Prescription Drug Information: Rescon MX

RESCON MX — phenylephrine hydrochloride and dexchlorpheniramine maleate tablet, multilayer, extended release
Capellon Pharmaceuticals, LLC

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DESCRIPTION

Each long-acting tablet contains:

Phenylephrine Hydrochloride ….. 40 mg

Dexchlorpheniramine Maleate ….. 6 mg

Phenylephrine HCI is a sympathomimetic amine with the chemical structure: Benzenemethanol, 3- hydroxy-a-[(methylamino)methyl]- hydrochloride. It has a molecular weight of 203.67, a molecular formula of C9 H13 NO2 • HCI and the following structural formula:

fbe45a86-figure-01

C9 H13 NO2 • HCI M.W. 203.67

Dexchlorpheniramine Maleate is an antihistamine with the chemical structure: (+)-2-[p-Chloro-_-[2-(dimethylamino) ethyl]benzyl]pyridine maleate (1:1). It has a molecular weight of 390.86, a molecular formula of C16 H19 CIN2 • C4 H4 O4 and the following structural formula:

fbe45a86-figure-02

C16 H19 CIN2 • C4 H4 O4 M.W. 390.86

INACTIVE INGREDIENT

Calcium phosphate, hydrogenated vegetable oil, magnesium stearate, methylcellulose, povidone, stearic acid and green dye.

CLINICAL PHARMACOLOGY

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 is 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.

CONTRAINDICATIONS

This product is contraindicated in women who are pregnant or nursing. This product is contraindicated in children under twelve 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.

WARNINGS

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.

PRECAUTIONS

General

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:

• Do not take more medication than the amount recommended.

• May be taken with or without food; can be taken with food, a glass of water or milk to lessen stomach irritation if necessary.

• 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.

• If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose: not doubling doses.

• This medication should be stored in a tight, light-resistant container at temperatures between 20°- 25°C (68°-77°F), see USP Controlled Room Temperature. Avoid exposure to heat.

• Keep all medications out of the 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 troubled breathing.

• Blood dyscrasias — sore throat and fever; unusual bleeding or bruising; unusual tiredness or weakness.

• Fast or irregular heartbeat.

• Psychotic episodes.

• Tightness in chest.

Laboratory Tests

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.

Drug Interactions

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:

• α-adrenergic blocking agents or other medications with α- adrenergic blocking action — prior administration of α-adrenergics may block the pressor response to phenylephrine, possibly resulting in severe hypotension; medications with α- adrenergic blocking action may decrease the pressor effect and shorten the duration of action of phenylephrine.

• Anesthetics, hydrocarbon inhalation- Concurrent use of chloroform, cyclopropane, halothane, or trichloroethylene with phenylephrine may increase the risk of severe ventricular arrhythmias because these anesthetics greatly sensitize the myocardium to the effects of sympathomimetic amines; phenylephrine should be used with caution and in substantially reduced dosage in patients receiving these anesthetics.

Enflurane, isoflurane, or methoxyflurane may also cause some sensitization of the myocardium to the effects of sympathomimetic amines.

• Anesthetics, parenteral-local — Phenylephrine should be used cautiously and in carefully circumscribed quantities, if at all, with local anesthetics for anesthetizing areas with end arteries (such as the fingers, toes, or penis) or otherwise compromised blood supply; ischemia leading to gangrene may result.

• Anticholinergics — Concurrent use with anticholinergics may intensify anticholinergic effects; patients should be advised to report occurrence of gastrointestinal problems promptly since paralytic ileus may occur with concurrent therapy.

• Antidepressants, tricyclic or maprotiline — Concurrent use may potentiate the cardiovascular effects of phenylephrine, possibly resulting in arrhythmias, tachycardia, or severe hypertension or hyperpyrexia.

• Antihypertensives, or diuretics used as — Antihypertensive effects may be reduced when these medications are used concurrently with phenylephrine; the patient should be carefully monitored to confirm that the desired effect is being obtained.

• β-adrenergic blocking agents — Therapeutic effects may be inhibited when these medications are used concurrently with phenylephrine, especially larger doses; also, β-adrenergic blockade may result in unopposed α-adrenergic activity with a risk of hypertension and excessive bradycardia with possible heart block.

• CNS Depressants – Concurrent use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect.

• Cocaine, mucosal-local — Concurrent use with phenylephrine may increase the cardiovascular effects of either or both medications and the risk of adverse side effects.

• Digitalis glycosides – Concurrent use with phenylephrine may increase the risk of cardiac arrhythmias; caution and ECG monitoring are necessary if concurrent use is required.

• Ergoloid mesylates or Ergotamine — Concurrent ergoloid mesylates or ergotamine with phenylephrine may produce peripheral vascular ischemia and gangrene and is not recommended. Concurrent use of ergotamine with phenylephrine may potentiate the pressor effect of phenylephrine, resulting in possible severe hypertension and rupture of cerebral blood vessels.

• Doxapram — Concurrent use may increase the pressor effects of either doxapram or phenylephrine.

• Ketoconazole – Anticholinergics may increase gastrointestinal pH, possibly resulting in a marked reduction in ketoconazole absorption during concurrent use with anticholinergics; patients should be advised to take these medications at least 2 hours after ketoconazole.

• Methyldopa — In addition to possibly decreasing the hypotensive effects of these medications, concurrent use may enhance the pressor response to phenylephrine; caution is required with very small initial doses of methyldopa being administered.

• MAO inhibitors — Concurrent use may prolong and intensify cardiac stimulant and vasopressor effects of phenylephrine and dexchlorpheniramine, resulting in headache, cardiac arrhythmias, vomiting or sudden and severe hypertensive and/or hyperpyretic crises. These medications should not be administered during or within 14 days following the administration of MAO inhibitor therapy.

• Potassium chloride – Concurrent use with anticholinergics may increase the severity of potassium chloride-induced gastrointestinal lesions.

• Rauwolfia alkaloids – Concurrent use may prolong the direct-acting sympathomimetic amines by preventing the uptake into storage granules.

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.

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