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Ranitidine Syrup (Ranitidine Oral Solution, USP) | RANITIDINE [WOCKHARDT USA LLC] | BioPortfolio

11:59 EST 27th January 2019 | BioPortfolio
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Table 1. Ranitidine Pharmacokinetics in Pediatric Patients Following Oral Dosing
Population
(age)
n
Dosage Form
(dose)
Cmax
(ng/mL)
Tmax
(hours)
   Gastric or duodenal ulcer
   (3.5 to 16 years)
12
Tablets
(1 to 2 mg/kg)
54 to 492
2.0
   Otherwise healthy requiring ranitidine
   (0.7 to 14 years, Single dose)
10
Oral Solution
(2 mg/kg)
244
1.61
   Otherwise healthy requiring ranitidine
   (0.7 to 14 years, Multiple dose)
10
Oral Solution
(2 mg/kg)
320
1.66
Table 2. Effect of Oral Ranitidine on Gastric Acid Secretion
Time After
Dose, h
% Inhibition of Gastric Acid
Output by Dose, mg
75 - 80
100
150
200
   Basal
Up to 4
99
95
   Nocturnal
Up to 13
95
96
92
   Betazole
Up to 3
97
99
   Pentagastrin
Up to 5
58
72
72
80
   Meal
Up to 3
73
79
95
Table 3. Duodenal Ulcer Patient Healing Rates
* All patients were permitted p.r.n. antacids for relief of pain.
P<0.0001.
Ranitidine*
Placebo*
Number
Entered
Healed/
Evaluable
Number
Entered
Healed/
Evaluable
   Outpatients


195

69/182
(38%)


188

31/164
(19%)
   Week 2
   Week 4
137/187
(73%)
76/168
(45%)
Table 4. Mean Daily Doses of Antacid
 
Ulcer Healed
Ulcer Not Healed
   Ranitidine
0.06
0.71
   Placebo
0.71
1.43
Table 5. Duodenal Ulcer Prevalence
% = Life table estimate.
* = P<0.05 (ranitidine versus comparator).
RAN = ranitidine.
PLC = placebo.
Double-Blind, Multicenter, Placebo-Controlled Trials
Multicenter
Trial
Drug
Duodenal Ulcer Prevalence
No. of
Patients
0 - 4
Months
0 - 8
Months
0 - 12
Months
   USA
RAN
20%*
24%*
35%*
138
PLC
44%
54%
59%
139
   Foreign
RAN
12%*
21%*
28%*
174
PLC
56%
64%
68%
165
Table 6. Gastric Ulcer Patient Healing Rates
* All patients were permitted p.r.n. antacids for relief of pain.
P = 0.009.
 
Ranitidine*
Placebo*
Number
Entered
Healed/
Evaluable
Number
Entered
Healed/
Evaluable
   Outpatients


 92

16/83
(19%)


 94

10/83
(12%)
   Week 2
   Week 6
50/73
(68%)
35/69
(51%)
Table 7. Erosive Esophagitis Patient Healing Rates
* All patients were permitted p.r.n. antacids for relief of pain.
P<0.001 versus placebo.
 
Healed/Evaluable
Placebo*
n = 229
Ranitidine 150 mg q.i.d.*
n = 215
   Week 4
43/198 (22%)
96/206 (47%)
   Week 8
63/176 (36%)
142/200 (71%)
   Week 12
92/159 (58%)
162/192 (84%)

The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to therapy with ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine. Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received. Cardiovascular: As with other H-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats. Gastrointestinal: Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis. Hepatic: There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, ranitidine should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg q.i.d. intravenously for 7 days, and in 4 of 24 subjects receiving 50 mg q.i.d. intravenously for 5 days. Musculoskeletal: Rare reports of arthralgias and myalgias. Hematologic: Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported. Endocrine: Controlled studies in animals and man have shown no stimulation of any pituitary hormone by ranitidine and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when ranitidine has been substituted. However, occasional cases of impotence and loss of libido have been reported in male patients receiving ranitidine, but the incidence did not differ from that in the general population. Integumentary: Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis. Respiratory: A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (HRAs) compared to patients who had stopped HRA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2.48). However, a causal relationship between use of HRAs and pneumonia has not been established. Other: Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, and small increases in serum creatinine.

Manufacturer

WOCKHARDT USA LLC

Active Ingredients

Source

Drugs and Medications [157 Associated Drugs and Medications listed on BioPortfolio]

Ranitidine [wockhardt limited]

Ranitidine Syrup (Ranitidine Oral Solution, USP)

Ranitidine [heritage pharmaceuticals inc.]

Ranitidine Syrup (Ranitidine Oral Solution, USP)

Ranitidine [unit dose services]

Ranitidine Syrup (Ranitidine Oral Solution, USP)

Ranitidine [blenheim pharmacal, inc.]

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Ranitidine [blenheim pharmacal, inc.]

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Clinical Trials [38 Associated Clinical Trials listed on BioPortfolio]

Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions

The purpose of this study is to compare the rate and extent of absorption of ranitidine 300 mg tablets versus Zantac 300 mg tablets administered as 1 x 300 mg tablet under fasting conditio...

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

To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected patients with CD4 counts of 400-700 cells/mm3.

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

The present study will compare the hemostasis-maintaining effects of intravenous omeprazole and ranitidine in patients with upper gastrointestinal hemorrhage that have undergone endoscopic...

Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer

The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric u...

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

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 ...

PubMed Articles [9 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetic Drug-Drug Interactions Between Trospium Chloride and Ranitidine Substrates of Organic Cation Transporters in Healthy Human Subjects.

Trospium chloride, a muscarinic receptor blocker, is poorly absorbed with different rates from areas in the jejunum and the cecum/ascending colon. To evaluate whether organic cation transporter (OCT) ...

Pharmacological antagonism of histamine H2R ameliorated L-DOPA-induced dyskinesia via normalization of GRK3 and by suppressing FosB and ERK in PD.

Parkinson's disease (PD) is often managed with L-3,4-dihydroxyphenylalanine (L-DOPA), which is still the gold standard to relieve the clinical motor symptoms of PD. However, chronic use of L-DOPA lead...

GSK recalls ranitidine products over potential carcinogen contamination.

Investigation on Beneficial Role of L-Carnosine in Neuroprotective Mechanism of Ischemic Postconditioning in Mice: Possible role of Histidine Histamine Pathway.

The present study was undertaken to investigate the possible role of histidine-histamine pathway in the neuroprotective effects produced by L-carnosine hand in hand with ischemic postconditioning in t...

Abnormal Presentation of Hypoxic Ischemic Encephalopathy Attributed to Polysubstance Exposure.

BACKGROUND With the increasing prevalence of substance use in pregnancy, the rates of neonatal abstinence syndrome (NAS) are dramatically increasing. There is little information on the use of multiple...

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