sphincter of Oddi and diminish biliary and pancreatic secretions.
Ultra-Rapid Metabolizers
Conversion of codeine into its active metabolite, morphine, may occur more rapidly and completely resulting in higher than expected morphine levels and overdose symptoms.
Impaired Mental/Physical Abilities
Caution must be used with potentially hazardous activities.
ADVERSE REACTIONS
Serious adverse reactions associated with codeine are respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.
The most frequently observed adverse reactions with codeine administration include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation.
Other adverse reactions include allergic reactions, euphoria, dysphoria, abdominal pain, and pruritis.
To report SUSPECTED ADVERSE REACTIONS, contact Roxane Laboratories, Inc. at 800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
CNS Depressants
Increased risk of additive CNS depression. Use with caution in reduced dosages.
Anticholinergics
Additive risk of urinary retention and paralytic ileus.
Antidepressants
May cause excessive sedation, acute hypotension and excessive anticholinergic effects. Codeine sulfate should not be used in patients taking MAOIs or within 14 days of stopping such treatment.
CYP2D6 Inhibitors and CYP3A4 Inhibitors and Inducers
Concomitant use of cytochrome P450 2D6 and 3A4 enzyme inducers or inhibitors may result in an altered response to codeine. Monitor analgesic activity and adverse drug reactions.
USE IN SPECIFIC POPULATIONS
Pregnancy Category C
Based on animal data, may cause fetal harm.
Nursing Mothers
Codeine is secreted into human milk. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and the baby.
Geriatric Patients, Renal Impairment, Hepatic Impairment
Use caution during dose selection, starting at the low end of the dosing range while carefully monitoring for side effects.
STORAGE AND HANDLING
Store at controlled room temperature, 20 degrees to 25 degrees Celsius (68 degrees to 77 degrees Fahrenheit), excursions permitted between 15 degrees and 30 degrees Celsius (between 59 degrees and 86 degrees Fahrenheit). Protect from light and moisture.
All opioids, including codeine sulfate, are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.
10007857/01 Revised March 2012, © RLI, 2012