Dexilant - Instructions For Use, Indications, Doses, Analogues

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Dexilant - Instructions For Use, Indications, Doses, Analogues
Dexilant - Instructions For Use, Indications, Doses, Analogues

Video: Dexilant - Instructions For Use, Indications, Doses, Analogues

Video: Dexilant - Instructions For Use, Indications, Doses, Analogues
Video: Dexilant; How it Works, Drug Errors, Harm, & Side Effects [Doctor Interview] 2024, September
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Dexilant

Instructions for use:

  1. 1. Release form and composition
  2. 2. Indications for use
  3. 3. Contraindications
  4. 4. Method of application and dosage
  5. 5. Side effects
  6. 6. Special instructions
  7. 7. Drug interactions
  8. 8. Analogs
  9. 9. Terms and conditions of storage
  10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 1180 rub.

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Dexilant Modified Release Capsules
Dexilant Modified Release Capsules

Dexilant - proton pump inhibitor (H + -K + -ATPase inhibitor); an agent that lowers the secretion of stomach glands.

Release form and composition

Dosage form - capsules with modified release:

  • 30 mg: with an opaque gray body and an opaque blue cap, with the "TAP" logo printed on the cap in dark gray ink, with "30" written on the body;
  • 60 mg: with an opaque blue body and lid, with the TAP logo printed on the lid in dark gray ink, with the word 60 written on the body.

Content of capsules: granules from white to almost white.

Packing of capsules: 14 and 28 pcs. in polyethylene bottles, 1 bottle in a cardboard box.

Active ingredient: dexlansoprazole, in 1 capsule - 30 or 60 mg.

Auxiliary components: dispersion of methacrylic acid copolymer (methacrylic acid, ethyl acrylate, sodium lauryl sulfate, polysorbate 80), sugar grits (corn starch, sucrose), titanium dioxide, hypromellose 2910, hyprolose, low-substituted hyprolose, magnesium carbonate, triethylcylcylate colloidal dioxide, polysorbate 80, copolymer of methacrylic acid and methyl methacrylate [1: 1], macrogol 8000, copolymer of methacrylic acid and methyl methacrylate [1: 2].

Shell composition:

  • capsules 30 mg: titanium dioxide, potassium chloride, carrageenan, hypromellose, iron dye black oxide, FD & C blue No. 2 dye aluminum lacquer, purified gray ink for marking (trace amounts);
  • 60 mg capsules: titanium dioxide, potassium chloride, carrageenan, hypromellose, FD & C blue No. 2 dye aluminum varnish, gray ink purified for marking (trace amounts).

The composition of the purified gray ink: carnauba wax, glyceryl monooleate, shellac, dye iron oxide yellow, dye iron oxide red, dye FD & C blue No. 2 aluminum varnish.

Indications for use

  • symptomatic therapy of gastroesophageal reflux disease (GERD), including non-erosive reflux disease (NERD);
  • treatment of erosive esophagitis of any severity;
  • supportive care after the end of the course of treatment for erosive esophagitis and relief of heartburn symptoms.

Contraindications

Absolute contraindications:

  • hereditary fructose intolerance, glucose-galactose malabsorption, sucrose-isomaltase deficiency;
  • age up to 18 years;
  • period of pregnancy and lactation;
  • simultaneous use of HIV protease inhibitors (nelfinavir, atazanavir);
  • hypersensitivity to any component of the drug.

Dexilant should be used with caution in patients who are simultaneously receiving any of the following drugs:

  • tacrolimus;
  • methotrexate;
  • warfarin;
  • an inhibitor of the isoenzyme CYP2C19 (eg, fluvoxamine).

Method of administration and dosage

Dexilant should be taken orally, regardless of food intake. Capsules can be swallowed whole or opened, mixed with applesauce and swallowed slowly without chewing.

Dosing modes:

  • erosive esophagitis: 60 mg once a day for 8 weeks;
  • maintenance therapy of erosive esophagitis and relief of heartburn: 30 mg 1 time per day, in cases of moderate and severe illness - 60 mg 1 time per day. Course - up to 6 months;
  • GERD: 30 mg once a day for 4 weeks.

Elderly people, patients with impaired renal function and mildly impaired liver function do not require dose adjustment.

In case of moderate liver dysfunctions, a daily dose of 30 mg should not be exceeded. With a severe degree of violations, there are no clinical data on the use of the drug.

Side effects

  • from the nervous system: often (from ≥ 1/100 to <1/10) - headache; infrequently (from ≥ 1/1000 to <1/100) - dizziness, dysgeusia; rarely (from ≥ 1/10 000 to <1/1000) - paresthesia, convulsions; the frequency is unknown (based on the available data, it is not possible to estimate the incidence of side effects) - stroke, transient ischemic attack;
  • from the side of metabolism: the frequency is unknown - a pathological decrease in the concentration of magnesium and sodium in the blood plasma;
  • from the immune system: the frequency is unknown - exfoliative dermatitis, hypersensitivity reactions (including anaphylactic reactions and anaphylactic shock), toxic epidermal necrolysis, malignant exudative erythema (Stevens-Johnson syndrome);
  • from the respiratory system: often - infectious diseases of the upper respiratory tract; infrequently - cough; frequency unknown - feeling of tightness in the throat, laryngeal edema;
  • from the digestive system: often - flatulence, discomfort and pain in the abdomen, nausea, vomiting, constipation or diarrhea; infrequently - dryness in the mouth; rarely - oral candidiasis; frequency unknown - pancreatitis, swelling of the oral mucosa;
  • from the liver and biliary tract: infrequently - a change in the indicators of the functional activity of the liver; frequency unknown - drug-induced hepatitis;
  • on the part of the cardiovascular system: infrequently - hot flashes, increased blood pressure;
  • on the part of the psyche: infrequently - insomnia, depression; rarely, auditory hallucinations;
  • from the urinary system: frequency is unknown - acute renal failure;
  • from the musculoskeletal system: frequency unknown - fractures;
  • on the part of the blood and lymphatic system: the frequency is unknown - idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia;
  • on the part of the organ of hearing, as well as labyrinth disorders: rarely - vertigo; frequency unknown - hearing impairment;
  • on the part of the organ of vision: rarely - disturbances in visual perception, including blurred vision;
  • on the part of the skin and subcutaneous tissues: infrequently - itching, urticaria, skin rashes; frequency unknown - generalized rash, leukocytoclastic vasculitis;
  • general disorders: infrequently - changes in appetite, weakness; frequency unknown - facial edema.

special instructions

Before prescribing Dexilant, an examination is indicated to exclude the likelihood of a malignant formation, since dexlansoprazole can mask its symptoms, which may delay the correct diagnosis.

If symptoms persist during treatment, a thorough evaluation should be done.

Dexlansoprazole, like other proton pump inhibitors, increases the risk of gastrointestinal infections accompanied by diarrhea caused by Clostridium difficile bacteria, especially in hospitalized patients. This should be taken into account in cases where the patient's condition does not improve with the treatment of diarrhea.

With prolonged use (for a year or more) or in high doses, Dexilant increases the risk of osteoporotic fractures of the hands, spine, and hip bones. Patients at risk should strictly adhere to the recommended dosage regimen.

In some cases, proton pump inhibitors cause hypomagnesemia: more often - within a year of taking the drug, less often - within 3 months. Its symptoms are arrhythmias, titania, convulsions. In this case, Dexilant is canceled and appropriate treatment is prescribed to replenish magnesium.

With long-term treatment with dexlansoprazole and with the simultaneous use of digoxin or other drugs that can cause hypomagnesemia (for example, diuretics), the concentration of magnesium in the blood serum should be monitored before starting therapy and periodically during it.

Dexilant can cause visual impairment and dizziness, and therefore it is recommended to refrain from driving a car, working with complex mechanisms and other activities that require increased attention.

Drug interactions

There was no clinically significant drug interaction with the simultaneous use of clopidogrel, diazepam, phenytoin and theophylline.

Dexlansoprazole can affect the absorption of drugs whose bioavailability depends on the pH of the stomach environment, for example, iron salts, ampicillin esters, ketoconazole, digoxin, erlotinib.

Fluvoxamine increases the systemic effect of dexlansoprazole.

Dexilant can increase the concentration of tacrolimus in blood plasma (especially in patients after transplantation) and methotrexate in blood serum.

Analogs

There is no information about Dexilant analogues.

Terms and conditions of storage

Store in a dry place, out of reach of children, at temperatures up to 25 ° C.

Shelf life is 4 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Dexilant: prices in online pharmacies

Drug name

Price

Pharmacy

Dexilant 30 mg modified release capsules 14 pcs.

1180 RUB

Buy

Dexilant 60 mg modified release capsules 14 pcs.

1376 RUB

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Dexilant 30 mg Modified Release Capsules 28 pcs.

1825 RUB

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Dexilant capsules with modif. release 30mg 28 Pcs.

1879 RUB

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Dexilant 60 mg modified release capsules 28 pcs.

2250 RUB

Buy

Dexilant capsules with modif. release 60mg 28 pcs.

2329 RUB

Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!

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