Rd20

REVIEW TOPIC
From time immemorial, mi- ability to pump out drugs, devel- Chloramphenicol and now even Advice to Prescribers
Source BMJ, Sept 1999
Dr Elizabeth Mathai, Professor and
Head, Clinical Microbiology &
Dr Sujith J Chandy, Associate
Professor, Clinical Pharmacology
CMC Vellore
Resistance & recent use of
antibiotics
Source: July 22, 2005; Pharmabiz
Resistance can be effectively
‘I have read the contents of “Rational Source: World Health Organisation/
NEW DRUGS
Though a number of combination formulations are approved by the Drugs Controller General India, for the pre- scriber it is the rationality of use that matters in practice. The following is the list of new drugs approved by the Drugs Controller General (India) between July and November 2004.
Name Of Drug
Pharmacological
Classification
Approval
FDC of Lamivudine 300 mg (E.R) +Zidovudine 600 mg (E.R) + Levosalbutamol Tablet 1 mg/2mg & Syrup 1 mg/5 ml.
FDC of Rabeprazole 20 mg + Mosapride S.R. 15 mg Tablet Diclofenac Transdermal patch 100 mg/50 Cm2 For Osteoarthritis & soft tissue injury 10-08-2004 FDC of Atorvastatin 10 mg/20 mg +Ezetimibe 10 mg Tablet FDC of Buprenorphin 2 mg + Naloxone 0.5 mg FDC of Sucralfate 0.07 + Metronidazole 0.01 gm + Citicholine Tablet 500 mg & Injection 250 mg/ml enhancer FDC of Glibenclamide 2.5 mg/ 5 mg + Metformin SR 500 mg tablet Anti-diabetic Lamotrigine S.R. Tablet 50 mg/100 mg/200 mg Risperidone long-acting suspension 25 mg/37.5 mg/50 mg per vial For Schizophrenia for injection Everolimus Tablets 0.25 mg/ 0.5 mg/0.75 mg/1.0 mg Dorzolamide 20 mg + Timolol 5 mg per ml Eye drops Ziprasidone powder for injection after reconstitution 20 mg/ml Voriconazole Tablet 50 mg/200 mg Infusion 200 mg/vial FDC of Nebivolol 5 mg + S (-) Amlodipine 2.5 mg tablet FDC of Valdecoxib 20 mg +Paracetamol 500 mg tablet FDC of Rabeprazole Sodium 20 mg +Domperidone 30 mg S.R Cap. For GERD Cefuroxime Axetil ER tablets 500 mg/1000mg Diclofenac Transdermal Patch 200 mg/75 cm2 Nimesulide Injection 100 mg/ml (Veterinary) FDC of Epi-Growth Factor 1 gm +Silversulphadiazine Cream Levosalbutamol rotacaps 100 mcg/Cap& inhaler 50 mcg /actuation For obstructive airway disease Atomoxetine HCl 10,18, 25 & 40mg Capsule REGULATORY MATTERS
The focus theme for the next issue Valdecoxib Ban REGULATORY MATTERS
will be on Drugs used in childhood The National Pharmacovigilence Advisory Committee (NPAC), after a meeting held on May 2 has recommended to the Government of India for contribute for ‘Readers Forum’ and banning valdecoxib formulations in India, on the basis of risk benefit profile.
On April 7th, the US FDA asked Pfizer to voluntarily withdraw its brand of valdecoxib from the market. This was followed by voluntarily withdrawal of valdecoxib by Ranbaxy Laboratories in India.
Labels of NSAIDs
MedWatch is the FDA’s safety information and adverse event reporting programme, through which it has alerted that valdecoxib’s overall risks outweigh the potential benefits. It has noted that valdecoxib has not been associated with any advantages compared with other nonsteroidal anti- inflammatory drugs (NSAIDs). The reasons for withdrawal include: a Reports of serious and potentially life-threatening skin reactions causing a Lack of adequate data regarding the Cardio Vascular (CV) safety of long- a Increased risk of adverse CV events observed in trials in coronary artery bypass postsurgical patients that may be relevant to chronic use a Potentially life-threatening Gastro Intestinal (GI) bleeding associated with Patients receiving valdecoxib therapy are advised to contact their healthcare providers to arrange for alternative therapy. Additional information, includ- Christian
ing a list of affected NSAIDs, is available on the FDA’s Web site at http:// www.fda.gov/cder/drug/infopage/cox2/default.htm Association of
The FDA has asked manufacturers to revise the labelling (package insert) for all prescription NSAIDs, including celecoxib to include a boxed warning, Published by
highlighting the potential for increased risk of (CV) events and the serious, potential life-threatening Gastro Intestinal (GI) bleeding associated with their use. Another Cox-2 selective NSAID Rofecoxib was already withdrawn from Christian Medical Association of IndiaPlot No 2, A-3 Local Shopping Centre Source: Medscape April 7, 2005
Janakpuri, New Delhi 110 058Phone: 2559 9991/2/3 or 2552 1502 On 18th and 19th March 2005, the advisory committee of Rational Drugs (RD) met in CMC, Vellore and had consultation on developing Rational Drug Use CMAI Bangalore OfficeHVS Court, 3rd Floor, 21 Cunningham systems in mission hospitals. Dr Alice Kuruvilla led the consultations.
Besides the RD advisory committee members, there were participants from Editorial Committee
There were also invitees from the pharmacy department of CMC, Vellore.
Dr Frank a volunteer from the USA and his wife Ms Mary, a pharmacist.
The consultation organised by CMAI was aimed to discuss interventions of different components of the rational drug use systems in mission hospitals like developing a desirable drug policy for each hospital, developing a
formulary of drugs or standard treatment guidelines, forming a list of essential medicines, monitoring adverse drug reactions, and form a drug Design & Production
committee. The focal themes for the future issues of RD were also finalised.
Susamma Mathew
Printed at: Impulsive Creations

Source: http://www.unimondo.org/content/download/17868/117551/file/rd20.pdf