DEHISTINE SYRUP
-
phenylephrine hydrochloride,
chlorpheniramine maleate and
methscopolamine nitrate liquid
Cypress Pharmaceutical, Inc.
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DEHISTINE SYRUPThis product provides relief of the symptoms resulting from irritation of sinus, nasal, and upper respiratory tract tissue.
Phenylephrine exerts a vasoconstrictive and decongestive action while chlorpheniramine maleate decreases the symptoms
of watering eyes, post-nasal drip, and sneezing. Methscopolamine nitrate further augments the antisecretory activity of
this product.
This product is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its ingredients. It is also
contraindicated in women who are pregnant or nursing. This product is contraindicated in children under six years
of age, because this age group is sensitive to the effects of sympathomimetic amines.
It is also contraindicated in newborn or premature infants, because this age group has an increased susceptibility
to the anticholinergic side effects of chlorpheniramine maleate. Geriatric patients may be more sensitive to the
effects of this medication.
Risk-benefit should be considered when the following conditions exist: Acute asthma; Bladder neck obstruction;
Brain damage in children; Cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary artery
disease, and mitral stenosis; Cardiovascular disease; Diabetes Mellitus; Down's Syndrome; Esophagitis, reflux;
Narrow angle glaucoma; Acute hemorrhage with unstable cardiovascular status; Hepatic function impairment; Hernia;
Hypertension; Hyperthyroidism; Intestinal atony in the elderly or debilitated patient; Chronic lung disease; Myasthenia
gravis; Autonomic neuropathy; Paralytic ileus; Prostatic hypertrophy; Psychiatric disorders; Pyloric obstruction; Renal
function impairment; Spastic paralysis, in children; Tachycardia; Toxemia of pregnancy; Ulcerative colitis; Urinary
retention, or predisposition to; Urothopy; Xerostomia.
This product may cause drowsiness or blurred vision. Patients taking this product should be warned
not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery
or to perform hazardous tasks while taking this drug.
Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease,
diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. The overdosage
of sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse
with accompanying hypotension. Do not exceed recommended dosage.
Heat prostration can occur with the use of methscopolamine when the environmental temperature is high. Diarrhea
may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy;
in this instance, use of methscopolamine would be inappropriate and possibly harmful.
Use Phenylephrine with caution in patients with hypoxia,
acidosis, or a history of arteriosclerosis, bradycardia, partial heart block,
hypertension, myocardial disease, thrombosis, or ventricular tachycardia. Antihistamines have an atropine-like action
and should
be used with caution in patients with a history of bronchial asthma,
emphysema, increased intraocular pressure, hyperthyroidism,
cardiovascular
disease and hypertension.
Use methscopolamine with caution in patients with hiatal
hernia associated with reflux Esophagitis.
Use extreme caution and only
when needed in patients with autonomic
neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure,
and cardiac
arrhythmia.
Patient consultation should include the following
information regarding proper use of this medication:
• Do not take more medication than the amount recommended.
• This medication should be used with caution during exercise or hot
weather, overheating may result in heat
stroke.
• Do not drive or operate machinery if drowsiness or dizziness occurs.
• Do not ingest alcoholic beverages, monoamine oxidase (MAO)
inhibitors, or CNS depression-
producing
medications (hypnotics, sedatives, tranquilizers) while
taking this medication.
• This medication possibly increases sensitivity of eyes to light.
• Methscopolamine nitrate may cause blurred vision.
• If a dose is missed, the medication should be taken as soon as possible
unless it is almost time for the next
dose. Do not double doses.
• This medication should be stored in a tight, light-resistant
container at temperatures between 15°-30°C (59°-86°F).
• Keep all medications out of reach of children. In case of accidental
overdose, seek professional assistance
or contact a poison
control center immediately.
Caution patients about the signs of potential side effects,
especially:
• Anticholinergic effects – clumsiness or unsteadiness; severe drowsiness;
severe dryness of mouth, nose, or
throat; flushing or
redness of face; shortness of breath or trouble
breathing.
• Blood dyscrasias-sore throat and fever; unusual bleeding
or bruising; unusual tiredness or weakness.
• Fast or irregular heartbeat.
• Psychotic episodes.
• Tightness in chest.
Note: When
anticholinergics are given to patients, especially children, where the
environmental temperature is high there is
a risk of a rapid increase in body
temperature because of suppression of sweat gland activity. Infants, patients with Down’s syndrome,
and
children with spastic paralysis or brain damage may show an increased response
to anticholinergics, thus increasing the potential for
side effects.
Geriatric or debilitated patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion.
The following may
be especially important in patient monitoring (other tests may be warranted in
some patients, depending on conditions):
Blood pressure determination – recommended at frequent intervals during
therapy: Electrocardiogram (ECG) –
monitoring may be required:
Intraocular pressure determination – recommended at
periodic intervals, as these medications may increase the intraocular pressure.
Do not take this product if you are presently taking, or have taken within the preceding two weeks, a prescription drug for high blood pressure or depression without first consulting your physician. Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying.
Combinations containing any or the following medications, depending on the amount present, may also interact with this product:
Antihistamines may interfere with diagnostic test results
for skin tests using allergen extracts. Anticholinergics may
interfere with diagnostic test results for gastric
acid secretion by antagonizing the effect of pantagastrin and histamine,
and
for radionucleotide gastric emptying studies by delaying gastric emptying.
No data is available on the long-term
potential of the components of this product for Carcinogenesis,
Mutagenesis or
Impairment of Fertility in animals or humans.
Use of phenylephrine during labor may cause fetal anoxia and
bradycardia by increasing contractility of the uterus and
decreasing uterine
blood flow.
Small amounts of sympathomimetic amines and antihistamines
are excreted in breast milk; use is not recommended
because of the risk of
adverse effects, such as unusual excitement or irritability in infants. Anticholinergics and
antihistamines may
inhibit lactation.
Use of
antihistamines is not recommended in newborn or premature infants because this
age group has an increased
susceptibility to anticholinergic side effects, such
as CNS excitation, and an increased tendency toward convulsion.
In infants and children, overdosage may cause
hallucinations, convulsions, and death.
A paradoxical reaction characterized
by hyperexcitability may occur in
older children taking antihistamines.
Use is not recommended for children under six years of
age. Infants and young children with
spastic paralysis or brain damage
since an increased response to anticholinergics
are given to children where the environmental temperature because of the
suppression of sweat gland activity. A
paradoxical reaction characterized by hyperexcitability may occur in children
taking
large doses of anticholinergics.
Appropriate studies with phenylephrine have not been performed in the pediatric population.
Confusion, hallucinations, seizures, and CNS depression may
be more likely to occur in geriatric patients taking
sympathomimetic
amines. Geriatric patients may also be
more sensitive to the effects, especially the vasopressor
effects, of
sympathomimetic amines. Confusion,
dizziness, sedation, hypotension, hyperexcitability, and
anticholinergic side
effects, such as dryness of mouth and urinary retention (especially in males),
may be more
likely to occur in geriatric patients taking antihistamines.
Geriatric patients may respond to usual doses of
anticholinergics with excitement, agitation, drowsiness, or confusion.
Geriatric patients are especially susceptible
to the anticholinergic side effects, such as constipation, dryness of the
mouth, and urinary retention (especially in males). If these side effects occur and continue or
are severe, medication
should probably be discontinued.
Caution is also recommended when anticholinergics are given
to geriatric patients, because of the danger of precipitating
undiagnosed
glaucoma. Memory may become severely
impaired in geriatric patients, with the continued use of anticholinergics,
since these drugs block the action of acetylcholine, which is responsible for
many functions of the brain, including memory function.
The following adverse reactions have been observed with the
use of phenylephrine, chlorpheniramine and methscopolamine;
Arrhytmias, blood
dyscrasias, CNS depression, CNS stimulation, dizziness, drowsiness, dryness of
mouth, hallucinations,
hypotension, hypertension, increased sweating, loss of
appetite, paradoxical reaction, restlessness, skin rash, stomach upset
or pain,
thickening of mucus, tingling in hands or feet, trembling, troubled breathing,
unusual tiredness or weakness, vomiting.
Note: Agitation;
confusion; difficult or painful urination; drowsiness; dizziness; and dryness
of mouth, nose and throat are more
likely to occur in the elderly. Nightmares, unusual excitement, nervousness,
restlessness, or irritability are more likely to occur
in children and the
elderly. When anticholinergics are given
to patients, especially children, where the environmental temperature
is high, there
is risk of a rapid increase in body temperature.
Central nervous system stimulants such as phenylephrine have
been abused. At high doses, subjects
commonly experience
an elevation of mood, a sense of increased energy and
alertness, and decreased appetite. Some
individuals become anxious,
irritable and loquacious. In addition to the marked euphoria, the user
experiences a sense of markedly enhanced physical
strength and mental
capacity. With continued use, tolerance
develops, the user increases the dose, and toxic signs and
symptoms
appear. Depression may follow rapid
withdrawal.
Stimulants, such as phenylephrine, are banned and tested for
by the U.S. Olympic Committee (USOC) and the National Collegiate
Athletic
Association (NCAA).
Treatment of acute overdosage would probably be based upon
treating the patient for phenylephrine toxicity which may
manifest itself as
excessive CNS stimulation resulting in excitement, tremor, restlessness, and
insomnia. Other effects
may include
hyperpyrexia, hypertension, mydriasis, hyperglycemia and urinary
retention. Severe hyperkalemia can
occur,
probably due to a compartmental shift.
No organ damage or significant metabolic derangement is associated with
overdosage.
Treatment is symptomatic and supportive with possible
utilization of the following:
• Induction of emesis (syrup of Ipecac recommended); however, precaution
against aspiration is necessary,
especially in
infants and children.
• Gastric lavage (isotonic or 0.45% sodium chloride solution) if patient
is unable to vomit within three
hours of ingestion
• Saline Cathartics (milk of magnesia) may be used.
• Vasopressors to treat hypotension; however epinephrine should
not be used since it may further
lower blood
pressure.
• For excessive hypertensive effect an α-adrenergic blocker, such as
phentolamine, may be administered.
• Hyperpyrexia, especially in children, may require treatment with tepid
water sponge bath.
• Excessive CNS stimulation may be counteracted with parenteral diazepam.
• Oxygen and intravenous fluids.
• Precaution against the use of stimulants (analeptic agents) is
recommended because they may cause
seizures.
• Excitement to a degree which demands attention may be managed with
sodium thiopental 2% solution
given slowly intravenously or chloral hydrate (100-200 mL of a 2%
solution) by rectal infusion.
In severe cases of overdosage it is essential to monitor
both the heart (by electrocardiograph) and plasma
electrolytes, and to give
intravenous potassium as indicated. In the event of progression of the
respiration
should be instituted and maintained until effective respiratory
action returns.
Adults and children 12 years of age and older: 1-2 teaspoonfuls (5-10 mL) every 4 to 6
hours, not to exceed
8 teaspoonfuls in 24 hours.
Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed
4 teaspoonfuls in 24 hours.
DEHISTINE Syrup is not recommended for children under 6 years of age.
Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. Adjust adult dose accordingly.
DEHISTINE Syrup is supplied as a brown, rootbeer flavored
liquid with no sugar and no alcohol in 16 fl oz
(473 mL) bottles, NDC 60258-220-16.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL
OVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Pharmacist: Store at
controlled room temperature, 15°-30°C (59°-86°F). Avoid exposure to heat. Dispense in a tight,
light-resistant container as defined in the USP/NF with a child-resistant closure.
Manufactured for:
Cypress Pharmaceutical, Inc.
Madison, MS 39110
Manufactured by:
Great Southern Laboratories
Houston, TX 77099
I-192
Rev. 01/09
The labeling below represents the labeling currently used.
NDC 60258-220-16
DEHISTINE
Syrup
Each teaspoonful (5 mL) contains:
Phenylephrine hydrochloride .....................10 mg
Chlorpheniramine Maleate.........................2 mg
Methscopolamine Nitrate...........................1.25 mg
SUGAR FREE/ALCOHOL FREE
Rx Only
CYPRESS PHARMACEUTICAL, INC.
16 fl oz (473 mL)
Labeling on Side Panel:
USUAL DOSAGE: Adults and children 12 years of age and older: 1-2 teaspoonfuls (5-10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours. Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in 24 hours. DEHISTINE Syrup is not recommended for children under 6 years of age.
See package insert for full prescribing information.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY
Store at controlled room temperature, 15o-30oC (59o-86oF). Avoid exposure to heat. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
Mfg. by: Great Southern Laboratories, Houston, TX 77099
Mfg. for: Cypress Pharmaceutical, Inc., Madison, MS 39110
L412 Rev. 01/09
DEHISTINE SYRUP
phenylephrine hydrochloride, chlorpheniramine maleate, methscopolamine nitrate liquid |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
unapproved other | 07/24/2009 |
Labeler - Cypress Pharmaceutical, Inc. (790248942) |
Registrant - Great Southern Laboratories (056139553) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Great Southern Laboratories | 056139553 | manufacture |