FLUXID (Page 4 of 4)

OVERDOSAGE

There is no experience to date with deliberate overdosage. 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.

Single oral doses of up to 3000 mg/kg in rats and mice and 2000 mg/kg in dogs were not lethal.

DOSAGE AND ADMINISTRATION

Instructions for Use/Handling FLUXID™ Tablets

Just prior to administration, remove the tablet from the bottle with dry hands. Immediately place the FLUXID™ Tablet on top of the tongue, wait until it dissolves, then swallow with saliva. The tablet typically disintegrates in less than 2 minutes. Administration with liquid is not necessary.

Duodenal Ulcer

Acute Therapy

The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective

Maintenance Therapy

The recommended adult oral dose is 20 mg once a day at bedtime.

Benign Gastric Ulcer

Acute Therapy

The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

Gastroesophageal Reflux Disease (GERD)

The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

Dosage for Pediatric Patients 6-16 years of age

See PRECAUTIONS, Pediatric Patients 6-16 years of age.

The studies described in PRECAUTIONS, Pediatric Patients 6-16 years of age suggest the following starting doses in pediatric patients 6-16 years of age:

Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations – 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

Tablet should not be broken.

While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease, 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 pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

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 oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

Concomitant Use of Antacids

Antacids may be given concomitantly if needed.

Dosage Adjustment 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 FLUXID™ may be reduced to half the dose or the dosing interval may be prolonged to 36-48 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.

HOW SUPPLIED

FLUXID™ (famotidine orally disintegrating tablets) 20 mg are white, round, biconvex, cherry-flavored and engraved “SP371” on one side and “20” on the other side. They are supplied as follows:

Bottles of 30 (unit-of-use)NDC 0091-3371-32

Bottles of 100NDC 0091-3371-01

FLUXID™ (famotidine orally disintegrating tablets) 40 mg are white, round, biconvex, cherry-flavored and engraved “SP372”on one side and “40” on the other side. They are supplied as follows:

Bottles of 30 (unit-of-use)NDC 0091-3372-32

Bottles of 100NDC 0091-3372-01

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture.

Dispense in a tight container as defined in the USP/NF.

Manufactured for:

Schwarz Pharma

Milwaukee, WI 53201, USA

By: CIMA LABS INC.®

Eden Prairie, MN 55344, USA

FLUXID™ uses CIMA® U.S. Patent Nos. 6,024,981 and 6,221,392.

FLUXID famotidine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0091-3371
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Famotidine (Famotidine) Famotidine 20 mg
Inactive Ingredients
Ingredient Name Strength
citric acid
colloidal silicon dioxide
corn starch
crospovidone
hypromellose
magnesium stearate
mannitol
methacrylic acid copolymer
microcrystalline cellulose
natural and artificial cherry flavor
sodium bicarbonate
sucralose
sucrose
Product Characteristics
Color WHITE (WHITE) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code SP371;20
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0091-3371-32 30 TABLET, ORALLY DISINTEGRATING (30 TABLET) in 1 BOTTLE None
2 NDC:0091-3371-01 100 TABLET, ORALLY DISINTEGRATING (100 TABLET) in 1 BOTTLE None
FLUXID famotidine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0091-3372
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Famotidine (Famotidine) Famotidine 40 mg
Inactive Ingredients
Ingredient Name Strength
citric acid
colloidal silicon dioxide
corn starch
crospovidone
hypromellose
magnesium stearate
mannitol
methacrylic acid copolymer
microcrystalline cellulose
natural and artificial cherry flavor
sodium bicarbonate
sucralose
sucrose
Product Characteristics
Color WHITE (WHITE) Score no score
Shape ROUND (ROUND) Size 13mm
Flavor Imprint Code SP372;40
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0091-3372-32 30 TABLET, ORALLY DISINTEGRATING (30 TABLET) in 1 BOTTLE None
2 NDC:0091-3372-01 100 TABLET, ORALLY DISINTEGRATING (100 TABLET) in 1 BOTTLE None
Labeler — Schwarz Pharma

Revised: 11/2006 Schwarz Pharma

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