Zeropep Capsules (Hard Gelatin)
Lansoprazole
30mg
Neopharma
| Pack size | 14's (7's Blister x 2) |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | NEW MEDICAL CENTRE |
| Retail Price | 37.00 AED |
Available as:
Indications
Zeropep Capsules (Hard Gelatin) is used for:
Peptic ulcer, H.pylori infection, Gastro-oesophageal reflux disease, Hypersecretory conditions, Acid-related dyspepsia, NSAID-induced ulcers, Erosive oesophagitis
Adult Dose
Oral
Peptic ulcer
Adult: 30 mg once daily in the morning given for up to 4 wk (duodenal ulcer) or for up to 8 wk (gastric ulcer). Maintenance: 15 mg/day.
Zollinger-Ellison syndrome
Adult: Initially, 60 mg once daily in the morning and adjust as required. Daily doses >120 mg should be given in 2 divided doses.
Acid-related dyspepsia
Adult: 15-30 mg once daily in the morning for 2-4 wk.
Gastro-oesophageal reflux disease
Adult: 15-30 mg once daily in the morning for 4-8 wk. Maintenance: 15-30 mg once daily according to response.
Prophylaxis of NSAID-induced ulcers
Adult: 15-30 mg once daily in the morning.
H.pylori infection
Adult: 1-wk triple therapy: 30 mg bid combined w/ clarithromycin 500 mg bid and amoxicillin 1 g bid or combined w/ clarithromycin 250 mg bid and metronidazole 400 mg bid.
Erosive oesophagitis
Adult: 30 mg once daily in the morning for up to 8 wk, additional 8 wk if not healed. Maintenance: 15 mg once daily.
NSAID-associated ulceration
Adult: 30 mg once daily in the morning for 4-8 wk.
Elderly: No dosage adjustment needed.
Hepatic impairment: Severe: Max: 30 mg/day.
Child Dose
Oral
Gastro-oesophageal reflux disease
1-11 yr
<30 kg: 15 mg once daily in the morning for up to 12 wk;
>30 kg: 30 mg once daily in the morning for up to 12 wk. May increase doses up to 30 mg bid if patient is still symptomatic after 2 or more wk of treatment.
12-17 yr
15 mg once daily for up to 8 wk.
Erosive oesophagitis
1-11 yr
<30 kg: 15 mg once daily in the morning for up to 12 wk;
>30 kg: 30 mg once daily in the morning for up to 12 wk. May increase doses up to 30 mg bid if patient is still symptomatic after 2 or more wk of treatment.
12-17 yr 30 mg once daily for up to 8 wk.
Renal Dose
Renal impairment: No dosage adjustment needed.
Administration
Should be taken on an empty stomach. Take before meals.
Contra Indications
Hypersensitivity.
Precautions
Hepatic impairment. Gastric malignancy should be ruled out. Pregnancy and lactation.
Lactation
Risk Summary
There is no information regarding presence of lansoprazole in human milk, effects on breastfed infant, or on milk production; however, lansoprazole and its metabolites are present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from treatment or from underlying maternal condition.
Pregnancy-Lactation
Pregnancy
Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment; estimated background risk of major birth defects and miscarriage for the indicated populations are unknown
Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and lansoprazole use; methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy
No adverse effects on embryo-fetal development occurred in studies performed in pregnant rats at oral lansoprazole doses up to 150 mg/kg/day (40 times the recommended human dose [30 mg/day] based on body surface area) administered during organogenesis and pregnant rabbits at oral lansoprazole doses up to 0 mg/kg/day (16 times the recommended human dose based on body surface area) administered during organogenesis
Lactation
There is no information regarding presence of lansoprazole in human milk, effects on breastfed infant, or on milk production; however, lansoprazole and its metabolites are present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from treatment or from underlying maternal condition
Interactions
Increased risk of hypomagnesaemia w/ diuretics and digoxin. May decrease plasma concentration of erlotinib, dasatinib and lapatinib. May decrease the bioavailability of itraconazole and ketoconazole. May increase plasma concentration of cilostazol and methotrexate. Reduced bioavailability w/ antacids and sucralfate.
Potentially Fatal: May decrease serum levels and pharmacological effects of rilpivirine and atazanavir.
Adverse Effects
Side effects of Lansoprazole :
1-10%
Headache (3-7%), Diarrhea (1-5%), Constipation (1-5%), Nausea (1-3%), Abdominal pain (1-3%)
<1%
Anxiety, Angina, Palpitations, Syncope, Edema, Anorexia, Dry mouth, Tenesmus, Flatulence, Melena, Myalgia, Tinnitus, Allergic reaction
Mechanism of Action
Lansoprazole is a substituted benzimidazole, and is also known as PPI due to its property to block the final step of acid secretion by inhibiting H+/K+ ATPase enzyme system in gastric parietal cell. Both basal and stimulated acid are inhibited.
Note
Zeropep 30mg Capsules (Hard Gelatin) manufactured by Neopharma. Its generic name is Lansoprazole. Zeropep is availble in United Arab Emirates.
Farmaco UAE drug index information on Zeropep Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
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