Covis' Zantac® Injection Returns to the Market

CARY, N.C., March 29, 2012 /PRNewswire/ -- Covis Pharmaceuticals, Inc. announced today that Zantac® (ranitidine hydrochloride) Injection is once again widely available for therapeutic use throughout the United States and Puerto Rico. The company launched last year as a distributor for a product portfolio that addresses life threatening and other serious medical conditions in the cardiovascular, central nervous system and acute care markets.

"Covis was formed to reliably provide critical therapies to clinicians and their patients," said Bill Collins, CEO of Covis Pharmaceuticals Inc. "By making Zantac Injection available again we are delivering on our company's promise to develop efficient, quick and dependable responses to current needs."

Covis markets and distributes Zantac® Injection in three SKUs that are available now, including 2 mL, 6 mL and 40 ml vials. The company expects to make available Zantac® Injection 50 mg premixed bags by the summer. Orders for Zantac® Injection are being taken through the wholesalers.

With five brands currently in market, Covis Pharmaceuticals, Inc. aims to become a leading specialty pharmaceutical distributor. "Global pharmaceutical companies need to focus on development and delivery of blockbuster therapies, while we can identify and support specialty products based on their clinical and market values," says Collins.  "Covis can invest the necessary work and focused expertise to reduce distribution interruptions for critical therapies."

About Zantac® (ranitidine hydrochloride) Injection
Zantac® (ranitidine hydrochloride) Injection is a histamine H2-receptor antagonist indicated for the treatment of some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication.

Important Safety Information about ZANTAC Injection and ZANTAC Injection Premixed
ZANTAC Injection and ZANTAC Injection Premixed are contraindicated in patients known to have hypersensitivity to the drug.

Since ZANTAC is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function (see Dosage and Administration section of the complete Prescribing Information). Caution should be observed in patients with hepatic dysfunction since ZANTAC is metabolized in the liver.

In controlled studies in normal volunteers, elevations in serum glutamic pyruvic transaminase (SGPT) have been observed when H(2)‑antagonists have been administered intravenously at greater-than-recommended dosages for 5 days or longer. Therefore, in patients receiving IV ranitidine at dosages ≥100 mg 4 times daily for periods of 5 days or longer, SGPT levels should be monitored daily (starting on Day 5 of treatment) for the remainder of IV ranitidine therapy.

Bradycardia in association with rapid administration of ZANTAC Injection has been reported rarely, usually in patients with predisposing factors for cardiac rhythm disturbances; therefore, recommended rates of administration should not be exceeded (see Dosage and Administration section of the complete Prescribing Information).

Rare reports suggest that ZANTAC may precipitate acute porphyric attacks in patients with acute porphyria. ZANTAC should, therefore, be avoided in patients with a history of acute porphyria.

Symptomatic response to therapy with ZANTAC does not preclude the presence of gastric malignancy.

Transient pain at the site of IM injection of ZANTAC has been reported. Transient local burning or itching has been reported with IV administration of ZANTAC. Headache, sometimes severe, seems to be related to the administration of ZANTAC.

Zantac Injection Complete Prescribing Information http://www.covispharma.com/assets/pdfs/zantac-pi.pdf

About Covis
Covis Pharmaceuticals is a specialty pharmaceutical distributor dedicated to improving the lives of people with life-threatening conditions and chronic illnesses. The company's mission is to provide customers with a continuous supply of safe, efficacious, and affordable therapeutic solutions. The company's current product portfolio includes Lanoxin® (digoxin) Tablets, Lanoxin® (digoxin) IV, Parnate® (tranylcypromine sulfate tablets), Zantac® (ranitidine hydrochloride) Injection, Fortaz® (ceftazidime for injection) and Zinacef® (cefuroxime for injection). Covis Pharmaceuticals is an affiliate of Covis Pharma, Sarl, a Switzerland-based specialty pharmaceutical company. For more information, visit www.covispharma.com. 

For full prescribing information on Covis products, including BOXED WARNINGS for PARNATE, please visit www.covispharma.com or contact the Company at 919-535-3049.

SOURCE Covis Pharmaceuticals, Inc.