COMPOSITION :
Cimetidine Tablet 200 mg, each tablet contains : Cimetidine 200 mg.
DESCRIPTIONS :
Cimetidine with Cimetidine as active ingredient is available in tablet 200 mg.
INDICATIONS :
- Active duodenal ulceration short-term therapy.
- Maintenance therapy for duodenal ulceration in reduced dose after recuperation of active ulcer.
- Active benign gastric ulcer short-term therapy.
- Erosive gastro-oesophageal reflux therapy.
- Prevention of upper gastrointestinal bleeding in patients who are critical.
- Pathological hypersecretory conditions therapy such as : Zollinger-Ellison syndrome, systemic mastocytosis and multiple endocrine adenomas.
DOSAGE AND ADMINISTRATIONS :
- Therapy of active duodenal ulceration :
800 mg, once daily at night. Or 300 mg 4 times a day during meals and bedtime. Or 400 mg 2 times a day in the morning and bedtime. Duration of the treatment is 4 – 6 weeks.
Concomitant Antacids should be given as needed for relief of pain; however, simultaneous administration should be avoided because Antacids reduce the absorption of Cimetidine.
- Maintenance therapy of recurrent duodenal ulcer :
400 mg, once daily at bedtime.
- Active benign gastric ulcer :
800 mg, once daily bedtime or 300 mg 4 times a day during meals and bedtime for 6 – 8 weeks.
- Treatment of reflux gastroesofagus erosive :
1600 mg per day in divided doses (800 mg 2 times daily or 400 mg 4 times daily) for 12 weeks.
- Pathological hypersecretory conditions :
300 mg 4 times a day during meals and bedtime. On some patients, when needed, doses can be given greater more frequently, according to need but may not exceed 2.4 grams a day.
OVERDOSAGE :
Study on animals showed the toxic dose is characterized by respiratory system failure and tachycardia. This situation can be solved by awarding β-blockers and respiratory assistance.
WARNINGS AND PRECAUTIONS :
- Cimetidine should not be given to children under 16 years old, unless over physician considerations.
- Cimetidine can be given to pregnant and lactating women only if really necessary.
- Cimetidine can’t be used in symptomatic therapy for gastric malignancy.
DRUG INTERACTIONS :
Cimetidine can inhibit metabolisms of Coumarin anticoagulant, Phenytoin, Propranolol, Nifedipine, Chlordiazepoxide, Diazepam, tricyclic antidepresant, Lidocaine, Theophylline and Metronidazole, therefore it can inhibit the elimination and will increase these drugs concentrations in blood.
ADVERSE REACTIONS :
- In the gastrointestinal tract : Mild diarrhea.
- In the central nervous system : Headache, dizziness, drowsiness, mental confusion, agitation, psychosis, depression, anxiety, hallucinations.
- In the endocrine system : Gynecomastia.
- In the hematology system : Leucopenia, agranulocytosis, thrombocytopenia, aplastic anemia or pancytopenia have been reported rarely.
- Hypersensitivity : Fever and allergic reactions including anaphylactic.
- In the cardiovascular system : Bradycardia and tachycardia (rarely happens).
- Renal : Increase in plasma creatinine, interstitial nephritis and urine retention.
PRESENTATION :
Cimetidine Tablet 200 mg Box, 10 strips @ 10 tablets Reg. No. GKL9302317510A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
