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1. Drug name
Sucrage 18
2. Drug formula ingredients
Each package contains:
Sucralfate (as 30% Sucrafat suspension) 1 g
3. Dosage form
Oral suspension.
4. Route of administration
Oral route.
5. Indications
- Peptic ulcer.
- Chronic gastritis.
- Prevent recurrence of gastric and duodenal ulcers.
- Treatment of gastroesophageal reflux disease.
6. Administration, dosage
Dosage
- Treatment of gastric and duodenal ulcers: Usual dose: 1g x 4 times/day, taken before each meal and before going to bed; Or 2 g x 2 times/day, before breakfast and before going to bed. Each treatment session usually lasts from 4 to 8 weeks depending on the severity of the ulcer until endoscopy or X-ray results show that the ulcer is completely healed. However, if necessary, the treatment course can be longer but should not exceed 2 weeks.
- Effective treatment is often combined with histamine H2 blockers or proton pump inhibitors and antibiotics.
- Preventing recurrence of gastric and duodenal ulcers: Usual dose: 1g x 2 times/day
- Treatment should not last longer than 6 months. Should be combined with antibiotics to eliminate the factor that causes recurrence, which is Helicobacter pylori bacteria.
- Treatment of gastroesophageal reflux - Normal dose: 1g x 4 times/day, taken before each main meal and before going to bed.
Children over 4 years old : 40 - 80 mg/kg body weight/day divided into 4 times (take 1 hour before each meal and before going to bed).
Administration:
Drink on an empty stomach (about ½ hour or 1 hour before eating).
7. Contraindications
Patients who are hypersensitive to any ingredient of the drug.
8. Special warnings and precautions for use
- A small amount of aluminum contained in Sucralfate can be absorbed through the digestive tract and will be excreted through the kidneys.
- The risk of aluminum accumulation occurs in people with severe renal impairment or concurrent use with other aluminum-containing drugs.
- Children under 4 years old.
- Pregnant and lactating women.
People who need to pay attention before using the drug: Elderly people, pregnant women, breastfeeding women, children under 15 years old, people with liver failure, kidney failure, people who are sensitive and allergic to any substance in the ingredients. part of the medicine... Or subjects with myasthenia gravis, liver coma, stomach ulcers
9. Fertility, pregnancy and lactation
Pregnant
FDA pregnancy classification: Category B. Harmful effects on the fetus have not been established. Sucralfate is very little absorbed from the digestive tract. However, during pregnancy, medication should only be used if absolutely necessary.
Breastfeeding women
It has not been determined whether sucralfate is excreted in breast milk. If excreted into breast milk, the amount of sucralfate will be very small, because the drug is very little absorbed into the body. Use caution when using sucralfate in breast-feeding women.
10. Effects on ability to drive and use machines
Sucralfate can cause dizziness, vertigo, and drowsiness on the nervous system. In case the patient experiences the above unwanted effects, do not drive, operate machinery, work at height or do other potentially dangerous work that requires alertness and concentration.
11. Interaction with other medicinal products and other forms of interaction
May reduce the absorption of digoxin, quinidine, fluoroquinolones, tetracycline, ketoconazole, sulpiride, levothyroxine, phenytoin, ranitidine, cimetidine, warfarin and theophylline. Consider a dosing interval of at least 2 hours between sucralfate and other concomitantly administered non-antacids.
It is possible to chelate with aluminum to increase the amount of aluminum absorbed, increasing the concentration of aluminum in the blood when sucralfate is used concurrently with other preparations containing Al (eg, antacids containing Al, citrate). If concurrent use of antacids is necessary, a 30-minute dosing interval between sucralfate and the antacid is recommended .
12. Undesirable effects
Common: Digestive system: Constipation.
Less common:
Digestive system: Dry mouth, nausea, diarrhea, bloating, indigestion.
Skin: Itching, erythema.
Neurological: Dizziness, vertigo, insomnia, drowsiness.
Other: Back pain, headache.
Rarely:
Digestive system: Foreign objects in the stomach.
Allergy: Hives, difficulty breathing, Quincke's edema, difficulty breathing, rhinitis, laryngospasm, facial swelling.
Report unwanted effects
It is important to report unwanted effects after a drug is approved. It allows continued monitoring of the benefit/risk assessment of the drug. Healthcare professionals are asked to report any unwanted effects to:
National DI &ADR Center
13 - 15 Le Thanh Tong, Hanoi
Website: www.canhgiacduoc.org.vn
13. Overdose
Most have no symptoms, a few cases have symptoms of abdominal pain, nausea, and vomiting. If the prescribed dose is exceeded, it should be monitored and taken to the nearest medical facility for timely treatment.
14. Pharmacodynamic properties
Pharmacological group: Drugs for treating peptic ulcers and other gastroesophageal reflux disease (GORD).
ATC code: A02BX02
Sucralfate is the aluminum salt of sulfate disaccharide, used for short-term treatment of gastric and duodenal ulcers. The drug has local effects (ulcers) rather than systemic effects.
The drug's mechanism of action is to form a complex with substances such as albumin and fibrinogen of the exudate that adhere to the ulcer, forming a barrier that prevents the effects of acid, pepsin and bile. Sucralfate also binds to the gastric and duodenal mucosa at much lower concentrations than at the ulcer site. Sucralfate also inhibits the activity of pepsin, binding with bile salts to increase the production of prostaglandin E2 and gastric mucus.
15. Pharmacokinetic properties
Absorption: Sucralfate is very little absorbed (< 5%) from the gastrointestinal tract. Poor absorption may be due to the high polarity and low solubility of the drug in the stomach.
Distribution: Sucralfate acts locally on ulcer sites, does not bind in the gastrointestinal tract to Al and sucrose octasulfate.
Metabolism: Sucralfate reacts with hydrochloric acid in the stomach to form sucrose sulfate, which cannot be metabolized.
Excretion: 90% of sucralfate is excreted in feces, a very small amount is absorbed and excreted in urine as unchanged compound.
16. Packaging
Box of 30 packs x 5 ml with instructions for use.
17. Storage conditions, expiration date, and quality standards of the drug
Storage:Cool and dry place, protect from light, temperature below 30oC.
Shelf life: 2 years.
Quality standards of drugs: In house
18. Name and address of the drug manufacturing facility
Euro Santé Pharmaceutical Joint Stock Company
Song Cung industrial site, Dong Thap commune, Dan Phuong district, Hanoi city, Vietnam.
