Famotidine 40 mg Tablet, Film Coated, 500-count — NDC 68001-398-03 (Billing 68001-0398-03)
This is a package of 500 tablets of Famotidine 40 mg Tablet, Film Coated from BluePoint Laboratories, marketed since Jun 2019 and currently FDA-listed; retail pharmacies pay about $0.0483 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 68001-398-03 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68001 labeler · 398 product · 03 package
- Package marketed since
- Jun 19, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 500 EA per package
- Barcode (UPC)
- 0368001398008
- Medicaid fills, this package
- 97,385 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Famotidine (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 011678
- GCN: 46431
- GPI-14 (Medi-Span): 49200030000340
- HICL (First Databank): 004521
- AHFS class code: 04:92.00.00
- RxCUI (RxNorm): 284245
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Histamine-2 Receptor Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It reduces stomach acid. Over-the-counter versions relieve and prevent heartburn from acid indigestion and sour stomach. Prescription versions treat ulcers, GERD and erosive esopha...
- With the over-the-counter tablets, swallow one with water and do not chew it. To prevent heartburn, take it shortly before a food or drink that triggers it. Do not take more than 2...
- Headache, dizziness, constipation and diarrhea are the most common, and they are usually mild. Call your doctor if you have confusion, hallucinations, seizures, a rash with swellin...
- Not always. Famotidine can lower absorption of some drugs that need stomach acid and can raise tizanidine levels. Tell me or your doctor everything you take before you start.
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?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.048 | $24.15 / 500 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2501 | $125.05 / 500 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.0827 | $41.35 / 500 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68001-0398-00 68001-398-00 | 100 TABLET, FILM COATED in 1 BOTTLE | $0.0483 / ea | $4.83 | 2019-06-19 | — | Active |
| 68001-0398-03 You're viewing this Main listing | 500 TABLET, FILM COATED in 1 BOTTLE | $0.0483 / ea | $24.17 | 2019-06-19 | — | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0483 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 80% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 68001-0398-00?
What NDC number is used to bill for this package of Famotidine 40 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Famotidine 40 mg 00172-5729-60 | Teva | 100 tablets | $0.048 | AB | Availability likely | — |
| Famotidine 40 mg 31722-0018-01 | Camber | 100 tablets | $0.048 | AB | Availability likely | — |
| Famotidine 40 mg 50268-0304-15 | AvPAK | 50 tablets | $0.048 | AB | Availability likely | — |
| Famotidine 40 mg 61442-0122-01 | Carlsbad | 2400 tablets | $0.048 | AB | Availability likely | — |
| famotidine 40 mg 62135-0808-90 | Chartwell | 90 tablets | $0.048 | AB | Availability likely | — |
| Famotidine 40 mg 64980-0624-01 | Rising | 100 tablets | $0.048 | AB | Availability likely | — |
| Famotidine 40 mg 65862-0860-01 | Aurobindo | 100 tablets | $0.048 | — | Availability likely | — |
| Famotidine 40 mg 67877-0843-01 | Ascend | 100 tablets | $0.048 | AB | Discontinued | — |
| Famotidine 40 mg 67877-0889-01 | Ascend | 100 tablets | $0.048 | AB | Availability likely | — |
| Famotidine 40 mgthis 68001-0398-03 | BluePoint | 500 tablets | $0.048 | AB | Availability likely | — |
| Famotidine 40 mg 69367-0401-10 | Westminster | 1000 tablets | $0.048 | AB | Availability likely | — |
| Famotidine 40 mg 70710-1684-00 | Zydus | 1000 tablets | $0.048 | AB | Availability likely | — |
| Famotidine 40 mg 70756-0052-11 | Lifestar | 100 tablets | $0.048 | AB | Availability likely | — |
| Famotidine 40 mg 72205-0146-05 | Novadoz | 500 tablets | $0.048 | AB | Availability likely | — |
| Pepcid 40 mg 00187-4440-10 | Bausch | 100 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 00615-8559-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 10267-5690-01 | Contract | 100 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 43063-0533-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 43063-0696-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 46708-0294-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 50090-1432-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 50090-6790-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 50090-6916-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 50090-7196-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 50090-7966-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 50090-7981-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 50090-7982-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 51407-0684-01 | Golden | 3600 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 51655-0102-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 55111-0120-01 | Dr.Reddy's | 100 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 60760-0736-60 | St. | 60 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 60760-0843-07 | ST. | 7 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 60760-0937-07 | ST. | 7 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 62332-0002-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 63187-0908-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 63629-2014-01 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 63629-2015-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 63629-2782-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 68071-3413-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 68071-3521-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 68071-3584-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 68071-4197-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 68788-8518-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 68788-8733-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 70518-4084-01 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 70518-4394-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 70771-1703-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 71205-0257-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 71205-0634-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 71205-0781-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 71335-0231-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 71335-2442-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 71335-2527-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 71335-9615-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 71335-9724-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 72162-1737-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 72189-0207-30 | direct | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 72789-0345-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 72789-0427-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 72789-0453-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 72865-0215-01 | XLCare | 100 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 76420-0713-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 82804-0228-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 82804-0981-00 | Proficient | 100 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 85766-0222-01 | Sportpharm | 100 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 85534-0092-00 | HAWAII | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 68788-4144-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 72789-0589-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 67296-2330-02 | Redpharm | 20 tablets | — | AB | FDA listed | — |
| Famotidine 40 mg 53401-0036-53 | Aphena | 60 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from BluePoint Laboratories labeler code 68001
- Triamterene and Hydrochlorothiazide 75 mg; 50 mg Tablet NDC 68001-388-00
- Mitomycin 5 mg/10mL Injection, Powder, Lyophilized, For Solution NDC 68001-389-36
- Mitomycin 20 mg/40mL Injection, Powder, Lyophilized, For Solution NDC 68001-390-77
- Mitomycin 40 mg/80mL Injection, Powder, Lyophilized, For Solution NDC 68001-391-79
- Potassium Chloride 750 mg Capsule, Extended Release NDC 68001-396-00
- Famotidine 20 mg Tablet, Film Coated NDC 68001-397-00
- Fluoxetine 10 mg Capsule NDC 68001-399-00
- Fluoxetine 20 mg Capsule NDC 68001-400-00
- Fluoxetine 40 mg Capsule NDC 68001-401-00
- Levetiracetam 250 mg Tablet, Film Coated NDC 68001-402-03
- Levetiracetam 500 mg Tablet, Film Coated NDC 68001-403-03
- Levetiracetam 750 mg Tablet, Film Coated NDC 68001-404-03
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence.
Famotidine is a histamine-2 (H 2 ) receptor antagonist indicated (1) : In adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer. symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. In adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of DU recurrence.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Indication Recommended Dosage (2.1) Adult and Pediatric Patients 40 kg and greater Active DU 40 mg once daily; or 20 mg twice daily Active Gastric Ulcer 40 mg once daily GERD 20 mg twice daily Erosive Esophagitis 20 mg twice daily; or 40 mg twice daily Adults Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Recurrence 20 mg once daily See full prescribing information for complete dosing information, including dosing in renal impairment, and recommended treatment duration.
( 2.1 , 2.2 ) Administration (2.3) : Take once daily before bedtime or twice daily in the morning and before bedtime with or without food.
2.1Recommended Dosage Table 1 shows the recommended dosage of famotidine 20 mg and 40 mg tablets in adult and pediatric patients weighing 40 kg and greater with normal renal function. The use of famotidine 20 mg and 40 mg tablets is not recommended in pediatric patients weighing less than 40 kg because the lowest available strength (20 mg) exceeds the recommended dose for these patients . Use another famotidine formulation for pediatric patients weighing less than 40 kg.
Table 1: Recommended Dosage and Duration of Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Normal Renal Function Indication Recommended Dosage Recommended Duration Active duodenal ulcer (DU) 40 mg once daily; or 20 mg twice daily a Up to 8 weeks b,c Active gastric ulcer 40 mg once daily Up to 8 weeks c Symptomatic nonerosive GERD 20 mg twice daily Up to 6 weeks c Erosive esophagitis diagnosed by endoscopy 20 mg twice daily; or 40 mg twice daily a Up to 12 weeks Pathological hypersecretory conditions d Starting dosage: 20 mg every 6 hours; adjust dosage to individual patient needs Maximum dosage 160 mg every 6 hours As clinically indicated Reduction of the risk of DU recurrence d 20 mg once daily 1 year c or as clinically indicated a Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies (14) ] . b In clinical trials, the majority of patients healed within 4 weeks.
For patients who do not heal after 4 weeks, consider an additional 2 to 4 weeks of treatment [see Clinical Studies (14.1) ]. c Longer treatment durations have not been studied in clinical trials [see Clinical Studies (14.1 , 14.2 , 14.3) ] . d In pediatric patients, the safety and effectiveness of famotidine tablets have not been established for the reduction of the risk of duodenal ulcer recurrence or for treatment of pathological hypersecretory conditions [see Use in Specific Populations (8.4) ] .
2.2Dosage in Renal Impairment Dosage adjustments of famotidine tablets are recommended for patients with moderate to severe renal impairment (creatinine clearance less than 60 mL/min) [see Use in Specific Populations (8.6) ] . Table 2 shows the recommended maximum dosage of famotidine 20 mg or 40 mg tablets for patients with renal impairment, by indication. Use the lowest effective dose.
Some dosage adjustments may require switching to other formulations of famotidine (e.g., oral suspension, lower dose tablet). Table 2: Recommended Maximum Dosage of Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Moderate and Severe Renal Impairment a An alternate dosage regimen is 10 mg once daily. Since 20 mg or 40 mg tablet strength cannot be used for this dosage regimen, use an alternate famotidine formulation. b Dosage adjustments for renal impairment are provided for both dosing regimens (20 mg twice daily and 40 mg twice daily) which showed effectiveness for the treatment of erosive esophagitis in clinical trials [see Clinical Studies (14.4) ] . c In pediatric patients, the safety and effectiveness of famotidine tablets have not been established for the reduction of the risk of duodenal ulcer recurrence or for treatment of pathological hypersecretory conditions [see Use in Specific Populations (8.4) ] . d Doses required… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Famotidine Tablets USP, 20 mg are yellow, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘60’ on the other side. Famotidine Tablets USP, 40 mg are white, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘61’ on the other side. Tablets: 20 mg, 40 mg (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists. History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 receptor antagonists. (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Central Nervous System (CNS) Adverse Reactions : Elderly patients and patients with renal impairment at increased risk; reduce the dosage. ( 2.2 , 5.1 , 8.5 , 8.6 ) GI Malignancy : Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy. ( 5.2 )
5.1Central Nervous System Adverse Reactions Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been reported in elderly patients and patients with moderate and severe renal impairment treated with famotidine. Since famotidine blood levels are higher in patients with renal impairment than in patients with normal renal function, dosage adjustments are recommended in patients with renal impairment [see Dosage and Administration (2.2) , Clinical Pharmacology (12.3) ].
5.2Concurrent Gastric Malignancy In adults, symptomatic response to therapy with famotidine does not preclude the presence of gastric malignancy. Consider evaluation for gastric malignancy in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with famotidine.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Famotidine was studied in 7 U.S. and international placebo- and active-controlled trials in approximately 2500 patients [see Clinical Studies (14)] . A total of 1442 patients were treated with famotidine, including 302 treated with 40 mg twice daily, 456 treated with 20 mg twice daily, 461 treated with 40 mg once daily, and 396 treated with 20 mg once daily.
The population was 17 to 91 years old, fairly well distributed between gender and race; however, the predominant race treated was Caucasian. The following adverse reactions occurred in greater than or equal to 1% of famotidine-treated patients: headache, dizziness and constipation. The following other adverse reactions were reported in less than 1% of patients in clinical trials: Body as a Whole: fever, asthenia, fatigue Cardiovascular: palpitations Gastrointestinal: elevated liver enzymes, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic: thrombocytopenia Hypersensitivity: orbital edema, rash, conjunctival injection, bronchospasm Musculoskeletal: musculoskeletal pain, arthralgia Nervous System/Psychiatric: seizure, hallucinations, depression, anxiety, decreased libido, insomnia, somnolence Skin: pruritus, dry skin, flushing Special Senses: tinnitus, taste disorder Other: impotence
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, AV block, prolonged QT interval Gastrointestinal: cholestatic jaundice, hepatitis Hematologic: agranulocytosis, pancytopenia, leukopenia Hypersensitivity: anaphylaxis, angioedema, facial edema, urticaria Musculoskeletal: rhabdomyolysis, muscle cramps Nervous System/Psychiatric: confusion, agitation, paresthesia Respiratory: interstitial pneumonia Skin: toxic epidermal necrolysis/Stevens-Johnson syndrome
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Drugs Dependent on Gastric pH for Absorption : Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy. See full prescribing information for a list of interacting drugs. (7.1) Tizanidine (CYP1A2) Substrate: Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive drowsiness; avoid concomitant use, if possible. (7.2)
7.1Drugs Dependent on Gastric pH for Absorption Famotidine can reduce the absorption of other drugs, due to its effect on reducing intragastric acidity, leading to loss of efficacy of the concomitant drug. Concomitant administration of famotidine with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir is not recommended. See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine.
7.2Tizanidine (CYP1A2 Substrate) Although not studied clinically, famotidine is considered a weak CYP1A2 inhibitor and may lead to substantial increases in blood concentrations of tizanidine, a CYP1A2 substrate. Avoid concomitant use with famotidine. If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness. Refer to the full prescribing information for tizanidine.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Geriatric Use: Use the lowest effective dose for an elderly patient and monitor renal function. ( 2.2 , 5.1 , 8.5 ) Renal Impairment: Risk of CNS adverse reactions and QT prolongation in patients with moderate and severe renal impairment; reduce the dosage. (2.2 , 8.6 )
8.1Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see Data) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data 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 intravenous 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 (about 49 times the recommended human dose of 80 mg per day, based on body surface area) 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.
8.2Lactation Risk Summary There are limited data available on the presence of famotidine in human breast milk. There were no effects on the breastfed infant. There are no data on famotidine effects on milk production.
Famotidine is present in the milk of lactating rats (see Data) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for famotidine and any potential adverse effects on the breastfed child from PEPCID or from the underlying maternal condition. Data Animal Data Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of famotidine at least 600 times the usual human dose.
8.4Pediatric Use The safety and effectiveness of famotidine have been established in pediatric patients for the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and GERD (i.e., symptomatic nonerosive GERD, erosive esophagitis as diagnosed by endoscopy). The use of famotidine and the recommended dosage of famotidine in these pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine in adults and published pharmacokinetic and pharmacodynamic data in pediatric patients [see Dosage and Administration (2.1) , Clinical Pharmacology (12.2, 12.3) ] .
In pediatric patients, the safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established. Famotidine 20 and 40 mg tablets are not recommended for use in pediatric patients weighing less than 40 kg because these tablet strengths exceed the recommended dose for these patients [see Dosage and Administration (2.1) ] . For pediatric patients weighing less than 40 kg, consider another famotidine formulation (e.g., oral suspension, lower dose tablet).
8.5Geriatric Use Of the 1442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see Data) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data 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 intravenous 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 (about 49 times the recommended human dose of 80 mg per day, based on body surface area) 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 ▾
8.4Pediatric Use The safety and effectiveness of famotidine have been established in pediatric patients for the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and GERD (i.e., symptomatic nonerosive GERD, erosive esophagitis as diagnosed by endoscopy). The use of famotidine and the recommended dosage of famotidine in these pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine in adults and published pharmacokinetic and pharmacodynamic data in pediatric patients [see Dosage and Administration (2.1) , Clinical Pharmacology (12.2, 12.3) ] .
In pediatric patients, the safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established. Famotidine 20 and 40 mg tablets are not recommended for use in pediatric patients weighing less than 40 kg because these tablet strengths exceed the recommended dose for these patients [see Dosage and Administration (2.1) ] . For pediatric patients weighing less than 40 kg, consider another famotidine formulation (e.g., oral suspension, lower dose tablet).
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older. In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients. In postmarketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine [see Warnings and Precautions (5.1) ] .
Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine may be greater in elderly patients, particularly those with impaired renal function [see Use in Specific Populations (8.6) ] . In general, use the lowest effective dose of famotidine for an elderly patient and monitor renal function [see Dosage and Administration (2.2) ].
🆘 Overdosage ▾
10 OVERDOSAGE The types of adverse reactions in overdosage of famotidine are similar to the adverse reactions encountered with use of recommended dosages [see Adverse Reactions (6.1) ] . 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.
Due to low binding to plasma proteins, famotidine is eliminated by hemodialysis. There is limited experience on the usefulness of hemodialysis as a treatment for famotidine overdosage.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Famotidine is a competitive inhibitor of histamine-2 (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.
12.2Pharmacodynamics Adults Famotidine inhibited both basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration of famotidine, 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.
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.
In clinical pharmacology studies, systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocrine systems were not noted. Also, no anti-androgenic effects were noted. Serum hormone levels, including prolactin, cortisol, thyroxine (T 4 ), and testosterone, were not altered after treatment with famotidine.
Pediatric Patients Pharmacodynamics of famotidine, assessed by gastric pH, were evaluated in 5 pediatric patients 2 to 13 years of age using the sigmoid E max model. These data suggest that the relationship between serum concentration of famotidine and gastric acid suppression is similar to that observed in adults (see Table 3). Table 3: Serum Concentrations of Famotidine Associated with Gastric Acid Reduction in Famotidine-Treated Pediatric and Adult Patients a EC 50 (ng/mL) a Pediatric Patients 26 ± 13 Adults Healthy adult subjects 26.5 ±
10.3Adult patients with upper GI bleeding 18.7 ± 10.8 a Using the Sigmoid E max model, serum concentrations of famotidine associated with 50% maximum gastric acid reduction are presented as means ± SD. In a study examining the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients, four pediatric patients ages 11 to 15 years of age using the oral formulation at a dose of 0.5 mg/kg, maintained a gastric pH above 5 for 13.5 ± 1.8 hours.
12.3Pharmacokinetics Absorption Famotidine is incompletely absorbed. The bioavailability of oral doses is 40 to 45%. Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence.
Peak famotidine plasma levels occur in 1 to 3 hours. Plasma levels after multiple dosages are similar to those after single doses. Distribution Fifteen to 20% of famotidine in plasma is protein bound.
Elimination Metabolism Famotidine undergoes minimal first-pass metabolism. Twenty-five to 30% of an oral dose was recovered in the urine as unchanged compound. The only metabolite identified in humans is the S-oxide.
Excretion Famotidine has an elimination half-life of 2.5 to 3.5 hours. Fam… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Famotidine is a competitive inhibitor of histamine-2 (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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Famotidine Tablets USP, 20 mg are yellow, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘60’ on the other side. Bottles of 100 NDC 68001-397-00 Bottles of 1,000 NDC 68001-397-08 Famotidine Tablets USP, 40 mg are white, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘61’ on the other side. Bottles of 100 NDC 68001-398-00 Bottles of 500 NDC 68001-398-03 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a USP tight, light-resistant container.
📋 Description ▾
11 DESCRIPTION The active ingredient in famotidine tablets USP is a histamine-2 (H 2 ) receptor antagonist. Famotidine is N ′‑(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propanimidamide. The molecular formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.43.
Its structural formula is: Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine USP and the following inactive ingredients: carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, and titanium dioxide. In addition the 20 mg tablets contain red iron oxide, and yellow iron oxide. Famotidine USP is a white to pale yellowish white crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. str1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Central Nervous System (CNS) Adverse Reactions Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy [see Warnings and Precautions (5.1) ] . Report symptoms immediately to a healthcare provider. QT Prolongation Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [see Use in Specific Populations (8.6) ] .
Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider. Administration Advise patients: Take famotidine tablets once daily before bedtime or twice daily in the morning and before bedtime, as recommended. Famotidine tablets may be taken with or without food.
Famotidine tablets may be given with antacids. Manufactured by: APL Health Care Limited, Unit-1 SEZ, Mahabubnagar (Dt) – 509302, India For BluePoint Laboratories M.L. No.: 16/MN/TS/2014/F/G Issued: 02/2021
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Famotidine is incompletely absorbed. The bioavailability of oral doses is 40 to 45%. Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence.
Peak famotidine plasma levels occur in 1 to 3 hours. Plasma levels after multiple dosages are similar to those after single doses. Distribution Fifteen to 20% of famotidine in plasma is protein bound.
Elimination Metabolism Famotidine undergoes minimal first-pass metabolism. Twenty-five to 30% of an oral dose was recovered in the urine as unchanged compound. The only metabolite identified in humans is the S-oxide.
Excretion 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/minute, indicating some tubular excretion.
Specific Populations Pediatric Patients Bioavailability studies of 8 pediatric patients (11 to 15 years of age) showed a mean oral bioavailability of 0.5 compared to adult values of 0.42 to 0.49. Oral doses of 0.5 mg per kg achieved AUCs of 580 ± 60 ng•hr/mL in pediatric patients 11 to 15 years of age, compared to 482 ± 181 ng•hr/mL in adults treated with 40 mg orally. Patients with Renal Impairment In adult patients with severe renal impairment (creatinine clearance less than 30 mL/minute), the systemic exposure (AUC) of famotidine increased at least 5-fold.
In patients with moderate renal impairment (creatinine clearance between 30 to 60 mL/minute), the AUC of famotidine increased at least 2-fold [see Dosage and Administration (2.2) , Use in Specific Population (8.6) ] . Drug Interaction Studies Human Organic Anion Transporter (OAT) 1 and 3: In vitro studies indicate that famotidine is a substrate for OAT1 and OAT3. Following coadministration of probenecid (1500 mg), an inhibitor of OAT1 and OAT3, with a single oral 20 mg dose of famotidine in 8 healthy subjects, the serum AUC 0-10h of famotidine increased from 424 to 768 ng●hr/mL and the maximum serum concentration (C max ) increased from 73 to 113 ng/mL.
Renal clearance, urinary excretion rate and amount of famotidine excreted unchanged in urine were decreased. The clinical relevance of this interaction is unknown. Multidrug and Toxin Extrusion Protein 1 (MATE-1): An in vitro study showed that famotidine is an inhibitor of MATE-1.
However, no clinically significant interaction with metformin, a substrate for MATE-1, was observed. CYP1A2: Famotidine is a weak CYP1A2 inhibitor.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Adults Famotidine inhibited both basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration of famotidine, 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.
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.
In clinical pharmacology studies, systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocrine systems were not noted. Also, no anti-androgenic effects were noted. Serum hormone levels, including prolactin, cortisol, thyroxine (T 4 ), and testosterone, were not altered after treatment with famotidine.
Pediatric Patients Pharmacodynamics of famotidine, assessed by gastric pH, were evaluated in 5 pediatric patients 2 to 13 years of age using the sigmoid E max model. These data suggest that the relationship between serum concentration of famotidine and gastric acid suppression is similar to that observed in adults (see Table 3). Table 3: Serum Concentrations of Famotidine Associated with Gastric Acid Reduction in Famotidine-Treated Pediatric and Adult Patients a EC 50 (ng/mL) a Pediatric Patients 26 ± 13 Adults Healthy adult subjects 26.5 ±
10.3Adult patients with upper GI bleeding 18.7 ± 10.8 a Using the Sigmoid E max model, serum concentrations of famotidine associated with 50% maximum gastric acid reduction are presented as means ± SD. In a study examining the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients, four pediatric patients ages 11 to 15 years of age using the oral formulation at a dose of 0.5 mg/kg, maintained a gastric pH above 5 for 13.5 ± 1.8 hours.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Active Duodenal Ulcer In a U.S. multicenter, double-blind trial in adult outpatients with endoscopically confirmed duodenal ulcer (DU), orally administered famotidine was compared to placebo. As shown in Table 4, 70% of patients treated with famotidine 40 mg at bedtime were healed by Week 4. Most patients’ DU healed within 4 weeks.
Patients not healed by Week 4 were continued in the trial. By Week 8, 83% of patients treated with famotidine had healed DU, compared to 45% of patients treated with placebo. The incidence of DU healing with famotidine was greater than with placebo at each time point based on proportion of endoscopically confirmed healed DUs.
Trials have not assessed the safety of famotidine in uncomplicated active DU for periods of more than 8 weeks. Table 4: Patients with Endoscopically Confirmed Healed Duodenal Ulcers a p<0.001 vs. placebo Famotidine 40 mg at bedtime (N=89) Famotidine 20 mg twice daily (N=84) Placebo at bedtime (N=97) Week 2 32% a 38% a 17% Week 4 70% a 67% a 31% In this study, time to relief of daytime and nocturnal pain was shorter for patients receiving famotidine than for patients receiving placebo; patients receiving famotidine also took less antacid than patients receiving placebo.
14.2Active Gastric Ulcer In both a U.S. and an international multicenter, double-blind trials in patients with endoscopically confirmed active gastric ulcer (GU), orally administered famotidine 40 mg at bedtime was compared to placebo. Antacids were permitted during the trials, but consumption was not significantly different between the famotidine and placebo groups. As shown in Table 5, the incidence of GU healing confirmed by endoscopy (dropouts counted as unhealed) with famotidine was greater than placebo at Weeks 6 and 8 in the U.S. trial, and at Weeks 4, 6 and 8 in the international trial.
In these trials, most famotidine-treated patients healed within 6 weeks. Trials have not assessed the safety of famotidine in uncomplicated active GU for periods of more than 8 weeks. Table 5: Patients with Endoscopically Confirmed Healed Gastric Ulcers a p≤0.01 vs. placebo b p≤0.05 vs. placebo U.S.
Study (N=149) International Study (N=294) Famotidine 40 mg at bedtime (N=74) Placebo at bedtime (N=75) Famotidine 40 mg at bedtime (N=149) Placebo at bedtime (N=145) Week 4 45% 39% 47% a 31% Week 6 66% a 44% 65% a 46% Week 8 78% b 64% 80% a 54% Time to complete relief of daytime and nighttime pain was statistically significantly shorter for patients receiving famotidine than for patients receiving placebo; however, neither trial demonstrated a statistically significant difference in the proportion of patients whose pain was relieved by the end of the trial (Week 8).
14.3Symptomatic Gastroesophageal Reflux Disease (GERD) Orally administered famotidine was compared to placebo in a U.S. trial that enrolled patients with symptoms of GERD and without endoscopic evidence of esophageal erosion or ulceration. As shown in Table 6, patients treated with famotidine 20 mg twice daily had greater improvement in symptomatic GERD than patients treated with 40 mg at bedtime or placebo. Table 6: Patients with Improvement of Symptomatic GERD (N=376) a p≤0.01 vs. placebo Famotidine 20 mg twice daily (N=154) Famotidine 40 mg at bedtime (N=149) Placebo at bedtime (N=73) Week 6 82% a 69% 62%
14.4Erosive Esophagitis due to GERD Healing of endoscopically verified erosion and symptomatic improvement were studied in a U.S. and an international double-blind trials. Healing was defined as complete resolution of all erosions visible with endoscopy. The U.S. trial comparing orally administered famotidine 40 mg twice daily to placebo and orally administered famotidine 20 mg twice daily showed a significantly greater percentage of healing of erosive esophagitis for famotidine 40 mg twice daily at Weeks 6 and 12 (Table 7).
Table 7: Patients with Endoscopic Healing of Erosive Esophagitis - U.S. Study (N=318) a p≤0.01 vs. placebo b p≤… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenic potential of famotidine was assessed in a 106-week oral carcinogenicity study in rats and a 92-week oral carcinogenicity study in mice. In the 106-week study in rats and the 92-week study in mice at oral doses of up to 2000 mg/kg/day (approximately 243 and 122 times, respectively, based on body surface area, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis), there was no evidence of carcinogenic potential for famotidine.
Famotidine was negative in the microbial mutagen test (Ames test) using Salmonella typhimurium and Escherichia coli with or without rat liver enzyme activation at concentrations up to 10,000 mcg/plate. In in vivo studies in mice, with a micronucleus test and a chromosomal aberration test, no evidence of a mutagenic effect was observed. In studies with rats given oral doses of up to 2000 mg/kg/day (approximately 243 times, based on body surface area, the recommended human dose of 80 mg per day) fertility and reproductive performance were not affected.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenic potential of famotidine was assessed in a 106-week oral carcinogenicity study in rats and a 92-week oral carcinogenicity study in mice. In the 106-week study in rats and the 92-week study in mice at oral doses of up to 2000 mg/kg/day (approximately 243 and 122 times, respectively, based on body surface area, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis), there was no evidence of carcinogenic potential for famotidine.
Famotidine was negative in the microbial mutagen test (Ames test) using Salmonella typhimurium and Escherichia coli with or without rat liver enzyme activation at concentrations up to 10,000 mcg/plate. In in vivo studies in mice, with a micronucleus test and a chromosomal aberration test, no evidence of a mutagenic effect was observed. In studies with rats given oral doses of up to 2000 mg/kg/day (approximately 243 times, based on body surface area, the recommended human dose of 80 mg per day) fertility and reproductive performance were not affected.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (100 Tablets Bottle) NDC 68001-397-00 Rx only Famotidine Tablets USP 20 mg BluePoint Laboratories 100 Tablets label 20mg
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg (100 Tablets Bottle) NDC 68001-398-00 Rx only Famotidine Tablets USP 40 mg BluePoint Laboratories 100 Tablets label 40mg