31152 Aviane-28 From Duramed Pharms Barr With Ethinyl Estradiol; Levonorgestrel 0.02mg;0.1mg listed at Acne Zits Drugs

The Ingredients: Ethinyl Estradiol; Levonorgestrel
Dosage Form and Administration: Tablet; Oral-28
Drug Trade Name: Aviane-28
Firm: Duramed Pharms Barr
Strength: 0.02MG;0.1MG
New Drug Application Type: A
The Drug Application Number: 75796
Medicine Product Number: 1
Approval Date: 4/30/2001
Reference Listed Drug: No
Type: RX
Applicant Full Name: Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc
Local Number: 31152

Lap Band

A lap band is an inflatable silicone device that a surgeon places around the top portion of the stomach, via laparoscopic surgery, in order to treat obesity. Lap band surgery is an example of bariatric surgery designed for obese patients with a body mass index (BMI) of 40 or greater, or between 35 to 40 in cases of patients with certain co-morbidities that are known to improve with weight loss, such as sleep apnea, diabetes, osteoarthritis, high blood pressure or metabolic syndrome, among others. Lap banding is the least invasive surgery of all bariatric surgeries. Lap banding using laparoscopic surgery usually results in a shorter hospital stay, faster recovery, smaller scars, and less pain than open surgical procedures. The patient can continue to absorb nutrients from food normally. Lap bands are made entirely of biocompatible materials, so they can stay in the body without causing harm. However, not all patients are eligible for laparoscopy. Patients who are extremely obese, who have had previous abdominal surgery or have complicating medical problems may require a more open surgery approach. The surgeon creates a small incision near the belly button and pumps carbon dioxide into the abdomen to create a workspace. Then the surgeon inserts a small laparoscopic camera through the incision into the abdomen. The camera sends a picture of the stomach and abdominal cavity to a video monitor. It gives the surgeon a good view of the key structures in the abdominal cavity. The surgeon makes more small incisions in the abdomen. The surgeon watches the video monitor and works through these small incisions using instruments with long handles to complete the procedure. The surgeon creates a small, circular tunnel behind the stomach, inserts the lap band through the tunnel and locks the band around the stomach. Clinical studies of lap band surgery patients found that they felt better, spent more time doing recreational and physical activities, benefited from enhanced productivity and economic opportunities and had more self-confidence than they did before surgery. The placement of the band creates a small pouch, or stoma, at the top of the stomach. This pouch holds approximately one half cup of food. A typical stomach holds about six cups of food. The pouch fills with food quickly, and the band slows the passage of food from the pouch to the lower part of the stomach, causing the sensation of being full. As the upper part of the stomach registers as full, the message to the brain is that the entire stomach is full, and this sensation helps a person to be hungry less often, feel full more quickly and for a longer period, eat smaller portions, and lose weight over time. As patients lose weight, their bands will need adjustments, or "fills," to ensure comfort and effectiveness. The surgeon can adjust the lap band by introducing a saline solution into a small access port just under the skin. There are many port designs and a surgeon may place them in varying positions, but they always connect to the muscle wall in and around the diaphragm via sutures or staples.

Sleep Apnea

In people who have sleep apnea (also recalled sleep-disordered breathing), breathing briefly stops or becomes very shallow during sleep. This change is from intermittent blocking of the upper airway, usually when the soft tissue in the rear of the throat collapses and partially or completely closes the airway. Each breath­ing stop typically lasts 10 to 20 seconds or more and may occur 20 to 30 times or more each sleeping hour.
If a person has sleep apnea, not enough air can flow into the lungs through the mouth and nose during sleep, even though breathing efforts continue. When this happens, the amount of oxygen in the blood decreases. The brain responds by waking up enough to tighten the upper airway muscles and open the windpipe. Normal breaths then start again, often with a loud snort or choking sound. Although people who have sleep apnea typically snore loudly and frequently, not everyone who snores has sleep apnea.
Because people who have sleep apnea frequently rouse from deeper sleep stages to lighter sleep during the night, these people rarely spend enough time in deep, restorative stages of sleep. These people are therefore often excessively sleepy during the day. Such sleepiness can trigger mood and behavioral problems, including depression and such sleepiness more than triples the risk of being in a traffic- or work-related accident.
The many brief drops in blood-oxygen levels can result in morning headaches and a decreased ability to concentrate, think prop­erly, learn and remember. In sleep apnea, the combination of the intermittent oxygen drops and reduced sleep quality triggers the release of stress hormones. These hormones in turn raise blood pressure and heart rate and boost the risk of heart attack, stroke, irregular heartbeats and congestive heart failure. In addition, untreated sleep apnea can lead to altered energy metabolism that increases the risk for developing obesity and diabetes.
Anyone can have sleep apnea. Approximately 12 to 18 million American adults have sleep apnea, making it as common as asthma. More than one-half of the people who have sleep apnea are overweight. Sleep apnea is more common in men. More than 1 in 25 middle-aged men and 1 in 50 middle-aged women have sleep apnea along with excessive daytime sleepiness. About 3 percent of children and 10 percent or more of people over age 65 have sleep apnea. This condition occurs more frequently in African Americans, Asians, Native Americans and Hispanics than in Caucasians.
More than one-half of all people who have sleep apnea do not receive a diagnosis. People who have sleep apnea generally are not aware that breathing stops in the night. These people just notice not feeling rested when in the morning and are sleepy throughout the day. Some bed partners are likely to notice, however, that the other person snores loudly and frequently and even often stop breathing briefly while sleeping. With these symptoms present, doctors suspect sleep but must confirm the diagnosis with overnight sleep monitoring. (See "How Are Sleep Disorders Diagnosed?"). This monitoring will reveal pauses in breathing, frequent sleep arousals and intermittent drops in levels of oxygen in the blood.
Like adults who have sleep apnea, children who have this disorder usually snore loudly, snort or gasp and have brief stops in breathing while sleeping. Small children often have enlarged tonsils and ade­noids that increase their risk for sleep apnea. But doctors may not suspect sleep apnea in children because, instead of showing the typical signs of sleepiness during the day, these children often become agitat­ed and may be considered hyperactive. The effects of sleep apnea in children may include diminished school performance and difficult, aggressive behavior.

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