preloder

Ranitidine Hydrochloride


Ranitidine hydrochloride is a

histamine-2 blocker

that works by
reducing
the amount of
acid
your

stomach

produces.

Ranitidine

is

used

to
treat
and
prevent

ulcers

in the

stomach

and

intestines

. It also
treats
conditions in which the

stomach

produces too much
acid
, such as

Zollinger-Ellison syndrome

.
Dosing
Adult dosing of

Ranitidine hydrochloride

:

Important Note of

Ranitidine hydrochloride

:

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 15mg/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


50mg intermittent

IV

bolus at a concentration no greater that 2.5mg/ml every 6 to

8 hours

; at a rate up to 4 ml/minute; may increase frequency of

dosing

based on patient needs

50mg intermittent

IV

infusion
at a concentration no greater than 0.5mg/ml every 6 to

8 hours

; at a rate no more than 5 to 7 ml/minute; may increase frequency of

dosing

based on patient needs
6.25mg/hour continuous

IV

infusion


Duodenal ulcer disease

; Maintenance:
150
mg

orally

or 10ml of a 15 mg/ml

oral

solution
once daily at bedtime

Erosive esophagitis:
Initial:
150
mg

orally

or 10ml of a 15mg/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 10ml of a 15 mg/ml

oral

solution
twice daily; may administer more frequently based on individual patient needs; up to 6g/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



50mg intermittent

IV

bolus at a concentration no greater that 2.5mg/ml every 6 to

8 hours

; at a rate up to 4 ml/minute; may increase frequency of

dosing

based on patient needs

50mg intermittent

IV

infusion
at a concentration no greater than 0.5mg/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
6.25mg/hour continuous

IV

infusion


Gastric ulcer:
150
mg

orally

or 10ml of a 15mg/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 hour
6.25mg/hour

IV

continuous
infusion


Zollinger-Ellison syndrome:
150
mg

orally

or 10ml of a 15mg/ml

oral

solution
twice daily; may administer more frequently based on individual patient needs; up to 6g/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

50mg intermittent

IV

bolus at a concentration no greater that 2.5mg/ml every 6 to

8 hours

; at a rate up to 4 ml/minute; may increase frequency of

dosing

based on patient needs

50mg intermittent

IV

infusion
at a concentration no greater than 0.5mg/ml every 6 to

8 hours

; at a rate no more than 5 to 7 ml/minute; may increase frequency of

dosing

based on patient needs

1 mg/kg/hour continuous

IV

infusion
; if after

4 hours

; gastric acid output is greater than 10 mEq/

hours

or patient becomes symptomatic;

dose

may be increased in 0.5-mg/kg/hour increments; dosages up to 2.5mg/kg/

hours

and rates as high as 220 mg/

hours

have been

used

.

Pediatric dosing of

Ranitidine hydrochloride

:

Important Note of

Ranitidine hydrochloride

:

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 minute 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 hours


Children: 3 to 6 mg/kg/day

IV

divided every

6 hours

; Maximum 200mg/day
Neonates: 0.0625 to 0.2mg/kg/hour

IV

continuous
infusion

Neonates, full-term: 1.5 to 3 mg/kg/day

IV

divided every 8 hour
Neonates, preterm: 0.5mg/kg/day

IV

divided every 12 hour
Indications
FDA-Labeled Indications of

Ranitidine hydrochloride

:

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 of

Ranitidine hydrochloride

:

Aspiration

pneumonitis

; Prophylaxis

Asthma


Duodenitis


Gastritis medicamentosa


Gastrointestinal hemorrhage


Hypochlorhydria

; 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

Adverse 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
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.

Major:
Acalabrutinib (theoretical)
Alfentanil (theoretical)
Amiodarone (theoretical)
Atazanavir (theoretical)
Benzhydrocodone (theoretical)
Buprenorphine (theoretical)
Bupropion (theoretical)
Codeine (theoretical)
Dasatinib (theoretical)
Delavirdine (theoretical)
Dihydrocodeine (theoretical)
Domperidone (theoretical)
Eliglustat (theoretical)
Erlotinib (probable)
Fentanyl (established)
Gefitinib (theoretical)
Hydrocodone (theoretical)
Ketoconazole (probable)
Ledipasvir (theoretical)
Meperidine (theoretical)
Methadone (theoretical)
Neratinib (theoretical)
Oxycodone (theoretical)
Pazopanib (theoretical)
Pentazocine (theoretical)
Piperaquine (theoretical)
Rilpivirine (theoretical)
Secretin Human (theoretical)
Sufentanil (theoretical)
Tolazoline (probable)
Tramadol (theoretical)
Vismodegib (theoretical)
Moderate:
Amprenavir (probable)
Cefpodoxime Proxetil (probable)
Dicumarol (probable)
Didanosine (established)
Enoxacin (probable)
Fosamprenavir (probable)
Glipizide (probable)
Risperidone (probable)
Triazolam (probable)
Warfarin (probable)
Phamacokinetics
Absorption of

Ranitidine hydrochloride

:

Oral:
Adults: 50%
Children: 48%
Intramuscular: 90% to 100%

Effect of food: minimal

Distribution of

Ranitidine hydrochloride

:

Volume of Distribution (Vd):
Adults: 1.04 to 4.09L/kg
Children: 0.98 to 4L/kg

Plasma Protein binding: 15%
Metabolism of

Ranitidine hydrochloride

:

Hepatic: minor

Excretion of

Ranitidine hydrochloride

:

Renal: 30% to 70%
Fecal: 3.1ml/minute/kg
Dialyzable:
Hemodialysis and peritoneal dialysis: Yes
Hemodialysis: 35% to 54%

Elimination of

Ranitidine hydrochloride

:

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



Precaution
Beers Criteria of

Ranitidine hydrochloride

:

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 (i.e.; between 401 to 1500g) 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.
Pregnancy 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

50mg (2ml) in NS or other compatible

IV

solution
to a concentration no greater than 2.5mg/mL (20ml) and inject at a rate no greater than 4 ml/min (usually 5 minutes).

Injection
for
intermittent
infusion
:
Dilute

Ranitidine

50mg (2ml) in D5W or other compatible

IV

solution
to a concentration no greater than 0.5mg/mL (100ml) 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 6.25mg/hour.

Injection
for
continuous
infusion
:
For Zollinger-Ellison patients, dilute in D5W or other compatible

IV

solution
to a concentration no greater than 2.5mg/mL; start
infusion
at a rate of 1 mg/kg/hour.
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



Oral Capsule; Liquid Filled:

300 mg



Oral Solution:
15 mg/1ml

Oral
Syrup
:

15 mg/1ml

Oral

Tablet

:

75 mg
150 mg

300 mg



Oral Powder for Suspension:
25 mg/1 mL

Treatment
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 of

Ranitidine hydrochloride

:

These

medications

have a large therapeutic window and no more than minimal toxicity is expected even with very large overdoses.

Patient Counselling 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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