Ranitidine
Ranitidine Syrup (Ranitidine Oral Solution, USP)
FULL PRESCRIBING INFORMATION: CONTENTS*
- RANITIDINE DESCRIPTION
- CLINICAL PHARMACOLOGY
- RANITIDINE INDICATIONS AND USAGE
- RANITIDINE CONTRAINDICATIONS
- PRECAUTIONS
- RANITIDINE ADVERSE REACTIONS
- OVERDOSAGE
- RANITIDINE DOSAGE AND ADMINISTRATION
- 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
- Dosage Adjustment for Patients With Impaired Renal Function
- HOW SUPPLIED
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 mg/mL (474 mL Bottle)
FULL PRESCRIBING INFORMATION
RANITIDINE DESCRIPTION
2
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
| 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
| 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
| * 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%) |
||
| |
Ulcer Healed |
Ulcer Not Healed |
| Ranitidine |
0.06 |
0.71 |
| Placebo |
0.71 |
1.43 |
Maintenance Therapy in Duodenal Ulcer
| % = 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
| * 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
| * 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
RanitidineRanitidine Hydrochloride SYRUP
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
