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RANITIDINE

Physicians Total Care, Inc.

PRODUCT INFORMATION Rx Only


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

RANITIDINE DESCRIPTION

2132243



RANITIDINE

CLINICAL PHARMACOLOGY

2

Pharmacokinetics:

Absorption:

Distribution:

Metabolism:

Excretion:

Geriatrics:

Pediatrics: 1/2max max

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 Syrup
(2 mg/kg)
244 1.61
Otherwise healthy requiring Ranitidine
(0.7 to 14 years, Multiple dose)
10 Syrup
(2 mg/kg)
320 1.66


Pharmacodynamics:

Antisecretory Activity: 1. Effects on Acid Seretion:

Table 2. Effect of Oral Ranitidine on Gastric Acid Secretion
Time After
Dose, hours
% 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
Pentagastin 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
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%)

p



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 Uicer:

Table 5. Duodenal Ulcer Prevalence
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

p



2

Gastric Ulcer:

Table 6. Gastric Ulcer Patient Healing Rates
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%)

p



Maintenance of Helaing of Gastric Ulcers:

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

Gastroesophageal Reflux Disease (GERD):





Erosive Esophagitis:

Table 7. Erosive Esophagitis Patient Healing Rates
Healed / Evaluable
Placebo*
n=229
Ranitidine HCl
150 mg 4 times daily*
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%)

p



Maintenance of Healing of Erosive Esophagitis:

RANITIDINE 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 twice daily.
  • Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine 150 mg 4 times daily.
  • Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.

RANITIDINE 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 Test:

Drug Interactions:

Procainamide:

Warfarin:



Atazanavir:

Delavirdine:

Gefitinib:

Glipizide:

Ketoconazole:

Midazolam:

Triazolam:

Carcinogenesis, Mutagenesis, Impairment of Fertility:
Escherichia coli


Pregnancy:
Teratogenic Effects:

Nursing Mothers:


Pediatric Use:



Geriatric Use:

RANITIDINE ADVERSE REACTIONS



Central Nervous System:

Cardiovascular: 2

Gastrointestinal:

Hepatic:


Musculoskeletal:

Hematologic:

Endocrine:



Integumentary:

Respiratory:222

Other:

OVERDOSAGE





RANITIDINE 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



Bottles of 30
NDC 54868-4048-2
Bottles of 60
NDC 54868-4048-0
Bottles of 90
NDC 54868-4048-3
Bottles of 100
NDC 54868-4048-1
Bottles of 180
NDC 54868-4048-4




Bottles of 30
NDC 54868-4350-0
Bottles of 100
NDC 54868-4350-1






Manufactured by:



Distributed by:







Relabeling and Repackaging by:


PRINCIPAL DISPLAY PANEL



RANITIDINE



RANITIDINE

RANITIDINE

RANITIDINE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:54868-4048(NDC:64679-906)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE RANITIDINE 150 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
talc
SILICON DIOXIDE
MAGNESIUM STEARATE
castor oil
HYPROMELLOSES
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white (white) 11 mm W906 HEXAGON (6 sided)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-4048-0 60 in 1 BOTTLE, PLASTIC
2 NDC:54868-4048-1 100 in 1 BOTTLE, PLASTIC
3 NDC:54868-4048-2 30 in 1 BOTTLE, PLASTIC
4 NDC:54868-4048-3 90 in 1 BOTTLE, PLASTIC
5 NDC:54868-4048-4 180 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075208 1999-09-21


RANITIDINE

RANITIDINE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:54868-4350(NDC:64679-907)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE RANITIDINE 300 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
talc
SILICON DIOXIDE
MAGNESIUM STEARATE
castor oil
HYPROMELLOSES
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white (white) 16 mm W907 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-4350-0 30 in 1 BOTTLE, PLASTIC
2 NDC:54868-4350-1 100 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075208 2003-09-19


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