Pemozar (esomeprazole) gastroresistive tablets 20 mg. №14

Description

Pemozar storage
active substance: esomeprazole;
1 tablet contains esomeprazole magnesium (amorphous) equivalent to esomeprazole 20 mg;
Excipients: spherical sugar, hydroxypropylcellulose, crospovidone, povidone, macrogol 400, talc, hypromellose phthalate, diethyl phthalate, macrogol 6000, microcrystalline cellulose, sodium stearyl fumarate, macrogol 4000, opadroprozalo1Z86 talc, iron oxide red (E 172)).

Dosage form
Gastro-resistant tablets.

Pharmacological properties
Esomeprazole is the S-isomer of omeprazole, which reduces the secretion of gastric juice due to a specifically directed mechanism of action. It is a specific proton pump inhibitor in the parietal cell. The R- and S-isomers of omeprazole have the same pharmacodynamic activity.
Esomeprazole is a weak base, it concentrates and becomes active in the highly acidic environment of the secretory tubules of the parietal cell, where it inhibits the enzyme H + K + -ATPase – acid pump, and inhibits basal and stimulated acid secretion.

Indication Pemozar 
Gastroesophageal reflux disease:

• treatment of erosive reflux esophagitis;
• for long-term treatment to prevent recurrence;
• symptomatic treatment of gastroesophageal reflux disease.

In combination with antibacterial agents for the eradication of Helicobacter pylori:

• treatment of duodenal ulcer associated with Helicobacter pylori;
• prevention of recurrence of peptic ulcers in patients with ulcers caused by Helicobacter pylori.

Treatment and prevention of ulcers caused by long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs):

• treatment of ulcers caused by NSAID therapy;
• prevention of gastric and duodenal ulcers in patients at risk due to NSAIDs.

Long-term treatment after intravenous prevention of recurrent bleeding from peptic ulcers.

Treatment of Zollinger-Ellison syndrome.

Children from 12 years old
Gastroesophageal reflux disease (GERD):

• treatment of erosive reflux esophagitis;
• long-term treatment of patients with cured esophagitis to prevent recurrence;
• symptomatic treatment of gastroesophageal reflux disease (GERD).

In combination with antibiotics in the treatment of duodenal ulcers caused by Helicobacter pylori.

Contraindication
Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients.
Esomeprazole should not be used concomitantly with nelfinavir.

Children
It should not be used in children under 12 years of age, as there are no data on such use.

Use during pregnancy or breastfeeding
There are currently insufficient data on the use of Pemozar during pregnancy. A slightly larger number of epidemiological studies using the racemic mixture of omeprazole during pregnancy indicates the absence of birth defects and fetotoxic effects. Animal studies with esomeprazole did not indicate direct or indirect harmful effects with respect to embryonal / fetal development. Animal studies with racemic formula have not shown direct or indirect effects on pregnancy, childbirth or postnatal development. Caution should be exercised when prescribing to pregnant women. Moderate data on pregnant women (300 to 1000 pregnancies) indicate no malformative effects or toxic effects of esomeprazole on the fetus / health of the newborn. The results of animal studies indicate the absence of direct or indirect harmful effects of the drug on reproductive function due to its toxic effects.
It is not known whether esomeprazole passes into human breast milk. There is insufficient information on the effects of esomeprazole on neonates / infants. Esomeprazole should not be used during breast-feeding.

Method of application and dosage Pemozar 
Adults
Gastroesophageal reflux disease
Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. An additional 4 weeks is recommended for patients whose esophagitis has not been cured or whose symptoms persist.
Long-term treatment of relapses in patients with cured esophagitis: 20 mg once daily.
Symptomatic treatment of gastroesophageal reflux disease: 20 mg once daily in patients without esophagitis. If symptom control is not achieved within 4 weeks of treatment, the patient should be examined. At elimination of symptoms for the further control application of 20 mg 1 time a day can be enough. For adults, you can use the scheme “if necessary”, taking 20 mg once a day. In patients who have used NSAIDs and who are at risk of developing gastric or duodenal ulcers, further monitoring of symptoms using the “if necessary” scheme is not recommended.
In combination with antibacterial agents for eradication of Helicobacter pylori
Treatment of duodenal ulcer associated with Helicobacter pylori and
Prevention of recurrence of peptic ulcers in patients with ulcers caused by Helicobacter pylori: 20 mg of Pemozar with 1 g of amoxicillin and 500 mg of clarithromycin 2 times a day for 7 days.
Treatment and prevention of ulcers caused by long-term use of NSAIDs
Treatment of gastric ulcers caused by NSAID therapy: the recommended dose is 20 mg once daily. The duration of treatment is 4-8 weeks.
Prevention of gastric and duodenal ulcers associated with NSAID treatment in patients at risk: the recommended dose is 20 mg once daily.
Long-term treatment after intravenous use of the drug to prevent recurrence of bleeding from peptic ulcers:
40 mg 1 time per day for 4 weeks after intravenous administration of the drug to prevent recurrence of bleeding from peptic ulcers.
Treatment of Zollinger-Ellison syndrome: 40 mg 2 times a day. The dosage should be selected individually, the duration of treatment is determined by clinical indications. According to the available clinical data, in most patients the disease can be controlled by taking 80 and 160 mg of esomeprazole per day. If the dose exceeds 80 mg / day, it should be divided into two doses.
Patients of special groups
Patients with impaired renal function
No dose adjustment is required for patients with impaired renal function. Due to the lack of experience in the use of Pemozar for the treatment of patients with severe renal insufficiency in such patients, the drug should be prescribed with caution.
Patients with impaired liver function
No dose adjustment is required for patients with mild to moderate hepatic impairment. For patients with severe hepatic impairment, the maximum dose of Pemozar should not exceed 20 mg.
Elderly patients
No dose adjustment is required for elderly patients.
Pediatric population
Children from 12 years old
Gastroesophageal reflux disease (GERD):

• Treatment of erosive reflux esophagitis:
  40 mg once daily for 4 weeks.
  Patients with untreated esophagitis or persistent symptoms are recommended to use the drug for an additional 4 weeks.
• Long-term treatment of patients with cured esophagitis to prevent recurrence:
  20 mg once daily.
• Symptomatic treatment of gastroesophageal reflux disease (GERD)
  The dose for patients without esophagitis is 20 mg once a day. If after 4 weeks of treatment control of symptoms is not achieved, the patient should undergo additional examination. After relief of symptoms, further control over them can be achieved by using the drug at a dose of 20 mg 1 time per day.

Treatment of duodenal ulcer caused by Helicobacter pylori
Official national, regional, and local guidelines for bacterial resistance, duration of treatment (usually 7 days, but sometimes up to 14 days), and appropriate use of antibacterial agents should be considered when selecting appropriate combination therapy. Treatment should be performed under the supervision of a specialist.

Application method
Pemozar tablets should be swallowed whole with plenty of fluids. The tablets should not be chewed or crushed.
Patients who have difficulty swallowing may be advised to dissolve the tablet in 100 ml of still water. No other liquids should be used as they may damage the intestinal soluble membrane. The water in the glass should be shaken to dissolve the tablet. Drink the liquid with microgranules immediately or for 30 minutes. You should collect another half glass of water, rinse the walls with water and drink. Microgranules should not be chewed or crushed.
Patients who have difficulty swallowing can be injected through a nasogastric tube, pre-dissolved in half a glass of still water. It is very important that the syringe and probe are appropriate for this procedure.
Introduction of the drug through a nasogastric tube
1. Put the tablet Pemozar in a suitable syringe and fill it with approximately 25 ml of water and 5 ml of air. Some probes may require 50 ml of water to prevent difficulty in passing the tablet through the probe.
2. Shake the syringe for 2 minutes to disintegrate the tablet.
3. Hold the syringe upright, tip up, check the patency of the tip.
4. Attach the syringe to the probe, holding it upright.
5. Shake the syringe and turn it upside down. Quickly inject 5-10 ml of liquid. Turn the syringe over after injection and shake again (keep the syringe upright so as not to clog the tip).
6. Turn the syringe over again and insert another 5-10 ml of liquid into the probe. Repeat the procedure until the syringe is empty.
7. To flush out any drug residue, fill the syringe with 25 ml of water and 5 ml of air, shake the syringe, invert it and inject the liquid quickly. Some probes may require 50 ml of water.

Overdose
Data on intentional overdose are very limited. Symptoms described when the drug was administered at a dose of 280 mg included symptoms from the gastrointestinal tract and weakness. A single dose of esomeprazole at a dose of 80 mg did not cause any adverse effects. The specific antidote is unknown. Esomeprazole is significantly bound to plasma proteins, so excretion by dialysis is not significant. As with any overdose, symptomatic and general supportive care should be provided.

Side effects:

• From the blood and lymphatic system: leukopenia, thrombocytopenia.
• On the part of the immune system: hypersensitivity reactions such as fever, angioneurotic edema and anaphylactic reaction / shock.
• From the metabolism: peripheral edema.
• Mental disorders: insomnia, agitation, depression, confusion.
• From the nervous system: headache.
• From the point of view: blurred vision.
• From the hearing organs: dizziness.
• From the respiratory system: bronchospasm.
• From the digestive system: abdominal pain, constipation, diarrhea, bloating, nausea, vomiting, fundus polyps (benign), dry mouth, stomatitis, candidiasis of the gastrointestinal tract.
• From the hepatobiliary system: increased levels of liver enzymes, hepatitis with or without jaundice.
• From the skin and subcutaneous tissue: dermatitis, itching, urticaria, rash, alopecia, photosensitivity.
• From the musculoskeletal system and connective tissue: fracture of the thigh, wrist or spine, arthralgia, myalgia, muscle weakness.
• From the kidneys and urinary system: interstitial nephritis; renal failure has been reported concomitantly in some patients.
• From the reproductive system: gynecomastia.
• General disorders: weakness, increased sweating.

Expiration date
2 years.

Storage conditions
Store Pemozar at a temperature not exceeding 30 ° C in the original package.
Keep out of reach of children.