WARNINGS
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Nervousness, dizziness or sleeplessness may occur at higher doses.
Hypertensive crises can occur with concurrent
use of pseudoephedrine and MAOI, indomethacin, or with beta blockers and
methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued
immediately and therapy to lower blood pressure should be instituted. Fever
should be managed by means of external cooling.
Do not exceed recommended dosage.
PRECAUTIONS
General:
Before prescribing medication to suppress or modify cough, it is important that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is instituted. Check with physician if cough persists after medication has been used for seven days or if high fever, skin rash, or continued headache, or sore throat is present with cough. Caution should be exercised in patients with
high blood pressure, heart disease, diabetes mellitus, or thyroid disease.
Dextromethorphan should be used with caution in sedated or debilitated
patients, and in patients confined to the supine position. Administration of dextromethorphan
may be accompanied by histamine release and should be used with caution in
atopic children. The antihistamine in Atuss® DS Tannate Suspension may exhibit additive effects with CNS depressants, including alcohol.
Phenylketonurics:
Contains Phenylalanine 25.25 mg. per 5 mL.
Information for Patients:
Patient consultation should include the
following information regarding proper use of
Atuss® DS Tannate Suspension
:
-
Atuss® DS Tannate Suspension
may be taken with food to minimize gastric irritation
.
-
Do not take
MAOI while taking
Atuss® DS Tannate Suspension
.
-
Keep all
medications out of the reach of children. In case of accidental overdose, seek
professional assistance or contact a poison control center immediately.
-
Antihistamines
may impair mental and physical abilities required for the performance of
potentially hazardous tasks, such as driving a vehicle or operating machinery.
Drug Interactions:
-
MAOI and
tricyclic antidepressants may prolong and intensify the anticholinergic
(drying) effects of antihistamines.
-
Beta-adrenergic
blockers and MAOI may potentiate the pressor effect of pseudoephedrine.
-
Concurrent
use of digitalis glycosides may increase the possibility of cardiac
arrhythmias.
-
Sympathomimetics
may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa,
reserpine and veratrum alkaloids.
-
Concurrent
use of tricyclic antidepressants may antagonize the effects of pseudoephedrine.
-
Concomitant
use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and
other CNS depressants may have an additive effect.
Laboratory Test Interactions:
The in vitro addition of pseudoephedrine to sera
containing the cardiac isoenzyme MB of serum creatine phosphokinase
progressively inhibits the activity of the enzyme. The inhibition becomes
complete over six hours.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
No data is available on the long-term potential of the components of Atuss® DS Tannate Suspension for carcinogenesis, mutagenesis or impairment of fertility in animals or humans.
Pregnancy: Category C:
Animal reproduction studies have not been conducted with Atuss® DS Tannate Suspension. It is also not known if Atuss® DS Tannate Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Nursing Mothers:
Pseudoephedrine is excreted in breast milk. Use of Atuss® DS Tannate Suspension by nursing mothers is not recommended because of the higher-than-usual risk for infants from sympathomimetic amines.
Pediatric Use:
Safety and effectiveness of
Atuss® DS Tannate
Suspension
in pediatric patients under the age of two years have not been
established. Pseudoephedrine may be more likely to cause side effects in
infants, especially newborn and premature infants, than in older children and
adults. No age specific problems related to dextromethorphan or
chlorpheniramine have been documented in the pediatric population to date.
Demonstrate safe use of a short-acting sympathomimetic amine before use of a
sustained-action formulation in pediatric patients.
Geriatric Use: (Ages 65 and older)
Geriatric patients taking sympathomimetics may be more likely to experience confusion, hallucinations, seizures, and central nervous system depression. Geriatric patients may also be more sensitive to the effects, especially to the vasopressor effects, of sympathomimetic amines. Demonstrate safe use of a short-acting sympathomimetic formulation before use of a sustained-action formulation in elderly patients.
WARNINGS:
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.
Manufactured for:
Atley Pharmaceuticals, Inc.
Ashland, VA 23005
U.S. Patent's # 6,869,618 # 7,094,429
PIN 400425 ISS. 10/09 Rx Only
© 2007 Atley Pharmaceuticals, Inc. All Rights Reserved
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