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Ampyra™ Approved to Improve Walking for Individuals with MS
On January 22, 2010, the United States’ Food and Drug Administration (FDA) approved Ampyra™ (dalfampridine), to improve walking in individuals with MS. Ampyra is an oral, timed-release medication developed to improve the conduction of impulses between damaged nerves of the central nervous system (CNS). Phase III clinical trials showed that a greater number of individuals with MS experienced improvement in walking speed when taking Ampyra, compared to when taking a placebo.
Ampyra (pronounced “am-PEER-ah”) was developed by Acorda Therapeutics and is manufactured by Elan Corporation. Formerly known as Fampridine-SR, Ampyra is a sustained-release version of 4-aminopyridine (4AP). In earlier studies, larger doses of the drug were given and the risk of seizures became a concern. Given in timed-release tablets, the risk of seizures did not differ from the placebo group.
MSAA Chief Medical Officer Jack Burks, MD notes, “The majority of my patients experience problems with mobility, so this approval comes as welcomed news to the entire MS community, especially since it has shown positive results with both relapsing and progressive forms of MS.
“Following the instructions for correct dosing is absolutely essential. Taking more than one tablet within 12 hours, or crushing or splitting a tablet, will increase the risk for seizures. Some patients tend to think that taking more of a symptom-management drug will result in greater effectiveness, but this is definitely not the case with this type of medication. I strongly advise patients not to exceed the recommended dosing.”
Individuals with a history or evidence of seizures, or with moderate to severe kidney problems, should not be given Ampyra. Kidney function is important, since nearly all of this medication is removed from the body through the kidneys. If the kidneys are not functioning properly, levels of the drug will rise and increase the risk for seizures.
Ampyra is a symptom-management drug to improve walking in MS patients. It may be given in conjunction with any FDA-approved disease-modifying therapy and with other symptom-management drugs, but patients need to check with their doctor before combining Ampyra with other medications.
According to the FDA, the most common side effects reported for Ampyra include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling in the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling, or itching of skin.
Anyone interested in this drug for symptom management should consult his or her physician, who can help to determine if this drug is appropriate. It is distributed exclusively through a network of specialty pharmacies, coordinated by Ampyra Patient Support Services. Consumers as well as healthcare professionals may contact Ampyra Patient Support Services at (888) 881-1918 or visit www.ampyra.com for more information.