Saxagliptin -A Story of a New Drug

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.

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.

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Diabetes drug Avandia gets heart warnings

The diabetes drug Avandia now comes with warnings in Canada about heart risks, the drug's manufacturer said Thursday.

Canadians taking Avandia should make an appointment with their doctor as soon as possible about their treatment because of the Type 2 diabetes drug's potential risks, but not stop treatment abruptly, GlaxoSmithKline said.

The company, in consultation with Health Canada, announced new restrictions on the use of drugs containing rosiglitazone, such as Avandia, in people with Type 2 diabetes.

Package warnings say the drugs may increase the risk of serious heart problems, including heart failure, chest pain, heart attack and fluid retention.

The drugs should not be used in people who have or have had heart problems. People should talk to their doctor about other options before using the drug.

Based on Health Canada's review of recent data suggesting a higher risk of heart-related problems in patients treated with Avandia, the company has updated information for consumers and health-care professionals, including new restrictions on using the drug.

The restrictions include:

Avandia, Avandamet and Avandaryl, brand names for rosiglitazone, are now indicated only in patients with Type 2 diabetes when all other oral medicines have not lowered blood sugar enough or are not appropriate.
Patients currently taking the drugs should make an appointment with their doctor as soon as possible to discuss their diabetes treatment.
Patients should not abruptly stop treatment based on these new restrictions, since stopping medications can cause poorer diabetes control with high blood-sugar levels.
Patients should discuss treatment options and the benefits and risks of rosiglitazone with their doctor and then complete an informed consent form.

Before filling in the form, doctors will ask patients to read the consumer information for the product, read and sign the form to show they understand the heart-related risks of the medication.

In September, the drug was taken off shelves in Europe while U.S. regulators restricted its use because of heart attack risks. At the time, the company said Health Canada was reviewing the proposed warning changes that are now in effect.

Avandia is used to treat Type 2 diabetes, the most common form of the disease, which is linked to obesity and afflicts 200 million people worldwide. This form of diabetes occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.

Avandia helps sensitize the body to insulin.

Gujarat Drug Control Administration to recruit 60 drug inspectors soon

The government of Gujarat will be recruiting 60 new drug inspectors as part of its strengthening of the state Drugs Control Administration. The state public service commission has almost finished the selection process and the appointment will take place in three months' time, said H G Koshia, Commissioner, FDA, Gujarat.

The total number of drug inspectors in the state will thus rise to 102, which is the sanctioned strength for the total 25 districts. Currently, the state has only 42 drug inspectors and senior drug inspectors are assigned to do the work of drug inspectors in certain areas.

While speaking to this reporter, the Commissioner said his department has recently started district offices in six more districts with ADCs in charge of each district. Previously these districts were looked after by the officers of neighbouring districts. Thus all the districts in the state got district drug control offices.

Koshia said the shortage of inspectors happened because of a recent promotion given to 50 drug control officials to the rank of ADCs and senior drug inspectors. So the staff strength of inspectors came down to 42. Along with the forthcoming recruitment, the department will create two more posts of Joint Commissioner and four posts of deputy commissioner. Now the department comprises five Joint Commissioners, six Deputy Commissioners and one Assistant Commissioner. Out of these, five JCs, one JC is looking after the state Drug Testing Lab. He further said, in 2010, the government has recruited 192 staff members through promotion and direct recruitment.

According to the Commissioner, the state has three drug testing laboratories with modern facilities located in Baroda, Rajkot and Bhuj. The department has sent a proposal to the government for a new laboratory with state-of-the-art facilities to be established in Gandhinagar.

Gujarat has a total of 26659 drug traders including retailers, wholesalers and both, he said. The number of licensed retail shops is 13235 and wholesalers are 11003. There are 2421 traders dealing in both retail and wholesale. The number of blood banks is 145, out of which 50 are under the control of Government and Red Cross Society. The state faces no shortage of any group of blood and all the blood banks and blood storage centres have surplus stocks.

He said his department has made many reforms for the convenience of the public. Now any person from any part of the state can receive the license within 24 hours of filing the application. The ADCs in the district head quarters have been given charge for issuance of drug licenses.

Gujarat has 3270 manufacturing companies for generics. Thirty one units have US FDA facilities, 475 companies have WHO GMP facilities and 175 units comply state GMP norms, the Commissioner said.

Dehydration

INTRODUCTION:-Dehydration (hypohydration) is defined as an excessive loss of body fluid. It is literally the removal of water (Ancient Greek: ὕδωρ hýdōr) from an object, however in physiological terms, it entails a deficiency of fluid within an organism.There are three main types of dehydration: hypotonic or hyponatremic (primarily a loss of electrolytes, sodium in particular), hypertonic or hypernatremic (primarily a loss of water), and isotonic or isonatremic (equal loss of water and electrolytes).[1] In humans, the most commonly seen type of dehydration by far is isotonic (isonatraemic) dehydration which effectively equates with hypovolemia, but the distinction of isotonic from hypotonic or hypertonic dehydration may be important when treating people who become dehydrated

CAUSE:-There are many things that can cause dehydration, the most common are vomiting, diarrhea, blood loss, malnutrition, and plain old failure to replenish liquids lost from sweating and urination (Not drinking enough water). Many illnesses and diseases can trigger acute dehydration due to the increased body temperature and sweating that usually occur. This is why your doctor tells you to drink plenty of fluids when you are ill. Your body uses fluids to expel toxins as well as to keep your system flexible, lubricated and running smoothly

SYMPTOMS:-Symptoms of dehydration usually begin with thirst and progress to more alarming manifestations as the need for water becomes more dire. The initial signs and symptoms of mild dehydration in adults appear when the body has lost about 2% of it's total fluid. These mild dehydration symptoms are often (but not limited to): Thirst,Loss of Appetite, Dry Skin ,Skin Flushing DarkColoredUrine,Dry Mouth ,fatigue or Weakness ,Chills ,Head Rushes

DIAGNOSIS:-In humans, dehydration can be caused by a wide range of diseases and states that impair water homeostasis in the body. These include:External or stress-related causes Prolonged physical activity with sweating without consuming adequate water, especially in a hot and/or dry environmentProlonged exposure to dry air, e.g., in high-flying airplanes (5%–12% relative humidity)Blood loss or hypotension due to physical traum.Diarrhea,Hyperthermia,Shock (hypovolemic),Vomiting,Burns,Lacrimation

TREATMENT:-If dehydration is the removal of water from an object, then the treatment of dehydration to reverse its effects would logically be rehydration. When a person becomes dehydrated they have also lost electrolytes so it is very important to replenish them along with the water. The type of electrolytes needed for rehydration are sodium and potassium salts usually found in sports drinks like Gatorade and pediatric formulas like Pedialite. Electrolytes are needed for electro-chemical reactions within cells. A lack of electrolytes in the body can interfere with the chemical reactions needed for healthy cell operation and is known as water intoxication. This can become a serious condition and has lead to death in extreme cases.

PREVENTION:-The average person loses between two and three litres of water a day through the breath, sweat, and urine. This number can increase or decrease based on the types of activities that a person engages in. Heavy exercise can cause a body to lose more than 2 litres an hour! To prevent dehydration you simply need to replenish the liquids that are lost throughout the day. Many resources and sites will tell you to drink 8 glasses of water a day, or give you a set number of litres to drink but the honest truth is that every BODY is different and only you will know how much your BODY needs.

High blood pressure -Symptoms and Treatment

What is high blood pressure?

It causes the heart to work harder than normal putting both the heart and arteries at greater risk of damage. High blood pressure, or hypertension, increases the risk of heart attacks, strokes, kidney failure, damage to the eyes, congestive heart failure and atherosclerosis.

Hypertension exists where the pressure at which blood is pushing against blood vessel walls is consistently above average.  Untreated high blood pressure can cause the heart to become abnormally large and less efficient (ventricular hypertrophy) causing heart failure and increased risk of heart attack.

Symptoms

Although high blood pressure can cause headaches, dizziness and problems with vision, the majority of people suffer no symptoms at all. As a result many people with hypertension remain undiagnosed because they have no symptoms to motivate them to see a doctor or get their blood pressure checked.

Causes and risk factors

In over 90 per cent of cases, the cause is unknown. In the remaining cases, high blood pressure is a symptom of a recognisable underlying problem such as a kidney abnormality, tumor of the adrenal gland or congenital defect of the aorta (in these cases when the root cause is corrected, blood pressure usually returns to normal). This type of high blood pressure is called secondary hypertension.

If high blood pressure isn't treated and is combined with obesity, smoking, high blood cholesterol levels or diabetes, the risk of heart attack is several times higher.

Treatment and recovery

The only way to find out if you have high blood pressure is to have your blood pressure checked. A doctor or other qualified health professional should check a patient's blood pressure at least once every two years.

It’s measured in millimetres of mercury (mm Hg) and is defined in an adult by the recording of two readings:

•             The first is called the systolic pressure and represents the force of the blood as the heart contracts (beats) to pump it around the body. This is the higher of the two readings and records blood pressure at or above 140mm Hg.

•             The second, called the diastolic, is the pressure while the heart is relaxed and filling with blood again in preparation for the next contraction or heart beat. This value is lower than the systolic pressure and records blood pressure at or above 90mm Hg.

When high blood pressure is first diagnosed, tests may be done for an underlying cause (i.e. secondary hypertension) especially if the person is young or has very high blood pressure. If an underlying cause is found it should be treated.

There's no cure as such for essential  hypertension, but following a healthy lifestyle can be enough to bring blood pressure down to a normal level. This is one reason why drug treatment may not be offered for healthy individuals with only mild hypertension (above 140/90 mmHg but below 160/100 mmHg).

All medicines can have side effects and sometimes it’s necessary to try different drugs if initial treatments cause problems. 

Virus breakthrough raises hope over ending common cold

Scientists say they have made a landmark discovery which could pave the way for new drugs to beat illnesses like the common cold. Until now experts had thought that antibodies could only tackle viral infections by blocking or attacking viruses outside cells. But work done by the Medical Research Council shows antibodies can pass into cells and fight viruses from within.

PNAS journal said the finding held promise for a new antiviral drugs.The Cambridge scientists stressed that it would take years of work and testing to find new therapies, and said that the pathway they had discovered would not work on all viruses. Read More...

Diabetes drugs may help control lung cancer: study

Commonly used diabetes drugs such as metformin may help control lung cancer, and may help prevent it, U.S. researchers reported on Tuesday.
The team reviewed the medical records of 157 lung cancer survivors with diabetes.
Those who had taken either a metformin drug or a TZD were significantly less likely to have advanced lung cancer that had spread -- 20 percent of those who took the drugs had tumors that had spread, versus 42 percent of those who had not.

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Cell find may aid cancer vaccines

A type of normal cell often found in cancerous growths may be the reason for the failure of anti-cancer vaccines.

Stromal cells may act to protect tumours from the body's immune system, a study in the journal Science reports.
Cambridge University scientists eliminated some of these cells in mice, and shrank their lung tumours.
Cancer Research UK said the study offered "exciting clues" to how cancer recruited healthy cells, and how to prevent that happening.

Tumours are not just made up of cancer cells - often these are interspersed with normal cells carrying on with their normal functions. Stromal cells are part of the body's connective tissue, helping provide fibres and structures to support other tissues and cells. The Cambridge study suggests that, in some tumours at least, their activity is holding back the immune system from launching attacks which could shrink or destroy tumours.
Read more....