LONDON, May 28, 2020 /PRNewswire/ -- Hikma
Pharmaceuticals PLC (Hikma), the multinational generic
pharmaceutical company, has launched Dicyclomine Hydrochloride Oral
Solution, USP, 10 mg/5 mL, an AA-rated version of
Bentyl®1 Oral Syrup, 10 mg/5 mL in the United States through its US affiliate,
Hikma Pharmaceuticals USA Inc.
Hikma's Dicyclomine Hydrochloride Oral Solution USP was approved
with a Competitive Generic Therapy (CGT) designation from the US
Food and Drug Administration. Hikma is the "first approved
applicant" for this CGT and therefore is eligible for 180 days of
CGT exclusivity which began upon commercial marketing of Hikma's
product.
Dicyclomine Hydrochloride Oral Solution is indicated for the
treatment of patients with functional bowel/irritable bowel
syndrome.
According to IQVIA, US sales of Dicyclomine Hydrochloride Oral
Solution USP, 10 mg/5 mL were approximately $3 million in the 12 months ending March 2020.
Enquiries
Hikma Pharmaceuticals PLC
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Susan
Ringdal
EVP, Strategic
Planning and Global Affairs
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+44 (0)20 7399 2760/
+44 7776 477050
uk-investors@hikma.uk.com
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Steve
Weiss
David
Belian
US Communications and
Public Affairs
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+1 732 720 2830/ +1
732 788 8279
+1 732 720 2814/+1
848 254 4875
uscommunications@hikma.com
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About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC:
HKMPY) (rated Ba1/stable Moody's and BB+/positive S&P)
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 are 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 8,600
colleagues are helping to shape a healthier world that enriches all
our communities. We are a leading licensing partner, 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 Dicyclomine
Hydrochloride Oral Solution, USP, 10 mg/5 mL:
CONTRAINDICATIONS
Dicyclomine hydrochloride is
contraindicated in infants less than 6 months of age, nursing
mothers and in patients with:
- Unstable cardiovascular status in acute hemorrhage
- Myasthenia gravis
- Glaucoma
- Obstructive uropathy
- Obstructive disease of the gastrointestinal tract
- Severe ulcerative colitis
- Reflux esophagitis
WARNINGS AND PRECAUTIONS
Cardiovascular Conditions
Use dicyclomine
hydrochloride with caution in patients with conditions
characterized by tachyarrhythmia such as thyrotoxicosis, congestive
heart failure and in cardiac surgery, where they may further
accelerate the heart rate. Investigate any tachycardia before
administration of dicyclomine hydrochloride. Care is required in
patients with coronary heart disease, as ischemia and infarction
may be worsened, and in patients with hypertension.
Peripheral and Central Nervous System (CNS)
Peripheral
effects of dicyclomine hydrochloride include dryness of the mouth
with difficulty in swallowing and talking, thirst, reduced
bronchial secretions, dilatation of the pupils (mydriasis) with
loss of accommodation (cycloplegia) and photophobia, flushing and
dryness of the skin, transient bradycardia followed by tachycardia,
with palpitations and arrhythmias, and difficulty in micturition,
as well as reduction in the tone and motility of the
gastrointestinal tract leading to constipation.
In the presence of high environmental temperature, heat
prostration can occur with drug use. Use with caution in patients
with fever. If symptoms occur, the drug should be discontinued and
supportive measures instituted. Use with caution in patients with
autonomic neuropathy.
CNS signs and symptoms include confusion, disorientation,
short-term amnesia, hallucinations, dysarthria, ataxia, coma,
euphoria, fatigue, insomnia, agitation and mannerisms and
inappropriate affect. Psychosis has been reported in sensitive
individuals given anticholinergic drugs.
Dicyclomine hydrochloride may produce drowsiness, dizziness or
blurred vision. Warn the patient not to engage in activities
requiring mental alertness, such as operating a motor vehicle or
other machinery or performing hazardous work while taking
dicyclomine hydrochloride.
Myasthenia Gravis
With overdosage, a curare-like
action may occur. Do not give dicyclomine hydrochloride to patients
with myasthenia gravis except to reduce adverse muscarinic effects
of an anticholinesterase.
Intestinal Obstruction
Diarrhea may be an early
symptom of incomplete intestinal obstruction, especially in
patients with ileostomy or colostomy. In this instance, treatment
with this drug would be inappropriate and possibly harmful.
Rarely, development of Ogilvie's Syndrome has been reported.
Toxic Dilatation of Intestinemegacolon
Toxic
dilatation of intestine and intestinal perforation is possible when
anticholinergic agents are administered in patients with Salmonella
dysentery.
Ulcerative Colitis
Use with caution in patients with
ulcerative colitis. Large doses may suppress intestinal motility to
the point of producing a paralytic ileus and the use of this drug
may precipitate or aggravate the serious complication of toxic
megacolon. Contraindicated in patients with severe ulcerative
colitis.
Prostatic Hypertrophy
Use with caution in patients
with known or suspected prostatic enlargement.
Hepatic and Renal Disease
Use with caution in patients
with known hepatic and renal impairment.
Geriatric Population
Use with caution in elderly
patients who may be more susceptible to its adverse effects.
ADVERSE REACTIONS
The pattern of adverse effects seen
with dicyclomine hydrochloride is dose-related and usually
reversible when treatment is discontinued.
The most serious adverse reactions reported include
cardiovascular and CNS symptoms.
DRUG INTERACTIONS
Antiglaucoma Agents
Anticholinergics antagonize the
effects of antiglaucoma agents. Anticholinergic drugs in the
presence of increased intraocular pressure may be hazardous when
taken concurrently with agents such as corticosteroids. Use of
dicyclomine hydrochloride in patients with glaucoma is not
recommended.
Other Drugs With Anticholinergic Activity
Amantadine,
antiarrhythmic agents of Class I, antihistamines, antipsychotic
agents, benzodiazepines, MAO inhibitors, narcotic analgesics,
nitrates and nitrites, sympathomimetic agents, tricyclic
antidepressants and other drugs having anticholinergic activity may
increase certain actions or side effects of anticholinergic drugs,
including dicyclomine hydrochloride.
Other Gastrointestinal Motility Drugs
Interaction with
other gastrointestinal motility drugs may antagonize the effects of
drugs that alter gastrointestinal motility.
Effect of Antacids
Simultaneous use of dicyclomine
hydrochloride and antacids should be avoided.
Effect of Absorption of Other Drugs
Anticholinergic
agents may affect gastrointestinal absorption of various drugs by
affecting gastrointestinal motility, such as slowly dissolving
dosage forms of digoxin; increased serum digoxin concentration may
result.
Effect on Gastric Acid Secretion
The inhibiting
effects of anticholinergic drugs on gastric hydrochloric acid
secretion are antagonized by agents used to treat achlorhydria and
those used to test gastric secretion.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category B
Adequate and
well-controlled studies have not been conducted with dicyclomine
hydrochloride in pregnant women at the recommended doses of 80 to
160 mg/day. This drug should be used during pregnancy only if
clearly needed.
Nursing Mothers
Dicyclomine hydrochloride is
contraindicated in women who are breastfeeding.
Pediatric Use
Dicyclomine hydrochloride is
contraindicated in infants younger than 6 months of age. Safety and
effectiveness in other pediatric patients have not been
established.
Geriatric Use
Dose selection for an elderly patient
should be cautious, usually starting at the low end of the dosing
range in adults, reflecting the greater frequency of decreased
hepatic, renal or cardiac function and of concomitant disease or
other drug therapy.
Because elderly patients are more likely to have decreased renal
function, care should be taken to determine the appropriate dose.
Renal function should be monitored.
Patients with Renal Impairment
Effects of renal
impairment on pharmacokinetics (PK), safety and efficacy of
dicyclomine hydrochloride have not been studied. However,
dicyclomine hydrochloride is known to be substantially excreted by
the kidney and the risk of toxic reactions to this drug may be
greater in patients with impaired renal function. Administer with
caution in these patients.
Patients with Hepatic Impairment
Effects of renal
impairment on PK, safety and efficacy of dicyclomine hydrochloride
have not been studied. Administer with caution in patients with
hepatic impairment.
DOSAGE AND ADMINISTRATION
Dosage must be adjusted to
individual patient needs. If efficacy is not achieved within 2
weeks or side effects require doses below 80 mg/day, the drug
should be discontinued. Documented safety data are not available
for doses above 80 mg/day for periods longer than 2 weeks.
For more information, please see the full Prescribing
Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit https://www.fda.gov/medwatch
or call 1-800-FDA-1088.
Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228
Distributed by: Hikma Pharmaceuticals USA Inc., Eatontown,
NJ 07724
Document Identification Number: WW40010
1 Bentyl® is a registered trademark
of Aptalis Pharma Canada ULC.
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SOURCE Hikma Pharmaceuticals USA Inc.