Application Information

This drug has been submitted to the FDA under the reference 019404/001.

Names and composition

"OCUFEN" is the commercial name of a drug composed of FLURBIPROFEN SODIUM.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
019404/001 OCUFEN FLURBIPROFEN SODIUM SOLUTION/DROPS/OPHTHALMIC 0.03%

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
019404/001 OCUFEN FLURBIPROFEN SODIUM SOLUTION/DROPS/OPHTHALMIC 0.03%
074447/001 FLURBIPROFEN SODIUM FLURBIPROFEN SODIUM SOLUTION/DROPS/OPHTHALMIC 0.03%

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Answered questions

Does anyone know the symptoms of a bleeding stomach ulcer?
Asked by Jonathon Wackerly 1 year ago.

In general, an ulcer is any eroded area of skin or a mucous membrane, marked by tissue disintegration. In common usage, however, ulcer is usually used to refer to disorders in the upper digestive tract. The terms ulcer, gastric ulcer, and peptic ulcer are often used loosely and interchangeably. Peptic ulcers can develop in the lower part of the esophagus, the stomach, the first part of the small intestine (the duodenum), and the second part of the small intestine (the jejunum). Description It is estimated that 2% of the adult population in the United States has active peptic ulcers, and that about 10% will develop ulcers at some point in their lives. There are about 500,000 new cases of peptic ulcer in the United States every year, with as many as 4 million recurrences. The male/female ratio for ulcers of the digestive tract is 3:1. The most common forms of peptic ulcer are duodenal and gastric. About 80% of all ulcers in the digestive tract are duodenal ulcers. This type of ulcer may strike people in any age group but is most common in males between the ages of 20 and 45. The incidence of duodenal ulcers has dropped over the past 30 years. Gastric ulcers account for about 16% of peptic ulcers. They are most common in males between the ages of 55 and 70. The single most common cause of gastric ulcers is the use of nonsteroidal anti-inflammatory drugs, or NSAIDs. The widespread use of NSAIDs is thought to explain why the incidence of gastric ulcers in the United States is rising. Causes and symptoms Causes of peptic ulcers There are three major causes of peptic ulcers: infection, certain types of medication, and disorders that cause oversecretion of stomach juices. HELICOBACTER PYLORI INFECTION Helicobacter pylori is a rod-shaped gram-negative bacterium that lives in the mucous tissues that line the digestive tract. Infection with H. pylori is the most common cause of duodenal ulcers. About 95% of patients with duodenal ulcers are infected with H. pylori, as opposed to only 70% of patients with gastric ulcers. USE OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) Nonsteroidal anti-inflammatory drugs, or NSAIDs, are painkillers that many people use for headaches, sore muscles, arthritis, menstrual cramps, and similar complaints. Many NSAIDs are available without prescriptions. Common NSAIDs include aspirin, ibuprofen (Advil, Motrin), flurbiprofen (Ansaid, Ocufen), ketoprofen (Orudis), and indomethacin (Indacin). Chronic NSAID users have 40 times the risk of developing a gastric ulcer as nonusers. Users are also three times more likely than nonusers to develop bleeding or fatal complications of ulcers. Aspirin is the NSAID that is most likely to cause ulcers. MISCELLANEOUS SYNDROMES AND DISORDERS Fewer than 5% of peptic ulcers are due to these disorders. They include Zollinger-Ellison syndrome, a disorder in which small tumors, called gastrinomas, secrete a hormone (gastrin) that stimulates the production of digestive juices. Because of this excess secretion, these disorders are sometimes called hypersecretory syndromes. OTHER RISK FACTORS Smoking is an important risk factor that increases a patient's chance of developing an ulcer, decreases the body's response to therapy, and increases the chances of dying from ulcer complications. Blood type appears to be a predisposing factor for ulcer location; people with type A blood are more likely to have gastric ulcers, while those with type O are more likely to develop duodenal ulcers. The role of emotional stress in ulcer development is currently debated. Present research indicates that an individual's attitudes toward stress, rather than the amount of stress by itself, is a better predictor of vulnerability to peptic ulcers. Preferences for high-fat or spicy foods do not appear to be significant risk factors. Symptoms GASTRIC ULCERS The symptoms of gastric ulcers include feelings of indigestion and heartburn, weight loss, and repeated episodes of gastrointestinal bleeding. Ulcer pain is often described as gnawing, dull, aching, or resembling hunger pangs. The patient may be nauseated and suffer loss of appetite. About 30% of patients with gastric ulcers are awakened by pain at night. Many patients have periods of chronic ulcer pain alternating with symptom-free periods that last for several weeks or months. This characteristic is called periodicity. DUODENAL ULCERS The symptoms of duodenal ulcers include heartburn, stomach pain relieved by eating or antacids, weight gain, and a burning sensation at the back of the throat. The patient is most likely to feel discomfort two to four hours after meals, or after having citrus juice, coffee, or aspirin. About 50% of patients with duodenal ulcers awake during the night with pain, usually between midnight and three a.m. A regular pattern of ulcer pain associated with certain periods of day or night or a time interval after meals is called rhythmicity. Not all digestive ulcers produce symptoms; as many as 20% of ulcer patients have so-called painless or silent ulcers. Silent ulcers occur most frequently in the elderly and in chronic NSAID users. Complications Between 10-20% of peptic ulcer patients develop complications at some time during the course of their illness. All of these are potentially serious conditions. Complications are not always preceded by diagnosis of or treatment for ulcers; as many as 60% of patients with complications have not had prior symptoms. HEMORRHAGE Bleeding is the most common complication of ulcers. It may result in anemia, vomiting blood (hematemesis), or the passage of bright red blood through the rectum (melena). About half of all cases of bleeding from the upper digestive tract are caused by ulcers. The mortality rate from ulcer hemorrhage is 6-10%. PERFORATION About 5% of ulcer patients develop perforations, which are holes in the duodenal or gastric wall through which the stomach contents can leak out into the abdominal cavity. The incidence of perforation is rising because of the increased use of NSAIDs, particularly among the elderly. The signs of an ulcer perforation are severe pain, fever, and tenderness when the doctor touches the abdomen. Most cases of perforation require emergency surgery. The mortality rate is about 5%. PENETRATION Ulcer penetration is a complication in which the ulcer erodes through the intestinal wall without digestive fluid leaking into the abdomen. Instead, the ulcer penetrates into an adjoining organ, such as the pancreas or liver. The signs of penetration are more severe pain without rhythmicity or periodicity, and the spread of the pain to the lower back. OBSTRUCTION Obstruction of the stomach outlet occurs in about 2% of ulcer patients. It is caused by swelling or scar tissue formation that narrows the opening between the stomach and the duodenum (the pylorus). Over 90% of patients with obstruction have recurrent vomiting of partly digested or undigested food; 20% are seriously dehydrated. These patients also usually feel full after eating only a little food, and may lose weight. Diagnosis Physical examination and patient history The diagnosis of peptic ulcers is rarely made on the basis of a physical examination alone. The only significant finding may be mild soreness in the area over the stomach when the doctor presses (palpates) it. The doctor is more likely to suspect an ulcer if the patient has one or more of the following risk factors: male sex age over 45 recent weight loss, bleeding, recurrent vomiting, jaundice, back pain, or anemia history of using aspirin or other NSAIDs history of heavy smoking family history of ulcers or stomach cancer Endoscopy and imaging studies An endoscopy is considered the best procedure for diagnosing digestive ulcers and for taking samples of stomach tissue for biopsies. An endoscope is a slender tube-shaped instrument that allows the doctor to view the tissues lining the stomach and duodenum. Duodenal ulcers are rarely malignant. If the ulcer is in the stomach, however, the doctor will take a tissue sample because 3-5% of gastric ulcers are malignant. Radiological studies are sometimes used instead of endoscopy because they are less expensive, more comfortable for the patient, and are 85% accurate in detecting malignancies. Laboratory tests BLOOD TESTS Blood tests usually give normal results in ulcer patients without complications. They are useful, however, in evaluating anemia from a bleeding ulcer or a high white cell count from perforation or penetration. Serum gastrin levels can be used to screen for Zollinger-Ellison syndrome. TESTS FOR HELICOBACTER PYLORI It is important to test for H. pylori because almost all ulcer patients who are not taking NSAIDs are infected. Noninvasive tests include blood tests for immune response and a breath test. In the breath test, the patient is given an oral dose of radiolabeled urea. If H. pylori is present, it will react with the urea and the patient will exhale radiolabeled carbon dioxide. Invasive tests for H. pylori include tissue biopsies and cultures performed from fluid obtained by endoscopy. Treatment Medications Most drugs that are currently given to treat ulcers work either by lowering the rate of stomach acid secretion or by protecting the mucous tissues that line the digestive tract. ANTISECRETORY DRUGS Medications that lower the rate of stomach acid secretions fall into two major categories: proton pump inhibitors, which bind an enzyme that secretes stomach acid, and H2 receptor antagonists, which work by reducing intracellular acid secretion. The proton pump inhibitors include omeprazole (Prilosec) and lansoprazole (Prevacid). The H2 receptor antagonists include ranitidine (Zantac), cimetidine (Tagamet), famotidine (Pepcid), and nizatidine (Axid). Both types of drugs have few serious side effects and appear to be safe for long-term use. PROTECTIVE DRUGS The drugs that are currently used to protect the stomach tissues are sucralfate (Carafate), which forms a pastelike substance that clings to the mucous tissues and prevents further damage from stomach acid; and bismuth preparations. A third type of protective drug includes misoprostol (Cytotec), which is often given to patients with ulcers caused by NSAIDs. Surgery Surgical treatment of ulcers is generally used only for complications and suspected malignancies. The most common surgical procedures that are used are vagotomies, in which the connections of the vagus nerve to the stomach are cut in order to reduce acid secretion; and antrectomies, which involve the removal of a part of the stomach (the antrum). Eradication of Helicobacter pylori Most doctors presently recommend treatment to eliminate H. pylori in order to prevent ulcer recurrences. Without such treatment, ulcers recur at the rate of 80% per year. The usual regimen used to eliminate the bacterium is a combination of tetracycline, bismuth subsalicylate (Pepto-Bismol), and metronidazole (Metizol). Alternative treatment Alternative treatments can relieve symptoms and promote healing of ulcers. A primary goal of these treatments is to rebalance the stomach's hydrochloric acid output and to enhance the mucosal lining of the stomach. Food allergies have been pointed to as a major cause of peptic (stomach) ulcers. An elimination/challenge diet can help identify the allergenic food(s) and continued elimination of these foods can assist in healing the ulcer. People with ulcers should not take aspirin. They should also stop smoking, since smoking irritates the mucosal lining of the stomach. Antacids should be avoided by anyone with an ulcer, because they can cause a rebound effect of increasing gastric acid secretion, as well as deplete vital nutrients necessary for healing. Stress reduction is also important for ulcer sufferers. Botanical medicine offers a variety of remedies that may be helpful in ulcer treatment. Deglycyrrhizinated licorice or DGL, in a chewable or powder form, can help heal the mucous membranes and increase mucous so that it mixes with saliva to protect the membranes. Raw cabbage juice, high in glutanic acid, is very effective in healing an ulcer (take 1 quart per day in divided doses). Soothing herbs, such as plantain (Plantago major), marsh mallow (Althaea officinalis), and slippery elm (Ulmus fulva); astringent herbs, such as geranium (Pelargonium odoratissimum); and the anitmicrobial herb goldenseal (Hydrastis canadensis) can all be effective. Nutritionists advise taking antioxidant nutrients, including vitamins A, C, and E, zinc, and selenium. Prognosis The prognosis for recovery from ulcers is good for most patients. Very few ulcers fail to respond to the medications that are currently used to treat them. Recurrences can be cut to 5% by eradication of H. pylori. Most patients who develop complications recover without problems even when emergency surgery is necessary. Prevention Strategies for the prevention of ulcers or their recurrence include the following: eradication of H. pylori in patients already diagnosed with ulcers giving misoprostol to patients who must take NSAIDs avoiding unnecessary use of aspirin and NSAIDs giving up smoking cutting down on alcohol, tea, coffee, and sodas containing caffeine Answered by Roy Fire 1 year ago.

An untreated peptic ulcer — a sore in the lining of your stomach or small intestine — can cause internal bleeding. When this occurs, it's referred to as a bleeding ulcer. Signs and symptoms of a bleeding ulcer include: * Black, tarry, loose stools, sometimes with abdominal cramps * Vomiting blood, which may appear bright red or black like coffee grounds * Nausea, heartburn, indigestion or abdominal pain Peptic ulcers usually cause pain due to stomach acid washing over the open sore. But when bleeding occurs, it may buffer the acid and decrease the pain. So, some people with bleeding ulcers may not have pain. Answered by Nada Minister 1 year ago.

Bleeding during urination, throwing up blood. Stomach pain. Those are the biggest symptoms. If you gush out blood from both ends get to the hospital immediately. Answered by Terry Ardizone 1 year ago.

You will have a sharp pain in your stomach. You will have a bloody stool. Don't mess around with this. You need to get to a hospital and get things checked out and let them get you on medication. Answered by Marvin Weinreb 1 year ago.

A person can have black stools, be dizzy at times, have pain in the ears, and tired. If your doctor gives you a blood test you can have a low blood count. Answered by Rob Lax 1 year ago.

severe stomach pain and ur stool would be bloody Answered by Cristobal Brookskennedy 1 year ago.

vomiting blood that should be a real sign Answered by Dalia Maute 1 year ago.

being very nauseous and throwing up blood Answered by Jolene Folan 1 year ago.

Black stool!! Answered by Mechelle Nuce 1 year ago.


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