Sucralfin

Sucralfin

sucralfate

Manufacturer:

Aurochem Lab

Distributor:

Endure Medical
Full Prescribing Info
Contents
Sucralfate.
Description
Each tablet contains Sucralfate 1 g.
Each 10 mL suspension contains Sucralfate 1 g.
Action
Pharmacology: Pharmacokinetics: Sucralfate is only slightly absorbed from the gastrointestinal tract after oral doses. However, there can be some release of aluminium ions and of sucrose sulfate; small quantities of sucrose sulfate may then be absorbed and excreted, primarily in the urine; some absorption of aluminium may also occur.
Indications/Uses
Treatment of duodenal ulcer, gastric ulcer and chronic gastritis.
Dosage/Direction for Use
Administer orally on an empty stomach, 1 hour before each meal and at bedtime. Antacids may be used as needed for relief of pain but should not be taken within 30 minutes before or after sucralfate.
Adults: For the treatment of active duodenal ulcer, the usual adult dose is 1 g four (4) times daily. Although healing of the ulcer may occur during the first or second week of therapy, treatment should be continued for 4-8 weeks unless healing has been shown by radiographic or endoscopic examination; if longer-term therapy is required sucralfate may be given for up to 12 weeks. For maintenance, the usual adult dosage of sucralfate is 1 g two times daily. For the treatment of gastric ulcer, 1 g four (4) times daily may be given in adults. For prophylaxis of gastrointestinal hemorrhage from stress ulceration, the usual dose of sucralfate is 1 g six times daily; a dose of 8 g daily should not be exceeded. Or as prescribed by the physician.
Children: Dosage has not yet been established however doses of 40-80 mg/kg/day in divided doses every 6 hours have been used. Or as prescribed by the physician.
Contraindications
Contraindicated in severe renal insufficiency and history of hypersensitivity to the drug or any of its components.
Warnings
Caution is advised in seriously ill patients using sucralfate because of the risks of bezoar formation and intestinal obstruction. Patients with delayed gastric emptying or receiving concomitant enteral feeds may be at increased risk. Not recommended in infants and young children.
Special Precautions
Duodenal ulcer is a chronic recurrent disease; successful therapy with sucralfate should not be expected to alter the post-healing frequency of recurrence or the severity of duodenal ulcer.
Renal impairment: Sucralfate under acid conditions can release aluminium ions that may be absorbed systemically. Aluminium toxicity in patients with normal renal function receiving sucralfate would not be expected, but seizures, muscle weakness, bone pain, and severe aluminium encephalopathy have been reported in patients with end-stage renal disease requiring dialysis. Sucralfate should be used with caution in patients with renal impairment, especially if other aluminium-containing agents are also taken, and such patients should be monitored for signs of aluminium toxicity.
Pediatric: Safety and efficacy of sucralfate have not been established in children.
Pregnancy, Fertility and Lactation: There are no adequate and controlled studies to date using sucralfate in pregnant women and the drugs should be used during pregnancy only when clearly needed. Effects of sucralfate on fertility in humans are not known. It is not known if sucralfate is distributed into milk; the drug should be used with caution in nursing women.
Use In Pregnancy & Lactation
There are no adequate and controlled studies to date using sucralfate in pregnant women and the drugs should be used during pregnancy only when clearly needed. Effects of sucralfate on fertility in humans are not known. It is not known if sucralfate is distributed into milk; the drug should be used with caution in nursing women.
Adverse Reactions
Constipation is the most frequently reported adverse effect of sucralfate although diarrhea, nausea, vomiting, flatulence, or gastric discomfort may also occur. Other adverse effects include dry mouth, dizziness, drowsiness, headache, vertigo, back pain, and skin rashes. Hypersensitivity reactions such as pruritus, edema, urticaria, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported.
Drug Interactions
Sucralfate may interfere with the absorption of other drugs and it has been suggested that there should be an interval of 2 hours between giving sucralfate and other non-antacid medication. Some of the drugs reported to be affected by sucralfate include cimetidine, ranitidine, digoxin, fluoroquinolone antibacterials, ketoconazole, levothyroxine, phenytoin, tetracycline, quinidine, theophylline, and possibly warfarin. The recommended interval between sucralfate and antacids is 30 minutes. An interval of 1 hour should elapse between giving sucralfate and enteral feeding.
Storage
Store at temperatures not exceeding 25°C.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BX02 - sucralfate ; Belongs to the class of other drugs used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Sucralfin oral susp 1 g/10 mL
Packing/Price
100 mL x 1's
Form
Sucralfin tab 1 g
Packing/Price
10's;50's
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