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FDA updated information about a safety review of Ezetimibe/Simvastatin (Vytorin), Ezetimibe (Zetia), and Simvastatin (Zocor)
FDA updated yesterday ( January 8, 2009) information related to their review of the ENHANCE trial: On January 25, 2008, FDA announced that it would be reviewing data from the ENHANCE trial (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia). (http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm). Preliminary results from this
Idiosyncratic Response definition
Idiosyncratic Response: a pharmacological definition.
Absorption rate constant (ka) definition
Absorption rate constant (ka), a pharmacokinetic definition.
Bivalirudin (Angiox) for acute coronary syndromes: SMC review
The Scottish Medicines Consortium issued on 7th December, 2008 an advice on bivalirudin (Angiox): Bivalirudin (Angiox) is accepted for restricted use within NHS Scotland for the treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction) planned for urgent or early intervention. It is restricted to use in patients who would
Infusion kinetics definition
The following pharmacology definition has been taken from the Pharmacology and Experimental Therapeutics Department Glossary at Boston University School of Medicine. Infusion Kinetics: Infusion, as a means of drug administration, involves an effectively continuous flow of a drug solution into the blood stream over a relatively long period of time. (Intravascular injections are separate administrations
Sertraline (Zoloft and associated names): review by the CHMP
The CHMP has issued a question and answer document dated 18 December 2008, about the review of sertraline (Zoloft and associated names) Questions and answers on the referral for Zoloft – Sertraline Hard capsules and Film coated tablets – 25 mg, 50 mg, and 100 mg Concentrate for oral solution – 20 mg/ml The European
Aripiprazole IM (Abilify) for agitation control in patients with schizophrenia: SMC review
The Scottish Medicines Consortium issued on 7th December, 2008 an advice on the aripiprazole intramuscular injection (Abilify): Aripiprazole intramuscular injection (Abilify ) is accepted for use in NHS Scotland for the rapid control of agitation and disturbed behaviours in patients with schizophrenia when oral therapy is not appropriate.
Atazanavir (Reyataz) for HIV-1 infection: SMC review
The Scottish Medicines Consortium issued on 7th December, 2008 an advice on the recently approved protease inhibitor Atazanavir (Reyataz) Atazanavir (Reyataz) is accepted for use within NHS Scotland in antiretroviral treatment naïve HIV-1 infected adults in combination with other antiretroviral medicinal products. The combination of atazanavir and ritonavir was non-inferior to a standard boosted protease inhibitor
Elimination rate constant (kel) definition
The following pharmacology definition has been taken from the Pharmacology and Experimental Therapeutics Department Glossary at Boston University School of Medicine. kel: The “elimination rate constant” for a drug eliminated according to the laws of first-order reaction kinetics; the slope of the plot of the logarithm of concentration against time, when natural logarithms, i.e. logarithms
Ramipril and hydrochlorothiazide (Tritazide and related) indications, contraindications and posology updated in a review by the CHMP
The CHMP has issued a question and answer document dated 18 December 2008, about the review of Titrazide (ramipril and hydrochlorothiazide) and associated names: Questions and answers on the referral for Tritazide tablets containing ramipril and hydrochlorothiazide 2.5/12.5 mg, 5/12.5 mg, 5/25 mg The European Medicines Agency (EMEA) has completed a review of Tritazide. The
Ramipril (Tritrace): indications, contraindications and posology updated in a review by the CHMP
The CHMP has issued a question and answer document dated 18 December 2008, about the review of Titrace (ramipril) and associated names: Questions and answers on the referral for Tritace tablet and hard capsules containing ramipril 1.25 mg, 2.5 mg, 5 mg and 10 mg The European Medicines Agency (EMEA) has completed a review of
Nilotinib (Tasigna) for chonic myeloid leukemia: Health Canada evaluation
Information from Health Canada issued October 14, 2008 about the recently approval of nilotinib (Tasugna) On September 9, 2008, Health Canada issued a Notice of Compliance under the Notice of Compliance with Conditions (NOC/c) Policy to Novartis Pharmaceuticals Canada Inc. for the drug product Tasigna*. The product was authorized under the NOC/c Policy on the
Methylnaltrexone (Relistor) for opioid induced constipation: SMC review
The Scottish Medicines Consortium issued on 8th December, 2008 an advice on the recently approved opioid antagonist methylnaltrexone ADVICE: following a full submissionMethylnaltrexone (Relistor) is accepted for restricted use within NHS Scotland for treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been
Propolis side effects and association with renal failure: Health Canada case report
From the Canadian Adverse Reaction Newsletter: Propolis: suspected association with renal failure Propolis is a natural resinous product collected by bees that is used in the construction of hives.[1] It is available in Canada as a single ingredient or in combination in many natural health products (NHPs). Propolis is used for the relief of various
Local anesthetic infusion with postoperative pain pumps and articular chondrolysis
New information from the Canadian Adverse Reaction Newsletter: Local anesthetic infusion with postoperative pain pumps and articular chondrolysis Postoperative pain pumps are infusion devices designed to continuously deliver controlled amounts of medication.[1,2] They can be used to infuse local anesthetic solutions directly into operative sites, for pain management following surgical procedures. The device consists of