The active ingredient in Famotdine Amarox (famotidine) for oral suspension 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:

Each 5 mL of Famotdine Amarox for oral suspension when prepared as directed contains 40 mg of famotidine and the following inactive ingredients: citric acid, flavors (cherry, banana, and mint), microcrystalline cellulose and carboxymethylcellulose sodium sucrose and xanthan gum. Added as preservatives are sodium benzoate 0.1%, sodium methylparaben 0.1% and sodium propylparaben 0.02%.

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.

Famotdine Amarox for oral suspension is indicated in adults 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.

·      treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).

·      reduction of the risk of duodenal ulcer recurrence.

Famotdine Amarox for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of :

·      peptic ulcer disease.

·      GERD with or without esophagitis and ulcerations.

Famotdine Amarox for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of:

·      GERD.

Do not take Famotdine Amarox

Famotdine Amarox for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H2) receptor antagonists.

Warnings and precautions

Central 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)].

Concurrent Gastric Malignancy

In adults, symptomatic response to therapy with Famotdine Amarox for oral suspension 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 FAMOTDINE AMAROX for oral suspension.

Recommended Dosage in Adults

The recommended dosage and duration of Famotdine Amarox for oral suspension in adults with normal renal function is shown in Table 1.

Table 1: Recommended Dosage and Duration of Famotdine Amarox for Oral Suspension^a in Adults with Normal Renal Function

a After preparation, the concentration of Famotdine Amarox oral suspension is 8 mg/mL [See Dosage and Administration (2.3)]

b Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies (14)].

c 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)].

d Longer treatment durations have not been studied in clinical trials [see Clinical Studies (14.1, 14.2, 14.3)].

Recommended Dosage in Pediatric Patients

The recommended dosage and duration of Famotdine Amarox for oral suspension in pediatric patients with normal renal function is shown in Table 2.

Table 2: Recommended Dosage and Duration of Famotdine Amarox for Oral Suspension^a in Pediatric Patients with Normal Renal Function

a After preparation, the concentration of Famotdine Amarox oral suspension is 8 mg/mL [See Dosage and Administration (2.3)]

b Treatment duration based on adult recommendations (see Table 1). Individualize the dose and duration based upon clinical response an/or pH determinations (gastric or esophageal) and endoscopy.

c Use conservative measures (e.g., thickened feedings) concurrently [see Use in Specific Populations (8.4)].

d After 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.

Recommended Dosage in Adults with Renal Impairment

Recommended dosage adjustments for adults with moderate to severe renal impairment (creatinine clearance less than 60 mL/min) by indication are shown in Table 4. Use the lowest effective dosage [see Use in Specific Populations (8.6)].

A safe and effective dosage has not been established in pediatric patients with renal impairment.

Table 3: Recommended Maximum Dosage of Famotdine Amarox for Oral Suspension in Adults with Moderate and Severe Renal Impairment

a 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)].

b The dosage required to treat pathological hypersecretory conditions may exceed the maximum dosage evaluated in patients with impaired renal function. The risk for increased adverse reactions in renally impaired patients treated with Famotdine Amarox for oral suspension for pathological hypersecretory conditions is unknown.

Administration Instructions

Preparation of Constituted Suspension by a Healthcare Provider Prior to Dispensing

·      Prior to dispensing, constitute Famotdine Amarox for oral suspension by slowly adding 46 mL of Purified Water to the bottle. Shake vigorously for 5 to 10 seconds immediately after adding the water.

·      The constituted suspension contains 40 mg of famotidine per 5 mL, and should be a smooth, mobile, off-white, and homogeneous suspension.

Administration and Storage of Constituted Suspension

·      Shake the bottle of constituted Famotdine Amarox suspension vigorously for 5 to 10 seconds prior to each use.

·      Take Famotdine Amarox once daily before bedtime or twice daily in the morning and before bedtime, as recommended.

·      Famotdine Amarox may be taken with or without food [see Clinical Pharmacology (12.3)].

·      Famotdine Amarox may be given with antacids.

·      Store the constituted suspension at 25°C (77°F). Protect from freezing. Discard unused constituted suspension after 30 days.

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.

The safety of Famotdine Amarox for oral suspension has been established based on adequate and well-controlled studies of another oral famotidine product. The following is a summary of the adverse reactions reported in those studies.

Oral famotidine was studied in 7 US and international placebo- and active-controlled trials in approximately 2500 patients. 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 sex and race; however, the predominant race 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

Pediatric Patients Less Than One Year of Age

In a clinical study in 35 pediatric patients less than 1 year of age with GERD symptoms, two patients discontinued due to adverse reactions. Agitation observed in 5 patients resolved when famotidine was discontinued [see Use in Specific Populations (8.4)].

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, urticarial

Musculoskeletal: rhabdomyolysis, muscle cramps

Nervous System/Psychiatric: confusion, agitation, paresthesia

Respiratory: interstitial pneumonia

Skin: toxic epidermal necrolysis/Stevens-Johnson syndrome

Reporting of side effects

If any of side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton, bottle and blister after EXP. The expiry date refers to the last day of that month.

Store Famotdine Amarox for oral suspension dry powder and constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from freezing. Discard unused constituted suspension after 30 days.

Dispense in a USP tight, light-resistant container.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.