Hikma Pharmaceuticals PLC (Hikma, Group) announces that its wholly owned US subsidiary West-Ward Pharmaceuticals Corp. (West-Ward), has launched Pantoprazole Sodium for Injection, 40mg.
According to IMS Health, US sales of Pantoprazole Sodium for Injection were approximately $104 million in the 12 months ending August 2017.
Riad Mechlaoui, Chief Executive Officer of Injectables said, “We are very pleased to launch Pantoprazole Sodium for Injection, reducing the shortage of this product in the US market. We are successfully executing our Injectables pipeline and leveraging the additional capacity we have been adding to our Portuguese facility to support future growth.”
Indications: Gastroesophageal reflux disease associated with a history of erosive esophagitis
Pantoprazole Sodium for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of Pantoprazole Sodium for Injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.
Pathological hypersecretion including Zollinger-Ellison Syndrome. Pantoprazole Sodium for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
Gastric malignancy: In adults, symptomatic response to therapy with Pantoprazole Sodium for Injection does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. Hypersensitivity and severe skin reactions: Anaphylaxis has been reported. Injection site reactions: Thrombophlebitis is associated with intravenous use. Acute Interstitial Nephritis: Observed in patients taking proton pump inhibitors (PPIs). Clostridium difficile - associated diarrhea: PPI therapy may be associated with increased risk. Bone fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Cutaneous and systemic lupus erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Pantoprazole Sodium for Injection and refer to specialist for evaluation.
·Pantoprazole Sodium for Injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticarial. PPIs, including Pantoprazole Sodium for Injection, are contraindicated in patients receiving rilpivirine-containing products. Consult the labelling of concomitantly used drugs to obtain further information about interactions with PPIs.