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A cool solution to treat the burning condition

SOKOOL

Generic Name:Sucralfate
Therapeutic Class:Antiulcer Agent
Composition:Each 5 ml of the Suspension contains Sucralfate 500 mg
Pregnancy Category:B
Presentation:200 ml bottle with a measuring cap

What is Sokool and what is it used for?

Sokool contains Sucralfate 500 mg/5ml in suspension form. Sucralfate is a superior mucosal protectant that provides a protective coating to the ulcer sites in the stomach and duodenum thus preventing further damage and relieving the patients from agonizing burning pain. It is used in:

 

How does it work?

Sucralfate forms cross-linking, viscous, paste-like protective barriers forming at the ulcer surface, preventing further damage from acid, pepsin, and bile.

 

How to take Sucralfate (Sokool)?

Initial dose: 1 gm four times a day for 8 weeks

Maintenance Dose: 1 gm two times a day

 

  • Take on empty stomach (1 hour before or 2 hours after meal).
  • Shake the oral suspension (liquid) before you measure a dose. Use the measuring cup provided, or use a medicine dose-measuring device (not a kitchen spoon).
  • The liquid form of this medicine should never be injected through a needle into the body, or death may occur. Sucralfate oral suspension is to be taken only by mouth.
  • If you are diabetic, check your blood sugar regularly. Your doctor may adjust your dose based on your blood sugar levels.

 

What if you miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

                                                                                             

What to do in case of overdose?

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.

 

What do you need to know before you take Sokool?

Do not take Sucralftae (Sokool)

  • If you are allergic to sucralfate or any of the other ingredients of this medicine
  • Infants and Neonates: Safety and efficacy not established

 

Warnings and precautions

Talk to your healthcare professional before taking Sucralfate (Sokool):

  • 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.
  • Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with sucralfate suspension is recommended. Adjustment of the antidiabetic treatment dose during the use of sucralfate suspension might be necessary.
  • Patients with Hypophosphatemia must take caution while administrating Sucralfate.
  • Geriatric patients (Older patients) must have their dose adjusted since the renal function is diminished.

 

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

 

Sucralfate and other medications

Avoid taking any other medications within 2 hours before or after you take sucralfate. Sucralfate can make it harder for your body to absorb other medications you take by mouth.

 

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for sucralfate to work in your stomach. Avoid taking an antacid within 30 minutes before or after taking sucralfate.

 

Pregnancy and breast-feeding

Sucralfate is generally considered safe during pregnancy.

 

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.

 

Driving and using machines

This medicine is not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Come reports suggest that this drug may cause dizziness and/or drowsiness, and they should avoid driving or operating machinery until the full effects of the drug are seen.

 

 

What are the possible side effects?

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

Mechanism of action:

Sucralfate, the Active Pharmaceutical Ingredient (API) present in Sokool,  is composed of sucrose octasulfate and aluminum hydroxide, which dissociate in the acid environment of the stomach. Minimal systemic absorption of either compound occurs and it gets chemically modified into a viscous sticky substance in the acidic environment of stomach. Thus formed viscous substance binds and adheres to ulcer sites thus protecting the ulcerated tissues from further damage caused by gastric acid, pepsin and bile acids.

 

Sucralfate also induces an increment in mucosal concentration of prostaglandin which causes an enhancement in bicarbonate and mucus secretion, mucosal hydrophobicity and blood flow.

 

All of these actions of Sucralfate ultimately contribute in ulcer healing.

 

Pharmacokinetic properties:

Absorption: This drug is absorbed from the gastrointestinal tract in very minimal quantities. The adsorbed sulfated disaccharide is excreted in the urine. This drug contains aluminum and after the administration of 1 g of sucralfate 4 times per day, about 0.001% to 0.017% of this aluminum content is absorbed in patients with normal renal function. This number is expected to increase in those with impaired renal function.

Protein binding: Sucralfate is bound to plasma proteins, especially albumin and transferrin.

Volume of distribution: This drug is absorbed in a very small quantity, and normally localizes to inflamed gastrointestinal lesions.

Metabolism: This drug is absorbed in very small quantities and is not significantly metabolized.

Excretion: The negligible amount of this drug that is absorbed is excreted mainly in the urine within 48 hours.

Elimination Half-life: The half-life is not known. In animals, the elimination half-life of the sucrose component of this drug is from 6-20 hours.

Clearance: Sucralfate contains aluminum. The administration of sucralfate in non-dialyzed chronic renal failure patients warrants careful consideration from the treating physician as the excretion of absorbed aluminum may be decreased, causing possible aluminum toxicity.

In dialyzed patients diagnosed with chronic renal failure, aluminum toxicity related to sucralfate has been observed and reported. The daily amount of aluminum ingestion (including sucralfate) should be carefully examined before administering sucralfate in combination with other drugs also containing aluminum, including various antacids.

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 non-systemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract.

In all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Due to sucralfate`s potential 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.

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