British Pharmacopoeia 2010
The BP 2010 is now available, effective from 1st January 2010. It is available in hardcopy, CD-ROM, eBook or online versions. The publication package can be purchased from The Stationary Office TSO
New for the BP 2010
■40 New formulated preparation monographs
■Additional standards for widely used unlicensed formulations
■European Pharmacopoeia 6th Edition material up to and including Supplement 6.5
■Three free in-year updates for the BP 2010 online to harmonise with the European Pharmacopoeia
■Availability of Single Monographs. For further details contact TSO
Updates to the British Pharmacopoeia Website
Draft new monographs for:
■ Etidronate Tablets
■Iopamidol Injection
■Iopamidol Oral Solution
■Oxybutynin Oral Solution
■Perindopril Tablets
■Sertraline TabletsDraft revised monographs for:
■Enalapril Tablets
■Oxybutynin Tablets
New images to complement the BP 2010:
■Guidance herbal TLC chromatograms
■Guidance LC chromatogramsRevised list of initiated monographs.
Technical and editorial details of revisions made to monographs in the BP 2010.
FAQ's updated.
British Pharmacopoeia Commission Annual Report 2008
The activities of the BPC are reported annually as part of the Medicines Act 1968 Advisory Bodies Annual Reports.
Notice
The Ph. Eur. Monograph for Quinine Sulphate published in the BP 2009 is not correct.
* The current monograph has been posted in the on-line version of the BP 2009.
* The hard copy text will be corrected by means of the BP 2010.
Users of the BP may wish to note that Part I of the General Notices in the BP 2009 states that Ph Eur monographs are reproduced in the BP for the convenience of users and in cases of doubt or dispute reference should be made to the Council of Europe text.
Monday 23 November 2009
About BP 2010
About BP 2010
Setting the standard for compliance across the globe
The British Pharmacopoeia (BP) is the official collection of standards for UK medicinal products and pharmaceutical substances. Produced by the British Pharmacopoeia Commission Secretariat, part of the Medicines and Healthcare products Regulatory Agency, the BP makes an important contribution to public health by setting publicly available standards for the quality of medicines.
Since 1864, the BP has been providing authoritative standards for pharmaceutical substances and it continues to play an important role in the standard-setting process worldwide. Now used in almost 100 countries, the BP remains an essential reference for all individuals and organisations working within pharmaceutical research and development, manufacture and testing around the world.
Updated annually, the BP 2010 contains monographs of pharmaceutical substances, formulated preparations and other articles used in the practice of medicine. Clearly laid out sections include monographs, which set out the mandatory standards for active substances, excipients, formulated preparations, blood-related products, immunological products, radiopharmaceutical preparations, surgical materials, herbal and complementary medicines, together with supporting General Notices, test methods, infrared spectra and supplementary information.
The BP 2010 is available in a variety of formats designed to be flexible to suit the needs and requirements of your organisation:
In print
•Five volume printed edition
•Single-user licence for the CD-ROM
•Single-user licence for the online edition via www.pharmacopoeia.co.uk
•Three free in-year updates to the content of the online version
•£830
•ISBN 9780113228287.
CD-ROM
The BP 2010 CD-ROM enables you to install fully the complete text of the BP, together with its search and linking functionality, directly onto your laptop or PC.
Once installed and activated, the 2010 version enables you to access the content of the BP without inserting the CD-ROM, providing complete portability if used on a laptop, without requiring internet access.
Online
www.pharmacopoeia.co.uk is an integral part of the BP package, enabling access to the full text of the BP 2010. New to the BP 2010 Online are three in-year updates to harmonise with the requirements of the European Pharmacopoeia. These updates are available free, as part of your online package in January, April and July 2010.
Advanced search features include an A-Z listing on monographs and articles, inclusion of ‘did you mean?’ and other close matches and a personalised ‘My BP’ area making searching for the information you use regularly easier and more efficient.
eBook
Enables you to access the full five volume set of the BP on your PDA or any other compatible device.
•Exclusively available to BP 2010 print customers
•£398 (£457.70 inc VAT)
•ISBN 9780113228461.
Setting the standard for compliance across the globe
The British Pharmacopoeia (BP) is the official collection of standards for UK medicinal products and pharmaceutical substances. Produced by the British Pharmacopoeia Commission Secretariat, part of the Medicines and Healthcare products Regulatory Agency, the BP makes an important contribution to public health by setting publicly available standards for the quality of medicines.
Since 1864, the BP has been providing authoritative standards for pharmaceutical substances and it continues to play an important role in the standard-setting process worldwide. Now used in almost 100 countries, the BP remains an essential reference for all individuals and organisations working within pharmaceutical research and development, manufacture and testing around the world.
Updated annually, the BP 2010 contains monographs of pharmaceutical substances, formulated preparations and other articles used in the practice of medicine. Clearly laid out sections include monographs, which set out the mandatory standards for active substances, excipients, formulated preparations, blood-related products, immunological products, radiopharmaceutical preparations, surgical materials, herbal and complementary medicines, together with supporting General Notices, test methods, infrared spectra and supplementary information.
The BP 2010 is available in a variety of formats designed to be flexible to suit the needs and requirements of your organisation:
In print
•Five volume printed edition
•Single-user licence for the CD-ROM
•Single-user licence for the online edition via www.pharmacopoeia.co.uk
•Three free in-year updates to the content of the online version
•£830
•ISBN 9780113228287.
CD-ROM
The BP 2010 CD-ROM enables you to install fully the complete text of the BP, together with its search and linking functionality, directly onto your laptop or PC.
Once installed and activated, the 2010 version enables you to access the content of the BP without inserting the CD-ROM, providing complete portability if used on a laptop, without requiring internet access.
Online
www.pharmacopoeia.co.uk is an integral part of the BP package, enabling access to the full text of the BP 2010. New to the BP 2010 Online are three in-year updates to harmonise with the requirements of the European Pharmacopoeia. These updates are available free, as part of your online package in January, April and July 2010.
Advanced search features include an A-Z listing on monographs and articles, inclusion of ‘did you mean?’ and other close matches and a personalised ‘My BP’ area making searching for the information you use regularly easier and more efficient.
eBook
Enables you to access the full five volume set of the BP on your PDA or any other compatible device.
•Exclusively available to BP 2010 print customers
•£398 (£457.70 inc VAT)
•ISBN 9780113228461.
The British Pharmacopoeia 2010
Setting the standard for compliance across the globe
The British Pharmacopoeia (BP) is the official collection of standards for UK medicinal products and pharmaceutical substances. Produced by the British Pharmacopoeia Commission Secretariat, part of the Medicines and Healthcare products Regulatory Agency, the BP makes an important contribution to public health by setting publicly available standards for the quality of medicines.
The BP comprises a five volume printed set, including a single volume of the BP (Veterinary) 2010 together with a fully searchable CD-ROM and online access to provide you with a flexible resource.
The British Pharmacopoeia 2010 contains:
•Monographs including British Pharmacopoeia (Veterinary) monographs
•Test methods
•Infrared reference
•Spectra
•Supplementary information
New for 2010
•40 new monographs for formulated preparations
•Additional standards for widely used unlicensed formulations
•European Pharmacopoeia 6th edition material up to and including Supplement 6.5
•Three free in-year updates for the BP 2010 online to harmonise with the European Pharmacopoeia
•Updates available in January, April and July 2010
Order now
The BP 2010 is now available. Place your order now to ensure you remain compliant.
British Pharmacopeia 2010 package
•Five volume printed edition
•Single-user licence for the CD-ROM
•Single-user licence for the online edition via www.pharmacopoeia.co.uk
•£830
•ISBN 9780113228287
The BP eBook is available to order, exclusively to BP 2010 print customers
•£398 (£457.70 inc VAT)
•ISBN 9780113228461
Over-the-Counter Drugs
11/23/09 - Latest Report for the United States Pharmaceuticals and Healthcare Industry as We Find out Healthcare Spending in 2008 Reached US$2.3 Trillion
2009 NOV 23 - (NewsRx.com) Research and Markets (http://www.researchandmarkets.com/research/00af33/united-states-phar) has announced the addition of the "United States Pharmaceuticals and Healthcare Report Q4 2009" report to their offering (see also Research and Markets).
United States Pharmaceuticals and Healthcare Report provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on the United States' pharmaceuticals and healthcare industry.
Despite a downturn in growth rates in the US pharmaceuticals & healthcare markets, the country remains a core component for any company looking to achieve global success. Healthcare spending in 2008 reached US$2.3trn, while sales of pharmaceuticals topped US$309bn.
For BMI's US Pharmaceuticals & Healthcare Report Q409, our new 10-year Drug Expenditure Model has been introduced, giving a longer-term view of potential for sales. By 2018 BMI forecasts that pharmaceutical expenditure will be approaching US$400bn, representing a compound annual growth rate (CAGR) of 2.5%. This, combined with the US's strong regulatory environment, stable political and economic environment and country structure-related opportunities mean that the country is ranked first globally within our Business Environment Ratings.
Much is currently at stake in the US pharmaceutical & healthcare industry. President Barack Obama's healthcare reform is set to dramatically change the industry landscape over the next few years. Among the proposals are: the possible introduction of a government health insurer, which would place significant downward pressures on prices; reviewing the length of exclusivity for biologics and entry for biosimilars, which could tilt the balance of generic and patented market growth; the level of prescription coverage enacted under any universal insurance model; and the introduction of re-imported drug legislation.
Patent expiries for many high value products are set to significantly erode sales for many major pharmaceutical companies. However, due to the complexity of patent files and litigation efforts, calculating the exact entry for generic medicines can be troublesome. The possible ban of pay-to-delay settlements and authorised generics could also provide a major downside for patented drugs. The shape of economic recovery in the US will also have a major bearing on market dynamics, particularly in the case of over-the-counter (OTC) medicines or prescription drugs, which require substantial co-payments.
The epidemiological profile of the US resembles that of many developed states. BMI's Burden of Disease Database (BoDD) reveals that of the 37.76mn disability-adjusted life years (DALYs) lost to all diseases and injuries in 2008, just 5.13% were accountable to communicable diseases. This is fairly typical for a developed state and is a reflection of the US's generally high access to basic medical care and the effects of Westernised lifestyles causing an increase in the burden of non-communicable diseases, despite beneficial developments in medicine and medical technology. Key Topics Covered: Executive Summary
SWOT Analysis
Pharmaceutical Business Environment Ratings
US - Market Summary
Regulatory Regime
Industry Developments
Industry Forecast Scenario
Competitive Landscape
Company Profiles
2009 NOV 23 - (NewsRx.com) Research and Markets (http://www.researchandmarkets.com/research/00af33/united-states-phar) has announced the addition of the "United States Pharmaceuticals and Healthcare Report Q4 2009" report to their offering (see also Research and Markets).
United States Pharmaceuticals and Healthcare Report provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on the United States' pharmaceuticals and healthcare industry.
Despite a downturn in growth rates in the US pharmaceuticals & healthcare markets, the country remains a core component for any company looking to achieve global success. Healthcare spending in 2008 reached US$2.3trn, while sales of pharmaceuticals topped US$309bn.
For BMI's US Pharmaceuticals & Healthcare Report Q409, our new 10-year Drug Expenditure Model has been introduced, giving a longer-term view of potential for sales. By 2018 BMI forecasts that pharmaceutical expenditure will be approaching US$400bn, representing a compound annual growth rate (CAGR) of 2.5%. This, combined with the US's strong regulatory environment, stable political and economic environment and country structure-related opportunities mean that the country is ranked first globally within our Business Environment Ratings.
Much is currently at stake in the US pharmaceutical & healthcare industry. President Barack Obama's healthcare reform is set to dramatically change the industry landscape over the next few years. Among the proposals are: the possible introduction of a government health insurer, which would place significant downward pressures on prices; reviewing the length of exclusivity for biologics and entry for biosimilars, which could tilt the balance of generic and patented market growth; the level of prescription coverage enacted under any universal insurance model; and the introduction of re-imported drug legislation.
Patent expiries for many high value products are set to significantly erode sales for many major pharmaceutical companies. However, due to the complexity of patent files and litigation efforts, calculating the exact entry for generic medicines can be troublesome. The possible ban of pay-to-delay settlements and authorised generics could also provide a major downside for patented drugs. The shape of economic recovery in the US will also have a major bearing on market dynamics, particularly in the case of over-the-counter (OTC) medicines or prescription drugs, which require substantial co-payments.
The epidemiological profile of the US resembles that of many developed states. BMI's Burden of Disease Database (BoDD) reveals that of the 37.76mn disability-adjusted life years (DALYs) lost to all diseases and injuries in 2008, just 5.13% were accountable to communicable diseases. This is fairly typical for a developed state and is a reflection of the US's generally high access to basic medical care and the effects of Westernised lifestyles causing an increase in the burden of non-communicable diseases, despite beneficial developments in medicine and medical technology. Key Topics Covered: Executive Summary
SWOT Analysis
Pharmaceutical Business Environment Ratings
US - Market Summary
Regulatory Regime
Industry Developments
Industry Forecast Scenario
Competitive Landscape
Company Profiles
Friday 20 November 2009
Floxin
Generic Name: ofloxacin (oh FLOX a sin)
Brand Names: Floxin
What is Floxin?
Floxin is in a group of antibiotics called fluoroquinolones. This group of antibiotics is used to fight bacteria in the body.
Floxin is used to treat bacterial infections that cause bronchitis, pneumonia, chlamydia, gonorrhea, skin infections, urinary tract infections, and infections of the prostate.
Floxin may also be used for other purposes not listed in this medication guide.
Important information about Floxin
You should not use Floxin if you are allergic to ofloxacin or similar antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others.
Before taking Floxin, tell your doctor if you have kidney or liver disease, joint problems, myasthenia gravis, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of "Long QT syndrome."
Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take Floxin. These other medicines can make Floxin much less effective when taken at the same time. Floxin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Floxin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share Floxin with another person (especially a child), even if they have the same symptoms you have.
Before taking Floxin
You should not use Floxin if you are allergic to ofloxacin or other fluoroquinolones such as ciprofloxacin (Cipro), levofloxacin (Levaquin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others.
Before taking Floxin, tell your doctor if you have a heart rhythm disorder, especially if you are being treated with one of these medications: quinidine (Cardioquin, Quinidex, Quinaglute), disopyramide (Norpace), bretylium (Bretylol), procainamide (Pronestyl, Procan SR), amiodarone (Cordarone, Pacerone), or sotalol (Betapace).
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take Floxin, tell your doctor if you have:
a history of allergic reaction to an antibiotic;
myasthenia gravis;
joint problems;
kidney or liver disease;
epilepsy or a history of seizures;
diabetes;
low levels of potassium in your blood (hypokalemia); or
a personal or family history of "Long QT syndrome."
FDA pregnancy category C: It is not known whether Floxin is harmful to an unborn baby. Do not use Floxin without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Floxin can pass into breast milk and may harm a nursing baby. Do not use Floxin without telling your doctor if you are breast-feeding a baby. Floxin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Floxin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you have.
Generic Name: ofloxacin (oh FLOX a sin)
Brand Names: Floxin
What is Floxin?
Floxin is in a group of antibiotics called fluoroquinolones. This group of antibiotics is used to fight bacteria in the body.
Floxin is used to treat bacterial infections that cause bronchitis, pneumonia, chlamydia, gonorrhea, skin infections, urinary tract infections, and infections of the prostate.
Floxin may also be used for other purposes not listed in this medication guide.
Important information about Floxin
You should not use Floxin if you are allergic to ofloxacin or similar antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others.
Before taking Floxin, tell your doctor if you have kidney or liver disease, joint problems, myasthenia gravis, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of "Long QT syndrome."
Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take Floxin. These other medicines can make Floxin much less effective when taken at the same time. Floxin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Floxin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share Floxin with another person (especially a child), even if they have the same symptoms you have.
Before taking Floxin
You should not use Floxin if you are allergic to ofloxacin or other fluoroquinolones such as ciprofloxacin (Cipro), levofloxacin (Levaquin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others.
Before taking Floxin, tell your doctor if you have a heart rhythm disorder, especially if you are being treated with one of these medications: quinidine (Cardioquin, Quinidex, Quinaglute), disopyramide (Norpace), bretylium (Bretylol), procainamide (Pronestyl, Procan SR), amiodarone (Cordarone, Pacerone), or sotalol (Betapace).
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take Floxin, tell your doctor if you have:
a history of allergic reaction to an antibiotic;
myasthenia gravis;
joint problems;
kidney or liver disease;
epilepsy or a history of seizures;
diabetes;
low levels of potassium in your blood (hypokalemia); or
a personal or family history of "Long QT syndrome."
FDA pregnancy category C: It is not known whether Floxin is harmful to an unborn baby. Do not use Floxin without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Floxin can pass into breast milk and may harm a nursing baby. Do not use Floxin without telling your doctor if you are breast-feeding a baby. Floxin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Floxin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you have.
Pharmaceutical News and Articles
Juvederm
Generic Name: hyaluronic acid gel
Date of Approval: June 5, 2006
Company: Allergan, Inc.
Treatment for: Facial Wrinkles and Folds
FDA approves Juvederm
The U.S. Food and Drug Administration (FDA) has approved the Juvederm gel family of products, a 'next generation' of hyaluronic acid dermal fillers that provide a smooth, long-lasting correction of facial wrinkles and folds.
Juvederm is natural, biodegradable and currently the only approved hyaluronic acid dermal filler that has demonstrated its safety and effectiveness in patients of all skin types and colors. Juvederm also is the only hyaluronic acid dermal filler developed using a proprietary, technologically advanced manufacturing process that results in a malleable smooth gel that flows easily into the skin, creating a smooth, natural look and feel. All other currently approved hyaluronic acid dermal fillers utilize a gel particle suspension formulation.
The Juvederm family of products offers the highest concentration of cross-linked hyaluronic acid available in a dermal filler, which results in a long duration of effect and may be attributed to the majority of patients not requiring touch-ups following their initial treatment. The smooth consistency of the Juvederm formula also may help to minimize the discomfort that can sometimes occur during the injection procedure.
The FDA approved three different formulations for Juvederm providing physicians with the flexibility to tailor each treatment to the particular needs of the patient. The three product formulations include: Juvederm 24HV, a highly cross-linked formulation for more versatility in contouring and volumizing of facial wrinkles and folds; Juvederm 30HV, a more highly cross-linked robust formulation for volumizing and correction of deeper folds and wrinkles; and Juvederm 30, a highly cross-linked formulation for subtle correction of facial wrinkles and folds.
Hyaluronic Acid
Hyaluronic acid dermal fillers represent the fastest growing non-invasive aesthetic procedure in the United States. Occurring naturally in the body, hyaluronic acid is a natural complex sugar found in all living organisms and creates volume and elasticity in the skin. Juvederm adds volume to facial wrinkles, such as nasolabial folds (the folds running from the sides of the bottom of the nose to the outer corners of the mouth). Hyaluronic acid treats multiple medical conditions, including those associated with the eye and the knee, and has been used for more than 20 years.
Juvederm Clinical Studies
The FDA's approval of Juvederm was based on data from a double-blind, randomized and controlled clinical trial. A total of 439 subjects were followed for six months after injection with one of three Juvederm formulations in one nasolabial fold, and Zyplast (bovine-based collagen) in the other.
Juvederm was found to provide a more persistent wrinkle correction than Zyplast over the 6-month course of the study, with up to 90% of subjects maintaining at least a 1-grade improvement in nasolabial fold correction with Juvederm compared to 36-45% with Zyplast. At the conclusion of the study, up to 88% of subjects expressed a preference for Juvederm while only 5-12% expressed a preference for Zyplast. In addition, among non-Caucasian patients (all Fitzpatrick Skin Types), Juvederm was found safe and effective and demonstrated no increased risk of hyperpigmentation or hypertrophic scarring.
Important Juvederm Safety Information
In clinical studies, Juvederm adverse events were usually mild to moderate in nature, did not require intervention and lasted seven days or less. The most common Juvederm side effects included temporary injection site reactions including redness, pain/tenderness, firmness, swelling, lumps and bumps and bruising.
Generic Name: hyaluronic acid gel
Date of Approval: June 5, 2006
Company: Allergan, Inc.
Treatment for: Facial Wrinkles and Folds
FDA approves Juvederm
The U.S. Food and Drug Administration (FDA) has approved the Juvederm gel family of products, a 'next generation' of hyaluronic acid dermal fillers that provide a smooth, long-lasting correction of facial wrinkles and folds.
Juvederm is natural, biodegradable and currently the only approved hyaluronic acid dermal filler that has demonstrated its safety and effectiveness in patients of all skin types and colors. Juvederm also is the only hyaluronic acid dermal filler developed using a proprietary, technologically advanced manufacturing process that results in a malleable smooth gel that flows easily into the skin, creating a smooth, natural look and feel. All other currently approved hyaluronic acid dermal fillers utilize a gel particle suspension formulation.
The Juvederm family of products offers the highest concentration of cross-linked hyaluronic acid available in a dermal filler, which results in a long duration of effect and may be attributed to the majority of patients not requiring touch-ups following their initial treatment. The smooth consistency of the Juvederm formula also may help to minimize the discomfort that can sometimes occur during the injection procedure.
The FDA approved three different formulations for Juvederm providing physicians with the flexibility to tailor each treatment to the particular needs of the patient. The three product formulations include: Juvederm 24HV, a highly cross-linked formulation for more versatility in contouring and volumizing of facial wrinkles and folds; Juvederm 30HV, a more highly cross-linked robust formulation for volumizing and correction of deeper folds and wrinkles; and Juvederm 30, a highly cross-linked formulation for subtle correction of facial wrinkles and folds.
Hyaluronic Acid
Hyaluronic acid dermal fillers represent the fastest growing non-invasive aesthetic procedure in the United States. Occurring naturally in the body, hyaluronic acid is a natural complex sugar found in all living organisms and creates volume and elasticity in the skin. Juvederm adds volume to facial wrinkles, such as nasolabial folds (the folds running from the sides of the bottom of the nose to the outer corners of the mouth). Hyaluronic acid treats multiple medical conditions, including those associated with the eye and the knee, and has been used for more than 20 years.
Juvederm Clinical Studies
The FDA's approval of Juvederm was based on data from a double-blind, randomized and controlled clinical trial. A total of 439 subjects were followed for six months after injection with one of three Juvederm formulations in one nasolabial fold, and Zyplast (bovine-based collagen) in the other.
Juvederm was found to provide a more persistent wrinkle correction than Zyplast over the 6-month course of the study, with up to 90% of subjects maintaining at least a 1-grade improvement in nasolabial fold correction with Juvederm compared to 36-45% with Zyplast. At the conclusion of the study, up to 88% of subjects expressed a preference for Juvederm while only 5-12% expressed a preference for Zyplast. In addition, among non-Caucasian patients (all Fitzpatrick Skin Types), Juvederm was found safe and effective and demonstrated no increased risk of hyperpigmentation or hypertrophic scarring.
Important Juvederm Safety Information
In clinical studies, Juvederm adverse events were usually mild to moderate in nature, did not require intervention and lasted seven days or less. The most common Juvederm side effects included temporary injection site reactions including redness, pain/tenderness, firmness, swelling, lumps and bumps and bruising.
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