1. PREVACID HISTORY

How was Prevacid discovered?
Prevacid is a product of TAP pharmaceuticals.

TAP began in 1977 as a joint venture between two global pharmaceutical leaders, Abbott, based in the United States, and Takeda Pharmaceutical Company Limited, based in Japan.

TAP Pharmaceutical is a creative, diverse, and unique company led by a team dedicated to delivering high-quality pharmaceutical products for patients.

Note: World-drugs.net sells generic version of Prevacid

2. PREVACID FACTS

Prevacid is a medication that is effective for many people in fighting heartburn associated with acid reflux disease and healing damage to your esophagus.

One Prevacid a day can:

• Help prevent the acid that causes heartburn pain
• Provide heartburn relief for up to 24 hours
• Heal damage to your esophagus
• Stop the damage from coming back if maintenance therapy is prescribed

Prevacid is indicated for the treatment of acid reflux disease including erosive esophagitis.

Prevacid is generally well tolerated and has a low occurrence of side effects such as diarrhea, abdominal pain, and nausea. Symptom relief does not rule out serious stomach conditions.

3. ABOUT PREVACID MEDICATION

What Is GERD?
GERD stands for Gastro Esophageal Reflux Disease. "Gastro" refers to the stomach. Esophageal refers to the esophagus, the tube that carries food from the mouth to the stomach. Reflux means to back-up or flow backwards. GERD is a condition in which acid; bile and partially digested food in the stomach back up into the esophagus.

• Partially digested food contains a strong acid. It also contains powerful enzymes that break down food. When acid and enzymes come into contact with the esophagus, they cause irritation, inflammation, pain, and other symptoms.
• The stomach lining has a special protective layer that protects the stomach from acid attack. However, this protective layer does not exist in the esophagus, making it vulnerable to damage from stomach acid and digestive enzymes

• Many people think that heartburn (or acid indigestion) is a separate disease. It actually is one symptom of GERD. Heartburn is an unpleasant burning sensation behind the breastbone that usually occurs after a meal.
• Most individuals with GERD also have hiatal hernias, which make it easier for stomach contents to reflux into the esophagus. A hiatal hernia occurs when part of the stomach bulges into the chest cavity through an opening in the diaphragm (hiatus). The diaphragm is a sheet of muscle that separates the stomach cavity from the chest cavity.

What are the symptoms of GERD?
Heartburn is the most common symptom of GERD. It feels like a burning chest pain right behind the breastbone. Pain may move upward toward the throat. It often is worse after meals. Bending over or lying down also may make heartburn worse. Standing up may bring relief. Heartburn often occurs after going to bed at night.

Other GERD symptoms include:

• Burping-up, or regurgitation, of sour-tasting, acidy material into the mouth.
• Difficult or painful swallowing.
• Sore throat, hoarseness, and/or cough.
• Wheezing in people with asthma.

GERD also occurs in young children who may have the same symptoms as adults but cannot describe them. The only noticeable symptoms in infants and children may be vomiting, coughing, wheezing or other respiratory problems, and failure to gain weight normally.

What Causes GERD?
GERD occurs when a muscle at the lower end of the esophagus does not work properly. The muscle is called the lower esophageal sphincter (LES). Sphincters are ring-like bands of muscle that contract, or squeeze together, to close off body passageways. The body has many sphincters. Perhaps the most familiar is the anal sphincter, which seals off the rectum between bowel movements.

• The LES acts like a one-way valve that closes off the esophagus. It allows food to travel freely downward into the stomach. But it also seals off the stomach, preventing partially digested food from refluxing, or passing back up, through the esophagus.
• Normally, the LES closes immediately after a person swallows food, keeping irritating stomach acid and digestive enzymes out of the esophagus.
• In individuals with GERD, the LES may not close in a normal way or relaxes inappropriately between swallows. Stomach juices and partially digested food may flow back up and burn the lower esophagus. The result is heartburn and other symptoms of GERD.

Treating Acid Reflux Disease
There is a range of treatment options for acid reflux disease and associated symptoms. It's best to talk to your doctor about which treatment might work best for you.

Antacids are available without a prescription (over-the-counter, or "OTC") and are used primarily for heartburn. Typically, they can provide limited, short-term relief. If you are experiencing heartburn two or more days a week, even though you've tried some over-the-counter treatments and changed your diet, it may be a sign of something more serious, and you should talk to your doctor.

H2 blockers are available over-the-counter and by prescription. They get their name from the way they block one particular stimulus of acid production. H2 blockers reduce the amount of acid that is produced in the stomach, but not as much as proton pump inhibitors. If you continue to suffer from heartburn while you are taking an H2 blocker, you should see your doctor. Your doctor may develop a different treatment plan.

proton pump inhibitors (PPIs) are available by prescription. PPIs block the final stage of acid production. They are very effective and can relieve symptoms in most people who have acid reflux disease.

Prevacid contains the active ingredient lansoprazole, which is a type of medicine called a proton pump inhibitor. Prevacid works by reducing the production of stomach acid.

stomach acid is produced as a normal part of the digestive process. When we digest food, the cells lining the inside of the stomach use a mechanism called a proton pump to produce stomach acid. Prevacid works by stopping the proton pumps from working. This reduces the production of stomach acid.

Prevacid is therefore used to relieve the symptoms of indigestion and heartburn that are caused by excess production of stomach acid.

Prevacid is also used to treat various medical complaints that result from the effect of stomach acid on the lining of the stomach and duodenum (an area of the intestine directly after the stomach). The linings of the stomach and duodenum usually resist attack from stomach acid. However, if these linings are damaged, or large amounts of stomach acid are produced, the acid can irritate them, causing an ulcer to develop on the wall of the stomach or duodenum. This is known as a peptic ulcer, and continuing production of acid in the stomach will continue to irritate it and prevent it from healing.

As Prevacid reduces the amount of acid in the stomach and duodenum it is used to help ulcers to heal. Treatment with lansoprazole can also be continued after the ulcer has healed to help prevent it from recurring.

Prevacid is also used in combination with antibiotics to help eradicate a type of bacteria called Helicobacter pylori from the stomach. This type of bacteria is associated with the development of most duodenal ulcers. Prevacid allows the ulcers to heal and also creates an environment in the gut in which the antibiotics can work most effectively to eradicate the bacteria.

In addition, Prevacid is used to treat peptic ulcers that can sometimes occur as a side effect of non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac. NSAIDs relieve pain and inflammation by reducing the production of substances called prostaglandins. Unfortunately, prostaglandins are also produced in the stomach and help to protect the stomach lining from acid, so NSAIDs can allow the acid to irritate the stomach. Prevacid is used to treat peptic ulcers that occur due to this irritation. It also relieves side effects such as indigestion that can be associated with taking these medicines. Prevacid is also sometimes prescribed in combination with NSAIDs to help prevent ulcers from developing.

Prevacid can also treat other conditions related to excess production of stomach acid, such as the Zollinger-Ellison syndrome.

4. PREVACID EFFECTIVENESS

When is Prevacid best taken?
Pharmacokinetics and Metabolism
Prevacid Delayed-Release Capsules contain an enteric-coated granule formulation of lansoprazole. Absorption of lansoprazole begins only after the granules leave the stomach. Absorption is rapid, with mean peak plasma levels of lansoprazole occurring after approximately 1.7 hours. Peak plasma concentrations of lansoprazole (C max) and the area under the plasma concentration curve (AUC) of lansoprazole are approximately proportional in doses from 15 mg to 60 mg after single-oral administration. Prevacid does not accumulate and its pharmacokinetics are unaltered by multiple dosing.

Absorption
The absorption of lansoprazole is rapid, with mean C max occurring approximately 1.7 hours after oral dosing, and relatively complete with absolute bioavailability over 80%. In healthy subjects, the mean (±SD) plasma half-life was 1.5 (±1.0) hours. Both C max and AUC are diminished by about 50% to 70% if the drug is given 30 minutes after food as opposed to the fasting condition. There is no significant food effect if Prevacid is given before meals.

Distribution
Lansoprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 0.05 to 5.0 µg/mL.

Metabolism
Lansoprazole is extensively metabolized in the liver. Two metabolites have been identified in measurable quantities in plasma (the hydroxylated sulfinyl and sulfone derivatives of lansoprazole). These metabolites have very little or no antisecretory activity. Prevacid is thought to be transformed into two active species which inhibit acid secretion by (H +, K + )-ATPase within the parietal cell canaliculus, but are not present in the systemic circulation. The plasma elimination half-life of Prevacid does not reflect its duration of suppression of gastric acid secretion. Thus, the plasma elimination half-life is less than two hours, while the acid inhibitory effect lasts more than 24 hours.

Elimination
Following single-dose of Prevacid oral administration, virtually no unchanged lansoprazole was excreted in the urine. In one study, after a single oral dose of 14 C-lansoprazole, approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the feces. This implies a significant biliary excretion of the metabolites of lansoprazole.

5. PREVACID EFFECTS ON SPECIAL POPULATION

How do different people react to Prevacid?
Geriatric
The clearance of Prevacid is decreased in the elderly; with elimination half-life increased approximately 50% to 100%. Because the mean half-life in the elderly remains between 1.9 to 2.9 hours, repeated once daily dosing does not result in accumulation of Prevacid . Peak plasma levels were not increased in the elderly. No dosage adjustment is necessary in the elderly.

Pediatric
The pharmacokinetics of Prevacid was studied in pediatric patients with GERD aged 1 to 11 years, with Prevacid doses of 15 mg q.d. for subjects weighing </= 30 kg and 30 mg q.d. for subjects weighing > 30 kg. Prevacid pharmacokinetics in these pediatric patients were similar to that observed in healthy adult subjects. The mean C max and AUC values were similar between the two dose groups and were not affected by weight or age within each weight-adjusted dose group used in this study.

Gender
In a study comparing 12 male and 6 female human subjects, no gender differences were found in pharmacokinetics and intragastric pH results.

6. PREVACID EFFECTS ON MEDICAL CONDITIONS

How does Prevacid affect your existing condition/ailment?
Renal Insufficiency
In patients with severe renal insufficiency, plasma protein binding decreased by 1.0%-1.5% after administration of 60 mg of Prevacid. Patients with renal insufficiency had a shortened elimination half-life and decreased total AUC. AUC for free Prevacid in plasma, however, was not related to the degree of renal impairment, and C max and T max were not different from subjects with healthy kidneys. No dosage adjustment is necessary in patients with renal insufficiency.

Hepatic Insufficiency
In patients with various degrees of chronic hepatic disease, the mean plasma half-life of Prevacid was prolonged from 1.5 hours to 3.2-7.2 hours. An increase in mean AUC of up to 500% was observed at steady state in hepatically impaired patients compared to healthy subjects. Dose reduction in patients with severe hepatic disease should be considered.

7. OTHER/ALTERNATE USES OF PREVACID

What else does Prevacid treat?
Prevacid works by reducing the amount of acid produced in the stomach.

Treatment with Prevacid is usually short-term (up to 4 weeks) for duodenal ulcers (ulcers near the exit from the stomach). It is also used for up to 8 weeks in the treatment of stomach ulcers, gastroesophageal reflux disease (backflow of acid into the canal to the stomach), and a condition called erosive esophagitis (severe inflammation of the canal). Once a duodenal ulcer or case of esophagitis has cleared up, the doctor may continue prescribing Prevacid to prevent a relapse.

Prevacid is also prescribed to reduce the risk of stomach ulcers in people who develop this problem while taking non-steroidal anti-inflammatory drugs such as Advil, Motrin, and Naprosyn.

Prevacid is also used for long-term treatment of certain diseases marked by excessive acid production, such as Zollinger-Ellison syndrome.

Prevacid is also prescribed as part of a combination treatment to eliminate the H. pylori infection that causes most cases of duodenal ulcer.

8. ADVERSE/SIDE EFFECTS of PREVACID

What are the side effects of Prevacid?
Worldwide, over 10,000 patients have been treated with Prevacid in Phase 2-3 clinical trials involving various dosages and durations of treatment. The adverse reaction profiles for Prevacid Delayed-Release Capsules are similar. In general, Prevacid treatment has been well tolerated in both short-term and long-term trials.

The following adverse events were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of Prevacid treated patients and occurred at a greater rate in Prevacid-treated patients than placebo-treated patients:

Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received Prevacid 15 mg and 30 mg, but higher in the patients who received Prevacid 60 mg (2.9%, 1.4%, 4.2%, and 7.4%, respectively).

The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

In the risk reduction study of Prevacid for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with Prevacid was 5%, misoprostol 22%, and placebo 3%.

Additional adverse experiences occurring in <1% of patients or subjects in domestic trials are shown below.

Body as a Whole - abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain, chills, edema, fever, flu syndrome, halitosis, infection, malaise, neck pain, neck rigidity, pain, pelvic pain;

Cardiovascular System - angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation;

Digestive System - abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcers, esophagitis, fecal discoloration, flatulence, gastric nodules/funded gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, oral moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis;

Endocrine System - diabetes mellitus, goiter, hypothyroidism;

Hemic and Lymphatic System - anemia, hemolysis, lymphadenopathy;

Metabolic and Nutritional Disorders - gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss;

Musculoskeletal System - arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, synovitis;

Nervous System - abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo;

Respiratory System - asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor;

Skin and Appendages - acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria;

Special Senses - abnormal vision, blurred vision, conjunctivitis, deafness, dry eyes, ear disorder, eye pain, otitis media, parosmia, photophobia, retinal degeneration, taste loss, taste perversion, tinnitus, visual field defect;

Urogenital System - abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary tract infection, urinary urgency, urination impaired, vaginitis.

Postmarketing
Additional adverse experiences have been reported since Prevacid has been marketed. The majority of these cases are foreign-sourced and a relationship to lansoprazole has not been established. Because these events were reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

Body as a Whole - anaphylactoid-like reaction;

Digestive System - hepatotoxicity, vomiting;

Hemic and Lymphatic System - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Special Senses - speech disorder;

Urogenital System - urinary retention.