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.

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NEWS HIGHLIGHTS

Published Studies Related to Zantac (Ranitidine)

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.

Lansoprazole for long-term maintenance therapy of erosive esophagitis: double-blind comparison with ranitidine. [2009.05]
In a study evaluating the efficacy and safety of lansoprazole to prevent the relapse of erosive esophagitis (EE), 206 of 241 patients (85%) healed after open-label treatment with lansoprazole 30 mg once daily for 8 weeks and received double-blind maintenance treatment with lansoprazole 15 mg once daily or ranitidine 150 mg twice daily for up to 1 year...

Immediate acid-suppressing effects of ranitidine hydrochloride and rabeprazole sodium following initial administration and reintroduction: A randomized, cross-over study using wireless pH monitoring capsules. [2009.04]
BACKGROUND AND AIM: Histamine 2 receptor antagonists and proton-pump inhibitors, drugs that are widely used for the treatment of acid-related diseases, have different clinical characteristics. The objective of this study was to compare the acid-suppressing effects of ranitidine hydrochloride and those of rabeprazole sodium at the first administration and re-administration after withdrawal... CONCLUSION: In view of our observations, we expect symptoms associated with gastric acidity to be more adequately controlled with rabeprazole sodium in the short term when compared to ranitidine hydrochloride.

Clinical trial: intravenous pantoprazole vs. ranitidine for the prevention of peptic ulcer rebleeding: a multicentre, multinational, randomized trial. [2009.03.01]
BACKGROUND: Controlled pantoprazole data in peptic ulcer bleeding are few. AIM: To compare intravenous (IV) pantoprazole with IV ranitidine for bleeding ulcers... CONCLUSIONS: Outcomes amongst pantoprazole and ranitidine-treated patients were similar; pantoprazole provided benefits in patients with arterial spurting and gastric ulcers.

The efficacy of ranitidine bismuth citrate, amoxicillin and doxycycline or tetracycline regimens as a first line treatment for Helicobacter pylori eradication. [2009.01]
BACKGROUND: The eradication rates of Helicobacter pylori (H. pylori) clearly decreased with standard PPI-based triple therapies. AIM: To assess the efficacy of two different triple therapies consisting of ranitidine bismuth citrate-amoxicillin-doxycycline and ranitidine bismuth citrate-amoxicillin-tetracycline combinations as a first line treatment option... CONCLUSIONS: Two-week therapy with neither ranitidine bismuth citrate-amoxicillin-doxycycline nor ranitidine bismuth citrate-amoxicillin-tetracycline is adequately effective for H. pylori eradication as a first line therapy.

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Clinical Trials Related to Zantac (Ranitidine)

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.

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 in Subjects in the US Only [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 for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.

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 Intravenous Omeprazole to Ranitidine on Recurrent Bleeding After Endoscopic Treatment of Bleeding Ulcer [Withdrawn]
The present study will compare the hemostasis-maintaining effects of intravenous omeprazole and ranitidine in patients with upper gastrointestinal hemorrhage that have undergone endoscopic hemostasis, to establish which anti-secretory medication prior to the start of oral alimentation is effective in preventing re-hemorrhage after hemostasis.

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PATIENT REVIEWS / RATINGS / COMMENTS

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 26 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		hives
Dosage & duration:		don't remember (dosage frequency: daily) for the period of 3 months
Other conditions:		hay fever
Other drugs taken:		none
		Reported Results
Benefits:		Extreme urticaria (hives) on forearms and mild (hives) on face and legs were near completely cured with the Zantac.
Side effects:		No side effects that I remember
Comments:		I had horrible rashes on my forearms, the right one especially, that were extremely itchy. I tried topical anti-itch creams and put ice on it to soothe the itching but nothing relieved my symptoms more than slightly. I thought it would eventually go away by itself. After suffering for 4 or 5 weeks I went to my doctor. He took 1 look at my arms and said I had hives. Probably due to seasonal allergies. He wrote a prescription for Zantac and sent me on my way. Within the 1st day of taking the medication my hives were less than half than they'd been. Within a week they were nearly gone.

Zantac review by 26 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		hives
Dosage & duration:		don't remember (dosage frequency: daily) for the period of 3 months
Other conditions:		hay fever
Other drugs taken:		none
		Reported Results
Benefits:		Extreme urticaria (hives) on forearms and mild (hives) on face and legs were near completely cured with the Zantac.
Side effects:		No side effects that I remember
Comments:		I had horrible rashes on my forearms, the right one especially, that were extremely itchy. I tried topical anti-itch creams and put ice on it to soothe the itching but nothing relieved my symptoms more than slightly. I thought it would eventually go away by itself. After suffering for 4 or 5 weeks I went to my doctor. He took 1 look at my arms and said I had hives. Probably due to seasonal allergies. He wrote a prescription for Zantac and sent me on my way. Within the 1st day of taking the medication my hives were less than half than they'd been. Within a week they were nearly gone.