Drug interactions - summary
 

Sucralfate +

Antacids / Aluminiun containing
total body burden of aluminium increased with sucralfate coadministration                      

Anticoagulants
 decrease in the hypoprothrombinemic effect of warfarin occur

Digoxin
 serum digoxin levels reduced, decreasing the therapeutic effects

Hydantoins
phenytoin absorption decreased

Ketoconazole 
ketoconazole bioavailability  decreased

Quinidine
 serum quinidine levels reduced, decreasing the therapeutic effects.

Quinolones
 bioavailability of  quinolones decreased . Administering quinolones
  > 2 hours before sucralfate may eliminate the interaction.

LIST OF DRUGS DURING 2004

New Drugs Approved by (DCI) Drug Controller  GENERAL -  India  For Marketing                                                                                            (Ref- IDMA Publication)

For infected wounds and ulcers

Constipation is the most frequent complaint.

Others include- Diarrhea, nausea, vomiting, gastric discomfort, indegestion,

flatulaence, dry mouth, rash, pruritus, back pain, headache, dizziness,

sleepiness, vertigo, larygospasm, facial swelling,

hypersensitivity reactions, (including urticaria, angioedema, respiratory difficulty, rhinitis)

None reported.

Special Precautions:
Systemic aluminium toxicity may occur in patients with chronic renal failure.

Ulcer recurrence- duodenal ulcer is a chronic recurrent disease. While short-term treatment can completely heal the ulcer, do not expect a successful course to alter post healing frequency or severity of duodenal ulceration

Warning-

Chronic renal failiure/dialysis- During sucralfate administration small amiounts of of aluminium are absorbed from the GI tract.. Concomittant use with other aluminium products containing antacids may  incresase the total body burden of aluminium.Use with caution in patients with chronic renal failure  or receiving dialysis.

Pregnancy- Use this drug in pregnancy only if clearly needed.

Lactation- Excercise caution when sucralfate is administered to a nursing mother.

Children- Safety and efficacy in children have not been established.

 Approved  on   2002/2004

Indications:

Duodenal ulcer

Dosage:

1 g 4 times a day on an empty stomach and at bed time.

Take antacids as needed for pain relief,but not 1/2 an hour before or after taking sucralfate.

Overdosage- Symptoms/Treatrment

Risks asociated with overdosage apear to minimal.

 Missed dose-

 1. If you miss a dose of this medicine, take it as soon as possible.

2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.

3. Do not double doses.

SUCRALFATE

1.Take on an empty stomach at least 1 hour before or 2 hours after meals  and bed time.
2.Do not take antacids half an hour before or after taking sucralfate

3. Allergies- tell your doctor if you have ever had any unusual or allergic reaction to sucralfate.  Also tell your doctor  if you are allergic to any other substances, such as foods, presevatives
 or dyes.
  
4.Pregnancy- sucralfate has not been shown to cause birth defects or other problems in
animal studies.
  
5.Breast feeding-  sucralfate has not been to cause problems in nursing babies.  

6.Children- this medicine is not expected to cause different side effects or problems
   in children than  it does in adults.   
   
7.Elderly-  this medicine is not expected to cause different side effects or problems
  in children than  it does in adults.         

8. Other medicines -  Tell your Doctor the other medicines you are taking other medicines
            
9. Other medical problems -  Tell your doctor if you have any other medical problems
         

10. Missed dose - If you miss a dose of this medicine, take it as soon as possible.
     however,   if it is almost time for the next dose, skip the missed dose.
      Do not double doses.

11. Storage - Keep out of reach of children. Store away from heat or direct sunlight.
      Do not store  the capsule in bathroom, near the kitchen sink, or in other damp places.

12. Outdated medicines -  Do not keep outdated medicine or medicine no longer needed.
     Be sure that any  discarded medicine is out of reach of children.

Pharmacology:

Sucralfate exerts a local rather than systemic action.Sucralfate forms an ulcer-adherent complex with proteinaceous exudate. The ulcer-adhrent complex covers the ulcer site and protects it against acid,pepsin and bile salts. Sucralfate has minimal acid neutralising capacity.

Pharmacokinetics:

Sucralfate is minimally absorbed(about 3 to 5%) from G.I.tract. Approximately 90% is excreted in the stool.

May be bound to food proteins. To be administered before food.

Pregnancy:

No adequate and well controlled studies on pregnant women. Use this drug during pregnancy only if needed.

Lactation:

Not known whether the drug is excreted in breast milk. Excercise caution while administering to a nursing mother Children; Safety and efficacy in children, not established.