Sucralfate (Page 2 of 2)

Pregnancy

Teratogenic effects.

Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Sucralfate Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see DOSAGE AND ADMINISTRATION).

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see PRECAUTIONS; Special Populations: Chronic Renal Failure and Dialysis Patients). Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS

Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%).

Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:

Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting

Dermatological: pruritus, rash

Nervous System: dizziness, insomnia, sleepiness, vertigo

Other: back pain, headache

Post-marketing cases of hypersensitivity have been reported with the use of sucralfate oral suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria.

Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate.

Cases of hyperglycemia have been reported with sucralfate.

Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.

OVERDOSAGE

Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer. The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Sucralfate Oral Suspension should be administered on an empty stomach.

Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after Sucralfate Oral Suspension.

While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.

Elderly. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see PRECAUTIONS Geriatric Use).

Call your doctor for medical advice about side effects. You may report side effects to VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

HOW SUPPLIED

Sucralfate Oral Suspension, 1 g/10 mL is a pink suspension supplied as follows:

NDC 66689-790-01: 10 mL unit-dose cup

NDC 66689-790-30: Case contains 30 unit-dose cups of 10 mL

(NDC 66689-790-01), packaged in 3 trays of 10 unit-dose cups each.

NDC 66689-790-40: Case contains 40 unit-dose cups of 10 mL

(NDC 66689-790-01), packaged in 4 trays of 10 unit-dose cups each.

NDC 66689-790-50: Case contains 50 unit-dose cups of 10 mL

(NDC 66689-790-01), packaged in 5 trays of 10 unit-dose cups each.

NDC 66689-790-99: Case contains 100 unit-dose cups of 10 mL

(NDC 66689-790-01), packaged in 10 trays of 10 unit-dose cups each.

SHAKE WELL BEFORE USING. AVOID FREEZING.

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

Rx Only

Distributed by:

VistaPharm, Inc.

Largo, FL 33771, USA

VP1059R10

02/2020

PRINCIPAL DISPLAY PANEL — 10 mL Cup Label

Sucralfate Oral Suspension

1 g / 10 mL

Shake Well

Delivers 10 mL

Store at 20°–25°C (68°– 77°F)

Rx Only

VP1060R6

01/18

XACTDOSE

Distributed by:

VistaPharm, Inc.

Largo, FL 33771, USA

NDC 66689-790-01

Lidding label
(click image for full-size original)
SUCRALFATE sucralfate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-790(NDC:58914-170)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUCRALFATE (SUCRALFATE) SUCRALFATE 1 g in 10 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
METHYLPARABEN
SORBITOL
WATER
FD&C RED NO. 40
Product Characteristics
Color pink Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66689-790-30 3 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-790-30) and contains a CUP, UNIT-DOSE (66689-790-01)
1 NDC:66689-790-01 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-790-30)
2 NDC:66689-790-40 4 TRAY in 1 CASE contains a TRAY
2 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-790-40) and contains a CUP, UNIT-DOSE (66689-790-01)
2 NDC:66689-790-01 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-790-40)
3 NDC:66689-790-50 5 TRAY in 1 CASE contains a TRAY
3 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-790-50) and contains a CUP, UNIT-DOSE (66689-790-01)
3 NDC:66689-790-01 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-790-50)
4 NDC:66689-790-99 10 TRAY in 1 CASE contains a TRAY
4 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-790-99) and contains a CUP, UNIT-DOSE (66689-790-01)
4 NDC:66689-790-01 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-790-99)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019183 08/16/2012
Labeler — VistaPharm, Inc. (116743084)

Revised: 09/2022 VistaPharm, Inc.

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