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זרידקס 300 ZARIDEX 300 (RANITIDINE AS HYDROCHLORIDE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

קפליות : CAPLETS

Posology : מינונים

4.2 Posology and method of administration
Posology
Adults (including the elderly)
• The usual dosage is 150 mg twice daily, taken in the morning and evening.
• Alternatively, patients with duodenal ulceration, gastric ulceration or oesophageal reflux disease may be treated with a single bedtime dose of 300 mg. It is not necessary to time the dose in relation to meals.
• Duodenal ulcer, benign gastric ulcer and post-operative ulcer: In most cases of duodenal ulcer, benign gastric ulcer and post-operative ulcer, healing occurs in 4 weeks. Healing usually occurs after a further 4 weeks of treatment in those patients whose ulcers have not fully healed after the initial course of therapy.
• NSAID associated peptic ulceration: In ulcers following non-steroidal anti-inflammatory drug therapy or associated with continued non-steroidal anti-inflammatory drugs, 8 weeks treatment may be necessary.
• In duodenal ulcer 300 mg twice daily for 4 weeks results in healing rates which are higher than those at 4 weeks with ranitidine 150 mg twice daily or 300 mg nocte. The increased dose has not been associated with an increased incidence of unwanted effects.

• Maintenance treatment at a reduced dosage of 150 mg at bedtime is recommended for patients who have responded to short-term therapy, particularly those with a history of recurrent ulcer.
• Oesophageal reflux disease: In the management of oesophageal reflux disease, the recommended course of treatment is either 150 mg twice daily or 300 mg at bedtime for up to 8 weeks or if necessary 12 weeks.
• Moderate to severe oesophagitis: In patients with moderate to severe oesophagitis, the dosage of ranitidine may be increased to 150 mg 4 times daily for up to 12 weeks. The increased dose has not been associated with an increased incidence of unwanted effects.
• Healed oesophagitis:
For long term treatment, recommended adult dose is 150 mg twice daily.
Long term treatment is not indicated in management of patients with unhealed oesophagitis with or without Barrett's epithelium.

• Zollinger-Ellison syndrome:
In patients with Zollinger-Ellison syndrome, the starting dose is 150 mg three times daily and this may be increased as necessary. Patients with this syndrome have been given increasing doses up to 6 g per day and these doses have been well tolerated.

• Prophylaxis of haemorrhage from stress ulceration:
In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients, treatment with ZARIDEX 150 mg twice daily may be substituted for ranitidine injection once oral feeding commences in patients considered to be still at risk from this condition.
• Prophylaxis of acid aspiration (Mendleson's syndrome):
In patients thought to be at risk of acid aspiration syndrome an oral dose of 150 mg can be given 2 hours before induction of general anaesthesia, and preferably also 150 mg the previous evening.

In obstetric patients at commencement of labour, an oral dose of 150 mg may be given followed by 150 mg at six hourly intervals. It is recommended that since gastric emptying and drug absorption are delayed during labour, any patient requiring emergency general anaesthesia should be given, in addition, a non-particulate antacid (e.g. sodium citrate) prior to induction of anaesthesia. The usual precautions to avoid acid aspiration should also be taken.
• Children 12 years and over:
For children 12 years and over the adult dosage is given.
• Children from 6 to 11 years and over 30kg of weight: See section 5.2 Pharmacokinetic Properties (Other special populations).
• Patients over 50 years of age See section 5.2 Pharmacokinetic Properties (Other special populations).

• Peptic Ulcer Acute Treatment:
The recommended oral dose for treatment of peptic ulcer in children is 4 mg/kg/day to 8 mg/kg/day administered as two divided doses to a maximum of 300 mg ranitidine per day for a duration of 4 weeks. For those patients with incomplete healing, another 4 weeks of therapy is indicated, as healing usually occurs after eight weeks of treatment.

• Gastro-Oesophageal Reflux:
The recommended oral dose for the treatment of gastro-oesophageal reflux in children is 5 mg/kg/day to 10 mg/kg/day administered as two divided doses to a maximum of 600 mg (the maximum dose is likely to apply to heavier children or adolescents with severe symptoms).

• Patients with Renal Impairment
Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with renal impairment (creatinine clearance less than 50 ml/min). Accordingly, it is recommended that the daily dose of ranitidine in such patients should be 150 mg at night for 4-8 weeks. The same dose should be used for maintenance treatment, if necessary. If an ulcer has not healed after treatment, 150 mg twice daily dosage should be instituted followed, if need be, by maintenance treatment of 150 mg at night.
• Method of administration For oral administration.

שימוש לפי פנקס קופ''ח כללית 1994 Active gastric & duodenal ulcer, prevention of ulcer recurrence, pathological hypersecretory conditions (Zollinger-Ellison), reflux esophagitis, hematemesis due to peptic ulcer
תאריך הכללה מקורי בסל 01/01/1995
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בעל רישום

DEXCEL LTD, ISRAEL

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109 45 29273 00

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זרידקס 300

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