DUBLIN, March 10, 2023 /PRNewswire/ -- Endo
International plc (OTC: ENDPQ) announced today that one of its
operating companies, Par Pharmaceutical, Inc., has begun shipping
the first generic version of Allergan's Pylera® (bismuth
subcitrate potassium, metronidazole, tetracycline hydrochloride)
140 mg, 125 mg and 125 mg capsules in the U.S., following final
approval from the U.S. Food and Drug Administration of its
Abbreviated New Drug Application.
"We're proud to be a reliable, quality supplier providing
choices to healthcare professionals and their appropriate
patients," said Scott Sims, Senior
Vice President and General Manager, Injectable Solutions &
Generics at Endo. "This first-to-market generic product strengthens
our portfolio and is a lower-cost option for people who need the
medication."
Bismuth subcitrate potassium, metronidazole and tetracycline
hydrochloride capsules, in combination with omeprazole, are
indicated for the treatment of patients with Helicobacter pylori
infection and duodenal ulcer disease (active or history of within
the past five years) to eradicate H. pylori.
According to IQVIA™, Pylera® sales were
approximately $30 million for the 12
months ended December 31, 2022.
Pylera® is a registered trademark of Aptalis Pharma
Canada ULC, an Allergan affiliate.
IMPORTANT SAFETY INFORMATION FOR BISMUTH
SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
CAPSULES
WARNING: POTENTIAL
FOR CARCINOGENICITY
Metronidazole has
been shown to be carcinogenic in mice and rats. It is unknown
whether metronidazole is associated with carcinogenicity in
humans
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CONTRAINDICATIONS
Methoxyflurane: Bismuth
subcitrate potassium, metronidazole and tetracycline hydrochloride.
the concurrent use of tetracycline hydrochloride, a component of
bismuth subcitrate potassium, metronidazole and tetracycline
hydrochloride reported to result in fatal renal toxicity.
Disulfiram: Bismuth subcitrate potassium, metronidazole and
tetracycline hydrochloride psychotic reactions have been reported
in alcoholic patients who are using metronidazole, a component of
bismuth subcitrate potassium, metronidazole and tetracycline
hydrochloride.
Alcohol: Alcoholic beverages or other products containing
propylene glycol should not be consumed during and for at least 3
days after therapy with bismuth subcitrate potassium, metronidazole
and tetracycline hydrochloride occur due to the interaction between
alcohol or propylene glycol and metronidazole, a component of
bismuth subcitrate potassium, metronidazole and tetracycline
hydrochloride.
Cockayne Syndrome: Bismuth subcitrate potassium,
metronidazole and tetracycline hydrochloride is contraindicated in
patients with Cockayne Syndrome. Severe irreversible
hepatotoxicity/acute liver failure with fatal outcomes have been
reported after initiation of metronidazole in patients with
Cockayne Syndrome.
Severe Renal Impairment: Bismuth subcitrate potassium,
metronidazole and tetracycline hydrochloride is contraindicated in
patients with severe renal impairment. The antianabolic action of
the tetracyclines may cause an increase in blood urea nitrogen
(bun). In patients with significantly impaired renal
function, higher serum concentrations of tetracyclines may lead to
azotemia, hyperphosphatemia, and acidosis.
Pregnancy: Bismuth subcitrate potassium, metronidazole and
tetracycline hydrochloride is contraindicated during
pregnancy.
Hypersensitivity Reactions: Bismuth subcitrate potassium,
metronidazole and tetracycline hydrochloride is contraindicated in
patient with known hypersensitivity (e.g. urticaria, erythematous
rash, flushing and fever) to bismuth subcitrate potassium,
metronidazole or other nitroimidazole derivatives, or
tetracyclines.
WARNINGS AND PRECAUTIONS
Fetal Toxicity:
Tetracycline can cause fetal harm when administered to a pregnant
woman. Based on animal data, use of drugs of the tetracycline class
during the second and third trimester of pregnancy can cause
permanent discoloration of the teeth (yellow-gray brown) and
possibly inhibit bone development. If bismuth subcitrate
potassium, metronidazole and tetracycline hydrochloride is used
during pregnancy, or if the patient becomes pregnant while taking
bismuth subcitrate potassium, metronidazole and tetracycline
hydrochloride, advise the patient of the potential risk to the
fetus.
Maternal Toxicity: Tetracycline, a component of bismuth
subcitrate potassium, metronidazole and tetracycline hydrochloride,
administered during pregnancy at high doses (> 2 g iv) was
associated with rare but serious cases of maternal hepatotoxicity.
This syndrome may result in stillborn or premature birth due to
maternal pathology.
Tooth Enamel Discoloration and Hypoplasia: The use of drugs
of the tetracycline class during tooth development (last half of
pregnancy, infancy, and childhood to the age of 8 years) may cause
permanent discoloration of the teeth (yellow-gray-brown). This
adverse reaction is more common during long-term use of the drug,
but has been observed following repeated short-term courses.
Central and Peripheral Nervous System Effects:
Metronidazole: convulsive seizures, encephalopathy, aseptic
meningitis and peripheral neuropathy (including optic neuropathy)
have been reported. CNS symptoms are generally reversible within
days to weeks upon discontinuation of metronidazole. CNS lesions
seen on MRI have also been described as reversible. Aseptic
meningitis symptoms may occur within hours of dose administration
and generally resolve after metronidazole therapy is
discontinued.
Tetracycline: intracranial hypertension (IH), including pseudotumor
cerebri, has been associated with the use of tetracyclines.
Clinical manifestations of IH include headache, blurred vision,
diplopia, and vision loss; papilledema can be found on fundoscopy.
Women of childbearing age who are overweight or have a history of
IH are at greater risk for developing tetracycline associated IH.
Concomitant use of isotretinoin should be avoided because
isotretinoin is also known to cause IH.
Bismuth-containing products: cases of neurotoxicity associated with
excessive doses of various bismuth-containing products have been
reported. Effects have been reversible with discontinuation of
bismuth therapy.
Development of Potential for Microbial Overgrowth: Known or
previously unrecognized candidiasis may present more prominent
symptoms during therapy with metronidazole and requires treatment
with an antifungal agent. As with other antibacterial drugs, use of
tetracycline hydrochloride may result in overgrowth of
nonsusceptible organisms, including fungi. If superinfection
occurs, discontinue bismuth subcitrate potassium, metronidazole and
tetracycline hydrochloride and institute appropriate therapy.
Photosensitivity: Photosensitivity, manifested by an
exaggerated sunburn reaction, has been observed in patients taking
tetracycline. Instruct patients taking bismuth subcitrate
potassium, metronidazole and tetracycline hydrochloride to avoid
exposure to the sun or sun lamps. Discontinue treatment at the
first evidence of skin erythema.
Darkening of the Tongue and/or Black Stool: Bismuth
subcitrate potassium may cause temporary and harmless darkening of
the tongue and/or black stools, generally reversible within several
days after treatment [see Adverse Reactions]. Stool
darkening should not be confused with melena.
Use in Patients with Blood Dyscrasias: Metronidazole is a
nitroimidazole, and should be used with care in patients with
evidence of or history of blood dyscrasia. Total and differential
leukocyte counts are recommended before and after therapy.
Increased Drug Plasma Concentrations in Patients with Hepatic
Impairment: Patients with mild to moderate hepatic impairment
should be monitored for metronidazole associated adverse events.
Bismuth subcitrate potassium, metronidazole and tetracycline
hydrochloride is not recommended in patients with severe hepatic
impairment.
Cutaneous Reactions: Skin and subcutaneous disorders
including Stevens-Johnson Syndrome, toxic epidermal necrolysis and
dress syndrome (drug rash with eosinophilia and systemic symptoms)
have been reported. Discontinue treatment at the first evidence of
a cutaneous reaction.
ADVERSE REACTIONS
Most frequently reported adverse
reactions (>5o): abnormal feces, diarrhea, nausea, and
headache.
DRUG INTERACTIONS
Methoxyfurane: risk of fatal renal
toxicity; do not co-administer.
Disulfram: psychotic reactions can occur; do not take concurrently
or within the last 2 weeks of disulfram.
- Alcohol: abdominal cramps, nausea, vomiting, headaches, and
flushing can occur; do not consume during therapy and for at least
3 days afterwards.
- Oral contraceptives: decreased efficacy possibly resulting in
pregnancy; use a different or additional form of
contraception.
- Anticoagulants: potentiation of the anticoagulant effect;
prothrombin time, international normalized ratio (INR), or other
suitable anticoagulation tests should be closely monitored.
- Lithium: increased lithium serum concentrations; measure serum
lithium and serum creatinine concentrations during therapy.
- Antacids, multivitamins or dairy products: decreased absorption
of bismuth subcitrate potassium, metronidazole and tetracycline
hydrochloride; do not take concomitantly.
- Busulfan: increased busulfan serum concentrations; avoid
concomitant use, monitor for busulfan toxicity.
- CYP inducers and CYP inhibitors: prolonged or accelerated
half-life of metronidazole or concomitant medications; use with
caution.
INDICATION
Bismuth subcitrate potassium, metronidazole
and tetracycline hydrochloride capsules in combination with
omeprazole are indicated for the treatment of patients with
Helicobacter pylori infection and duodenal ulcer disease (active or
history of within the past 5 years) to eradicate H. pylori. The
eradication of Helicobacter pylori has been shown to reduce the
risk of duodenal ulcer recurrence.
Please see Full Prescribing Information, including Boxed
Warning, for bismuth subcitrate potassium, metronidazole
and tetracycline hydrochloride.
About Endo
Endo (OTC: ENDPQ) is a specialty
pharmaceutical company committed to helping everyone we serve live
their best life through the delivery of quality, life-enhancing
therapies. Our decades of proven success come from passionate team
members around the globe collaborating to bring treatments forward.
Together, we boldly transform insights into treatments benefiting
those who need them, when they need them. Learn more at
www.endo.com or connect with us on LinkedIn.
About Par Pharmaceutical
Par Pharmaceutical develops,
manufactures and markets innovative and cost-effective generic
pharmaceutical and branded injectable products that help improve
patients' lives. Par, among the top leaders in the U.S. generics
industry, possesses an expanding portfolio that includes sterile
injectables, alternative dosage forms and other differentiated
products. Par Pharmaceutical is an Endo company. Learn more at
www.parpharm.com.
Cautionary Note Regarding Forward-Looking
Statements
Certain information in this press release may be
considered "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995 and any applicable
Canadian securities legislation, including, but not limited to, the
statements by Mr. Sims, any statements relating to product launch,
shipments, sales potential, quality, safety or cost. and any
statements that refer to expected, estimated or anticipated future
results or that do not relate solely to historical facts.
Statements including words or phrases such as "believe," "expect,"
"anticipate," "intend," "estimate," "plan," "will," "may," "look
forward," "intend," "guidance," "future," "potential" or similar
expressions are forward-looking statements. All forward-looking
statements in this communication reflect the Company's current
views as of the date of this communication about its plans,
intentions, expectations, strategies and prospects, which are based
on the information currently available to it and on assumptions it
has made. Actual results may differ materially and adversely from
current expectations based on a number of factors, including, among
other things, the outcome of the Company's contingency planning and
restructuring activities; the timing, impact or results of any
pending or future litigation, investigations, proceedings or
claims, including opioid, tax and antitrust related matters; any
actual or contingent liabilities; settlement discussions or
negotiations; the Company's liquidity, financial performance, cash
position and operations; the risks and uncertainties associated
with chapter 11 proceedings; the time, terms and ability to confirm
a sale of the Company's businesses under Section 363 of the U.S.
Bankruptcy Code; the risk that the Company's chapter 11 cases may
be converted to cases under chapter 7 of the Bankruptcy Code; the
adequacy of the capital resources of the Company's businesses and
the difficulty in forecasting the liquidity requirements of the
operations of the Company's businesses; the unpredictability of the
Company's financial results; the Company's ability to discharge
claims in chapter 11 proceedings; negotiations with the holders of
the Company's indebtedness and its trade creditors and other
significant creditors; the risks and uncertainties with performing
under the terms of the restructuring support agreement and any
other arrangement with lenders or creditors while in chapter 11
proceedings; the performance, including the approval, introduction,
and consumer and physician acceptance of new products and the
continuing acceptance of currently marketed products; and the
Company's ability to obtain and successfully manufacture, maintain
and distribute a sufficient supply of products to meet market
demand in a timely manner. The Company expressly disclaims any
intent or obligation to update these forward-looking statements,
except as required to do so by law.
Additional information concerning risk factors, including those
referenced above, can be found in press releases issued by the
Company, as well as the Company's public periodic filings with the
U.S. Securities and Exchange Commission and with securities
regulators in Canada, including
the discussion under the heading "Risk Factors" in the Company's
most recent Annual Report on Form 10-K and any subsequent Quarterly
Reports on Form 10-Q or other filings with the U.S. Securities and
Exchange Commission. Copies of the Company's press releases and
additional information about the Company are available at
www.endo.com or you can contact the Company's Investor Relations
Department at relations.investor@endo.com.
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