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Zantac (Ranitidine Hydrochloride) - Summary

 
 



ZANTAC SUMMARY

The active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, ZANTAC 25 EFFERdose Tablets, ZANTAC 150 EFFERdose Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist.

ZANTAC 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 ZANTAC 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 ZANTAC 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.


See all Zantac indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Zantac (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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Clinical Trials Related to Zantac (Ranitidine)

Effect of Ranitidine on Hyper-IgE Recurrent Infection (Job's) Syndrome [Recruiting]
This study will examine the safety and effectiveness of ranitidine (Zantac) in patients with Hyper-IgE recurrent infection syndrome, a disease characterized by recurrent infections of the ears, sinuses, lungs and skin, and abnormal levels of the antibody immunoglobulin E (IgE).

Patients age 2 and older who have Hyper-IgE recurrent infection syndrome and who have had chronic or frequent infections in the last 12 months may be eligible for this study.

Participants are randomly assigned to take ranitidine or placebo in pill or liquid form twice a day for 12 months. In addition to treatment, patients undergo the following procedures during visits scheduled on day 0 of the study (baseline) and at 3, 12, 15 and 24 months. Evaluations at 6, 9, 18 and 21 months are by telephone.

- Medical history and physical examination - baseline and 3 and 24 months.

- Clinical severity score - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months.

- Dermatology exam - baseline and 3, 12, 15 and 24 months.

- Pulmonary function test - baseline and 12 and 24 months.

- Chest CT - baseline and 12 and 24 months.

- Quality of life assessment - baseline and 3, 12, 15 and 24 months.

- Pregnancy testing - baseline and 3, 12, 15 and 24 months.

- HIV test - baseline and 12 and 24 months.

- Contraception evaluation - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months.

- Missed school/work days assessment - baseline and 3, 12, 15 and 24 months.

- Medication adherence - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months.

In addition to the above procedures, participants who are not enrolled in study 00-I-0159 have a baseline scoliosis series and genetic consult....

Comparison of Pantoprazole and Ranitidine in Dyspepsia [Recruiting]
The H0 hypothesis of the study there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency deparment.

The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.

A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers [Recruiting]
This randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.

A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued [Completed]
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.

A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine. [Completed]
Current treatment for gastroesophageal reflux disease (GERD) confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric-acid suppression. Clinical data on AH234844 demonstrates a rapid onset of action, high potency, and prolonged duration of effect. The present study endeavors, in part, to compare lavoltidine to two GERD drugs, NEXIUM and ranitidine.

more trials >>

Reports of Suspected Zantac (Ranitidine) Side Effects

Drug Ineffective (76)Dyspepsia (39)Malaise (35)Dyspnoea (29)Chronic Obstructive Pulmonary Disease (24)Gastrooesophageal Reflux Disease (23)Emphysema (23)Nausea (22)Amnesia (22)Bedridden (21)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 8 ratings/reviews, Zantac has an overall score of 7.50. The effectiveness score is 7.75 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Zantac review by 46 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   excess acidity
Dosage & duration:   2 tabs per day taken twice per day for the period of 2 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   relief from burning associated with reflux
Side effects:   slight nausea during the first 24 hours.
Comments:   Part of my treatment plan was to undergo an endoscopy to find out what the problem was initially. The doctor who performed the endoscopy prescribed the Zantac. In the first 24 hour period I felt no differently, but the second day I started to feel alot better. At the end of the two weeks period of taking 2x tabs per day I felt completely back to normal. I ceased taking the Zantac after my follow up visit with the doctor but was advised to keep some handy for future use.

 

Zantac review by 40 year old male patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   acid reflux
Dosage & duration:   30 mg taken once/day for the period of 5 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The Ranitidine can be taken at any, time throught out the day, with or without food, but should be taken with lots of water. can try 30 mag first then 60 mg etc. It can be taken up to 4 times per day.
Side effects:   no
Comments:   may have to repeat fairly often, how ever if you have serious acid problem, you may have to take Nexium for up to 2 months. The best is to check if you have H.pylori using a breath test, if you have HP then you have to take A HP pack or the cheaper alternative of nexium or pepacid + an antibiotic like Ammoxilin, the Hp pack is way overprice.

 

Zantac review by 59 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Reflux, Gastritis
Dosage & duration:   300 mg taken 1 per day for the period of 1 day
Other conditions:   DVT, asthma, allergies, depression
Other drugs taken:   coumadin, advair, protonix,levothroid, wellbutrin, allegra
  
Reported Results
Benefits:   none
Side effects:   lump in throat, trouble breathing, tiredness, muscle pain
Comments:   Prescribed 300 mg, once a day at bedtime for severe reflux and gastritis. Took one pill and stared to have trouble breathing. Took Albuterol and in a couple of hours breathing returned to normal. Called doctor next morning and was told to discontinue use. Did not work to control reflux. Started on Pepcid the next day which along with Tums has made reflux managable.

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Page last updated: 2013-02-10

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