Pantoprazole 40mg Tablet (H-PANTO 40) 50s

585.00

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Description

ndications

Listed in Dosage.

Dosage

Adult : PO Gastro-oesophageal reflux disease 20-40 mg once daily for 4 weeks (increased to 8 weeks if necessary). Maintenance: 20-40 mg daily. Peptic ulcer 40 mg for 2-4 weeks for duodenal ulcer or 4-8 weeks for benign gastric ulcer. Prophylaxis of NSAID-induced ulcers 20 mg once daily. Zollinger-Ellison syndrome 40 mg bid (adjusted up to 240 mg/day if needed). Daily doses >80 mg should be given in 2 divided doses. IV Gastro-oesophageal reflux disease, Peptic ulcer 40 mg daily until PO can be resumed. Zollinger-Ellison syndrome 80 mg once or twice daily until PO can be resumed.

Dosage Details

Intravenous
Zollinger-Ellison syndrome

Adult: 80 mg once or twice daily as slow injection or short-term infusion over 2-15 minutes. Switch to oral therapy as soon as possible.

Intravenous
Gastro-oesophageal reflux disease, Peptic ulcer

Adult: 40 mg daily as slow injection or short-term infusion over 2-15 minutes. Switch to oral therapy as soon as possible.

Oral
Peptic ulcer

Adult: 40 mg once daily (increased up to 80 mg if necessary) for 2-4 weeks for duodenal ulcer or 4-8 weeks for benign gastric ulcer.

Oral
Gastro-oesophageal reflux disease

Adult: 20-40 mg once daily for 4 weeks (increased to 8 weeks if necessary). Maintenance: 20-40 mg daily. Alternatively, 20 mg daily on recurring symptoms.
Child: ≥5 years 15–40 kg: 20 mg once daily for up to 8 weeks; >40 kg: 40 mg once daily for up to 8 weeks.

Oral
Prophylaxis of NSAID-induced ulcers

Adult: 20 mg once daily.

Oral
Zollinger-Ellison syndrome

Adult: 40 mg bid (adjusted up to 240 mg/day if needed). Daily doses >80 mg should be given in 2 divided doses.

Hepatic Impairment

Max: 20 mg daily.

Administration

Normal Release: May be taken with or without food.
Controlled-Release: Should be taken on an empty stomach. Take 1 hr before meals. Swallow whole, do not chew/crush.

Reconstitution

Reconstitute 40 mg vial with 10 mL 0.9% NaCl inj to make a final concentration of approx 4 mg/mL. IV Infusion: Further dilute with 100 mL of D5W, normal saline, or Lactated Ringer’s inj to achieve a concentration of approx. 0.4 mg/mL. For an 80 mg dose: Reconstitute two 40 mg vials and dilute 10mL of the reconstituted solution in 100 mL of IV infusion solutions.

Contraindications

Concomitant use with rilpivirine and atazanavir.

Special Precautions

Patient with gastric malignancy, risk factors for reduced vitamin B12 absorption or at risk for osteoporosis. Hepatic impairment. Pregnancy and lactation.

Adverse Drug Reactions

Significant: Hypomagnesaemia, cutaneous lupus erythematosus, SLE, osteoporosis-related fractures, fundic gland polyp, carcinoma, Clostridium difficile-associated diarrhoea, interstitial nephritis, Vitamin B12deficiency (long-term therapy), gastrointestinal infection (e.g. salmonella, Campylobacter).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, flatulence, abdominal pain, dyspepsia, dry mouth.
General disorders and administration site conditions: Asthenia, fatigue, malaise.
Hepatobiliary disorders: Increased liver enzymes.
Immune system disorders: Urticaria.
Metabolism and nutrition disorders: Peripheral oedema.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache, dizziness, vertigo.
Psychiatric disorders: Insomnia.
Reproductive system and breast disorders: Gynaecomastia.
Skin and subcutaneous tissue disorders: Rash, pruritus.

Pregnancy Category (US FDA)

IV/Parenteral/PO: C

Patient Counselling

This drug may cause dizziness or visual disturbances, if affected, do not drive or operate machinery.

Monitoring Parameters

Monitor bone loss, fractures, Clostridium difficile-associated diarrhoea (CDAD), serum Mg (at baseline and periodically), serum gastrin level concentrations.

Drug Interactions

May decrease plasma concentrations of rilpivirine and atazanavir. Increased risk of hypomagnesaemia with diuretics. Increased risk of digoxin-induced cardiotoxic effects. May increase INR and prothrombin time of warfarin. May increase plasma concentration of methotrexate. May decrease absorption of itraconazole, ketoconazole, posaconazole, erlotinib. May diminish the therapeutic effect of clopidogrel. 

Food Interaction

St John’s wort may decrease serum levels of pantoprazole.

Lab Interference

May increase serum chromogranin A (CgA) levels causing false-positive result in diagnostic tests for neuroendocrine tumours and urine screening tests for tetrahydrocannabinol.

Mechanism of Action

Description: Pantoprazole is a substituted benzimidazole gastric antisecretory agent and is also known as proton pump inhibitor (PPI). It blocks the final step in gastric acid secretion by specific inhibition of H+/K+adenosine triphosphatase (ATPase) enzyme system present on the secretory surface of the gastric parietal cell. Both basal and stimulated acid are inhibited.
Onset: 2.5 hours (oral); 15-30 minutes (IV).
Duration: 24 hours.
Pharmacokinetics: 
Absorption: Rapidly absorbed. Time to peak plasma concentration: Approx 2-2.5 hours (oral). Bioavailability: Approx 77%.
Distribution: Enters breast milk. Volume of distribution: 11-23.6 L. Plasma protein binding: Approx 98% (mainly to albumin).
Metabolism: Extensive hepatic metabolism, mainly by CYP2C19 isoenzyme to desmethylpantoprazole and slightly by CYP3A4, CYP2D6 and CYP2C9 isoenzymes.
Excretion: Mainly via urine (approx 80%); faeces. Elimination half-life: Approx 1 hour.

Storage

Store between 20-25°C.

MIMS Class

Antacids, Antireflux Agents & Antiulcerants

ATC Classification

A02BC02 – pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

Additional information

location

davao, cdo, dipolog, butuan