Famotidine 10 mg/mL Injection
Other active recalls for Famotidine (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Histamine-2 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Famotidine injection is used in people who are hospitalized to treat certain conditions in which the stomach produces too much acid or to treat ulcers (sores in the lining of the stomach or intestine) that were not successfully treated with other medications. Famotidine injection is also used on a short-term basis in people who cannot take oral medication to treat ulcers, to prevent ulcers from returning after they have healed, to treat gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube betwe...
Read the full MedlinePlus article ↗- Great question. Antacids (like Tums) neutralize acid that's already in your stomach — they work fast but don't last long. Famotidine is different: it actually blocks a signal in yo...
- What exactly does famotidine do — and how is it different from antacids?
- The over-the-counter tablets are meant to relieve heartburn when it happens, or to prevent it if you take them 10 to 60 minutes before a meal that usually causes trouble. You shoul...
- Can I take the OTC version whenever I have heartburn, or is there a limit?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Famotidine — tap one for details:
Famotidine may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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4 mg / 1 mL
UNII 30KYC7MIAI
Aspartic acid is an amino acid used in pharmaceutical formulations as a pH buffer and to help stabilize active ingredients. It works to maintain the proper acidity level in the medicine.
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9 mg / 1 mL
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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20 mg / 1 mL
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $39.61 | $396.10 / 10 vials |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1308 | $0.008 / J1308 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Famotidine 10 mg/mL 63323-0739-16 | Fresenius | 25 vials | $0.327 | AP | Availability likely | — |
| Famotidine 10 mg/mL 70860-0751-02 | Athenex | 25 vials | $0.327 | AP | Discontinued | — |
| Famotidine 10 mg/mL 25021-0753-02 | Sagent | 25 vials | $0.327 | AP | Availability likely | — |
| Famotidine 10 mg/mL 67457-0433-22 | Mylan | 25 vials | $0.327 | AP | Availability likely | — |
| Famotidine 10 mg/mL 00641-6022-25 | Hikma | 25 vials | $0.327 | AP | Availability likely | — |
| Famotidine 10 mg/mL 00641-6021-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Famotidine 10 mg/mLthis 00641-6023-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Famotidine 10 mg/mL 25021-0754-04 | Sagent | 10 vials | — | AP | FDA listed | — |
| Famotidine 10 mg/mL 63323-0738-09 | Fresenius | 10 vials | — | AP | FDA listed | — |
| Famotidine 10 mg/mL 67457-0448-43 | Mylan | 10 vials | — | AP | FDA listed | — |
| Famotidine 10 mg/mL 67457-0457-20 | Mylan | 10 vials | — | AP | FDA listed | — |
| Famotidine 10 mg/mL 51662-1375-01 | HF | 2 ml | — | AP | FDA listed | — |
| Famotidine 10 mg/mL 71872-7220-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Famotidine 10 mg/mL 71872-7235-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Famotidine 10 mg/mL 71872-7366-01 | Medical | 1 vial | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00641-6023-25 | 25 VIAL in 1 CARTON (0641-6023-25) / 4 mL in 1 VIAL (0641-6023-01) | 2001-04-16 | Active |
| 00641-6023-10 You're viewing this | 10 VIAL in 1 CARTON (0641-6023-10) / 4 mL in 1 VIAL (0641-6023-01) | 2001-04-16 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 90% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00641-6023-10?
What NDC number is used to bill for this package of Famotidine 10 mg/mL Injection?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
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Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Famotidine Injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions: Short term treatment of active duodenal ulcer . Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks.
Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer . Controlled studies in adults have not extended beyond one year.
Short term treatment of active benign gastric ulcer . Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
Short term treatment of gastroesophageal reflux disease (GERD) . Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ). Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ).
Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.
Dosage for Pediatric Patients < 1 Year of Age Gastroesophageal Reflux Disease (GERD) See PRECAUTIONS, Pediatric Patients < 1 Year of Age . The studies described in PRECAUTIONS, Pediatric Patients < 1 Year of Age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) – 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age.
Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied. Dosage for Pediatric Patients 1 to 16 Years of Age See PRECAUTIONS, Pediatric Patients 1 to 16 Years of Age .
The studies described in PRECAUTIONS, Pediatric Patients 1 to 16 Years of Age suggest that the starting dose in pediatric patients 1 to 16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy.
Published uncontrolled studies in pediatric patients 1 to 16 years of age have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients.
Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of Famotidine Injection may be reduced to half the dose, or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response. Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated.
In some patients, a higher starting dose may be required. Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome. To prepare intravenous solutions, aseptically dilute 2 mL of Famotidine Injection (solution containing 10 mg/mL) with Sodium Chloride Injection 0.9% or other compatible intravenous solution (see Stability ) to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.
To prepare in…
⛔ Contraindications ▾
CONTRAINDICATIONS Hypersensitivity to any component of these products. Cross sensitivity in this class of compounds has been observed. Therefore, Famotidine Injection should not be administered to patients with a history of hypersensitivity to other H 2 -receptor antagonists.
⚠️ Warnings ▾
WARNINGS Famotidine Injection 4 mL and 20 mL multiple dose vials contain the preservative benzyl alcohol. There have been reports of fatal ‘gasping syndrome’ in neonates (children less than one month of age) following the administration of intravenous solutions containing the preservative benzyl alcohol. Symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse.
Benzyl alcohol, given its small size, presumably crosses the placental barrier into immature fetal tissues as readily as it crosses the blood-brain barrier. Therefore, Famotidine Injection from multiple dose vials containing benzyl alcohol should not be used in neonates and pregnant women.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The adverse reactions listed below have been reported during domestic and international clinical trials in approximately 2500 patients. In those controlled clinical trials in which famotidine tablets were compared to placebo, the incidence of adverse experiences in the group which received famotidine tablets, 40 mg at bedtime, was similar to that in the placebo group. The following adverse reactions have been reported to occur in more than 1% of patients on therapy with famotidine in controlled clinical trials, and may be causally related to the drug: headache (4.7%), dizziness (1.3%), constipation (1.2%) and diarrhea (1.7%).
The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed. The relationship to therapy with famotidine has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity.
Body as a Whole: fever, asthenia, fatigue Cardiovascular: arrhythmia, AV block, palpitation, prolonged QT interval Gastrointestinal: cholestatic jaundice, hepatitis, elevated liver enzyme, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic: agranulocytosis, pancytopenia, leukopenia, thrombocytopenia Hypersensitivity: anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival injection, bronchospasm Musculoskeletal: rhabdomyolysis, musculoskeletal pain, muscle cramps, arthralgia Nervous System/Psychiatric: seizure, hallucinations, confusion, agitation, depression, anxiety, decreased libido, paresthesia, insomnia, somnolence Respiratory: interstitial pneumonia Skin: toxic epidermal necrolysis/Stevens Johnson syndrome, pruritus, dry skin, flushing Special Senses: tinnitus, taste disorder Other: impotence The adverse reactions reported for Famotidine Tablets may also occur with Famotidine for Oral Suspension or Famotidine Injection.
In addition, transient irritation at the injection site has been observed with Famotidine Injection. Pediatric Patients In a clinical study in 35 pediatric patients < 1 year of age with GERD symptoms [e.g. vomiting (spitting up), irritability (fussing)], agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued.
🔄 Drug Interactions ▾
Drug Interactions No drug interactions have been identified. Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine.
Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.
🤰 Pregnancy ▾
Pregnancy Reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at IV doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine. While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (250 times the usual human dose) or higher.
There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Patients < 1 Year of Age Use of famotidine in pediatric patients < 1 year of age is supported by evidence from adequate and well-controlled studies of famotidine in adults, and by the following studies in pediatric patients < 1 year of age. Two pharmacokinetic studies in pediatric patients < 1 year of age (N=48) demonstrated that clearance of famotidine in patients > 3 months to 1 year of age is similar to that seen in older pediatric patients (1 to 15 years of age) and adults. In contrast, pediatric patients 0 to 3 months of age had famotidine clearance values that were 2- to 4-fold less than those in older pediatric patients and adults.
These studies also show that the mean bioavailability in pediatric patients < 1 year of age after oral dosing is similar to older pediatric patients and adults. Pharmacodynamic data in pediatric patients 0 to 3 months of age suggest that the duration of acid suppression is longer compared with older pediatric patients, consistent with the longer famotidine half-life in pediatric patients 0 to 3 months of age. (See CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS, Pharmacokinetics and Pharmacodynamics .) In a double-blinded, randomized, treatment-withdrawal study, 35 pediatric patients < 1 year of age who were diagnosed as having gastroesophageal reflux disease were treated for up to 4 weeks with famotidine oral suspension (0.5 mg/kg/dose or 1 mg/kg/dose).
Although an intravenous famotidine formulation was available, no patients were treated with intravenous famotidine in this study. Also, caregivers were instructed to provide conservative treatment including thickened feedings. Enrolled patients were diagnosed primarily by history of vomiting (spitting up) and irritability (fussiness).
The famotidine dosing regimen was once daily for patients < 3 months of age and twice daily for patients ≥ 3 months of age. After 4 weeks of treatment, patients were randomly withdrawn from the treatment and followed an additional 4 weeks for adverse events and symptomatology. Patients were evaluated for vomiting (spitting up), irritability (fussiness) and global assessments of improvement.
The study patients ranged in age at entry from 1.3 to 10.5 months (mean 5.6 ± 2.9 months), 57% were female, 91% were white and 6% were black. Most patients (27/35) continued into the treatment withdrawal phase of the study. Two patients discontinued famotidine due to adverse events.
Most patients improved during the initial treatment phase of the study. Results of the treatment withdrawal phase were difficult to interpret because of small numbers of patients. Of the 35 patients enrolled in the study, agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued; agitation was not observed in patients on placebo (see ADVERSE REACTIONS, Pediatric Patients ).
These studies suggest that a starting dose of 0.5 mg/kg/dose of famotidine oral suspension may be of benefit for the treatment of GERD for up to 4 weeks once daily in patients < 3 months of age and twice daily in patients 3 months to < 1 year of age; the safety and benefit of famotidine treatment beyond 4 weeks have not been established. Famotidine should be considered for the treatment of GERD only if conservative measures (e.g., thickened feedings) are used concurrently and if the potential benefit outweighs the risk.
Pediatric Patients 1 to 16 Years of Age Use of famotidine in pediatric patients 1 to 16 years of age is supported by evidence from adequate and well-controlled studies of famotidine in adults and by the following studies in pediatric patients: In published studies in small numbers of pediatric patients 1 to 15 years of age, clearance of famotidine was similar to that seen in adults. In pediatric patients 11 to 15 years of age, oral doses of 0.5 mg/kg were associated with a mean AUC similar to that seen in adults treated orally with 40 mg.
Similarly, in pediatric patients 1 to 15 years of age, intravenous doses o…
🧓 Geriatric Use ▾
Geriatric Use Of the 4,966 subjects in clinical studies who were treated with famotidine, 488 subjects (9.8%) were 65 and older, and 88 subjects (1.7%) were greater than 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, greater sensitivity of some older patients cannot be ruled out.
No dosage adjustment is required based on age (see CLINICAL PHARMACOLOGY IN ADULTS, Pharmacokinetics ). This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Dosage adjustment in the case of moderate or severe renal impairment is necessary (see PRECAUTIONS, Patients with Moderate or Severe Renal Insufficiency and DOSAGE AND ADMINISTRATION, Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency ).
🆘 Overdosage ▾
OVERDOSAGE The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see ADVERSE REACTIONS ). Oral doses of up to 640 mg/day have been given to adult patients with pathological hypersecretory conditions with no serious adverse effects. In the event of overdosage, treatment should be symptomatic and supportive.
Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed. The intravenous LD 50 of famotidine for mice and rats ranged from 254 to 563 mg/kg and the minimum lethal single IV dose in dogs was approximately 300 mg/kg. Signs of acute intoxication in IV treated dogs were emesis, restlessness, pallor of mucous membranes or redness of mouth and ears, hypotension, tachycardia and collapse.
The oral LD 50 of famotidine in male and female rats and mice was greater than 3000 mg/kg and the minimum lethal acute oral dose in dogs exceeded 2000 mg/kg. Famotidine did not produce overt effects at high oral doses in mice, rats, cats and dogs, but induced significant anorexia and growth depression in rabbits starting with 200 mg/kg/day orally.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY IN ADULTS GI Effects Famotidine is a competitive inhibitor of histamine H 2 -receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.
In normal volunteers and hypersecretors, famotidine inhibited basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration, the onset of the antisecretory effect occurred within one hour; the maximum effect was dose-dependent, occurring within one to three hours. Duration of inhibition of secretion by doses of 20 mg and 40 mg was 10 to 12 hours.
After intravenous administration, the maximum effect was achieved within 30 minutes. Single intravenous doses of 10 mg and 20 mg inhibited nocturnal secretion for a period of 10 to 12 hours. The 20 mg dose was associated with the longest duration of action in most subjects.
Single evening oral doses of 20 mg and 40 mg inhibited basal and nocturnal acid secretion in all subjects; mean nocturnal gastric acid secretion was inhibited by 86% and 94%, respectively, for a period of at least 10 hours. The same doses given in the morning suppressed food-stimulated acid secretion in all subjects. The mean suppression was 76% and 84%, respectively, 3 to 5 hours after administration, and 25% and 30%, respectively, 8 to 10 hours after administration.
In some subjects who received the 20 mg dose, however, the antisecretory effect was dissipated within 6 to 8 hours. There was no cumulative effect with repeated doses. The nocturnal intragastric pH was raised by evening doses of 20 mg and 40 mg of famotidine to mean values of 5.0 and 6.4, respectively.
When famotidine was given after breakfast, the basal daytime interdigestive pH at 3 and 8 hours after 20 mg or 40 mg of famotidine was raised to about 5. Famotidine had little or no effect on fasting or postprandial serum gastrin levels. Gastric emptying and exocrine pancreatic function were not affected by famotidine.
Other Effects Systemic effects of famotidine in the central nervous system (CNS), cardiovascular, respiratory or endocrine systems were not noted in clinical pharmacology studies. Also, no antiandrogenic effects were noted. (See ADVERSE REACTIONS .) Serum hormone levels, including prolactin, cortisol, thyroxine (T 4 ) and testosterone, were not altered after treatment with famotidine.
Pharmacokinetics Orally administered famotidine is incompletely absorbed, and its bioavailability is 40 to 45%. Famotidine undergoes minimal first-pass metabolism. After oral doses, peak plasma levels occur in 1 to 3 hours.
Plasma levels after multiple doses are similar to those after single doses. Fifteen to 20% of famotidine in plasma is protein bound. Famotidine has an elimination half-life of 2.5 to 3.5 hours.
Famotidine is eliminated by renal (65 to 70%) and metabolic (30 to 35%) routes. Renal clearance is 250 to 450 mL/min, indicating some tubular excretion. Twenty-five to 30% of an oral dose and 65 to 70% of an intravenous dose are recovered in the urine as unchanged compound.
The only metabolite identified in man is the S-oxide. There is a close relationship between creatinine clearance values and the elimination half-life of famotidine. In patients with severe renal insufficiency, i.e., creatinine clearance less than 10 mL/min, the elimination half-life of famotidine may exceed 20 hours and adjustment of dose or dosing intervals in moderate and severe renal insufficiency may be necessary (see PRECAUTIONS , DOSAGE AND ADMINISTRATION ).
In elderly patients, there are no clinically significant age-related changes in the pharmacokinetics of famotidine. However, in elderly patients with decreased renal function, the clearance of the drug may be decreased (see PRECAUTIONS, Geriatric Use ). Clinical Studies The majority of clini…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED FOR INTRAVENOUS USE ONLY Famotidine Injection, USP 10 mg/mL is available in the following: Containing no preservative 2 mL (20 mg) Single Dose Vial packaged in 25s (NDC 0641-6022-25) Containing benzyl alcohol as preservative 4 mL (40 mg) Two Dose Vial packaged in 10s (NDC 0641-6023-10) 20 mL Multiple Dose Vial packaged in 10s (NDC 0641-6021-10) Storage Store Famotidine Injection at 2°C to 8°C (36°F to 46°F). If solution freezes, bring to room temperature; allow sufficient time to solubilize all the components.
Although diluted Famotidine Injection has been shown to be physically and chemically stable for 7 days at room temperature, there are no data on the maintenance of sterility after dilution. Therefore, it is recommended that if not used immediately after preparation, diluted solutions of Famotidine Injection should be refrigerated and used within 48 hours (see DOSAGE AND ADMINISTRATION ).
📦 Storage and Handling ▾
Storage Store Famotidine Injection at 2°C to 8°C (36°F to 46°F). If solution freezes, bring to room temperature; allow sufficient time to solubilize all the components. Although diluted Famotidine Injection has been shown to be physically and chemically stable for 7 days at room temperature, there are no data on the maintenance of sterility after dilution.
Therefore, it is recommended that if not used immediately after preparation, diluted solutions of Famotidine Injection should be refrigerated and used within 48 hours (see DOSAGE AND ADMINISTRATION ).
📋 Description ▾
DESCRIPTION The active ingredient in Famotidine Injection, USP is a histamine H 2 -receptor antagonist. Famotidine is [1-Amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propylidene] sulfamide. Its structural formula is: C 8 H 15 N 7 O 2 S 3 MW 337.45 Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.
Famotidine Injection is supplied as a sterile concentrated solution for intravenous injection. Each mL of the single dose solution contains 10 mg of famotidine and the following inactive ingredients: L-aspartic acid 4 mg, mannitol 20 mg and Water for Injection q.s. 1 mL.
The multiple dose vials of 4 mL and 20 mL also contain benzyl alcohol 0.9% added as preservative. Structural formula