Pantoprazole Injection

• It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
• It is used to treat syndromes caused by lots of stomach acid.
• It may be given to you for other reasons. Talk with the doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking pantoprazole injection as you have been told by your doctor or other health care provider, even if you feel well.
• It is given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Very bad dizziness or passing out.
• Very bad belly pain.
• Bone pain.
• Fever or chills.
• Sore throat.
• A big weight loss.
• Irritation where the shot is given.
• This medicine may raise the chance of a very bad form of diarrhea called Clostridium difficile (C diff)-associated diarrhea. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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 Syndrome in adults.

Experience in patients taking very high doses of pantoprazole greater than 240 mg is limited. Adverse reactions seen in spontaneous reports of overdose generally reflect the known safety profile of pantoprazole.

Pantoprazole is not removed by hemodialysis. In case of overdose, treatment should be symptomatic and supportive.

Single intravenous doses of pantoprazole at 378, 230, and 266 mg/kg (38, 46, and 177 times the recommended human dose based on body surface area) were lethal to mice, rats and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.

The active ingredient in pantoprazole sodium for injection (pantoprazole sodium) a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is:



Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of pantoprazole sodium for injection is in the pH range 9.0 to 10.5.

Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried, white to off-white, porous cake or powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP), edetate disodium (1 mg), and sodium hydroxide to adjust pH.

Adverse Reactions

Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:

•   Hypersensitivity and Severe Skin Reactions [see Warnings and Precautions (5.2)]

•   Injection Site Reactions [see Warnings and Precautions (5.3)]

•   Potential for Exacerbation of Zinc Deficiency [see Warnings and Precautions (5.4)]

•   Acute Interstitial Nephritis [see Warnings and Precautions (5.5)]

•   Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.6)]

•   Bone Fracture [see Warnings and Precautions (5.7)]

•   Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8)]

•   Hepatic Effects [see Warnings and Precautions (5.9)]

•   Hypomagnesemia [see Warnings and Precautions (5.10)]

Drug Interactions

Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [Contraindications (4)], high dose methotrexate [Warnings and Precautions (5.12)] and over-the-counter medications.

Pregnancy

Inform female patients of reproductive potential that pantoprazole sodium may cause fetal harm and to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Distributed by:
AuroMedics Pharma LLC
279 Princeton-Hightstown Rd.
E. Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad - 500038
India