000758 Chlorpheniramine Maleate

CATEGORIES: Common coldCongestion, nasalRhinitis, perennial allergicRhinitis, seasonal allergicRhinitis, vasomotorPregnancy Category CFDA Approval Pre 1982

FDS Drug Classes: Antihistamines, H1Decongestants, nasal

BRAND NAMES: Balnade C-Nade Chlornade Chlorprophen Lanacaps Condrin-La Cophene-Pl Cpa Deconade Decongen Decongest Decongestant Decongex-3 Dehist Dixade Dristan Ultra Drize Dura-Vent A Eazit Equi-Nade Harber-Nade Hista-Vadrin Histabid Mapesil Neatep Or-Phen-Ade Orabid Oragest-Td Orahist Oraminic Ordrine Ornade Panadyl Forte Parhist Phenade Pleoral Propade Propagen Propanade Resaid Rhinolar Ru-Tuss II Sin-U-Span Triaminic Triphenyl Truxade Vernade Vinade T.D.

FOREIGN BRAND AVAILABILITY:

Dristan Ultra (Colombia)Eazit (Bahrain; Cyprus; Egypt; Iran; Iraq; Jordan; Kuwait; Lebanon; Libya; Oman; Qutar; Republic-of-Yemen; Saudi-Arabia; Syria; United-Arab-Emirates)Mapesil (Ecuador)Pleoral (Peru)Triaminic (India)

DESCRIPTION

This drug is a combination of an oral nasal decongestant and an antihistamine.

Each sustained release capsule contains phenylpropanolamine hydrochloride, 75 mg and chlorpheniramine maleate, 12 mg. Inactive ingredients consist of benzyl alcohol, cetylpyridinium chloride, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6, D&C Red No. 27, D&C Red No. 30, gelatin, glyceryl distearate, iron oxide, polyethylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, starch, sucrose, titanium dioxide, wax and trace amounts of other inactive ingredients.

Each sustained release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period.

Chemically, phenylpropanolamine hydrochloride is Benzenemethanol α-(1-amino-ethyl)-, hydrochloride.

Chemically, chlorpheniramine maleate is 2-p-Chloro-α-[2-(dimethylaminoethyl]benzyl]pyridine maleate (1:1).

CLINICAL PHARMACOLOGY

Phenylpropanolamine Hydrochloride:

Phenylpropanolamine hydrochloride is a sympathomimetic agent which is closely related to ephedrine in chemical structure and pharmacologic action, but produces less central nervous system stimulation than ephedrine. It is a vasoconstrictor with decongestant action on nasal and upper respiratory tract mucosal membranes.

Chlorpheniramine Maleate:

Chlorpheniramine maleate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for H1 cell receptor sites on effector cells.

Pharmacokinetics

A single sustained release capsule produces blood levels comparable to those produced by administration of three 25 mg doses of phenylpropanolamine hydrochloride and three 4 mg doses of chlorpheniramine maleate in conventional release form given at four-hour intervals. At steady-state conditions, the following peak levels are reached after the oral administration of an sustained release capsule: 21 ng/ml chlorpheniramine maleate in 7.7 hours; 173 ng/ml phenylpropanolamine hydrochloride in 6.1 hours; under these circumstances, the half-lives are approximately 21 and 7 hours, respectively.

INDICATIONS AND USAGE

For the treatment of the symptoms of seasonal and perennial allergic rhinitis and vasomotor rhinitis, including nasal obstruction (congestion); also for the treatment of runny nose, sneezing and nasal congestion associated with the common cold.

CONTRAINDICATIONS

Hypersensitivity to either phenylpropanolamine hydrochloride or chlorpheniramine maleate and other antihistamines of similar chemical structure: severe hypertension; coronary artery disease.

This drug should NOT be used in newborn or premature infants.

Because of the higher risk of antihistamines for infants generally, and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

As with any product containing a sympathomimetic, sustained release capsules should NOT be used in patients taking monoamine oxidase (MAO) inhibitors.

WARNINGS

Sustained release capsules may potentiate the effects of alcohol and other CNS depressants. Also, this product should not be taken simultaneously with other products containing phenylpropanolamine hydrochloride or amphetamines.

Sustained release capsules should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder neck obstruction.

Use in Children:

In infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation.

Use in the Elderly

(approximately 60 years or older): Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.

PRECAUTIONS

General:

Use with caution in patients with lower respiratory disease including asthma, hypertension, cardiovascular disease, hyperthyroidism, increased intraocular pressure, or diabetes.

Information for the Patient:

Caution patients about activities requiring alertness (e.g., operating vehicles or machinery). Also caution patients about the possible additive effects of alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.), and not to take simultaneously other products containing phenylpropanolamine hydrochloride or amphetamines. Patients should not take sustained release capsules in conjunction with a monoamine oxidase inhibitor or an oral anticoagulant.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

A long-term oncogenic study in rats with the chlorpheniramine maleate component of sustained release capsules did not produce an increase in the incidence of tumors in the drug-treated groups, as compared with the controls. No evidence of mutagenicity was found when chlorpheniramine maleate was evaluated in a battery of mutagenic studies, including the Ames test.

In an early study in rats with chlorpheniramine maleate a reduction in fertility was observed in female rats at doses approximately 67 times the human dose. More recent studies in rabbits

and rats, using more appropriate methodology and doses up to approximately 50 and 85 times the human dose, showed no reduction in fertility.

There are no studies available which indicate whether phenylpropanolamine hydrochloride has carcinogenic or mutagenic effects or impairs fertility.

Pregnancy, Teratogenic Effects, Pregnancy Category B:

Reproduction studies have been performed with the components of sustained release capsules. Studies with chlorpheniramine maleate in rabbits and rats at doses up to 50 times and 85 times the human dose, respectively, revealed no evidence of harm to the fetus. A study with phenylpropanolamine hydrochloride in rats at doses up to 7 times the human dose revealed no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, sustained release capsules should be used during pregnancy only if clearly needed.

Nonteratogenic Effects:

Studies of chlorpheniramine maleate in rats showed a decrease in the postnatal survival rate of offspring of animals dosed with 33 and 67 times the human dose.

Nursing Mothers:

Small amounts of antihistamines are excreted in breast milk. Because of the higher risk with antihistamines in infants generally, and for newborns and prematures in particular. Sustained release capsules should not be administered to a nursing mother (see CONTRAINDICATIONS.)

Pediatric Use:

The safety and effectiveness of sustained release capsules in children under 12 years of age have not been established.

In infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.

As in adults, antihistamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation. (See WARNINGS.)

DRUG INTERACTIONS

Sustained release capsules may interact with alcohol and other CNS depressants to potentiate their effects.

This product may have additive effects when taken simultaneously with other products containing phenylpropanolamine hydrochloride or amphetamines.

MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and potentiate the pressor effects of sympathomimetics such as phenylpropanolamine hydrochloride (see CONTRAINDICATIONS.)

Phenylpropanolamine hydrochloride should not be used with ganglionic blocking drugs - such as mecamylamine - which potentiate reactions of sympathomimetics. It also should not be used with adrenergic blocking drugs, such as guanethidine sulfate or bethanidine, since it antagonizes the hypotensive action of these drugs.

The action of oral anticoagulants may be inhibited by antihistamines.

The CNS depressant and atropine-like effects of anticholinergics may be potentiated by concomitant administration of antihistamines. Concomitant administration of anticholinergics such as trihexyphenidyl, and other drugs with anticholinergic action (such as imipramine), with antihistamines may result in xerostomia.

β-adrenergic blockers may be antagonized by antihistamines.

Concomitant administration of corticosteroids and antihistamines may decrease the effects of the corticosteroids by enzyme induction.

Antihistamines inhibit norepinephrine reuptake by tissues and therefore potentiate the cardiovascular effects of norepinephrine.

Concomitant use of antihistamines with phenothiazines may produce an additive CNS depressant effect; concomitant use also may cause urinary retention or glaucoma.

ADVERSE REACTIONS

The following adverse reactions have been reported following the use of antihistamines and/or sympathomimetic amines:

General:

Anaphylactic shock; chills; drug rash; excessive dryness of mouth, nose and throat; increased intraocular pressure; excessive perspiration; photosensitivity; urticaria; weakness.

Cardiovascular System:

Angina pain; extrasystoles; headache; hypertension; hypotension; palpitations; tachycardia.

Hematologic:

Agranulocytosis; hemolytic anemia; leukopenia; thrombocytopenia.

Nervous System:

Blurred vision; confusion; convulsions; diplopia; disturbed coordination; dizziness; drowsiness; euphoria; excitation; fatigue; hysteria; insomnia; irritability; acute labyrinthitis; nervousness; neuritis; paresthesia; restlessness; sedation; tinnitus; tremor; vertigo.

GI System:

Abdominal pain; anorexia; constipation; diarrhea; epigastric distress; nausea; vomiting.

GU System:

Dysuria; early menses; urinary frequency; urinary retention.

Respiratory System:

Thickening of bronchial secretions; tightness of chest and wheezing; nasal stuffiness.

OVERDOSAGE

In the event of overdosage, emergency treatment should be started immediately.

Symptoms:

Effects of antihistamine overdosage may vary from central nervous system depression (sedation, apnea, diminished mental alertness, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors, or convulsions) to death.

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). In large doses, sympathomimetics may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure.

Toxicity:

In acute oral toxicity tests in rats, the LD50 for the ratio of 75 mg phenylpropanolamine hydrochloride and 12 mg chlorpheniramine maleate was 774.2 mg/kg; in mice, the LD50 for the formulation was 757.4 mg/kg.

Treatment:

The patient should be induced to vomit even if emesis has occurred spontaneously. Pharmacologically induced vomiting by the administration of ipecac syrup is a preferred method. But vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of 8 to 12 fluid ounces of water. If emesis does not occur within 15 minutes, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in infants and children.

Following emesis, any drug remaining in the stomach may be adsorbed by activated charcoal administered as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Isotonic and one-half isotonic saline are the lavage solutions of choice. Since much of the capsule medication is coated for gradual release, saline cathartics should be administered to hasten evacuation of pellets that have not already released medication. Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and therefore may be valuable for the action in rapid dilution of bowel content. Dialysis has not been reported to be effective in the treatment of phenylpropanolamine hydrochloride and chlorpheniramine maleate overdosage. After emergency treatment, the patient should continue to be medically monitored.

Treatment of the signs and symptoms of overdosage is symptomatic and supportive. Stimulants (analeptic agents) should not be used. Vasopressors may be used to treat hypotension. Short-acting barbiturates, diazepam, or paraldehyde may be administered to control seizures. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or a hypothermic blanket. Apnea is treated with ventilatory support.

DOSAGE AND ADMINISTRATION

Adults And Children 12 Years Of Age And Over:

One capsule every 12 hours.

This drug is not recommended in children under 12.

Capsules should be stored at controlled room temperature (59-86°F).

Chlorpheniramine Maleate

Pronunciation: (klor-fen-AIR-uh-meen MAL-ee-ate)Class: Alkylamine, nonselective Ads by Google

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Trade Names

Aller-Chlor- Tablets 4 mg- Syrup 2 mg per 5 mL

Allergy- Tablets 4 mg

Allergy Relief- Tablets 4 mg

Chlor-Trimeton- Tablets 4 mg

Chlor-Trimeton Allergy 8 Hour- Tablets, extended-release 8 mg

Chlor-Trimeton Allergy 12 Hour- Tablets, extended-release 12 mg

Chlorpheniramine Maleate- Capsules, sustained-release 8 mg- Capsules, sustained-release 12 mg

Chlorpheniramine Maleate- Tablets 4 mg

Chlor-Tripolon (Canada)

Pharmacology

Competitively antagonizes histamine at H 1 receptor sites.

Pharmacokinetics

Absorption

Readily absorbed.

Distribution

72% protein bound.

Metabolism

Metabolized predominantly in the liver, but also in the lung and kidneys.

Elimination

Renally eliminated, mostly as metabolites within 24 h.

Indications and Usage

Temporary relief of sneezing, itchy, watery eyes, itchy nose or throat, and runny nose caused by hay fever (allergic rhinitis), or other respiratory allergies.

Contraindications

Hypersensitivity to antihistamines; narrow-angle glaucoma; stenosing peptic ulcer; symptomatic prostatic hypertrophy; asthmatic attack; bladder neck obstruction; pyloroduodenal obstruction; MAO therapy; use in newborn or premature infants and in breast-feeding mothers.

Dosage and Administration

Immediate-release tablet or syrupAdults and children 12 yr of age and older

PO 4 mg every 4 to 6 h (max, 24 mg/day).

Children 6 to younger than 12 yr of age

PO 2 mg every 4 to 6 h (max, 12 mg/day).

Children younger than 5 yr of age

PO As recommended by health care provider.

Extended-release tabletsAdults and children 12 yr of age and older

PO 8 mg every 8 to 12 h or 12 mg every 12 h (max, 24 mg/day).

Extended-release capsulesAdults and children 12 yr of age and older

PO 8 or 12 mg in the morning and evening (max, 24 mg/day).

General Advice

Administer without regard to meals. Administer with food if GI upset occurs. Measure and administer prescribed dose of oral syrup using dosing syringe, dosing

spoon, or dosing cup. Advise patient receiving extended-release tablets or sustained-release capsules to

swallow tablets or capsules whole and not to crush, chew, break, or open.

Storage/Stability

Store all dose forms at controlled room temperature (59° to 86°F).

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Drug Interactions

Alcohol, CNS depressants, and tricyclic antidepressants

May cause additive CNS depressant effects.

MAOIs

May increase anticholinergic effects of chlorpheniramine.

Ototoxic medications

Concurrent use may mask the symptoms of ototoxicity.

Laboratory Test Interactions

Skin testing procedures

Antihistamines may prevent or diminish otherwise positive reaction to dermal reactivity indicators.

Adverse Reactions

Cardiovascular

Bradycardia; extrasystoles; orthostatic hypotension; palpitations; reflex tachycardia; tachycardia.

CNS

Confusion; convulsions; disturbed coordination; dizziness; drowsiness; euphoria; excitation; faintness; fatigue; headache; hysteria; insomnia; irritability; nervousness; neuritis; paresthesias; restlessness; sedation; tremor; vertigo.

EENT

Acute labyrinthitis; blurred vision; diplopia; dry nose and throat; nasal stuffiness; sore throat; tinnitus.

GI

Anorexia; constipation; diarrhea; dry mouth; epigastric distress; nausea; vomiting.

Genitourinary

Difficult urination; dysuria; early menses; urinary frequency or retention.

Hematologic

Agranulocytosis; hemolytic anemia; thrombocytopenia.

Metabolic

Increased appetite; weight gain.

Respiratory

Chest tightness; respiratory depression; thickening of bronchial secretions; wheezing.

Miscellaneous

Chills; excessive perspiration; hypersensitivity reactions; photosensitivity.

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Precautions

Monitor

Allergy symptoms

Assess allergy symptoms (eg, cough, rhinitis, nasal congestion, sneezing, watery eyes, or itching nose, throat, or eyes) before starting therapy and periodically during therapy. Notify health care provider if symptoms are not improving or are getting worse.

Dizziness/Drowsiness

Monitor patient for dizziness and excessive drowsiness. If noted, hold therapy and notify

health care provider.

Review therapy

Ensure therapy periodically is reviewed to determine if it needs to be continued without change or if a dose change (eg, increase, decrease, discontinuation) is indicated.

Pregnancy

Category C . Do not use during third trimester.

Lactation

Contraindicated in breast-feeding mothers.

Children

Overdosage may cause hallucinations, convulsions, and death. Antihistamines may diminish mental alertness. In young children, they may produce paradoxical excitation. Contraindicated in newborn or premature infants. Sustained-release form not recommended in children younger than 12 yr of age.

Elderly

Use with caution, usually starting at the low end of the dosage range because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Hypersensitivity

May occur. Have epinephrine 1:1,000 immediately available.

Hepatic Function

Use drug with caution in patients with cirrhosis or other liver disease.

Special Risk Patients

Use drug with caution in patients with predisposition to urinary retention, history of bronchial asthma, increased IOP, hyperthyroidism, CV disease, or hypertension. Avoid in patients with sleep apnea.

RESP disease

Generally not recommended to treat lower respiratory tract symptoms, including asthma.

Overdosage

Symptoms

CNS depression (including sedation, apnea, CV collapse), CNS stimulation (including insomnia, hallucination, tremors, convulsions), tinnitus, blurred vision, dizziness, ataxia, hypotension. Stimulation and atropine-like signs and symptoms (including dry mouth, fixed dilated pupils, flushing, hyperthermia, GI symptoms) are more likely in children.

Patient Information

Caution patient using OTC chlorpheniramine that each product has specific dosing instructions and to read package label before using and not to exceed dose or frequency of administration instructions.

Advise patient to take each dose without regard to meals, but to take with food if stomach upset occurs.

Advise patient or caregiver using oral syrup to measure and administer prescribed dose using dosing syringe, dosing spoon, or dosing cup.

Advise patient that if a dose is missed, to take it as soon as possible unless it is nearing time for the next scheduled dose. If it is nearing time for next scheduled dose, advise patient to skip the missed dose and take the next dose at the regularly scheduled time. Caution patient not to double the dose to catch up.

Advise patient that if allergy symptoms are not controlled, not to increase the dose of medication or frequency of use but to inform health care provider. Caution patient that larger doses or more frequent dosing does not increase efficacy and may cause excessive drowsiness or other adverse reactions.

Instruct patient to stop taking drug and immediately report any of these symptoms to health care provider: persistent dizziness; excessive drowsiness; severe dry mouth, nose, or throat; flushing; unexplained shortness of breath or difficulty breathing; unusual tiredness or weakness; sore throat, fever, or other signs of infection; bleeding or unusual bruising; fast or irregular heartbeat; excitability, confusion, or changes in thinking or behavior; chest tightness; difficulty with urination.

Advise patient medication may cause drowsiness or dizziness and not to drive or perform other activities requiring mental alertness until tolerance is determined.

Advise patient to take sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.

Caution patient alcohol and other CNS depressants (eg, sedatives) will have additional sedative effects if taken with chlorpheniramine.

Caution patient not to take any other OTC antihistamines while taking this medication unless advised by health care provider.

Caution patient that medication may cause sensitivity to sunlight and to avoid excessive exposure to the sun or UV light (eg, tanning booths) and to wear protective clothing and use sunscreens until tolerance is determined.

If patient is to have allergy skin testing, advise patient not to take the medication for at least 4 days before the skin testing.

Copyright © 2009 Wolters Kluwer Health.

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Allergic Reactions Cold Symptoms Hay Fever Urticaria

GENERIC NAME: chlorpheniramine and pseudoephedrine

BRAND NAMES: Deconamine and others...(Sudafed and others are pseudoephedrine alone)

DRUG CLASS AND MECHANISM: Deconamine is a brand name medication that contains 2 different drugs, an antihistamine (chlorpheniramine) and a decongestant (pseudoephedrine). The antihistamine effects of chlorpheniramine account for its affect in reducing allergy symptoms. The decongestant action of pseudoephedrine is a result of blood vessel constriction in the nasal air passages, such as in the nose or sinuses.

PRESCRIPTION: yes

GENERIC AVAILABLE: yes

PREPARATIONS: tablets of 4 mg chlorpheniramine/60 mg pseudoephedrine; chew tabs of 1 mg c/15 mg p; syrup of 2 mg c/30 mg p.

STORAGE: Room temperature in a tight container.

PRESCRIBED FOR: Deconamine is used for the temporary relief of runny nose, sneezing, nasal congestion from the common cold. Deconamine is also used for inflamed nasal passages (sinusitis), hay fever (allergic rhinitis) and sinus congestion.

DOSING: Deconamine may be taken with or without food. It must be used cautiously in patients with heart (coronary artery) disease and angina, diabetes, lung diseases, especially asthma, glaucoma, narrowing of the stomach exit (pyloric stenosis).

DRUG INTERACTIONS: Deconamine can cause drowsiness and impaired ability to operate machinery. Deconamine contains pseudoephedrine which should not be taken with MAO inhibitors drugs. Caution must be exercised in the administration of this drug to patients with heart or lung disease. Deconamine should not be combined with other drugs containing pseudoephedrine (such as Sudafed) because of increased risk of side effects on the heart and blood vessels.

While misuse of Deconamine for the purpose of getting "high" is unfamiliar to the editors, it is a specific warning from the manufacturer that patients be aware of possible "additive" effects of Deconamine when taken with alcohol and other central nervous depressants (such as sedatives and tranquilizers). This means that when Deconamine is taken with, for example, alcohol, the effect of the alcohol could be magnified. Conversely, alcohol increases the sedating qualities of Deconamine.

SIDE EFFECTS: Side effects of antihistamines include drowsiness, impaired ability to accurately operate machinery, worsening of glaucoma or asthma or chronic lung diseases, rash, hives, perspiration, chills dry mouth or throat, low blood counts, restlessness, ringing in the ears, stomach upset, urinary frequency or difficulty.

Side effects of pseudoephedrine include stimulation of the nervous system leading to nervousness, restlessness, excitability, dizziness, headache, fear, anxiety, tremor, and even hallucinations and convulsions (seizures).