Ranitidine (Ranitidine Hydrochloride) - Summary

RANITIDINE SUMMARY

Ranitidine
Tablets USP
Revised: June 2005
Rx only

Ranitidine hydrochloride (HCl) is a histamine H₂-receptor antagonist.

Ranitidine tablets are 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 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 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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RANITIDINE NEWS HIGHLIGHTS

Published Studies Related to Ranitidine

Clinical trial: the effects of adding ranitidine at night to twice daily omeprazole therapy on nocturnal acid breakthrough and acid reflux in patients with systemic sclerosis--a randomized controlled, cross-over trial. [2007.11.01]

Effects of itopride hydrochloride and ranitidine in patients with functional dyspepsia: comparison between prokinetic and acid suppression therapies. [2007.09]

Pharmacokinetic interaction between darunavir boosted with ritonavir and omeprazole or ranitidine in human immunodeficiency virus-negative healthy volunteers. [2007.03]

Single dose oral ranitidine improves MRCP image quality: a double-blind study. [2007.01]

Pharmacokinetic and bioequivalence study of meloxicam tablets in healthy male subjects. [2007]

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Clinical Trials Related to 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]

A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine. [Completed]

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]

Comparison of Intravenous Omeprazole to Ranitidine on Recurrent Bleeding After Endoscopic Treatment of Bleeding Ulcer [Withdrawn]

A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3 [Completed]

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RANITIDINE PATIENT REVIEWS / RATINGS / COMMENTS

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 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