LANSOX ® Lansoprazole

LANSOX ® is a lansoprazole-based drug.

THERAPEUTIC GROUP: Antireflux - Antiulcer-Inhibitors of the proton pump

Indications LANSOX ® Lansoprazole

LANSOX ® is used in the short-term treatment of duodenal and gastric ulcers also caused by H. Pylori or from prolonged treatment with non-steroidal anti-inflammatory drugs, reflux esophagitis and Zollinger-Ellison syndrome.

LANSOX ® Lansoprazole Mechanism of Action

The lansoprazole contained in LANSOX ® and taken orally, preferably in the early morning on an empty stomach, given the greater availability, is absorbed at the duodenal level, reaching maximum plasma concentrations after about 90 minutes from oral ingestion.
Compared to other proton pump inhibitors, its bioavailability is at very different values, usually equal to 70 - 80% of the total dose taken.
Through plasma proteins, it reaches the various organic districts, carrying out its therapeutic action, only at the level of the gastric microenvironment, where the acidity of the intracellular canaliculi of the parietal cells guarantees the protonation of lansoprazole and its activation.
Here the active principle is able to selectively bind the acid proton pump, exerting an inhibitory action, which prevents the release of hydrogen ions in the intragastric lumen.
After hepatic metabolism, supported by cytochrome p450 enzymes, the metabolites of lansoprazole are eliminated in the urine and faeces.

Studies carried out and clinical efficacy

1. LANSOPRAZOLE AND STOMACH BURNS

Aliment Pharmacol Ther. 2009 Sep 1; 30: 459-68. Epub 2009 Jun 11.

Clinical trial: lansoprazole 15 or 30 mg once daily vs. placebo for treatment of frequent nighttime heartburn in self-treating subjects.

Peura DA, Riff DS, Snoddy AM, Fennerty MB.

Night heartburn is a very frequent condition in the western population, associated with gastric hyperacidity and which also significantly reduces the quality of life of affected patients. The one-off intake of 15 or 30 mg of lansoprazole is it has been shown to be effective in reducing heartburn in 61% of treated patients, preventing the onset of the same symptoms even in the 24 hours following intake.

2. GASTROESOPHAGEAL REFLUX, LANSOPRAZOLE AND LIFESTYLE

Am J Gastroenterol. 2009 May; 104: 1106-11. Epub 2009 Mar 31.

The impact of lifestyle modification on the health-related quality of life of patients with reflux esophagitis receiving treatment with a proton pump inhibitor.

Kinoshita Y, Ashida K, Miwa H, Hongo M.

In this very interesting study conducted on patients suffering from gastroesophageal reflux and undergoing therapy with lansoprazole, it was shown how the modification of lifestyle could exert a particularly significant action on the improvement of the quality of life, and on the more rapid regression of the symptoms associated with gastroesophageal reflux.

3. SAFETY AND EFFECTIVENESS OF MAINTENANCE THERAPY WITH LANSOPRAZOLE

Aliment Pharmacol Ther. 2009 Jun 15; 29: 1249-60. Epub 2009 Mar 17.

The clinical safety of long-term lansoprazole for the maintenance of healed erosive oesophagitis.

Freston JW, Hisada M, Peura DA, Haber MM, Kovacs TO, Atkinson S, Hunt B.

Although the administration of lansoprazole is particularly indicated in the short-term treatment of symptoms, this study shows that maintenance therapy for about 6 years with lansoprazole, in patients with cured erosive esophagitis, can be particularly safe and effective in preventing a relapse.

Method of use and dosage

LANSOX ® orodispersible tablets and gastro-resistant capsules of 15 - 30 mg of lansoprazole:
while the dosage remains practically unchanged regardless of the pharmaceutical form of the product, the method of assumption instead tends to vary.
In fact, the gastro-resistant tablets should be swallowed whole with a glass of water, while the orodispersible ones should be placed on the tongue and sucked slowly without breaking them.
Generally, the daily dose of 15 mg of lansoprazole should be sufficient to improve symptoms associated with gastroesophageal reflux in a few weeks of treatment, and facilitate the healing of ulcers, while the dosage should be doubled in the treatment of Zollinger-Ellison syndrome.
In any case, the correct formulation of the dosage should be established by the doctor after a "careful evaluation of the physio-pathological conditions of the patient and of his therapeutic objectives.

LANSOX ® Lansoprazole Warnings

The intake of lansoprazole could mask some important signs and symptoms for a correct and timely diagnosis of malignant pathologies of the gastrointestinal tract, therefore it would be advisable to carefully monitor the patient's health conditions before starting therapy with LANSOX ®
In addition, this medicine should be taken with particular care in patients with reduced liver and kidney function, in order to avoid the appearance of unpleasant side effects.
The presence of lactose and aspartame in LANSOX ® could be associated with the onset of even serious side effects in patients suffering from lactase deficiency or glucose / galactose malabsorption and phenylketonuria, respectively.
The possible presence of dizziness, headache and drowsiness following the intake of lansoprazole, could cause a reduction in the patient's perceptive and reactive abilities, thus making the use of machinery and driving cars dangerous.

PREGNANCY AND BREASTFEEDING

At the moment, the absence of studies and clinical trials relating to the use of lansoprazole in pregnancy does not allow us to fully understand the safety profile of this active ingredient.
Therefore we do not recommend the use of this medicine both during pregnancy and in the subsequent lactation period.

Interactions

The inhibition exerted by the metabolites of lansoprazole on the cytochrome p450 enzyme system, could alter the normal pharmacokinetic properties of active substances metabolized by the same system such as diazepam, phenytoin, oral contraceptives, warfarain and vitamin K antagonists.
Furthermore, the reduction of intragastric acidity determined by LANSOX ® could reduce the absorption of drugs such as ketoconazole and other antifungals, which require particularly acidic pH in order to be absorbed.

Contraindications LANSOX ® Lansoprazole

LANSOX ® is contraindicated in pregnancy and lactation, and in case of hypersensitivity to the active ingredient or to other benzimidazole derivatives, belonging to the same pharmaceutical category.
The presence of aspartame in the buccal tablets extends the contraindications of this drug also to patients suffering from phenylketonuria.

Undesirable Effects - Side Effects

Headache, diarrhea, abdominal pain, dyspepsia, nausea, vomiting, dizziness, constipation, flatulence, skin rash, pruritus, Stevens Johnson syndrome, toxic epidermal necrolysis, anaphylactic reactions, thrombocytopenia, agranulocytosis representing the most documented side effects in both literature scientific research and post-marketing monitoring.
In any case, the aforementioned side effects, and others that are rarer but clinically more relevant, tend to spontaneous regression once therapy is suspended.

Note

LANSOX ® can only be sold under medical prescription.

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