Zallanz 15 mg

COMPOSITION:

Active ingredient:

Each Zallanz Delayed release hard gelatin capsule contains 15 mg lansoprazole.

Inactive ingredients:

Sugar sheres ,sucrose, Mannital, Crosscarmellose Sodium, Sodium Lauryl Sulphate, DI Sodium Hydrogen Ortho Phosphate, H.P.M.C.P-55 (Enteric Coated material), H.P.M.C. E-5, Acetone, Acetyl Alcohol, Gelatin, titanium dioxide, quinoline yellow and carmoisin red

PHARMACEUTICAL DOSAGE FORM : Delayed release hard gelatin capsule.

Therapeutic indications

  • Treatment of duodenal and gastric ulcer
  • Treatment of reflux oesophagitis
  • Prophylaxis of reflux oesophagitis
  • Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy for treatment of H.pylori-associated ulcers
  • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment
  • Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk requiring continued therapy
  • Symptomatic gastroesophageal reflux disease
  • Zollinger-Ellison syndrome.
Category:
Contraindications
drugs
pregnancy
Pharmacodynamic
Absorption
Biotransformation
STORAGE
SUPPLIED

Contraindications

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

drugs

Effects of other drugs on lansoprazole Drugs which inhibit CYP2C19 Fluvoxamine: A dose reduction may be considered when combining lansoprazole with the CYP2C19 inhibitor fluvoxamine. The plasma concentrations of lansoprazole increase up to 4-fold. Drugs which induces CYP2C19 and CYP3A4 Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin, and St John´s wort (Hypericum perforatum) can markedly reduce the plasma concentrations of lansoprazole. Others Sucralfate/Antacids: Sucralfate/Antacids may decrease the bioavailability of lansoprazole. Therefore lansoprazole should be taken at least 1 hour after taking these drugs. No clinically significant interactions of lansoprazole with nonsteroidal anti-inflammatory drugs have been demonstrated, although no formal interactions studies have been performed.

pregnancy

Fertility, pregnancy and lactation Pregnancy For lansoprazole no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Therefore, the use of lansoprazole during pregnancy is not recommended. Breast feeding It is not known whether lansoprazole is excreted in human breast milk. Animal studies have shown excretion of lansoprazole in milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with lansoprazole should be made taking into account the benefit of breastfeeding to the child and the benefit of lansoprazole therapy to the woman.

Pharmacodynamic

Pharmacodynamic properties Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC03 Lansoprazole is a gastric proton pump inhibitor. It inhibits the final stage of gastric acid formation by inhibiting the activity of H+/K+ ATPase of the parietal cells in the stomach. The inhibition is dosedependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid. Lansoprazole is concentrated in the parietal cells and becomes active in their acidic environment, whereupon it reacts with the sulphydryl group of H+/K+ATPase causing inhibition of the enzyme activity. Pharmacokinetic properties Lansoprazole is a racemate of two active enantiomers that are biotransformed into the active form in the acidic environment of the parietal cells. As lansoprazole is rapidly inactivated by gastric acid, it is administered orally in enteric-coated form(s) for systemic absorption.

Absorption

Absorption and distribution Lansoprazole exhibits high (80-90%) bioavailability with a single dose. Peak plasma levels occur within 1.5 to 2.0 hours. Intake of food slows the absorption rate of lansoprazole and reduces the bioavailabilty by about 50%. The plasma protein binding is 97%. Studies have shown that granules from opened capsules give equivalent AUC as the intact capsule if the granules are suspended in a small amount of orange juice, apple juice, or tomato juice mixed with a tablespoon of apple or pear puree or sprinkled on a tablespoon of yoghurt, pudding or cottage cheese. Equivalent AUC has also been shown for granules suspended in apple juice administered through a naso-gastric tube.

Biotransformation

Lansoprazole is extensively metabolised by the liver and the metabolites are excreted by both the renal and biliary route. The metabolism of lansoprazole is mainly catalysed by the enzyme CYP2C19. The enzyme CYP3A4 also contributes to the metabolism. The plasma elimination half-life ranges from 1 to 2 hours following single or multiple doses in healthy subjects. There is no evidence of accumulation following multiple doses in healthy subjects. Sulphone, sulphide and 5-hydroxyl derivatives of lansoprazole have been identified in plasma. These metabolites have very little or no antisecretory activity. A study with 14C labelled lansoprazole indicated that approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the faeces.

STORAGE

Store at a temp. not exceeding 30 ºC in dry place.

SUPPLIED

HOW SUPPLIED: Carton box containing 1, 2 or 3 PVC-Al  blisters  each of 10  Delayed release hard gelatin capsule and pamphlet

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