Prevacid online in Australia

What is Prevacid used for?

· Treatment of duodenal ulcer and gastric ulcer.

· Treatment of reflux esophagitis.

· Prevention of reflux esophagitis.

Eradication of Helicobacter pylori (H. pylori) by concomitant administration of adequate antibiotic therapy for the treatment of ulcers associated with H. pylori.

Treatment of duodenal ulcer and benign gastric ulcer, induced by NSAIDs in patients requiring continuous treatment with NSAIDs.

Prevention of duodenal ulcer and NSAID-induced gastric ulcer in patients at risk (see section 4.2) who require continued treatment with NSAIDs.

Symptomatic gastroesophageal reflux.

Zollinger-Ellison syndrome.

Conditions for which this medicine may be prescribed

• Duodenal ulcer
• Gastric ulcer
• Gastroesophageal reflux esophagitis
• Prevention of reflux esophagitis
• Helicobacter pylori eradication in case of peptic ulcer
• NSAID-induced duodenal ulcer and gastric ulcer in patients requiring continuous treatment
• Prevention of duodenal ulcer and NSAID-induced gastric ulcer in patients at risk
• Gastroesophageal reflux
• Zollinger-Ellison syndrome

Method of administration and dosage of the drug Prevacid

For optimal effect, Prevacid should be taken once a day in the morning, except in the case of an H. pylori eradication for which the treatment should be taken twice a day, once in the morning and once in the evening. . . Prevacid must be taken at least 30 minutes before meals (see section Pharmacokinetic properties). The capsules should be swallowed whole with a liquid.

For patients with difficulty swallowing, studies and clinical practice suggest that the capsules can be opened and the microgranules mixed with a small amount of water, apple or tomato juice, or sprinkled on a small amount of food. non-solid (example: yogurt, applesauce) to facilitate administration. The capsules can also be opened and the microgranules are mixed with 40 ml of apple juice for administration by nasogastric tube (see section Pharmacokinetic properties). After preparation of the suspension or mixture, the medicine should be administered immediately.

Duodenal ulcer treatment:

The recommended dose is 30 mg once a day for 2 weeks. In patients whose healing does not complete after this period, treatment will continue, at the same dose, for an additional 2 weeks.

Gastric ulcer treatment:

The recommended dose is 30 mg once a day for 4 weeks. The ulcer usually heals within 4 weeks, but in patients whose healing does not complete after this period, treatment can be continued, at the same dose, for an additional 4 weeks.

Reflux esophagitis:

The recommended dose is 30 mg once a day for 4 weeks. In patients whose healing does not complete after this period, treatment can be continued, at the same dose, for an additional 4 weeks.

Prevention of reflux esophagitis:

15 mg once a day. The dose can be increased up to 30 mg per day if necessary.

Helicobacter pylori eradication:

The choice of appropriate associated treatment should be made in accordance with official local recommendations on bacterial resistance, duration of treatment (generally 7 days, but sometimes up to 14 days), and the appropriate use of antibacterial agents.

The recommended dose is Prevacid 30 mg twice daily for 7 days in combination with one of the following combinations:

250-500 mg clarithromycin twice daily + 1 g amoxicillin twice daily,

250 mg clarithromycin twice daily + 400-500 mg metronidazole twice daily.

H. pylori eradication rates of up to 90% are obtained when clarithromycin is combined with Prevacid and amoxicillin or metronidazole.

Six months after successful eradication treatment, the risk of reinfection is low, and therefore relapse is unlikely.

The use of a dose comprising 30 mg of lansoprazole twice a day, 1 g of amoxicillin twice a day and 400-500 mg of metronidazole twice a day was also studied. Using this combination, lower eradication rates have been observed than for doses involving clarithromycin. They can be adapted for patients who cannot take clarithromycin as part of eradication treatment, when local rates of resistance to metronidazole are low.

Treatment of duodenal ulcer and benign gastric ulcer, induced by NSAIDs in patients requiring continuous treatment with NSAIDs:

30 mg once a day for four weeks. In patients with incomplete cure, treatment can be continued for an additional four weeks. In patients at risk or with ulcers that are difficult to heal, a longer treatment and / or a higher dose may be used.

Prevention of duodenal ulcer and NSAID-induced gastric ulcer in patients at risk (over 65 years of age or with a history of gastric or duodenal ulcer) requiring prolonged treatment with NSAIDs:

15 mg once a day. If treatment fails, the 30 mg dose should be used once daily.

Symptomatic gastroesophageal reflux:

The recommended dose is 15mg or 30mg per day. Relief of symptoms is obtained quickly. Adjustment of the individual dose should be considered. If symptoms are not alleviated in 4 weeks with a daily dose of 30 mg, additional tests are recommended.

Zollinger-Ellison syndrome:

The recommended starting dose is 60 mg once a day. The dose should be individually adjusted and treatment should be continued for as long as necessary. Daily doses of up to 180 mg have been used. If the required daily dose exceeds 120 mg, it should be divided and administered in two divided doses.

Kidney or liver failure:

No dosage adjustment is necessary in patients with renal impairment.

Patients with severe or moderate liver disease should be kept under regular supervision and a 50% reduction in the daily dose is recommended (see sections 4.4 and 4.4).

Aged subjects:

Due to the reduced clearance of lansoprazole in the elderly, an individual dose adjustment may be necessary. A daily dose of 30 mg should not be exceeded in the elderly, unless there are relevant clinical indications.

Children:

In the absence of sufficient clinical data, the use of Prevacid in children is not recommended (see also Pharmacokinetic properties section).

Possible side effects of the drug Prevacid

• Thrombocytopenia
• Eosinophilia
• Leukopenia
• Anemia
• Agranulocytosis
• Pancytopenia
• Hypomagnesemia
• Depression
• Insomnia
• Hallucination
• Confusion
• Headache
• Dizziness
• Psychomotor instability
• Vertigo
• Paresthesia
• Drowsiness
• Shaking
• Visual disturbances
• Sickness
• Diarrhea
• Abdominal pain
• Constipation
• Vomiting
• Flatulence
• Dry mouth
• Dry throat
• Gloss
• Esophageal candidiasis
• Pancreatitis
• Altered taste
• Colitis
• Stomatitis
• Increased liver enzymes.
• Hepatitis
• Jaundice
• Hives
• Pruritus
• Eruption
• Petechiae
• Purple
• Hair loss
• Polymorphic erythema
• Photosensitivity
• Stevens-Johnson syndrome
• Lyell syndrome
• Arthralgia
• Myalgia
• Hip fracture
• Broken wrist
• Vertebral fracture
• Interstitial nephritis
• Gynecomastia
• Tired
• Edema
• Fever
• Hyperhidrosis
• Angioedema
• Anorexy
• Impotence
• Anaphylactic shock
• Increased cholesterol levels
• Increased triglyceride levels.
• Hyponatremia

Show more Frequencies are defined as frequent (plus 1/100; minus 1/10); infrequent (plus 1 / 1,000; minus 1/100); rare (plus 1 / 10,000; minus 1 / 1,000); Very rare (minus 1 / 10,000).

Contraindications: when not to use this medicine?

• Lansoprazole hypersensitivity
• Breastfeeding
• Fructose intolerance
• Glucose malabsorption syndrome
• Galactose malabsorption syndrome
• Sucrase-isomaltase deficiency
• Under 18 years old
• Pregnancy

Hypersensitivity to the active substance or to any of the excipients.

Lansoprazole should not be administered with atazanavir (see section Interactions with other medicinal products and other forms of interaction).

Presentation of this medicine

30 capsules in blister (aluminum / aluminum).

Appearance and shape

Lack of information in the Marketing Authorization.

Prevacid: its other forms

• Prevacid 15 mg, orodispersible tablet, box of 28
• Prevacid 30 mg, orodispersible tablet, box of 14
• Prevacid 30 mg, orodispersible tablet, box of 28
• Prevacid 15 mg, gastro-resistant capsule, bottle of 30
• Prevacid 30 mg, gastro-resistant capsule, bottle of 30
• Prevacid 15 mg, gastro-resistant capsule, box of 15
• Prevacid 30 mg, gastro-resistant capsule, box of 7
• Prevacid 30 mg, gastro-resistant capsule, box of 14
• Prevacid 30 mg, gastro-resistant capsule, box of 28
• Prevacid 15 mg, orodispersible tablet, box of 14

View all forms of the drugComposition of the drug Prevacid

* per unit dose Active ingredients: Lansoprazole Excipients with known effects? : Sucrose, ethanol Other excipients: hypromellose, titanium dioxide, triethyl citrate, talc, corn starch, copolymer of: methacrylic acid, ethyl acrylate, capsule shell: gelatin, titanium dioxide, black ink to print: lacquers , isopropanol, propylene glycol, butanol, ammonium hydroxide, potassium hydroxide, black iron oxide Effects on ability to drive and use machines

Unwanted effects such as dizziness, vertigo, visual disturbances and drowsiness may occur (see section Unwanted Effects). Under these conditions, the reaction capacity can be reduced.

Warnings and precautions for use

• Hypomagnesemia
• Severe or moderate liver failure.
• Diarrhea
• Osteoporotic site
• Old subject

As with all other ulcer treatments, the possibility of malignant gastric tumor should be ruled out when treating gastric ulcer with lansoprazole, as it may mask symptoms and delay diagnosis.

Severe hypomagnesemia has been reported in patients treated with proton pump inhibitors (PPIs) such as lansoprazole for at least three months and, in most cases, for one year. Hypomagnesemia can manifest as serious clinical signs such as fatigue, tetany, hot flashes, seizures, dizziness, ventricular arrhythmia, but it can start insidiously and go unnoticed. In most patients, hypomagnesemia improved after magnesium supplementation and discontinuation of the PPI.

In patients requiring prolonged therapy or in combination with PPIs with digoxin or with drugs that can induce hypomagnesemia (for example, diuretics), healthcare professionals should consider a blood magnesium level test before starting treatment with PPIs and then regularly during treatment.

Lansoprazole should be used with caution in patients with severe or moderate hepatic impairment (see sections 4.2 and 5.2 and Pharmacokinetic properties).

A decrease in stomach acid due to lansoprazole can increase the levels of bacteria that are normally found in the gastrointestinal tract. Lansoprazole treatment may lead to a slight increase in the risk of gastrointestinal infections, particularly due to Salmonella and Campylobacter.

In patients with peptic ulcers, the possibility of H. pylori infection should be considered as an etiologic factor.

If lansoprazole is used in combination with antibiotics for the treatment of H. pylori eradication, then the conditions of use of these antibiotics should also be followed.

Due to limited safety data in patients on maintenance therapy for more than one year, regular monitoring of treatment and a comprehensive risk / benefit assessment should be performed on these patients on a regular basis.

Very rare cases of colitis have been reported in patients taking lansoprazole. Therefore, in the case of severe and / or persistent diarrhea, discontinuation of treatment should be considered.

Treatment for prevention of peptic ulcer in patients requiring continuous NSAID treatment should be limited to high-risk patients (eg, history of gastrointestinal bleeding, perforation or ulcer, older age, combination of medications known to increase the likelihood occurrence of adverse events in the upper digestive tract (eg, corticosteroids or anticoagulants), presence of a serious comorbidity factor, or prolonged use of NSAIDs at the maximum recommended doses).

Proton pump inhibitors, especially if used in large doses and for an extended period (more than 1 year), can moderately increase the risk of hip, wrist, and vertebra fractures, primarily in elderly patients or in the presence of others. identified risk factors. Observational studies suggest that proton pump inhibitors can increase the overall risk of fracture by 10 to 40%. This increase may be due in part to other risk factors. Patients at risk of osteoporosis should be treated according to current recommendations and receive an adequate intake of vitamin D and calcium.

This medicine contains sucrose. It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase / isomaltase deficiency.

Mechanism of action: how does it work?

Pharmacotherapeutic group: proton pump inhibitors.

ATC code: A02BC03

Lansoprazole is a gastric proton pump inhibitor. It inhibits the last stage of gastric acid formation by inhibiting the activity of the ATPase H + / K + proton pump in the parietal cells of the stomach. Inhibition is reversible and dose dependent. Its effects are exerted on both basal and stimulated gastric acid secretions. Lansoprazole is concentrated in parietal cells and becomes active in its acidic environment and reacts with the sulfohydroxylated group of the ATPase H + / K + proton pump, resulting in inhibition of enzyme activity.

Effect on gastric acid secretion:

Lansoprazole is a specific proton pump inhibitor for parietal cells. A single oral dose of lansoprazole inhibits pentagastrin-stimulated gastric acid secretion by approximately 80%. After repeated daily administration over a period of seven days, approximately 90% of gastric secretion is inhibited. It has a similar effect on basal gastric acid secretion. A single oral administration of 30 mg reduces basal secretion by approximately 70%; Therefore, the patient's symptoms improve from the first dose. After 8 days of repeated administration, the reduction is approximately 85%. Rapid symptom relief is achieved with one capsule (30 mg) daily, and most patients with duodenal ulcers heal within 2 weeks, patients with gastric ulcers or reflux esophagitis within 4 weeks. By reducing stomach acid, lansoprazole creates an environment in which appropriate antibiotics can be effective against H. pylori.

Interactions: do not take this medicine with ..

Effects of lansoprazole on other medications.

Drugs with pH dependent absorption.

Lansoprazole may interfere with the absorption of drugs for which bioavailability depends on gastric pH.

+ Atazanavir:

Co-administration of lansoprazole (60 mg once daily) and atazanavir 400 mg to healthy volunteers has significantly reduced exposure to atazanavir (approximately 90% decrease in AUC (area under the curve) and Cmax (one study). maximum concentration)). Lansoprazole must not be combined with atazanavir (see section 4.3).

+ Ketoconazole and itraconazole:

The absorption of ketoconazole and itraconazole from the gastrointestinal tract increases in the presence of gastric acid. Lansoprazole may induce concentrations below the therapeutic threshold of ketoconazole and itraconazole and the combination should be avoided.

+ Digoxin:

The combination of lansoprazole and digoxin can cause an increase in plasma digoxin concentration. Therefore, plasma digoxin concentrations should be monitored and the digoxin dose adjusted if necessary at the start and at the end of treatment with lansoprazole.

Medicines metabolized by cytochrome P450 enzymes

Lansoprazole can increase plasma concentrations of drugs metabolized by CYP3A4. Caution is recommended when combining lansoprazole with drugs metabolized by this enzyme and with a low therapeutic margin.

+ Theophylline:

Lansoprazole reduces the plasma concentration of theophylline, which may decrease the expected clinical effect. Caution is recommended when combining these two medications.

+ Tacrolimus:

Co-administration of lansoprazole increases plasma concentrations of tacrolimus (a substrate for CYP3A and P-gp). Taking lansoprazole increases the average tacrolimus rate by up to 81%. It is recommended to monitor plasma concentrations of tacrolimus at the beginning or at the end of treatment with lansoprazole.

P-glycoprotein-transported drug

Inhibition of P glycoprotein (P-gp) by lansoprazole has been observed in vitro. The clinical relevance is unknown.

Effects of other drugs on lansoprazole

Medicines that inhibit CYP2C19

+ Fluvoxamine:

A dose reduction may be considered when lansoprazole is combined with fluvoxamine, a CYP2C19 inhibitor. Plasma lansoprazole concentrations are increased up to 4 times normal.

CYP2C19 and CYP3A4 inducing medicinal products

Enzyme inducers that affect CYP2C19 and CYP3A4 such as rifampin and St. John's wort (Hypericum perforatum) can significantly reduce plasma lansoprazole concentrations.

Others

+ Sucralfate / Antacids:

Sucralfate and antacids can decrease the bioavailability of lansoprazole. Therefore, lansoprazole should be taken at least 1 hour after taking these medications.

A clinically significant interaction between lansoprazole and non-steroidal anti-inflammatory drugs has not been demonstrated, although no formal interaction studies have been performed.

Incompatibilities

Aimlessly.

How to react in case of overdose?

The effects of an overdose with lansoprazole in humans are unknown (although acute toxicity is likely to be low), and therefore treatment regimens cannot be specified. However, daily doses of up to 180 mg of oral lansoprazole and up to 90 mg of intravenous lansoprazole have been administered in clinical trials without causing significant adverse effects.

See the Undesirable Effects section for possible symptoms of a lansoprazole overdose.

In case of suspected overdose, the patient should be monitored. Lansoprazole is not significantly removed by hemodialysis. If necessary, gastric lavage, charcoal, and symptomatic treatment are recommended.

Prevacid: Pregnancy, lactation and fertility

Pregnancy

There are no clinical data available during pregnancies exposed to lansoprazole. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonic / fetal development, childbirth, or postnatal development.

Therefore, for safety, the use of lansoprazole is not recommended during pregnancy.

Breastfeeding

Lansoprazole excretion in breast milk is unknown. Animal studies have shown excretion of lansoprazole in milk.

The decision to continue / stop breastfeeding or to continue / stop treatment with lansoprazole should take into account the benefit of breastfeeding for the child and the benefit of treatment with lansoprazole for the mother.