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Ranitidine

Aurobindo Pharma Limited

Ranitidine Syrup (Ranitidine Oral Solution, USP)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

RANITIDINE DESCRIPTION


2
Ranitidine
132243



CLINICAL PHARMACOLOGY


2++

Pharmacokinetics

Absorption


Distribution


Metabolism


Excretion


DOSAGE AND ADMINISTRATION

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
   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, hours
% Inhibition of Gastric Acid
Output by Dose, mg
75 to 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







Pediatrics


Clinical Trials

Active Duodenal Ulcer



Table 3. Duodenal Ulcer Patient Healing Rates
* All patients were permitted antacids as needed 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 to 4
Months
0 to 8
Months
0 to 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 antacids as needed 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 antacids as needed for relief of pain.
P<0.001 versus placebo.
 
Healed/Evaluable
Placebo*
n = 229
Ranitidine 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%)

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.

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.

RANITIDINE CONTRAINDICATIONS

Ranitidine is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).

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




















2



















Carcinogenesis, Mutagenesis, Impairment Of Fertility




Salmonella, Escherichia coli

Pregnancy

Teratogenic Effects

Pregnancy Category B.

Nursing Mothers


Pediatric Use


CLINICAL PHARMACOLOGY: Pediatrics  DOSAGE AND ADMINISTRATION: Pediatric Use



CLINICAL PHARMACOLOGY: Pediatrics

Geriatric Use




CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics DOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients With Impaired Renal Function

RANITIDINE ADVERSE REACTIONS




Central Nervous System



Cardiovascular
 
2

Gastrointestinal



Hepatic
 


Musculoskeletal



Hematologic



Endocrine



Integumentary



Respiratory

222

Other

OVERDOSAGE


ADVERSE REACTIONS



50

RANITIDINE DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer


Clinical Trials: Active Duodenal Ulcer

CLINICAL PHARMACOLOGY: Pharmacokinetics

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




CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics PRECAUTIONS: Geriatric Use

HOW SUPPLIED


Ranitidine Syrup (Ranitidine Oral Solution, USP),



Store at





Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 mg/mL (474 mL Bottle)


Rx only          NDC 65862-431-74
Ranitidine Syrup
(Ranitidine Oral Solution, USP)

15 mg/mL (75 mg/5 mL)

474 mL
AUROBINDO
Ranitidine

Ranitidine

Ranitidine Hydrochloride SYRUP

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-431
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
ALCOHOL
BUTYLPARABEN
SODIUM PHOSPHATE, DIBASIC ANHYDROUS
HYPROMELLOSE 2910 (4000 CPS)
POTASSIUM PHOSPHATE, MONOBASIC
PROPYLPARABEN
water
saccharin sodium
SODIUM CHLORIDE
sorbitol

Product Characteristics

Color
YELLOW (Colorless to Pale Yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-431-74 474 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090623 2010-07-28


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