ANTODINE 20MG 30 TAB ; famotidine, gastrointestinal agents .
ANTODINE 20MG 30 TAB
ACTIVE-INGREDIENT OF ANTODINE 20MG 30 TAB
famotidine 20 mg .
INDICATION OF ANTODINE 20MG 30 TAB
What is Antodine | Famotidine is indicated in : –
Short-term treatment of active duodenal ulcer ( All Drugs for treatment of Duodena Ulcers ).
Most adult patients heal within 4 weeks , there is rarely to use famotidine at full dosage for longer than 6 to 8 weeks.
Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
– Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
- Controlled studies in adults have not extended beyond one year .
- – short term treatment of active benign gastric ulcer . most adult patients heal within 6 weeks .
- studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks .
- – short-term treatment of gastroesophageal reflux disease (GERD), famotidine is indicated for short-term treatment of patients with symptoms of GERD.
- Famotidine is also indicated for short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy.
- – treatment of pathological hypersecretory conditions ( eg. zaallinger-ellison syndrome , multiple endocrine adenomas .
DOSAGE OF ANTODINE 20MG 30 TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
duodenal ulcer acute therapy : –
The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime.
Most patients heal within 4 weeks ; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks . A regimen of 20 mg b.i.d. is also effective.
Maintainance therapy : the recommended adult oral dose is 20 mg once a day at bedtime.
– Benign gastric ulcer : acute therapy :
the recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.
– gastroesophageal reflux disease (GERD) the recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d . for up to 6 weeks.
The recommended oral dosage for treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks.
– dosage for pediatric patients 6 to 16 years of age pediatric patients 6 to 16 years of age.
– pediatric patients of 6 to 16 years of age suggest the following starting doses in pediatric patients 6 to 16 years of age : peptic ulcer – 0.5 mg/kg/day p.o.at bedtime or divided b.i.d up to 40 mg/day .
gastroesophageal reflux disease with or without esophagitis including erosions and ulcerations – 1.0 mg/kg/day p.o. divided b.i.d . up to 40 mg b.i.d.
While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. therefore, treatment duration ( initially based on adult duration recommendation ) and dose should be individualized based on clinical responce and /or pH determination ( gastric or esophageal ) and endoscopy.
Puplished uncontrolled clinical studies in pediatric patients 6 to 16 years of age have employed doses up to 1 mg /kg/day for 2 mg /kg/day for GERD with or wighout esophagitis including erosions and ulcerations.
-pathological hypersectomy conditions ( e.g . zollinger-ellison syndrome , multiple endocrine adenomas ) the dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient.
The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h.
In some patients , a higher starting dose may be required.
Doses should be adjusted to individual patient needs and should continue as long as clinically indicated . doses up to 160 mg q 6 h have been adminestered to some adult patients with severe zollinger-ellison syndrome .
– concomitant use of antacids : antacids may be given concomitantly if needed . dosage adjustment for patients with moderate or severe renal insufficiency: in adult patients with moderate (creatinine clearance < 50 ml/min ) or severe (creatinine clearance < 10 ml/min ) renal insufficiency, the elimination half-life of famotidine is increased.
For patients with severe renal insufficiency, it may exceed 20 hours , reaching approximately 24 hours in anuric patients.
Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency , to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.
Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients , dosage adjustment in pediatric patients moderate or severe renal insufficiency should be considered .
OVER-DOSAGE OF ANTODINE 20MG 30 TAB
The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience.
Oral doses of up to 640 mg/day have been given to adult patients with pathological hyper secretory conditions with no serious adverse effects.
In the event of over dosage, treatment should be symptomatic and supportive.
Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed .
The oral LD50 of famotidine in male and female rats and mice was greater than 3000 mg / kg and the minimum lethal acute oral dose in dogs exceeded 2000 mg/kg famotidine did not produce overt effects at high oral doses in mice, rats, and dogs, but induced significant anorexia and growth depression in rabbits starting with 200 mh/kg/day orally.
The intravenous LD50 of famotidine for mice and rats ranged from 254 to 563 mg/kg and the minimum lethal single i.v.
Dose in dogs was approximately 300 mg/kg .
Signs of acute intoxication in i.v. treated gogs were emesis, restlessness, pallor of mucous membranes or redness of mouth and ears, hypotension, tachycardia and collapse .
CONTRA-INDICATION OF ANTODINE 20MG 30 TAB
hypersensitivity to any component of these products . Cross sensitivity in this class of compounds has been observed .
famotidine should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
In patientwith suger intolerance as it contains lactose .
STORAGE OF ANTODINE 20MG 30 TAB
store at temperature not exceeding 25° C .in dry place .
PACK OF ANTODINE 20MG 30 TAB
carton box containing (AL/colorless transparent PVC/PVDC) strips each of 10 film coated tablet+ inner tablet .
ANTODINE 20MG 30 TAB MANUFACTURED BY
AMOUN PHARMACEUTICAL CO . El-Obour City , Cairo, Egypt.
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