Gastroenterology Case No 10. PPI-5

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Gastroenterology Case No 10. PPI-5

একটা ঔষধ এর কথা যদি বলা হয় যেটা সব প্রেসক্রিপশনে থাকে সেটা ppi..

এবং এটার দাম ও একদম কম নয়।6-8tk/cap

এই ঔষধ গুলা আমারা গতানুগতিক ভাবে দিনে ২ বেলা দিয়ে থাকি।।

কিন্তু এটা omeprazole 20mg /esomeprazole20mg//rabeprazole20mg/pantoprazole 40/lansoprazole 30mg সবগুলোই Once daily dose..যেটা davidson এর ২৪ edition এ অনেক আগেই এসেছে।।

High dose এ দেয়ার indication থাকলে হয়তো আপনি ome/esomeprazole 40mg দিতে পারেন তাও once daily

Once daily মানে দিনে যেকোনো সময় দিতে পারেন, কিন্তু গবেষণায় দেখা গেছে 1st thing in the morning.. সকালে খালি পেটে PPI খেলে সবচেয়ে ভাল কাজ করে।।তাই আমরা

1.Omeprazole :-20mg 1+0+0 দিতে পারি।।

Capsule 1:-Omenix 20mg (AS A Omeprazole AS A Proton Pump Inhibitor).

Indications of Capsule 1:-Omenix 20mg (AS A Omeprazole AS A Proton Pump Inhibitor).

Omenix is indicated for the treatment of-

Gastric and duodenal ulcer
NSAID-associated duodenal and gastric ulcer
As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
Gastro-esophageal reflux disease
Long-term management of acid reflux disease
Acid-related dyspepsia
Severe ulcerating reflux esophagitis
Prophylaxis of acid aspiration during general anesthesia
Zollinger-Ellison syndrome
Helicobacter pylori-induced peptic ulcer.

Pharmacology of Capsule 1:-Omenix 20mg (AS A Omeprazole AS A Proton Pump Inhibitor).

Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H⁺/K⁺ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.

Dosage of Capsule 1:-Omenix 20mg (AS A Omeprazole AS A Proton Pump Inhibitor).

Oral-

Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
Long-term management of acid reflux disease: 10-20 mg daily.
Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.

IV Injection-

Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.

Administration

Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.

Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.

Interaction of Capsule 1:-Omenix 20mg (AS A Omeprazole AS A Proton Pump Inhibitor).

Due to the decreased intragastric acidity the absorption of ketoconazole may be reduced during Omenix treatment as it is during treatment with other acid secretion inhibitors. As Omenix is metabolised in the liver through cytochrome P450 it can delay the elimination of diazepam, phenytoin and warfarin. Monitoring of patients receiving warfarin or pheytoin is recommended and a reduction of warfarin or phenytoin dose may be necessary. However concomitant treatment with Omenix 20mg daily did not change the blood concentration of phenytoin in patients on continuous treatment with phenytoin. Similarly concomitant treatment with Omenix 20mg daily did not change coagulation time in patients on continuous treatment with warfarin. Plasma concentrations of Omenix and clarithromycin are increased during concomitant administration. This is considered to be a useful interaction during H. pylori eardication. There is no evidence of an interaction with phenacetin, theophylline, caffeine, propranolol, metoprolol, cyclosporin, lidocaine, quinidine, estradiol, amoxycillin or antacids. The absorption of Omenix is not affected by alcohol or food. There is no evidence of an interaction with piroxicam, diclofenac or naproxen. This is considered useful when patients are required to continue these treatments. Simultaneous treatment with Omenix and digoxin in healthy subjects lead to a 10% increase in the bioavailability of digoxin as a consequence of the increased intragastric pH.

Contraindications of Capsule 1:-Omenix 20mg (AS A Omeprazole AS A Proton Pump Inhibitor).

Omeprazole is contraindicated in patients with known hypersensitivity to it. When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with omeprazole is instituted, as treatment may alleviate symptoms and delay diagnosis.

Side Effects of Capsule 1:-Omenix 20mg (AS A Omeprazole AS A Proton Pump Inhibitor).

Omenix is well tolerated and adverse reactions have generally been mild and reversible. Skin rash, urticaria and pruritus have been reported. Usually resolving after discontinuation of treatment. In addition photosensitivity, bullous eruption, erythema multiforme, angioedema and alopecia have been reported in isolated cases. Diarrhoea and headache have been reported and may be severe enough to require discontinuation of therapy in a small number of patients. In the majority of cases the symptoms resolved after discontinuation of therapy. Other gastrointestinal reactions have included constipation, nausea/vomiting, flatulence and abdominal pain. Dry mouth, stomatitis and candidiasis have been reported as isolated cases. Paraesthesia has been reported. Dizziness, light headedness and feeling faint have been associated with treatment, but all usually resolve on cessation of therapy. Also reported are somnolence, insomnia and vertigo. Reversible mental confusion, agitation, depression and hallucinations have occurred predominantly in severely ill patients. Arthritic and myalgic symptoms have been reported and have usually resolved when therapy is stopped. In isolated cases, the following have been reported: blurred vision, taste disturbance, peripheral oedema, increased sweating, gynaecomastia, leucopenia, thrombocytopenia, agranulocytosis, pancytopenia, anaphylactic shock, malaise, fever, bronchospasm, encephalopathy in patients with pre-existing severe liver disease, hepatitis with or without jaundice, rarely interstitial nephritis and hepatic failure. Increases in liver enzymes have been observed.

Pregnancy & Lactation of Capsule 1:-Omenix 20mg (AS A Omeprazole AS A Proton Pump Inhibitor).

Results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. Omeprazole can be used during pregnancy. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.

Use in Children & Adolescents: Safety and effectiveness of Omeprazole have not been established in pediatric patients less than 18 years of age.

Precautions & Warnings of Capsule 1:-Omenix 20mg (AS A Omeprazole AS A Proton Pump Inhibitor).

Avoid concomitant use of clopidogrel and Omenix as the pharmacological activity of clopidogrel is reduced if given concomitantly. 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. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with Omenix. Concomitant use of PPIs with methotrexate may lead to methotrexate toxicities.

Therapeutic Class of Capsule 1:-Omenix 20mg (AS A Omeprazole AS A Proton Pump Inhibitor).

Proton Pump Inhibitor

2.Esomeprazole:-

Tablet 2:Esonix 20 mg (AS A Esomeprazole AS A Proton Pump Inhibitor ).

Indications of Tablet 2:Esonix 20 mg (AS A Esomeprazole AS A Proton Pump Inhibitor ).

Esonix is indicated:

To relieve from chronic heartburn symptoms and other symptoms associated with GERD
For the healing of erosive esophagitis
For maintenance of healing of erosive esophagitis
In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
Zollinger-Ellison Syndrome
Acid related Dyspepsia
Duodenal & Gastric ulcer

Pharmacology of Tablet 2:Esonix 20 mg (AS A Esomeprazole AS A Proton Pump Inhibitor ).

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.

Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (C_max) occur at approximately 1.5 hours (T_max). The C_maxincreases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.

Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.

Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.

Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.

Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.

Dosage of Tablet 2:Esonix 20 mg (AS A Esomeprazole AS A Proton Pump Inhibitor ).

Oral dosage form-

Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks. The majority of patients are healed within 4 to 8 weeks. For patients who don’t heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. Maintenance of Healing of Erosive
Esophagitis: 20 mg Once Daily (Clinical studies did not extend 6 months).
Symptomatic GERD: 20 mg Once Daily for 4 Weeks. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days.
Zollinger-Ellison Syndrome: The dose is 20-80 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated.
Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to the response.
Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.

IV Injection or IV infusion:

GERD with Erosive Esophagitis–
Adult Patients (≥18 years):

20 mg or 40 mg once daily
IV Injection: >3 Minutes, IV Infusion: 10-30 minutes

Pediatric Patients (1 year to 17 years)

Body weight <55 kg: 10 mg Once daily
Body Weight ≥55 kg: 20 once daily
1 month to <1 year: 0.5 mg/kg once daily
IV Infusion: 10-30 minutes

Risk reduction of rebleeding of Gastric or Duodenal Ulcers following therapeutic endoscopy in adults–
Adult Patients (≥18 years)

80 mg
IV Infusion: 30 minutes, followed by a continuous infusion of 8 mg/h for a total treatment duration of 72 hours.

Administration

Tablet or capsule: should be swallowed whole and taken one hour before a meal.

Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

IV Injection: Solution for injection is prepared by adding 5 ml of 0.9% Sodium Chloride for intravenous injection into the vial containing the dry powder. The reconstituted solution for injection is clear and colorless to very slightly yellow. IV injection must be administrated intravenously over a period of at least 3 minutes. Prepared solution must be used within 12 hours of preparation and can be exposed to normal indoor lighting at a maximum of 30°C.

Interaction of Tablet 2:Esonix 20 mg (AS A Esomeprazole AS A Proton Pump Inhibitor ).

Esonix is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esonix is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esonix does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Esonix may potentially interfere with CYP2C19, the major Esonix metabolizing enzyme. Co-administration of Esonix 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esonix inhibits gastric acid secretion. Therefore, Esonix may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).

Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esonix.

Combination Therapy with Clarithromycin: Co-administration of Esonix, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of Esonix and 14-hydroxyclarithromycin.

Contraindications of Tablet 2:Esonix 20 mg (AS A Esomeprazole AS A Proton Pump Inhibitor ).

Esomeprazole is contraindicated in-patient with known hypersensitivity to any of the formulation.

Side Effects of Tablet 2:Esonix 20 mg (AS A Esomeprazole AS A Proton Pump Inhibitor ).

The most frequently occurring adverse events reported with Esonix include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.

Pregnancy & Lactation of Tablet 2:Esonix 20 mg (AS A Esomeprazole AS A Proton Pump Inhibitor ).

There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects. The excretion of esomeprazole in milk has not been studied. Breast-feeding should be therefore be discontinued if the use of esomeprazole is considered essential.

3. Rabeprazole:-

Tablet 3:Finix 20 mg (AS A Rabeprazole Sodium AS A Proton Pump Inhibitor).

Indications of Tablet 3:Finix 20 mg (AS A Rabeprazole Sodium AS A Proton Pump Inhibitor).

Finix is indicated for the treatment of:

Active duodenal ulcer
Active benign gastric ulcer
Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD).
Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)
Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD)
Zollinger-Ellison Syndrome
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.

Pharmacology of Tablet 3:Finix 20 mg (AS A Rabeprazole Sodium AS A Proton Pump Inhibitor).

Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H⁺/K⁺-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.

Dosage

Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.

Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.

Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.

Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.

Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.

Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.

Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.

Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.

Administration of Tablet 3:Finix 20 mg (AS A Rabeprazole Sodium AS A Proton Pump Inhibitor).

For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.

Interaction

Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH dependent may occur. Co-administration of Finix with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.

Contraindications of Tablet 3:Finix 20 mg (AS A Rabeprazole Sodium AS A Proton Pump Inhibitor).

Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contra-indicated in pregnancy and during breastfeeding.

Side Effects of Tablet 3:Finix 20 mg (AS A Rabeprazole Sodium AS A Proton Pump Inhibitor).

In general, Finix is well-tolerated in both short-term and long-term studies. Finix may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.

Pregnancy & Lactation of Tablet 3:Finix 20 mg (AS A Rabeprazole Sodium AS A Proton Pump Inhibitor).

US FDA pregnancy category ‘C’. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Precautions & Warnings of Tablet 3:Finix 20 mg (AS A Rabeprazole Sodium AS A Proton Pump Inhibitor).

Symptomatic response to therapy with Finix does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Finix 20 mg Gastro-resistant Tablets.
Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care and they should have an adequate intake of vitamin D and calcium.
A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles cannot be excluded.
Patients should be cautioned that Finix gastro-resistant tablets should not be chewed or crushed, but should be swallowed whole.
There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation. In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
No evidence of significant drug related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However because there are no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Finix 20mg Gastro-resistant. Tablets is first initiated in such patients.
Co-administration of atazanavir with Finix is not recommended.
Treatment with proton pump inhibitors, including rabeprazole, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.

Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with PPIs like rabeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Influence on vitamin B12 absorption: Finix, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Finix. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Finix 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

Use in Special Populations

Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.

Pediatric populations: Finix is not recommended for use in children due to a lack of data on safety and efficacy.

Overdose Effects

The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Finix is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.

Therapeutic Class of Tablet 3:Finix 20 mg (AS A Rabeprazole Sodium AS A Proton Pump Inhibitor).

Proton Pump Inhibitor.

4. Pantoprazole:-

Tablet 4:Pantonix 20 (AS A Pantoprazole Sodium AS A Proton Pump Inhibitor).

Indications of Tablet 4:Pantonix 20 (AS A Pantoprazole Sodium AS A Proton Pump Inhibitor).

Pantonix is indicated where suppression of acid secretion has therapeutic benefit; i.e

Peptic ulcer diseases
Gastroesophageal reflux diseases
Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
Eradication of Helicobacter pylori (in combination with antibiotics)
Zollinger-Ellison Syndrome

Pharmacology of Tablet 4:Pantonix 20 (AS A Pantoprazole Sodium AS A Proton Pump Inhibitor).

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Dosage & Administration of Tablet 4:Pantonix 20 (AS A Pantoprazole Sodium AS A Proton Pump Inhibitor).

Oral:

Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Interaction of Tablet 4:Pantonix 20 (AS A Pantoprazole Sodium AS A Proton Pump Inhibitor).

No significant drug interactions have been observed in clinical studies.

Contraindications of Tablet 4:Pantonix 20 (AS A Pantoprazole Sodium AS A Proton Pump Inhibitor).

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Side Effects of Tablet 4:Pantonix 20 (AS A Pantoprazole Sodium AS A Proton Pump Inhibitor).

Pantonix is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pregnancy & Lactation of Tablet 4:Pantonix 20 (AS A Pantoprazole Sodium AS A Proton Pump Inhibitor).

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, 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.

Precautions & Warnings

Patients should be cautioned that Pantonix tablet should not be split, chewed or crushed. Long-term therapy of Pantonix may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

Overdose Effects

There are no known symptoms of overdosage in humans. Since Pantonix is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Therapeutic Class of Tablet 4:Pantonix 20 (AS A Pantoprazole Sodium AS A Proton Pump Inhibitor).

Proton Pump Inhibitor

5.Lansoprazole:-

Capsule 5:- Lanso 30 mg (AS A Lansoprazole AS A Proton Pump Inhibitor).

Indications of Capsule 5:- Lanso 30 mg (AS A Lansoprazole AS A Proton Pump Inhibitor).

Lanso is indicated for:

Short term treatment of active duodenal ulcer
Maintenance of healed duodenal ulcers
Short term treatment of active benign gastric ulcers
Short term treatment of active erosive esophagitis
Maintenance of healing of erosive esophagitis
Pathological hypersecretory conditions including Zollinger-Ellison Syndrome
H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Pharmacology of Capsule 5:- Lanso 30 mg (AS A Lansoprazole AS A Proton Pump Inhibitor).

Lansoprazole is a substituted benzimidazole, and is also known as PPI due to its property to block the final step of acid secretion by inhibiting H⁺/K⁺ ATPase enzyme system in gastric parietal cell. Both basal and stimulated acid are inhibited.

Dosage & Administration of Capsule 5:- Lanso 30 mg (AS A Lansoprazole AS A Proton Pump Inhibitor).

Benign gastric ulcer: 30 mg daily in the morning for 8 weeks.

Duodenal ulcer: 30 mg daily in the morning for 4 weeks; maintenance 15 mg.

NSAID-associated duodenal or gastric ulcer: 15-30 mg daily for 4 weeks, followed by a further 4 weeks if not fully healed.

Zollinger-Ellison syndrome (and other hypersecretory conditions): Initially 60 mg once daily adjusted according to response; daily doses of 120 mg or more is given in two divided doses.

Gastroesophageal reflux disease: 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily.

Acid-related dyspepsia: 15-30 mg daily in the morning for 2-4 weeks.

Interaction of Capsule 5:- Lanso 30 mg (AS A Lansoprazole AS A Proton Pump Inhibitor).

Lanso appears to be a selective inhibitor of the cytochrome P-450 monooxygenase system; there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Lanso on the oral combined contraceptive pill. Further assessment is currently underway. Physiological changes similar to those found with Omeprazole are likely to take place because of the reduction in gastric acid, which is likely to influence the bacterial colonization of the stomach and duodenum and also vitamin B12 absorption.

Contraindications of Capsule 5:- Lanso 30 mg (AS A Lansoprazole AS A Proton Pump Inhibitor).

Lansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

Side Effects of Capsule 5:- Lanso 30 mg (AS A Lansoprazole AS A Proton Pump Inhibitor).

Severe or irreversible adverse effects: The possible induction of carcinoid tumors by profound acid suppression, and a rise in serum gastrin may occur. There is a rise in serum gastrin levels in the first 3 months of treatment, which are then maintained though at a lower level than those found in pernicious anaemia. Long term treatment with a proton pump inhibitor in patients with Helicobacter pylori infection may accelerate the development of atrophic gastritis.

Symptomatic adverse effect: Dose dependent diarrhoea occurs with an incidence of about 4% at 30 mg per day, rising to 8% at 60 mg per day. Headache occurs in 2-3% of treated patients

Pregnancy & Lactation of Capsule 5:- Lanso 30 mg (AS A Lansoprazole AS A Proton Pump Inhibitor).

Lansoprazole should be avoided in pregnancy unless there are compelling reasons.

Precautions & Warnings

Gastric malignancy should be ruled out. Hepatic impairment. Pregnancy and lactation.

Use in Special Populations of Capsule 5:- Lanso 30 mg (AS A Lansoprazole AS A Proton Pump Inhibitor).

Neonates:There is no relevant human data. The drug is not recommended for use with neonates.

Children: The youngest person to have received Lanso in clinical trials was 13 years old.

The Elderly: No problems have been encoun- tered in clinical use and there has been no increase in adverse drug reaction in the elderly.

Therapeutic Class of Capsule 5:- Lanso 30 mg (AS A Lansoprazole AS A Proton Pump Inhibitor).

Proton Pump Inhibitor

Digest medicine Raiyyan Tahsan Date:25-01-2025 Saturday Time:7-45-55 Pm

Raiyyan Tahsan

Raiyyan Tahsan