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| Product NDC Code | 72189-207 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Famotidine |
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| Type | Generic | ||||||
| Pharm Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 284245 | ||||||
| Application Number | ANDA075805 | ||||||
| Labeler Name | direct rx | ||||||
| Packages |
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Overdosage of FAMOTIDINE
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6.1 Clinical 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 US 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 17-91 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 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to 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
FAMOTIDINE Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7.1 Drugs 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. 7.2 Tizanidine (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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H2 receptor antagonists.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.The active ingredient in Famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is: [Formula] Each Famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hypromellose, microcrystalline cellulose, magnesium stearate, modified corn starch, polydextrose, polyethylene glycol, talc, sodium starch glycolate, titanium dioxide and triacetin. 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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2.1 Recommended Dosage Table 1 shows the recommended dosage of Famotidine 20 mg and 40 mg tablets in adults and pediatric patients weighing 40 kg or greater with normal renal function. The use of Famotidine 20 mg and 40 mg tablets is not recommended for use 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 Adults and Pediatric Patients 40kg and Greater with Normal Renal Function Indication Recommended Dosage Recommended Duration Active duodenal ulcer (DU) 40mg once daily; or 20mg twice daily a Up to 8 weeks b,c Active gastric ulcer 40mg once daily Up to 8 weeks Symptomatic non-erosive GERD 20mg twice daily Up to 6 weeks c Erosive esophagitis diagnosed by endoscopy 20mg tiwce daily; or 40mg twice daily a Up to 12 weeks Pathological hypersecretory conditions d Starting dosage: 20mg every 6 hours; adjust dosage to individual patient needs Maximum dosage 160mg every 6 hours As clinically indicated Reduction of the risk of DU recurrence d 20mg once daily 1 year c or as clinidally indicated aBoth dosages demonstrated effectiveness in clinical trials [see Clinical Studies (14)]. bIn 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)]. cLonger treatment durations have not been studied in clinical trials [see Clinical Studies (14.1, 14.2, 14.3)]. dIn pediatric patients, the safety and effectiveness of Famotidine 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)]. 2.2 Dosage in Renal Impairment Dosage adjustments of Famotidine 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 Adults and Pediatric Patients 40 kg and Greater with Moderate and Severe Renal Impairment Indication Creatinine clearence 30 to 60mL/minute Creatinine clearence less than 30 mL/minute Active duodenal ulcer (DU) 20mg once daily; or 40mg every other day 20mg every other day a Active gastric ulcer 20mg once daily; or 40mg every other day 20mg every other day a Symptomatic non-erosive GERD 20mg once daily 20mg every other day a Erosive esophagitis diagnosed by endoscopy a 20mg once daily; or 40mg every other day b 20mg every other day a,b Pathological hypersecretory conditions a Avoid use d Reduction of the risk of DU recurrence c 20mg every other day a (see footnote) e 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 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 to treat pathological hypersecretory conditions may exceed the maximum doses evaluated in patients with impaired renal function. The risk for increased adverse reactions in renally-impaired patients treated with Famotidine for pathological hypersecretory conditions is unknown. eRecommended dosage regimen is 10 mg every other day. Since 20 mg or 40 mg tablet strength cannot be used for this dosage regimen, use an alternative famotidine formulation. 2.3 Administration Instructions • Take Famotidine once daily before bedtime or twice daily in the morning and before bedtime, as recommended. • Famotidine tablets may be taken with or without food [see Clinical Pharmacology (12.3)]. • Famotidine tablets may be given with antacids.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.• 20 mg tablets: A white, round, film-coated tablet engraved with CTI 121 on one side. • 40 mg tablets: A white, round, film-coated tablet engraved with CTI 122 on one side.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of: • active duodenal ulcer. • active gastric ulcer. • symptomatic non-erosive 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.
Spl product data elements
Usually a list of ingredients in a drug product.FAMOTIDINE FAMOTIDINE POLYDEXTROSE TALC TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE STARCH, CORN FAMOTIDINE FAMOTIDINE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO CTI;122
Nonclinical toxicology
Information about toxicology in non-human subjects.13.1 Carcinogenesis, 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
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.207
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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.
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14.1 Active 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 tablets 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 Famotidine Tablets 40mg at bedtime (N=89) Famotidine Tablets 20mg twice daily (N=84) Placebo at bedtime (N=97) Week 2 32% a 38% a 17% Week 4 70% 67% a 31% ap<0.001 vs. placebo 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. 14.2 Active 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 Famotidine 40mg at bedtime (N-74) Placebo at bedtime (N=75) Famotidine 40mg 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% ap≤0.01 vs. placebo bp≤0.05 vs. placebo 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). 14.3 Symptomatic 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) Famotidine 20mg twice daily (N=154) Famotidine 40mg at bedtime (N=149) Placebo at bedtime (N=73) Week 6 82% a 69% 62% ap≤0.01 vs. placebo 14.4 Erosive 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 tablets twice daily at Weeks 6 and 12 (Table 7). Table 7: Patients with Endoscopic Healing of Erosive Esophagitis - U.S. Study (N=318) Famotidine 40mg twice daily (N=127) Famotidine 20mg twice daily (N=125) Placebo twice daily (N=66) Week 6 48% a,b 32% 18% Week 12 69% a,c 54% a 29% ap0.01 vs. placebo bp0.01 vs. Famotidine tablets 20 mg twice daily cp0.05 vs. Famotidine tablets 20 mg twice daily As compared to placebo, patients in the U.S. trial who received Famotidine tablets had faster relief of daytime and nighttime heartburn, and a greater percentage of Famotidine-treated patients experienced complete relief of nighttime heartburn. These differences were statistically significant. In the international trial, when orally-administered Famotidine 40 mg tablets twice daily was compared to orally-administered ranitidine 150 mg twice daily, a statistically significantly greater percentage of healing of erosive esophagitis was observed with Famotidine 40 mg tablets twice daily at Week 12 (Table 8). There was, however, no significant difference in symptom relief among treatment groups. Table 8: Patients with Endoscopic Healing of Erosive Esophagitis-International Study(N=440) Famotidine 40mg twice daily (N=175) Famotidine 20mg twice daily (N=93) Ranitidine 150mg twice daily (N=172) Week 6 48% 52% 42% Week 12 71% a 68% 60% ap≤0.05 vs ranitidine 150 mg twice daily 14.5 Pathological Hypersecretory Conditions In trials of patients with pathological hypersecretory conditions such as Zollinger-Ellison Syndrome with or without multiple endocrine neoplasias, Famotidine significantly inhibited gastric acid secretion and controlled associated symptoms. Orally administered Famotidine dosages from 20 mg to 160 mg every 6 hours maintained basal acid secretion below 10 mEq/hour; initial dosages were titrated to the individual patient need and subsequent adjustments were necessary with time in some patients. 14.6 Risk Reduction of Duodenal Ulcer Recurrence Two randomized, double-blind, multicenter trials in patients with endoscopically-confirmed healed DUs demonstrated that patients receiving treatment with orally-administered Famotidine 20 mg tablets at bedtime had lower rates of DU recurrence, as compared with placebo. • In the U.S. trial, DU recurrence within 12 months was 2.4 times greater in patients treated with placebo than in the patients treated with Famotidine tablets. The Famotidine-treated 89 patients had a cumulative observed DU recurrence rate of 23%, compared to a 57% in the 89 patients receiving placebo (p<0.01). • In the international trial, the cumulative observed DU recurrence within 12 months in the 307 Famotidine-treated patients was 36%, compared to 76% in the 325 patients who received placebo (p<0.01). Controlled trials have not extended beyond one year.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8.1 Pregnancy Risk Summary Available data with H2-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. 8.2 Lactation 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 Famotidine 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. 8.4 Pediatric 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 non-erosive 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). 8.5 Geriatric 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)]. 8.6 Renal Impairment CNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment [see Warnings and Precautions (5.1)]. The clearance of famotidine is reduced in adults with moderate and severe renal impairment compared to adults with normal renal function [see Clinical Pharmacology (12.3)]. No dosage adjustment is needed in patients with mild renal impairment (creatinine clearance greater than or equal to 60 mL/minute). Dosage reduction is recommended in adult and pediatric patients greater than or equal to 40 kg with moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [see Dosage and Administration (2.2)].
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Famotidine 20 mg tablets are white, round, film-coated tablets engraved with CTI 121 on one side, supplied as follows: Famotidine 40 mg tablets are white, round, film-coated tablets engraved with CTI 122 on one side, supplied as follows: Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense in a tight, light-resistant container.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API