Astepro From Meda Pharms With Azelastine Hydrochloride Eq 0.1876mg Base/spray Information
The Ingredients: Azelastine Hydrochloride
Dosage Form and Administration: "spray, Metered; Nasal"
Drug Trade Name: Astepro
Firm: Meda Pharms
Strength: EQ 0.1876MG BASE/SPRAY
New Drug Application Type: N
The Drug Application Number:22371
Medicine Product Number: 1
Approval Date: 8/31/2009
Reference Listed Drug: Yes
Type: RX
Applicant Full Name: Meda Pharmaceuticals Inc
Surgical Weight
A fat loss surgeon performs bariatric surgery, bypass surgery, gastric banding and obesity surgery. Surgical weight control is an option for very overweight who cannot lose pounds with only a healthy diet and exercise. Weight loss surgery limits the amount of food a person can intake. Some operations also restrict the amount of food the stomach can digest. Many people who have fat loss surgery lose weight quickly. If patients follow all diet and exercise recommendations, most can keep the weight off. Like all surgeries, fat loss surgery has risks and complications, including infections, hernias and blood clots. Men who are at least 100 pounds overweight and women who are at least 80 pounds overweight are eligible for this surgery. If candidates somewhat less overweight, surgery still might be an option if they also have diabetes, heart disease or sleep apnea. Bariatric surgery, or weight loss surgery, is a type of procedure that doctors perform on people who are dangerously obese. This procedure achieves weight loss by surgical reduction of the size of the stomach by means of an implanted gastric banding device, through removal of a portion of the stomach or by re-sectioning and re-routing the small intestines to a small stomach pouch as gastric bypass surgery. Long-term studies show the procedures result in significant long-term weight loss, recovery from diabetes, improvement in cardiovascular risk factors and a reduction in mortality of 23 percent to 40 percent. The U.S. National Institutes of Health recommends bariatric surgery for obese people with a body mass index (BMI) of at least 40.
Continuous Positive Airway Pressure
Continuous Positive Airway Pressure (CPAP) is the most effective treatment for sleep apnea in adults. CPAP delivers air into the airway through a specially designed nasal mask attached to a machine that acts as a pump. The mask does not breathe for the person; the flow of air creates enough increased pressure to keep the airways in the nose and mouth more open while the person sleeps. The air pressure adjusts so that it is just enough to stop the airways from briefly becoming too small during sleep. The pressure is constant and continuous. Sleep apnea will return if a person uses CPAP incorrectly or stops using CPAP all together.
People who have severe sleep apnea symptoms generally feel much better once treatment with CPAP begins. CPAP treatment can cause side effects in some people. Possible side effects include dry or stuffy nose, irritation of the skin on the face, bloating of the stomach, sore eyes or headaches. If troubles with CPAP side effects persist, sleep medicine specialists and support staff can help.
Currently, no medications cure sleep apnea. However, the prescription drug modafinil may help relieve the excessive sleepiness that sometimes persists even with CPAP treatment of sleep apnea.
Another treatment approach that may help some people is the use of a mouthpiece (oral or dental appliance). If a person suffers from have mild sleep apnea or do not have sleep apnea but snores very loudly, a doctor or dentist may also recommend a mouthpiece. A dentist or an orthodontist will make a custom-fitted plastic mouthpiece. The mouthpiece will adjust the lower jaw and tongue to help keep the airway in the throat more open while sleeping. Air can then flow more easily into the lungs because there is less resistance to breathing. Following up with the dentist or orthodontist is important to correct any side effects and to be sure that the mouthpiece continues to fit properly.
Some people who have sleep apnea, depending on the findings of the evaluation by the sleep medicine specialist, may benefit from surgery. Removing tonsils and adenoids that block the airway often helps children who suffer from sleep apnea. For some adults who suffer from sleep apnea, an uvulopalatopharyngoplasty (UPPP), which removes the tonsils, uvula (the tissue that hangs from the middle of the back of the roof of the mouth) and part of the soft palate (roof of the mouth in the back of the throat) is helpful. Doctors rarely perform tracheotomies and only do so in severe sleep apnea cases when no other treatments have been successful. Doctors cut a small hole in the windpipe and insert a tube. Air will flow through the tube and into the lungs, bypassing the obstruction in the upper airway.
Restless Legs Syndrome (RLS)
Restless legs syndrome (RLS) causes an unpleasant prickling or tingling in the legs, especially in the calves, that moving or massaging relieves. This sensation creates a need to stretch or move the legs to get rid of these uncomfortable or painful feelings. As a result, a person may have difficulty falling asleep and staying asleep. A person may suffer from RLS in one or both legs. Some people feel these sensations in the arms. These sensations can also occur with lying down or sitting for prolonged periods, such as while at a desk, riding in a car or watching a movie.
Many people who have RLS also have brief limb movements during sleep, often with abrupt onset, occurring every 5 to 90 seconds. This condition, known as periodic limb movements in sleep (PLMS), can repeatedly awaken people who have RLS and reduce total sleep time. Some people have PLMS but have no abnormal sensations in the legs while awake.
RLS affects 5 to 15 percent of Americans and its prevalence increases with age. RLS occurs more often in women than men. One study found that RLS accounted for one-third of the insomnia seen in patients older than age 60. Children also can have RLS. This condition can be difficult to diagnose in children and doctors sometimes confuse it with hyperactivity or "growing pains."
Most people inherit RLS. Pregnancy, kidney failure and anemia related to iron or vitamin deficiency can trigger or worsen RLS symptoms. Researchers suspect that these conditions cause insufficient iron that results in a lack of dopamine. The brain uses dopamine to control limb movements. Doctors usually can diagnose RLS by symptoms and a telltale worsening of symptoms at night or while at rest. Some doctors may order a blood test for iron, although many people who have RLS have normal levels of iron in the blood but abnormal levels of iron in the fluid that bathes the brain. Doctors may also ask people who have RLS to spend a night in a sleep lab so that specialists can monitor and rule out other sleep disorders and to document the excessive limb movements.
RLS is a treatable but not curable condition. Patients improve dramatically when taking dopamine-like drugs. Alternatively, people who have milder cases may improve with sedatives or by behavioral strategies. These strategies include stretching, taking a hot bath or massaging the legs before bedtime. Avoiding caffeinated beverages can also help reduce symptoms. If iron or vitamin deficiency underlies RLS, symptoms may improve with prescribed iron, vitamin B12 or folate supplements. Some people may require anticonvulsant medications to stem the creeping and crawling sensations in the limbs. Others who have severe symptoms may need pain relievers, such as codeine or morphine or a combination of drug treatments.
Narcolepsy
A main symptom of narcolepsy is excessive and overwhelming daytime sleepiness, even after adequate nighttime sleep. In addition, nighttime sleep may be fragmented by frequent awakenings. People who have narcolepsy often fall asleep at inappropriate times and places. Although television sitcoms occasionally feature these individuals to generate a few laughs, narcolepsy is no laughing matter. People who have narcolepsy experience daytime "sleep attacks" that last from seconds to more than one-half hour, can occur without warning and may cause injury. These embarrassing sleep spells can also make it difficult to work and to maintain normal personal or social relationships.
With narcolepsy, people experience the usually sharp distinctions between being asleep and awake as a blur. Also, people who have narcolepsy tend to fall directly into dream-filled REM sleep, rather than enter REM sleep gradually after passing through the non-REM sleep stages first.
In addition to overwhelming daytime sleepiness, narcolepsy has three other commonly associated symptoms, but these may not occur in all people:
- Sudden muscle weakness (cataplexy). This weakness is similar to the paralysis that normally occurs during REM sleep, but can last up to a few minutes while the individual is awake. Sudden emotional reactions, such as anger, surprise, fear or laughter can trigger cataplexy. The weakness may show up as limpness at the neck, buckling of the knees or sagging facial muscles affecting speech or it may cause a complete body collapse.
- Sleep paralysis. People who have narcolepsy may experience a temporary inability to talk or move when falling asleep or waking up, as if glued to the bed.
- Vivid (hypnogogic) dreams. These dreams tend to surface when people who have narcolepsy first fall asleep. The dreams are so lifelike that people may become confused with reality.
Experts estimate that as many as 350,000 Americans have narcolepsy, but fewer than 50,000 have diagnoses. The disorder is as widespread as Parkinson's disease or multiple sclerosis and more prevalent than cystic fibrosis, but people know less about narcolepsy. Sometimes doctors mistake narcolepsy for depression, epilepsy or the side effects of medicines.
Narcolepsy can be difficult to diagnose in people who have only the symptom of excessive daytime sleepiness. Doctors can more easily diagnose narcolepsy with overnight sleep recording (PSG) and the MSLT. Both tests reveal signs of narcolepsy--the tendency to fall asleep rapidly and enter REM sleep early, even during brief naps.
Narcolepsy can develop at any age, but symptoms tend to appear first during adolescence or early adulthood. About 1 of every 10 people who have narcolepsy has a close family member who has the disorder, suggesting that one can inherit a tendency to develop narcolepsy. Studies suggest that a neurotransmitter called hypocretin plays a key role in narcolepsy. Most people who have narcolepsy lack hypocretin, which promotes wakefulness. Scientists believe that an autoimmune reaction, perhaps triggered by disease or brain injury, specifically destroys the hypocretin-generating cells in the brains of people who have narcolepsy.
Eventually, researchers may develop a treatment for narcolepsy that restores hypocretin to normal levels. In the meantime, most people who have narcolepsy find relief to some to all of the symptoms from various drug treatments. For example, central nervous system stimulants can reduce daytime sleepiness. Antidepressants and other drugs that suppress REM sleep can prevent muscle weakness, sleep paralysis and vivid dreaming. Doctors also usually recommend that people who have narcolepsy take short naps (10 to 15 minutes) two or three times a day, if possible, to help control excessive daytime sleepiness.
Parasomnias (Abnormal Arousals)
In some people, walking, talking and other body functions normally suppressed during sleep emerge during certain sleep stages. Alternatively, the paralysis or vivid images people usually experience during dreaming may persist after awakening. Specialists call these arousal malfunctions parasomnias and include confusional arousals, sleep talking, sleep walking, night terrors, sleep paralysis and REM sleep behavior disorder (acting out dreams). Most of these disorders appear more often in children, who tend to outgrow them once in adulthood. Sleep-deprived individuals also may experience some of these disorders, including sleep walking and sleep paralysis. Sleep paralysis also commonly occurs in people who have narcolepsy. Certain medications or neurological disorders appear to lead to other parasomnias, such as REM sleep behavior disorder and these parasomnias tend to occur more in elderly people.
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