PANTIN 20

Pharmacotherapeutic group: proton pump inhibitors ATC code: A02B C02

Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of ant secretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).

PANTIN 20 (Pantoprazole Sodium Delayed Release Tablets USP 20 mg)

Therapeutic indications

Pantoprazole Sodium Delayed-Release Tablets indicated for:

Short-term treatment of erosive esophagitis associated with gas Gastro-esophageal reflux disease ( (GERD): Pantoprazole Sodium Delayed-Release Tablets is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole Sodium Delayed-Release Tablets 40mg may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.

Maintenance of Healing of Erosive Esophagitis: Pantoprazole Sodium Delayed-Release Tablets 40 mg is indicated for maintenance of healing of EE andreduction in relapse rates of daytime and Night time heartburn symptoms in adult patients with GERD.Controlled studies did not extend beyond 12 months.

Pathological Hypers ecretory Conditions Including Zollinger-Ellis on Syndrome: Pantoprazole Sodium Delayed-Release Tablets is indicated for the long-term treatment of pathologicalhypersecretory conditions,including Zollinger-Ellison (ZE) Syndrome.

Posology and method of administration

Tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.

Recommended dose

Short-Term Treatment of Erosive Esophagitis Associated With GERD

Adults: 40 mg Once daily for up to 8 weeks*

Children (5 years and older)

≥ 15 kg to < 40 kg: 20 mg Once daily for up to 8 weeks

≥ 40 kg: 40 mg Once daily for up to 8 weeks

Maintenance of Healing of Erosive Esophagitis

Adults: 40 mg Once daily†

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Adults: 40 mg Twice daily‡

* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole Sodium Delayed-Release Tablets may be considered.

† Controlled studies did not extend beyond 12 months

‡ Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.

Contraindications

Pantoprazole Sodium Delayed-Release Tablets is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria.

Proton pump inhibitors (PPIs), including Pantoprazole Sodium Delayed-Release Tablets are contraindicated with rilpivirine-containing products

Special warnings and precautions for use

Presence of Gastric Malignancy: In adults, symptomatic response to therapy with Pantoprazole Sodium Delayed-Release Tablets does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

Acute Interstitial Nephritis: Acute interstitial nephritis has been observed in patients taking PPIs including Pantoprazole Sodium Delayed-Release Tablets. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Pantoprazole Sodium Delayed-Release Tablets if acute interstitial nephritis develops.

Clostridium difficile-Associated Diarrhoea: Published observational studies suggest that PPI therapy like Pantoprazole Sodium Delayed-Release Tablets may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines

Cutaneous and Systemic Lupus Erythematosus: Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole sodium. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE.

Cyanocobalamin (Vitamin B-12) Deficiency: Generally, daily treatment with any acid-suppressing medications over a long period of time (e.g., longervthan 3 years) may lead to malabsorption of cyanocobalamin (Vitamin B-12) caused by hypo- or achlorhydria.

Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.

Hypomagnesemia: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.

Tumorigenicity: Due to the chronic nature of GERD, there may be a potential for prolonged administration of Pantoprazole Sodium Delayed-Release Tablets. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown

Fundic Gland Polyps: PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.

Interference with Investigations for Neuroendocrine Tumours: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.

Healthcare providers should temporarily stop Pantoprazole Sodium Delayed-Release Tablets treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

Interference with Urine Screen for THC: There have been reports of false-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs, including Pantoprazole Sodium Delayed-Release Tablets.

Concomitant Use of Pantoprazole Sodium Delayed-Release Tablets with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients

Excipients:

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Interaction with other medicinal products and other forms of interaction

Antiretrovirals: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.

Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with pantoprazole may reduce antiviral effect and promote the development of drug resistance.
Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with pantoprazole may increase toxicity of the antiretroviral drugs.

There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole.

Rilpivirine-containing products: Concomitant use with Pantoprazole Sodium Delayed-Release Tablets is contraindicated

Nelfinavir: Avoid concomitant use with Pantoprazole Sodium Delayed-Release Tablets

Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities.

Warfarin: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.

Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range.

Methotrexate: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted.

A temporary withdrawal of Pantoprazole Sodium Delayed-Release Tablets may be considered in some patients receiving high-dose methotrexate.

Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole): Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.

Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving Pantoprazole Sodium Delayed-Release Tablets and MMF. Use Pantoprazole Sodium Delayed-Release Tablets with caution in transplant patients receiving MMF.

Interactions with Investigations of Neuroendocrine Tumors: CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors

Temporarily stop Pantoprazole Sodium Delayed-Release Tablets treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

False Positive Urine Tests for THC: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs

An alternative confirmatory method should be considered to verify positive results.

Clopidogrel: Concomitant administration of pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition

No dose adjustment of clopidogrel is necessary when administered with an approved dose of Pantoprazole Sodium Delayed-Release Tablets.

Pregnancy and lactation

Pregnancy: Pregnancy Category B

Reproduction studies have been performed in rats at oral pantoprazole doses up to 450 mg/kg/day (about 88 times the recommended human dose based on body surface area) and in rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals. The studies have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole.

Nursing Mothers: Pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodium. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole sodium in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

Effects on ability to drive and use machines

Adverse drug reactions such as dizziness and visual disturbances may occur. If affected, patients should not drive or operate machines.

Overdose

Experience in patients taking very high doses of Pantoprazole Sodium Delayed-Release Tablets (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile Pantoprazole Sodium Delayed-Release Tablets Pantoprazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive. Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limbsplay, lateral position, segregation, absence of ear reflex, and tremor.

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PANTIN 20 (Pantoprazole Sodium Delayed Release Tablets USP 20 mg)

PANTIN 20