pseudoephedrine hydrochloride and chlorpheniramine maleate
Dosage Form: tablet, chewable
Sudal® 12 TANNATE CHEWABLE PSEUDOEPHEDRINE HCL - CHLORPHENIRAMINE MALEATE
DESCRIPTION:
Each Sudal®-12 Tannate Chewable tablet contains: 30 mg of pseudoephedrine hydrochloride and 4 mg of chlorpheniramine maleate. Sudal®-12 Tannate Chewable tablets are used for oral administration only. Sudal®-12 Tannate Chewable tablets contain the following inactive ingredients: Acesulfame K, Aluminum Lake Blue #2, Aspartame, Avicel, Bitter Mask, Calcium Phosphate Dibasic, Carmine Red, Citric Acid, Corn Starch, DI-PAC, Grape Flavor, Hypromelose, Magnasweet, Magnesium Aluminometasilicate, Magnesium Stearate, Mannitol, Purified Water, Sucralose, Talc, Tannic Acid, Vanilla Flavor and Xanthan Gum.
Pseudoephedrine hydrochloride: [S(R*,R*)]-α-[1-(methylamino)ethyl] benzenemethanol hydrochloride.
Chlorpheniramine maleate: 2-[p-chloro-α-[2-(dimethylamino) ethyl]-benzyl] pyridine.
CLINICAL PHARMACOLOGY:
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. It has a plasma half-life of 6 to 8 hours. 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 Sudal®-12 Tannate Chewable tablets 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.
INDICATIONS AND USAGE:
Sudal®-12 Tannate Chewable tablets are indicated for temporary relief of symptoms associated with seasonal and perennial allergic rhinitis, cold and sinusitis, including rhinorrhea, sneezing and nasal congestion.
CONTRAINDICATIONS:
Sudal®-12 Tannate Chewable tablets are contraindicated in patients with hypersensitivity to antihistamines or sympathomimetic amines, nursing mothers and patients receiving monoamine oxidase inhibitor (MAOI) therapy (see Drug Interactions section). Sympathomimetic amines are contraindicated in patients with severe hypertension or severe coronary artery disease and patients that are taking a prescription MAOI (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug.
WARNINGS:
Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism and prostatic hypertrophy. Sympathomimetics may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Nervousness, dizziness or sleeplessness may occur at higher doses. Alkylamine-type antihistamines should be used with extreme caution in patients with narrow angle glaucoma; stenosing peptic ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy, or bladder neck obstruction. Due to its mild atropine-like action, chlorpheniramine should be used cautiously in patients with bronchial asthma, emphysema, or chronic pulmonary disease. May cause excitability, especially in children. Do not exceed recommended dosage.
PRECAUTIONS:
General:
Caution should be exercised in patients with high blood pressure, heart disease, diabetes mellitus, or thyroid disease. The antihistamine in Sudal®-12 Tannate Chewable tablets may exhibit additive effects with CNS depressants, including alcohol. Phenylketonurics: contains Phenylalanine 25 mg per chewable tablet.
Information for Patients:
- Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.
- Patients should also be warned about possible additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers).
Drug Interactions:
- MAOIs and tricyclic antidepressants may prolong and intensify the anticholinergic (drying) effects of antihistamines.
- Beta-adrenergic blockers and MAOIs.
- 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 Sudal®-12 Tannate Chewable tablets for carcinogenesis, mutagenesis or impairment of fertility in animals or humans.
Pregnancy: Category C:
Animal reproduction studies have not been conducted with components of Sudal®-12 Tannate Chewable tablets. It is also not known whether Sudal®-12 Tannate Chewable tablets 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 Sudal®-12 Tannate Chewable tablets by nursing mothers is contraindicated because of the higher-than-usual risk for infants from sympathomimetic amines.
Pediatric Use:
Safety and effectiveness of Sudal®-12 Tannate Chewable tablets in pediatric patients under age two 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. 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 CNS 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.
ADVERSE REACTIONS:
Pseudoephedrine may cause mild CNS 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. Sympathomimetic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias and cardiovascular collapse with hypotension. Chlorpheniramine may cause slight to moderate drowsiness and is the most frequent side effect. Other possible side effects of antihistamines include:
General:
Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat;
Cardiovascular:
Hypotension, headache,palpitation, tachycardia, extra systoles;
Hematological:
Hemolytic anemia, thrombocytopenia, agranulocytosis;
CNS:
Sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, hysteria, neuritis, convulsion;
Gastrointestinal:
Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation;
Genitourinary:
Urinary frequency, difficult urination, urinary retention, early menses;
Respiratory:
Thickening of bronchial secretions, tightness of chest, wheezing and nasal stuffiness.
DRUG ABUSE AND DEPENDENCE:
Pseudoephedrine, like other CNS stimulants, has 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. Narcotic antitussives and stimulants, such as pseudoephedrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).
OVERDOSE:
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).
Treatment:
In the event of overdosage, emergency treatment should be started immediately. Since the action of long- acting products may continue for as long as 18 hours, treatment of overdosage should be directed toward reducing further absorption and supporting the patient for at least that length of time. Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. Either isotonic or half-isotonic saline may be used for lavage. Administration of an activated charcoal slurry is beneficial after lavage and/or emesis if less than four hours have passed since ingestion. Saline cathartics, such as Milk of Magnesia, are useful for hastening the evacuation of unreleased medication. Adrenergic Receptor-blocking agents are antidotes to pseudoephedrine. In practice, the most useful is the beta-blocker propanolol, which is indicated when there are signs of cardiac toxicity. 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. Vasopressors may be used to treat hypotension. Excessive CNS stimulation may be counteracted with parenteral diazepam. Stimulants should not be used. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or a hyperthermic blanket. Apnea is treated with ventilatory support.
DOSAGE AND ADMINISTRATION:
Adults and children over age 12: 1 — 2 tablets every 12 hours.
Children ages 6 to 12: 1/2 — 1 tablet every 12 hours.
Children ages 2 to 6: 1/2 tablet every 12 hours.
Children under age 2: As directed by a physician.
HOW SUPPLIED:
Sudal®-12 Tannate Chewable tablets are supplied as a purple, grape-flavored tablet embossed "S / 12" on one side and "4 / 30" on the other. Available in sample bins of 20 pouches, containing one tablet each, NDC 59702-819-05, and in bottles of 100, NDC 59702-819-01.
STORAGE AND HANDLING:
Dispense in a well closed, light-resistant container.
Store at controlled room temperature, 20° — 25°C (68° — 77°F).
REPRESENTATIVE PACKAGING
See How Supplied section for a complete list of available packages of Sudal® 12 Tannate Chewable
NDC 59702-819-01
Sudal® 12
TANNATE CHEWABLE
PSEUDOEPHEDRINE HCL - CHLORPHENIRAMINE MALEATE
NEW FORMULATION
Decongestant - Antihistamine
Pseudoephedrine HCL..........30 mg
Chlorpheniramine Maleate......4 mg
Atley
Rx Only
100 Tablets
Store at controlled room temperature betwee 20° — 25°C (68° — 77°F) (see USP).
WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Rx Only
Manufactured for:
Atley Pharmaceuticals, Inc.
Ashland, VA 23005
Utilizing: TANNATE CONVERSION TECHNOLOGY(TM)
4004?? REV 11/06
USUAL DOSAGE:
Adults and children over age 12: 1 — 2 tablets every 12 hours.
Children ages 6 to 12: 1/2 — 1 tablet every 12 hours.
Children ages 2 to 6: 1/2 tablet every 12 hours.
Children under age 2: As directed by a physician.
For full prescribing information, see attached product literature.
Pharmacist: Dispense well closed, light-resistant container.
| Sudal 12 Tannate Chewable pseudoephedine hydrochloride chlorpheniramine maleate tablet, chewable | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 03/01/2007 | 09/01/2010 | |
| Labeler - Atley Pharmaceuticals, Inc. (928666536) |
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