RANITIDINE description, usages, side effects, indications, overdosage, supplying and lots more!

RANITIDINE

Wockhardt Limited

Ranitidine Syrup (Ranitidine Oral Solution, USP)

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION

2
DESCRIPTION
132243





CLINICAL PHARMACOLOGY

2

Pharmacokinetics:

Absorption:

Distribution:

Metabolism:

Excretion:

Geriatrics:
PRECAUTIONS: Geriatric Use DOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients With Impaired Renal Function)

Pediatrics: 1/2maxmax

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
PRECAUTIONS: Pediatric Use DOSAGE AND ADMINISTRATION: Pediatric Use

Pharmacodynamics:

Antisecretory Activity: 1. Effects on Acid Secretion:

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


2. Effects on Other Gastrointestinal Secretions:
Pepsin:
Intrinsic Factor:
Serum Gastrin:

Other Pharmacologic Actions:

  • Gastric bacterial flora-increase in nitrate-reducing organisms, significance not known.
  • Prolactin levels-no effect in recommended oral or intravenous (IV) dosage, but small, transient, dose-related increases in serum prolactin have been reported after IV bolus injections of 100 mg or more.
  • Other pituitary hormones-no effect on serum gonadotropins, TSH, or GH. Possible impairment of vasopressin release.
  • No change in cortisol, aldosterone, androgen, or estrogen levels.
  • No antiandrogenic action.
  • No effect on count, motility, or morphology of sperm.
Pediatrics:

Clinical Trials: Active Duodenal Ulcer:
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



Maintenance Therapy in Duodenal Ulcer:

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
2

Gastric Ulcer:
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%)


Maintenance of Healing of Gastric Ulcers:

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):

Gastroesophageal Reflux Disease (GERD):



Erosive Esophagitis:
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%)


Maintenance of Healing of Erosive Esophagitis:

INDICATIONS AND USAGE


  • 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.
  • 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.
  • The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
  • 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.
  • Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
  • Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg b.i.d.
  • 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.
  • Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.

CONTRAINDICATIONS

PRECAUTIONS


General:

  • Symptomatic response to therapy with ranitidine does not preclude the presence of gastric malignancy.
  • Since ranitidine is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function (see DOSAGE AND ADMINISTRATION). Caution should be observed in patients with hepatic dysfunction since ranitidine is metabolized in the liver.
  • Rare reports suggest that ranitidine may precipitate acute porphyric attacks in patients with acute porphyria. Ranitidine should therefore be avoided in patients with a history of acute porphyria.  
Laboratory Tests: ®

Drug Interactions:

Procainamide:

Warfarin:



Atazanavir:

Delavirdine: 2

Gefitinib:

Glipizide:

Ketoconazole:

Midazolam:

Triazolam:

Carcinogenesis, Mutagenesis, Impairment of Fertility:
Salmonella, Escherichia coli


Pregnancy: Teratogenic Effects:  

Nursing Mothers:

Pediatric Use:



Geriatric Use:

ADVERSE REACTIONS

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 H2-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 (H2RAs) compared to patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2.48). However, a causal relationship between use of H2RAs 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.

OVERDOSAGE



50

DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer: Active Duodenal Ulcer


Maintenance of Healing of Duodenal Ulcers:

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):

Benign Gastric Ulcer:

Maintenance of Healing of Gastric Ulcers:

GERD:

Erosive Esophagitis:

Maintenance of Healing of Erosive Esophagitis:

Pediatric Use:


Treatment of Duodenal and Gastric Ulcers:

Maintenance of Healing of Duodenal and Gastric Ulcers:

Treatment of GERD and Erosive Esophagitis:  

Dosage Adjustment for Patients With Impaired Renal Function:

HOW SUPPLIED



Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured by:



Distributed by:





RANITIDINE

RANITIDINE HYDROCHLORIDE SYRUP

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55648-694
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE RANITIDINE 15 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE
HYPROMELLOSES
sorbitol
PROPYLPARABEN
BUTYLPARABEN
SODIUM PHOSPHATE, DIBASIC ANHYDROUS
POTASSIUM PHOSPHATE, MONOBASIC
saccharin sodium
ALCOHOL
PEPPERMINT
water

Product Characteristics

Color
yellow (clear, pale yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55648-694-01 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079211 2009-05-26


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