Ultera (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Manufactured By

Emcure Pharmaceuticals, Ltd. (India)

ATC Code

A02BC02 (Pantoprazole)

Active Substance

Pantoprazole (Rec.INN registered by WHO)

Dosage Form

Ultera

Enteric-coated tablets, 20 mg: 14 or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets yellow-orange in color, round, biconvex: on the cross-section – a core from white to cream-colored; marbling is allowed.

Excipients : sodium carbonate – 20 mg, mannitol – 43.838 mg, povidone – 40 mg, calcium stearate – 3.2 mg.

Isolating coating composition hypromellose (hydroxypropyl methylcellulose) 2.75 mg.
Enteric coating composition methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, (Eudragit L30 D-55) – 55.27 mg, sodium hydroxide – 0.225 mg, macrogol – 1.98 mg, talc – 4.18 mg, titanium dioxide – 0.825 mg, iron oxide yellow dye (E172) – 0.475 mg, iron oxide red dye (E172) – 0.103 mg.

7 pcs. – blisters (2) – cardboard packs.
10 pcs. – strips (10) – cardboard packs.
14 pcs. – strips (1) – cardboard packs.

Clinical-Pharmacological Group

H⁺-K⁺-ATPase inhibitor. Antiulcer drug

Pharmacotherapeutic Group

Proton pump inhibitor

Pharmacological Action

S-Pantoprazole sodium is the chirally pure S-enantiomer of racemic pantoprazole. S-Pantoprazole is a proton pump inhibitor that suppresses the final stage of hydrochloric acid secretion by forming covalent bonds with two sites of the enzyme (H+/K+-ATPase) of the parietal cells on the secretory surface of the stomach. This effect is dose-dependent and leads to inhibition of both basal and stimulated secretion, regardless of the nature of the stimulus. Inhibition of (H+/K+-ATPase) leads to a long-lasting antisecretory effect, the duration of which is more than 24 hours.

Pharmacokinetics

S-pantoprazole tablets are enteric-coated, which is why the release of the active substance begins after the drug leaves the stomach. The absorption of S-pantoprazole is not dependent on concomitant use with antacids. C_max – 1.85±0.66 µg/ml is reached within 2.96±0.736 h. Taking the drug with food may slow its absorption; however, the C_max and AUC values remain unchanged. Thus, the drug can be taken regardless of meals. Metabolized in the liver.T_1/2 – 2.341±0.908 h.

Indications

• Gastric and duodenal ulcer in the acute phase;
• Gastroesophageal reflux disease;
• Pathological conditions accompanied by gastric hypersecretion (e.g., Zollinger-Ellison syndrome).

ICD codes

Dosage Regimen

Orally, do not chew or divide the tablet. It should be swallowed whole, and can be taken with or without food.

The recommended regimen for Ultera in peptic ulcer disease is 20-40 mg/day.

In elderly patients, with chronic renal failure (CRF) – no more than 20 mg/day.

The course of treatment for exacerbation of duodenal ulcer is 2 weeks, for exacerbation of gastric ulcer and for gastroesophageal reflux disease – 4-8 weeks. For conditions accompanied by gastric hypersecretion, the course of treatment can be quite long; it depends on the individual characteristics of the patient’s body and is established by the attending physician depending on the rate of healing of erosive and ulcerative defects and the reduction of basal hydrochloric acid secretion to within physiological limits. Based on clinical experience, the recommended initial dose of the drug is 20 mg twice a day.

In Zollinger-Ellison syndrome, the level of basal hydrochloric acid secretion should be below 10 mEq/h for patients without surgical treatment, for which a dose of up to 120 mg of the drug per day may be required, and 5 mEq/h for patients after surgical treatment.

For hepatic insufficiency – 20 mg once every 2 days.

Adverse Reactions

From the CNS headache, dizziness, depression.

From the GI tract diarrhea, nausea, vomiting, abdominal pain.

From the skin skin rash, itching.

Other weakness, asthenia, chest pain.

Contraindications

• Dyspepsia of neurotic origin;
• Pregnancy and lactation (safety and efficacy not established);
• Children under 18 years of age (efficacy and safety in pediatrics not established);
• Hypersensitivity to the components of the drug.

With caution hepatic insufficiency.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

In chronic renal failure, it is prescribed in a dose not exceeding 20 mg/day.

Pediatric Use

Contraindicated in children under 18 years of age.

Geriatric Use

In elderly patients, it is prescribed in a dose not exceeding 20 mg/day.

Special Precautions

Precautions for use

Endoscopic control is mandatory before and after treatment with Ultera to exclude a malignant neoplasm, because treatment may mask symptoms and delay correct diagnosis.

Effect on ability to drive vehicles and operate machinery

No specific studies on the effect on the ability to drive a car or other mechanisms have been conducted.

Attention should be paid to the fact that dizziness may develop during treatment, and therefore caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Reduces the effect of drugs absorbed at acidic pH values (including ketoconazole).

Storage Conditions

In a dry place, protected from light, at a temperature not exceeding 25°C (77°F). Keep out of reach of children!

Shelf Life

Shelf life – 2 years.

Dispensing Status

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.