Each ampoule 2 ml contains 20 mg famotidine in aqueous solution for intramuscular or intravenous administration.The inactive ingredients :
L aspartic acid , Mannitol.
- Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use Antodine® at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of Antodine® 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.
- Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks.
- Short term treatment of gastroesophageal reflux disease (GERD). Antodine® is indicated for short term treatment of patients with symptoms of GERD. Antodine® is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy.
- Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas)
The following adverse reactions have been reported to occur in patients on therapy with famotidine:
headache, dizziness, constipation and diarrhea.
The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed.
The relationship to therapy with famotidine has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity:Body as a Whole: fever, asthenia, fatigue Cardiovascular: arrhythmia, AV block, palpitation
Gastrointestinal: cholestatic jaundice, hepatitis , liver enzyme abnormalities, vomiting, nausea, abdominal discomfort, anorexia, dry mouth.
Hypersensitivity: anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival injection.
Musculoskeletal: musculoskeletal pain including muscle cramps, arthralgia.
Nervous System/Psychiatric: grand mal seizure; psychic disturbances, which were reversible in cases for which followup was obtained, including hallucinations, confusion, agitation, depression, anxiety, decreased libido; paresthesia; insomnia; somnolence.
Special Senses: tinnitus, taste disorder.
No drug interactions have been identified with Antodine® (Famotidine) as it does not interfere with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. e.g. warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine.Pregnancy: Pregnancy Category B This drug should be used during pregnancy only if clearly needed.
The starting dose for Antodine® (Famotidine) injection in pediatric patients is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15 minute infusion) every 12 h up to 40 mg/day.Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency
In adult patients with moderate (creatinine clearance <50 ml="" min="" or="" severe="" creatinine="" clearance="" 10="" renal="" insufficiency="" the="" elimination="" half-life="" of="" famotidine="" is="" increased="" p=""> 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 injection 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 with moderate or severe renal insufficiency should be considered.
Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) The dosage of Antodine® (Famotidine) in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg every 12 h.
To prepare Antodine® (Famotidine) intravenous solutions, aseptically dilute 2 mL of Antodine® injection with 0.9% Sodium Chloride Injection or other compatible intravenous solution to a total volume of either 5 mL or 10 mL, and inject over a period of not less than 2 minutes.To prepare Antodine® (Famotidine) intravenous infusion solutions, aseptically dilute 2 mL of Antodine® injection with 100 mL of 5% dextrose or other compatible solution, and infuse over a 15 to 30 minute period.