sailajabyrisetty's blog

Alertec is used for the symptomatic treatment of excessive sleepiness in patients with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder.

Shire Canada Inc. in consultation with Health Canada announced new warnings concerning modafinil ( Alertec) as it can cause severe cutaneous adverse reactions, serious hypersensitivity reactions and psychiatric symptoms. Accordingly, the product monograph has been updated to include the following new warning and important safety information:

• Modafinil can cause life-threatening skin and other serious hypersensitivity reactions:
* Severe cutaneous adverse reactions (SCARs), including Toxic Epidermal Necrolysis (TEN), Steven-Johnson syndrome (SJS), and Drug Rash with Eosinophilia and systemic Symptoms (DRESS), have occurred in adults and children using modafinil.

FDA has received reports of sudden decreased or loss of hearing after using the Erectile Dysfunction drugs such as, Viagra, Levitra, and Cialis. Revatio, a Sildenafil product marketed for pulmonary arterial hypertension, is also included in the list. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. So, FDA asked manufacturers to add a precaution about potential hearing loss to the products labeling.

This request is based on 29 post-marketing reports of sudden hearing loss. In most cases, hearing loss involved one ear and occurred within hours to 3 days of the last dose. Hearing loss appears to be persistent in about 2 out of 3 cases. As per FDA request, the labeling for Viagra, Levitra and Cialis was revised to address this new safety information.
FDA is working on revising label for ‘Revatio’ too.

AstraZeneca, makers of Nexium, announced that Nexium is now indicated for use in pediatric patients aged from 1 year to 17 years for the treatment of reflux esophagitis and nonerosive reflux disease. Based on the new dose, this company launching a new 10 mg sachet formulation for pediatric patients aged between 1 and 11 years to be taken orally as a drink or via naso-gastric tube.
The new dose ‘reflux esophagitis’ in children aged between 1 and 11 years is based on the weight. If the weight is less than 20 kg, the dose would be 10 mg sachet once daily for 3 weeks, or if weight is more than 20 kg, then dose would be 20 mg (2 sachets of 10 mg) once daily for 8 weeks. The dose for children aged between 12 and 17 years would be 20 mg to 40 mg once daily for 4 to 8 weeks. Safety study is not done beyond 8 weeks.

By end of January 2008, Eli Lilly Company is planning to introduce two new strengths of ‘CIALIS’ (tadalafil). They are 2.5mg and 5 mg tablets while 10 mg and 20 mg tablets already exist. These new strengths are indicated for daily continuous use in managing male erectile dysfunction. The recommended dosage for daily use is 5 mg once daily taken with or without food.

The dose can be reduced to 2.5 mg once daily, depending on patient tolerability. Higher strengths are only for on-demand dosing but not for continuous daily use. Keep enough space on pharmacy shelves then.

See how pharmacy market is balancing! One side, there are drugs withdrawn from the market for some reason and on the other side new drugs, strengths adding up to the shelves…

A new Canadian study revealed that a popular class of osteoporosis drugs, Fosamax, Actonel, Didrocal, belong to ‘bisphosphonates’ triple the risk of developing a painful and disfiguring bone condition. I was surprised to read this news. A team from British Columbia researchers has found that bisphosphonates, a class of drugs used by millions of women worldwide to help prevent bone fractures due to osteoporosis, nearly triple the risk of developing ‘bone necrosis’ ( a condition that can lead to disfigurement and incapacitating pain, may lead to permanent loss of blood supply to the bones).
This research is the largest ever study of bone necrosis and bisphosphonates conducted by the University of British Columbia and Vancouver coastal Health research Institute.
It seems more than 190 million prescriptions have been written for bisphosphonates worldwide, according to the American Dental Association.

Let us see the reaction from Health Canada based on these studies.

'SEASONALE'(levonorgestrel/ethinyl estradiol 0.15/0.03 mg tablets), the first and only oral contraceptive developed to provide 4 menstrual cycles per year, is now available in Canada. SEASONALE is used for the prevention of pregnancy. Each pack is comprised of 84 active pills and 7 inactive pills for one 3 month cycle. Hence it requires only 4 pill pack transitions per year. The dosage of SEASONALE is one pink (active) tablet taken daily for 84 consecutive days followed by 7 days of white (inert) tablets. During the first cycle of medication, the patient supposed to start taking on the first Sunday after the onset of menstruation. If menstration begin on a Sunday, the first tablet (pink) should be taken on that day. Like to know more about this product ? why don't you visit www.seasonale.com
How comfortable life is becoming !

Article from Pharmacygateway

The Federal Government of Canada has announced the availability of more than $7 million for communities across Canada to tackle the challenge of drug use among young people. The funding is available through the Drug Strategy Community Initiatives Fund (DSCIF), which was created in 2004 to promote public awareness of substance use issues and provide support for substance abuse prevention initiatives. The DSCIF provides financial support for a wide range of projects at the national, provincial and local levels. The deadline for proposals is February 29, 2008.
Suggestions for project proposals include those focusing on:
• Informing and educating the public about illicit drugs and the adverse health and social effects of use among youth;
• Facilitating the development of healthy attitudes, resiliency and coping skills among youth to avoid engaging in drug use;

From Pharmacy Post: 'what's happening in pharmacy across Canada'

The Alberta College of Pharmacists (ACP) and Pharmacists' Association of Alberta (RxA) have teamed up to create a single pharmacy awards program. The Apex (Alberta Pharmacy Excellence) Awards acknowledge the achievements and passion of pharmacists, healthcare teams and pharmacy stakeholders across the province. Awards will be presented in seven categories and the first APEX Awards will be handed out at the joint ACP/RxA pharmacy conference in May 2008.

From Pharmacy Post: 'what's happening in pharmacy across Canada'

Prince Edward Island has expanded its Family Health Benefit Program (FHBP), which helps families with children cover the costs of prescription drugs. The program covers medication costs, while the family pays only the pharmacy fee. Eligibility is based on family size and the net family income from the previous year, and families must reapply and re-qualify annually for the coverage to continue. On November 1, the threshold for eligibility for the program changed from a net family income of less than $22,000 to less than $24,800 plus $3,000 for each additional child under 18. FHBP began in 1999 and the number of paid claims has grown from 5,297 in 2001 to 9,307 in 2005-06.

Based on article published in ‘ TORONTO STAR ’, A Canadian-led study has confirmed that an enzyme (PAF acetylhydrolase) found in the blood seems to decrease the severity of allergic reactions, suggesting a way to develop drugs to protect against life threatening allergies to foods such as peanuts or shellfish, or reactions triggered by certain drugs or insect stings. The enzyme had been shown to play this role in animal studies, but this new research is the first time to confirm in humans. The study shows that people who have life-threatening allergies and who have low levels of PAF acetylhydrolase in their blood suffer more severe allergic reactions than people with high levels of PAF acetylhydrolase. Lead author Dr. Peter Vadas says PAF acetylhydrolase breaks down a chemical called platelet activating factor (PAF) that is produced during an allergic reaction. Dr.