Zolopent Pantoprazole tablets 40mg №30

Zolopent Pantoprazole tablets 40mg №30

Product Code: 8208
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Composition

active substance:pantорrazole;

1 tablet contains pantoprazole sodium sesquihydrate equivalent to pantoprazole 40mg

other ingredients:sodium carbonate anhydrous, beckons (E 421), crospovidone, hydroxypropyl cellulose, calcium stearate, Eudragit L30D55, triethylcitrate, sodium lauryl sulfate, titanium dioxide (E 171), iron oxide yellow (E172), talc, Opadry white 03F58750 *.

* Opadry 03F58750 white: hypromellose, titanium dioxide (E 171), polyethylene glycol, talc.

The

Dosage form

Tablet coated liner.

basic physico-chemical properties:oval biconvex tablets coated in yellow.

The

drug description

drugs for the treatment of acid-related diseases. Proton pump inhibitor. Code a02v ATX S02.

The

Pharmacological properties

Pharmacodynamics.

the Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of parietal cells.

Pantoprazole is transformed into an active form in an acidic environment in parietal cells, where it inhibits the enzyme H + -K + -Atphase, that is, it blocks the final stage of hydrochloric acid production in the stomach. The inhibition is dose related and inhibits both basal and stimulated secretion of hydrochloric acid. The therapeutic effect of pantoprazole is achieved in most patients within 2 weeks of treatment. The use of pantoprazole, as in the case of other proton pump inhibitors and inhibitors H2receptors, reduces acidity in the stomach and thus increases gastrin secretion in proportion to the decrease in acidity. Increasing gastrin secretion is reversible. Since pantoprazole binds to the enzyme distal relative to the cell receptor, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect of oral and intravenous use is the same.

the use of pantoprazole increased fasting gastrin level. With short - term use pantoprozole gastrin level in most cases does not exceed the upper limit of the norm. With long - term treatment of gastrin levels in most cases grow twice. Excessive increase, however, occurs only in rare cases. As a result, a small number of cases with long-term treatment observed slight or moderate increase in the number enterochromaffin (ECL) cells in the stomach (like adenomatoid hyperplasia). However, according to current research, the formation of precursor cells of neuroendocrine tumors (atypical hyperplasia) or neuroendocrine tumors of the stomach, which were found in experiments on animals, was not observed in humans.

Based on the results of animal studies, the effect of long-term (more than 1 year) treatment with pantoprazole on the endocrine parameters of the thyroid gland cannot be ruled out.

Pharmacokinetics.

Suction

.Pantoprazole is absorbed, and the maximum concentration in plasma achieved after a single oral dose of 40 mg. In an average of 2.5 hours after intake maximum concentration is reached in serum at about 2-3 mg/ml, the concentration remains at a constant level after repeated administration. Pharmacokinetic properties do not change after a single or repeated administration. In the dose range from 10 to 80 mg pharmacokinetics pantoprazole in plasma remains linear as oral administration and intravenous. It was found that the bioavailability of tablets is about 77%. Simultaneous eating does not affect the AUC (area under the curve "concentration-time") or the maximum concentration in the blood serum and, therefore, bioavailability. Simultaneous food intake increases only the variance of the latent period.

Distribution.the Binding of pantoprazole with blood plasma proteins is about 98%. The volume of distribution is about 0.15 l/kg.

Metabolism.Pantoprazole is metabolized almost exclusively in the liver. The main metabolic pathway is demethylation by CYP2C19 followed by sulfur conjugation; another metabolic pathway is oxidation by CYP3A4.

Output.the Final half-life is around 1: 00 and clearance is 0.1 l/h/kg.

there have been several cases of delayed withdrawal of pantoprazole in patients. Due to specific binding of pantoprazole with proton pump of parietal cells, the half-life period does not correlate with much longer duration of action (inhibition of acid secretion).

the Main part of metabolites of pantoprazole are excreted in urine (about 80%), the rest is excreted in feces. The main metabolite in serum and urine desmethyldonepezil conjugated with sulfate. The half-life of the primary metabolite (about 1.5 hours) slightly exceeds the half-life of pantoprazole.

Special groups of patients.

Slow metabolizers. About 3% of Europeans do not have the active enzyme CYP2C19; they are called slow metabolizers. In the organisms of such persons metabolism pantoprazole, probably mainly catalyzed by the enzyme CYP3A4. After taking one dose of 40 mg pantoprazole average area, limited pharmacokinetic curve "concentration in plasma-time" was about 6 times higher in slow metabolizers than in individuals with an active enzyme CYP2C19 (fast metabolizers). The maximum concentration in plasma increased by about 60%. These results do not affect the dosage of pantoprazole.

impaired renal function. Recommendations to reduce the dose in appointing pantoprazole patients with impaired renal function (including patients on dialysis) no. Like healthy people, they have a short half-life of pantoprazole. Only very small amounts of pantoprazole are dialyzed. Despite the fact that the main metabolite moderately long half-life (2-3 hours), the conclusion is still fast, so the cumulation does not occur.

impaired liver function. Although in patients with liver cirrhosis (classes a and B for child Pugh), the half-life increases to 7-9 hours, and AUC increases 5-7 times, the maximum concentration in serum increases only slightly, 1.5 times compared to healthy volunteers.

elderly Patients. A slight increase in AUC and Cmaxin older volunteers compared to younger volunteers is also of no clinical significance.

Children.After a single oral dose of 20 or 40 mg of oral pantoprazole AUC and Cmaxchildren aged 5 to 16 years were in the range of those in adults. After a single administration of pantoprazole at a dose of 0.8 or 1.6 mg/kg in children from 2 to 16 years, there was no significant relationship between the clearance of pantoprazole and age or body weight. AUC and the volume of distribution with data obtained in adult studies.

Reading

Adults and children over 12 years of age.

The
    The
  • Reflux esophagitis.

Adults.

The
    The
  • Eradication ofHelicobacter pylori (H. pylori)in patients withH. pyloriassociated with ulcers stomach and duodenal ulcers in combination with appropriate antibiotics
  • The
  • duodenal ulcers;
  • The
  • a stomach ulcer;
  • Zollinger-Ellison Syndrome and other hypersecretory pathological conditions.

Contra

hypersensitivity to the active substance, benzimidazole derivatives and any component of the drug.

The

Interaction with other medicinal products and other forms of interaction

the effect of pantoprazole on the absorption of other drugs. Pantoprazole may reduce the absorption of drugs whose bioavailability depends on the pH of gastric juice (for example, some antifungal drugs such as ketoconazole, Itraconazole, Posaconazole or other drugs such as erlotinib).

drugs against HIV (atazanavir). The joint use of proton pump inhibitors with atazanavir and other drugs that are used in the treatment of HIV, adsorption of which depends on pH, can lead to a significant reduction in the bioavailability of the latter and affect their effectiveness. Therefore, the joint use of proton pump inhibitors with atazanavir is not recommended.

Indirect anticoagulants (warfarin and phenprocoumon).Despite the lack of interaction in concurrent use with phenprocoumon and warfarin in clinical trials have been registered single cases of changes in the PIM (international normalizing index) in post-marketing period. Thus, patients who used anticoagulants (e.g. warfarin and phenprocoumon), it is recommended to monitor PV/PIM after the commencement, termination or during irregular intake of pantoprazole.

Methotrexate.concomitant use of high doses of methotrexate (e.g. 300 mg) and proton pump inhibitors has been Reported to increase blood methotrexate levels in some patients. Patients taking high doses of methotrexate, such as cancer patients or psoriasis, are recommended to temporarily discontinue treatment with pantoprazole.

other interactions.Pantoprazole is highly metabolized in the liver through the cytochrome P450 enzyme system. The main pathway is demethylation via 2C19 and other metabolic pathways, including oxidation by the enzyme СУРЗА4. Studies with drugs that are also metabolized using these pathways, like carbamazepine, diazepam, glibenclamide, nifedipine, phenprocoumon and oral contraceptives containing levonorgestrel and ethinyl estradiol, did not reveal clinically significant interactions.

the Results of several studies on possible interactions indicate that pantoprazole does not affect the metabolism of active substances metabolised via CYP1A2 (e.g., caffeine, theophylline), CYP2C9 (e.g., piroxicam, diclofenac, naproxen), CYP2D6 (eg, metoprolol), СУР2Е1 (e.g., ethanol), does not affect p-glycoprotein, which ensures the absorption of digoxin.

there was No interaction simultaneously with the prescribed antacids.

studies have been conducted to study the interaction of pantoprazole with simultaneously prescribed certain antibiotics (clarithromycin, metronidazole, amoxicillin). Clinically significant interactions between these drugs have not been revealed.

application Features

liver dysfunction. Patients with severely impaired liver should regularly monitor the level of liver enzymes, especially in long-term care. In case of increasing the level of liver enzymes, treatment should be stopped.

Combination therapy.in combination therapy, follow the instructions for the use of appropriate medicines.

existing anxiety symptoms. In the presence of anxiety symptoms (for example, in the case of significant loss of body weight, periodic vomiting, dysphagia, vomiting with blood, anemia, melena), as well as the suspected or presence of gastric ulcer, it is necessary to exclude the presence of a malignant process, since the treatment of pantoprazole can mask the symptoms and delay the diagnosis.

If symptoms persist with adequate treatment, it is necessary to conduct additional screening.

Joint application with atazanavir. The joint use of atazanavir with proton pump inhibitors (PPI) is not recommended (see section "Interaction with other drugs and other types of interactions"). If the combination of IPP with atazanavir is necessary, careful clinical monitoring (for example, measurement of viral load) should be carried out in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir. The dose of pantoprazole is 20 mg per day should not be exceeded (if necessary, the appointment of a dose of 20 mg use the drug pantoprazole in the appropriate dosage).

absorption of vitamin B12. In patients with Zollinger-Ellison syndrome and other hypersecretory pathological conditions requiring long - term treatment, pantoprazole, like all drugs that block the production of hydrochloric acid, can reduce the absorption of vitamin b12(cyanocobalamin) in connection with the emergence of Hypo-and ahlorgidrii . This should be taken into account in patients with reduced body weight or risk factors for vitamin b uptake in12in long-term treatment, or the presence of appropriate clinical symptoms.

Long-term treatment. With long-term treatment, especially more than 1 year, patients should be under regular medical supervision.

infections of the gastrointestinal tract caused by bacteria.Pantoprazole, like other proton pump inhibitors, can increase the number of bacteria that are usually present in the upper gastrointestinal tract. Treatment with the drug may slightly increase the risk of gastrointestinal infections caused by bacteria such asSalmonellaandCampylobacterorC. Difficult.

Hypomagnesemia. There have been cases of severe hypomagnesaemia in patients taking proton pump inhibitors such as pantoprazol at least for three months, and in most cases within a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can begin unnoticed and can be skipped. In most cases, the condition of patients improves after magnesium substitution therapy and discontinuation of treatment with proton pump inhibitors. Patients planning long-term therapy or taking proton pump inhibitors in conjunction with digoxin or drugs that may cause hypomagnesemia (such as diuretics) are advised to measure magnesium levels before starting treatment with proton pump inhibitors and periodically during therapy.

fractures of bones.proton pump Inhibitors, especially when used in high doses and for long-term treatment (more than 1 year), may to some extent increase the risk of hip, wrist and spine fractures, mainly in elderly patients or in the presence of other existing risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%. Some of them may be due to other risk factors. Patients at risk of osteoporosis should receive treatment in accordance with the current clinical guidelines and an adequate amount of vitamin d and calcium.

use during pregnancy or lactation.

Pregnancy.experience with the use of pantoprazole in pregnant women is limited. In the course of studies of reproductive function in animals reproductive toxicity was observed. The potential risk to humans is unknown. The drug should not be used during pregnancy, except in cases of emergency.

breastfeeding.Are data on the excretion of pantoprazole in breast milk of a person. The decision to stop breastfeeding or discontinue/abstain from treatment Zolopantmust take into account the benefit of breast feeding for the child and benefits Zolopantfor women.

Ability to influence the reaction rate when driving motor transport or operating other mechanisms.

it is Necessary to take into account the possible development of adverse reactions such as dizziness and blurred vision. In such cases, you should not drive vehicles or work with other mechanisms.

Method of application and doses

Zolopant, tablets, coated tablets, it should take 1:00 to food whole without chewing but not grind with water.

recommended dosage.

Adults and children over 12 years of age.

Treatment of reflux esophagitis.

the recommended dose is 1 tablet Zolopant40 mg per day. In some cases, dose can be doubled (2 tablets of the drug Zolopant40 mg per day), especially in the absence of effect from the use of other drugs for the treatment of reflux esophagitis.

For the treatment of reflux esophagitis usually requires 4 weeks. If this is not enough, treatment can be expected over the next 4 weeks.

Adults.

Eradication ofH. руloriin combination with two antibiotics.

in patients with gastric and duodenal ulcers and with a positive result onH. pylori, it is necessary to achieve the eradication of the microbe by combination therapy. Local bacterial resistance data and national recommendations on the use and administration of appropriate antibacterial agents should be considered. Depending on the sensitivity of microorganisms for eradicationHelicobacter pyloriin adults may be prescribed such therapeutic combinations:

a) 1 tablet Zolopant40 mg 2 times a day

+ 1000 mg amoxicillin 2 times a day

+ 500 mg of clarithromycin 2 times a day;

b) 1 tablet Zolopant40 mg 2 times a day

+ 400-500 mg metronidazole (or 500 mg tinidazole) 2 times a day

+ 500 mg of clarithromycin 2 times a day;

) 1 tablet Zolopant40 mg 2 times a day

+ 1000 mg amoxicillin 2 times a day

+ 400-500 mg metronidazole (or 500 mg tinidazole) 2 times a day.

the use of combination therapy for eradication ofH. pylorithe second tablet of the drug Zolopant40 mg should be taken in the evening in 1:00 before eating. The duration of treatment is 7 days and can be extended for another 7 days with a total duration of treatment not more than two weeks. If further treatment with pantoprazole is indicated to ensure ulcer healing, recommendations for dosage in gastric and duodenal ulcers should be considered.

If combined therapy is not shown, for example, patients with a negative result onH. руlori, for monotherapy, the drug Zolopant40 mg is used in the following dosage.

treatment of gastric ulcer.

1 tablet Zolopant 40 mg per day. In some cases, the dose can be doubled

(2 tablets of the drug Zolopant40 mg per day), especially in the absence of the effect of the use of other drugs.

it usually takes 4 weeks to treat stomach ulcers. If this is not enough, ulcer healing can be expected within the next 4 weeks.

Treatment of duodenal ulcer.

1 tablet Zolopant 40 mg per day. In some cases, the dose can be doubled

(2 tablets of the drug Zolopant40 mg per day), especially in the absence of the effect of the use of other drugs.

For the treatment of ulcers of the duodenum usually requires 2 weeks. If this is not enough, ulcer healing can be expected within the next 2 weeks.

treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions.

for long-term treatment of Zollinger-Ellison syndrome and other pathological conditions gipersecrethornykh States the initial daily dose is 80 mg (2 tablets of the drug Zolopant40 mg). If necessary, then the dose can be titrated, increasing or decreasing depending on the acidity of gastric juice. The dose exceeding 80 mg per day should be divided into two doses. Perhaps a temporary increase in the dose of more than 160 mg pantoprazole, but the duration of use should be limited only to the period necessary for adequate control of acidity.

the Duration of treatment for Zollinger-Ellison syndrome and other pathological conditions is unlimited and depends on clinical necessity.

in Patients with impaired liver function.Patients with severely impaired liver function should not exceed daily dose of 20 mg (1 tablet Zolopant20 mg). Patients with human liver moderate or severe should not use the drug Zolopantfor eradication ofH. руloriin combination therapy, as currently there is no data on the efficacy and safety of this use for this category of patients.

Patients with impaired renal function. For patients with impaired renal function dose adjustment is not required. Patients with impaired renal function should not use the drug Zolopantfor eradication ofH. руloriin combination therapy, as currently there is no data on the efficacy and safety of this use for this category of patients.

elderly Patientsdose adjustment is not required.

Children.

Zolopant40 mg shown to the children over 12 years for the treatment of reflux esophagitis. The drug is not recommended for children under 12 years, as data on safety and efficacy of pantoprazole for this age group are limited.

Overdose

the Symptoms of an overdose are unknown.

Doses up to 240 mg when administered intravenously within 2 minutes was well tolerated. As pantoprazole is extensively protein bound, it does not apply to drugs that can be easily displayed with the help of dialysis.

in the case of an overdose with the appearance of clinical signs of intoxication, symptomatic and supportive therapy is used. There are no recommendations for specific therapy.

Side effects

from blood and lymphatic system: agranulocytosis, leukopenia, thrombocytopenia, pancytopenia.

from the immune system: hypersensitivity reactions (including anaphylactic reactions, anaphylactic shock).

Metabolism and metabolic disorders:hyperlipidemia and lipid (triglyceride, cholesterol) changes in body weight, hyponatremia, hypomagnesemia, hypocalcemia1, hypokalemia.

Mental disorders:sleep disorders, depression (including exacerbations), disorientation (including exacerbations), hallucination, confusion (especially in patients with a predisposition to these disorders, as well as exacerbation of these symptoms if they exist).

from the nervous system: headache, dizziness, taste disorders, paresthesia.

on the part of organs of sight: blurred vision/blurred vision.

from the digestive tract: diarrhea, nausea, vomiting, bloating, constipation, dry mouth, abdominal pain and discomfort.

the digestive system: increase in liver enzymes (transaminases, gamma-glutamyltransferase), increase in bilirubin, destruction of hepatocytes, hepatitis, hepatocellular insufficiency.

skin and subcutaneous tissue:skin rash, exanthema, itching, urticaria, angioedema, Stevens-Johnson syndrome, Lyell syndrome, multiform erythema, photosensitization.

from the musculoskeletal system and connective tissue:arthralgia, myalgia, muscle spasm2, fractures of hip, wrist, spine.

on the part of the kidneys and urinary system:interstitial nephritis (with the possible development of renal failure).

on the part of the reproductive system and mammary glands: gynecomastia.

Common disorders: asthenia, fatigue, malaise, fever, peripheral edema.

1.at the same time hypocalcemia with hypomagnesemia.

2.muscle Spasm as a consequence of electrolyte imbalance.

The

shelf Life

3 years.

storage Conditions

Store in its original packaging at a temperature not exceeding 25 ° C.

keep out of reach of children.

The

Packaging

For 14 tablets in a blister, for 1 blister in a cardboard box.

there are 10 tablets in blister, 3 blisters in a carton box.

The

Category vacation

According to the recipe.

The

Manufacturer

LLC "Kusum Pharm".

location of the manufacturer and address of the place of business

Ukraine, 40020, M. Sumi, 54, Skryabina str.

PILLS ZOLOPANT 40MG

Zolopant tablets 40 mg №30 – the medicament for the treatment of acid-related diseases. Acts as a proton pump inhibitor. The active ingredient-sodium pantoprazole, inhibits the production of gastric acid. As a result, the total acidity of the stomach decreases, gastrin production increases. The medication is indicated for the treatment of gastroesophageal reflux disease. It is used to prevent relapses of reflux esophagitis, the formation of ulcers of the stomach and intestines with prolonged admission of NSAIDs.

the Procedure for dosing and contraindications

the Optimal norm is determined by the specialist taking into account the severity of the pathology, the age and the General physical condition of the patient. Recommended dose (adults) - up to 40 mg per day. The total duration of therapy is 4 weeks.

the Medication is contraindicated in:

    The
  • Intestinal bleeding.
  • The
  • Obstruction of the stomach.
  • The
  • intolerance of individual components.

it is not recommended to take pharmaceuticals during pregnancy, lactation, and simultaneously with antifungal agents, warfarin and other indirect anticoagulants. Zolopant reduces absorption of vitamin B12. The medicine is released without a prescription.

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