Pantostad 40 Cap Stella Treatment of esophagitis (4 blisters x 7 tablets)
Dosage form Box of 4 blisters x 7 tablets
Specifications Pantoprazol
Ingredient
| Composition information | Content |
| Pantoprazol | 40mg |
Uses
Indications
Pantostad 40 CAP is indicated in the following cases:
Pantoprazole is converted into a form of active in the acidic environment of the cell, where the enzyme inhibitor H+/K+ ATPASE, the final stage of the hydrochloride acid excretion in the stomach. The inhibition depends on the dose and affects the normal acid secretion and when stimulated: in most patients, symptoms will end within 2 weeks.
As proton pump inhibitors (PPI) and other H2 receptors inhibitors, the treatment with pantoprazole reduces the acidity in the stomach, thus increasing gaastin corresponding to reducing acidity. Gastrin increases can be reversed. Because Pantoprazole is connected to the enzyme away from the cell receptor, Pantoprazole can inhibit the secretion of independent hydrochloride acid with stimulation by other substances (acetylcholine, histamine, gastrin).
pharmacokinetic
absorption
Pantoprazole quickly absorbed and even achieved peak plasma concentrations after taking a single dose of 40 mg. On average, about 2.5 hours after oral, the drug achieves the peak concentration in the serum about 2 - 3 μg/ml and these values do not change when using multiple dose. Pharmacokinetics do not change after single dose or repeat dose.
absolute bioavailability of the tablet form is about 77%. Simultaneous use with non -influential food on AUC, the peak concentration in serum and the use of the drug.
Distribution
Pantoprazole binds to serum protein about 98%. The distribution volume is about 0.15 l/kg.
Metabolism - Elimination
The drug is metabolized almost entirely in the liver. The main metabolic path is to remove methyl thanks to CYP2C19 with a combination of sulfate, in addition to oxidation by CYP3A4.
The final selling time is about 1 hour and the clearance is about 0.1 l/hour/kg. There are several cases of slow elimination. Due to the special cohesion of Pantoprazole with the cell's proton pump into the semi -disposal time is not correlated with the long impact time of the drug (acid secretion).
The metabolites of Pantoprazole are excreted mainly through the kidneys (about 80%), the rest is excreted through feces.
The main metabolites both in serum and urine are desmethylpantoprazole, through sulfate.
The semi -waste time of the main metabolites (about 1.5 hours) is not longer than the semi -exhaust time of Pantoprazole.
Before taking Pantostad 40 Cap Stella Treatment of esophagitis (4 blisters x 7 tablets)
How to use
Pantostad 40 cap for oral. Do not chew or crush pills, should take whole tablets 1 hour before meals with water.
Dosage
adults and adolescents aged 12 and older
esophagitis due to gastroesophageal reflux - esophagus
1 tablet/day. Depending on the patient, the dose may double (up to 2 tablets/day) especially when not responding to other treatment. The time to treat esophagitis due to gastroesophageal reflux - esophagus usually takes 4 weeks. Treatment for 4 more weeks if not cured.
Adults
Eliminating H. Pylori in combination with two appropriate antibiotics
In patients with peptic ulcer and duodenum with H. pylori, combined therapy can eradicate the pathogens. Depending on the type of resistance, the following combinations are recommended to kill H. pylori:
If the patient is negative with H.pylori, there is no choice of combined therapy, the following dose instruction should be applied for Pantoprazole:
For long -term treatment of Zollinger - Ellison syndrome and other pathological secretion, it is advisable to start treatment at a dose of 80 mg/day (2 pantoprazole 40 mg tablets). After that, the dose may be increased or decreased if necessary, using stomach acid secretion measurements as instructed. With a dose of over 80 mg/day, the dose should be divided 2 times/day. The temporary dose may be increased over 160 mg of pantoprazole but should not be used longer than the time it takes to control the acid satisfactory. Unlimited time for the treatment of Zollinger - Ellison syndrome and other conditions of increased diseases and should be adjusted according to clinical needs.
Patients with liver failure
Do not exceed 20 mg of pantoprazole/day (use other preparations to match this dose) in patients with severe liver failure. Pantoprazole is not used in H. Pylori to combine H. Pylori in patients with medium to severe liver dysfunction because there is currently no data on effectiveness and safety of Pantoprazole in combined therapy in these patients.
Patients with renal failure
No dose adjustment in patients with renal function. Pantoprazole is not used in H. Pylori to combine H. Pylori in patients with renal failure because there is currently no data on the effectiveness and safety of Pantoprazole in combined therapy in these patients.
Children under 12 years old
Pantoprazole 40 mg is not recommended for children under 12 years old because data on safety and efficiency in this age group is limited.
Elderly
No dose adjustment.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose?
What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using 40 -cap Pantostad, you may experience unwanted effects (ADR).
Uncommon, 1/1000 Skin: ban, foreign rash, rash, itching. Systemic: weakness, fatigue and discomfort. Rare, 1/10000 The immune system: Hypersensitivity (including anaphylactic reaction and anaphylaxis). metabolic and nutrition: hyperlipidemia and lipid hyperplation (triglyceride, cholesterol), weight change. Liver: Increase bilirubin. Very rare, ADR Mental: disoriented. Unknown frequency Nervous system: Perception. Skin: Stevens - Johnson syndrome, Lyell syndrome, diverse roses, light sensitivity, semi -acute erythema lupus. Instructions on how to handle ADR When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Pantostad 40 Cap drug is contraindicated in cases of hypersensitivity to active ingredients, Benzimidazole derivatives or any excipient ingredients of the drug.
Precautions when used
The drug contains sucrose. This drug should not be used for patients with rare genetic problems that are free -intolerant, Glucose - Galactose or SUCRASE - Isomaltase.
Cystic shell contains FD and C Yellow 6 (Sunset Yellow FCF), which can cause allergic reactions.
In patients with severe liver failure, liver enzymes should be monitored during treatment with pantoprazole, especially for long -term use. In case of increasing liver enzyme, the drug should be stopped.
When there is the presence of any warning symptoms (noticeable weight loss, recurrent vomiting, difficulty swallowing, vomiting blood, anemia or black stool defecation) and when suspected or showing stomach ulcers, eliminating malignant diseases because pantoprazole can reduce symptoms and slow down the diagnostic. An additional research should be conducted to assess if the symptoms do not decrease despite the appropriate treatment.
It is not recommended to simultaneously use Atazanavir with PPIs. If there is a combination of Atazanavir with a PPI, it is advisable to closely monitor (such as the virus load) when the coordination of increasing the dose of Atazanavir to 400 mg with 100 mg of ritonavir. Pantoprazole 40 mg is not used in this combination because the dose recommends pantoprazole should not exceed 20 mg/day.
affect the absorption of vitamin B12
In patients with Zollinger - Elison syndrome and other diseases of disease, which requires long -term treatment, Pantoprazole as well as all acid secretion inhibitors can reduce the absorption of vitamin B12 (cyanocobalamin) due to reduced or no gastric acid secretion. This should be considered in patients who reduce vitamins in the body or have risk factors that reduce the absorption of vitamin B12 while long -term treatment or if the corresponding clinical symptoms are found.
In long -term treatment, especially when the treatment time is over one year, regular supervision should be monitored.
Risk of fracture
Using PPIs, especially when taking high doses and for a long time (> 1 year), may increase the risk of hip, wrist and backbone fractures, mainly occurs in the elderly or when there are other risk factors.
Patients with osteoporosis must be taken care of under the current clinical instructions and need adequate vitamin D and calcium.
Gastrointestinal infections caused by bacteria
Like all PPIs, Pantoprazole increases the number of permanent bacteria in the digestive tract. Treatment with Pantoprazole may increase the risk of gastrointestinal infections caused by Salmonella and Campylobacter.
Severe blood magges have been reported in patients treated with PPIs like Pantoprazole for at least three months and a year in most cases. The serious manifestation of the blood magnesi is like fatigue, unintentional muscle contraction, delirium, convulsions, dizziness and ventricular arrhythmia may occur but may start smoldering and disappearing.
In patients most affected, lowering blood magnesia is improved after supplementing magnesi and stopping PPI. The doctor must measure the level of Magnesi blood before starting treatment with PPI and periodically in patients who have to treat for a long time or take PPI with digoxin or drugs that cause blood magam (for example, diuretics).
Lupus erythematosus in skin (SCLE)
PPIs are related to very rare SCLE cases. If the lesions occur, especially in the skin -exposed skin areas and if accompanied by joint pain, patients should find timely help and doctor should consider stopping pantoprazole.
Scre after treatment with a previous PPI may increase the risk of other PPIs.
The ability to drive and operate machinery
pantoprazole does not have or negatively affect the ability to drive or operate machinery. The drug can cause unwanted effects such as dizziness and visual disorders. If affected, patients should not drive or operate machinery.
Pregnancy
There is no adequate data on the use of pantoprazole in pregnant women. Animal studies have shown toxicity on fertility. It is unknown the potential risks to people. Do not use pantoprazole during pregnancy if not really necessary.
Breastfeeding period
Animal studies show that Pantoprazole is excreted in milk. In humans, there has been a Pantoprazole report on breast milk. Therefore, decide to continue/stop breastfeeding or continue/stop using pantoprazole, so the benefits of breastfeeding on babies and the benefits of using Pantoptazole on the mother.
Drug interaction
The effect of Pantoprazole on the absorption of other drugs
Due to the strong and prolonged inhibition of stomach acid secretion, Pantoprazole can reduce the absorption of drugs that depend on the stomach pH such as Azole antifungal drugs (Ketoconazole, Itraconazole, Posaconazole) and other drugs such as Erlotinib.
HIV treatment (Atazanavir)
Simultaneous use of Atazanavir and other HIV medications (the absorption depends on the stomach pH) with PPIs that significantly reduce the bioavailability of HIV treatments and affect the effectiveness of these drugs. Therefore, not simultaneously ppi with Atazanavir.
anticoagulant drugs (phenprocoumon or warfarin)
Although there is no interaction when using Phenprocoumon or Wartarin in clinical pharmacokinetic studies, some special cases change international standardized ratio (INR) when used simultaneously. Therefore, in patients who have used anticoagulants, should monitor the time of prothrombin/INR after starting, ending or during the use of abnormal pantoprazole.
methotrexate
Concentrated with high doses of methotrexate (e.g. 300 mg) with ppi increases methotrexate levels in some patients. Some diseases using high doses of methotrexate such as cancer and psoriasis, can temporarily consider Pantoprazole.
There is no clinical interaction between pantoprazole and drugs such as carbamazepine, diazepam, glibenclamide, nifedipine and oral contraceptives containing levonorgestrel and ethinyl estradiol.
Results from a series of interactive studies prove Pantoprazole does not affect the metabolism of active substances metabolized by CYP1A2 (Cafeine, Theophyllline), CYP2C9 (Piroxicam, Diclofenac, Naproxen), CYP2D6 (Metoprolol), CYP2E1 (ETHANOL) or no intercession of relevant relevant relevant relevant relevant relevant relevant relevant relevant relevant relevant relevant relevant p-glycoprotein.
There is no interaction when using pantoprazole with antacids. Interactive research has simultaneously used Pantoprazole with antibiotics (clarithromycin, metronidazole, amoxicillin).
There is no clinical related interaction.
Storage
Store in closed packaging, dry in, avoid light and avoid moisture. The temperature does not exceed 30ºC.
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