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phenylephrine hydrochloride and
dexchlorpheniramine maleate tablet, multilayer, extended release
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Nasal Decongestant / Antihistamine, sustained-release tablets for oral administration.
Each RESCON-Jr.® tablet contains:
Phenylephrine Hydrochloride 20 mg
Dexchlorpheniramine Maleate 3 mg
Phenylephrine HCI is a sympathomimetic amine with the chemical structure: Benzenemethanol, 3- hydroxy-α- [(methylamino)methyl]- hydrochloride.
C9H13NO2 • HCI M.W. 203.67
Dexchlorpheniramine Maleate is an antihistamine with the chemical structure: (+)-2-[p-Chloro-α- [2-(dimethylamino) ethyl]benzyl] pyridine maleate (1:1)
C16H19CIN2 • C4H4O4 M.W. 390.86
calcium phosphate dibasic, D&C Yellow #10, magnesium stearate (veg.), methylcellulose, povidone, and silicified microcrystalline cellulose.
Phenylephrine Hydrochloride is a sympathomimetic amine, which acts directly on α-adrenergic receptors in the mucosa of the respiratory tract to produce vasoconstriction that increases peripheral resistance, resulting in an increase in both systolic and diastolic blood pressure. Accompanying the pressor response is a marked reflex bradycardia due to increased vagal activity. It produces vasoconstriction that lasts longer than that produced by ephedrine and epinephrine, and in therapeutic doses, produces little or no central nervous system (CNS) stimulation. Phenylephrine has reduced bioavailability from the gastrointestinal tract because of first pass metabolism by monoamine oxidase in the stomach and liver.
Dexchlorpheniramine Maleate is the dextro-isomer of the racemic compound chlorpheniramine maleate. In vitro and in vivo assays of the antihistamine potencies of the optically active isomers of chlorpheniramine demonstrate that the predominant activity is in the dextro-isomer. The dextro-isomer is approximately two times more active than the racemic compound. Dexchlorpheniramine maleate competitively antagonizes most of the smooth muscle stimulating actions of histamine on the H1 receptors of the GI tract, uterus, large blood vessels, and bronchial muscle. It also antagonizes the action of histamine that results in increased capillary permeability and the formation of edema. Dexchlorpheniramine maleate is an alkylamine-type antihistamine. This group of antihistamines is among the most active histamine antagonists and are generally effective in relatively low doses. They thereby prevent, but do not reverse, responses mediated by histamine alone. The anticholinergic actions of most antihistamines provide a drying effect on the nasal mucosa. These drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use, but a significant proportion of patients do experience this effect.
INDICATIONS AND USAGE
This 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 dexchlorpheniramine maleate decreases the symptoms of watering eyes, post-nasal drip, and sneezing.
This product is 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 dexchlorpheniramine maleate. Geriatric patients may be more sensitive to the effects of this medication. Risk-benefit should be considered when the following conditions exist:
Sensitivity to phenylephrine or dexchlorpheniramine; Acute asthma; Bladder neck obstruction; Brain damage in children; Cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary artery disease, and mitralstenosis; Cardiovascular disease; Diabetes mellitus; Down’s Syndrome; Esophagitis, reflux; 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; Uropathy; 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. Sympathomimetic amines in overdosage may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage. Antihistamines should be used with considerable caution in pyloroduodenal obstruction; symptomatic prostatic hypertrophy; bladder neck obstruction. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage.
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.
Information for Patients
Patient consultation should include the following information regarding proper use of this medication:
Caution patients about the signs of potential side effects, especially:
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 without first consulting your physician. Combinations containing any of the following medications, depending on the amount present, may also interact with this product:
DRUG & OR LABORATORY TEST INTERACTIONS
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 pentagastrin and histamine, and for radio nucleotide gastric emptying studies by delaying gastric emptying.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No data are available on the long term potential of the components of this product for carcinogenesis, mutagenesis or impairment of fertility in animals or humans.
Pregnancy: Category C: Reproduction studies have been performed with chlorpheniramine maleate. Studies in rabbits and rats at doses up to 50 times and 85 times the human dose revealed no evidence of harm to the fetus. There are, however, no adequate and well controlled studies in pregnant women. Therefore, it is not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with phenylephrine. This product should be given to a pregnant woman only if clearly needed.
Labor and Delivery
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. Appropriate studies with phenylephrine have not been performed in the pediatric population; however, no pediatric specific problems have been documented to date.
Confusion, hallucinations, seizures and CNS depression may be more likely to occur in geriatric patients taking sympathomimetic amines. Geriatric patients also may 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 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, especially those who already have memory problems, 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 and dexchlorpheniramine: Arrhythmias, blood dyscrasias, CNS depression, CNS stimulation, dizziness, drowsiness, dryness of mouth, hallucinations, hypotension, hypertension, increased sensitivity of skin to sun, 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 or 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.
DRUG ABUSE AND DEPENDENCE
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 US Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).
This product is comprised of pharmacologically different components (sympathomimetic amine, and antihistamine). Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual. Reaction to an overdose of this product may vary from CNS depression to stimulation. A description of symptoms which are likely to appear after ingestion of an excess of the individual components follows:
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 overdosage may cause tachypnea or hyperpnea, convulsions or delirium, but in some individuals there may be CNS depression with somnolence, stupor, or respiratory depression. Arrhythmias 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 overdosage.
General Treatment: Treatment is symptomatic and supportive with possible utilization of the following:
DOSAGE AND ADMINISTRATION
Adults and adolescents 12 years of age and older: 1 or 2 tablets every 12 hours as directed by a physician.
Children 6 to 12 years of age: 1 tablet every 12 hours as directed by a physician.
Not recommended for children under 6 years of age. Do not crush or chew tablets prior to swallowing.
Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. Adjust adult dose accordingly.
Supplied as yellow & white, bilayered, capsule-shaped tablets debossed “RES JR” on one side and scored on the opposite. Available in bottles of 90 tablets, NDC 64543-084-90, and sample packs of 2 tablets, NDC 64543-084-02.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Storage and Handling
Dispense in tight, light resistant containers as defined in the USP/NF, with child resistant closures. Store at controlled room temperature between 20°- 25°C (68°- 77°F); see USP Controlled Room Temperature. Avoid exposure to heat.
Call Your Doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Revised: 01/2010 Capellon Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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