I. Aciphex Fact File

Aciphex is manufactured by Eisai Inc.

Eisai Inc. is supported by a strong parent company, Eisai Co., Ltd., which was founded in Japan in 1941 as Nihon Eisai Co., Ltd. To this day, Eisai Co., Ltd. is one of the few Japanese pharmaceutical companies to undertake aggressive global expansion through substantial infrastructure investments in its foreign affiliates.

Eisai Inc. is a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of more than $1.7 billion in fiscal year 2003 (year ending March 31, 2004).

II. Aciphex Medication

Aciphex medication is in a class of drugs known as Proton Pump Inhibitors. Generic Aciphex is used for the treatment of persistent, frequent (2 or more days a week) heartburn and other symptoms associated with acid reflux disease.

Aciphex medication is used for:

1. Short-term healing of a gradual breakdown (erosion) or sore (ulceration) in the esophagus which may be caused by the backward flow of gastric acid from the stomach into the esophagus (gastroesophageal reflux disease or GERD);
2. Maintenance of healing of erosive or ulcerative GERD;
3. Treatment of daytime and nighttime heartburn and other symptoms associated with GERD;
4. Short-term (up to 4 weeks) healing of an ulcer in the duodenum;
5. Elimination of Helicobacter pylori, in combination with amoxicillin and clarithromycin, to reduce the risk of duodenal ulcer recurrence in patients with a current duodenal ulcer or a duodenal ulcer in the past 5 years;
6. Medical conditions that result in the body secreting too much acid, including Zollinger-Ellison syndrome.

Generic Aciphex medication has a well-established safety profile. The most common side effect possibly related to Aciphex is headache. Symptom relief does not rule out other serious stomach conditions.

Antacids: Information

Antacids are medicines that neutralize stomach acid. Antacids are used to relieve acid indigestion, upset stomach, sour stomach, and heartburn.

Antacids may be divided into two classes, those that work by chemical neutralization of gastric acid, most notably sodium bicarbonate; and those that act by adsorption of the acid (non-absorbable antacids), such as calcium and magnesium salts.

The chemical antacids show the most rapid onset of action, but may cause "acid rebound," a condition in which the gastric acid returns in greater concentration after the drug effect has stopped. Also, since these antacids may contain high concentrations of sodium, they may be inappropriate in patients with hypertension.

Calcium and magnesium salts act by adsorption of the acid, and are less prone to the rebound effect, but may have other significant disadvantages. These antacids are particularly prone to drug interactions, and patients taking other medications must often avoid simultaneous administration of the medications. These antacids are more effective in liquid formulations than in tablet or capsule form, and so may be inconvenient for routine dosing.

Additional components of some formulations include dimethicone, to reduce gas pains (flatulence) and alginic acid, which, in combination with antacids, may help manage GERD (gastro-esophageal reflux disease). Antacids should not be confused with gastric acid inhibitors, such as the H-2 receptor blockers (cimetidine, ranitide and others) or the proton pump inhibitors (lansoprazole, omeprazole, Esomeprazole, pantoprazole and rabeprazole). Although all three classes of drugs act to reduce the levels of gastric acid, their mechanisms are different, and this affects the appropriate use of the drug.

Proton pump inhibitors (PPIs) are one of the most commonly prescribed classes of medications in the primary care setting and are considered a major advance in the treatment of acid-peptic diseases. Since the introduction of omeprazole (Prilosec) in 1989, several other PPIs have become available. The intravenous form of pantoprazole (Protonix I.V.) is available, and the U.S. Food and Drug Administration (FDA) approved the newest PPI, esomeprazole (Nexium), in 2001. PPIs inhibit the production of gastric acid. This allows the inflamed and damaged lining in the gullet (oesophagus) and the stomach to heal. Damage to the lining occurs in conditions such as oesophagitis (inflammation of the gullet), gastritis (inflammation of the stomach lining) and stomach ulcers (both duodenal & peptic).

Antacids have a rapid onset and short duration of action, and are most appropriate for rapid relief of gastric discomfort for a short period of time.

Gastroesophageal Reflux Disease (GERD): Information

Gastroesophageal reflux disease (GERD) is a digestive disorder that is caused by gastric acid flowing from the stomach into the esophagus.

Gastroesophageal refers to the stomach and esophagus, and reflux means to flow back or return. Gastroesophageal reflux (GER) is the return of acidic stomach juices, or food and fluids, back up into the esophagus.

GERD is very common in infants, though it can occur at any age. It is the most common cause of vomiting during infancy.

Diagram 1: Gastroesophageal reflux disease

Diagram 2: Gastroesophageal reflux disease

Causes of GERD

GERD is often the result of conditions that affect the lower esophageal sphincter (LES). The LES, a muscle located at the bottom of the esophagus, opens to let food in and closes to keep food in the stomach. When this muscle relaxes too often or for too long, acid refluxes back into the esophagus, causing vomiting or heartburn.

Everyone has gastroesophageal reflux from time to time. If you have ever burped and had an acid taste in your mouth, you have had reflux. The lower esophageal sphincter occasionally relaxes at inopportune times, and usually, all your child will experience is a bad taste in the mouth, or a mild, momentary feeling of heartburn.

Infants are more likely to have the lower esophageal sphincter (LES) relax when it should remain shut. As food or milk is digesting, the LES opens and allows the stomach contents to go back up the esophagus. Sometimes, the stomach contents go all the way up the esophagus and the infant or child vomits. Other times, the stomach contents only go part of the way up the esophagus, causing heartburn, breathing problems, or, possibly, no problems at all.

Some foods seem to affect the muscle tone of the lower esophageal sphincter, allowing it to stay open longer than normal. These include, but are not limited to, the following:

• chocolate
• peppermint
• high-fat foods

Other foods increase acid production in the stomach, including:

• citrus foods
• tomatoes and tomato sauces

Symptoms of GERD

Heartburn, also called acid indigestion, is the most common symptom of GERD. Heartburn is described as a burning chest pain that begins behind the breastbone and moves upward to the neck and throat. It can last as long as two hours and is often worse after eating. Lying down or bending over can also result in heartburn.

The following are other common symptoms of GERD:

• belching
• refusal to eat
• stomachache
• fussiness around mealtimes
• frequent vomiting
• hiccups
• gagging
• choking
• frequent cough
• coughing fits at night
• wheezing
• frequent upper respiratory infections (colds)
• rattling in the chest
• frequent sore throats in the morning
• sour taste in the mouth

The symptoms of GERD may resemble other conditions or medical problems. Consult your physician for a diagnosis.

Side effects of Antacids

Side effects are very rare when antacids are taken as directed. They are more likely when the medicine is taken in large doses or over a long time. Minor side effects include a chalky taste, mild constipation or diarrhea, thirst, stomach cramps, and whitish or speckled stools. These symptoms do not need medical attention unless they do not go away or they interfere with normal activities.

Other uncommon side effects may occur. Anyone who has unusual symptoms after taking antacids should get in touch with his or her health care provider.

PPIs are generally well tolerated and any undesirable effects are usually mild and transient.

The most common adverse effects are headache, dizziness and tiredness. You may also experience diarrhea, rash, itching, gastric upsets, blurred vision, swollen ankles, depression, dry mouth & allergy. A problem that can occur with long-term use of proton pump inhibitors is stomach infections. Stomach acid helps to kill microscopic organisms (microbes) such as bacteria in the stomach. Because proton pump inhibitors completely stop acid production using them can lead to a growth of microbes in the stomach.

Alternate uses of Antacids

• The non-absorbable antacids may have additional uses beyond control of hyperacidity. Calcium salts may be used as diet supplements in prevention of osteoporosis.
• Aluminum carbonate is useful for binding phosphate, and has been effective in treatment and control of hyperphosphatemia or for use with a low phosphate diet to prevent formation of phosphate urinary stones. This application is particularly valuable in patients with chronic renal failure.
• Antacids with aluminum and magnesium hydroxides or aluminum hydroxide alone effectively prevent significant stress ulcer bleeding in post-operative patients or those with severe burns.
• Proton pump inhibitors are used to heal stomach and duodenal ulcers. This includes stomach ulcers caused by taking non-steroidal anti-inflammatory drugs. They are also used to relieve symptoms of oesophagitis (inflammation of the oesophagus or gullet) and severe gastro-oesophageal reflux, a condition where acid leaks up from the stomach into the gullet.
• In combination with certain antibiotics (e.g. amoxycillin and clarithromycin), proton pump inhibitors are used to get rid of Helicobacter pylori infection (a bacterial infection of the stomach), which is thought to be one of the main causes of recurring stomach ulcers.
• Proton pump inhibitors are also the drugs of first choice for a rare condition called Zollinger-Ellison syndrome. This is a condition where a tumor in the pancreas causes too much stomach acid to be produced and so leads to severe stomach ulceration.

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III. Useful links

http://www.cdc.gov/

http://www.fda.gov/

http://www.fda.gov/cder/ogd/

http://www.nih.gov/

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi

http://www.health.gov.on.ca/

National Library of Medicine

World Health Organization

http://www.mayoclinic.com/index.cfm

MedicineNet.com

Drugdigest.org

Healthsquare.com

http://www.aciphex.com

http://www.eisai.com

http://www.fda.gov/cder/consumerinfo/druginfo/Aciphex.HTM

http://www.heartburn.about.com

http://www.healthatoz.com/healthatoz/Atoz/ency/antacids.jsp

http://www.bupa.co.uk/health_information/html/medicine/proton_pump.html

Pharmacy sites

http://www.roche.com/home/company/com_hist.htm

http://www.healthdigest.org/Bactrim-DS(Oral)_2006_PRO.php

http://www.hsforum.com/stories/storyReader$1509

http://www.hsforum.com/stories/storyReader$1504

http://www.people.vcu.edu/~urdesai/atc.htm#Process%20of%20clotting

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