Xantid 150mg

Tablet
Ranitidine
ACI Pharmaceuticals

Other Strength:

Alternative:
- RANIDIN 150mg
- Neofast-S 150mg
- Rhine 150mg
- Ranitack 150mg
- Ranid 150mg
- Veridin 150mg
- Rani 150mg
- Amuran 150mg
- Astac 150mg
- Bentid 150mg
- Norma-H 150mg



Xantid
Presentation
Xantid®Tablets: Each tabletcontains Ranitidine 150mg as Hydrochloride USPXantid®-hs Tablets: Each tabletcontains Ranitidine 300m9 as Hydrochloride USPXantid®lnjection: Each 2ml contains 50mg Ranitidine as hydrochloride USP

Uses
Xantid®, Xantid®-hs and Xantid®injection are indicated for the treatmentof duodenal ulcer and benign gastric ulcer, including that associated withnon-steroidal anti-inflammatory agents. Xantid®, Xantid®-hs and Xantid®injection are also indicated for the treatment of postoperative ulcer,oesophageal reflux disease and Zollinger-Ellison Syndrome. Ranitidinetreatment is beneficial for patients with chronic episodic dyspepsia,characterized by pain (epigastric of retrosternal), which is related to mealsor disturbs sleep but isnot associated with the preceding conditions.Xantid®, Xantid®-hs and Xantid®injection are indicated for conditionswhere reduction of gastric secretion and acid output is desirable; such asthe prophylaxis of gastrointestinal haemorrhage from stress ulceration inseriously ill patients, the prophylaxis of recurrent hemorrhage in patientswithbleeding peptic ulcers and before general anesthesia in patientsconsidered to be at risk of acid aspiration (Mendelson's Syndrome);particularly obstetric patients during labour. Concomitant antacid may begiven as needed for relief of pain.

Dosage and administration
Adults: The usual dosage is 150mg Xantid®twice daily, taken in themorning and evening. Alternatively, patients with duodenal ulcerationgastric ulceration or oesophageal reflux disease may be treated withasingle bed-time dose of 300mgXantid®-hs. lt is not necessary to time thedose in relation to meals. ln most cases of duodenal ulcer, benign gastriculcer and post-operative ulcer, healing occurs in 4 weeks. A further4weeks of treatment may be needed in those patients whose ulcers havenot fully healed after the initial course of therapy.

ln ulcers following non-steroidal anti-inflammatory drugs therapy orassociated with continued non-steroidal anti-inflammatory drugs, 8 weekstreatment may be necessary.In duodenal ulcer 300m9 twice daily for4weeks results in rapid healing than those at 4 weeks with Ranitidine150mgtwice daily or 300mgonce at bed-time. The increased dose hasnot been associated with an increased incidence of unwanted effects. Forpatients with a history of recurrent ulcer or after a short-term therapy,maintenance treatment at a reduced dosage of 150m9 at bedtimeisrecommended.

ln the management of oesophageal reflux disease, the recommendedcourse of treatment is either 150mgtwice daily or 300mgat bedtime forup to 8 weeks. ln patients with severe
oesophagitis, and those who fail torespond to standard doses of Ranitidine, the dosage of Ranitidine may beincreased to 300mg Xantid®-hs four times daily for up to 8 weeks. Theincreased dose has not been associated with an increased incidence ofunwanted effects.

ln patients with Zollinger Ellison Syndrome, the starting dose is 150mgthree times daily and this may be increased up to 6gm daily as necessaryand these doses have been well toleraled. For patients with chronicepisodic dyspepsia the recommended course of treatment is 150mg twicedaily forup to 6 weeks. Anyone not responding or relapsing shortlyafterwards should be investigated. In the prophylaxis of hemorrhage fromstress ulceration in seriously ill patients or the prophylaxis of recurrenthemorrhage in patients bleeding from peptic ulceration, treatment withXantid®150mgtwice daily may be used.

ln patients thought to be at risk of acid aspiration syndrome a dose of150mg can be given 2 hours before induction of general anesthesia, andpreferably also 150mg the previous evening.

ln obstetric patients at commencement of labor. Xantid®may be givenfollowed by 150mg at 6 hourly intervals. Since gastric emptying and drugabsorption are delayed during labor, it is recommended that any patientrequiring emergency general anesthesia should be given, in addition, a non-particulate antacid (e.g. sodium citrate) prior to induction of anesthesia. Theusual precautions to avoid acid aspjration should also be taken.

Children: Use of Ranitidine in children has not been fully evaluated inclinical studies. However, it has been used successfully in children aged8to 18 years in dose up to 150mg(2 mg/kg) twice daily.Parenteral administration: ln some hospitalized patients with pathologicalhypersecretory conditions or interactable duodenal ulcers, or in patientswho are unable to take oral medication, Xantid®may be administeredparenterally according to the following recommendations:
Intramuscular lnjection; 50mg (2ml) every 6 to 8hours. (No dilution necessary.)Intermittent IntravenousInjection :

a. Intermittent Bolus: 50mg (2ml) every 6 to 8 hours. Dilute Xantid®lnjection, 50mg, in 0.9% sodium chloride jnjection or other compatiblelV solution to a concentration no greater thin 2.5mg/ml (20ml). Injectat a rate no greater than 4ml/min (5 minutes).
b.Intermittent lnfusion 50mg (2ml) every 6 to 8hours. Dilute Xantid®injection,50mg, in 5% dextrose injection or oiher compatible lVsolution to a concentration no greater than 0.5 mg/ ml (100ml). Infuseata rate no greater than 5 to 7 ml/ min ( 15 to 20 minutes).ln some patients it may be necessary to increase dosage. When this is necessary, the increases should be made by morefrequentadministration of the dose, but generally should not exceed 400 mg/ ml.

Continuous lntravenous Infuslon: Add Xantid®injection to 5% dextrose injectionOrother compatible lV sotution . Deliver at a rate of 6.25 .mg/h (e.g.,150mg [6 ml] of Xantid®injection in 250mlof 5% dextrose injectionat10.7 ml/h).

Contra-indications, warnings, etc.
Contra-indications: Known hypersensitivity to the drug.
Precautions: Histamine H2-antagonist may mask symptoms associatedwith carcinoma ofthe stomach and may therefore delay diagnosis of the condition. As Ranitidine is excreted through kidney,in severe renalimpairment plasmalevel of the drug increases.Therefore, it isrecommended that the dosage of Ranitidine in such patients be 150mg at nightfor 4 to 8weeks. lf an ulcer has not healed after treatment thestandard dosage regimen of 150mg twice daily be instituted, followed if need be, by maintenance treatment at 150mg at night. Regularsupervision of patients with peptic ulcer and on non-steroidal anti-inflammatory drugs is recommended, especially in elderly. Ranitidinecrosses the placenta but therapeutic doses administered to obstetricpatients in-labor or undergoing cesarean section have been without any adverse effect on labour, delivery or subsequent neonatal progress.Ranitidine is also excreted in human breastmilk. Likeother drugsRanitidine should only be used during pregnancy and lactation ifessential.

Side effects:ln clinical trials or in the routine management of patientstreated with Ranitidine the following events have beenreported. Therelationship to Ranitidine therapy has not been established in manycases.Transient and reversible changes in liver function tests can occur.Occasionally hepatitis (hepatocellular, hepatocanalicular or mixed) with orwithout jaundice has been reported. These were usualty reversible. In rare occasions reversible leucopeniaand thrombocytopenia have beenobserved in patients.

Rare cases of agranulocytosis or of pancytopenia, sometimes with marrowhyperplasia, or aplasia have been reported. Hypersensitivity reactions(urticaria, angioneurotic oedema. fever, bronchospasm, hypotension,anaphylactic shock) have been seen rarely following the administration ofRanitidine. These reactions have occasionally occured after a single dose.

As with other H2-receptor antagonists, there have been rare reportsofbradycardia and A-V block. Headache, sometimessevere, anddizzinesshave been reported in a very small oroportion of patients.Rare cases of reversible mental confusion and hallucinations have beenreported predominantly in severely ill and elderly patients. Skin rash hasbeen rarely reported.

Ranitidine does notinterfere significantly with endocrine or gonadalfunction. Few reports of breast symptoms (swelling and/or discomfort; inmen taking Ranitidine have been reported; some cases have resolved oncontinued Ranitidine treatment. Discontinuation of therapy may benecessary in order to establish the underlying cause.

Use in elderly patients:Inclinical trial the ulcer healing rates have beenfound similar in patients age 65 and over with those inyounger patients.Additionally, there was no difference in the incidence of adverseeffects.

Overdosage: Ranitidine is very specific in action and accordingly no particularproblems are expected following overdosage with the-drug.Symptomatic and supportive therapy should be given as appropriate. Ifrequired, the drug may be removed from the plasma by haemodiaiysis.

Pharmaceutical precautions
Store in a cool and dry place. protect from light.

Package quantities
Xantid®Tablets: Carton of 150 tablets in blister.
Xantid®-hs Tablets:Carton of 100tablets in blister.
Xantid®lnjection: Carton of 10ampoules.

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