Pantaz (Tablets) Instructions for Use

Marketing Authorization Holder

Medley Pharmaceuticals, Ltd. (India)

ATC Code

A02BC02 (Pantoprazole)

Active Substance

Pantoprazole (Rec.INN registered by WHO)

Dosage Form

Pantaz

Enteric-coated tablets, 40 mg: 10, 30 or 100 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (100) – cardboard packs.

Clinical-Pharmacological Group

H⁺-K⁺-ATPase inhibitor. Antiulcer drug

Pharmacotherapeutic Group

Proton pump inhibitor

Pharmacological Action

It inhibits the H+/K+-ATPase enzyme (“proton pump”) in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid synthesis. This leads to a decrease in basal and stimulated secretion of hydrochloric acid, regardless of the nature of the stimulus. After a single oral dose of 20 mg of pantoprazole, the effect of pantoprazole occurs within the first hour, with the maximum effect achieved after 2-2.5 hours. It does not affect the motility of the gastrointestinal tract (GIT). After discontinuation of the drug, secretory activity is completely restored after 3-4 days.

Pharmacokinetics

Pantoprazole is rapidly absorbed from the gastrointestinal tract, C_max(1-1.5 µg/ml) is reached 2-2.5 hours after oral administration, with the C_maxvalue remaining constant upon repeated administration. The bioavailability of the drug is 77%. Concurrent food intake does not affect the area under the concentration-time curve (AUC), C_max, or bioavailability; only a change in the onset of the drug’s action is observed.

Plasma protein binding is about 98%. V_dis approximately 0.15 l/kg, and clearance is 0.1 l/h/kg. Pantoprazole is almost completely metabolized in the liver. It is an inhibitor of the CYP2C19 enzyme system. The half-life (T_1/2) is 1 hour. Due to the specific binding of pantoprazole to the proton pump of parietal cells, T_1/2does not correlate with the duration of the therapeutic effect. Metabolites are excreted (80%) mainly through the kidneys; the remainder is excreted in the bile. The main metabolite determined in blood serum and urine is desmethylpantoprazole, which is conjugated with sulfate. The T_1/2of desmethylpantoprazole, the main metabolite (approximately 1.5 hours), is much longer than the T_1/2of pantoprazole itself.

In chronic renal failure (including patients on hemodialysis) no dose adjustment of the drug is required. T_1/2is short, as in healthy individuals. Very small amounts of pantoprazole may be dialyzed.

In patients with liver cirrhosis (Child-Pugh classes A and B) taking pantoprazole 20 mg/day, T_1/2increased to 3-6 hours, AUC increased 3-5 times, and C_maxincreased 1.3 times compared to healthy individuals.

A slight increase in AUC and an increase in C_max in elderly patients compared to the corresponding data in younger patients are not clinically significant.

Indications

• Gastroesophageal reflux disease (GERD), including erosive-ulcerative reflux esophagitis and GERD-associated symptoms: heartburn, acid regurgitation, pain on swallowing;
• Gastric and duodenal ulcer (treatment and prevention);
• Eradication of Helicobacter pylori as part of combination therapy;
• Zollinger-Ellison syndrome.

ICD codes

Dosage Regimen

Orally, the tablet should not be chewed or broken. The tablet should be swallowed whole with a small amount of liquid, before meals, usually before breakfast. When taken twice a day, the second dose of the drug is recommended to be taken before dinner.

For gastric and duodenal ulcers, Zollinger-Ellison syndrome – 40-80 mg/day.

For reflux esophagitis – 20-40 mg/day.

In elderly patients and in chronic renal failure – no more than 40 mg/day. In hepatic insufficiency – 40 mg once every 2 days.

The course of treatment for duodenal ulcer healing is 2 weeks, for gastric ulcer and reflux esophagitis – 4-8 weeks.

Eradication of Helicobacter pylori

Pantoprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, clarithromycin 500 mg twice daily; Pantoprazole 20 mg twice daily, metronidazole 500 mg twice daily, clarithromycin 500 mg twice daily; Pantoprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, metronidazole 500 mg twice daily. Treatment is carried out for 7-14 days.

Adverse Reactions

Adverse effects are presented according to the WHO classification: common (1-10%), uncommon (0.1-1%), rare (0.1-0.01%), very rare (less than 0.01%).

From the hematopoietic system: very rarely – leukopenia, thrombocytopenia. From the digestive system: frequently – abdominal pain, diarrhea, constipation, flatulence; uncommon – nausea, vomiting; rarely – dry mouth; very rarely – increased activity of “liver” transaminases and GGT (GGT), severe liver damage leading to jaundice with or without liver failure.

From the immune system: very rarely – anaphylactic reactions, including anaphylactic shock.

From the musculoskeletal system: rarely – arthralgia; very rarely – myalgia.

From the central and peripheral nervous system: frequently – headache, uncommon – dizziness, visual disturbance (blurred vision).

Mental disorders: very rarely – depression, hallucinations, disorientation, confusion (especially in predisposed individuals).

From the genitourinary system: very rarely – interstitial nephritis. Allergic reactions: uncommon – itching and rash; very rarely – urticaria, angioedema, Stevens-Johnson syndrome, erythema multiforme, Lyell’s syndrome, photosensitivity.

General disorders: very rarely – peripheral edema, hyperthermia, weakness, painful breast tension, increased triglyceride concentration,

If severe adverse effects occur, treatment with the drug should be discontinued.

Contraindications

• Hypersensitivity to pantoprazole or other components of the drug;
• Dyspepsia of neurotic origin;
• Children under 18 years of age (efficacy and safety have not been studied).

With caution: pregnancy, lactation period, hepatic insufficiency, risk factors.

Use in Pregnancy and Lactation

Experience with the use of pantoprazole in pregnant women is limited. The use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. There are no data on the excretion of pantoprazole in breast milk.

Use in Hepatic Impairment

Use this drug with caution in hepatic insufficiency (dose adjustment is required).

Use in Renal Impairment

In chronic renal failure, dose adjustment is required.

Pediatric Use

Contraindicated in children under 18 years of age (efficacy and safety have not been studied).

Geriatric Use

In elderly patients, dose adjustment is required.

Special Precautions

Before starting therapy, it is necessary to exclude the presence of a malignant neoplasm (endoscopic control, with biopsy if necessary – especially in gastric ulcer), because treatment, by masking symptoms, may delay the correct diagnosis. If after 4 weeks of pantoprazole therapy the patient does not have the desired therapeutic effect, they should be re-examined.

Like other proton pump inhibitors, Pantoprazole may reduce the absorption of cyanocobalamin (vitamin B12) against the background of hypo- and achlorhydria. This should be especially taken into account during long-term treatment and in patients with risk factors for vitamin B12 deficiency.

Long-term therapy, especially lasting more than 1 year, requires regular monitoring of the patient.

May lead to false-positive results when performing a urine test for tetrahydrocannabinol.

Effect on the ability to drive a car and other mechanical means

No studies have been conducted on the effect of the drug on the ability to drive a car or other technical means, however, some side effects (blurred vision, dizziness) may affect the performance of activities requiring increased concentration and speed of psychomotor reactions.

Overdose

Symptoms of overdose in humans are not known.

Treatment: there is no specific antidote. In case of drug overdose, symptomatic and supportive treatment is carried out.

Drug Interactions

Pantoprazole reduces the absorption of drugs whose bioavailability depends on the pH of the gastric environment and which are absorbed at acidic pH values (for example, ketoconazole, iron preparations ).

Pantoprazole is metabolized in the liver via the cytochrome P₄₅₀ enzyme system. Interactions of pantoprazole with drugs that are metabolized by the same system cannot be excluded. Nevertheless, clinical studies have not revealed significant interactions with digoxin, diazepam, diclofenac, ethanol, phenytoin, glibenclamide, carbamazepine, caffeine, metoprolol, naproxen, nifedipine, piroxicam, theophylline and oral contraceptives. Although no significant interactions were detected in clinical pharmacokinetic studies with concurrent use of warfarin, several isolated reports of changes in the international normalized ratio (INR) have been noted. In patients receiving coumarin anticoagulants concurrently with pantoprazole, it is recommended to regularly monitor prothrombin time or INR.

No drug interactions have been registered with the simultaneous administration of pantoprazole with antacids.

Concomitant use of atazanavir and nelfinavir with proton pump inhibitors (including pantoprazole) is not recommended, as they may reduce the plasma concentrations of atazanavir and nelfinavir and lead to a decrease in the therapeutic effect of antiretroviral therapy.

Storage Conditions

The drug should be stored at a temperature not exceeding 25°C (77°F), in a dry place.

Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Do not use the drug after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.