The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.
Mechanism of Action of Pantoprazole
Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade 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. In most patients, freedom from symptoms is achieved within 2 weeks. As with other proton pump inhibitors and H2 receptor inhibitors, treatment with pantoprazole reduces acidity in the stomach and thereby 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 level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously.
Indications of Pantoprazole
Pentoprazole is used to treat conditions caused by too much acid production in the stomach, such as
- To treat symptoms of GORD such as heartburn and acid regurgitation
- Gastroesophageal reflux disease (GERD)
- Erosive esophagitis (acid-related damage to the esophagus, the tube that connects your mouth to your stomach)
- Erosive Esophagitis
- Zollinger-Ellison Syndrome
- Gastric (stomach) ulcers or duodenal ulcers. Duodenal ulcers occur in your duodenum. This is the first part of your small intestine. It is the part connected to your stomach.
- Duodenal Ulcer
- Erosive Esophagitis
- Helicobacter Pylori Infection
- Peptic Ulcer
- Stress Ulcer Prophylaxis
- Conditions where your stomach makes too much acid, such as Zollinger-Ellison Syndrome
- Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
- Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
- Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Pentoprazole 20 mg capsules can also be used to stop ulcers from forming if you are taking NSAIDs.
- Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
- Benign gastric ulcers
- Heartburn and other symptoms associated with GERD,
- Erosive esophagitis, and long-term treatment of pathological hypersecretory conditions
- Multiple endocrine adenomas,
- Systemic mastocytosis.
Therapeutic Uses of Pantoprazole [FDA Level]
- Short-term (up to 16 weeks) treatment of erosive esophagitis.
- 20 mg gastro-resistant tablets Symptomatic gastro-oesophageal reflux disease
- For long-term management and prevention of relapse in reflux oesophagitis
- Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment
- 40 mg gastro-resistant tablets
- Reflux oesophagitis
- Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers
- Gastric and duodenal ulcer
- Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions
- Intravenous (i.v.) 40 mg powder for solution for injection
- Gastric and duodenal ulcer
- Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions
- Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
- PANTOLOC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
- Pantoprazole is a proton pump inhibitor (PPI), indicated for the treatment of gastrointestinal diseases
Therapeutic Indications of Pantoprazole
- Pantoprazole delayed-release tablets are indicated for the short-term (up to 8 weeks) treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD).
- Pantoprazole for injection is indicated for the short-term (7 to 10 days) treatment of GERD in patients who are unable to continue taking pantoprazole delayed-release tablets.
- Pantoprazole for injection is not indicated for the initial treatment of GERD.
- Pantoprazole is indicated for the prevention of relapse in patients with reflux esophagitis.
- Pantoprazole is indicated for short-term (up to 4 weeks) treatment for symptom relief and healing in patients with active duodenal ulcer.
- Pantoprazole, in combination with clarithromycin and either amoxicillin or metronidazole, is indicated for the treatment of patients with an active duodenal ulcer who are Helicobacter pylori positive.
- Pantoprazole is indicated for short-term (up to 8 weeks) treatment in patients with active benign gastric ulcer.
- Pantoprazole sodium is used orally or IV for the treatment of pathologic GI hypersecretory conditions associated with Zollinger-Ellison syndrome or other neoplastic conditions. The drug reduces the volume of gastric acid output and hydrogen ion concentration of gastric secretions in patients with these conditions
Contra Indications of Pantoprazole
- People with a known hypersensitivity to PPI, substituted benzimidazoles or any other component of the capsule formulation (e.g. certain dyes)
- People with known hypersensitivity (allergy) to PPI or any of the ingredients in the medication.
- Inadequate Vitamin B12
- Low amount of magnesium in the blood
- Liver problems
- Interstitial Nephritis
- Subacute cutaneous lupus erythematosus
- Systemic Lupus Erythematosus
- Osteoporosis
- Broken Bone
- Allergies to Proton Pump Inhibitors
Taking a proton pump inhibitor such as pantoprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medicine long term or at high doses, and in those who are age 50 and older.
Dosage of Pantoprazole
Strengths: 2.5 mg; 2 mg/mL; 10 mg;20 mg, 40 mg; 20, 40 mg I.V injection
Gastroesophageal Reflux Disease
- Oral: 40 mg orally once a day
- Duration of therapy: 8 weeks
- Parenteral: 40 mg IV once a day, given over at least 2 minutes OR over 15 minutes
- Duration of therapy: 7 to 10 days
Erosive Esophagitis
- Treatment: 40 mg orally once a day
- Duration of therapy: 8 weeks
- Maintenance: 40 mg once daily
Zollinger-Ellison Syndrome
- Oral: 40 mg orally 2 times a day
- Maximum dose: 240 mg/day
Parenteral
- Initial dose: 80 mg IV every 12 hours, given over at least 2 minutes OR over 15 minutes
- Maintenance dose: 80 mg IV every 8 to 12 hours, given over at least 2 minutes OR over 15 minutes
- Maximum dose: 240 mg/day
- The maximum duration of therapy: 6 days
Pediatric Gastroesophageal Reflux Disease
5 years and older
- 15 to less than 40 kg: 20 mg orally once a day
- 40 kg and greater: 40 mg orally once a day
- Duration of therapy: Up to 8 weeks
Side Effects of Pantoprazole
The most common
- Disturbances of the gut such as diarrhea, constipation, nausea, vomiting or abdominal pain.
- Drowsiness and lightheadedness
- Confusion.
- Nausea and vomiting
- joint pain
- Severe stomach ache
- Severe diarrhea
- Vaginal thrush
- Skin rash
- A headache
- chest pain
- constipation
- a cough
- diarrhea or loose stools
- difficulty with breathing
- dizziness
- heartburn
- muscle pain
More common
- Abdominal or stomach pain, discomfort, or tenderness
- Chills or fever
- Constipation
- Diarrhea
- Loss of muscle coordination
- Sleepiness or unusual drowsiness
- Clumsiness or unsteadiness
- Dizziness
- Drowsiness
- Dry mouth
- Lightheadedness
- Muscle weakness.
- A headache.
- Skin rashes.
- joint or back pain
- muscle aching or cramping
- muscle pains or stiffness
- chest pressure or squeezing pain in the chest
- discomfort in arms, shoulders, neck or upper back
- excessive sweating
- feeling of heaviness, pain, warmth and/or swelling in a leg or in the pelvis
- sudden tingling or coldness in an arm or leg
- sudden slow or difficult speech
Rare
- muscle weakness
- spasms of the hands and feet
- cramps or muscle aches
- trouble breathing, coughing, wheezing, hoarse voice, or
- throat tightness
- watery stool
- rash on the skin and nose, raised, red, scaly, red or purple rash on your body
- convulsions (seizures)
- a sore throat
- difficulty with breathing
- blurred vision
- chest pain or discomfort
- convulsions
- extra heartbeats
- hallucinations
- a headache
- irritability
- muscle pain or cramps
- muscle spasm or jerking of all extremities
Drug Interactions of Pantoprazole
Pantoprazole may interact with following drugs, supplements, & may change the efficacy of the drug
- amphetamines
- “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
- bisphosphonates (e.g., alendronate, etidronate)
- carbamazepine
- carvedilol
- celecoxib
- certain tyrosine kinase inhibitors (e.g.dasatinib, nilotinib)
- cilostazol
- citalopram
- clobazam
- clopidogrel
- clozapine
- cyclosporine
- diazepam
- escitalopram
- fluoxetine
- iron salts (e.g., ferrous fumarate, ferrous sulfate)
- montelukast
- multivitamins with iron, folate
- mycophenolate
- methotrexate
- methylphenidate
- mycophenolate
- phenobarbital
- phenytoin
- pioglitazone
- rosiglitazone
- phenobarbital
- phenytoin
- other proton pump inhibitors (e.g., esomeprazole, lansoprazole)
- “statin” anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
- tizanidine
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- trimethoprim
- warfarin
- zafirlukast
Pregnancy Catagory of Pantoprazole
FDA Pregnancy Category B
Pregnancy
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of Pantoprazole. Animal studies have shown reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Pantoprazole during pregnancy.
Lactation
Animal studies have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. A risk to the newborns/infants cannot be excluded. Therefore, a decision on whether to discontinue breastfeeding or to discontinue/abstain from Pantoprazole therapy should take into account the benefit of breastfeeding for the child and the benefit of Pantoprazole therapy for the woman. There was no evidence of impaired fertility following the administration of pantoprazole in animal studies
Before taking this medicine
Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.
You should not use this medicine if
- you are allergic to pantoprazole or to similar medicines such as lansoprazole (Prevacid), esomeprazole (Nexium), omeprazole (Prilosec, Zegerid), or rabeprazole (AcipHex); or
- you also take medicine that contains rilpivirine (Edurant, Complera, Odefsey).
To make sure pantoprazole is safe for you, tell your doctor if you have:
- severe liver disease;
- low levels of magnesium in your blood;
- lupus;
- osteoporosis; or
- low bone mineral density (osteopenia).
- It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
- Pantoprazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
- Pantoprazole is not approved for use by anyone younger than 5 years old.