Matching articles for "Midazolam"
Dexmedetomidine Sublingual Film (Igalmi) for Acute Agitation
The Medical Letter on Drugs and Therapeutics • December 26, 2022; (Issue 1666)
The FDA has approved a sublingual film formulation
of the alpha-2 adrenergic receptor agonist
dexmedetomidine (Igalmi — BioXcel Therapeutics)
for acute treatment of agitation associated with
schizophrenia...
The FDA has approved a sublingual film formulation
of the alpha-2 adrenergic receptor agonist
dexmedetomidine (Igalmi — BioXcel Therapeutics)
for acute treatment of agitation associated with
schizophrenia or bipolar I or II disorder in adults. It is
the first alpha-2 agonist and the only sublingual film
to be approved for this indication. Dexmedetomidine
has been available for many years in an injectable
formulation (Precedex) for sedation in the intensive
care unit and to facilitate procedures such as
mechanical ventilation.
Remimazolam (Byfavo) for Short-Term Procedural Sedation
The Medical Letter on Drugs and Therapeutics • February 21, 2022; (Issue 1644)
The FDA has approved remimazolam (Byfavo – Acacia
Pharma), an ultra-short-acting IV benzodiazepine,
for induction and maintenance of sedation in adults
undergoing procedures of up to 30 minutes'...
The FDA has approved remimazolam (Byfavo – Acacia
Pharma), an ultra-short-acting IV benzodiazepine,
for induction and maintenance of sedation in adults
undergoing procedures of up to 30 minutes' duration.
Intranasal Diazepam (Valtoco) and Midazolam (Nayzilam) for Seizure Clusters
The Medical Letter on Drugs and Therapeutics • April 20, 2020; (Issue 1596)
The FDA has approved nasal spray formulations of
the benzodiazepines diazepam (Valtoco — Neurelis)
and midazolam (Nayzilam — UCB) for acute treatment
of intermittent episodes of frequent seizure...
The FDA has approved nasal spray formulations of
the benzodiazepines diazepam (Valtoco — Neurelis)
and midazolam (Nayzilam — UCB) for acute treatment
of intermittent episodes of frequent seizure activity
(seizure clusters). Diazepam rectal gel (Diastat, Diastat
AcuDial, and generics) has been used for this indication
for many years.
Genvoya - A New 4-Drug Combination for HIV
The Medical Letter on Drugs and Therapeutics • February 15, 2016; (Issue 1488)
The FDA has approved Genvoya (Gilead), a fixed-dose
combination of the integrase strand transfer
inhibitor (INSTI) elvitegravir, the pharmacokinetic
enhancer cobicistat, and the...
The FDA has approved Genvoya (Gilead), a fixed-dose
combination of the integrase strand transfer
inhibitor (INSTI) elvitegravir, the pharmacokinetic
enhancer cobicistat, and the nucleoside/nucleotide
reverse transcriptase inhibitors (NRTIs) emtricitabine
and tenofovir alafenamide, for treatment of HIV-1 infection in patients ≥12 years old. This is the first
approval for tenofovir alafenamide (TAF), a tenofovir
prodrug. Stribild, a fixed-dose combination of
elvitegravir, cobicistat, emtricitabine, and tenofovir
disoproxil fumarate (TDF), was approved in 2012.
In Brief: Technivie for HCV Genotype 4 Infection (online only)
The Medical Letter on Drugs and Therapeutics • November 23, 2015; (Issue 1482)
The FDA has approved Technivie (Abbvie), a fixed-dose combination of the direct-acting antiviral agents ombitasvir and paritaprevir and the pharmacokinetic enhancer ritonavir, for oral treatment of chronic...
The FDA has approved Technivie (Abbvie), a fixed-dose combination of the direct-acting antiviral agents ombitasvir and paritaprevir and the pharmacokinetic enhancer ritonavir, for oral treatment of chronic hepatitis C virus (HCV) genotype 4 infection in patients without cirrhosis. It is indicated for use in combination with ribavirin. Ombitasvir/paritaprevir/ritonavir copackaged with dasabuvir, an HCV RNA polymerase inhibitor that has little activity against HCV genotype 4, is approved as Viekira Pak for treatment of HCV genotype 1 infection.1
HCV genotype 4 is uncommon in the US and Canada. It is the most prevalent strain of HCV in Central sub-Saharan Africa, North Africa, and the Middle East.2 Technivie plus ribavirin was the first all-oral treatment approved for treatment of HCV genotype 4. Ledipasvir/sofosbuvir (Harvoni)3 was also recently approved for this indication; it does not require coadministration with ribavirin and can be used in patients with or without cirrhosis. Its use for this and other new indications will be reviewed in a future issue.
FDA approval of Technivie was based on an open-label trial (PEARL-I) in 86 treatment-naive and 49 treatment-experienced non-cirrhotic patients with HCV genotype 4 infection. Treatment-naive patients were randomized to receive Technivie with or without ribavirin for 12 weeks; all treatment-experienced patients received the combination plus ribavirin for 12 weeks. The rate of sustained virologic response 12 weeks after stopping treatment (SVR12), the primary endpoint, was 91% (40/44) in treatment-naive patients not receiving ribavirin and was 100% in both treatment-naive (42/42) and treatment-experienced (49/49) patients receiving the combination plus ribavirin.4
Adverse effects observed with Technivie in the clinical trial included asthenia, fatigue, nausea, insomnia, pruritus, and skin reactions. Like Viekira Pak, Technivie has been associated with serious, sometimes fatal cases of hepatic decompensation and is contraindicated in patients with moderate to severe (Child-Pugh B/C) hepatic impairment.5 It is also contraindicated in patients taking ethinyl estradiol (because of a risk of ALT elevation), CYP3A4 inducers such as rifampin, or certain sensitive CYP3A4 substrates such as midazolam or simvastatin.6
Each Technivie tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir, and 50 mg of ritonavir. The recommended dosage is two tablets taken once daily in the morning with a meal for 12 weeks. Ribavirin should be coadministered with Technivie at a daily dose of 1000 mg in patients weighing <75 kg or 1200 mg in those weighing ≥75 kg. Use of Technivie alone may be considered in treatment-naive patients who cannot take or tolerate ribavirin. A 12-week supply of Technivie costs $76,653.7
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HCV genotype 4 is uncommon in the US and Canada. It is the most prevalent strain of HCV in Central sub-Saharan Africa, North Africa, and the Middle East.2 Technivie plus ribavirin was the first all-oral treatment approved for treatment of HCV genotype 4. Ledipasvir/sofosbuvir (Harvoni)3 was also recently approved for this indication; it does not require coadministration with ribavirin and can be used in patients with or without cirrhosis. Its use for this and other new indications will be reviewed in a future issue.
FDA approval of Technivie was based on an open-label trial (PEARL-I) in 86 treatment-naive and 49 treatment-experienced non-cirrhotic patients with HCV genotype 4 infection. Treatment-naive patients were randomized to receive Technivie with or without ribavirin for 12 weeks; all treatment-experienced patients received the combination plus ribavirin for 12 weeks. The rate of sustained virologic response 12 weeks after stopping treatment (SVR12), the primary endpoint, was 91% (40/44) in treatment-naive patients not receiving ribavirin and was 100% in both treatment-naive (42/42) and treatment-experienced (49/49) patients receiving the combination plus ribavirin.4
Adverse effects observed with Technivie in the clinical trial included asthenia, fatigue, nausea, insomnia, pruritus, and skin reactions. Like Viekira Pak, Technivie has been associated with serious, sometimes fatal cases of hepatic decompensation and is contraindicated in patients with moderate to severe (Child-Pugh B/C) hepatic impairment.5 It is also contraindicated in patients taking ethinyl estradiol (because of a risk of ALT elevation), CYP3A4 inducers such as rifampin, or certain sensitive CYP3A4 substrates such as midazolam or simvastatin.6
Each Technivie tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir, and 50 mg of ritonavir. The recommended dosage is two tablets taken once daily in the morning with a meal for 12 weeks. Ribavirin should be coadministered with Technivie at a daily dose of 1000 mg in patients weighing <75 kg or 1200 mg in those weighing ≥75 kg. Use of Technivie alone may be considered in treatment-naive patients who cannot take or tolerate ribavirin. A 12-week supply of Technivie costs $76,653.7
- A 4-drug combination (Viekira Pak) for hepatitis C. Med Lett Drugs Ther 2015; 57:15.
- JP Messina et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology 2015; 61:77.
- A combination of ledipasvir plus sofosbuvir (Harvoni) for hepatitis C. Med Lett Drugs Ther 2014; 56:11.
- C Hézode et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet 2015; 385:2502.
- In brief: hepatic injury with hepatitis C drugs. Med Lett Drugs Ther 2015; 57:156.
- Inhibitors and inducers of CYP enzymes and P-glycoprotein. Med Lett Drugs Ther 2013; 55:e44.
- Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. November 5, 2015. Reprinted with permission by First Databank, Inc. All rights reserved. ©2015 www.fdbhealth.com/policies/drug-pricing-policy.
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A 4-Drug Combination (Viekira Pak) for Hepatitis C
The Medical Letter on Drugs and Therapeutics • February 2, 2015; (Issue 1461)
The FDA has approved Viekira Pak (Abbvie), a fixed-dose
combination of two new direct-acting antiviral
agents (ombitasvir, paritaprevir) with the pharmacologic
enhancer ritonavir in one tablet, co-packaged...
The FDA has approved Viekira Pak (Abbvie), a fixed-dose
combination of two new direct-acting antiviral
agents (ombitasvir, paritaprevir) with the pharmacologic
enhancer ritonavir in one tablet, co-packaged with
a third new direct-acting antiviral agent (dasabuvir) in
a second tablet, for oral treatment of chronic hepatitis
C virus (HCV) genotype 1 infection. Genotype 1 is
responsible for 70-80% of HCV infections in the US.
Dexmedetomidine (Precedex) for ICU Sedation
The Medical Letter on Drugs and Therapeutics • May 30, 2011; (Issue 1365)
Opioids, benzodiazepines, propofol, antipsychotics
and dexmedetomidine (Precedex) are frequently used
in the intensive care unit (ICU) to manage pain, anxiety,
agitation and delirium, and to facilitate...
Opioids, benzodiazepines, propofol, antipsychotics
and dexmedetomidine (Precedex) are frequently used
in the intensive care unit (ICU) to manage pain, anxiety,
agitation and delirium, and to facilitate procedures
such as mechanical ventilation. The use of dexmedetomidine,
a centrally-acting selective α2-receptor agonist
approved by the FDA in 1999, has been increasing in
recent years. Some new studies comparing it to other
drugs for ICU sedation have been published.
Telavancin (Vibativ) for Gram-Positive Skin Infections
The Medical Letter on Drugs and Therapeutics • January 11, 2010; (Issue 1329)
Telavancin (Vibativ - Astellas and Theravance), a lipoglycopeptide derivative of vancomycin (Vancocin, and others), has received FDA approval for treatment of complicated skin and skin structure infections...
Telavancin (Vibativ - Astellas and Theravance), a lipoglycopeptide derivative of vancomycin (Vancocin, and others), has received FDA approval for treatment of complicated skin and skin structure infections caused by susceptible gram-positive bacteria in adults.
Antifungal Drugs
The Medical Letter on Drugs and Therapeutics • January 1, 2008; (Issue 65)
The drugs of choice for treatment of some fungal infections are listed in the tables. Some of the indications and dosages recommended here have not been approved by the FDA. Other guidelines are available from...
The drugs of choice for treatment of some fungal infections are listed in the tables. Some of the indications and dosages recommended here have not been approved by the FDA. Other guidelines are available from the Infectious Diseases Society of America (www.idsociety.org).
Ziconotide (Prialt) for Chronic Pain
The Medical Letter on Drugs and Therapeutics • December 5, 2005; (Issue 1223)
The FDA has approved ziconotide (Prialt - Elan) intrathecal infusion for management of severe chronic pain in patients who are intolerant of or refractory to other treatments. Ziconotide is a synthetic neuronal...
The FDA has approved ziconotide (Prialt - Elan) intrathecal infusion for management of severe chronic pain in patients who are intolerant of or refractory to other treatments. Ziconotide is a synthetic neuronal N-type calcium channel blocker. It is intended for use with a programmable implanted microinfusion device, but an external microinfusion device can be used temporarily.
Tipranavir (Aptivus) for HIV
The Medical Letter on Drugs and Therapeutics • October 10, 2005; (Issue 1219)
Tipranavir (Aptivus - Boehringer Ingelheim), a new protease inhibitor, has received accelerated approval from the FDA. It must be given with ritonavir (Norvir). The combination is indicated for use with other...
Tipranavir (Aptivus - Boehringer Ingelheim), a new protease inhibitor, has received accelerated approval from the FDA. It must be given with ritonavir (Norvir). The combination is indicated for use with other antiretrovirals to treat HIV infection in highly treatment-experienced adults who have ongoing viral replication or in those with HIV strains known to be resistant to multiple protease inhibitors.
CYP3A and Drug Interactions
The Medical Letter on Drugs and Therapeutics • July 4, 2005; (Issue 1212)
Serious adverse interactions between drugs continue to be reported. Many of these are due to inhibition or induction of cytochrome P450 (CYP) enzymes, particularly CYP3A4. CYP3A is thought to be involved in the...
Serious adverse interactions between drugs continue to be reported. Many of these are due to inhibition or induction of cytochrome P450 (CYP) enzymes, particularly CYP3A4. CYP3A is thought to be involved in the metabolism of more than 50 percent of currently prescribed drugs.2 CYP3A4, which is more abundantly expressed than CYP3A5, accounts for most CYP3A activity in vivo.
Solifenacin and Darifenacin for Overactive Bladder
The Medical Letter on Drugs and Therapeutics • March 14, 2005; (Issue 1204)
Solifenacin succinate (VESIcare - Yamanouchi and GlaxoSmithKline) and darifenacin hydrobromide (Enablex - Novartis) have been approved by the FDA for oral treatment of overactive...
Solifenacin succinate (VESIcare - Yamanouchi and GlaxoSmithKline) and darifenacin hydrobromide (Enablex - Novartis) have been approved by the FDA for oral treatment of overactive bladder.
Antifungal Drugs
The Medical Letter on Drugs and Therapeutics • February 1, 2005; (Issue 30)
The drugs of choice for treatment of some fungal infections are listed in the table that begins on page 8. Some of the indications and dosages recommended here have not been approved by the...
The drugs of choice for treatment of some fungal infections are listed in the table that begins on page 8. Some of the indications and dosages recommended here have not been approved by the FDA.
Telithromycin (Ketek) for Respiratory Infections
The Medical Letter on Drugs and Therapeutics • August 16, 2004; (Issue 1189)
Telithromycin (Ketek - Aventis) has been approved by the FDA for oral treatment of mild to moderate community-acquired pneumonia, acute exacerbations of chronic bronchitis and acute bacterial sinusitis in...
Telithromycin (Ketek - Aventis) has been approved by the FDA for oral treatment of mild to moderate community-acquired pneumonia, acute exacerbations of chronic bronchitis and acute bacterial sinusitis in patients age 18 and older. The drug is the first in a new class of antibiotics, the ketolides, derived from the macrolide erythromycin. Telithromycin has been marketed in Europe since 2001.
Drug Interactions with Grapefruit Juice
The Medical Letter on Drugs and Therapeutics • January 5, 2004; (Issue 1173)
The ability of grapefruit juice to increase serum concentrations of drugs was first discovered during a study of the effect of ethanol on felodipine (Plendil) pharmacokinetics. Double-strength grapefruit juice...
The ability of grapefruit juice to increase serum concentrations of drugs was first discovered during a study of the effect of ethanol on felodipine (Plendil) pharmacokinetics. Double-strength grapefruit juice used to disguise the taste of ethanol resulted in higher than expected serum concentrations of felodipine (DG Bailey et al, Clin Invest Med 1989; 12:357).
Drug Interactions
The Medical Letter on Drugs and Therapeutics • June 8, 2003; (Issue 1158)
Changes caused by one drug in the absorption, distribution, metabolism or excretion of another may lead to a pharmacokinetic adverse drug interaction (DN Juurlink et al, JAMA 2003; 289:1652). Additive drug...
Changes caused by one drug in the absorption, distribution, metabolism or excretion of another may lead to a pharmacokinetic adverse drug interaction (DN Juurlink et al, JAMA 2003; 289:1652). Additive drug interactions, such as vasodilation caused by both sildenafil (Viagra) and nitrates, can also have adverse effects.
Quinupristin/Dalfopristin
The Medical Letter on Drugs and Therapeutics • November 19, 1999; (Issue 1066)
Quinupristin and dalfopristin, two streptogramin antibacterials marketed in a 30:70 combination as Synercid, have received accelerated approval from the FDA for intravenous treatment of bacteremia and...
Quinupristin and dalfopristin, two streptogramin antibacterials marketed in a 30:70 combination as Synercid, have received accelerated approval from the FDA for intravenous treatment of bacteremia and life-threatening infection....
Amprenavir: A New HIV Protease Inhibitor
The Medical Letter on Drugs and Therapeutics • July 16, 1999; (Issue 1057)
Amprenavir is the fifth protease inhibitor to become available for treatment of HIV infection. It was approved by the FDA for use with other drugs in the treatment of HIV-infected adults and children at least...
Amprenavir is the fifth protease inhibitor to become available for treatment of HIV infection. It was approved by the FDA for use with other drugs in the treatment of HIV-infected adults and children at least four years old.
Drug Interactions
The Medical Letter on Drugs and Therapeutics • July 2, 1999; (Issue 1056)
Reports of adverse interactions between drugs continue to accumulate. Recently, the FDA has expanded the recommendations on drug interactions found in the package inserts of new...
Reports of adverse interactions between drugs continue to accumulate. Recently, the FDA has expanded the recommendations on drug interactions found in the package inserts of new drugs.
Systemic Antifungal Drugs
The Medical Letter on Drugs and Therapeutics • September 12, 1997; (Issue 1009)
The drugs of choice for treatment of deep fungal infections are listed in the table below. Some of the indications and dosages recommended here have not been approved by the...
The drugs of choice for treatment of deep fungal infections are listed in the table below. Some of the indications and dosages recommended here have not been approved by the FDA.
Systemic Antifungal Drugs
The Medical Letter on Drugs and Therapeutics • February 2, 1996; (Issue 967)
The drugs of choice for treatment of deep fungal infections are listed in the table on page 101. Some of the indications and dosages recommended here have not been approved by the US Food and Drug...
The drugs of choice for treatment of deep fungal infections are listed in the table on page 101. Some of the indications and dosages recommended here have not been approved by the US Food and Drug Administration. More detailed guidelines are available from the Infectious Diseases Society of America (J Sobel et al, Clin Infect Dis, volume 30, April 2000).
Itraconazole for Onychomycosis
The Medical Letter on Drugs and Therapeutics • January 19, 1996; (Issue 966)
Itraconazole (Sporanox - Janssen), an oral antifungal triazole that has been available in the USA since 1992 for treatment of deep fungal infections (Medical Letter, 35:7, 1993), is now being marketed for...
Itraconazole (Sporanox - Janssen), an oral antifungal triazole that has been available in the USA since 1992 for treatment of deep fungal infections (Medical Letter, 35:7, 1993), is now being marketed for treatment of dermatophyte infections of the toenails, with or without fingernail involvement.
Grapefruit Juice Interactions With Drugs
The Medical Letter on Drugs and Therapeutics • August 18, 1995; (Issue 955)
In a study of the interaction between alcohol and the calcium-channel blocker felodipine (Plendil), the grapefruit juice vehicle for the alcohol appeared to increase felodipine plasma concentrations....
In a study of the interaction between alcohol and the calcium-channel blocker felodipine (Plendil), the grapefruit juice vehicle for the alcohol appeared to increase felodipine plasma concentrations. Subsequent studies have found that grapefruit juice increases plasma concentrations of several calcium-channel blockers and of some other drugs as well (DG Bailey et al, Clin Pharmacokinet, 26:91, 1994).
Flumazenil
The Medical Letter on Drugs and Therapeutics • July 10, 1992; (Issue 874)
Flumazenil (Mazicon - Roche), a benzodiazepine receptor antagonist, has been approved by the US Food and Drug Administration to reverse the sedative effects of benzodiazepines after anesthesia, sedation for...
Flumazenil (Mazicon - Roche), a benzodiazepine receptor antagonist, has been approved by the US Food and Drug Administration to reverse the sedative effects of benzodiazepines after anesthesia, sedation for brief surgical or diagnostic procedures, or after benzodiazepine overdosage. The drug does not antagonize opioids, non-benzodiazepine sedatives, or anesthetic drugs.