INDICATIONS AND USAGE :
Saxagliptin is a dipeptidyl peptidase-4 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important limitations of use:
Should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Has not been studied in combination with insulin.
DOSAGE AND ADMINISTRATION:
The recommended dose is 2.5 mg or 5 mg once daily taken regardless of meals.
• 2.5 mg daily is recommended for patients with moderate or severe renal impairment, or end-stage renal disease (CrCl ≤50 mL/min). Assess renalfunction prior to initiation of Saxagliptin and periodically thereafter.
• 2.5 mg daily is recommended for patients also taking strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole).
DOSAGE FORMS AND STRENGTHS :
Tablets: 5 mg and 2.5 mg
ADVERSE REACTIONS:
Adverse reactions reported in ≥5% of patients treated with Saxagliptin and more commonly than in patients treated with placebo are: upper respiratory tract infection, urinary tract infection, and headache.
• Peripheral edema was reported more commonly in patients treated with the combination of Saxagliptin and a thiazolidinedione (TZD) than in patients treated with the combination of placebo and TZD.
• Hypoglycemia was reported more commonly in patients treated with the combination of Saxagliptin and sulfonylurea than in patients treated with the combination of placebo and sulfonylurea.
• Hypersensitivity-related events (e.g., urticaria, facial edema) were reported more commonly in patients treated with Saxagliptin than in patients treated with placebo.
DRUG INTERACTIONS :
• Coadministration with strong CYP3A4/5 inhibitors (e.g., ketoconazole)significantly increases saxagliptin concentrations. Recommend limiting Saxagliptin dose to 2.5 mg once daily.
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Students of pharmacy need strong background in regulatory affairs: Experts
The young pharmacists who wish to get into regulatory affairs must have a strong background of pharmacy practices and regulatory understanding. The pharmacy profession in the country today needs a large number of such specialists, felt pharma experts and officials of enforcement bodies.
India's pharmacovigilance system is poor and the coming generation should increase their awareness about this area. The awareness on regulatory affairs and strong pharmacy background will help them to be absorbed into industry also. The students must be encouraged to get into industry projects in regulatory to gain better understanding.
Pharmaceutical and biotechnology products are regulated products and with globalization the demand of these products has increased which requires more regulatory staff. The medicine exported from one country needs to comply with the rules of other country. India exports an equal number of medicines produced and used for domestic use in the country. US FDA has set up its offices in New Delhi and Mumbai and US Pharmacopeia opened its office in Hyderabad. With the arrival of international agencies to our country, we can imagine that India will soon emerge as a global player.
Proper training should be imparted to the personal working in the patent offices and trainers from our country and US could be utilized for this purpose.The students of pharmacy must know about patent rules and their curriculum must be updated with new policies and rules.
India is becoming the destination of clinical trials, but personally he does not agree with the development as Indians are becoming guinea pigs for the trials. It is mandatory that the students of pharmacy to understand the basics of regulatory affairs from early stages. The course on regulatory affairs has bright future globally and the person indulging in regulatory affairs is acting as an ambassador between industry and enforcement bodies.
India's pharmacovigilance system is poor and the coming generation should increase their awareness about this area. The awareness on regulatory affairs and strong pharmacy background will help them to be absorbed into industry also. The students must be encouraged to get into industry projects in regulatory to gain better understanding.
Pharmaceutical and biotechnology products are regulated products and with globalization the demand of these products has increased which requires more regulatory staff. The medicine exported from one country needs to comply with the rules of other country. India exports an equal number of medicines produced and used for domestic use in the country. US FDA has set up its offices in New Delhi and Mumbai and US Pharmacopeia opened its office in Hyderabad. With the arrival of international agencies to our country, we can imagine that India will soon emerge as a global player.
Proper training should be imparted to the personal working in the patent offices and trainers from our country and US could be utilized for this purpose.The students of pharmacy must know about patent rules and their curriculum must be updated with new policies and rules.
India is becoming the destination of clinical trials, but personally he does not agree with the development as Indians are becoming guinea pigs for the trials. It is mandatory that the students of pharmacy to understand the basics of regulatory affairs from early stages. The course on regulatory affairs has bright future globally and the person indulging in regulatory affairs is acting as an ambassador between industry and enforcement bodies.
DCGI may ban three controversial drugs
The Central Drugs Standard Control Organisation (CDSCO), the apex drug regulator, may soon ban the production and sale of three medicines in the country.
The drugs - cisapride, phenylpropanolamine (PPA) and human placenta extracts - have been controversial medicines for their alleged adverse reactions for several years now. The CDSCO move comes against the backdrop of its aggressive stance to get rid of drugs that are potentially harmful in the domestic market. A few weeks ago, the drug regulator had suspended the marketing of two medicines - anti-obesity drug sibutramine and anti-diabetic drug rosiglitazone - from sale counters over complaints of adverse reactions.
The market value of the three medicines that are currently being considered for a sale ban were not known, industry analysts said. However, the first two, cisapride and PPA did not have significant market presence, while the third one, human placenta extacts, were being sold as Placentrex lotion, gel, and an inject able remedy for a variety of unrelated disorders such as vitiligo, wound dressing, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc, they added.
According to professional journal Monthly Index of Medical Specialties (MIMS), PPA, widely used in cold and cough remedies, has been banned or discared in all North American and West European countries. Similarly, all products containing extracts of human placenta have been banned by the United States Food and Drug Administration (USFDA) as they transmit diseases and pose serious health hazard to consumers.
"Placenta extract was never permitted for use as medicine in the western countries, such as the US, Canada, Britain, Australia and European Union states, due to lack of efficacy and safety data. However, some companies in US were importing products containing human placenta as dietary supplements. Since April 14, all products containing human placenta extracts even in use as cosmetics have been banned," MIMS says.
India has so far banned over 80 specific drugs and fixed-dose combination of drugs from being sold in the country.
The drugs - cisapride, phenylpropanolamine (PPA) and human placenta extracts - have been controversial medicines for their alleged adverse reactions for several years now. The CDSCO move comes against the backdrop of its aggressive stance to get rid of drugs that are potentially harmful in the domestic market. A few weeks ago, the drug regulator had suspended the marketing of two medicines - anti-obesity drug sibutramine and anti-diabetic drug rosiglitazone - from sale counters over complaints of adverse reactions.
The market value of the three medicines that are currently being considered for a sale ban were not known, industry analysts said. However, the first two, cisapride and PPA did not have significant market presence, while the third one, human placenta extacts, were being sold as Placentrex lotion, gel, and an inject able remedy for a variety of unrelated disorders such as vitiligo, wound dressing, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc, they added.
According to professional journal Monthly Index of Medical Specialties (MIMS), PPA, widely used in cold and cough remedies, has been banned or discared in all North American and West European countries. Similarly, all products containing extracts of human placenta have been banned by the United States Food and Drug Administration (USFDA) as they transmit diseases and pose serious health hazard to consumers.
"Placenta extract was never permitted for use as medicine in the western countries, such as the US, Canada, Britain, Australia and European Union states, due to lack of efficacy and safety data. However, some companies in US were importing products containing human placenta as dietary supplements. Since April 14, all products containing human placenta extracts even in use as cosmetics have been banned," MIMS says.
India has so far banned over 80 specific drugs and fixed-dose combination of drugs from being sold in the country.
Workshop on PHARMACOVIGILANCE by CliniLife
CliniLife conducting a one day "WORKSHOP on PHAMRACOVIGILANCE " on 12-12-2010
Its our request to register with us for free(students).
thank you.
For more information plz contact us @ 80080 59958
mail us : clinilife@gmail.com
Its our request to register with us for free(students).
thank you.
For more information plz contact us @ 80080 59958
mail us : clinilife@gmail.com
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