PANTAKIND-40 (Pantoprazole)

Pantakind-40 is a medication that contains the active ingredient pantoprazole, which belongs to a group of drugs known as proton pump inhibitors (PPIs). It is used to treat a variety of conditions related to excessive stomach acid production, including gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Pantoprazole works by reducing the amount of acid produced in the stomach, thereby reducing the symptoms associated with these conditions. Pantakind-40 is typically taken orally, and the dosage may vary depending on the condition being treated and the individual patient's needs. It is important to follow the prescribing physician's instructions carefully when taking this medication, as improper use can lead to unwanted side effects.

Proton Pump Inhibitors, ATC code: A02B C02

Therapeutic Indications

• Benign Gastric Ulcer
• Gastro-oesophageal Reflux Disease
• Duodenal Ulcer
• Duodenal Ulcer associated with Helicobacter pylori
• Prophylaxis of Non Steroidal Anti-inflammatory Drugs (NSAID)-associated gastric & duodenal ulcer in patients with an increased risk of gastroduodenal complications who require continued NSAID treatment.
• Zollinger-Ellison syndrome

Dosage & Administration

Benign Gastric Ulcer: Adult over 18 years, 40-80 mg daily in the morning for 4 weeks, continued for further 4 weeks if not fully healed.

Gastro-oesophageal Reflux Disease: Adult and children over 12 years, 20-80 mg daily in the morning for 4 weeks, continued for further 4 weeks if not healed; maintenance 20mg daily, increased to 40 mg if symptoms return.

Duodenal ulcer: Adult over 18 years, 40-80 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.

Prophylaxis of NSAID-associated gastric and duodenal ulcer in patients with an increased risk of gastroduodenal complications who require continued NSAID treatment: Adult over 18 years, 20mg daily.

Zollinger-Ellison syndrome (and other hypersecretory conditions): Adult over 18 years, initially 80 mg once daily and adjusted according to response (Elderly max, 40mg daily); daily doses above 80mg given in 2 divided doses.

Mode of administration

Tablet should be swallowed as whole with or without food & it should not be split, chewed, or crushed.

Contraindications

PANTAKIND-40 is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole.

Special warnings and precautions

In patients with severe hepatic impairment, the liver enzymes should be monitored regularly during treatment with Pantoprazole, particularly for long-term use.

In presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or malaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with pantoprazole may be alleviate symptoms and delay diagnosis. Further investigation is to be considered if symptoms persist despite adequate treatment.

Co-administration of atazanavir with proton pump inhibitor is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, dose clinical monitoring (e.g. virus load) is recommended in combination with an increase in the dose of atazanavir to 400mg with 100mg of ritonavir. A pantoprazole dose of 20mg per day should not be exceeded.

In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long term treatment, pantoprazole, as all aacid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo-or achlorhydria. This should be considered in patients with reduced body stores or risk of factors for reduced vitamin B12 absorption on long-term therapy  or if respective clinical symptoms are observed.

In long term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with Pantoprazole 40mg may lead to slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.

Several published observational studies suggest that proton pump inhibitor (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.

PANTAKIND-40 contains Lactose and hence patients with rare hereditary problems of fructose intolerance should not take this medicine. It also contains Propylene glycol which may cause skin irritation.

Interactions with other medicinal products and other form of interaction

Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may reduce the absorption of medicinal drugs with a gastric pH-dependent bioavailability (e.g. some azole antifungals such as ketoconazole, itraconazole, posaconazole and other medicines such as erlotinib).

Co-administration of atazanavir and other HIV medications whose absorption is pH-dependent with proton pump inhibitors might result in a substantial reduction in the bioavailability of these HIV medications and might impact the efficacy of these medicines. Therefore, co-administration of proton pump inhibitors with atazanavir is not recommended.

There have been post-marketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including Pantoprazole and Warfarin concomitantly. Increase in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly should be monitored for increases in INR and prothrombin time.

Pregnancy and lactation

Use in pregnancy: Pregnancy category B. There are no adequate and well-controlled studies of pantoprazole in pregnant women. Pantoprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Use in lactation: There are no adequate and well controlled studies of pantoprazole in lactating women and hence should be used only if clearly indicated.

Effects on ability to drive and use machines

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

Undesirable Effects

Side-effects of the proton pump inhibitors include gastro-intestinal disturbances including nausea, vomiting, abdominal pain, flatulence, diarrhea, constipation, and headache. Less frequent side-effects include dry mouth, peripheral oedema, dizziness, sleep disturbances, fatigue, paraesthesia, arthragia, myalgia, rash and pruritus.

Overdosage

Experience in patients taking very high dose of Pantoprazole (>240mg) is limited. Pantopraazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive.

Single oral doses of Pantoprazole at 709mg/kg, 798mg/kg and 887mg/kg 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.

Pharmacological Properties

Pantoprazole is a substitute benzimidazole which inhibits gastric acid secretion of hydrochloric acid in the stomach by specific blockage of  the proton pumps of the parietal cells.

Pantoprazole is converted to its active form in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i.e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both basal and stimulated acid secretion. As with other proton pump inhibitors and H2 receptor inhibitors, treatment with pantoprazole reduces acidity in the stomach, there by increases gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible. Since pantoprazole binds to the enzyme distal to the cell receptor levels, it can inhibit hydrochloric acid secretion independent of stimulation by other substances (acetylcholine, histamine, gastrin).