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Drug overview for ACID REDUCER (famotidine):
Generic name: FAMOTIDINE (fa-MOE-ti-deen)
Drug class: Peptic Ulcer Agents
Therapeutic class: Gastrointestinal Therapy Agents
Famotidine is a histamine H2-receptor antagonist.
Famotidine is used orally for the treatment of active duodenal or gastric ulcer, gastroesophageal reflux disease, endoscopically diagnosed erosive esophagitis, and as maintenance therapy for duodenal ulcer. Oral famotidine also is used for the management of pathological GI hypersecretory conditions. IV famotidine is used in hospitalized individuals with pathological GI hypersecretory conditions or intractable ulcers, or when oral therapy is not feasible.
Generic name: FAMOTIDINE (fa-MOE-ti-deen)
Drug class: Peptic Ulcer Agents
Therapeutic class: Gastrointestinal Therapy Agents
Famotidine is a histamine H2-receptor antagonist.
Famotidine is used orally for the treatment of active duodenal or gastric ulcer, gastroesophageal reflux disease, endoscopically diagnosed erosive esophagitis, and as maintenance therapy for duodenal ulcer. Oral famotidine also is used for the management of pathological GI hypersecretory conditions. IV famotidine is used in hospitalized individuals with pathological GI hypersecretory conditions or intractable ulcers, or when oral therapy is not feasible.
DRUG IMAGES
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The following indications for ACID REDUCER (famotidine) have been approved by the FDA:
Indications:
Dyspepsia
Gastroesophageal reflux disease
Heartburn prevention
Heartburn
Professional Synonyms:
Brash prophylaxis
Brash
Functional dyspepsia
Gastro-esophageal reflux
GE reflux disease
Heartburn prophylaxis
Pyrosis prophylaxis
Pyrosis
Indications:
Dyspepsia
Gastroesophageal reflux disease
Heartburn prevention
Heartburn
Professional Synonyms:
Brash prophylaxis
Brash
Functional dyspepsia
Gastro-esophageal reflux
GE reflux disease
Heartburn prophylaxis
Pyrosis prophylaxis
Pyrosis
The following dosing information is available for ACID REDUCER (famotidine):
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.
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.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ACID REDUCER (famotidine):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ACID REDUCER (famotidine):
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 |
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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 |
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Kidney disease with likely reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for ACID REDUCER (famotidine):
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 25 severe adverse reactions.
More Frequent | Less Frequent |
---|---|
None. | None. |
Rare/Very Rare |
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Abnormal hepatic function tests Agranulocytosis Anaphylaxis Anemia Angioedema Atrioventricular block Bronchospastic pulmonary disease Cardiac arrhythmia Dyspnea Hepatitis Hypotension Increased alanine transaminase Increased aspartate transaminase Interstitial pneumonitis Leukopenia Obstructive hyperbilirubinemia Pancytopenia Psychiatric disorder Rhabdomyolysis Seizure disorder Skin rash Stevens-johnson syndrome Thrombocytopenic disorder Toxic epidermal necrolysis Urticaria |
There are 32 less severe adverse reactions.
More Frequent | Less Frequent |
---|---|
Constipation Diarrhea Dizziness Headache disorder |
None. |
Rare/Very Rare |
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Acne vulgaris Acute abdominal pain Acute cognitive impairment Agitation Allergic conjunctivitis Alopecia Anorexia Anticholinergic toxicity Arthralgia Cramps Delirium Drowsy Dry skin Dysgeusia Facial edema Fatigue Fever Flushing General weakness Hallucinations Insomnia Lethargy Nausea Paresthesia Pruritus of skin Tinnitus Vomiting Xerostomia |
The following precautions are available for ACID REDUCER (famotidine):
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.
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.
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.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Drug Name | Excretion Potential | Effect on Infant | Notes |
---|---|---|---|
Famotidine | Excreted.This drug is known to be excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Limited data suggest low amounts excreted, with no resulting effect on infant |
No enhanced Geriatric Use information available for this drug.
Precaution Exists
Geriatric management or monitoring precaution exists.
Precaution Exists
Geriatric management or monitoring precaution exists.
Drug Name | Narrative | REN | HEP | CARDIO | NEURO | PULM | ENDO |
---|---|---|---|---|---|---|---|
Famotidine | Neuro/Psych-Avoid in older adults with or at high risk of delirium because of inducing or worsening delirium. Avoid in elderly with dementia or cognitive impairment. Renal-Dose adjustment may be required for CrCL<50 mL/min. to minimize CNS effects (e.g., mental status changes). | Y | N | N | Y | N | N |
The following prioritized warning is available for ACID REDUCER (famotidine):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ACID REDUCER (famotidine)'s list of indications:
Dyspepsia | |
K30 | Functional dyspepsia |
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 |
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