TIDMHIK
Hikma Pharmaceuticals Plc
19 November 2018
London, 19 November 2018 - Hikma Pharmaceuticals PLC (Hikma,
Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1
Moody's / BB+ S&P, both stable) announces that Hikma
Pharmaceuticals USA Inc., formerly known as West-Ward
Pharmaceuticals Corp., has launched Triazolam Tablets, 0.125mg and
0.25mg the generic equivalent to Halcion(R) .(1)
Hikma's Triazolam tablets are indicated for the short-term
treatment of insomnia (generally seven to ten days). Use for more
than two or three weeks requires complete reevaluation of the
patient.
Prescriptions for triazolam tablets should be written for
short-term use (seven to ten days) and it should not be prescribed
in quantities exceeding a one-month supply.
According to IQVIA, US sales of Triazolam Tablets were
approximately $27 million in the 12 months ending September
2018.
Brian Hoffmann, President, Generics Division, said, "We are
excited to launch Triazolam Tablets, improving patients' access to
this product. This launch highlights the successful execution of
our strategy to develop more differentiated products by leveraging
our specialised manufacturing capabilities."
(1) Halcion(R) is a registered trademark of Pfizer
--S -
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global 477050
Affairs uk-investors@hikma.com
FTI Consulting
Ben Atwell/Brett Pollard +44 (0)20 3727 1000
About Hikma
Hikma helps put better health within reach every day for
millions of people in more than 50 countries around the world. For
40 years, we've been creating high-quality medicines and making
them accessible to the people who need them. 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
8,500 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 Triazolam Tablets, 0.125mg and
0.25mg:
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
See full Prescribing Information here
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db564864-17fc-4ba5-a438-a467ef57a0ca
for complete boxed warning.
Concomitant use of benzodiazepines and opioids may result in
profound sedation, respiratory depression, coma and death.
-- Reserve concomitant prescribing of these drugs for use in
patients for whom alternative treatment options are inadequate.
-- Limit dosages and durations to minimum required.
-- Follow patients for signs and symptoms of respiratory depression and sedation.
Contraindications
Triazolam tablets are contraindicated in patients with known
hypersensitivity to this drug or other benzodiazepines.
Triazolam tablets are contraindicated in pregnant women. If
there is a likelihood of the patient becoming pregnant while
receiving triazolam tablets, she should be warned of the potential
risk to the fetus. Patients should be instructed to discontinue the
drug prior to becoming pregnant. The possibility that a woman of
childbearing potential may be pregnant at the time of institution
of therapy should be considered.
Triazolam tablets are contraindicated with medications that
significantly impair the oxidating metabolism mediated by
cytochrome P450 3A (CYP 3A) including ketoconazole, itraconazole,
nefazone and several HIV protease inhibitors.
Risks from Concomitant Use with Opioids (see Boxed Warning)
Observational studies have demonstrated that concomitant use of
opioid analgesics and benzodiazepines increases the risk of
drug-related mortality compared to use of opioids alone. If a
decision is made to prescribe triazolam tablets concomitantly with
opioids, prescribe the lowest effective dosages and minimum
durations of concomitant use, and follow patients closely for signs
and symptoms of respiratory depression and sedation. In patients
already receiving an opioid analgesic, prescribe a lower initial
dose of triazolam tablets than indicated in the absence of an
opioid and titrate based on clinical response. If an opioid is
initiated in a patient already taking triazolam tablets, prescribe
a lower initial dose of the opioid and titrate based upon clinical
response.
Advise both patients and caregivers about the risks of
respiratory depression and sedation when triazolam tablets are used
with opioids. Advise patients not to drive or operate heavy
machinery until the effects of concomitant use with the opioid have
been determined.
Persistent or Worsening Insomnia
Because sleep disturbances may be the presenting manifestation
of a physical and/or psychiatric disorder, symptomatic treatment of
insomnia should be initiated only after a careful evaluation of the
patient. The failure of insomnia to remit after 7 to 10 days of
treatment may indicate the presence of a primary psychiatric and/or
medical illness that should be evaluated. Worsening of insomnia or
the emergence of new thinking or behavior abnormalities may be the
consequence of an unrecognized psychiatric or physical disorder.
Such findings have emerged during the course of treatment with
sedative-hypnotic drugs. Because some of the important adverse
effects of sedative-hypnotics appear to be dose related, it is
important to use the smallest possible effective dose, especially
in the elderly.
"Sleep-driving" and Other Complex Behaviors
Complex behaviors such as "sleep-driving" (i.e., driving while
not fully awake after ingestion of a sedative-hypnotic, with
amnesia for the event) have been reported. These events can occur
in sedative-hypnotic-naïve as well as in
sedative-hypnotic-experienced persons. Although behaviors such as
sleep-driving may occur with sedative-hypnotics alone at
therapeutic doses, the use of alcohol and other CNS depressants
with sedative-hypnotics appears to increase the risk of such
behaviors, as does the use of sedative-hypnotics at doses exceeding
the maximum recommended dose. Due to the risk to the patient and
the community, discontinuation of sedative-hypnotics should be
strongly considered for patients who report a "sleep-driving"
episode.
Other complex behaviors (e.g., preparing and eating food, making
phone calls or having sex) have been reported in patients who are
not fully awake after taking a sedative-hypnotic. As with
sleep-driving, patients usually do not remember these events.
Severe Anaphylactic and Anaphylactoid Reactions
Rare cases of angioedema involving the tongue, glottis or larynx
have been reported in patients after taking the first or subsequent
doses of sedative-hypnotics, including triazolam. Some patients
have had additional symptoms such as dyspnea, throat closing or
nausea and vomiting that suggest anaphylaxis. If angioedema
involves the tongue, glottis or larynx, airway obstruction may
occur and be fatal. Patients who develop angioedema after treatment
with triazolam should not be rechallenged with the drug.
Central Nervous System Manifestations
An increase in daytime anxiety has been reported for triazolam
tablets after as few as 10 days of continuous use. In some patients
this may be a manifestation of interdose withdrawal. If increased
daytime anxiety is observed during treatment, discontinuation of
treatment may be advisable.
A variety of abnormal thinking and behavior changes have been
reported to occur in association with the use of benzodiazepine
hypnotics including triazolam tablets. Some of these changes may be
characterized by decreased inhibition, e.g., aggressiveness and
extroversion that seem excessive, similar to that seen with alcohol
and other CNS depressants (e.g., sedative/hypnotics). Other kinds
of behavioral changes have also been reported, for example, bizarre
behavior, agitation, hallucinations, depersonalization. In
primarily depressed patients, the worsening of depression,
including suicidal thinking, has been reported in association with
the use of benzodiazepines. The emergence of any new behavioral
sign or symptom of concern requires careful and immediate
evaluation.
Because of its depressant CNS effects, patients receiving
triazolam should be cautioned against engaging in hazardous
occupations requiring complete mental alertness such as operating
machinery or driving a motor vehicle. For the same reason, patients
should be cautioned about the concomitant ingestion of alcohol and
other CNS depressant drugs during treatment with triazolam
tablets.
As with some, but not all benzodiazepines, anterograde amnesia
of varying severity and paradoxical reactions have been reported
following therapeutic doses of triazolam tablets. Data from several
sources suggest that anterograde amnesia may occur at a higher rate
with triazolam tablets than with other benzodiazepine
hypnotics.
Triazolam Interactions With Drugs That Inhibit Metabolism via
Cytochrome P450 3A
Triazolam should be avoided in patients receiving very potent
inhibitors of CYP 3A. With drugs inhibiting CYP 3A to a lesser but
still significant degree, triazolam should be used only with
caution and consideration of appropriate dosage reduction. Examples
of drugs known to inhibit the metabolism of triazolam and/or
related benzodiazepines include ketoconazole, itraconazole,
nefazodone, and several HIV protease inhibitors.
Precautions
Human studies have not been performed; however, studies in rats
have indicated that triazolam and its metabolites are secreted in
milk. Therefore, administration of triazolam tablets to nursing
mothers is not recommended.
The elderly are especially susceptible to the dose related
adverse effects of triazolam tablets. In elderly and/or debilitated
patients it is recommended that treatment with triazolam tablets be
initiated at 0.125 mg to decrease the possibility of development of
oversedation, dizziness or impaired coordination.
Some side effects reported in association with the use of
triazolam tablets appear to be dose-related. These include
drowsiness, dizziness, light-headedness and amnesia.
Cases of "traveler's amnesia" have been reported by individuals
who have taken triazolam tablets to induce sleep while
traveling.
Caution should be exercised if triazolam tablets are prescribed
to patients with signs or symptoms of depression that could be
intensified by hypnotic drugs.
The usual precautions should be observed in patients with
impaired renal or hepatic function, chronic pulmonary
insufficiency, and sleep apnea.
Safety and effectiveness of triazolam tablets in individuals
younger than 18 years of age have not been established.
Adverse Reactions
During placebo-controlled clinical studies in which 1,003
patients received triazolam tablets, the most troublesome side
effects were extensions of the pharmacologic activity of triazolam,
e.g., drowsiness, dizziness or light-headedness.
Untoward events occurring in >=1% of patients receiving
triazolam tablets (vs placebo) include: drowsiness: 14.0% (placebo:
6.4%), headache: 9.7% (placebo 8.4%), dizziness: 7.8% (placebo:
3.1%), nervousness: 5.2% (placebo: 4.5%), light-headedness: 4.9%
(placebo: 0.9%), coordination disorders/ataxia: 4.6% (placebo:
0.8%) and nausea/vomiting: 4.6% (placebo: 3.7%). Note that these
figures cannot be used to predict precisely the incidence of
untoward events in the course of usual medical practice where
patient characteristics and other factors often differ from those
in clinical trials.
In addition to the relatively common (i.e., 1% or greater)
untoward events enumerated above, the following adverse events have
been reported less frequently (i.e., 0.9% to 0.5%): euphoria,
tachycardia, tiredness, confusional states/memory impairment,
cramps/pain, depression, visual disturbances.
Rare (i.e., less than 0.5%) adverse reactions included
constipation, taste alterations, diarrhea, dry mouth,
dermatitis/allergy, dreaming/nightmares, insomnia, paresthesia,
tinnitus, dysesthesia, weakness, congestion, death from hepatic
failure in a patient also receiving diuretic drugs.
In addition to these untoward events for which estimates of
incidence are available, the following adverse events have been
reported in association with the use of triazolam tablets and other
benzodiazepines: amnestic symptoms (anterograde amnesia with
appropriate or inappropriate behavior), confusional states
(disorientation, derealization, depersonalization, and/or clouding
of consciousness), dystonia, anorexia, fatigue, sedation, slurred
speech, jaundice, pruritus, dysarthria, changes in libido,
menstrual irregularities, incontinence, and urinary retention.
Other factors may contribute to some of these reactions, e.g.,
concomitant intake of alcohol or other drugs, sleep deprivation, an
abnormal premorbid state, etc.
Other events reported include: paradoxical reactions such as
stimulation, mania, an agitational state (restlessness,
irritability, and excitation), increased muscle spasticity, sleep
disturbances, hallucinations, delusions, aggressiveness, falling,
somnambulism, syncope, inappropriate behavior and other adverse
behavioral effects. Should these occur, use of the drug should be
discontinued.
The following events have also been reported: chest pain,
burning tongue/glossitis/stomatitis.
When treatment with triazolam tablets is protracted, periodic
blood counts, urinalysis, and blood chemistry analyses are
advisable.
Interactions
When benzodiazepines and opioids are combined, the potential for
benzodiazepines to significantly worsen opioid-related respiratory
depression exists. Limit dosage and duration of concomitant use of
benzodiazepines and opioids, and monitor patients closely for
respiratory depression and sedation. In particular, triazolam
produces additive CNS depressant effects when co-administered with
other psychotropic medications, anticonvulsants, antihistamines,
ethanol, and other drugs which themselves produce CNS depression.
Co-administration of triazolam with with isoniazid, oral
contraceptives, grapefruit juice, and ranitidine increased maximum
plasma concentrations of triazolam.
Available data from clinical studies of benzodiazepines other
than triazolam suggest a possible drug interaction with triazolam
for the following: fluvoxamine, diltiazem, and verapamil. Data from
in vitro studies of triazolam suggest a possible drug interaction
with triazolam for the following: sertraline and paroxetine. Data
from in vitro studies of benzodiazepines other than triazolam
suggest a possible drug interaction with triazolam for the
following: ergotamine, cyclosporine, amiodarone, nicardipine, and
nifedipine.
Overdosage
Because of the potency of triazolam, some manifestations of
overdosage may occur at 2 mg, four times the maximum recommended
therapeutic dose (0.5 mg).
Manifestations of overdosage with triazolam tablets include
somnolence, confusion, impaired coordination, slurred speech, and
ultimately, coma. Respiratory depression and apnea have been
reported with overdosages of triazolam tablets. Seizures have
occasionally been reported after overdosages.
For more information, please see the full Prescribing
Information here
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db564864-17fc-4ba5-a438-a467ef57a0ca,
including Boxed Warning regarding risks from concomitant use with
opioids, and the Medication Guide.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit MedWatch or call
1-800-FDA-1088.
Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228
Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ
07724
(c)2018 Hikma Pharmaceuticals USA Inc. All rights reserved.
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END
NRAFKADKABDDCDD
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