SUCRALFATE

Main information

  • Trade name:
  • SUCRALFATE- sucralfate tablet
  • Composition:
  • SUCRALFATE 1 g
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SUCRALFATE- sucralfate tablet
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Sucralfate tablets, USP are indicated in: - Short-term treatment (up to 8 weeks) of active duodenal ulcer. 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. - Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.
  • Product summary:
  • Sucralfate tablets, USP are available as white, capsule-shaped, biconvex, scored tablets, debossed “TEVA” on one side, and “22” and “10” on the scored side, containing 1 gram of sucralfate USP, packaged in bottles of 90 (NDC 0093-2210-98), 100 (NDC 0093-2210-01) and 500 (NDC 0093-2210-05) tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. L 9/ 2015

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 70518-0775-0, 70518-0775-1
  • Last update:
  • 26-05-2019

Summary of Product characteristics: dosage, interactions, side effects

SUCRALFATE- sucralfate tablet

REMEDYREPACK INC.

----------

SUCRALFATE TABLETS, USP

2210

Rx only

DESCRIPTION

Sucralfate, USP is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum

complex.

R = SO

Al(OH)

Tablets for oral administration contain 1 g of sucralfate, USP and the following inactive ingredients:

corn starch, magnesium stearate, and microcrystalline cellulose.

Therapeutic Category

antiulcer

CLINICAL PHARMACOLOGY

Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated

disaccharide that are absorbed are excreted primarily in the urine.

Although the mechanism of sucralfate’s ability to accelerate healing of duodenal ulcers remains to be

fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The

following observations also appear pertinent:

1. Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms

an ulcer-adherent complex with proteinaceous exudate at the ulcer site.

2. In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.

3. In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity

in gastric juice by 32%.

4. In vitro, sucralfate adsorbs bile salts.

These observations suggest that sucralfate’s antiulcer activity is the result of formation of an ulcer-

adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile

salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1 g dose of sucralfate.

CLINICAL TRIALS

Acute Duodenal Ulcer

Over 600 patients have participated in well-controlled clinical trials worldwide. Multicenter trials

conducted in the United States, both of them placebo-controlled studies with endoscopic evaluation at 2

and 4 weeks, showed:

STUDY 1

Treatment Groups

Ulcer Healing/No. Patients

2 wk

4 wk (Overall)

Sucralfate

37/105 (35.2%)

82/109 (75.2%)

Placebo

26/106 (24.5%)

68/107 (63.6%)

STUDY 2

Treatment Groups

Ulcer Healing/No. Patients

2 wk

4 wk (Overall)

Sucralfate

8/24 (33%)

22/24 (92%)

Placebo

4/31 (13%)

18/31 (58%)

The sucralfate-placebo differences were statistically significant in both studies at 4 weeks but not at 2

weeks. The poorer result in the first study may have occurred because sucralfate was given 2 hours

after meals and at bedtime rather than 1 hour before meals and at bedtime, the regimen used in

international studies and in the second United States study. In addition, in the first study liquid antacid

was utilized as needed, whereas in the second study antacid tablets were used.

Maintenance Therapy After Healing of Duodenal Ulcer

Two double-blind randomized placebo-controlled U.S. multicenter trials have demonstrated that

sucralfate (1 g bid) is effective as maintenance therapy following healing of duodenal ulcers.

In one study, endoscopies were performed monthly for 4 months. Of the 254 patients who enrolled, 239

were analyzed in the intention-to-treat life table analysis presented below.

Duodenal Ulcer Recurrence Rate (%)

Months of Therapy

Drug

n

1

2

3

4

Sucralfate

Placebo

In this study, prn antacids were not permitted.

In the other study, scheduled endoscopies were performed at 6 and 12 months, but for-cause

endoscopies were permitted as symptoms dictated. Median symptom scores between the sucralfate and

placebo groups were not significantly different. A life table intention-to-treat analysis for the 94

p < 0.05

p < 0.01

patients enrolled in the trial had the following results:

Duodenal Ulcer Recurrence Rate (%)

Drug

n

6 months

12 months

Sucralfate

Placebo

In this study, prn antacids were permitted.

Data from placebo-controlled studies longer than 1 year are not available.

INDICATIONS AND USAGE

Sucralfate tablets, USP are indicated in:

1. Short-term treatment (up to 8 weeks) of active duodenal ulcer. 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.

2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

CONTRAINDICATIONS

Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active

substance or to any of the excipients.

PRECAUTIONS

The physician should read the PRECAUTIONS section when considering the use of this drug in

pregnant or pediatric patients, or patients of childbearing potential.

Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with sucralfate can result in

complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected

to alter the post healing frequency or severity of duodenal ulceration.

Isolated reports of sucralfate tablet aspiration with accompanying respiratory complications have been

received. Therefore, sucralfate tablets should be used with caution by patients who have known

conditions that may impair swallowing, such as recent or prolonged intubation, tracheostomy, prior

history of aspiration, dysphagia, or any other conditions that may alter gag and cough reflexes, or

diminish oropharyngeal coordination or motility.

Special Populations

Chronic Renal Failure and Dialysis Patients

When sucralfate is administered orally, small amounts of aluminum are absorbed from the

gastrointestinal tract. Concomitant use of sucralfate with other products that contain aluminum, such as

aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal

renal function receiving the recommended doses of sucralfate and aluminum-containing products

adequately excrete aluminum in the urine. Patients with chronic renal failure or those receiving dialysis

have impaired excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes

because it is bound to albumin and transferrin plasma proteins. Aluminum accumulation and toxicity

(aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal

impairment. Sucralfate should be used with caution in patients with chronic renal failure.

p < 0.002

Drug Interactions

Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the

extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin,

fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and

theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have

been reported in spontaneous and published case reports. However, two clinical studies have

demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of

sucralfate to chronic warfarin therapy.

The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from

sucralfate binding to the concomitant agent in the gastrointestinal tract. In all case studies to date

(cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant

medication 2 hours before sucralfate eliminated the interaction. Because of the potential of sucralfate to

alter the absorption of some drugs, sucralfate should be administered separately from other drugs when

alterations in bioavailability are felt to be critical. In these cases, patients should be monitored

appropriately.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1

g/kg (12 times the human dose).

There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38

times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not

conducted.

Pregnancy

Teratogenic Effects

Pregnancy category B

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 tablets 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 in clinical trials were minor and only rarely led to discontinuation of the

drug. In studies involving over 2700 patients treated with sucralfate tablets, 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:

Gas trointes tinal

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

Dermatological

pruritus, rash

Nervous System

dizziness, insomnia, sleepiness, vertigo

Other

back pain, headache

Postmarketing cases of hypersensitivity have been reported with the use of sucralfate tablets, including

dyspnea, lip swelling, pruritus, rash, and urticaria.

Cases of anaphylactic reactions, bronchospasm, laryngeal edema, edema of the mouth, pharyngeal

edema, respiratory tract edema and swelling of the face have been reported with an unknown oral

formulation of 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.

Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications,

including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.

OVERDOSAGE

Due to limited experience in humans with overdosage of sucralfate, no specific treatment

recommendations can be given. Acute oral toxicity 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 g four times per day 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.

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.

Maintenance Therapy

The recommended adult oral dosage is 1 g twice a day.

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 TEVA USA,

PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-

1088 or www.fda.gov/medwatch.

HOW SUPPLIED

Sucralfate tablets, USP are available as white, capsule-shaped, biconvex, scored tablets, debossed

“TEVA” on one side, and “22” and “10” on the scored side, containing 1 gram of sucralfate USP,

packaged in bottles of 90 (NDC 0093-2210-98), 100 (NDC 0093-2210-01) and 500 (NDC 0093-2210-

05) tablets.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as

required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured In Croatia By:

PLIVA HRVATSKA d.o.o.

Zagreb, Croatia

Manufactured For:

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. L 9/2015

DRUG: Sucralfate

GENERIC: Sucralfate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0775-0

NDC: 70518-0775-1

COLOR: white

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 19 mm

IMPRINT: TEVA;22;10

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 60 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

SUCRALFATE 1g in 1

INACTIVE INGREDIENT(S):

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE

STARCH, CORN

SUCRALFATE

sucralfate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:70 518 -0 775(NDC:0 0 9 3-2210 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SUCRALFATE (UNII: XX7320 5DH5) (SUCRALFATE - UNII:XX7320 5DH5)

SUCRALFATE

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

Product Characteristics

Color

white

S core

2 pieces

REMEDYREPACK INC.

S hap e

OVAL (capsule-shaped)

S iz e

19 mm

Flavor

Imprint Code

TEVA;22;10

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 518 -0 775-

30 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

10 /10 /20 17

2

NDC:70 518 -0 775-

6 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/27/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 70 8 48

10 /10 /20 17

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 7/2018