LONDON, May 1, 2019 /PRNewswire/ -- Hikma
Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK)
(OTC: HKMPY) (rated Ba1 Moody's / BB+ S&P, both stable) the
multinational pharmaceutical company, today launched its
100th injectable medicine in the United States with the introduction of
Vancomycin Hydrochloride for Injection, USP, 5g, 10g and 750mg,
through its US affiliate, Hikma Pharmaceuticals USA Inc.1
"Vancomycin Hydrochloride for Injection is an essential
antibiotic used by hospitals to treat patients who have failed to
respond to a number of other antibiotics, and it's another
important addition to our growing US portfolio," said Dan Motto, Executive Vice President, Commercial
and Development, Injectables. "This launch marks a great milestone
– Hikma's 100th injectable medicine in the US – and it
demonstrates our commitment to providing doctors and hospitals with
a broad range of high-quality medicines needed to treat the current
and future needs of patients."
Hikma's Vancomycin Hydrochloride for Injection, USP is indicated
for:
- the treatment of serious or severe infections caused by
susceptible strains of methicillin-resistant (β-lactam- resistant)
staphylococci;
- patients who cannot receive or who have failed to respond to
other drugs, including the penicillins or cephalosporins, and for
infections caused by Vancomycin-susceptible organisms that are
resistant to other antimicrobial drugs;
- initial therapy when methicillin-resistant staphylococci are
suspected, but after susceptibility data are available, therapy
should be adjusted accordingly;
- the treatment of staphylococcal endocarditis. Its effectiveness
has been documented in other infections due to staphylococci,
including septicemia, bone infections, lower respiratory tract
infections, skin and skin structure infections. When staphylococcal
infections are localized and purulent, antibiotics are used as
adjuncts to appropriate surgical measures;
and has been:
- reported to be effective alone or in combination with an
aminoglycoside for endocarditis caused by S. viridans or
S. bovis. For endocarditis caused by enterococci (e.g.,
E. faecalis), has been reported to be effective only in
combination with an aminoglycoside;
- reported to be effective for the treatment of diphtheroid
endocarditis;
- used successfully in combination with either rifampin, an
aminoglycoside, or both in early-onset prosthetic valve
endocarditis caused by S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order
to isolate and identify causative organisms and to determine their
susceptibilities to Vancomycin.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of Vancomycin Hydrochloride for
Injection, USP and other antibacterial drugs, Vancomycin
Hydrochloride for Injection, USP should be used only to treat or
prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility
information are available, they should be considered in selecting
or modifying antibacterial therapy. In the absence of such data,
local epidemiology and susceptibility patterns may contribute to
the empiric selection of therapy.
The parenteral form of Vancomycin Hydrochloride may be
administered orally for treatment of antibiotic-associated
pseudomembranous colitis produced by C. difficile and for
staphylococcal enterocolitis. Parenteral administration of
Vancomycin Hydrochloride alone is of unproven benefit for these
indications. Vancomycin is not effective by the oral route for
other types of infection.
According to IQVIA, US sales of Vancomycin Hydrochloride for
Injection, USP, 5g, 10g and 750mg were approximately $247 million in the 12 months ending February 2019.
"Our portfolio of 100 injectable medicines now covers many
vital, large and growing therapeutic areas including oncology,
anti-infectives, anaesthesia and pain management," continued Mr.
Motto. "We are expecting to launch 15 additional products
this year, further strengthening Hikma's position as a top
manufacturer and supplier in the US generic injectable market with
a strong portfolio that can't easily be replicated."
"Our customers prefer to work with manufacturers that have a
large product portfolio and a long record of successful FDA
inspections," said Riad Mechlaoui, Hikma's President of
Injectables. "Over the years Hikma has established a strong
reputation for quality products and reliability. We have made
significant investments to build flexible manufacturing
capabilities allowing us to shift capacity to where it is needed
most, and enabling us to quickly address changing market demands,
including US drug shortage situations as they arise."
Hikma is the third largest US supplier of generic injectable
medicines by volume, with a growing portfolio of 100 products.
Today one in every six injectable generic medicines used in US
hospitals is a Hikma product.
About Hikma
Hikma helps put better health within reach every day for
millions of people in more than 50 countries around the
world. For more than 40 years, we've been creating
high-quality medicines and making them accessible to the people who
need them. Headquartered in the UK, we're a global company
with a local presence across the United
States (US), the Middle
East and North Africa
(MENA) and Europe, and we use our
unique insight and expertise to transform cutting-edge science into
innovative solutions that transform people's lives. We're
committed to our customers, and the people they care for, and by
thinking creatively and acting practically, we provide them with a
broad range of branded and non-branded generic medicines.
Together, our 8,400 colleagues are helping to shape a healthier
world that enriches all our communities. We are a leading
licensing partner in the MENA region, and through our venture
capital arm, are helping bring innovative health technologies to
people around the world. For more information, please visit
www.hikma.com
Important Safety Information for Vancomycin Hydrochloride for
Injection, USP, 5g, 10g, and 750mg:
WARNINGS AND PRECAUTIONS
The following warnings and precautions should be taken when
administering Vancomycin Hydrochloride for Injection, USP:
- A pharmacy bulk package is a container of a sterile preparation
for parenteral use that contains many single doses. The contents of
this pharmacy bulk package are intended for use by a pharmacy
admixture service for addition to suitable parenteral fluids in the
preparation of admixtures for intravenous infusion. FURTHER
DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.
- Mixtures of solutions of Vancomycin and beta-lactam antibiotics
have been shown to be physically incompatible. The likelihood of
precipitation increases with higher concentrations of Vancomycin.
It is recommended to adequately flush the intravenous lines between
the administration of these antibiotics. It is also recommended to
dilute solutions of Vancomycin to 5 mg/mL or less.
- Although intravitreal injection is not an approved route of
administration for Vancomycin, precipitation has been reported
after intravitreal injection of Vancomycin and Ceftazidime for
endophthalmitis using different syringes and needles. The
precipitates dissolved gradually, with complete clearing of the
vitreous cavity over two months and with improvement of visual
acuity.
- Vancomycin Hydrochloride for Injection should be administered
in a diluted solution over a period of not less than 60 minutes to
avoid rapid-infusion-related reactions.
- Monitor renal function in all patients, especially patients
with underlying renal impairment, patients with co-morbidities that
predispose to renal impairment, and patients receiving concomitant
therapy with a drug known to be nephrotoxic.
- Clostridium difficile associated diarrhea (CDAD) has
been reported with use of nearly all antibacterial agents. Careful
observation of the patient is essential.
- Hemorrhagic occlusive retinal vasculitis, including permanent
loss of vision, occurred in patients receiving intracameral or
intravitreal administration of Vancomycin during or after cataract
surgery.
- Reversible neutropenia has been reported in patients receiving
Vancomycin Hydrochloride for Injection.
- Must be given by a secure IV route of administration.
- Infusion-related events may be minimized by the administration
of Vancomycin as a 60-minute infusion prior to anesthetic
induction.
- Prescribing Vancomycin Hydrochloride for Injection in the
absence of a proven or strongly suspected bacterial infection or a
prophylactic indication is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
- Concomitant administration of Vancomycin and anesthetic agents
has been associated with erythema and histamine-like flushing and
anaphylactoid reactions.
- Vancomycin should be given to a pregnant woman only if clearly
needed.
- Caution should be exercised when Vancomycin Hydrochloride for
Injection is administered to a nursing woman.
- Confirm desired Vancomycin serum concentrations in pediatric
patients.
- Patients should be counseled that antibacterial drugs including
Vancomycin Hydrochloride for Injection should only be used to treat
bacterial infections.
Vancomycin Hydrochloride for Injection is contraindicated in
patients with known hypersensitivity to this antibiotic.
The following adverse reactions have been reported:
anaphylactoid reactions, flushing of the upper body, acute kidney
injury, pseudomembranous colitis symptoms, hearing loss, vertigo,
reversible neutropenia, inflammation at the injection site, drug
fever, nausea, chills, rashes, and vasculitis. Chemical peritonitis
has been reported following intraperitoneal administration.
Postmarketing reports include skin and subcutaneous tissue
disorders, drug rash with eosinophilia and systemic symptoms
(DRESS).
Vancomycin is poorly removed by dialysis. Hemofiltration and
hemoperfusion with polysulfone resin have been reported to result
in increased Vancomycin clearance. To obtain up-to-date information
about the treatment of overdose, a good resource is your certified
Regional Poison Control Center.
For additional information, please refer to the
Package Insert for the vial and the
Package Insert for the pharmacy bulk pack for full
prescribing information, available on www.hikma.com.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit MedWatch or call
1-800-FDA-1088.
Manufactured by:
HIKMA FARMACÊUTICA (PORTUGAL)
S.A.
Estrada do Rio da Mó nos.8, A/B
2705-906 Terrugem SNT
Portugal
Distributed by:
WEST-WARD
A HIKMA COMPANY
Eatontown, NJ 07724
USA
Document Identification Number: WW30336
1 Hikma Pharmaceuticals USA Inc. was formerly known as West-Ward
Pharmaceuticals Corp.
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SOURCE Hikma