Vomizole Tablet

Vomizole Tablet

pantoprazole

Manufacturer:

Dexa Medica
Full Prescribing Info
Contents
Pantoprazole.
Description
VOMIZOLE 20: Each enteric coated tablet contains: Pantoprazole sodium sesquihydrate equivalent to Pantoprazole 20 mg.
VOMIZOLE 40: Each enteric coated tablet contains: Pantoprazole sodium sesquihydrate equivalent to Pantoprazole 40 mg.
Action
Pharmacology: Pantoprazole is proton pump inhibitor.
Pantoprazole is substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific action on 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 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 receptors 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.
Pharmacokinetics: Pantoprazole is completely and rapidly absorbed after oral administration. The maximal plasma concentration is achieved even after one single 40 mg oral dose.
Pharmacokinetic do not vary after single or repeated administration.
The absolute bioavailability from the tablet was found to be about 77%. Concomitant intake of food had no influence on AUC, maximum serum concentration and thus bioavailability. Only the variability of the lag time will be increased by concomitant food intake.
Pantoprazole's serum protein binding is about 98%. Volume of distribution of pantoprazole is about 0.15 l/kg.
Pantoprazole is almost exclusively metabolized in the liver. Terminal half-life is about 1 hour and clearance is about 0.1 l/hour/kg. There were a few case of patients with delayed elimination. Because of the specific binding of pantoprazole to the proton pumps of the parietal cell, the elimination half-life does not correlate with the much longer duration of action (inhibition of acid secretion).
Renal elimination represents the major route of excretion (about 80%) for the metabolites of pantoprazole, the rest are excreted with the feces. The half-life of the main metabolite (about 1.5 hours) is not much longer than that of pantoprazole.
Indications/Uses
Symptomatic gastroesophageal reflux disease (GERD) or nonerosive reflux disease (NERD).
For long-term management of moderate and severe form of reflux esophagitis.
Dosage/Direction for Use
Tablet should not be chewed or crushed and should be swallowed whole, 1 hour before a meal with some water.
Symptomatic gastroesophageal reflux disease (GERD) or nonerosive reflux disease (NERD): The recommended oral dose is 20 mg per day. Symptom relieve is generally accomplished within 2-4 weeks and a 4 weeks treatment period is usually required for healing of associated esophagitis. If this is not sufficient, healing will normally be achieved within a further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily when required. A switch to continuous therapy may be considered in case satisfactory symptom control cannot be maintained with on-demand treatment.
For long-term management of moderate and severe form of reflux esophagitis: For long-term management, a maintenance dose 20 mg per day is recommended, increasing to 40 mg per day if relapse occur. After healing of relapse the dosage can be reduced again to 20 mg pantoprazole.
A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment.
No dose adjustment is necessary in elderly patients or in patients with impaired renal function.
Patients who do not respond after 4 weeks should be investigated.
To date there has been no experience with treatment in children.
Overdosage
There are no known symptoms of overdose in human.
In the case of overdose with clinical signs of intoxication, the usual rules of intoxication therapy apply.
Contraindications
Pantoprazole should not be used in cases of known hypersensitivity to pantoprazole or to any of its constituents, or other substituted benzimidazole.
Special Precautions
Liver impairment: In patients with severe liver impairment, particularly on long-term use, the liver enzymes should be monitored regularly during treatment with pantoprazole. In the case of rise in the liver enzymes, pantoprazole should be discontinued.
Influence on vitamin B12 absorption: Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypochlorhydria or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.
Long-term treatment: In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.
Prior to treatment, the possibility of malignancy of gastric ulcer or malignant disease of the esophagus should be excluded as the treatment with pantoprazole may alleviate the symptoms of malignant ulcers and can thus delay diagnosis.
Hypomagnesemia: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors for at least three months, in most cases after a year of therapy. Serious adverse events which can occur include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the proton pump inhibitors.
For patients expected to be on prolonged treatment or who take proton pump inhibitors 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 proton pump inhibitors treatment and periodically.
Bone fracture: Several published observational studies suggest that proton pump inhibitor 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 proton pump inhibitor therapy (a year or longer). Patients should use the lowest dose and shortest duration of proton pump inhibitor therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
Clostridium difficile associated diarrhea: Published observational studies suggest that proton pump inhibitor therapy like pantoprazole 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 proton pump inhibitor therapy appropriate to the condition being treated.
Effect on ability to drive and use of machines: There are not known effect on the ability to drive and use machines.
Use in Pregnancy & Lactation: Clinical experience in pregnant women is limited.
There is no information on the excretion of the pantoprazole into human breast milk.
Pantoprazole should only be used when benefit to the mother is considered greater than the potential risk to the fetus/baby.
Use In Pregnancy & Lactation
Clinical experience in pregnant women is limited.
There is no information on the excretion of the pantoprazole into human breast milk.
Pantoprazole should only be used when benefit to the mother is considered greater than the potential risk to the fetus/baby.
Adverse Reactions
Blood and lymphatic system: leukopenia, thrombocytopenia.
Gastrointestinal disorders: upper abdominal pain, diarrhea, constipation, flatulence, nausea/vomiting, dry mouth.
General disorders: peripheral edema.
Hepatobiliary disorders: severe hepatocellular damage leading to jaundice with or without liver failure.
Immune system disorders: anaphylactic reactions including anaphylactic shock.
Musculoskeletal connective tissue disorders: arthralgia, myalgia.
Nervous system disorders: headache, dizziness, disturbances in vision (blurred vision).
Psychiatric disorders: mental depression.
Renal and urinary disorders: interstitial nephritis.
Skin and subcutaneous disorders: allergic reactions (such as pruritis and skin rash), urticaria, angioedema, severe skin reactions such as Stevens Johnson syndrome, erythema multiforme, Lyell syndrome, photosensitivity.
Drug Interactions
Pantoprazole may reduce the absorption of drugs whose bioavailability is pH-dependent (e.g., ketoconazole).
Pantoprazole is metabolized in the liver via the cytochrome P450 enzyme system. An interaction of pantoprazole with other drugs or compounds which are metabolized using the same enzyme system cannot be excluded. However, no clinically significant interactions were observed in specific test with a number of such drugs or compounds namely carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, antipyrine, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline, and an oral contraceptive.
Although no interaction drug in concomitant administration on phenprocoumon and warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in INR have been reported during concomitant treatment in the postmarketing period. Therefore, in patients being treated with coumarin anticoagulants, monitoring of prothrombin time/INR is recommended after initiation, termination, or during irregular use of pantoprazole.
There were also no interaction with concomitantly administered antacids.
Storage
Store at temperature below 30°C.
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).
Presentation/Packing
EC tab 20 mg x 1 x 10's. 40 mg x 1 x 10's.
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