Dexilant® [Dexlansoprazole]

Composition and form of release

Composition 1 capsule

• Active ingredients: dexlansoprazole 30 mg
• Excipients:
  • sugar grains - 28.8 mg (including sucrose 18-26.352 mg, corn starch 2.448-10.8 mg),
  • magnesium carbonate - 11.5 mg,
  • sucrose - 41.5 mg,
  • low-substituted hyprolose - 8.64 mg,
  • hyprolose - 0.34 mg,
  • hypromellose 2910 - 7.54 mg,
  • talcum powder - 16.64 mg,
  • titanium dioxide - 5.5 mg,
  • the dispersion of methacrylic acid of the copolymer is 9.66 mg (including methacrylic acid - 4.4436 mg, ethyl acrylate - 4.2504 mg, sodium lauryl sulfate - 0.2254 mg, polysorbate-80 - 0.7406 mg),
  • macrogol 8000 - 0.96 mg,
  • polysorbate-80 - 0.44 mg,
  • colloidal silicon dioxide - 0.09 mg,
  • methacrylic acid and methyl methacrylate copolymer [1: 2] - 15.95 mg,
  • methacrylic acid and methyl methacrylate copolymer [1: 1] - 5.32 mg,
  • triethyl citrate - 2.12 mg.
• The composition of the capsule shell:
  • carrageenan - 0.192-0.624 mg,
  • potassium chloride - 0.144-0.48 mg,
  • titanium dioxide - 2.4768 mg,
  • dye FD & C blue No. 2 aluminum varnish - 0.3456 mg,
  • iron oxide black oxide - 0.0576 mg,
  • hypromellose - q.s. up to 48 mg
  • peeled gray ink for marking - trace amounts.
• Ink composition: iron oxide red oxide, iron oxide yellow, FD & C blue No. 2 aluminum varnish, carnauba wax, shellac, glyceryl monooleate.

Release form

Modified-release capsules with an opaque blue cap and an opaque gray body; the TAP logo is applied on the cap with dark gray ink, and the inscription "30" is on the case. The contents of the capsules are granules from white to almost white.

Indications for use

• treatment of erosive esophagitis of any severity;
• maintenance therapy after treatment of erosive esophagitis and relief of manifestations of heartburn;
• symptomatic treatment of gastroesophageal reflux disease of GERD (i.e., NERD - non-erosive reflux disease);

Contraindications

• hypersensitivity to any of the components of the drug;
• combined use with HIV protease inhibitors (atazanavir, nelfinavir);
• age up to 18 years;
• pregnancy, lactation.

The drug contains sucrose, therefore its use is not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency.

Take with caution

• patients taking tacrolimus;
• patients taking inhibitors of the CYP2C19 isoenzyme, such as fluvoxamine; patients taking warfarin under the control of prothrombin time and MHO;
• patients taking methotrexate.

special instructions

Before starting dexlansoprazole treatment, the possibility of a malignant neoplasm should be excluded, since the drug can mask the symptoms and delay the correct diagnosis.

If symptoms persist despite adequate treatment, further examination should be carried out.

When taking proton pump inhibitors, which include dexlansoprazole, an increased risk of gastrointestinal infections accompanied by diarrhea caused by bacteria of the genus Clostridium difficile, especially in hospitalized patients. This must be taken into account if, in the treatment of diarrhea, the patients condition does not improve.

In this case, patients are recommended to take the minimum effective dose of dexlansoprazole with the shortest duration of treatment.

In patients receiving high doses of the drug or during prolonged therapy with proton pump inhibitors (IPI) for a year or more, the risk of osteoporotic fractures of the bones of the thighs, hands and spine increases. Patients at risk of osteoporotic fractures should adhere to the recommended dosages (see section "Dosage and Administration").

In rare cases, patients had symptomatic and asymptomatic hypomagnesemia when taking PPI drugs for at least three months, and in most cases when taking them for a year. Symptoms of hypomagnesemia are tetany, arrhythmia, and seizures.Treatment - replenishment of magnesium and cancellation of the intake of PPI drugs. In patients who need long-term treatment or who are taking IPI drugs with digoxin or other drugs that can cause hypomagnesemia (for example, diuretics), it is necessary to control the concentration of magnesium in the blood serum before and during treatment.

Dose adjustment

In case of impaired renal function: dose adjustment in patients with impaired renal function is not required.

In case of impaired liver function: in patients with impaired liver function of moderate severity (class B but Child-Pugh), the daily dose should not exceed 30 mg of dexlansoprazole.

Clinical data on the administration of the drug in patients with severe disorders (Child-Pugh class C) are not available.

Dose adjustment in patients with impaired liver function of mild severity (Child-Pugh class A) is not required.

Use in old age: dose adjustment in elderly patients is not required.

Influence on the ability to drive vehicles / mechanisms.

Due to the likelihood of dizziness and visual impairment, one should refrain from driving vehicles and other mechanisms that require increased attention.