SOPRAN 30mg Capsule (Lansoprazole)

SOPRAN 30mg Capsule (Lansoprazole)

SOPRAN 30mg Capsule (Lansoprazole)

The active ingredient in SOPRAN Capsules is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37 and structure is.

COMPOSITION                                  

SOPRAN CAPSULE

Each capsule contains:

Lansoprazole enteric coated micro granules. 30mg

CLINICAL PHARMACOLOGY       

Mechanism of Action

SOPRAN (lansoprazole) belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+ K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.

Lansoprazole does not exhibit anticholinergic or histamine type-2 antagonist activity.

Pharmacodynamics

Antisecretory Activity: After oral administration, lansoprazole was shown to significantly decrease the basal acid output and significantly increase the mean gastric pH and percent of time the gastric pH was greater than 3 and greater than 4. Lansoprazole also significantly reduced meal-stimulated gastric acid output and secretion volume, as well as pentagastrin-stimulated acid output. In patients with hypersecretion of acid, lansoprazole significantly reduced basal and pentagastrin-stimulated gastric acid secretion. Lansoprazole inhibited the normal increases in secretion volume, acidity and acid output induced by insulin.

Microbiology 

Lansoprazole, clarithromycin and/or amoxicillin have been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections as described in the INDICATIONS AND USAGE section

[see Indications and Usage]

Helicobacter pylori Pretreatment Resistance

Clarithromycin pretreatment resistance (≥2.0 mcg/mL) was 9.5% (91/960) by E-test and 11.3% (12/106) by agar dilution in the dual and triple therapy clinical trials (M93-125, M93-130, M93-131, M95-392, and M95-399).

Patients not eradicated of H. pylori following lansoprazole/amoxicillin/clarithromycin triple therapy will likely have clarithromycin resistant H. pylori. Therefore, for those patients who fail therapy, clarithromycin susceptibility testing should be done when possible. Patients with clarithromycin resistant H. pylori should not be treated with lansoprazole/amoxicillin/clarithromycin triple therapy or with regimens which include clarithromycin as the sole antimicrobial agent.

Pharmacokinetics:

SOPRAN Capsules and contain an enteric-coated granule formulation of lansoprazole. Absorption of lansoprazole begins only after the granules leave the stomach. Absorption is rapid, with mean peak plasma

levels of lansoprazole occurring after approximately 1.7 hours. After a single-dose administration of 15 mg to 60 mg of oral lansoprazole, the peak plasma concentrations (Cmax) of lansoprazole and the area under the plasma concentration curves (AUCs) of lansoprazole were approximately proportional to the administered dose. Lansoprazole does not accumulate and its pharmacokinetics is unaltered by multiple dosing.

Absorption: The absorption of lansoprazole is rapid, with the mean Cmax occurring approximately 1.7 hours after oral dosing, and the absolute bioavailability is over 80%. In healthy subjects, the mean (±SD) plasma half-life was 1.5 (±1.0) hours. Both the Cmax and AUC are diminished by about 50% to 70% if lansoprazole is given 30 minutes after food, compared to the fasting condition. There is no significant food effect if lansoprazole is given before meals.

Distribution:

Lansoprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 0.05 to 5.0 mcg/ml.

Metabolism:

Lansoprazole is extensively metabolized in the liver. Two metabolites have been identified in measurable quantities in plasma (the hydroxylated sulfinyl and sulfone derivatives of lansoprazole). These metabolites have very little or no antisecretory activity. Lansopra weight or agezole is thought to be transformed into two active species which inhibit acid secretion by blocking the proton pump [(H+, K+)-ATPase enzyme system] at the secretory surface of the gastric parietal cell. The two active species are not present in the systemic circulation. The plasma elimination half-life of lansoprazole is less than 2 hours while the acid inhibitory effect lasts more than 24 hours. Therefore, the plasma elimination half-life of lansoprazole does not reflect its duration of suppression of gastric acid secretion.

Specific Populations

Pediatric Use:  One to 17 years of age

The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged 1 to 11 years and 12 to 17 years in two separate clinical studies. In children aged 1 to 11 years, lansoprazole was dosed 15 mg daily for subjects weighing ≤30 kg and 30 mg daily for subjects weighing greater than 30 kg. Mean Cmax and AUC values observed on Day 5 of dosing were similar between the two dose groups and were not affected by weight or age within each weight-adjusted dose group used in the study. In adolescent subjects aged 12 to 17 years, subjects were randomized to receive lansoprazole at 15 mg or 30 mg daily. Mean Cmax and AUC values of lansoprazole were not affected by body or age; and nearly dose-proportional increases n mean Cmax and AUC values were observed   between the two dose groups in the study. Overall, lansoprazole pharmacokinetics in pediatric patients aged 1 to 17 years were similar to those observed in healthy adult subjects.

THERAPEUTIC INDICATIONS            

SOPRAN CAPSULE) is indicated for the treatment of:

Treatment of heartburn and acid regurgitation:

Treatment of duodenal ulcer

Treatment of stomach ulcer:

Treatment of inflammation in your oesophagus (reflux oesophagitis):

Treatment of infection of Helicobacter pylori:

Treatment of duodenal or stomach ulcer in patients requiring continued NSAID treatment.

Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment:

DOSAGE AND ADMINISTRATION

For adults:

one 30mg capsule every day for 2 weeks

Treatment of stomach ulcer: one 30mg capsule every day for 4 weeks.

Long-term prevention of reflux oesophagitis: one 15mg capsule every day, your doctor may adjust your dose to one 30mg capsule every day.

The recommended dose is one 30mg capsule in combination with two different antibiotics in the morning and one 30mg capsule in combination with two different antibiotics in the evening. Treatment will usually be every day for 7 days.

  • 30mg Lansoprazole together with 250-500mg clarithromycin and 1000mg amoxicillin
  • 30mg Lansoprazole together with 250mg clarithromycin and 400-500mg metronidazole.

The recommended dose is two 30mg capsules every day to start with, then

depending on how you respond to Lansoprazole Capsules the dose that your doctor decides is best for you.

Lansoprazole Capsules should not be given to children.

Lansoprazole is contraindicated in patients who are hypersensitive to this drug.

  • Headache, dizziness
  • diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat
  • Skin rash, itching
  • Changes in liver function test values
  • Tiredness
  • benign polyps in the stomach

If diarrhea occurs during the treatment with Lansoprazole contact your doctor immediately, as Lansoprazole has been associated with a small increase in infectious diarrhoea.

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Lansoprazole Capsules. Remember to also mention any other ill-effects like pain in your joints. Tell your doctor before taking this medicine, if you are due to have a specific blood test (Chromogranin A)

Use of Lansoprazole Capsules is not recommended during pregnancy, as there is no adequate experience on the use of lansoprazole during pregnancy.

Do not store above 25°C.

Store in the original package in order to protect from moisture.

Keep this medicine out of the sight and reach of children.