Atuss DS Tannate Suspension

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Overview

What is Atuss DS Tannate Suspension?

Each teaspoonful (5 mL) of contains:

Dextromethorphan Hydrobromide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 mg

Pseudoephedrine Hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 mg

Chlorpheniramine Maleate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . 4 mg

Atuss® DS Tannate Suspension

is used for oral administration only.

Atuss® DS Tannate Suspension

contains the following inactive ingredients:

Acesulfame K, Artificial Bubblegum Flavor, Artificial Grape Flavor, Aspartame, Bitter Mask, Citric Acid, FDC Blue #1, FDC Red #40,

Glycerin, Hydrochloric Acid, Methylparaben, Magnesium Aluminometasilicate, Purified Water, Sodium Citrate Dihydrate, Sodium Hydroxide, Sucralose, Xanthan Gum. Plus tannic acid yielding a tannate suspension.

Dextromethorphan Hydrobromide:

3-Methoxy-17-methyl-9α, 13α, 14α-morphinan.

Pseudoephedrine Hydrochloride:

[S(R*, R*)]- α -[1-(methylamino)ethyl] benzenemethanol hydrochloride.

Chlorpheniramine Maleate:

2-[p-chloro- α -[2-(dimethylamino) ethyl]-benzyl] pyridine.

What does Atuss DS Tannate Suspension look like?

What are the available doses of Atuss DS Tannate Suspension?

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What should I talk to my health care provider before I take Atuss DS Tannate Suspension?

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How should I use Atuss DS Tannate Suspension?

Atuss® DS Tannate Suspension

Atuss® DS Tannate Suspension

Adults and children over age 12

Children ages 6 to 12

Children ages 2 to 6

Children under age 2

Shake well before use.

Note

: The hydrobromide salt of dextromethorphan, the hydrochloride salt of pseudoephedrine, and the maleate salt of chlorpheniramine are provided in a tannate suspension by means of the TCT manufacturing process. This yields a corresponding 60 mg of dextromethorphan tannate, 60 mg of pseudoephedrine tannate, and 8 mg of chlorpheniramine tannate.

What interacts with Atuss DS Tannate Suspension?

Atuss® DS Tannate Suspension

What are the warnings of Atuss DS Tannate Suspension?

Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing. All concentrates of glycerinated allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death. An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection. When switching patients to a new lot of the same extract the initial dose should be reduced 3/4 so that 25% of previous dose is administered.

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.

What are the precautions of Atuss DS Tannate Suspension?

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. The antihistamine in 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

:

Array

Drug Interactions:

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 for carcinogenesis, mutagenesis or impairment of fertility in animals or humans.

Pregnancy: Category C:

Animal reproduction studies have not been conducted with . 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 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.

What are the side effects of Atuss DS Tannate Suspension?

Pseudoephedrine may cause mild central nervous system stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs. Nervousness, excitability, restlessness, dizziness, weakness and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause lightheadedness, nausea and/or vomiting. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Adverse effects associated with dextromethorphan are generally infrequent and mild. Products containing dextromethorphan have been associated with nausea, dizziness, fatigue, gastrointestinal disturbances, and skin eruptions.

Chlorpheniramine may cause slight to moderate drowsiness and is the most frequent side effect. Other possible side effects of antihistamines include:

General

Cardiovascular

Hematological

CNS

Gastrointestinal

Genitourinary

Respiratory

What should I look out for while using Atuss DS Tannate Suspension?

Atuss® DS Tannate Suspension

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.

What might happen if I take too much Atuss DS Tannate Suspension?

Overdosage with pseudoephedrine may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness and insomnia. Other effects may include tachycardia, hypertension, pallor, mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, convulsions or delirium, but in some individuals there may be CNS depression with somnolence, stupor or respiratory depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather than a depletion of potassium. No organ damage or significant metabolic derangement is associated with pseudoephedrine overdosage. Manifestations of antihistamine overdosage may vary from CNS depression (sedation, apnea, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors or convulsions). Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision, and hypotension. Stimulation is particularly likely in children, as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; hyperthermia and gastrointestinal symptoms).

How should I store and handle Atuss DS Tannate Suspension?

Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F). See USP Controlled Room Temperature. Protect from light and moisture.Atuss® DS Tannate Suspension is a grape bubblegum flavored suspension. Available in 16 fl. oz. (473 mL) NDC 59702-800-16 and 1/2 fl. oz. (15 mL) NDC 59702-800-15.Atuss® DS Tannate Suspension is a grape bubblegum flavored suspension. Available in 16 fl. oz. (473 mL) NDC 59702-800-16 and 1/2 fl. oz. (15 mL) NDC 59702-800-15.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Dextromethorphan is an antitussive agent which, unlike the isomeric levorphanol, has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage, dextromethorphan does not inhibit ciliary activity. Dextromethorphan is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine

Pseudoephedrine is an α-adrenergic receptor antagonist (sympathomimetic) which produces vasoconstriction by stimulating α-receptors within the mucosa of the respiratory tract. Clinically, pseudoephedrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway patency. The vasoconstriction action of pseudoephedrine is similar to that of ephedrine. In the usual dose it has minimal vasopressor effects. Pseudoephedrine is rapidly and almost completely absorbed from the gastrointestinal tract. Acidic urine is associated with faster elimination of the drug. The drug is distributed to body tissues and fluids, including the fetal tissue, breast milk and the central nervous system (CNS).

Chlorpheniramine is an alkylamine-type antihistamine. The antihistamine in acts by competing with histamine for H1 histamine receptor sites, thereby preventing the action of histamine on the cell. Clinically, chlorpheniramine suppresses the histamine-mediated symptoms of allergic rhinitis, relieving sneezing, rhinorrhea, and itching of the eyes, nose, and throat.

Non-Clinical Toxicology

Atuss® DS Tannate Suspension

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.

Pseudoephedrine may cause mild central nervous system stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs. Nervousness, excitability, restlessness, dizziness, weakness and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause lightheadedness, nausea and/or vomiting. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Adverse effects associated with dextromethorphan are generally infrequent and mild. Products containing dextromethorphan have been associated with nausea, dizziness, fatigue, gastrointestinal disturbances, and skin eruptions.

Chlorpheniramine may cause slight to moderate drowsiness and is the most frequent side effect. Other possible side effects of antihistamines include:

General

Cardiovascular

Hematological

CNS

Gastrointestinal

Genitourinary

Respiratory

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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