Pregnancy: No evidence of risk in humans. Lactation: Contraindicated or not recommended. Precautions: Exclude malignant disease before and during Zune 20mg treatment. Impaired renal or hepatic function, increased risk of Gl infection. Monitor patients on long term therapy.
Erosive reflux oesophagitis, prevention of relapse of oesophagitis, symptomatic treatment of GERD. Zollinger-Ellison syndrome, severe peptic ulcer bleeding (following endoscopic treatment). In combination with antibiotics for the eradication Zune 20mg of H. pylori, healing of H. pylori-associated duodenal ulcer and prevention of relapse of H. pylori-associated peptic ulcers. Treatment and prevention of NSAID-associated peptic ulceration.
ORAL: Adults: Erosive oesophagitis: 40 mg once daily for 4-8 wk. Prevention of relapse, 20 mg once daily. GERD without oesophagitis: 20 mg once daily for 4 wk. Maintenance, 20 mg once daily as required. Zollinger-Ellison syndrome: Initially 40 mg two times daily, can be altered according to response. Usual dose: 80-160 mg daily, doses over 80 mg must be given in two divided doses. Triple therapy vs H. pylori: 20 mg twice daily with amoxicillin 1 gm twice daily and clarithromycin 500 mg twice daily for 7 days. NSAID ulceration: 20 mg once daily for 4-8 wk, Prevention, 20 mg once daily. Children: Not recommended. INJECTION: Adults: Reflux oesophagitis: 40 mg once daily given as IV inj over a period of at least 3 min or as IV inf over a period of 10-30 min. Symptomatic treatment of reflux oesophagitis: 20 mg once daily, half of the reconstituted solution be given as IV inj over a period of at least 3 min or as IV inf over a period of 10-30 min. Healing of gastric ulcer associated with NSAID therapy & duodenal ulcers associated with NSAID therapy: 20 mg once daily to be given over atleast 3 min. Treatment Zune 20mg duration is usually short and shift to oral dose as soon as possible. Severe peptic ulcer bleeding (following endoscopic treatment: Initial IV infusion of 80 mg over 30 min, then by continuous IV infusion 8 mg/hr for 72 hr, then by mouth 40 mg once daily for 4 wk. Children: By IV injection or by IV infusion. GERD in the presence of erosive reflux oesophagitis: 1-12 yr, body weight under 20 kg, 10 mg once daily; body weight over 20 kg, 10-20 mg once daily; 12-18 yr, 40 mg once daily. GERD in the absence of erosive reflux oesophagitis: 1-12 yr, 10 mg once daily; 12-18 yr, 20 mg once daily.
Advice to Patient
Take at least 1 hour before meals. Do not crush or chew, swallow whole. If there is difficulty in swallowing, open the capsule and mix all contents in a tablespoon of applesauce. Swallow immediately without chewing. Contact prescriber if there is constant headache, diarrhoea, constipation, stomach pain, changes in urination or pain on urination, chest pain or palpitations, alteration in respiratory status, CNS changes, constant muscular aches or pain, ringing in ears or visual changes.
Children: ORAL: GERD in the presence of erosive reflux oesophagitis: 1-12 yr, body weight 10-20 kg, 10 mg once daily for 8 wk; body weight over 20 kg, 10-20 mg once daily for 8 wk; 12-18 yr, 40 mg once daily for 4 wk, continued for further 4 wk if not fully healed or symptoms persist; maintenance 20 mg daily. GERD in the absence of erosive reflux oesophagitis: 1-12 yr, body weight over 10 kg, 10 mg once daily for 8 wk; 12-18 yr, 20 mg once daily for 4 wk.
Metabolism: Hepatic. Bioavailability: Oral: 64% after a single dose, 90% with repeat dosing. Half-life elimination: Infants: 0.93 hrs. Children: 1-5 yrs: 0.42-0.74 hrs. 6-11 yrs: 0.73-0.88 hrs. 12-17 yrs: 0.82-1.22 hrs. Adults: Approx. 1-1.5 hrs. Time to peak: Oral: Infants: Median: 3 hrs. Children: 1-5 yrs: 1.33-1.44 hrs. 6-11 yrs: 1.75-1.79 hrs. 12-17 yrs: 1.96-2.04 hrs. Adults: 1.5-2 hrs. Excretion: Urine (80%), faeces (20%).
Phenytoin, warfarin, clopidogrel, ketoconazole, itraconazole, voriconazole, protease inhibitors Zune 20mg, diazepam, citalopram, imipramine, clomipramine, other CYP2C19 substrates, CYP3A4 inhibitors or inducers, tacrolimus, digoxin, erlotinib, methotrexate.
Headache, Gl upset, skin reaction, dry mouth. Rarely angioedema, anaphylaxis, fundic gland polyps.