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Ranitidine (Ranitidine Hydrochloride) - Summary

 
 



RANITIDINE SUMMARY

The active ingredient in Ranitidine Tablets, USP 150 mg and Ranitidine Tablets, USP 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist.

Ranitidine Tablets, USP is indicated in:

1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.

2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.

3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).

4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated.

Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.

5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.

6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets, USP 150 mg b.i.d.

7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets, USP 150 mg q.i.d.

8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.

Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.


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NEWS HIGHLIGHTS

Published Studies Related to Ranitidine

Onset of relief of symptoms of gastroesophageal reflux disease: post hoc analysis of two previously published studies comparing pantoprazole 20 mg once daily with nizatidine or ranitidine 150 mg twice daily. [2010.04]
BACKGROUND: Systematic assessments of the onset of symptom relief in the treatment of gastroesophageal reflux disease (GERD) are lacking. OBJECTIVE: This work evaluated the time interval until complete symptom relief from heartburn (including both daytime and nighttime heartburn) and acid regurgitation in patients with GERD or endoscopy-negative GERD (NERD) during the first 7 days of treatment with pantoprazole, nizatidine, or ranitidine... CONCLUSION: In this post hoc reanalysis of data from 2 previously published clinical trials, use of pantoprazole 20 mg once daily was associated with effective early relief from heartburn and acid regurgitation among these patients with GERD and NERD; relief occurred as fast as and, in some cases, even faster than that seen with nizatidine or ranitidine.

Onset of relief of symptoms of gastroesophageal reflux disease: post hoc analysis of two previously published studies comparing pantoprazole 20 mg once daily with nizatidine or ranitidine 150 mg twice daily. [2010]
first 7 days of treatment with pantoprazole, nizatidine, or ranitidine... CONCLUSION: In this post hoc reanalysis of data from 2 previously published

Ranitidine is unable to maintain gastric pH levels above 4 in septic patients. [2009.12]
PURPOSE: The study aimed to evaluate whether ranitidine and pantoprazole are able to maintain gastric pH >or=4 in septic patients... CONCLUSIONS: Intravenous ranitidine was unable to maintain gastric pH above 4 in septic patients. All cases in the ranitidine group in whom pH remained above 4 had gastric hypotrophy or atrophy. Pantoprazole successfully maintained pH levels above 4.

Nosocomial pneumonia risk and stress ulcer prophylaxis: a comparison of pantoprazole vs ranitidine in cardiothoracic surgery patients. [2009.08]
BACKGROUND: Stress ulcer prophylaxis (SUP) using ranitidine, a histamine H2 receptor antagonist, has been associated with an increased risk of ventilator-associated pneumonia. The proton pump inhibitor (PPI) pantoprazole is also commonly used for SUP. PPI use has been linked to an increased risk of community-acquired pneumonia. The objective of this study was to determine whether SUP with pantoprazole increases pneumonia risk compared with ranitidine in critically ill patients... CONCLUSION: The use of pantoprazole for SUP was associated with a higher risk of nosocomial pneumonia compared with ranitidine. This relationship warrants further study in a randomized controlled trial.

Performance of acidified 14C-urea capsule breath test during pantoprazole and ranitidine treatment. [2009.07]
BACKGROUND AND AIM: Urea breath test (UBT) results could be false negative in patients taking antisecretory drugs. This effect would be prevented by citric acid administration during UBT. We prospectively investigated whether acidified 14C-urea capsule prevents false negative UBT results in patients taking antisecretory drugs and show interference with the duration of medications... CONCLUSIONS: The use of acidified 14C-urea capsule did not prevent false negative UBT results in patients taking pantoprazole and ranitidine, and the duration of medication does not affect the test results.

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Reports of Suspected Ranitidine Side Effects

Dyspnoea (67)Fatigue (51)Anaphylactic Reaction (41)Vomiting (36)Chest Discomfort (35)Abdominal Pain (30)Malaise (27)Urticaria (20)Headache (20)Chest Pain (18)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 5 ratings/reviews, Ranitidine has an overall score of 7.60. The effectiveness score is 7.60 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Ranitidine review by 48 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   heartburn
Dosage & duration:   300mg taken as needed for the period of as needed- 3 years
Other conditions:   scleroderma CREST w/Sjogren's
Other drugs taken:   levoxyl, prevacid, hydrocodone
  
Reported Results
Benefits:   heartburn was usually decreased significately if not totally
Side effects:   none
Comments:   I get heartburn caused more from my condition than from food. There were times that I had "breakthrough" heartburn even after using prevacid. I generally don't even use the prevacid now. I do try to not eat things that will cause heartburn but I still get heartburn often. I take the ranitidine often, but not every time I have heartburn. There are some times when I will take one or two Tums to get a jumpstart against the burning.

 

Ranitidine review by 36 year old male patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   heartburn
Dosage & duration:   20mg taken 2-3 pd for the period of permantly
Other conditions:   n/a
Other drugs taken:   n/a
  
Reported Results
Benefits:   to reduce acid production and stop acid reflux, the tablets are easy to swallow and moderately effective, their effectivity is diminished if reflux is already occuring.
Side effects:   there are no side effects
Comments:   take 2-3 times per day to aviod reflux acid. this is most effective prior to eating so take 30 minutes before eating or drinking alcohol will help to aviod heartburn

 

Ranitidine review by 34 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Rash
Dosage & duration:   150 mg taken bid for the period of 15 days
Other conditions:   N/A
Other drugs taken:   N/A
  
Reported Results
Benefits:   Decreased redness and bumpiness by day 6. I believe the benefits were associated with the prescribed medication. However, I was also using a histamine blocking topical cream during the course of treatment.
Side effects:   None noted
Comments:   Rash of unknown origin. Intense itching, redness, and bumpy texture beginning on neck and slowly migrating around to appendages. Took prescription described above, as recommended. On Day 6, I noticed decreased irritation associated with rash.

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Page last updated: 2013-02-10

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