Matching articles for "antibacterials"
Cefepime/Enmetazobactam (Exblifep) for Complicated Urinary Tract Infections
The Medical Letter on Drugs and Therapeutics • July 22, 2024; (Issue 1707)
The FDA has approved Exblifep (Allecra), a fixed-dose
combination of the cephalosporin cefepime and the
beta-lactamase inhibitor enmetazobactam, for IV
treatment of adults with complicated urinary...
The FDA has approved Exblifep (Allecra), a fixed-dose
combination of the cephalosporin cefepime and the
beta-lactamase inhibitor enmetazobactam, for IV
treatment of adults with complicated urinary tract
infections (cUTIs), including pyelonephritis, caused
by designated susceptible microorganisms (see
Spectrum of Activity). Exblifep is the first product that
contains enmetazobactam to be approved in the US.
Lotilaner (Xdemvy) for Demodex Blepharitis
The Medical Letter on Drugs and Therapeutics • June 24, 2024; (Issue 1705)
The FDA has approved a 0.25% ophthalmic solution
of the ectoparasiticide lotilaner (Xdemvy – Tarsus) for
treatment of Demodex blepharitis. Lotilaner is the first
drug to be approved in the US for this...
The FDA has approved a 0.25% ophthalmic solution
of the ectoparasiticide lotilaner (Xdemvy – Tarsus) for
treatment of Demodex blepharitis. Lotilaner is the first
drug to be approved in the US for this indication.
Antibiotic Prophylaxis for Dental Procedures
The Medical Letter on Drugs and Therapeutics • April 29, 2024; (Issue 1701)
Since 2007, antimicrobial prophylaxis for dental
procedures has been recommended to prevent
viridans group streptococcal infective endocarditis
only for patients at highest risk of an adverse
outcome....
Since 2007, antimicrobial prophylaxis for dental
procedures has been recommended to prevent
viridans group streptococcal infective endocarditis
only for patients at highest risk of an adverse
outcome. Limiting use to such patients does not
appear to have led to an increased incidence of
infective endocarditis or increased mortality due to
infective endocarditis.
Sulbactam/Durlobactam (Xacduro) for Acinetobacter Pneumonia
The Medical Letter on Drugs and Therapeutics • November 27, 2023; (Issue 1690)
The FDA has approved Xacduro (Innoviva), a
combination of the beta-lactam antibacterial
sulbactam and the beta-lactamase inhibitor
durlobactam, for IV treatment of adults with hospital-acquired
or...
The FDA has approved Xacduro (Innoviva), a
combination of the beta-lactam antibacterial
sulbactam and the beta-lactamase inhibitor
durlobactam, for IV treatment of adults with hospital-acquired
or ventilator-associated bacterial pneumonia
caused by susceptible isolates of Acinetobacter
baumannii-calcoaceticus complex (ABC).
Live Fecal Microbiota Oral Capsules (Vowst) for Prevention of CDI Recurrence
The Medical Letter on Drugs and Therapeutics • May 29, 2023; (Issue 1677)
The FDA has approved Vowst (Seres Therapeutics/Nestle HealthScience), an oral capsule containing live
fecal microbiota spores, for prevention of additional
recurrences of Clostridioides difficile infection...
The FDA has approved Vowst (Seres Therapeutics/Nestle HealthScience), an oral capsule containing live
fecal microbiota spores, for prevention of additional
recurrences of Clostridioides difficile infection (CDI)
in adults. Vowst is the first orally administered
microbiota-based treatment to be approved for
this indication. A rectally-administered live fecal
microbiota-based suspension (Rebyota) was
approved in 2022 for the same indication. Neither
product is approved for acute treatment of CDI.
Treatment of Common Respiratory Tract Infections
The Medical Letter on Drugs and Therapeutics • April 17, 2023; (Issue 1674)
Most respiratory tract infections are caused by
viruses. Bacterial respiratory tract infections are
usually treated empirically with antibiotic therapy
that targets the most probable causative...
Most respiratory tract infections are caused by
viruses. Bacterial respiratory tract infections are
usually treated empirically with antibiotic therapy
that targets the most probable causative pathogens.
Recommended antibiotic regimens for outpatient
treatment of some common respiratory tract
infections are listed in Table 1 for adults and Table 2
for children.
Live Fecal Microbiota (Rebyota) for Prevention of CDI Recurrence
The Medical Letter on Drugs and Therapeutics • March 6, 2023; (Issue 1671)
The FDA has approved Rebyota (Ferring), a rectally-administered,
live fecal microbiota suspension, for
prevention of additional recurrences of Clostridioides
difficile infection (CDI) following antibiotic...
The FDA has approved Rebyota (Ferring), a rectally-administered,
live fecal microbiota suspension, for
prevention of additional recurrences of Clostridioides
difficile infection (CDI) following antibiotic treatment
for a recurrent episode of CDI in adults. Rebyota is
the first microbiome-based treatment to be approved
for this indication. It is not approved for initial
treatment of CDI. Fecal microbiota transplantation
(FMT) has been used in patients with multiple
CDI recurrences.
Tretinoin/Benzoyl Peroxide Cream (Twyneo) for Acne
The Medical Letter on Drugs and Therapeutics • May 16, 2022; (Issue 1650)
The FDA has approved Twyneo (Galderma), a cream
containing the retinoid tretinoin and the oxidizing
agent benzoyl peroxide, for once-daily topical
treatment of acne in patients ≥9 years...
The FDA has approved Twyneo (Galderma), a cream
containing the retinoid tretinoin and the oxidizing
agent benzoyl peroxide, for once-daily topical
treatment of acne in patients ≥9 years old.
Clascoterone Cream (Winlevi) for Acne
The Medical Letter on Drugs and Therapeutics • December 27, 2021; (Issue 1640)
The FDA has approved Winlevi (Sun), a 1% cream
formulation of the androgen receptor inhibitor
clascoterone, for treatment of acne vulgaris in
patients ≥12 years old. It is the first topical...
The FDA has approved Winlevi (Sun), a 1% cream
formulation of the androgen receptor inhibitor
clascoterone, for treatment of acne vulgaris in
patients ≥12 years old. It is the first topical androgen
receptor inhibitor to be approved by the FDA.
Treatment of Clostridioides difficile Infection
The Medical Letter on Drugs and Therapeutics • September 6, 2021; (Issue 1632)
Clostridioides (formerly Clostridium) difficile infection
(CDI) is the most common infectious cause of
healthcare-associated diarrhea in adults. Guidelines
on management of CDI have recently been...
Clostridioides (formerly Clostridium) difficile infection
(CDI) is the most common infectious cause of
healthcare-associated diarrhea in adults. Guidelines
on management of CDI have recently been updated.
In Brief: Oritavancin (Kimyrsa) for Skin and Skin Structure Infections (online only)
The Medical Letter on Drugs and Therapeutics • August 23, 2021; (Issue 1631)
The FDA has approved Kimyrsa (Melinta), a new
IV formulation of the long-acting lipoglycopeptide
antibiotic oritavancin, for treatment of adults with acute
bacterial skin and skin structure infections caused...
The FDA has approved Kimyrsa (Melinta), a new
IV formulation of the long-acting lipoglycopeptide
antibiotic oritavancin, for treatment of adults with acute
bacterial skin and skin structure infections caused by
susceptible gram-positive bacteria. Orbactiv (Melinta),
another IV formulation of oritavancin, was approved in
2014 for the same indication. Kimyrsa has a smaller
infusion volume (250 mL vs 1 L) and a shorter infusion
time (1 hour vs 3 hours) compared to Orbactiv (see
Table 1).
Antibacterial Drugs for Lyme Disease
The Medical Letter on Drugs and Therapeutics • May 17, 2021; (Issue 1624)
Lyme disease in the US is caused by the spirochete
Borrelia burgdorferi, which is transmitted to humans
by Ixodes scapularis (blacklegged [deer] tick) and
I. pacificus (western blacklegged tick). Most cases...
Lyme disease in the US is caused by the spirochete
Borrelia burgdorferi, which is transmitted to humans
by Ixodes scapularis (blacklegged [deer] tick) and
I. pacificus (western blacklegged tick). Most cases of
Lyme disease occur in late spring and early summer
in northeastern and mid-Atlantic states, the upper
Midwest, and in northern California. B. mayonii, which
is also transmitted by I. scapularis, has been shown to
cause a similar illness in the upper Midwest.
Antibacterial Drugs for Community-Acquired Pneumonia
The Medical Letter on Drugs and Therapeutics • January 25, 2021; (Issue 1616)
Treatment of community-acquired pneumonia (CAP)
is usually empiric, with selected antibiotic regimens
directed against some of the most common causative
pathogens. Recommended empiric regimens are
listed in...
Treatment of community-acquired pneumonia (CAP)
is usually empiric, with selected antibiotic regimens
directed against some of the most common causative
pathogens. Recommended empiric regimens are
listed in Table 2; recommended antibiotic dosages for
treatment of CAP are listed in Tables 3 and 4. Joint
guidelines for treatment of CAP by the American
Thoracic Society and the Infectious Diseases Society of
America (ATS/IDSA) were updated in 2019.
Metoclopramide Nasal Spray (Gimoti) for Diabetic Gastroparesis
The Medical Letter on Drugs and Therapeutics • January 11, 2021; (Issue 1615)
The FDA has approved Gimoti (Evoke), a nasal
spray formulation of the dopamine-2 (D2) receptor
antagonist metoclopramide, for relief of symptoms in
adults with acute and recurrent diabetic...
The FDA has approved Gimoti (Evoke), a nasal
spray formulation of the dopamine-2 (D2) receptor
antagonist metoclopramide, for relief of symptoms in
adults with acute and recurrent diabetic gastroparesis.
Metoclopramide (Reglan, and generics) has been
available for years in conventional and orally-disintegrating
tablets and in an injectable formulation.
It is the only drug that is FDA-approved for treatment
of diabetic gastroparesis.
Drugs for Acne
The Medical Letter on Drugs and Therapeutics • November 30, 2020; (Issue 1612)
Acne is common among adolescents and young adults,
but its prevalence appears to have increased in people
of all ages due to prolonged wearing of masks during
the COVID-19 pandemic. Guidelines for treatment...
Acne is common among adolescents and young adults,
but its prevalence appears to have increased in people
of all ages due to prolonged wearing of masks during
the COVID-19 pandemic. Guidelines for treatment of
acne were last published in 2016.
Drugs for COPD
The Medical Letter on Drugs and Therapeutics • September 7, 2020; (Issue 1606)
The main goals of treatment for chronic obstructive
pulmonary disease (COPD) are to relieve symptoms,
reduce the frequency and severity of exacerbations,
and prevent disease progression. Several...
The main goals of treatment for chronic obstructive
pulmonary disease (COPD) are to relieve symptoms,
reduce the frequency and severity of exacerbations,
and prevent disease progression. Several guidelines
and review articles on COPD treatment have been
published in recent years. Treatment of acute
exacerbations is not discussed here.
Talicia - A 3-Drug Combination for Helicobacter pylori Infection
The Medical Letter on Drugs and Therapeutics • June 1, 2020; (Issue 1599)
The FDA has approved a fixed-dose combination
of omeprazole, amoxicillin, and rifabutin (Talicia –
RedHill) for treatment of Helicobacter pylori infection
in adults. Talicia is the first rifabutin-based...
The FDA has approved a fixed-dose combination
of omeprazole, amoxicillin, and rifabutin (Talicia –
RedHill) for treatment of Helicobacter pylori infection
in adults. Talicia is the first rifabutin-based product to
be approved for this indication.
Cefiderocol (Fetroja) - A New IV Cephalosporin for Complicated UTI
The Medical Letter on Drugs and Therapeutics • May 4, 2020; (Issue 1597)
The FDA has approved cefiderocol (Fetroja – Shionogi),
a new IV cephalosporin antibiotic, for treatment of
complicated urinary tract infections (UTI) caused by
susceptible gram-negative bacteria in adults...
The FDA has approved cefiderocol (Fetroja – Shionogi),
a new IV cephalosporin antibiotic, for treatment of
complicated urinary tract infections (UTI) caused by
susceptible gram-negative bacteria in adults who
have limited or no alternative treatment options.
Minocycline Foam (Amzeeq) for Acne
The Medical Letter on Drugs and Therapeutics • May 4, 2020; (Issue 1597)
The FDA has approved a 4% aerosol foam formulation
of minocycline (Amzeeq – Foamix) for topical
treatment of inflammatory lesions of non-nodular
moderate to severe acne in patients ≥9 years old. It...
The FDA has approved a 4% aerosol foam formulation
of minocycline (Amzeeq – Foamix) for topical
treatment of inflammatory lesions of non-nodular
moderate to severe acne in patients ≥9 years old. It is
the first topical tetracycline formulation to be approved
for use in patients with acne. Oral minocycline
(Minocin, Solodyn, and generics) is
Drugs for Irritable Bowel Syndrome
The Medical Letter on Drugs and Therapeutics • March 23, 2020; (Issue 1594)
Irritable bowel syndrome (IBS) is a common disorder
characterized by recurrent abdominal pain and altered
bowel habits, often accompanied by bloating.IBS
is classified according to the predominant...
Irritable bowel syndrome (IBS) is a common disorder
characterized by recurrent abdominal pain and altered
bowel habits, often accompanied by bloating.IBS
is classified according to the predominant bowel
symptom as IBS with constipation (IBS-C), IBS with
diarrhea (IBS-D), mixed type (IBS-M), or unclassified
(IBS-U). Alterations in the microbiome, stress
responses, sensory and motor function of the gut,
and host genetic factors may be contributing factors.
Since the exact cause of IBS is unknown, the goal of
treatment is symptom control.
Omadacycline (Nuzyra) - A New Tetracycline Antibiotic
The Medical Letter on Drugs and Therapeutics • May 20, 2019; (Issue 1572)
The FDA has approved omadacycline (Nuzyra – Paratek),
a semisynthetic tetracycline derivative, for once-daily
IV and oral treatment of community-acquired bacterial
pneumonia (CAP) and acute bacterial skin...
The FDA has approved omadacycline (Nuzyra – Paratek),
a semisynthetic tetracycline derivative, for once-daily
IV and oral treatment of community-acquired bacterial
pneumonia (CAP) and acute bacterial skin and skin
structure infections (ABSSSIs) in adults.
Eravacycline (Xerava) - An IV Tetracycline for Complicated Intra-Abdominal Infections
The Medical Letter on Drugs and Therapeutics • April 22, 2019; (Issue 1570)
Eravacycline (Xerava – Tetraphase), a new synthetic
tetracycline antibiotic, has been approved by the
FDA for IV treatment of complicated intra-abdominal
infections (cIAIs) in adults. Eravacycline is...
Eravacycline (Xerava – Tetraphase), a new synthetic
tetracycline antibiotic, has been approved by the
FDA for IV treatment of complicated intra-abdominal
infections (cIAIs) in adults. Eravacycline is structurally
similar to tigecycline (Tygacil, and generics), a broad-spectrum
tetracycline approved by the FDA for IV
treatment of complicated skin and skin structure
infections, complicated intra-abdominal infections,
and community-acquired pneumonia. A higher rate
of mortality has been reported with use of tigecycline
compared to other antibacterial drugs; it should be
used only when no suitable alternative is available.
Ozenoxacin 1% Cream (Xepi) for Impetigo
The Medical Letter on Drugs and Therapeutics • April 22, 2019; (Issue 1570)
The FDA has approved a 1% cream formulation
of ozenoxacin (Xepi – Cutanea), a nonfluorinated
quinolone antibiotic, for treatment of impetigo caused
by Staphylococcus aureus or Streptococcus pyogenes
in...
The FDA has approved a 1% cream formulation
of ozenoxacin (Xepi – Cutanea), a nonfluorinated
quinolone antibiotic, for treatment of impetigo caused
by Staphylococcus aureus or Streptococcus pyogenes
in patients ≥2 months old.
Drugs for Inflammatory Bowel Disease
The Medical Letter on Drugs and Therapeutics • July 2, 2018; (Issue 1550)
Management of both ulcerative colitis (UC) and Crohn's
disease (CD) is based on disease severity. Disease
location (proctitis, left-sided colitis, or extensive
colitis) also plays a role in drug selection....
Management of both ulcerative colitis (UC) and Crohn's
disease (CD) is based on disease severity. Disease
location (proctitis, left-sided colitis, or extensive
colitis) also plays a role in drug selection. Some
drugs for induction and maintenance of remission of
inflammatory bowel disease (IBD) are listed in Table 1.
Meropenem/Vaborbactam (Vabomere) for Complicated Urinary Tract Infection
The Medical Letter on Drugs and Therapeutics • June 18, 2018; (Issue 1549)
The FDA has approved a fixed-dose combination of
meropenem, a carbapenem antibiotic, and vaborbactam,
a new beta-lactamase inhibitor (Vabomere – Melinta),
for IV treatment of adults with complicated...
The FDA has approved a fixed-dose combination of
meropenem, a carbapenem antibiotic, and vaborbactam,
a new beta-lactamase inhibitor (Vabomere – Melinta),
for IV treatment of adults with complicated urinary
tract infections (UTIs) that are proven or strongly
suspected to be caused by Escherichia coli, Klebsiella
pneumoniae, or Enterobacter cloacae spp. complex.
Meropenem (Merrem, and generics) has been approved
for years for treatment of complicated skin and skin
structure infections, intra-abdominal infections, and
bacterial meningitis. Resistance to meropenem and
other carbapenems, mainly due to production of
carbapenemases and other extended-spectrum beta-lactamases
(ESBLs), has been increasing worldwide,
particularly among Enterobacteriaceae. Vabomere
is the first carbapenem/beta-lactamase inhibitor
combination to be marketed in the US.
Delafloxacin (Baxdela) - A New Fluoroquinolone Antibiotic
The Medical Letter on Drugs and Therapeutics • March 26, 2018; (Issue 1543)
The FDA has approved delafloxacin (Baxdela –
Melinta), an anionic fluoroquinolone antibiotic, for oral
and parenteral treatment of adults with acute bacterial
skin and skin structure infections (ABSSSIs),...
The FDA has approved delafloxacin (Baxdela –
Melinta), an anionic fluoroquinolone antibiotic, for oral
and parenteral treatment of adults with acute bacterial
skin and skin structure infections (ABSSSIs), including
those caused by methicillin-resistant Staphylococcus
aureus (MRSA). It is the first fluoroquinolone to be
approved for treatment of MRSA.
Comparison Table: Some Antibiotics for MRSA Skin and Skin Structure Infections (online only)
The Medical Letter on Drugs and Therapeutics • March 26, 2018; (Issue 1543)
...
View the Comparison Table: Some Antibiotics for MRSA Skin and Skin Structure Infections
Comparison Table: Some Systemic Fluoroquinolones (online only)
The Medical Letter on Drugs and Therapeutics • March 26, 2018; (Issue 1543)
...
View the Comparison Table: Some Systemic Fluoroquinolones (online only)
Drugs for GERD and Peptic Ulcer Disease
The Medical Letter on Drugs and Therapeutics • January 15, 2018; (Issue 1538)
Gastroesophageal reflux disease (GERD) is the most
frequent GI condition encountered in the outpatient
setting; it affects about 20% of the US population.
Heartburn and regurgitation are the classic...
Gastroesophageal reflux disease (GERD) is the most
frequent GI condition encountered in the outpatient
setting; it affects about 20% of the US population.
Heartburn and regurgitation are the classic symptoms
of GERD.
Drugs for Common Bacterial Infections in Adults
The Medical Letter on Drugs and Therapeutics • October 23, 2017; (Issue 1532)
Bacterial infections in adults are generally treated
empirically, with the antibiotic covering most, but not
all, of the potential causative pathogens. For some
infections, culture and sensitivity testing...
Bacterial infections in adults are generally treated
empirically, with the antibiotic covering most, but not
all, of the potential causative pathogens. For some
infections, culture and sensitivity testing can guide
treatment, allowing for use of narrower-spectrum
antibiotics. The recommended dosages and durations
of antibiotic treatment for common respiratory, skin, and
urinary tract infections are listed in Tables 1-3. Infectious
disease experts now recommend shorter treatment
durations for many infections to reduce the development
of antimicrobial resistance and minimize adverse effects.
Drugs for Helicobacter pylori Infection
The Medical Letter on Drugs and Therapeutics • July 17, 2017; (Issue 1525)
About 50% of the world’s population is infected with
Helicobacter pylori. These gastric bacteria can cause
chronic inflammation and have been associated with
development of gastritis, peptic ulcer disease,...
About 50% of the world’s population is infected with
Helicobacter pylori. These gastric bacteria can cause
chronic inflammation and have been associated with
development of gastritis, peptic ulcer disease, gastric
adenocarcinoma, and gastric mucosa-associated
lymphoid tissue (MALT) lymphoma. Eradication of H.
pylori can promote gastric healing, prevent recurrence
of duodenal and gastric ulcers, and reduce the
incidence of gastric cancer. Guidelines for treatment
of H. pylori infection were updated recently.
Drugs for Sexually Transmitted Infections
The Medical Letter on Drugs and Therapeutics • July 3, 2017; (Issue 1524)
The text and tables that follow include recommendations
for management of sexually transmitted
infections (STIs) other than HIV and viral hepatitis.
Some of the indications and dosages recommended
here have...
The text and tables that follow include recommendations
for management of sexually transmitted
infections (STIs) other than HIV and viral hepatitis.
Some of the indications and dosages recommended
here have not been approved by the FDA.
Dupilumab (Dupixent) for Moderate to Severe Atopic Dermatitis
The Medical Letter on Drugs and Therapeutics • April 24, 2017; (Issue 1519)
The FDA has approved dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously-injected fully human
monoclonal antibody, for treatment of adults with
moderate to severe atopic dermatitis (eczema) that
has...
The FDA has approved dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously-injected fully human
monoclonal antibody, for treatment of adults with
moderate to severe atopic dermatitis (eczema) that
has not responded to topical therapies. It can be used
with or without topical corticosteroids.
Antimicrobial Prophylaxis for Surgery
The Medical Letter on Drugs and Therapeutics • May 23, 2016; (Issue 1495)
Antimicrobial prophylaxis can decrease the
incidence of postoperative surgical site infection
after some procedures. Since the last Medical Letter
article on this subject, consensus guidelines have
been...
Antimicrobial prophylaxis can decrease the
incidence of postoperative surgical site infection
after some procedures. Since the last Medical Letter
article on this subject, consensus guidelines have
been published. Recommendations for prophylaxis
in specific surgical procedures are listed in Table 1.
Drugs for Acne
The Medical Letter on Drugs and Therapeutics • February 1, 2016; (Issue 1487)
The pathogenesis of acne is multifactorial: follicular
hyperkeratinization, bacteria, sebum production,
androgens, and inflammation all play a role. The gram-positive
microaerophilic bacteria...
The pathogenesis of acne is multifactorial: follicular
hyperkeratinization, bacteria, sebum production,
androgens, and inflammation all play a role. The gram-positive
microaerophilic bacteria Propionibacterium
acnes promotes development of acne lesions by
secreting chemotactic factors that attract leukocytes
to the follicle, causing inflammation.
Drugs for Rosacea
The Medical Letter on Drugs and Therapeutics • February 1, 2016; (Issue 1487)
This common, chronic inflammatory facial eruption
of unknown cause is more prevalent in women
than in men. Rosacea is characterized by erythema
and telangiectasia, and sometimes by recurrent,
progressive...
This common, chronic inflammatory facial eruption
of unknown cause is more prevalent in women
than in men. Rosacea is characterized by erythema
and telangiectasia, and sometimes by recurrent,
progressive crops of acneiform papules and pustules,
usually on the central part of the face. Some patients
develop granulomas and tissue hypertrophy, which
may lead to rhinophyma (a bulbous nose), particularly
in men. Blepharitis and conjunctivitis are common.
Keratitis and corneal scarring occur rarely.
Ceftolozane/Tazobactam (Zerbaxa) - A New Intravenous Antibiotic
The Medical Letter on Drugs and Therapeutics • March 2, 2015; (Issue 1463)
The FDA has approved ceftolozane/tazobactam
(Zerbaxa – Cubist), a combination of a new cephalosporin
antibiotic and a beta-lactamase inhibitor, for
intravenous treatment of complicated urinary tract
and...
The FDA has approved ceftolozane/tazobactam
(Zerbaxa – Cubist), a combination of a new cephalosporin
antibiotic and a beta-lactamase inhibitor, for
intravenous treatment of complicated urinary tract
and intra-abdominal infections in adults.
Oritavancin (Orbactiv) for Skin and Skin Structure Infections
The Medical Letter on Drugs and Therapeutics • January 5, 2015; (Issue 1459)
The FDA has approved oritavancin (Orbactiv – The
Medicines Company), a long-acting lipoglycopeptide
antibiotic given as a single intravenous (IV) dose, for
treatment of acute bacterial skin and skin...
The FDA has approved oritavancin (Orbactiv – The
Medicines Company), a long-acting lipoglycopeptide
antibiotic given as a single intravenous (IV) dose, for
treatment of acute bacterial skin and skin structure
infections caused by susceptible gram-positive
bacteria in adults. It is the third lipoglycopeptide
antibiotic to be marketed in the US; telavancin (Vibativ)
and dalbavancin (Dalvance) were approved earlier.
Two New Drugs for Skin and Skin Structure Infections
The Medical Letter on Drugs and Therapeutics • August 18, 2014; (Issue 1449)
The FDA has approved two new drugs for treatment
of adults with acute bacterial skin and skin structure
infections caused by susceptible gram-positive
bacteria. Dalbavancin (Dalvance – Durata) is a...
The FDA has approved two new drugs for treatment
of adults with acute bacterial skin and skin structure
infections caused by susceptible gram-positive
bacteria. Dalbavancin (Dalvance – Durata) is a long-acting
intravenous (IV) lipoglycopeptide antibiotic
similar to telavancin (Vibativ). Tedizolid phosphate
(Sivextro – Cubist) is an IV and oral oxazolidinone
antibacterial drug similar to linezolid (Zyvox). A
third IV antibiotic, oritavancin (Orbactiv), recently
approved by the FDA for the same indication, will be
reviewed in a future issue.
Drugs for Inflammatory Bowel Disease
The Medical Letter on Drugs and Therapeutics • August 4, 2014; (Issue 1448)
Aminosalicylates are effective for induction and maintenance
of remission in mild to moderate ulcerative
colitis. They are not recommended for treatment of
Crohn's disease.
FORMULATIONS — Oral mesalamine...
Aminosalicylates are effective for induction and maintenance
of remission in mild to moderate ulcerative
colitis. They are not recommended for treatment of
Crohn's disease.
FORMULATIONS — Oral mesalamine is rapidly absorbed in the small intestine and most of the drug does not reach the colon. Pentasa releases mesalamine gradually throughout the gastrointestinal tract. Delzicol, Asacol HD, Lialda, and Apriso delay the release of the drug until it reaches the distal ileum and colon. Sulfasalazine (Azulfidine, and generics), balsalazide (Colazal, and others), and olsalazine (Dipentum) are prodrugs; mesalamine is azo-bonded to a second moiety and released in the colon following bacterial cleavage of the bond. Mesalamine is also available as an enema (Rowasa, and generics) and as a rectal suppository (Canasa).
FORMULATIONS — Oral mesalamine is rapidly absorbed in the small intestine and most of the drug does not reach the colon. Pentasa releases mesalamine gradually throughout the gastrointestinal tract. Delzicol, Asacol HD, Lialda, and Apriso delay the release of the drug until it reaches the distal ileum and colon. Sulfasalazine (Azulfidine, and generics), balsalazide (Colazal, and others), and olsalazine (Dipentum) are prodrugs; mesalamine is azo-bonded to a second moiety and released in the colon following bacterial cleavage of the bond. Mesalamine is also available as an enema (Rowasa, and generics) and as a rectal suppository (Canasa).
Tobramycin Inhalation Solution (Bethkis) for Cystic Fibrosis
The Medical Letter on Drugs and Therapeutics • June 23, 2014; (Issue 1445)
The FDA has approved another solution of the
aminoglycoside antibiotic tobramycin (Bethkis –
Chiesi/Cornerstone) for oral inhalation via a nebulizer
for management of cystic fibrosis (CF) patients...
The FDA has approved another solution of the
aminoglycoside antibiotic tobramycin (Bethkis –
Chiesi/Cornerstone) for oral inhalation via a nebulizer
for management of cystic fibrosis (CF) patients with
Pseudomonas aeruginosa.
Drugs for MRSA Skin and Soft-Tissue Infections
The Medical Letter on Drugs and Therapeutics • May 12, 2014; (Issue 1442)
Methicillin-resistant Staphylococcus aureus (MRSA),
which was traditionally a nosocomially-acquired
organism but now frequently occurs in the absence
of healthcare exposure, is the predominant cause...
Methicillin-resistant Staphylococcus aureus (MRSA),
which was traditionally a nosocomially-acquired
organism but now frequently occurs in the absence
of healthcare exposure, is the predominant cause of
suppurative skin and soft-tissue infections in many parts
of the US. Community-associated MRSA usually
causes furunculosis, purulent cellulitis, and abscesses,
but necrotizing fasciitis, necrotizing pneumonia, and
sepsis can also occur.
In Brief: Prevention of Meningococcal B Disease
The Medical Letter on Drugs and Therapeutics • December 9, 2013; (Issue 1431)
An outbreak (8 cases to date) of meningococcal disease at Princeton University caused by Neisseria meningitidis serogroup B has led the FDA and CDC to permit importation and investigational use (at Princeton...
An outbreak (8 cases to date) of meningococcal disease at Princeton University caused by Neisseria meningitidis serogroup B has led the FDA and CDC to permit importation and investigational use (at Princeton University only) of a meningococcus B vaccine (4CMenB; Bexsero – Novartis) that has not been approved in the US. Bexsero has been approved for use in the European Union and in Australia.
THE VACCINE — Until recently, no serogroup B vaccine was widely available because the polysaccharide capsule of the B serogroup, unlike those of the other main meningococcal serogroups (A, C, Y, and W-135), is only weakly immunogenic. The 4CMenB vaccine contains 3 protein antigens identified in the N. meningitidis serogroup B genome and membrane components from a New Zealand outbreak strain. The vaccine has been tested in more than 8000 adults and children, has proved to be immunogenic, and appears to be safe.1 Its efficacy has not been established clinically, but laboratory testing, according to the CDC, has found that the vaccine should be protective against the strain causing the Princeton University outbreak. Bactericidal antibody levels develop about 2 weeks after one dose of the vaccine; a second dose is needed 1-6 months after the first to maintain protection.
CHEMOPROPHYLAXIS — Close contacts of patients with invasive meningococcal disease (e.g., same household, roommates, boyfriend or girlfriend) should receive antimicrobial chemoprophylaxis. Antimicrobial drugs can prevent secondary cases and eradicate the organism from the nasopharynx of healthy carriers. The susceptibility of serogroup B meningococci to antimicrobial agents is the same as that of other meningococcal serogroups. Regimens recommended by the CDC’s Advisory Committee on Immunization Practices are: oral rifampin 600 mg (10 mg/kg for children) q12h for 2 days; oral ciprofloxacin 500 mg once (not recommended for children); or a single IM injection of ceftriaxone 250 mg (125 mg for children).2
CONCLUSION — The new vaccine against serogroup B meningococcal disease, which is investigational in the US, appears to be immunogenic and safe. For immediate protection after close contact with an infected patient, antimicrobial prophylaxis is recommended.
1. NJ Carter. Multicomponent meningococcal serogroup B vaccine (4CMenB; Bexsero®): a review of its use in primary and booster vaccination. BioDrugs 2013; 27:263.
2. AC Cohn et al. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2013; 62(RR-2):1.
Download complete U.S. English article
THE VACCINE — Until recently, no serogroup B vaccine was widely available because the polysaccharide capsule of the B serogroup, unlike those of the other main meningococcal serogroups (A, C, Y, and W-135), is only weakly immunogenic. The 4CMenB vaccine contains 3 protein antigens identified in the N. meningitidis serogroup B genome and membrane components from a New Zealand outbreak strain. The vaccine has been tested in more than 8000 adults and children, has proved to be immunogenic, and appears to be safe.1 Its efficacy has not been established clinically, but laboratory testing, according to the CDC, has found that the vaccine should be protective against the strain causing the Princeton University outbreak. Bactericidal antibody levels develop about 2 weeks after one dose of the vaccine; a second dose is needed 1-6 months after the first to maintain protection.
CHEMOPROPHYLAXIS — Close contacts of patients with invasive meningococcal disease (e.g., same household, roommates, boyfriend or girlfriend) should receive antimicrobial chemoprophylaxis. Antimicrobial drugs can prevent secondary cases and eradicate the organism from the nasopharynx of healthy carriers. The susceptibility of serogroup B meningococci to antimicrobial agents is the same as that of other meningococcal serogroups. Regimens recommended by the CDC’s Advisory Committee on Immunization Practices are: oral rifampin 600 mg (10 mg/kg for children) q12h for 2 days; oral ciprofloxacin 500 mg once (not recommended for children); or a single IM injection of ceftriaxone 250 mg (125 mg for children).2
CONCLUSION — The new vaccine against serogroup B meningococcal disease, which is investigational in the US, appears to be immunogenic and safe. For immediate protection after close contact with an infected patient, antimicrobial prophylaxis is recommended.
1. NJ Carter. Multicomponent meningococcal serogroup B vaccine (4CMenB; Bexsero®): a review of its use in primary and booster vaccination. BioDrugs 2013; 27:263.
2. AC Cohn et al. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2013; 62(RR-2):1.
Download complete U.S. English article
In Brief: Fluoroquinolones and Peripheral Neuropathy
The Medical Letter on Drugs and Therapeutics • November 11, 2013; (Issue 1429)
The FDA is requiring new warnings about peripheral neuropathy in the labeling of all oral and injectable fluoroquinolones. The potential for this class of antibiotics to cause peripheral neuropathy was first...
The FDA is requiring new warnings about peripheral neuropathy in the labeling of all oral and injectable fluoroquinolones. The potential for this class of antibiotics to cause peripheral neuropathy was first identified more than 10 years ago and a warning was added to their labels in 2004. The new warnings are based on a recent review of the FDA’s Adverse Event Reporting System (AERS) database.1
The onset of peripheral neuropathy can occur rapidly, often within a few days of starting a fluoroquinolone, and in some patients the disorder may be permanent. Symptoms include pain, tingling, burning, numbness, weakness, and change in sensation to touch, pain, and temperature in the arms and/or legs. If peripheral neuropathy develops in a patient taking a fluoroquinolone, the drug should be stopped and an antibacterial from a different class should be used instead.2
1. FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection. Available at http://www.fda.gov. Accessed November 1, 2013.
2. Drugs for bacterial infections. Treat Guidel Med Lett 2013; 11:65.
Download complete U.S. English article
The onset of peripheral neuropathy can occur rapidly, often within a few days of starting a fluoroquinolone, and in some patients the disorder may be permanent. Symptoms include pain, tingling, burning, numbness, weakness, and change in sensation to touch, pain, and temperature in the arms and/or legs. If peripheral neuropathy develops in a patient taking a fluoroquinolone, the drug should be stopped and an antibacterial from a different class should be used instead.2
1. FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection. Available at http://www.fda.gov. Accessed November 1, 2013.
2. Drugs for bacterial infections. Treat Guidel Med Lett 2013; 11:65.
Download complete U.S. English article
Drugs for Bacterial Infections
The Medical Letter on Drugs and Therapeutics • July 1, 2013; (Issue 131)
The text that follows reviews some common bacterial
infections and their empiric treatment pending the
results of culture and susceptibility testing. The recommendations
made here are based on the results...
The text that follows reviews some common bacterial
infections and their empiric treatment pending the
results of culture and susceptibility testing. The recommendations
made here are based on the results of
susceptibility studies, clinical trials, and the opinions
of Medical Letter reviewers. Tables 1 and 2 list the usual
dosages of antibacterial drugs.
Tobramycin Inhalation Powder (Tobi Podhaler) for Cystic Fibrosis
The Medical Letter on Drugs and Therapeutics • June 24, 2013; (Issue 1419)
Inhaled antibiotics, which can achieve high concentrations
in the lung with minimal systemic side effects, are
probably the most effective therapy available for chronic
Pseudomonas aeruginosa infection in...
Inhaled antibiotics, which can achieve high concentrations
in the lung with minimal systemic side effects, are
probably the most effective therapy available for chronic
Pseudomonas aeruginosa infection in patients with
cystic fibrosis. An orally inhaled dry powder formulation
of the aminoglycoside antibiotic tobramycin (Tobi
Podhaler – Novartis) has been approved by the FDA for
management of P. aeruginosa pulmonary infection in
cystic fibrosis patients ≥6 years old. The new formulation
is administered via a hand-held pocket-sized inhaler.
Tobramycin is also available as an inhalation solution
(Tobi) for administration via a nebulizer. An inhalation
solution of aztreonam (Cayston), administered via a nebulizer,
is also approved for this indication.
Drugs for Allergic Disorders
The Medical Letter on Drugs and Therapeutics • May 1, 2013; (Issue 129)
The use of drugs to prevent and control symptoms of
allergic disorders can be optimized when patients
avoid exposure to specific allergens and/or environmental
conditions that trigger or worsen their...
The use of drugs to prevent and control symptoms of
allergic disorders can be optimized when patients
avoid exposure to specific allergens and/or environmental
conditions that trigger or worsen their symptoms.
In Brief: FDA Azithromycin Warning
The Medical Letter on Drugs and Therapeutics • April 1, 2013; (Issue 1413)
The FDA has announced that it is requiring changes in the labeling of the macrolide antibiotic azithromycin (Zithromax, Zmax) to warn about the risk of QT prolongation and cardiac arrhythmias.1 The new warnings...
The FDA has announced that it is requiring changes in the labeling of the macrolide antibiotic azithromycin (Zithromax, Zmax) to warn about the risk of QT prolongation and cardiac arrhythmias.1 The new warnings are based on a retrospective study in The New England Journal of Medicine (reviewed previously in The Medical Letter2), which found that among patients who received 347,795 prescriptions for azithromycin, there were 29 cardiovascular deaths, a significantly higher rate than the 42 that occurred among patients who received 1,348,672 prescriptions for amoxicillin (which does not prolong the QT interval) or the 41 that occurred among 1,391,180 patients who took no antibiotics. The risk with azithromycin was much higher in patients with cardiovascular risk factors.3
Other macrolides and fluoroquinolones can also prolong the QT interval. In the retrospective study, the risk of cardiovascular death with levofloxacin was not significantly different from the risk with azithromycin. As with any retrospective study, the possibility that baseline differences between patients taking azithromycin and those taking other or no antimicrobials could have been responsible for the difference in cardiovascular outcomes cannot be entirely ruled out.
1. FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms. Available at www.fda.gov/drugs/drugsafety/ucm341822.htm. Accessed March 14, 2013.
2. In brief: safety of azithromycin. Med Lett Drugs Ther 2012; 54:45.
3. WA Ray et al. Azithromycin and the risk of cardiovascular death. N Engl J Med 2012; 366:1881.
Download complete U.S. English article
Other macrolides and fluoroquinolones can also prolong the QT interval. In the retrospective study, the risk of cardiovascular death with levofloxacin was not significantly different from the risk with azithromycin. As with any retrospective study, the possibility that baseline differences between patients taking azithromycin and those taking other or no antimicrobials could have been responsible for the difference in cardiovascular outcomes cannot be entirely ruled out.
1. FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms. Available at www.fda.gov/drugs/drugsafety/ucm341822.htm. Accessed March 14, 2013.
2. In brief: safety of azithromycin. Med Lett Drugs Ther 2012; 54:45.
3. WA Ray et al. Azithromycin and the risk of cardiovascular death. N Engl J Med 2012; 366:1881.
Download complete U.S. English article
Antimicrobial Prophylaxis for Surgery
The Medical Letter on Drugs and Therapeutics • October 1, 2012; (Issue 122)
Antimicrobial prophylaxis can decrease the incidence
of postoperative infection, particularly surgical site
infection, after some procedures. Recommendations
for such prophylaxis are listed in the table that...
Antimicrobial prophylaxis can decrease the incidence
of postoperative infection, particularly surgical site
infection, after some procedures. Recommendations
for such prophylaxis are listed in the table that begins
on page 74. Antimicrobial prophylaxis for dental procedures
to prevent endocarditis was recently discussed
in The Medical Letter.
Addendum: Cost of Drugs for Acute Cystitis
The Medical Letter on Drugs and Therapeutics • August 20, 2012; (Issue 1397)
A reader suggested that our July 23 article on Drugs for Urinary Tract Infection (Med Lett Drugs Ther 2012; 54:57)1 should have included information on the cost of the drugs we recommended for treatment of...
A reader suggested that our July 23 article on Drugs for Urinary Tract Infection (Med Lett Drugs Ther 2012; 54:57)1 should have included information on the cost of the drugs we recommended for treatment of acute uncomplicated cystitis.
Trimethoprim/sulfamethoxazole DS — Generic formulations are available at large discount pharmacies for $4 for 20 tablets. Trimethoprim/sulfamethoxazole DS is generally found on tier 1 (lowest co-pay) of insurance company formularies.
Nitrofurantoin monohydrate/macrocrystals — The wholesale acquisition cost of the generic formulation is about $2.50 per tablet (PricePointRx™).2 The drug is on tier 1 of some insurance company formularies, but on tier 2 or 3 of others.
Fosfomycin — Available only as Monurol, a single dose of fosfomycin is effective in most cases of acute uncomplicated cystitis, but the manufacturer charges a wholesale acquisition cost of more than $40 for that dose (PricePointRx™).2 Most insurance companies place Monurol on tier 3 of their formularies, or do not include it on their formularies at all.
Not recommended: Ciprofloxacin – Fluoroquinolones should not be used empirically to treat acute uncomplicated cystitis. The fact that ciprofloxacin is available at large discount pharmacies for $4 for 20 500-mg tablets and is on tier 1 on most insurance company formularies may be part of the reason for its continued overuse.
1. Drugs for urinary tract infection. Med Lett Drugs Ther 2012; 54:57.
Trimethoprim/sulfamethoxazole DS — Generic formulations are available at large discount pharmacies for $4 for 20 tablets. Trimethoprim/sulfamethoxazole DS is generally found on tier 1 (lowest co-pay) of insurance company formularies.
Nitrofurantoin monohydrate/macrocrystals — The wholesale acquisition cost of the generic formulation is about $2.50 per tablet (PricePointRx™).2 The drug is on tier 1 of some insurance company formularies, but on tier 2 or 3 of others.
Fosfomycin — Available only as Monurol, a single dose of fosfomycin is effective in most cases of acute uncomplicated cystitis, but the manufacturer charges a wholesale acquisition cost of more than $40 for that dose (PricePointRx™).2 Most insurance companies place Monurol on tier 3 of their formularies, or do not include it on their formularies at all.
Not recommended: Ciprofloxacin – Fluoroquinolones should not be used empirically to treat acute uncomplicated cystitis. The fact that ciprofloxacin is available at large discount pharmacies for $4 for 20 500-mg tablets and is on tier 1 on most insurance company formularies may be part of the reason for its continued overuse.
1. Drugs for urinary tract infection. Med Lett Drugs Ther 2012; 54:57.
2. PricePointRx™. Reprinted with permission by FDB. All rights reserved. ©2012. http://www.firstdatabank.com/support/drug-pricing-policy.aspx. Accessed July 31, 2012. Actual retail prices may be higher.
Download complete U.S. English article
Drugs for Urinary Tract Infections
The Medical Letter on Drugs and Therapeutics • July 23, 2012; (Issue 1395)
The most recent guidelines from the Infectious
Diseases Society of America (IDSA) and its European
counterpart on the choice of antimicrobials for treatment
of uncomplicated urinary tract infections (UTIs)...
The most recent guidelines from the Infectious
Diseases Society of America (IDSA) and its European
counterpart on the choice of antimicrobials for treatment
of uncomplicated urinary tract infections (UTIs) in
non-pregnant women focus on the unnecessary use of
fluoroquinolones to treat uropathogens that are
increasingly becoming resistant to them. Resistance
of Escherichia coli to ciprofloxacin in the US has
increased from 3% in 2000 to 17.1% in 2010.
In Brief: Safety of Azithromycin
The Medical Letter on Drugs and Therapeutics • June 11, 2012; (Issue 1392)
Recently published results of a large, carefully conducted retrospective study indicated that use of the antibiotic azithromycin (Zithromax, and others) may increase the risk of cardiovascular death, especially...
Recently published results of a large, carefully conducted retrospective study indicated that use of the antibiotic azithromycin (Zithromax, and others) may increase the risk of cardiovascular death, especially in patients with a high baseline risk of cardiovascular disease.1 One possible mechanism is prolongation of the QT interval, which is known to occur rarely with azithromycin and more frequently with the other macrolide antibiotics erythromycin (Erythrocin, and others) and clarithromycin (Biaxin, and others).
Among the patients who received 347,795 prescriptions for azithromycin, there were 29 cardiovascular deaths, a significantly higher rate than the 42 that occurred among the patients who received 1,348,672 prescriptions for amoxicillin (which does not prolong the QT interval) or the 41 that occurred among the 1,391,180 patients who took no antibiotics. Among patients with the highest baseline risk of cardiovascular disease, treatment with azithromycin, compared to amoxicillin, would have resulted in 245 additional cardiovascular deaths per million courses of the antibiotic.
As with any retrospective study, there could have been some undetected differences between the patients who received one drug or the other, but use of an appropriate non-macrolide alternative2 instead of azithromycin might be reasonable in patients with cardiovascular disease or in those who are taking other drugs that can prolong the QT interval (www.azcert.org).
1. WA Ray et al. Azithromycin and the risk of cardiovascular death. N Engl J Med 2012; 366:1881.
2. Drugs for bacterial infections. Treat Guidel Med Lett 2010; 8:43.
Download complete U.S. English article
Among the patients who received 347,795 prescriptions for azithromycin, there were 29 cardiovascular deaths, a significantly higher rate than the 42 that occurred among the patients who received 1,348,672 prescriptions for amoxicillin (which does not prolong the QT interval) or the 41 that occurred among the 1,391,180 patients who took no antibiotics. Among patients with the highest baseline risk of cardiovascular disease, treatment with azithromycin, compared to amoxicillin, would have resulted in 245 additional cardiovascular deaths per million courses of the antibiotic.
As with any retrospective study, there could have been some undetected differences between the patients who received one drug or the other, but use of an appropriate non-macrolide alternative2 instead of azithromycin might be reasonable in patients with cardiovascular disease or in those who are taking other drugs that can prolong the QT interval (www.azcert.org).
1. WA Ray et al. Azithromycin and the risk of cardiovascular death. N Engl J Med 2012; 366:1881.
2. Drugs for bacterial infections. Treat Guidel Med Lett 2010; 8:43.
Download complete U.S. English article
Advice for Travelers
The Medical Letter on Drugs and Therapeutics • June 1, 2012; (Issue 118)
Patients planning to travel to other countries often ask
for information about appropriate vaccines and prevention
of diarrhea and malaria. More detailed advice for
travelers is available from the Centers...
Patients planning to travel to other countries often ask
for information about appropriate vaccines and prevention
of diarrhea and malaria. More detailed advice for
travelers is available from the Centers for Disease
Control and Prevention (CDC) at www.cdc.gov/travel.
Guidelines are also available from the Infectious
Diseases Society of America (IDSA).
Quetiapine (Seroquel) and QT-Interval Prolongation
The Medical Letter on Drugs and Therapeutics • October 3, 2011; (Issue 1374)
The FDA has required the manufacturer of the secondgeneration
antipsychotic quetiapine (Seroquel) to add a
warning to the labeling saying that use of the drug should
be avoided in combination with other...
The FDA has required the manufacturer of the secondgeneration
antipsychotic quetiapine (Seroquel) to add a
warning to the labeling saying that use of the drug should
be avoided in combination with other drugs that prolong
the electrocardiographic QTc interval (Table 1). The
warning is based only on postmarketing reports of QT-interval
prolongation in patients who overdosed on the
drug, had concomitant illness, or were taking other drugs
known to cause electrolyte imbalances or increase the
QT interval. QT prolongation can lead to torsades de
pointes, a potentially fatal cardiac arrhythmia.
Drugs for Peptic Ulcer Disease and GERD
The Medical Letter on Drugs and Therapeutics • September 1, 2011; (Issue 109)
Peptic ulcer disease (PUD) is usually caused by nonsteroidal
anti-inflammatory drugs (NSAIDs) or by
infection with Helicobacter pylori. Gastroesophageal
reflux disease (GERD) can be caused by...
Peptic ulcer disease (PUD) is usually caused by nonsteroidal
anti-inflammatory drugs (NSAIDs) or by
infection with Helicobacter pylori. Gastroesophageal
reflux disease (GERD) can be caused by transient
lower esophageal sphincter relaxation, reduced lower
esophageal sphincter tone, hiatal hernia, delayed gastric
emptying or hormonal changes due to pregnancy.
Acid suppressive therapy is the cornerstone of management
for both PUD and GERD.
New Simvastatin Dosing Recommendations
The Medical Letter on Drugs and Therapeutics • August 8, 2011; (Issue 1370)
The FDA has announced changes in the labeling of simvastatin to reduce the risk of myopathy. These changes include limiting the use of the 80-mg maximum dose to patients who have been taking it for 12 months or...
The FDA has announced changes in the labeling of simvastatin to reduce the risk of myopathy. These changes include limiting the use of the 80-mg maximum dose to patients who have been taking it for 12 months or more without evidence of myopathy and new recommendations for use of simvastatin with other drugs. Simvastatin is available alone (Zocor, and others) and in combination with ezetimibe (Vytorin) and with niacin (Simcor).
Levofloxacin Revisited
The Medical Letter on Drugs and Therapeutics • July 11, 2011; (Issue 1368)
A Medical Letter reader has asked us to review the
safety of the fluoroquinolone antibiotic levofloxacin
(Levaquin – Ortho-McNeil-Janssen), which has just
been approved for generic use by the FDA and...
A Medical Letter reader has asked us to review the
safety of the fluoroquinolone antibiotic levofloxacin
(Levaquin – Ortho-McNeil-Janssen), which has just
been approved for generic use by the FDA and has
been at the center of some recent lawsuits regarding
the adequacy of its safety warnings.
Treatment of Clostridium Difficile Infection
The Medical Letter on Drugs and Therapeutics • February 21, 2011; (Issue 1358)
Clostridium difficile infection (CDI) is the most common infectious cause of healthcare-associated diarrhea in adults. The incidence and severity of CDI have increased in recent years with the emergence of an...
Clostridium difficile infection (CDI) is the most common infectious cause of healthcare-associated diarrhea in adults. The incidence and severity of CDI have increased in recent years with the emergence of an epidemic virulent strain (NAP1/BI/027). Common risk factors include admission to a healthcare facility, increasing age and severity of underlying illness, gastric acid suppression and exposure to antimicrobials, particularly clindamycin, ampicillin, cephalosporins or fluoroquinolones. Patients who develop CDI while receiving a precipitating antibiotic should have the antibiotic discontinued, if possible, or switched to another appropriate antimicrobial with a lower risk of CDI.
Ceftaroline Fosamil (Teflaro) - A New IV Cephalosporin
The Medical Letter on Drugs and Therapeutics • January 24, 2011; (Issue 1356)
The FDA has approved ceftaroline fosamil (Teflaro –
Forest), an intravenous (IV) cephalosporin, for treatment
of acute bacterial skin and skin structure infections,
including those caused by...
The FDA has approved ceftaroline fosamil (Teflaro –
Forest), an intravenous (IV) cephalosporin, for treatment
of acute bacterial skin and skin structure infections,
including those caused by methicillin-resistant
Staphylococcus aureus (MRSA), and for treatment of
community-acquired bacterial pneumonia in adults. It
is the first beta-lactam antibiotic approved for treatment
of MRSA.
Drugs for Bacterial Infections
The Medical Letter on Drugs and Therapeutics • June 1, 2010; (Issue 94)
The text below reviews some common bacterial infections and their treatment. The recommendations made
here are based on the results of susceptibility studies, clinical trials and the opinions of Medical Letter...
The text below reviews some common bacterial infections and their treatment. The recommendations made
here are based on the results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants.
Ophthalmic Besifloxacin (Besivance)
The Medical Letter on Drugs and Therapeutics • December 14, 2009; (Issue 1327)
The FDA has approved the fluoroquinolone besifloxacin 0.6% ophthalmic suspension (Besivance - Bausch & Lomb) for treatment of bacterial conjunctivitis caused by susceptible bacteria. According to the...
The FDA has approved the fluoroquinolone besifloxacin 0.6% ophthalmic suspension (Besivance - Bausch & Lomb) for treatment of bacterial conjunctivitis caused by susceptible bacteria. According to the manufacturer, this product was developed specifically for ophthalmic use in a specialized vehicle designed to prolong contact time on the ocular surface. Besifloxacin is not available for systemic use.
In Brief: Fluoroquinolones and Tendon Injuries
The Medical Letter on Drugs and Therapeutics • December 1, 2008; (Issue 1300)
The FDA has added a boxed warning to fluoroquinolone package inserts about tendon injuries that may occur as a result of their use. Tendinitis or tendon rupture may occur rarely with systemic use of any...
The FDA has added a boxed warning to fluoroquinolone package inserts about tendon injuries that may occur as a result of their use. Tendinitis or tendon rupture may occur rarely with systemic use of any fluoroquinolone, either while the drug is being taken or for up to several months afterwards.
Fluoroquinolone-related tendon injury is rare; estimates for its incidence in the general population range from 0.14% to 0.4%. The risk is higher for patients >60 years old and for those taking corticosteroids. For patients with organ transplants, the incidence may be as high as 15%.1 A case-control study in Italy involving 22,194 cases of non-traumatic tendinitis and 104,906 controls found that fluoroquinolone use was significantly associated with tendon disorders in general (OR 1.7; 95% CI 1.4-2.0), tendon rupture (OR 1.3; 95% CI 1.0-1.8), and Achilles tendon rupture (OR 4.1; 95% CI 1.8-9.6). Achilles tendon rupture occurred with fluoroquinolone treatment in one of every 5989 patients in general and in one of every 1638 patients >60 years old.2
Widespread use of fluoroquinolones, particularly for treatment of respiratory infections, has produced substantial bacterial resistance to this class of drugs and has been associated with an increase in the incidence and severity of Clostridium difficile disease.3 Even when bacterial pneumonia is considered a likely possibility, other drugs are generally preferred, at least in non-elderly, otherwise healthy patients.4
1. F Muzi et al. Fluoroquinolones-induced tendinitis and tendon rupture in kidney transplant recipients: 2 cases and a review of the literature.Transplant Proc 2007; 39:1673.
2. G Corrao et al. Evidence of tendinitis provoked by fluoroquinolone treatment: a case-control study. Drug Saf 2006; 29:889.
3. Treatment of Clostridium difficile-associated disease (CDAD). Med Lett Drugs Ther 2006; 48:89.
4. Drugs for community-acquired bacterial pneumonia. Med Lett Drugs Ther 2007; 49:62.
Download: U.S. English
Fluoroquinolone-related tendon injury is rare; estimates for its incidence in the general population range from 0.14% to 0.4%. The risk is higher for patients >60 years old and for those taking corticosteroids. For patients with organ transplants, the incidence may be as high as 15%.1 A case-control study in Italy involving 22,194 cases of non-traumatic tendinitis and 104,906 controls found that fluoroquinolone use was significantly associated with tendon disorders in general (OR 1.7; 95% CI 1.4-2.0), tendon rupture (OR 1.3; 95% CI 1.0-1.8), and Achilles tendon rupture (OR 4.1; 95% CI 1.8-9.6). Achilles tendon rupture occurred with fluoroquinolone treatment in one of every 5989 patients in general and in one of every 1638 patients >60 years old.2
Widespread use of fluoroquinolones, particularly for treatment of respiratory infections, has produced substantial bacterial resistance to this class of drugs and has been associated with an increase in the incidence and severity of Clostridium difficile disease.3 Even when bacterial pneumonia is considered a likely possibility, other drugs are generally preferred, at least in non-elderly, otherwise healthy patients.4
1. F Muzi et al. Fluoroquinolones-induced tendinitis and tendon rupture in kidney transplant recipients: 2 cases and a review of the literature.Transplant Proc 2007; 39:1673.
2. G Corrao et al. Evidence of tendinitis provoked by fluoroquinolone treatment: a case-control study. Drug Saf 2006; 29:889.
3. Treatment of Clostridium difficile-associated disease (CDAD). Med Lett Drugs Ther 2006; 48:89.
4. Drugs for community-acquired bacterial pneumonia. Med Lett Drugs Ther 2007; 49:62.
Download: U.S. English
Drugs for Travelers' Diarrhea
The Medical Letter on Drugs and Therapeutics • July 28, 2008; (Issue 1291)
The most common cause of travelers' diarrhea, usually a self-limited illness without fever lasting several days, is infection with noninvasive enterotoxigenic (ETEC) or enteroaggregative (EAEC) strains of...
The most common cause of travelers' diarrhea, usually a self-limited illness without fever lasting several days, is infection with noninvasive enterotoxigenic (ETEC) or enteroaggregative (EAEC) strains of Escherichia coli. Campylobacter, Shigella, Salmonella, Aeromonas, viruses and parasites are less common.
Retapamulin (Altabax) - A New Topical Antibiotic
The Medical Letter on Drugs and Therapeutics • February 25, 2008; (Issue 1280)
Retapamulin (re-tap'-a-mue'-lin; Altabax - Glaxo SmithKline) is a topical antibiotic recently approved by the FDA for treatment of bullous and non-bullous impetigo due to Streptococcus pyogenes and...
Retapamulin (re-tap'-a-mue'-lin; Altabax - Glaxo SmithKline) is a topical antibiotic recently approved by the FDA for treatment of bullous and non-bullous impetigo due to Streptococcus pyogenes and methicillin-susceptible Staphylococcus aureus. It is available as a 1% ointment by prescription only.
Ophthalmic Azithromycin (AzaSite)
The Medical Letter on Drugs and Therapeutics • February 11, 2008; (Issue 1279)
The FDA has approved azithromycin 1% ophthalmic solution (AzaSite - Inspire) for treatment of bacterial conjunctivitis in patients > 1 year old. It is formulated, according to the manufacturer, in a...
The FDA has approved azithromycin 1% ophthalmic solution (AzaSite - Inspire) for treatment of bacterial conjunctivitis in patients > 1 year old. It is formulated, according to the manufacturer, in a controlled-release delivery system that keeps the drug in the eye for several hours.
Doripenem (Doribax) - A New Parenteral Carbapenem
The Medical Letter on Drugs and Therapeutics • January 28, 2008; (Issue 1278)
Doripenem (Doribax - Ortho-McNeil Janssen), an intravenous (IV) carbapenem antibiotic with a spectrum of activity similar to that of imipenem and meropenem, has been approved by the FDA for treatment of...
Doripenem (Doribax - Ortho-McNeil Janssen), an intravenous (IV) carbapenem antibiotic with a spectrum of activity similar to that of imipenem and meropenem, has been approved by the FDA for treatment of complicated intra-abdominal and urinary tract infections. Use of doripenem for treatment of nosocomial pneumonia, including ventilator-associated pneumonia, is still under FDA review.
Drugs for Community-Acquired Bacterial Pneumonia
The Medical Letter on Drugs and Therapeutics • July 30, 2007; (Issue 1266)
Most patients with community-acquired pneumonia (CAP) are treated empirically. New guidelines published jointly by the Infectious Diseases Society of America and the American Thoracic Society have recently...
Most patients with community-acquired pneumonia (CAP) are treated empirically. New guidelines published jointly by the Infectious Diseases Society of America and the American Thoracic Society have recently become available.
Choice of Antibacterial Drugs
The Medical Letter on Drugs and Therapeutics • May 1, 2007; (Issue 57)
Information about empirical treatment of bacterial infections, emerging trends in antimicrobial resistance, new drugs and new data about older drugs continue to become available. Usual pathogens and empiric...
Information about empirical treatment of bacterial infections, emerging trends in antimicrobial resistance, new drugs and new data about older drugs continue to become available. Usual pathogens and empiric treatment for some common types of infections are summarized in the text and a table listing the drugs of choice and alternatives for each pathogen begins on page 40. The recommendations made here are based on the results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants.
Tigecycline (Tygacil)
The Medical Letter on Drugs and Therapeutics • September 12, 2005; (Issue 1217)
Tigecycline (Tygacil - Wyeth), a derivative of minocycline, is a new intravenous (IV) antibiotic approved for treatment of complicated intra-abdominal and skin and skin-structure...
Tigecycline (Tygacil - Wyeth), a derivative of minocycline, is a new intravenous (IV) antibiotic approved for treatment of complicated intra-abdominal and skin and skin-structure infections.
Antibacterial Prophylaxis for Dental, GI and GU Procedures
The Medical Letter on Drugs and Therapeutics • July 18, 2005; (Issue 1213)
Many physicians believe that antimicrobial prophylaxis before procedures that may cause transient bacteremia can prevent endocarditis and prosthetic joint infection in patients at increased risk for these...
Many physicians believe that antimicrobial prophylaxis before procedures that may cause transient bacteremia can prevent endocarditis and prosthetic joint infection in patients at increased risk for these disorders. The effectiveness of this common practice has never been established by controlled trials in humans.
Drugs for Acne, Rosacea and Psoriasis
The Medical Letter on Drugs and Therapeutics • July 1, 2005; (Issue 35)
The pathogenesis of acne is multifactorial: follicular hyperkeratinization, Propionibacterium acnes bacteria, sebum production, androgens and inflammation have all been implicated. P. acnes, a gram-positive...
The pathogenesis of acne is multifactorial: follicular hyperkeratinization, Propionibacterium acnes bacteria, sebum production, androgens and inflammation have all been implicated. P. acnes, a gram-positive microaerophilic bacterium, plays an important role in the development of acne lesions by secreting chemotactic factors that attract leukocytes to the follicle, causing inflammation.
Antimicrobial Prophylaxis for Surgery
The Medical Letter on Drugs and Therapeutics • April 1, 2004; (Issue 20)
Antimicrobial prophylaxis can decrease the incidence of infection, particularly surgical site infection, after certain operations, but this benefit must be weighed against the risks of toxic and allergic...
Antimicrobial prophylaxis can decrease the incidence of infection, particularly surgical site infection, after certain operations, but this benefit must be weighed against the risks of toxic and allergic reactions, emergence of resistant bacteria, adverse drug interactions, superinfection and cost. Medical Letter consultants generally recommend antimicrobial prophylaxis only for procedures with high infection rates, those involving implantation of prosthetic material, and those in which the consequences of infection are likely to be especially serious.
Choice of Antibacterial Drugs
The Medical Letter on Drugs and Therapeutics • March 1, 2004; (Issue 19)
New drugs for bacterial infections and new information about older drugs continue to become available. Empirical treatment of some common bacterial infections is discussed in this article. A table listing the...
New drugs for bacterial infections and new information about older drugs continue to become available. Empirical treatment of some common bacterial infections is discussed in this article. A table listing the drugs of choice and alternatives for each pathogen begins on page 18. These recommendations are based on results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants. Local resistance patterns should be taken into account. Trade names are listed on page 24.
The Choice of Antimicrobial Drugs
The Medical Letter on Drugs and Therapeutics • March 27, 1998; (Issue 1023)
Since The Medical Letter last reviewed the choice of drugs for treatment of bacterial infections (vol. 38, page 25, 1996), and few new information and some new information about older drugs drugs have become...
Since The Medical Letter last reviewed the choice of drugs for treatment of bacterial infections (vol. 38, page 25, 1996), and few new information and some new information about older drugs drugs have become available. Empirical treatment of some infections is discussed. A table listing the drugs of choice and alternatives for each pathogen begins on page 37. These recommendations are based on results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants. (Superseded by issue 1064, 10/22/99)
Meropenem - A New Parenteral Broad-Spectrum Antibiotic
The Medical Letter on Drugs and Therapeutics • September 27, 1996; (Issue 984)
Meropenem (Merrem - Zeneca), a carbapenem similar to imipenem-cilastatin (Primaxin), has been approved by the US Food and Drug Administration for intravenous (IV) treatment of complicated intra-abdominal...
Meropenem (Merrem - Zeneca), a carbapenem similar to imipenem-cilastatin (Primaxin), has been approved by the US Food and Drug Administration for intravenous (IV) treatment of complicated intra-abdominal infections in adults and children and bacterial meningitis in children more than three months old. Imipenem (Medical Letter, 28:29, 1986) has been useful for treatment of serious infections in which broad coverage of nosocomial organisms, including anaerobes, is needed. Other drugs for these indications were reviewed in the Medical Letter article on 'The Choice of Antibacterial Drugs' (volume 38, page 25, March 29, 1996).
Cefepime (Maxipime) - A New Parenteral Cephalosporin
The Medical Letter on Drugs and Therapeutics • September 13, 1996; (Issue 983)
Cefepime hydrochloride (Maxipime - Bristol-Myers Squibb), a new 'fourth-generation' cephalosporin, has been approved by the US Food and Drug Administration (FDA) for parenteral treatment of urinary tract...
Cefepime hydrochloride (Maxipime - Bristol-Myers Squibb), a new 'fourth-generation' cephalosporin, has been approved by the US Food and Drug Administration (FDA) for parenteral treatment of urinary tract infections and skin and skin-structure infections due to susceptible pathogens, and for moderate to severe pneunmonia caused by Streptococcus pneumoniae (pneumococci), Pseudomonas aeruginosa, Enterobacter or Klebsiella pneumoniae.
The Choice of Antibacterial Drugs
The Medical Letter on Drugs and Therapeutics • March 29, 1996; (Issue 971)
New drugs for treatment of bacterial infections and new information about older drugs continue to become available. Empirical treatment of some infections is discussed below. A table listing the drugs of...
New drugs for treatment of bacterial infections and new information about older drugs continue to become available. Empirical treatment of some infections is discussed below. A table listing the drugs of choice and alternatives for each pathogen begins on page 73. These recommendations are based on results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants. Local resistance patterns should be taken into account.
Dirithromycin
The Medical Letter on Drugs and Therapeutics • November 24, 1995; (Issue 962)
Dirithromycin (Dynabac - manufactured by Lilly, distributed by Bock), an oral macrolide antibiotic chemically similar to erythromycin, clarithromycin (Biaxin) and azithromycin (Zithromax), has been approved...
Dirithromycin (Dynabac - manufactured by Lilly, distributed by Bock), an oral macrolide antibiotic chemically similar to erythromycin, clarithromycin (Biaxin) and azithromycin (Zithromax), has been approved for marketing by the US Food and Drug Administration (FDA).
Adderall and Other Drugs for Attention-Deficit/Hyperactivity Disorder
The Medical Letter on Drugs and Therapeutics • November 25, 1994; (Issue 936)
A drug that combines the neutral sulfate salts of dextroamphetamine and racemic amphetamine with the dextro isomer of amphetamine saccharate and d,l amphetamine aspartate (Adderall - Richwood Pharmaceutical)...
A drug that combines the neutral sulfate salts of dextroamphetamine and racemic amphetamine with the dextro isomer of amphetamine saccharate and d,l amphetamine aspartate (Adderall - Richwood Pharmaceutical) has recently been promoted for treatment of children with Attention-Deficit/Hyperactivity Disorder (ADHD). This same mixture of amphetamine salts was previously marketed as Obetrol for treatment of obesity.
The Choice of Antibacterial Drugs
The Medical Letter on Drugs and Therapeutics • June 24, 1994; (Issue 925)
Since The Medical Letter last reviewed the choice of antibacterial drugs (vol.34, page 49, 1992), a few new drugs have become available, and some clinical trials of older drugs have been...
Since The Medical Letter last reviewed the choice of antibacterial drugs (vol.34, page 49, 1992), a few new drugs have become available, and some clinical trials of older drugs have been published.
Gabapentin - A New Anticonvulsant
The Medical Letter on Drugs and Therapeutics • April 29, 1994; (Issue 921)
Gabapentin (Neurontin - Parke-Davis), a cyclohexane acetic acid derivative, has been approved by the US Food and Drug Administration for use in addition to other antiepileptic drugs in patients with partial...
Gabapentin (Neurontin - Parke-Davis), a cyclohexane acetic acid derivative, has been approved by the US Food and Drug Administration for use in addition to other antiepileptic drugs in patients with partial (focal) seizures with or without secondary generalization. Since this diagnostic category includes the largest number of patients with intractable epilepsy, new drugs with antiepileptic activity are generally tried first for this indication.
Piperacillin/Tazobactam
The Medical Letter on Drugs and Therapeutics • January 21, 1994; (Issue 914)
Piperacillin/tazobactam (Zosyn - Lederle), an antibiotic combination product, has been approved by the US Food and Drug Administration for intravenous treatment of intra-abdominal, pelvic, skin, and...
Piperacillin/tazobactam (Zosyn - Lederle), an antibiotic combination product, has been approved by the US Food and Drug Administration for intravenous treatment of intra-abdominal, pelvic, skin, and skin-structure infections and for community-acquired pneumonia of moderate severity.