1.CARAFATE HISTORY
(How was Carafate discovered?)

Carafate is a product of Hoechst Marion Roussel.

The US FDA approved Carafate in 1981.

Hoechst Marion Roussel is a long-standing chemical company - now part of the new Aventis.

In the year 2000, the Aventis Company created by the merger of Hoechst and Rhône-Poulenc is no longer a German chemical company with sites in many countries of the world. It is an internationally active group of companies with many of its roots in Germany and France and its headquarters is in the European city of Strasbourg.

2.CARAFATE FACTS

Carafate is a complex of aluminium hydroxide and sulphated sucrose. Carafate is taken to aid the healing of ulcers in the stomach and upper intestine (duodenum).

Carafate is not absorbed from the gut. It works by binding to the exudate produced from the ulcer site on the lining of the gut, and forming a protective barrier over the ulcer. This protects the ulcer from stomach acid and digestive enzymes, giving it time to it heal. 

3.ABOUT CARAFATE MEDICATION

What Is an Ulcer?

An ulcer is an open sore, or lesion, usually found on the skin or mucous membrane areas of the body.

An ulcer in the lining of the stomach or duodenum, where hydrochloric acid and pepsin are present, is referred to as a peptic ulcer.

When the peptic ulcer is located in the stomach, it is called a gastric ulcer. When the peptic ulcer is located in the duodenum, it is called a duodenal ulcer.

What Causes an Ulcer?

For almost 100 years, doctors believed that stress, spicy foods, and alcohol caused most ulcers. Now we know that most peptic ulcers are caused by a particular bacterial infection in the stomach and upper intestine, by certain medications, or by smoking.

Two doctors - Barry Marshall and Robin Warren - discovered a certain kind of bacteria that can live and grow in the stomach. The medical name for these bacteria is Helicobacter pylori (or H. pylori, for short). Today doctors know that most peptic ulcers are caused by an infection from H. pylori.

Lots of people have H. pylori infections. Almost two out of every 10 people younger than 40 have been exposed to this bacteria in their digestive systems.

Experts believe that 90% of the people around the world who have ulcers are infected with H. pylori. But strangely enough, most people infected with H. pylori don't develop an ulcer. Doctors aren't completely sure why, but they think that part of the reason may depend on the individual person - for example, people who develop ulcers may already have a problem with the lining of their stomachs. It is also believed that some people may naturally secrete more stomach acid than others - and it doesn't matter what stresses they're exposed to or what foods they eat. Peptic ulcers may have something to do with the combination of H. pylori infection and the level of acid in the stomach.

A MAJOR CAUSE OF PEPTIC ULCER, ALTHOUGH FAR LESS COMMON THAN H.PYLORI OR NSAIDS, IS ZOLLINGER-ELLISON SYNDROME. A LARGE AMOUNT OF EXCESS ACID IS PRODUCED IN RESPONSE TO THE OVERPRODUCTION OF THE HORMONE GASTRIN, WHICH IN TURN IS CAUSED BY TUMORS ON THE PANCREAS OR DUODENUM. THESE TUMORS ARE USUALLY MALIGNANT, MUST BE REMOVED AND ACID PRODUCTION SUPPRESSED TO RELIEVE THE RECURRENCE OF THE ULCERS.

When H. pylori bacteria do cause ulcers, here's how doctors think these ulcers develop:

• Bacteria weaken the protective coating of the stomach and upper small intestine.
• Acid in the stomach then gets through to the sensitive tissues lining the digestive system underneath.
• Acid and bacteria directly irritate this lining resulting in sores, or ulcers.

Although H. pylori are responsible for most cases of peptic ulcers, these ulcers can happen for other reasons, too. Sometimes people regularly take pain relievers (like aspirin or ibuprofen) that fight inflammation in the body. These medications, known as nonsteroidal anti-inflammatory drugs (NSAIDs), are used to treat certain long-term painful conditions like arthritis. If these medicines are taken in high daily doses over a long period of time, they can cause ulcers in some of the people who use them.

Smoking is also associated with peptic ulcers. Smoking increases a person's risk of getting an ulcer because the nicotine in cigarettes causes the stomach to produce more acid. Drinking a lot of alcohol each day for a period of time can also increase a person's risk of ulcers because over time alcohol can wear down the lining of the stomach and intestines.

In certain circumstances stress can help cause ulcers. But this usually only happens in situations when illness involving severe emotional or physical stress is involved - such as when someone is so sick that he or she cannot eat for a long period of time. Ulcers occur because of uncontrolled increased acid production in the stomach and changes in a person's immune system (the body system that fights infection). With any illness where the body's ability to heal is challenged (such as when a person has been burned badly in a fire), there is a risk for developing ulcers.

Signs and Symptoms

Stomach pain is the most common symptom of an ulcer. It usually feels like sharp aches between the breastbone and the belly button. This pain often comes a few hours after eating. It can also happen during the night or early in the morning, when the stomach is empty. Eating something or taking an antacid medication sometimes makes the pain go away for awhile.

Other symptoms of ulcers can include:

• loss of appetite
• sudden, sharp stomach pains
• nausea
• frequent burping
• weight loss
• vomiting (if blood is in the vomit or the vomit looks like coffee grounds, which only happens with severe ulcers, call a doctor right away)
• bloody or blackish bowel movements (this could indicate a serious problem, so call a doctor right away if you notice this)

Anyone who thinks he or she may have an ulcer needs to see a doctor. Over time, untreated ulcers grow larger and deeper and can lead to other problems. An untreated ulcer can cause bleeding in the digestive system or make a hole in the wall of the stomach or duodenum, making someone very sick.

What are some complications from ulcers?

Without proper treatment, people with ulcers may experience serious complications. The most common problems include:

• bleeding

As the lining of the stomach or duodenal wall is eroded, blood vessels may also be damaged, causing bleeding.

• perforation

Sometimes a hole has worn through the wall of the stomach or duodenum, and bacteria and partially digested food can spill through the opening into the sterile abdominal cavity (peritoneum) and cause peritonitis, an inflammation of the abdominal cavity and wall.

• narrowing and obstruction

Ulcers located at the end of the stomach (where the duodenum is attached) can cause swelling and scarring, which can narrow or close the intestinal opening. This obstruction can prevent food from leaving the stomach and entering the small intestine, resulting in vomiting the contents of the stomach.

How Are Ulcers Diagnosed and Treated?

In addition to doing a physical examination, the doctor will ask you about any concerns and symptoms you have, your past health, your family's health, any medications you're taking, any allergies you may have, and other issues. This is called the medical history. If someone has stomach pain or other symptoms of an ulcer, a doctor will perform some tests to help make the diagnosis.

One test to check for an ulcer is called an upper gastrointestinal (GI) series. This is a type of X-ray of the stomach, duodenum, and esophagus, the muscular tube that links the mouth to the stomach. A person drinks a whitish liquid called barium while getting an X-ray, and if he or she has an ulcer, it should be outlined on the X-ray.

Another common procedure to look for an ulcer is called an endoscopy. During this test, the doctor uses an endoscope, a skinny, lighted tube with a special camera on the end.

A doctor will give someone getting an endoscopy medicine to make the person feel relaxed. Then the doctor gently guides the endoscope into the throat and down into the esophagus, and finally into the stomach and upper intestines. The doctor is able to look at the inner lining of these organs from the camera on a television screen and can even take pictures. Tissue can be removed during an endoscopy and then tested for H. pylori bacteria.

ENDOSCOPY USES A SMALL, FLEXIBLE TUBE WITH A LIGHT AND A CAMERA LENS AT THE END (ENDOSCOPE) TO EXAMINE THE INSIDE OF PART OF THE DIGESTIVE TRACT. TISSUE SAMPLES FROM INSIDE THE DIGESTIVE TRACT MAY ALSO BE TAKEN FOR EXAMINATION AND TESTING.

A doctor can also do a blood test for H. pylori bacteria. This may be important if an ulcer is found in the upper GI series or is suspected before the endoscopy. The blood test can be done right in the doctor's office. Sometimes a bowel movement or a person's breath can also be specially tested to check for the H. pylori bacteria.

Ulcers caused by H. pylori bacteria are generally treated with a combination of medications; usually two to three medicines are taken every day for a few weeks. Antibiotics are prescribed to kill the H. pylori bacteria. The other medicines - acid blockers or proton pump inhibitors - lessen the amount of acid in the stomach and help protect the lining of the stomach so the ulcer can heal.

Ulcer Prevention

Doctors are not totally certain how H. pylori bacteria are transmitted from person to person. The bacteria have been found in saliva. It may also be spread through food, water, or contact with vomit (puke) that has been infected with the bacteria.

The best advice in ulcer prevention is to always wash your hands after you use the bathroom and before you eat and to take good care of your body by exercising regularly and not smoking or drinking.

4.CARAFATE EFFECTIVENESS
(When is Carafate best taken?)

Up to 5% of the disaccharide component and less than 0.02% of aluminum is absorbed from the gastrointestinal tract following an oral Carafate dose. 

5.CARAFATE EFFECTS ON SPECIAL POPULATION
(How do different people react to Carafate?)

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Carafate should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether Carafate 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.

6.CARAFATE EFFECTS ON MEDICAL CONDITIONS
(How does Carafate affect your existing condition/ailment?)

When Carafate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of Carafate 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 Carafate 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. Carafate should be used with caution in patients with chronic renal failure. 

7.OTHER/ALTERNATE USES OF CARAFATE
(What else does Carafate treat?)

Carafate may be used for other purposes as prescribed by your physician.

8.ADVERSE/SIDE EFFECTS of CARAFATE
(What are the side effects of Carafate?)

Adverse reactions to Carafate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with Carafate 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:

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

Dermatological: pruritus, rash

Nervous System : dizziness, insomnia, sleepiness, vertigo

Other : back pain, headache

Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving Carafate tablets. However, a causal relationship has not been established.

Bezoars have been reported in patients treated with Carafate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral t.b. feedings.