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The following indications for ACID REDUCER (ranitidine hcl) have been approved by the FDA:
Indications:
Duodenal ulcer
Dyspepsia prevention
Dyspepsia
Erosive esophagitis
Gastric hypersecretion with systemic mastocytosis
Gastric ulcer
Gastroesophageal reflux disease
Heartburn prevention
Heartburn
Maintenance of healing duodenal ulcer
Multiple endocrine neoplasia
Pathological gastric acid hypersecretory condition
Reflux esophagitis
Zollinger-Ellison syndrome
Professional Synonyms:
Adenomatosis partial multiple endocrine
Brash prophylaxis
Brash
Dyspepsia prophylaxis
Functional dyspepsia prophylaxis
Functional dyspepsia
Gastric acid hypersecretory conditions due to disease
Gastro-esophageal reflux disease with esophagitis
Gastro-esophageal reflux
GE reflux disease
Heartburn prophylaxis
Maintenance of healing DU
Multiple endocrine adenoma
Pancreatic ulcerogenic tumor syndrome
Pathological gastric acid hypersecretory states
Pathological hypersecretion state
Pathological hypersecretory condition
Pyrosis prophylaxis
Pyrosis
Systemic mast cell disease with gastric hypersecretion
Z-E syndrome
Indications:
Duodenal ulcer
Dyspepsia prevention
Dyspepsia
Erosive esophagitis
Gastric hypersecretion with systemic mastocytosis
Gastric ulcer
Gastroesophageal reflux disease
Heartburn prevention
Heartburn
Maintenance of healing duodenal ulcer
Multiple endocrine neoplasia
Pathological gastric acid hypersecretory condition
Reflux esophagitis
Zollinger-Ellison syndrome
Professional Synonyms:
Adenomatosis partial multiple endocrine
Brash prophylaxis
Brash
Dyspepsia prophylaxis
Functional dyspepsia prophylaxis
Functional dyspepsia
Gastric acid hypersecretory conditions due to disease
Gastro-esophageal reflux disease with esophagitis
Gastro-esophageal reflux
GE reflux disease
Heartburn prophylaxis
Maintenance of healing DU
Multiple endocrine adenoma
Pancreatic ulcerogenic tumor syndrome
Pathological gastric acid hypersecretory states
Pathological hypersecretion state
Pathological hypersecretory condition
Pyrosis prophylaxis
Pyrosis
Systemic mast cell disease with gastric hypersecretion
Z-E syndrome
The following dosing information is available for ACID REDUCER (ranitidine hcl):
Dosage of cimetidine hydrochloride is expressed in terms of cimetidine.
The usual adult IM or IV dosage of cimetidine is 300 mg every 6-8 hours. If necessary, parenteral dosage may be increased by increasing the frequency of administration, but the manufacturer recommends that IM or intermittent IV dosage not exceed 2.4 g daily.
When feasible, IV dosage should be adjusted to maintain an intragastric pH of 5 or greater.
When cimetidine is administered by continuous IV infusion in adults, the drug usually is infused at a rate of 37.5 mg/hour, but the rate should be individualized according to patient requirements. For patients requiring more rapid increases in GI pH, an initial 150-mg IV loading dose may be required.
In one study in patients with pathologic hypersecretory conditions, the average dosage by continuous IV infusion required to maintain gastric acid secretion at 10 or less mEq/hour was 160 mg/hour, but individual requirements varied considerably, ranging from 40-600 mg/hour.
In patients with renal impairment, doses and/or frequency of administration of famotidine can be modified in response to the degree of renal impairment. Adverse CNS effects have been reported in patients with moderate or severe renal insufficiency receiving famotidine, and modification of dosage and/or dosing interval may be used to avoid excess accumulation of the drug in such patients. In adults with moderate (creatinine clearances less than 50 mL/minute) or severe (creatinine clearances less than 10 mL/minute) renal impairment, the manufacturer states that dosage of famotidine may be reduced to half the usual dosage or the dosing interval may be prolonged to 36-48 hours as necessary according to the patient's clinical response.
Some clinicians have recommended that one-half the usual adult dosage be administered in adults with creatinine clearances of 30-60 mL/minute per 1.48 m2 and that one-fourth the usual adult dosage be administered in those with creatinine clearances less than 30 mL/minute per 1.48 m2.
Based on the comparison of pharmacokinetic parameters of famotidine in adults and children, dosage adjustment also should be considered in children with moderate or severe renal impairment.
For the prevention of upper GI bleeding in critically ill patients, cimetidine usually is administered to adults by continuous IV infusion at a rate of 50 mg/hour for up to 7 days; the manufacturer states that the safety and efficacy of continuously infused cimetidine for more prolonged periods have not been established. The manufacturer also indicates that an initial loading dose is not required when the drug is administered prophylactically in such patients. However, some clinicians recommend initiating cimetidine therapy in critically ill patients with a 300-mg IV loading dose administered over 5-20 minutes, followed by a continuous IV infusion initiated at a rate of 37.5-50
mg/hour and titrated according to gastric pH (e.g., maintenance of a pH of at least 3.5-4) by additional 25-mg/hour increments, generally up to a maximum rate of 100 mg/hour. Intermittent IV doses of the drug appear to be less effective in preventing upper GI bleeding than continuous IV infusions.
In the treatment of upper GI bleeding+, peptic esophagitis+, and stress ulcers+, IV or oral dosage of 1-2 g daily, administered in 4 divided doses, has been used.
When the potential benefits are thought to outweigh the possible risks, a pediatric cimetidine dosage of 20-40 mg/kg daily in divided doses has been used in a limited number of children.
Accumulation of cimetidine may occur in patients with severe renal failure; therefore, the lowest effective dosage of the drug should be used. In patients with creatinine clearances of less than 30 mL/minute, the manufacturer recommends oral or IV cimetidine dosage of 300 mg every 12 hours. Dosage may be adjusted on the basis of gastric acid secretory response.
Dosage intervals may be cautiously decreased from every 12 hours to every 8 hours or less, if necessary. In patients with severe renal impairment, accumulation of the drug may occur and the longest dosage interval compatible with an adequate response should be used. For the prevention of upper GI bleeding in critically ill patients, the manufacturer states that patients with renal impairment (creatinine clearance less than 30 mL/minute) can receive one half of the usual cimetidine dosage.
When hepatic impairment is also present, further reduction in dosage may be necessary. Because hemodialysis greatly reduces blood cimetidine concentrations, cimetidine should be administered at the end of dialysis and every 12 hours during the interdialysis period.
The usual adult IM or IV dosage of cimetidine is 300 mg every 6-8 hours. If necessary, parenteral dosage may be increased by increasing the frequency of administration, but the manufacturer recommends that IM or intermittent IV dosage not exceed 2.4 g daily.
When feasible, IV dosage should be adjusted to maintain an intragastric pH of 5 or greater.
When cimetidine is administered by continuous IV infusion in adults, the drug usually is infused at a rate of 37.5 mg/hour, but the rate should be individualized according to patient requirements. For patients requiring more rapid increases in GI pH, an initial 150-mg IV loading dose may be required.
In one study in patients with pathologic hypersecretory conditions, the average dosage by continuous IV infusion required to maintain gastric acid secretion at 10 or less mEq/hour was 160 mg/hour, but individual requirements varied considerably, ranging from 40-600 mg/hour.
In patients with renal impairment, doses and/or frequency of administration of famotidine can be modified in response to the degree of renal impairment. Adverse CNS effects have been reported in patients with moderate or severe renal insufficiency receiving famotidine, and modification of dosage and/or dosing interval may be used to avoid excess accumulation of the drug in such patients. In adults with moderate (creatinine clearances less than 50 mL/minute) or severe (creatinine clearances less than 10 mL/minute) renal impairment, the manufacturer states that dosage of famotidine may be reduced to half the usual dosage or the dosing interval may be prolonged to 36-48 hours as necessary according to the patient's clinical response.
Some clinicians have recommended that one-half the usual adult dosage be administered in adults with creatinine clearances of 30-60 mL/minute per 1.48 m2 and that one-fourth the usual adult dosage be administered in those with creatinine clearances less than 30 mL/minute per 1.48 m2.
Based on the comparison of pharmacokinetic parameters of famotidine in adults and children, dosage adjustment also should be considered in children with moderate or severe renal impairment.
For the prevention of upper GI bleeding in critically ill patients, cimetidine usually is administered to adults by continuous IV infusion at a rate of 50 mg/hour for up to 7 days; the manufacturer states that the safety and efficacy of continuously infused cimetidine for more prolonged periods have not been established. The manufacturer also indicates that an initial loading dose is not required when the drug is administered prophylactically in such patients. However, some clinicians recommend initiating cimetidine therapy in critically ill patients with a 300-mg IV loading dose administered over 5-20 minutes, followed by a continuous IV infusion initiated at a rate of 37.5-50
mg/hour and titrated according to gastric pH (e.g., maintenance of a pH of at least 3.5-4) by additional 25-mg/hour increments, generally up to a maximum rate of 100 mg/hour. Intermittent IV doses of the drug appear to be less effective in preventing upper GI bleeding than continuous IV infusions.
In the treatment of upper GI bleeding+, peptic esophagitis+, and stress ulcers+, IV or oral dosage of 1-2 g daily, administered in 4 divided doses, has been used.
When the potential benefits are thought to outweigh the possible risks, a pediatric cimetidine dosage of 20-40 mg/kg daily in divided doses has been used in a limited number of children.
Accumulation of cimetidine may occur in patients with severe renal failure; therefore, the lowest effective dosage of the drug should be used. In patients with creatinine clearances of less than 30 mL/minute, the manufacturer recommends oral or IV cimetidine dosage of 300 mg every 12 hours. Dosage may be adjusted on the basis of gastric acid secretory response.
Dosage intervals may be cautiously decreased from every 12 hours to every 8 hours or less, if necessary. In patients with severe renal impairment, accumulation of the drug may occur and the longest dosage interval compatible with an adequate response should be used. For the prevention of upper GI bleeding in critically ill patients, the manufacturer states that patients with renal impairment (creatinine clearance less than 30 mL/minute) can receive one half of the usual cimetidine dosage.
When hepatic impairment is also present, further reduction in dosage may be necessary. Because hemodialysis greatly reduces blood cimetidine concentrations, cimetidine should be administered at the end of dialysis and every 12 hours during the interdialysis period.
Cimetidine and cimetidine hydrochloride are administered orally. Cimetidine hydrochloride may also be given by IM or slow IV injection or by intermittent or continuous slow IV infusion, in hospitalized patients with pathologic hypersecretory conditions or intractable ulcer, or when oral therapy is not feasible. Antacids may be given as necessary for relief of pain in patients with ulcers but should not be administered simultaneously with oral cimetidine.
Commercially available prefilled syringes of cimetidine hydrochloride are intended for IM injection or for preparation of IV admixtures; because the drug must be diluted prior to IV administration, the prefilled syringemust not be used for direct IV injection. Parenteral solutions of cimetidine hydrochloride should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Commercially available prefilled syringes of cimetidine hydrochloride are intended for IM injection or for preparation of IV admixtures; because the drug must be diluted prior to IV administration, the prefilled syringemust not be used for direct IV injection. Parenteral solutions of cimetidine hydrochloride should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| EQ ACID REDUCER 200 MG TABLET | Maintenance | Adults take 1 tablet (200 mg) by oral route 2 times per day 30 minutes before meals |
| EQ ACID REDUCER 20 MG TABLET | Maintenance | Adults take 1 tablet (20 mg) by oral route 2 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| FAMOTIDINE 20 MG TABLET | Maintenance | Adults take 1 tablet (20 mg) by oral route 2 times per day |
| CIMETIDINE 200 MG TABLET | Maintenance | Adults take 1 tablet (200 mg) by oral route 2 times per day 30 minutes before meals |
| PUB FAMOTIDINE 20 MG TABLET | Maintenance | Adults take 1 tablet (20 mg) by oral route 2 times per day |
| EQ FAMOTIDINE 20 MG TABLET | Maintenance | Adults take 1 tablet (20 mg) by oral route 2 times per day |
| QC FAMOTIDINE 20 MG TABLET | Maintenance | Adults take 1 tablet (20 mg) by oral route 2 times per day |
The following drug interaction information is available for ACID REDUCER (ranitidine hcl):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ACID REDUCER (ranitidine hcl):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 5 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Gastric cancer |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for ACID REDUCER (ranitidine hcl):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 33 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Agranulocytosis Anaphylaxis Anemia Angioedema Atrioventricular block Bradycardia Bronchospastic pulmonary disease Cardiac arrhythmia Dyspnea Erythema multiforme Exfoliative dermatitis Fever Hepatitis Hypersensitivity drug reaction Hypotension Increased alanine transaminase Increased aspartate transaminase Interstitial nephritis Interstitial pneumonitis Leukopenia Obstructive hyperbilirubinemia Pancreatitis Pancytopenia Psychiatric disorder Rhabdomyolysis Seizure disorder Skin rash Stevens-johnson syndrome Tachycardia Thrombocytopenic disorder Toxic epidermal necrolysis Urticaria |
There are 45 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Constipation Diarrhea Dizziness Headache disorder |
Diarrhea Dizziness Drowsy Musculoskeletal pain Nausea Skin rash Vomiting |
| Rare/Very Rare |
|---|
|
Abnormal sexual function Acne vulgaris Acute abdominal pain Acute cognitive impairment Agitation Allergic conjunctivitis Alopecia Anorexia Anticholinergic toxicity Arthralgia Cramps Delirium Drowsy Dry skin Dysgeusia Erectile dysfunction Facial edema Fatigue Fever Flushing General weakness Gynecomastia Hallucinations Insomnia Lethargy Mastalgia Myalgia Nausea Paresthesia Pruritus of skin Tinnitus Urinary retention Vomiting Xerostomia |
The following precautions are available for ACID REDUCER (ranitidine hcl):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Reproduction studies in rats and rabbits using oral famotidine dosages up to 2 (approximately 2500 times the maximum human dosage) and 0.5 g/kg daily, respectively, or IV dosages up to 0.2 (approximately 250 times the maximum human dosage) and 0.1
g/kg daily, respectively, have not revealed evidence of harm to the fetus. Oral dosages of 2 g/kg daily inhibited weight gain in pregnant rats, and those of 0.5 and/or 2 g/kg daily on days 7-17 of gestation decreased fetal weight and delayed sternal ossification in the offspring.
Decreased food intake and decreased weight gain also occurred in offspring of rats receiving these dosages from days 10-28 post partum. Death and locomotor dysfunction were observed in pregnant rats receiving IV famotidine dosages of 100 or 200 mg/kg daily. IV dosages of 100 or 200 mg/kg daily in rats have decreased pup body weight during the post-weaning period.
Although no direct fetotoxic effects have been observed, sporadic abortions and decreases in fetal weight occurred secondary to substantial decreases in food intake in pregnant rabbits receiving oral dosages of 200 mg/kg (250 times the usual human dosage) or more daily. Decreased number of sacrocaudal vertebrae and delayed ossification have occurred in rabbits receiving oral famotidine dosages of 0.5 g/kg daily.
There are no adequate and controlled studies to date using famotidine in pregnant women, and the drug should be used during pregnancy only when clearly needed. Women who are pregnant or nursing should seek the advice of a health professional before using famotidine for self-medication. Reproduction studies in rats, rabbits, and mice at doses up to 40 times the normal human dose of cimetidine have revealed no evidence of impaired fertility or harm to the fetus. However, there are no adequate and controlled studies to date using cimetidine in pregnant women, and the drug should be used during pregnancy only when clearly needed.
g/kg daily, respectively, have not revealed evidence of harm to the fetus. Oral dosages of 2 g/kg daily inhibited weight gain in pregnant rats, and those of 0.5 and/or 2 g/kg daily on days 7-17 of gestation decreased fetal weight and delayed sternal ossification in the offspring.
Decreased food intake and decreased weight gain also occurred in offspring of rats receiving these dosages from days 10-28 post partum. Death and locomotor dysfunction were observed in pregnant rats receiving IV famotidine dosages of 100 or 200 mg/kg daily. IV dosages of 100 or 200 mg/kg daily in rats have decreased pup body weight during the post-weaning period.
Although no direct fetotoxic effects have been observed, sporadic abortions and decreases in fetal weight occurred secondary to substantial decreases in food intake in pregnant rabbits receiving oral dosages of 200 mg/kg (250 times the usual human dosage) or more daily. Decreased number of sacrocaudal vertebrae and delayed ossification have occurred in rabbits receiving oral famotidine dosages of 0.5 g/kg daily.
There are no adequate and controlled studies to date using famotidine in pregnant women, and the drug should be used during pregnancy only when clearly needed. Women who are pregnant or nursing should seek the advice of a health professional before using famotidine for self-medication. Reproduction studies in rats, rabbits, and mice at doses up to 40 times the normal human dose of cimetidine have revealed no evidence of impaired fertility or harm to the fetus. However, there are no adequate and controlled studies to date using cimetidine in pregnant women, and the drug should be used during pregnancy only when clearly needed.
Famotidine is distributed into milk in humans and in animals. The drug has produced transient growth depression in the offspring of lactating rats receiving dosages at least 600 times the usual human dosage. Because of the potential for serious adverse reactions to famotidine in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Since cimetidine is distributed into milk, nursing should generally not be undertaken during therapy with the drug. Women who are pregnant or nursing should seek the advice of a health professional before using cimetidine for self-medication.
Since cimetidine is distributed into milk, nursing should generally not be undertaken during therapy with the drug. Women who are pregnant or nursing should seek the advice of a health professional before using cimetidine for self-medication.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ACID REDUCER (ranitidine hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ACID REDUCER (ranitidine hcl)'s list of indications:
| Duodenal ulcer | |
| K26 | Duodenal ulcer |
| K26.0 | Acute duodenal ulcer with hemorrhage |
| K26.1 | Acute duodenal ulcer with perforation |
| K26.2 | Acute duodenal ulcer with both hemorrhage and perforation |
| K26.3 | Acute duodenal ulcer without hemorrhage or perforation |
| K26.4 | Chronic or unspecified duodenal ulcer with hemorrhage |
| K26.5 | Chronic or unspecified duodenal ulcer with perforation |
| K26.6 | Chronic or unspecified duodenal ulcer with both hemorrhage and perforation |
| K26.7 | Chronic duodenal ulcer without hemorrhage or perforation |
| K26.9 | Duodenal ulcer, unspecified as acute or chronic, without hemorrhage or perforation |
| Dyspepsia | |
| K30 | Functional dyspepsia |
| Dyspepsia prevention | |
| K30 | Functional dyspepsia |
| Erosive esophagitis | |
| K21.0 | Gastro-esophageal reflux disease with esophagitis |
| K21.00 | Gastro-esophageal reflux disease with esophagitis, without bleeding |
| K21.01 | Gastro-esophageal reflux disease with esophagitis, with bleeding |
| K22.1 | Ulcer of esophagus |
| K22.10 | Ulcer of esophagus without bleeding |
| K22.11 | Ulcer of esophagus with bleeding |
| Gastric hypersecretion with systemic mastocytosis | |
| C96.21 | Aggressive systemic mastocytosis |
| D47.02 | Systemic mastocytosis |
| K31.89 | Other diseases of stomach and duodenum |
| Gastric ulcer | |
| K25 | Gastric ulcer |
| K25.0 | Acute gastric ulcer with hemorrhage |
| K25.1 | Acute gastric ulcer with perforation |
| K25.2 | Acute gastric ulcer with both hemorrhage and perforation |
| K25.3 | Acute gastric ulcer without hemorrhage or perforation |
| K25.4 | Chronic or unspecified gastric ulcer with hemorrhage |
| K25.5 | Chronic or unspecified gastric ulcer with perforation |
| K25.6 | Chronic or unspecified gastric ulcer with both hemorrhage and perforation |
| K25.7 | Chronic gastric ulcer without hemorrhage or perforation |
| K25.9 | Gastric ulcer, unspecified as acute or chronic, without hemorrhage or perforation |
| Gastroesophageal reflux disease | |
| K21 | Gastro-esophageal reflux disease |
| K21.0 | Gastro-esophageal reflux disease with esophagitis |
| K21.00 | Gastro-esophageal reflux disease with esophagitis, without bleeding |
| K21.9 | Gastro-esophageal reflux disease without esophagitis |
| Heartburn | |
| R12 | Heartburn |
| Maintenance of healing duodenal ulcer | |
| K26 | Duodenal ulcer |
| K26.0 | Acute duodenal ulcer with hemorrhage |
| K26.1 | Acute duodenal ulcer with perforation |
| K26.2 | Acute duodenal ulcer with both hemorrhage and perforation |
| K26.3 | Acute duodenal ulcer without hemorrhage or perforation |
| K26.4 | Chronic or unspecified duodenal ulcer with hemorrhage |
| K26.5 | Chronic or unspecified duodenal ulcer with perforation |
| K26.6 | Chronic or unspecified duodenal ulcer with both hemorrhage and perforation |
| K26.7 | Chronic duodenal ulcer without hemorrhage or perforation |
| K26.9 | Duodenal ulcer, unspecified as acute or chronic, without hemorrhage or perforation |
| Multiple endocrine neoplasia | |
| E31.2 | Multiple endocrine neoplasia [MEn] syndromes |
| E31.20 | Multiple endocrine neoplasia [MEn] syndrome, unspecified |
| E31.21 | Multiple endocrine neoplasia [MEn] type I |
| E31.22 | Multiple endocrine neoplasia [MEn] type IIA |
| E31.23 | Multiple endocrine neoplasia [MEn] type IIB |
| Pathological gastric acid hypersecretory condition | |
| K31.89 | Other diseases of stomach and duodenum |
| Reflux esophagitis | |
| K21.0 | Gastro-esophageal reflux disease with esophagitis |
| K21.00 | Gastro-esophageal reflux disease with esophagitis, without bleeding |
| K21.01 | Gastro-esophageal reflux disease with esophagitis, with bleeding |
| Zollinger-ellison syndrome | |
| E16.4 | Increased secretion of gastrin |
Formulary Reference Tool