Drug Interaction:
Histamine H2 Antagonists include-
Cimetidine, Famotidine, Nizatidine, Ranitidine, Roxatidine
Refer - Cimetidine
Interacting drugs - summary
Nizatidine + Salicylates
increased serum salicylates levels levels occurred with nizatidine administered to patients receiving receiving high doses of aspirin ( 3.9g/day ).
H2 antogonists + Ethanol
concurrent use increase plasma ethanol levels and AUC. This interaction have minimal clinical importance
Antacids/ Anticholinergics / Metoclopramide + H2 antogonist
these agents decrease absorption of cimetidine .
Ranitidine absorption decreased by concurrent antacids Avoid simultaneous administration. Bioavailability of famotidine and nizatidine slightly decreased. No special precautions necessary.
Cigerette smoking + Cimetidine
cigarette smoking reverses cimetidine inhibition of nocturnal gastric secretion and ulcer healling. Cigarette use is closely related to ulcer recurrence
Indication:
Indications: Duodenal ulcer,benign gastric ulcer,gastroesophagal reflux disease (GERD).
Histamine H2 Antagonists include-
Cimetidine, Famotidine, Nizatidine, Ranitidine, Roxatidine
Refer - Cimetidine
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Nizatidine Gastrointestinal Eli Lily & Co 02-01-2002
Nizatidine Gastrointestinal Eli Lily & Co 02-10-2001
Adverse Reaction:
Adverse Reactions-
Nizatidine-
CNS - Rare cases of reversible mental confusio have been reported
Dermatologic - Sweating, vasculitis has been reported rarey
GU- Clinical pharmacology studies and controlled clinical trials showed no evidence
of antiandrogenic activity due to nizatidine
Hematologic- Aanemia, fatal thrombocytopenia was reported in a patient who was treated with nizatidine and another H2 antagonist. Rare cases of thrombocytopenic purpura
have been reported
Hepatic- Rare cases of cholestatic or mixed hepatocelluar and cholerstatic injury with jaundice have been reported with reversal of abnormalites after discontinuation of nizatidine
Miscellaneous - Serum sickness -like reaction have occurred rarely with nizatidine use
Hyperuremia unassociated with gout or nephritis was reported Eosinophillia and fever have been reported
Lab test abnormalities-
Small increase in serum creatinine and elevated ALT levels (at least pretreatment levels) occurred with ranitidine. Small possibly dose related increases in plasma creatinine and serum transaminase occurred with cimetidine. These are not common and do not signify deteriorating renal function.
Elevated AST, ALT, and alkaline phosphatase levels ocur with nizatidine
Contra-Indications:
Reports not available.
Special precautions:
Reports not available
Dosages/ Overdosage Etc:
Approved by FDA in April 1988
Indications:
Duodenal ulcer,benign gastric ulcer,gastroesophagal reflux disease (GERD).
Dosage: Active duodenal ulcer- 300mg once daily at bed time, or 150mg twice daily. Maintenance of healed duodenal ulcer- 150mg once daily at bed time.
GERD- 150mg twice daily at bed time
Missed dose-
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Other Information:
Gastro Osephageal Reflux Disease (GORD)
Evidence Based Medicine (MIMS- March 2003)
Beneficial
1. Proton Pump Inhibitors such as omeprazole, Lansoprazole, pantoprazole
2. H-2 Antagonists such as cimetidine, ranitidine, famotidine, (less than proton pump inhibitors)
3. Fundoplication
Likely to be beneficial
1. Medical and surgical tretment of GORD in selected patients with extraoesophageal
manifestations.
Unknown effectiveness
1. Medical and surgical treatment of GORD in patients with Barrets oesophagus
2. Surgical treatment for non erosive oesophagitis
Key Points
1. One systemic review of randomised clinical trials has found proton inhibitors to be more
effective than H-2 antagonists in both erosive and non-erosive oesophagitis. One trial has
found no significant differences in the effectiveness of different proton pump inhibitors
2. Surgical treatment has not been adequately evaluated in controlled clinical trials.
Medical and surgical treatments have not been adequately compared
3. It is not clear whether patients with Barretts oesophagitis benefit from medical or surgical
treatment of their gastro oesophageal reflux
4. There is limited, conflicting evidence on the basis on the benefits of treating gastro
oesophageal reflux in patients with extra oesophageal manifestations (such as asthma)
Patient Information:
Histamine H2 Antagonists include- Cimetidine, Famotidine, Nizatidine, Ranitidine, Roxatidine
Refer - Cimetidine
Pharmacology/ Pharmacokinetics:
Histamine H2 Antagonists include- Cimetidine, Famotidine, Nizatidine, Ranitidine, Roxatidine
Refer - Cimetidine
Interaction with Food:
Not avialable.
Pregnancy and lactation:
Pregnancy-
Use only when needed and when the potential benefits outweigh the potentaial hazards to the fetus.
Lactation-
Nizatidine- is excreted in breast milk in a concentration of 0.1% of oral dose in proportion to plasma concentrations. Decide whether to discontinue nursing or discontinue the drug depending on the importance of the drug to the mother.