(Phoenix, AZ) – The hCG Ultimate Fat Burning Diet has received significant publicity based on impressive weight-loss results. However, this diet is extremely sensitive and must be monitored by a medical professional to assure desired results are achieved.
“Many unqualified businesses and on-line companies have recently advertised their version of the hCG diet,” said Dr. Ann Watwood, Medical Director at Derma Health Institute of Ahwatukee. “It’s important for consumers to realize this is a specialized program that requires the close supervision of a doctor. At Derma Health Institute, patients are seen weekly to ensure they’re achieving a positive outcome without medical complications.”
The Ultimate Fat Burning Diet involves the hormone hCG, or human chorionic gonadotropin, to assist in weight loss. This natural hormone is found in both men and women and increases significantly during the early stages of pregnancy. Clinically, it has been shown that using this hormone in combination with a very specific low calorie diet will stimulate the body to mobilize and burn extra fat cells for energy.
When administered properly, patients can see a weight loss average of 10-25 pounds over the three week hCG program. When used incorrectly, consumers reported feeling faint and weak, dizziness, extreme hunger attributed to improper hormone administration and no weight loss at all.
“This type of extreme diet can be dangerous if a patient is not correctly monitored,” Watwood added. “At Derma Health Institute, blood samples are taken before the diet begins to confirm there are no underlying health problems like diabetes, high blood pressure, hyperthyroidism or issues with kidneys or liver that could adversely affect the patients overall health. Patients are then monitored by physicians in weekly meeting to ensure that there are no complications that could affect their health or success on the diet."
Consumers need to remember it’s illegal to purchase any drug without a prescription from a licensed practitioner and medications sold in other countries are not held to the same safety standards of those sold in the United States. Therefore, there is nothing in place to confirm a substance ordered on-line is really hCG.
For more information on the hCG diet contact Derma Health Institute at (480) 539-0777 Mesa/Gilbert, (480) 730-9000 Chandler/Tempe, (480) 460-1505 Ahwatukee/Phoenix or (480) 991-7900 Paradise Valley/Scottsdale.
http://www.dermahealthinstitute.com
Showing posts with label Dangers. Show all posts
Showing posts with label Dangers. Show all posts
Wednesday, February 17, 2010
Monday, August 31, 2009
FDA Accutane Dangers and Side Effects Guide
ACCUTANE (ACK-U-TANE)
(isotretinoin capsules)
Read the Medication Guide that comes with Accutane before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
For more information about safer Acne Treatments at Derma Health Institute, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=177
What is the most important information I should know about Accutane?
• Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
• Because Accutane can cause birth defects, Accutane is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program.
• Accutane may cause serious mental health problems.
1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Accutane. Female patients must not get pregnant:
• for 1 month before starting Accutane
• while taking Accutane
• for 1 month after stopping Accutane.
• If you get pregnant while taking Accutane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:
• FDA MedWatch at 1-800-FDA-1088, and
• the iPLEDGE pregnancy registry at 1-800-495-0654
2. Serious mental health problems. Accutane may cause:
• depression
• psychosis (seeing or hearing things that are not real)
• suicide. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives.
Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:
• start to feel sad or have crying spells
• lose interest in activities you once enjoyed
• sleep too much or have trouble sleeping
• become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
• have a change in your appetite or body weight
• have trouble concentrating
• withdraw from your friends or family
• feel like you have no energy
• have feelings of worthlessness or guilt
• start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
• start acting on dangerous impulses
• start seeing or hearing things that are not real
After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.
What is Accutane?
Accutane is a medicine taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Accutane can cause serious side effects (see “What is the most important information I should know about Accutane?”). Accutane can only be:
• prescribed by doctors that are registered in the iPLEDGE program
• dispensed by a pharmacy that is registered with the iPLEDGE program
• given to patients who are registered in the iPLEDGE program and agree to do everything required in the program
What is severe nodular acne?
Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars.
Who should not take Accutane?
• Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. See “What is the most important information I should know about Accutane?”
• Do not take Accutane if you are allergic to anything in it. Accutane contains parabens as the preservative. See the end of this Medication Guide for a complete list of ingredients in Accutane.
What should I tell my doctor before taking Accutane?
Tell your doctor if you or a family member has any of the following health conditions:
• mental problems
• asthma
• liver disease
• diabetes
• heart disease
• bone loss (osteoporosis) or weak bones
• an eating problem called anorexia nervosa (where people eat too little),
• food or medicine allergies
Tell your doctor if you are pregnant or breastfeeding. Accutane must not be used by women who are pregnant or breastfeeding.
Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:
• Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects.
• Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain.
• Progestin-only birth control pills (mini-pills). They may not work while you take Accutane. Ask your doctor or pharmacist if you are not sure what type you are using.
• Dilantin (phenytoin). This medicine taken with Accutane may weaken your bones.
• Corticosteroid medicines. These medicines taken with Accutane may weaken your bones.
• St. John’s Wort. This herbal supplement may make birth control pills work less effectively.
These medicines should not be used with Accutane unless your doctor tells you it is okay.
Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.
How should I take Accutane?
• You must take Accutane exactly as prescribed. You must also follow all the instructions of the iPLEDGE program. Before prescribing Accutane, your doctor will:
• explain the iPLEDGE program to you
• have you sign the Patient Information/Informed Consent (for all patients). Female patients who can get pregnant must also sign another consent form.
You will not be prescribed Accutane if you can not agree to or follow all the instructions of the iPLEDGE program.
• You will get no more than a 30-day supply of Accutane at a time. This is to make sure you are following the Accutane iPLEDGE program. You should talk with your doctor each month about side effects.
• The amount of Accutane you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
• Take Accutane 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your Accutane capsules whole with a full glass of liquid. Do not chew or suck on the capsule. Accutane can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole.
• If you miss a dose, just skip that dose. Do not take 2 doses at the same time.
• If you take too much Accutane or overdose, call your doctor or poison control center right away.
• Your acne may get worse when you first start taking Accutane. This should last only a short while. Talk with your doctor if this is a problem for you.
• You must return to your doctor as directed to make sure you don’t have signs of serious side effects. Your doctor may do blood tests to check for serious side effects from Accutane. Female patients who can get pregnant will get a pregnancy test each month.
• Female patients who can become pregnant must agree to use 2 separate forms of effective birth control at the same time 1 month before, while taking, and for 1 month after taking Accutane. You must access the iPLEDGE system to answer questions about the program requirements and to enter your 2 chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1-866-495-0654.
You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Accutane.
If you have sex at any time without using 2 forms of effective birth control, get pregnant, or miss your expected period, stop using Accutane and call your doctor right away.
What should I avoid while taking Accutane?
• Do not get pregnant while taking Accutane and for 1 month after stopping Accutane. See “What is the most important information I should know about Accutane?”
• Do not breast feed while taking Accutane and for 1 month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby.
• Do not give blood while you take Accutane and for 1 month after stopping Accutane. If someone who is pregnant gets your donated blood, her baby may be exposed to Accutane and may be born with birth defects.
• Do not take other medicines or herbal products with Accutane unless you talk to your doctor. See “What should I tell my doctor before taking Accutane?”.
• Do not drive at night until you know if Accutane has affected your vision. Accutane may decrease your ability to see in the dark.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
• Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light.
• Do not share Accutane with other people. It can cause birth defects and other serious health problems.
What are the possible side effects of Accutane?
• Accutane can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. See “What is the most important information I should know about Accutane?”
• Accutane may cause serious mental health problems. See “What is the most important information I should know about Accutane?”
• serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Accutane and call your doctor right away if you get any of these signs of increased brain pressure:
• bad headache
• blurred vision
• dizziness
• nausea, or vomiting
• seizures (convulsions)
• stroke
• stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your doctor if you get:
• severe stomach, chest or bowel pain
• trouble swallowing or painful swallowing
• new or worsening heartburn
• diarrhea
• rectal bleeding
• yellowing of your skin or eyes
• dark urine
• bone and muscle problems. Accutane may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your doctor if you plan hard physical activity during treatment with Accutane. Tell your doctor if you get:
• back pain
• joint pain
• broken bone. Tell all healthcare providers that you take Accutane if you break a bone.
Stop Accutane and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.
Accutane may stop long bone growth in teenagers who are still growing.
• hearing problems. Stop using Accutane and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
• vision problems. Accutane may affect your ability to see in the dark. This condition usually clears up after you stop taking Accutane, but it may be permanent. Other serious eye effects can occur. Stop taking Accutane and call your doctor right away if you have any problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking Accutane and after treatment.
• lipid (fats and cholesterol in blood) problems. Accutane can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Accutane treatment is finished.
• serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
• blood sugar problems. Accutane may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
• decreased red and white blood cells. Call your doctor if you have trouble breathing, faint, or feel weak.
The common, less serious side effects of Accutane are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get any side effect that bothers you or that does not go away.
These are not all of the possible side effects with Accutane. Your doctor or pharmacist can give you more detailed information.
How should I store Accutane?
• Store Accutane at room temperature, between 59° and 86°F. Protect from light.
• Keep Accutane and all medicines out of the reach of children.
General Information about Accutane.
Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Accutane for a condition for which it was not prescribed. Do not give Accutane to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Accutane. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Accutane that is written for health care professionals. You can also call iPLEDGE program at 1-800-495-0654 or visit www.ipledgeprogram.com.
What are the ingredients in Accutane?
Active Ingredient: Isotretinoin
Inactive Ingredients: beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg — iron oxide (red) and titanium dioxide; 20 mg — FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg — FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Dilantin is a registered trademark of Warner-Lambert Company LLC.
For more information about safer Acne Treatments at Derma Health Institute, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=177
Source: FDA.gov
(isotretinoin capsules)
Read the Medication Guide that comes with Accutane before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
For more information about safer Acne Treatments at Derma Health Institute, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=177
What is the most important information I should know about Accutane?
• Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
• Because Accutane can cause birth defects, Accutane is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program.
• Accutane may cause serious mental health problems.
1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Accutane. Female patients must not get pregnant:
• for 1 month before starting Accutane
• while taking Accutane
• for 1 month after stopping Accutane.
• If you get pregnant while taking Accutane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:
• FDA MedWatch at 1-800-FDA-1088, and
• the iPLEDGE pregnancy registry at 1-800-495-0654
2. Serious mental health problems. Accutane may cause:
• depression
• psychosis (seeing or hearing things that are not real)
• suicide. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives.
Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:
• start to feel sad or have crying spells
• lose interest in activities you once enjoyed
• sleep too much or have trouble sleeping
• become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
• have a change in your appetite or body weight
• have trouble concentrating
• withdraw from your friends or family
• feel like you have no energy
• have feelings of worthlessness or guilt
• start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
• start acting on dangerous impulses
• start seeing or hearing things that are not real
After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.
What is Accutane?
Accutane is a medicine taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Accutane can cause serious side effects (see “What is the most important information I should know about Accutane?”). Accutane can only be:
• prescribed by doctors that are registered in the iPLEDGE program
• dispensed by a pharmacy that is registered with the iPLEDGE program
• given to patients who are registered in the iPLEDGE program and agree to do everything required in the program
What is severe nodular acne?
Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars.
Who should not take Accutane?
• Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. See “What is the most important information I should know about Accutane?”
• Do not take Accutane if you are allergic to anything in it. Accutane contains parabens as the preservative. See the end of this Medication Guide for a complete list of ingredients in Accutane.
What should I tell my doctor before taking Accutane?
Tell your doctor if you or a family member has any of the following health conditions:
• mental problems
• asthma
• liver disease
• diabetes
• heart disease
• bone loss (osteoporosis) or weak bones
• an eating problem called anorexia nervosa (where people eat too little),
• food or medicine allergies
Tell your doctor if you are pregnant or breastfeeding. Accutane must not be used by women who are pregnant or breastfeeding.
Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:
• Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects.
• Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain.
• Progestin-only birth control pills (mini-pills). They may not work while you take Accutane. Ask your doctor or pharmacist if you are not sure what type you are using.
• Dilantin (phenytoin). This medicine taken with Accutane may weaken your bones.
• Corticosteroid medicines. These medicines taken with Accutane may weaken your bones.
• St. John’s Wort. This herbal supplement may make birth control pills work less effectively.
These medicines should not be used with Accutane unless your doctor tells you it is okay.
Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.
How should I take Accutane?
• You must take Accutane exactly as prescribed. You must also follow all the instructions of the iPLEDGE program. Before prescribing Accutane, your doctor will:
• explain the iPLEDGE program to you
• have you sign the Patient Information/Informed Consent (for all patients). Female patients who can get pregnant must also sign another consent form.
You will not be prescribed Accutane if you can not agree to or follow all the instructions of the iPLEDGE program.
• You will get no more than a 30-day supply of Accutane at a time. This is to make sure you are following the Accutane iPLEDGE program. You should talk with your doctor each month about side effects.
• The amount of Accutane you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
• Take Accutane 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your Accutane capsules whole with a full glass of liquid. Do not chew or suck on the capsule. Accutane can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole.
• If you miss a dose, just skip that dose. Do not take 2 doses at the same time.
• If you take too much Accutane or overdose, call your doctor or poison control center right away.
• Your acne may get worse when you first start taking Accutane. This should last only a short while. Talk with your doctor if this is a problem for you.
• You must return to your doctor as directed to make sure you don’t have signs of serious side effects. Your doctor may do blood tests to check for serious side effects from Accutane. Female patients who can get pregnant will get a pregnancy test each month.
• Female patients who can become pregnant must agree to use 2 separate forms of effective birth control at the same time 1 month before, while taking, and for 1 month after taking Accutane. You must access the iPLEDGE system to answer questions about the program requirements and to enter your 2 chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1-866-495-0654.
You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Accutane.
If you have sex at any time without using 2 forms of effective birth control, get pregnant, or miss your expected period, stop using Accutane and call your doctor right away.
What should I avoid while taking Accutane?
• Do not get pregnant while taking Accutane and for 1 month after stopping Accutane. See “What is the most important information I should know about Accutane?”
• Do not breast feed while taking Accutane and for 1 month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby.
• Do not give blood while you take Accutane and for 1 month after stopping Accutane. If someone who is pregnant gets your donated blood, her baby may be exposed to Accutane and may be born with birth defects.
• Do not take other medicines or herbal products with Accutane unless you talk to your doctor. See “What should I tell my doctor before taking Accutane?”.
• Do not drive at night until you know if Accutane has affected your vision. Accutane may decrease your ability to see in the dark.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
• Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light.
• Do not share Accutane with other people. It can cause birth defects and other serious health problems.
What are the possible side effects of Accutane?
• Accutane can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. See “What is the most important information I should know about Accutane?”
• Accutane may cause serious mental health problems. See “What is the most important information I should know about Accutane?”
• serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Accutane and call your doctor right away if you get any of these signs of increased brain pressure:
• bad headache
• blurred vision
• dizziness
• nausea, or vomiting
• seizures (convulsions)
• stroke
• stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your doctor if you get:
• severe stomach, chest or bowel pain
• trouble swallowing or painful swallowing
• new or worsening heartburn
• diarrhea
• rectal bleeding
• yellowing of your skin or eyes
• dark urine
• bone and muscle problems. Accutane may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your doctor if you plan hard physical activity during treatment with Accutane. Tell your doctor if you get:
• back pain
• joint pain
• broken bone. Tell all healthcare providers that you take Accutane if you break a bone.
Stop Accutane and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.
Accutane may stop long bone growth in teenagers who are still growing.
• hearing problems. Stop using Accutane and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
• vision problems. Accutane may affect your ability to see in the dark. This condition usually clears up after you stop taking Accutane, but it may be permanent. Other serious eye effects can occur. Stop taking Accutane and call your doctor right away if you have any problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking Accutane and after treatment.
• lipid (fats and cholesterol in blood) problems. Accutane can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Accutane treatment is finished.
• serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
• blood sugar problems. Accutane may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
• decreased red and white blood cells. Call your doctor if you have trouble breathing, faint, or feel weak.
The common, less serious side effects of Accutane are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get any side effect that bothers you or that does not go away.
These are not all of the possible side effects with Accutane. Your doctor or pharmacist can give you more detailed information.
How should I store Accutane?
• Store Accutane at room temperature, between 59° and 86°F. Protect from light.
• Keep Accutane and all medicines out of the reach of children.
General Information about Accutane.
Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Accutane for a condition for which it was not prescribed. Do not give Accutane to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Accutane. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Accutane that is written for health care professionals. You can also call iPLEDGE program at 1-800-495-0654 or visit www.ipledgeprogram.com.
What are the ingredients in Accutane?
Active Ingredient: Isotretinoin
Inactive Ingredients: beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg — iron oxide (red) and titanium dioxide; 20 mg — FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg — FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Dilantin is a registered trademark of Warner-Lambert Company LLC.
For more information about safer Acne Treatments at Derma Health Institute, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=177
Source: FDA.gov
Minimally Invasive Cosmetic Procedures Should Not Taken Lightly
Dermatologists urge patients to ask questions to ensure safety of procedure
BOSTON, July 29 /PRNewswire-USNewswire/ -- Today, there are more ways than ever before to "get a little work done." From skin fillers to fat-reduction procedures, the options are endless for those looking to improve their appearance and boost their self-esteem. But with so many physicians and options from which to choose, consumers can be confused about where to start and who to trust to perform a cosmetic procedure.
For more information about Derma Health Institute, go to:
http://www.dermahealthinstitute.com
At the American Academy of Dermatology's Summer Academy Meeting 2009 in Boston, dermatologist C. William Hanke, MD, MPH, FAAD, clinical professor at Indiana University School of Medicine in Indianapolis, offered advice to help patients determine if a cosmetic procedure is right for them, including questions to ask the physician to ensure a safe and effective result or outcome.
"The best advice I can offer consumers is not to be afraid to ask physicians direct questions about their credentials, training, and patient results with any cosmetic procedure," said Dr. Hanke. "If you are not satisfied with the answers to your questions or if a physician becomes defensive, then these are red flags and you should seek another opinion."
To help consumers in choosing a qualified physician for a safe and effective cosmetic procedure, Dr. Hanke recommends the following:
Look for a physician who specializes in the cosmetic procedure.
Dr. Hanke cautioned that no physician is an expert at every cosmetic procedure. For example, some physicians specialize in laser procedures or liposuction, so Dr. Hanke suggested that consumers look for physicians with particular expertise in the procedure they are considering. Ideally, patients should request to see "before and after" photos of a physician's actual patients, rather than of another physician's work.
"To help them learn about the expected outcomes and downtime involved with a procedure, patients should ask their physician if they can speak with a patient who has undergone the procedure," said Dr. Hanke. "This might help them feel more comfortable about asking questions and to determine if a procedure is right for them."
The American Academy of Dermatology (Academy) also recommends that consumers ask physicians how many procedures they have performed, what results can be expected, how long the recuperation period is and what are the risks.
Consider the highly trained skills of a dermatologist for minimally invasive cosmetic procedures.
Dr. Hanke explained that most of the minimally invasive cosmetic procedures available today were either developed or refined by dermatologists, such as tumescent liposuction (liposuction using tumescent local anesthesia on awake patients), soft tissue (skin) fillers, and cutaneous laser surgery which includes the removal of tattoos, unwanted hair, and vascular birthmarks, and the treatment of sun-damaged skin.
"Dermatologists specialize in minimally invasive procedures that do not require general anesthesia. This greatly reduces the potential for complications since the patient is awake during the procedure and recovery times are decreased," said Dr. Hanke. "These procedures offer patients an enhanced version of themselves, and most patients would rather have subtle results than a drastic change, which is indicative of a major procedure."
Ask who will be performing the procedure.
Dr. Hanke acknowledged that there is inconsistency among physicians as to which cosmetic procedures can be safely and effectively performed by non-physicians. In its official position statement on the use of non-physician clinical personnel that offers guidelines to its members on this practice, the Academy recommends that under appropriate circumstances, a physician may delegate certain procedures and services to appropriately trained non-physicians, such as physician assistants or nurse practitioners. Specifically, the physician must directly supervise the non-physician clinicians to protect the best interests and welfare of each patient.
"Each physician must determine what procedures can safely be performed by nurses or other staff members in his or her own individual practices. This distinction should be made to patients up front to ensure they are comfortable with the expertise and training of the person who will be performing the procedure," said Dr. Hanke. "However, it is imperative that a physician be on-site to evaluate patients prior to a procedure and to respond promptly to any questions or concerns during or after the procedure."
Evaluate a physician's credentials before considering a procedure.
Although it may be difficult for consumers to ask physicians about their credentials and professional background, Dr. Hanke believes this information is crucial for a safe result or outcome. According to Dr. Hanke, one of the most telling questions that consumers can ask physicians is whether they are board certified by one of the 24 boards of the American Board of Medical Specialties (ABMS), such as the American Board of Dermatology. He explained that board certification is important, as it could indicate a physician's knowledge and experience with certain procedures.
In addition, consumers can research physicians on the Internet. State medical board Web sites typically offer information on physicians at no charge. "If a person isn't comfortable broaching the subject of credentials with a physician, there are ways to research this information online," said Dr. Hanke. "What's important is that consumers do their homework before selecting a physician."
Dr. Hanke also pointed out that physicians who are members of professional associations must meet certain qualifying standards as part of their membership. Professional organizations such as the American Academy of Dermatology and the American Society for Dermatologic Surgery offer members high-quality, accredited educational courses to learn about the most recent advances in the field and to refine their skills.
Discuss where the procedure will be performed and if office-based surgery is an option.
"A fully equipped physician's office that follows accepted standards for safety is an excellent option for patients to undergo a minimally invasive cosmetic procedure," said Dr. Hanke. "Compared to hospitals and ambulatory surgery centers, office-based surgery provides many advantages - including decreased costs, greater privacy, efficiency and less risk of infection."
The Academy also cautions consumers to avoid cosmetic procedures performed by non-physicians in spas, shopping malls and private parties or functions. While these venues may appear convenient or more cost-effective than a traditional medical setting, they are not necessarily equipped to handle complications or medical emergencies.
"The success of any cosmetic procedure depends on patients doing their homework up front and selecting a qualified physician to ensure a safe and successful outcome," said Dr. Hanke. "A good doctor/patient relationship is extremely important, and it increases the likelihood that a patient will feel comfortable asking the physician critical questions and discussing their expectations and concerns."
For more information on cosmetic procedures, go to the "AgingSkinNet" section of www.skincarephysicians.com, an Academy Web site developed by dermatologists that provides patients with up-to-date information on the treatment and management of disorders of the skin, hair and nails.
Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 16,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.
SOURCE American Academy of Dermatology
For more information about Derma Health Institute, go to:
http://www.dermahealthinstitute.com
BOSTON, July 29 /PRNewswire-USNewswire/ -- Today, there are more ways than ever before to "get a little work done." From skin fillers to fat-reduction procedures, the options are endless for those looking to improve their appearance and boost their self-esteem. But with so many physicians and options from which to choose, consumers can be confused about where to start and who to trust to perform a cosmetic procedure.
For more information about Derma Health Institute, go to:
http://www.dermahealthinstitute.com
At the American Academy of Dermatology's Summer Academy Meeting 2009 in Boston, dermatologist C. William Hanke, MD, MPH, FAAD, clinical professor at Indiana University School of Medicine in Indianapolis, offered advice to help patients determine if a cosmetic procedure is right for them, including questions to ask the physician to ensure a safe and effective result or outcome.
"The best advice I can offer consumers is not to be afraid to ask physicians direct questions about their credentials, training, and patient results with any cosmetic procedure," said Dr. Hanke. "If you are not satisfied with the answers to your questions or if a physician becomes defensive, then these are red flags and you should seek another opinion."
To help consumers in choosing a qualified physician for a safe and effective cosmetic procedure, Dr. Hanke recommends the following:
Look for a physician who specializes in the cosmetic procedure.
Dr. Hanke cautioned that no physician is an expert at every cosmetic procedure. For example, some physicians specialize in laser procedures or liposuction, so Dr. Hanke suggested that consumers look for physicians with particular expertise in the procedure they are considering. Ideally, patients should request to see "before and after" photos of a physician's actual patients, rather than of another physician's work.
"To help them learn about the expected outcomes and downtime involved with a procedure, patients should ask their physician if they can speak with a patient who has undergone the procedure," said Dr. Hanke. "This might help them feel more comfortable about asking questions and to determine if a procedure is right for them."
The American Academy of Dermatology (Academy) also recommends that consumers ask physicians how many procedures they have performed, what results can be expected, how long the recuperation period is and what are the risks.
Consider the highly trained skills of a dermatologist for minimally invasive cosmetic procedures.
Dr. Hanke explained that most of the minimally invasive cosmetic procedures available today were either developed or refined by dermatologists, such as tumescent liposuction (liposuction using tumescent local anesthesia on awake patients), soft tissue (skin) fillers, and cutaneous laser surgery which includes the removal of tattoos, unwanted hair, and vascular birthmarks, and the treatment of sun-damaged skin.
"Dermatologists specialize in minimally invasive procedures that do not require general anesthesia. This greatly reduces the potential for complications since the patient is awake during the procedure and recovery times are decreased," said Dr. Hanke. "These procedures offer patients an enhanced version of themselves, and most patients would rather have subtle results than a drastic change, which is indicative of a major procedure."
Ask who will be performing the procedure.
Dr. Hanke acknowledged that there is inconsistency among physicians as to which cosmetic procedures can be safely and effectively performed by non-physicians. In its official position statement on the use of non-physician clinical personnel that offers guidelines to its members on this practice, the Academy recommends that under appropriate circumstances, a physician may delegate certain procedures and services to appropriately trained non-physicians, such as physician assistants or nurse practitioners. Specifically, the physician must directly supervise the non-physician clinicians to protect the best interests and welfare of each patient.
"Each physician must determine what procedures can safely be performed by nurses or other staff members in his or her own individual practices. This distinction should be made to patients up front to ensure they are comfortable with the expertise and training of the person who will be performing the procedure," said Dr. Hanke. "However, it is imperative that a physician be on-site to evaluate patients prior to a procedure and to respond promptly to any questions or concerns during or after the procedure."
Evaluate a physician's credentials before considering a procedure.
Although it may be difficult for consumers to ask physicians about their credentials and professional background, Dr. Hanke believes this information is crucial for a safe result or outcome. According to Dr. Hanke, one of the most telling questions that consumers can ask physicians is whether they are board certified by one of the 24 boards of the American Board of Medical Specialties (ABMS), such as the American Board of Dermatology. He explained that board certification is important, as it could indicate a physician's knowledge and experience with certain procedures.
In addition, consumers can research physicians on the Internet. State medical board Web sites typically offer information on physicians at no charge. "If a person isn't comfortable broaching the subject of credentials with a physician, there are ways to research this information online," said Dr. Hanke. "What's important is that consumers do their homework before selecting a physician."
Dr. Hanke also pointed out that physicians who are members of professional associations must meet certain qualifying standards as part of their membership. Professional organizations such as the American Academy of Dermatology and the American Society for Dermatologic Surgery offer members high-quality, accredited educational courses to learn about the most recent advances in the field and to refine their skills.
Discuss where the procedure will be performed and if office-based surgery is an option.
"A fully equipped physician's office that follows accepted standards for safety is an excellent option for patients to undergo a minimally invasive cosmetic procedure," said Dr. Hanke. "Compared to hospitals and ambulatory surgery centers, office-based surgery provides many advantages - including decreased costs, greater privacy, efficiency and less risk of infection."
The Academy also cautions consumers to avoid cosmetic procedures performed by non-physicians in spas, shopping malls and private parties or functions. While these venues may appear convenient or more cost-effective than a traditional medical setting, they are not necessarily equipped to handle complications or medical emergencies.
"The success of any cosmetic procedure depends on patients doing their homework up front and selecting a qualified physician to ensure a safe and successful outcome," said Dr. Hanke. "A good doctor/patient relationship is extremely important, and it increases the likelihood that a patient will feel comfortable asking the physician critical questions and discussing their expectations and concerns."
For more information on cosmetic procedures, go to the "AgingSkinNet" section of www.skincarephysicians.com, an Academy Web site developed by dermatologists that provides patients with up-to-date information on the treatment and management of disorders of the skin, hair and nails.
Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 16,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.
SOURCE American Academy of Dermatology
For more information about Derma Health Institute, go to:
http://www.dermahealthinstitute.com
Friday, March 13, 2009
BOTOX® COSMETIC Wrinkle Free Solutions
Author: Dr HariMuralidharan
It is the hottest craze. With one minute injection, within minutes your face can be youthful, devoid of any unsightly wrinkles. BOTOX® clinics are popping up all over the country, helping clients venture back a few years into their past. A hub for beauty, unblemished skin, and eternal youth. Now a day’s most of the senior film stars were using BOTOX® to keep their porcelain skin wrinkle free. Although BOTOX® has been used for other conditions in the past such as neck spasms, cranial nerve disorders and eye spasms, when the FDA finally approved BOTOX® to be used to treat wrinkles, the popularity of the toxin rose tremendously.
For more information about Botox Cosmetic at Derma Health Institute, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=175
BOTOX® is currently the only form of botulisum toxin approved for such cosmetic purposes. It is a nonsurgical, physician-administered treatment that can temporarily reduce moderate to severe frown lines between the brows in patients 18 to 65 years of age. It is a mixture of several protoplasmic proteins that are released from cells after autolysis. BOTOX® is the brand name for a special formulation of botulinum toxin A manufactured by Allergan Inc., of Irvine, CA, U.S.A.,. BOTOX® is used to generate lines or wrinkles between the eyebrows look better. Initially, the toxin was used for eye muscle problems.
What is BOTOX® COSMETIC?
BOTOX® COSMETIC (Botulinum Toxin Type A) Purified Neurotoxin Complex is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose and yeast extract. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing albumin human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying. The specific activity of BOTOX® COSMETIC is approximately 20 units/nanogram of neurotoxin protein complex. Each vial of BOTOX® COSMETIC contains 100 units (U) of Clostridium botulinum type A neurotoxin complex, 0.5 milligrams of albumin (human), and 0.9 milligrams of sodium chloride in a sterile, vacuum-dried form without a preservative.
How was this found?
United States Food and Drug Aadmistration (FDA) approved BOTOX® over 10 years ago to treat certain problems with the eye muscle. Doctors observed that some wrinkles around the eyes looked better, too. The company that makes BOTOX® tested it. They showed the FDA that BOTOX® worked and was safe for treating some kinds of wrinkles. The lines that appear between your brows actually result from muscle movement and the passage of time. Two muscles are largely responsible for frown lines between the brows. When those muscles contract, they draw the brows together. As skin becomes less elastic over time, repeated frowning can result in those moderate to severe lines between your brows.
BOTOX® works by blocking nerve impulses, which reduces the movement of those muscles. With less movement, the skin surface gradually smoothes out, and the moderate to severe frown lines between your brows begin to fade. A doctor skilled in the use of BOTOX® will inject little amounts of BOTOX® into the muscle. Only the `treated muscle can’t move. BOTOX® works for about four months. As the muscle returns to normal, you will see the wrinkle again.
How is BOTOX® Tested for Potency?
The standard method for assessing the potency of BOTOX® is the LD50 Test. This test involves giving mice a single injection of the product into their abdominal cavity and seeing if they die within 3-4 days. The mice are first assigned to one of various dose groups. The aim of the test is to approximation the dose that kills 50% of the animals (hence the name “Lethal Dose 50%”).
The LD value is designated as a unit (U) or a Mouse Unit (MU) of potency. The lower the LD50 value (or the U or MU), the higher the potency. Approximately 100 mice have conventionally been used to test each batch of botulinum toxins products, though Allergan has claimed that the company has significantly reduced this number. Depending on the dose injected and the potency of the batch being assessed, the test animals experience differing levels of muscular paralysis and impaired vision. The end point of the LD50 Test is death, usually by suffocation after the respiratory muscle becomes paralyzed.
Background of hazardous bacterial toxin as a biological weapon
The term “toxin” means the toxic material of plants, animals, microorganisms, viruses, fungi, or infectious substances, or a recombinant molecule, whatever its origin or method of production, including – (A) any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or (B) any poisonous isomer or biological product, homolog, or derivative of such a substance.
Over 60 years ago, botulinum toxin was first developed as a biological weapon; it can be aerosolised, or used to contaminate food, and the estimated lethal oral dose is 70 µg. Botulism is a rare paralytic disease caused by botulinum neurotoxin (BT), a protein produced by the soil anaerobic bacteria Clostridium botulinum. Eight types of Cl. botulinum have been identified (Types A, B, C1, C2, D, E, F, G) based on the immunological diversity in the toxins produced by them. The toxins are proteins with molecular weights of approximately 70,000 mgD. Botulinum toxin is the most poisonous substance known and the microorganism that manufactures it is relatively easy to isolate from nature and to culture. The only problem is making sure that oxygen is excluded from cultures. Despite its large size, the toxin molecule is stable enough to be dispersed as an aerosol.
The toxin was considered for use as a major biological weapon by Britain and Japan during the 1930's and there are suggestions that it was used by the Japanese to poison streams used as water sources by the Soviets. It has also been suggested that either the microorganism or the toxin were incorporated into grenades used in the assassination of the Reinhard Gehlen, Hitler's likely successor and Reichsprotektor of Czechoslovakia.
A biological warfare attack with botulinum toxin delivered by aerosol will expected to cause symptoms similar in most respects to those observed with food-borne botulism. Commercially this organism attacked in canned food industry due to contamination. Proper sterilization will remove these organisms. In pure form, the toxin is a white crystalline substance, which is readily dissolvable in water, but decays rapidly in the open air. The lethal dose of toxin is very minute amount, for mice, its amount is 0.000,000,033 mg .The lethal dose of human being is probably 1-2 µg. It is a neurotoxin and acts gradually, taking several hours to kill.
Naturally-occurring cases of botulism arise from food spoiling in the absence of oxygen in canned foods. The commonest source historically has been spoiled meat, notably sausage (the species name derives from the Latin botulus meaning "sausage") and poultry (especially duck), and improperly sterilized canned foods. The neurotoxin produced from Clostridium tetani (tetanus toxin)another bacteria from some genus is encountered by humans as a result of wounds and remains a serious public health problem in developing countries around the world.
How long does the effect last?
BOTOX® can help by reducing the over activity of the muscles very quickly. In fact, most people begin to see results within the first two weeks. Generally, BOTOX® provides release of spasticity in the injected muscle for over three months (12-14 weeks). Then patients begin to notice a gradual fading of its effects over several weeks. At this point the doctor can give another treatment. BOTOX® treatment may be required three or four times a year. It is not given more frequently than every three months.
Side effects may include:
All prescriptions may have some side effects. With BOTOX®, side effects are usually transient and mild to moderate in nature. Side effects are usually temporary, and BOTOX® is generally well tolerated. Mild bruising or swelling may occur at the site of the injection. The treatment may also cause a brief headache. In rare cases, the injections may cause the eyebrow or upper eyelid to droop, but this condition is temporary and corrects itself without treatment within 2 to 3 weeks. The effects of BOTOX® may be increased with the use of certain antibiotics or other drugs that interfere with neuromuscular transmission. Ensure your doctor is aware of any current medications you are taking. If you have any questions regarding the use of BOTOX® treatment, please consult your doctor. Some side effects includes
• Droopy eyelids, which can last for a few weeks
• Feeling like you have the flu
• Headache and upset stomach
• Risk of botulism (a life or death illness that makes it hard for a person to move the arms and legs or to breathe) is low with BOTOX® if used the right way
Most patients experience minimal pain or discomfort following injections. Swelling and puffiness at the site of the injection usually subside within a few days. Care must be taken to keep the head upright and avoid massaging the treated area, so that the BOTOX® affects only the desired areas.
Who Markets BOTOX®?
BOTOX® is marketed by Allergan, Incorporated, which describes itself as “a global specialty pharmaceutical company that develops and commercializes innovative products for the eye care, neuromodulator, skin care and other specialty markets.” Allergan made over $1.2 billion dollars in net BOTOX® sales in 2007. 50% of that ($606 million) came from BOTOX® COSMETIC. Total yearly sales of BOTOX® increased 406% between 2000 and 2007. Net sales in 2007 for all Allergan products reached $3.88 billion, of which BOTOX® and BOTOX® COSMETIC accounted for 31%.
In order to learn more specifically about the product BOTOX® please visit the official Allergan site, where you can also find listings of private offices offering a variety of services to treat many aesthetic issues, such as wrinkle reduction. Most wrinkles may be treated with BOTOX® injections.
References:
1. Wang YC, Burr DH, Korthals GJ, Sugiyama H. Acute toxicity of aminoglycoside antibiotics as an aid in detecting botulism. Appl Environ Microbiol 1984; 48:951-955.
2. Allergan (ELN 1145) BOTOX® COSMETIC (Botulinum Toxin Type A) Purified Neurotoxin Complex(Glabellar Lines) Manufactured by: Allergan Pharmaceuticals (Ireland) Ltd. A subsidiary of: Allergan, Inc. 2525 Dupont Dr. Irvine, California 92612.
3. Bazbek Davletov, Mark Bajohrs and Thomas Binz, Beyond BOTOX: advantages and limitations of individual botulinum neurotoxins, TRENDS in Neurosciences Vol.28 No.8 August 2005.
4. Harimuraleedharan , Book: Bioterrorism (Releasing book review),Tamilnadu book
house, Chapter:Biological agents/clostridium.
5. Teguh Thajeb, Yi-Min Chen, Dao-Fu Dai, Daniel Daile Thajeb, Peterus Thajeb Botulism: A Frequently Forgotten Old Malady, Review Article, International Journal of Gerontology September 2007 Vol 1 No 3.
6. Lewis, C. (2002) Botox Cosmetic: A look at looking good. FDA Consumer Magazine July–August, 1–4 .
Guidelines for BOTOX® Reconstitution
1. Using the reconstitution needle, draw up the proper amount of saline (see dilution table) in the appropriately sized sterile syringe. A 21-gauge, 1®-inch needle is recommended for reconstitution. Reconstituted BOTOX® neurotoxin should be clear, colorless, and free of particulate matter.
2. Insert the needle at a 45º angle and slowly inject the saline into the BOTOX® vial. Vacuum is present in the vial, which demonstrates that the sterility of the vial is intact. Do not use the vial if the vacuum does not pull the saline into the vial.
3. Release the vacuum by disconnecting the syringe from the needle and allowing air to flow into the vial. Gently mix BOTOX® neurotoxin with the saline by moving vial side-to-side or rotating the vial.
4. Draw the fluid into the injection syringe by placing the needle into the bottom corner of the vial for full extraction. Do not completely invert the vial.
5. Disconnect the injection syringe from the vial and attach an appropriate needle for injection. A 25-, 27-, or 30-gauge needle may be used for superficial muscles, and a longer 22-gauge needle may be used for deeper musculature.
Note: Because the product and diluent do not contain a preservative, use within 4 hours once opened and reconstituted. During the 4 hours, BOTOX® solution should be stored in a refrigerator at 2ºC to 8ºC.
For more information about Botox Cosmetic at Derma Health Institute, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=175
About the Author:
R&D scientistMIOBIO Biological Reserach Center(MBRC)Bnagloreinfo@miobio.comwww.miobio.in
Article Source: http://www.articlesbase.com/skin-care-articles/botox-botox-cosmetic-wrinkle-free-solutions-713380.html
It is the hottest craze. With one minute injection, within minutes your face can be youthful, devoid of any unsightly wrinkles. BOTOX® clinics are popping up all over the country, helping clients venture back a few years into their past. A hub for beauty, unblemished skin, and eternal youth. Now a day’s most of the senior film stars were using BOTOX® to keep their porcelain skin wrinkle free. Although BOTOX® has been used for other conditions in the past such as neck spasms, cranial nerve disorders and eye spasms, when the FDA finally approved BOTOX® to be used to treat wrinkles, the popularity of the toxin rose tremendously.
For more information about Botox Cosmetic at Derma Health Institute, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=175
BOTOX® is currently the only form of botulisum toxin approved for such cosmetic purposes. It is a nonsurgical, physician-administered treatment that can temporarily reduce moderate to severe frown lines between the brows in patients 18 to 65 years of age. It is a mixture of several protoplasmic proteins that are released from cells after autolysis. BOTOX® is the brand name for a special formulation of botulinum toxin A manufactured by Allergan Inc., of Irvine, CA, U.S.A.,. BOTOX® is used to generate lines or wrinkles between the eyebrows look better. Initially, the toxin was used for eye muscle problems.
What is BOTOX® COSMETIC?
BOTOX® COSMETIC (Botulinum Toxin Type A) Purified Neurotoxin Complex is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose and yeast extract. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing albumin human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying. The specific activity of BOTOX® COSMETIC is approximately 20 units/nanogram of neurotoxin protein complex. Each vial of BOTOX® COSMETIC contains 100 units (U) of Clostridium botulinum type A neurotoxin complex, 0.5 milligrams of albumin (human), and 0.9 milligrams of sodium chloride in a sterile, vacuum-dried form without a preservative.
How was this found?
United States Food and Drug Aadmistration (FDA) approved BOTOX® over 10 years ago to treat certain problems with the eye muscle. Doctors observed that some wrinkles around the eyes looked better, too. The company that makes BOTOX® tested it. They showed the FDA that BOTOX® worked and was safe for treating some kinds of wrinkles. The lines that appear between your brows actually result from muscle movement and the passage of time. Two muscles are largely responsible for frown lines between the brows. When those muscles contract, they draw the brows together. As skin becomes less elastic over time, repeated frowning can result in those moderate to severe lines between your brows.
BOTOX® works by blocking nerve impulses, which reduces the movement of those muscles. With less movement, the skin surface gradually smoothes out, and the moderate to severe frown lines between your brows begin to fade. A doctor skilled in the use of BOTOX® will inject little amounts of BOTOX® into the muscle. Only the `treated muscle can’t move. BOTOX® works for about four months. As the muscle returns to normal, you will see the wrinkle again.
How is BOTOX® Tested for Potency?
The standard method for assessing the potency of BOTOX® is the LD50 Test. This test involves giving mice a single injection of the product into their abdominal cavity and seeing if they die within 3-4 days. The mice are first assigned to one of various dose groups. The aim of the test is to approximation the dose that kills 50% of the animals (hence the name “Lethal Dose 50%”).
The LD value is designated as a unit (U) or a Mouse Unit (MU) of potency. The lower the LD50 value (or the U or MU), the higher the potency. Approximately 100 mice have conventionally been used to test each batch of botulinum toxins products, though Allergan has claimed that the company has significantly reduced this number. Depending on the dose injected and the potency of the batch being assessed, the test animals experience differing levels of muscular paralysis and impaired vision. The end point of the LD50 Test is death, usually by suffocation after the respiratory muscle becomes paralyzed.
Background of hazardous bacterial toxin as a biological weapon
The term “toxin” means the toxic material of plants, animals, microorganisms, viruses, fungi, or infectious substances, or a recombinant molecule, whatever its origin or method of production, including – (A) any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or (B) any poisonous isomer or biological product, homolog, or derivative of such a substance.
Over 60 years ago, botulinum toxin was first developed as a biological weapon; it can be aerosolised, or used to contaminate food, and the estimated lethal oral dose is 70 µg. Botulism is a rare paralytic disease caused by botulinum neurotoxin (BT), a protein produced by the soil anaerobic bacteria Clostridium botulinum. Eight types of Cl. botulinum have been identified (Types A, B, C1, C2, D, E, F, G) based on the immunological diversity in the toxins produced by them. The toxins are proteins with molecular weights of approximately 70,000 mgD. Botulinum toxin is the most poisonous substance known and the microorganism that manufactures it is relatively easy to isolate from nature and to culture. The only problem is making sure that oxygen is excluded from cultures. Despite its large size, the toxin molecule is stable enough to be dispersed as an aerosol.
The toxin was considered for use as a major biological weapon by Britain and Japan during the 1930's and there are suggestions that it was used by the Japanese to poison streams used as water sources by the Soviets. It has also been suggested that either the microorganism or the toxin were incorporated into grenades used in the assassination of the Reinhard Gehlen, Hitler's likely successor and Reichsprotektor of Czechoslovakia.
A biological warfare attack with botulinum toxin delivered by aerosol will expected to cause symptoms similar in most respects to those observed with food-borne botulism. Commercially this organism attacked in canned food industry due to contamination. Proper sterilization will remove these organisms. In pure form, the toxin is a white crystalline substance, which is readily dissolvable in water, but decays rapidly in the open air. The lethal dose of toxin is very minute amount, for mice, its amount is 0.000,000,033 mg .The lethal dose of human being is probably 1-2 µg. It is a neurotoxin and acts gradually, taking several hours to kill.
Naturally-occurring cases of botulism arise from food spoiling in the absence of oxygen in canned foods. The commonest source historically has been spoiled meat, notably sausage (the species name derives from the Latin botulus meaning "sausage") and poultry (especially duck), and improperly sterilized canned foods. The neurotoxin produced from Clostridium tetani (tetanus toxin)another bacteria from some genus is encountered by humans as a result of wounds and remains a serious public health problem in developing countries around the world.
How long does the effect last?
BOTOX® can help by reducing the over activity of the muscles very quickly. In fact, most people begin to see results within the first two weeks. Generally, BOTOX® provides release of spasticity in the injected muscle for over three months (12-14 weeks). Then patients begin to notice a gradual fading of its effects over several weeks. At this point the doctor can give another treatment. BOTOX® treatment may be required three or four times a year. It is not given more frequently than every three months.
Side effects may include:
All prescriptions may have some side effects. With BOTOX®, side effects are usually transient and mild to moderate in nature. Side effects are usually temporary, and BOTOX® is generally well tolerated. Mild bruising or swelling may occur at the site of the injection. The treatment may also cause a brief headache. In rare cases, the injections may cause the eyebrow or upper eyelid to droop, but this condition is temporary and corrects itself without treatment within 2 to 3 weeks. The effects of BOTOX® may be increased with the use of certain antibiotics or other drugs that interfere with neuromuscular transmission. Ensure your doctor is aware of any current medications you are taking. If you have any questions regarding the use of BOTOX® treatment, please consult your doctor. Some side effects includes
• Droopy eyelids, which can last for a few weeks
• Feeling like you have the flu
• Headache and upset stomach
• Risk of botulism (a life or death illness that makes it hard for a person to move the arms and legs or to breathe) is low with BOTOX® if used the right way
Most patients experience minimal pain or discomfort following injections. Swelling and puffiness at the site of the injection usually subside within a few days. Care must be taken to keep the head upright and avoid massaging the treated area, so that the BOTOX® affects only the desired areas.
Who Markets BOTOX®?
BOTOX® is marketed by Allergan, Incorporated, which describes itself as “a global specialty pharmaceutical company that develops and commercializes innovative products for the eye care, neuromodulator, skin care and other specialty markets.” Allergan made over $1.2 billion dollars in net BOTOX® sales in 2007. 50% of that ($606 million) came from BOTOX® COSMETIC. Total yearly sales of BOTOX® increased 406% between 2000 and 2007. Net sales in 2007 for all Allergan products reached $3.88 billion, of which BOTOX® and BOTOX® COSMETIC accounted for 31%.
In order to learn more specifically about the product BOTOX® please visit the official Allergan site, where you can also find listings of private offices offering a variety of services to treat many aesthetic issues, such as wrinkle reduction. Most wrinkles may be treated with BOTOX® injections.
References:
1. Wang YC, Burr DH, Korthals GJ, Sugiyama H. Acute toxicity of aminoglycoside antibiotics as an aid in detecting botulism. Appl Environ Microbiol 1984; 48:951-955.
2. Allergan (ELN 1145) BOTOX® COSMETIC (Botulinum Toxin Type A) Purified Neurotoxin Complex(Glabellar Lines) Manufactured by: Allergan Pharmaceuticals (Ireland) Ltd. A subsidiary of: Allergan, Inc. 2525 Dupont Dr. Irvine, California 92612.
3. Bazbek Davletov, Mark Bajohrs and Thomas Binz, Beyond BOTOX: advantages and limitations of individual botulinum neurotoxins, TRENDS in Neurosciences Vol.28 No.8 August 2005.
4. Harimuraleedharan , Book: Bioterrorism (Releasing book review),Tamilnadu book
house, Chapter:Biological agents/clostridium.
5. Teguh Thajeb, Yi-Min Chen, Dao-Fu Dai, Daniel Daile Thajeb, Peterus Thajeb Botulism: A Frequently Forgotten Old Malady, Review Article, International Journal of Gerontology September 2007 Vol 1 No 3.
6. Lewis, C. (2002) Botox Cosmetic: A look at looking good. FDA Consumer Magazine July–August, 1–4 .
Guidelines for BOTOX® Reconstitution
1. Using the reconstitution needle, draw up the proper amount of saline (see dilution table) in the appropriately sized sterile syringe. A 21-gauge, 1®-inch needle is recommended for reconstitution. Reconstituted BOTOX® neurotoxin should be clear, colorless, and free of particulate matter.
2. Insert the needle at a 45º angle and slowly inject the saline into the BOTOX® vial. Vacuum is present in the vial, which demonstrates that the sterility of the vial is intact. Do not use the vial if the vacuum does not pull the saline into the vial.
3. Release the vacuum by disconnecting the syringe from the needle and allowing air to flow into the vial. Gently mix BOTOX® neurotoxin with the saline by moving vial side-to-side or rotating the vial.
4. Draw the fluid into the injection syringe by placing the needle into the bottom corner of the vial for full extraction. Do not completely invert the vial.
5. Disconnect the injection syringe from the vial and attach an appropriate needle for injection. A 25-, 27-, or 30-gauge needle may be used for superficial muscles, and a longer 22-gauge needle may be used for deeper musculature.
Note: Because the product and diluent do not contain a preservative, use within 4 hours once opened and reconstituted. During the 4 hours, BOTOX® solution should be stored in a refrigerator at 2ºC to 8ºC.
For more information about Botox Cosmetic at Derma Health Institute, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=175
About the Author:
R&D scientistMIOBIO Biological Reserach Center(MBRC)Bnagloreinfo@miobio.comwww.miobio.in
Article Source: http://www.articlesbase.com/skin-care-articles/botox-botox-cosmetic-wrinkle-free-solutions-713380.html
Subscribe to:
Posts (Atom)