Ranitidine (Dosing, Interaction, Side Effect, Administration, Etc..)

DRUG CLASS:
Gastric Acid Secretion Inhibitor
Gastrointestinal Agent
Histamine H2 Antagonist

DOSING:

Adult Dose

:
Important Note:
Beers Criteria:

Use

caution or avoid

use as

potentially inappropriate in older adults.

General Dosage Information:

Ranitidine injection

may be

used as

an alternative to the

oral dosage form

for

short-term use

in patients who are unable to take oral medication.

Duodenal ulcer disease:
150 mg orally or 10 ml of a 15 mg/ml oral solution twice daily

Use 300 mg

or 20 ml of a 15 mg/ml oral solution once daily after the evening meal or at bedtime
Concomitant medications; antacids may be administered as needed for pain relief.

Intractable duodenal ulcers:
50 mg IM every 6 to 8 hours
50 mg intermittent IV bolus at a concentration no greater that 2.5 mg/ml every 6 to 8 hours; at a rate up to 4 ml/min; may increase frequency of dosing based on patient needs
50 mg intermittent IV infusion at a concentration no greater than 0.5 mg/ml every 6 to 8 hours; at a rate no more than 5 to 7 ml/min; may increase frequency of dosing based on patient needs
6.25 mg/hr continuous IV infusion

Duodenal ulcer disease; Maintenance:
150 mg orally or 10 ml of a 15 mg/ml oral solution once daily at bedtime

Erosive esophagitis:
Initial;
150 mg orally or 10 ml of a 15 mg/ml oral solution 4 times daily

Maintenance:
150 mg orally or 10 ml of a 15 mg/ml oral solution twice daily

Concomitant medications:
Antacids may be administered as needed for pain relief.

Gastric hypersecretion:
150 mg orally or 10 ml of a 15 mg/ml oral solution twice daily; may administer more frequently based on individual patient needs; up to 6 g/day have been

used in

patients with severe disease
Concomitant medications; antacids may be administered as needed for pain relief
50 mg IM every 6 to 8 hours
50 mg intermittent IV bolus at a concentration no greater that 2.5 mg/ml every 6 to 8 hours; at a rate up to 4 ml/min; may increase frequency of dosing based on patient needs
50 mg intermittent IV infusion at a concentration no greater than 0.5 mg/ml every 6 to 8 hours; at a rate no more than 5 to 7 ml/min; may increase frequency of dosing based on patient needs
6.25 mg/hr continuous IV infusion

Gastric ulcer:
150 mg orally or 10 ml of a 15 mg/ml oral solution twice daily

Gastric ulcer; Maintenance:
150 mg orally or 10 ml of a 15 mg/ml oral solution once daily at bedtime

Gastroesophageal reflux disease(GERD):
150 mg orally or 10 ml of a 15 mg/ml oral solution twice daily

Indigestion; Non-ulcer:
Prophylaxis:
75 to 150 mg orally 30 to 60 minutes before eating or drinking; maximum 300 mg/day

Treatment:
75 to 150 mg orally once or twice daily; maximum 300 mg/day

Stress ulcer; Prophylaxis:
150 mg NG or ORALLY twice daily
50 mg IV every 6-8 hr
6.25 mg/hr IV continuous infusion

Zollinger-Ellison syndrome:
150 mg orally or 10 ml of a 15 mg/ml oral solution twice daily; may administer more frequently based on individual patient needs; up to 6 g/day have been used in patients with severe disease
Concomitant medications; antacids may be administered as needed for pain relief
50 mg IM every 6 to 8 hours
50 mg intermittent IV bolus at a concentration no greater that 2.5 mg/ml every 6 to 8 hours; at a rate up to 4 ml/min; may increase frequency of dosing based on patient needs
50 mg intermittent IV infusion at a concentration no greater than 0.5 mg/ml every 6 to 8 hours; at a rate no more than 5 to 7 ml/min; may increase frequency of dosing based on patient needs
1 mg/kg/hr continuous IV infusion; if after 4 hours; gastric acid output is greater than 10 mEq/hr or patient becomes symptomatic;

dose

may be increased in 0.5-mg/kg/hr increments; dosages up to 2.5 mg/kg/hr and rates as high as 220 mg/hr have been used.

Pediatric Dose

:
Important Note:
Beers Criteria: Use caution or

avoid use

as potentially inappropriate in older adults.

General Dosage Information:

Ranitidine

injection may be used as an alternative to the

oral dosage

form for short-term use in patients who are unable to take oral medication.

Duodenal ulcer disease:
(1 month to 16 years)
2 to 4 mg/kg orally twice daily; maximum 300 mg/day
2 to 4 mg/kg/day IV in divided

doses every 6 to 8 hours

; maximum 50 mg every 6-8 hours

Duodenal ulcer disease; Maintenance:
(1 month to 16 years)
2 to 4 mg/kg orally once daily; maximum 150 mg/day

Erosive esophagitis:
(1 month to 16 years)
Initial; 5 to 10 mg/kg/day orally in 2 divided doses.

Gastric ulcer:
(1 month to 16 years)
2 to 4 mg/kg orally twice daily; maximum 300 mg/day

Gastric ulcer; Maintenance:
(1 month to 16 years)
2 to 4 mg/kg orally once daily; maximum 150 mg/day

Gastroesophageal reflux disease:
(1 month to 16 years)
5 to 10 mg/kg/day orally in 2 divided doses.

Indigestion; Non-ulcer:
(12 years or older): Prophylaxis:
75 to 150 mg orally 30 to 60 min before eating or drinking; maximum 300 mg/day

(12 years or older) Treatment:
75 to 150 mg orally once or twice daily; maximum 300 mg/day

Stress ulcer; Prophylaxis:
Infants; 3 to 6 mg/kg/day IV divided every 8 hr
Children; 3 to 6 mg/kg/day IV divided every 6 hr; Maximum 200 mg/day
Neonates; 0.0625 to 0.2 mg/kg/hr IV continuous infusion
Neonates; full-term; 1.5 to 3 mg/kg/day IV divided every 8 hr
Neonates; pre-term; 0.5 mg/kg/day IV divided every 12 hr.

INDICATIONS:
FDA-Labeled Indications:
Duodenal ulcer disease
Duodenal ulcer disease; Maintenance
Erosive esophagitis
Gastric hypersecretion
Gastric ulcer
Gastric ulcer; Maintenance
Gastroesophageal reflux disease
Indigestion, Non-ulcer
Zollinger-Ellison syndrome

Non-FDA Labeled Indications:
Aspiration pneumonitis; Prophylaxis
Asthma
Duodenitis
Gastritis medicamentosa
Gastrointestinal hemorrhage
Hyperchlorhydria; Nocturnal
Stress ulcer; Prophylaxis





MECHANISM OF ACTION:
Ranitidine is a competitive H2-receptor antagonist that reversibly inhibits the action of histamine at the histamine H2-receptors; including receptors on the gastric cells. It is a substituted aminoalkyl furan and does not contain the imidazole ring characteristic of cimetidine. Although it was previously thought that the imidazole group was essential for antisecretory activity; ranitidine has been demonstrated to be a potent inhibitor of gastric acid secretion

ADVERS E EFFECT:
Common:
Gastrointestinal:
Abdominal pain
Constipation
Diarrhea

Neurologic:
Headache

Serious:
Cardiovascular:
Bradyarrhythmia

Dermatologic:
Stevens-Johnson syndrome
Toxic epidermal necrolysis due to drug

Gastrointestinal:
Necrotizing enterocolitis in fetus OR newborn
Pancreatitis (rare)

Hematologic:
Agranulocytosis (rare)
Aplastic anemia (rare)
Pancytopenia (rare)
Thrombocytopenia

Hepatic:
Cholestatic hepatitis
Hepatitis
Liver failure (rare)
Liver function tests abnormal

CONTRAINDICATION:

Hypersensitivity to ranitidine

or any of its ingredients
DRUG INTERACTION:

Ranitidine

has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion; alteration of gastric pH; and inhibition of cytochrome P450 enzymes.

Procainamide:
Ranitidine; a substrate of the renal organic cation transport system; may affect the clearance of other drugs eliminated by this route. High

doses of ranitidine

(e.g.; such as those

used in the treatment

of Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs. Although this interaction is unlikely to be clinically relevant at usual

ranitidine doses

; it may be prudent to monitor for procainamide toxicity when administered with

oral ranitidine

at a dose exceeding 300 mg per day.

Warfarin:
There have been reports of altered prothrombin time among patients on concomitant warfarin and

ranitidine therapy

. Due to the narrow therapeutic index; close monitoring of increased or decreased prothrombin time is recommended during concurrent

treatment with ranitidine

. Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g.; triazolam; midazolam; glipizide) or a decrease in absorption (e.g.; ketoconazole; atazanavir; delavirdine; gefitinib). Appropriate clinical monitoring is recommended.

Atazanavir:
Atazanavir absorption may be impaired based on known interactions with other agents that increase gastric pH. Use with caution. See atazanavir label for specific recommendations.

Delavirdine:
Delavirdine absorption may be impaired based on known interactions with other agents that increase gastric pH. Chronic use of H2-receptor antagonists with delavirdine is not recommended.

Gefitinib:
Gefitinib exposure was reduced by 44% with the

co administration of ranitidine

and sodium bicarbonate (dosed to maintain gastric pH above 5.0). Use with caution.

Glipizide:
In diabetic patients, glipizide exposure was increased by 34% following a single 150-mg

dose of oral ranitidine

. Use appropriate clinical monitoring when initiating or discontinuing ranitidine.

Ketoconazole:
Oral ketoconazole exposure was reduced by up to 95% when oral ranitidine was coadministered in a regimen to maintain a gastric pH of 6 or above. The degree of interaction with

usual dose of ranitidine

(150 mg twice daily) is unknown.

Midazolam:
Oral midazolam exposure in 5 healthy volunteers was increased by up to 65% when administered with oral ranitidine at a

dose of 150 mg twice daily

. However; in another interaction study in 8 volunteers receiving IV midazolam; a

300 mg oral dose of ranitidine

increased midazolam exposure by about 9%. Monitor patients for excessive or prolonged sedation when ranitidine is coadministered with oral midazolam.

Triazolam:
Triazolam exposure in healthy volunteers was increased by approximately 30% when administered with oral ranitidine at a

dose of 150 mg twice daily

. Monitor patients for excessive or prolonged sedation.

PHARMACOKINETICS:
Absorption:
Oral;
Adults: 50%
Children: 48%
Intramuscular: 90% to 100%
Effect of food: minimal

Distribution:
Volume of Distribution (Vd):
Adults: 1.04 to 4.09 L/kg
Children: 0.98 to 4 L/kg
Plasma Protein binding: 15%

Metabolism:
Hepatic: minor

Excretion:
Renal: 30% to 70%
Fecal: 3.1 ml/min/kg

Dialyzable:
Hemodialysis and peritoneal dialysis: Yes
Hemodialysis: 35% to 54%

Elimination:
Adults: 1.9 to 3 hours.
Adults, renal impairment: 4.8 to 9.8 hours
Elderly: 3 to 4 hours
Children: 1.7 to 2.8 hours

PRECAUSION:
Beers Criteria:
Avoid in patients with cognitive impairment and dementia due to adverse CNS effects. Avoid use in patient with or at high risk of delirium as histamine H2 receptor antagonists nay induce or worsen delirium.

Cardiovascular:
Bradycardia has occurred with rapid

administration of ranitidine

in patients predisposed to cardiac rhythm disturbances.

Endocrine and Metabolic:
Use caution in phenylketonurics and granules contain phenylalanine.

Gastrointestinal:
Symptomatic response to

ranitidine does

not preclude presence of gastric malignancy.

Hematologic:
History of acute porphyria

Hepatic:
Elevation of transaminase enzymes has occurred with prolonged IV therapy.

Other:

Use caution in neonates

with very low birth weight (ie; between 401 to 1500 g) due to increased risk of necrotizing enterocolitis

Use caution in elderly

or immunocompromised patients and patients with chronic lung disease or diabetes due to increased risk of community acquired pneumonia
Renal and hepatic insufficiency
False-positive urine protein test may occur.

PREGNENCY CATEGORY:
B (FDA)
B1 (AUS)

BREAST FEEDING:
Infant Risk Cannot Be Ruled out

MONITORING:
Decreased abdominal and/or gastroesophageal discomfort
Endoscopic improvement
CBC

HOW TO TAKE OR ADMINISTRATION:
Intramuscular:
No dilution is necessary.

Intravenous:
(Injection for intermittent bolus)
Dilute

ranitidine 50 mg

(2 mL) in NS or other compatible IV solution to a concentration no greater than 2.5 mg/mL (20 mL) and inject at a rate no greater than 4 mL/min (usually 5 minutes).

(Injection for intermittent infusion)
Dilute ranitidine 50 mg (2 mL) in D5W or other compatible IV solution to a concentration no greater than 0.5 mg/mL (100 mL) and infuse at a rate no greater than 5 to 7 mL/min (usually 15 to 20 minutes).

(Injection for continuous infusion)
Dilute in D5W or other compatible IV solution and infuse at a rate of 6.25 mg/hr.

(Injection for continuous infusion)
For Zollinger-Ellison patients, dilute in D5W or other compatible IV solution to a concentration no greater than 2.5 mg/mL; start infusion at a rate of 1 mg/kg/hr.
Stable for 48 hours at room temperature when added to or diluted with most commonly

used IV solutions

DOSAGE FORM:
Injection Solution:
25 MG/1 ML

Oral:
Capsule:
150 MG
300 MG

Capsule; Liquid Filled:
300 MG

Solution:
15 MG/1 ML

Syrup:
15 MG/1 ML

Tablet:
75 MG
150 MG
300 MG

Powder for Suspension:
25 MG/1ML

TREATMENTS:
MANAGEMENT OF MILD TO MODERATE TOXICITY:
Treatment is symptomatic and supportive.

MANAGEMENT OF SEVERE TOXICITY:
Intravenous fluids for hypotension, supportive care for CNS depression.

TOXICOLOGY:
TOXICITY: These medications have a large therapeutic window and no more than minimal toxicity is expected even with

very large overdoses

.

PATIENT COUNSELING OR CLINICAL TEACHING:
This drug may cause bradyarrhythmia; abdominal pain; constipation; diarrhea; nausea; vomiting; dizziness; headache; insomnia; somnolence; agitation; and fatigue
Patients who are elderly; have chronic lung disease; diabetes; or are immunocompromised are at higher risk for developing community acquired pneumonia while taking this drug. Advise patient to report any signs/symptoms.
Patients taking drug to prevent heartburn should take drug 30 to 60 minutes before having foods/drinks that cause their heartburn

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For the Registered Medical Practitioner Only. We are not recommended for self medication. self medication is may harmful for health. We are only Provide information about medicine.