Chlorphen Mal, Dex HBr, Pseudoeph

Antihistaminic, antitussive, and decongestant actions.

Chlorpheniramine Maleate
Chlorpheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines.

Antihistamines compete with histamine for receptor sites on effector cells. Chlorpheniramine also has mild anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergicresponse (vasodilatation, increased vascular permeability, increased mucus secretion) of nasal tissue. Chlorpheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration reached in 2 to 6 hours in adults. Urinary excretion is the major route of elimination, mostly as products of biodegradation. The liver is assumed to be the main site of metabolic transformation.

Dextromethorphan Hydrobromide
Dextromethorphan hydrobromide is a nonnarcotic antitussive with effectiveness equal to codeine. It acts in the medulla oblongata to elevate the cough threshold. Dextromethorphan does not produce analgesia or induce tolerance, and has no potential for addiction. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration. At usual doses, it will not depress respiration nor inhibit respiratory cilia activity. Dextromethorphan is rapidly metabolized with trace amounts of the parent compound in blood and urine. About one-half of the administered dose is excreted in the urine as conjugated metabolites.

Pseudoephedrine Hydrochloride
Pseudoephedrine hydrochloride is an oralsympathomimetic amine that acts as a decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine, pseudoephedrine has less pressor effect in normotensive adults. The serum half-life in adults for pseudoephedrine is 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. About one-half of the administered dose is excreted in the urine.

This product is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its ingredients, to adrenergic agents, or to other drugs of similar chemical structures.

Do not use in newborn infants, premature infants, in nursing mothers, in patients with severe hypertension, severe coronary artery disease, ischemic heart disease, or in those receiving monoamine oxidase (MAO) inhibitors. Dextromethorphan is contraindicated in use with MAO inhibitors.

This product is contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer, and during an asthma attack.

Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

General
Before prescribing medication to suppress or modify cough, identify and provide therapy for the underlying cause of the cough and take caution that modification of cough does not increase the risk of clinical or physiologic complications. Dextromethorphan should be used with caution in sedated or debilitated patients and in patients confined to supine positions.

Because Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops contains an antihistamine, it should be used with caution in patients with a history of bronchial asthma, narrow-angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction.

Due to its sympathomimetic component, Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

Information for Patients (or Parents)
Patients (or parents) should be warned about engaging in activities requiring mental alertness.

Patients sensitive to antihistamines may experience moderate to severe drowsiness. In mild cases, or in particularly sensitive patients, less frequent doses may be adequate.

Drug Interactions
Do not use this medication in a child who is taking a prescription monoamine oxidase (MAO) inhibitor (certain drugs used for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAO inhibitor drug. Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextrometh- orphan. MAO inhibitor drugs prolong and intensify the anticholinergic effects of antihistamines and enhance the effect of pseudoephedrine HCl.

Sympathomimetic agents may reduce the effects of antihypertensive drugs. The effects of sympathomimetic amines, such as pseudoephedrine, are increased by beta-adrenergic blockers.

Antihistamines may enhance the effects of tricyclic antidepressants, barbiturates, alcohol, and other CNS depressants including hypnotics, sedatives, tranquilizers, and anti-anxiety agents.

The cough suppressant action of dextromethorphan and narcotic antitussives are additive.

Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed to assess the carcinogenic and mutagenic potential of Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops or its effect on fertility.

Pregnancy, Teratogenic Effects – Pregnancy Category C
Animal reproductive studies have not been performed with Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops. It is also not known if it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops should be given to a pregnant woman only if clearly needed.

Nursing Mothers
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops are contraindicated in nursing mothers.

Geriatric Use
The elderly (60 years of age or older) are more likely to exhibit adverse reactions. Caution should be taken when prescribing this drug to the elderly.

Applies to chlorpheniramine / dextromethorphan / pseudoephedrine: oral liquid, oral syrup

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

chlorpheniramine/dextromethorphan/PSE 2 mg-15 mg-15 mg/5 mL oral liquid: 10 mL orally four times daily

chlorpheniramine/dextromethorphan/PSE 4 mg-30 mg-30 mg/5 mL oral suspension, extended release or
chlorpheniramine/dextromethorphan/PSE 6 mg-30 mg-30 mg/5 mL oral suspension, extended release or
chlorpheniramine/dextromethorphan/PSE 5 mg-25 mg-75 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours

chlorpheniramine/dextromethorphan/PSE 2 mg-10 mg-30 mg oral tablet, chewable:
2 tablets orally every 4 to 6 hours not to exceed 4 doses in 24 hours.

chlorpheniramine/dextromethorphan/PSE 2 mg-15 mg-15 mg/5 mL oral liquid:
12 yrs or older: 10 mL orally four times daily
6 yrs to 11 yrs: 5 mL orally four times daily
2 yrs to 5 yrs: 2.5 mL orally four times daily

chlorpheniramine/dextromethorphan/PSE 4 mg-30 mg-30 mg/5 mL oral suspension, extended release or
chlorpheniramine/dextromethorphan/PSE 6 mg-30 mg-30 mg/5 mL oral suspension, extended release or
chlorpheniramine/dextromethorphan/PSE 5 mg-25 mg-75 mg/5 mL oral suspension, extended release:
12 yrs or older: 5 to 10 mL orally every 12 hours
6 yrs to 11 yrs: 2.5 to 5 mL orally every 12 hours
2 yrs to 5 yrs: 2.5 mL orally every 12 hours

chlorpheniramine/dextromethorphan/PSE 0.8 mg-3 mg-9 mg/mL oral liquid:
25 to 36 months: 1 mL orally 4 times a day. Do not exceed 4 doses in a 24 hour period.
13 to 24 months: 0.75 mL orally 4 times a day. Do not exceed 4 doses in a 24 hour period.
6 to 12 months: 0.5 mL orally 4 times a day. Do not exceed 4 doses in a 24 hour period.

chlorpheniramine/dextromethorphan/PSE 2 mg-10 mg-30 mg oral tablet, chewable:
6 yrs to 11 yrs: 1 tablet orally every 4 to 6 hours not to exceed 4 doses in 24 hours.
12 yrs or older: 2 tablets orally every 4 to 6 hours not to exceed 4 doses in 24 hours.

Data not available