CHLORPHEN MAL DEX HBR PSEUDOEPH HCL
-
chlorpheniramine maleate,
pseudoephedrine hydrochloride and
dextromethorphan hydrobromide solution/ drops
River's Edge Pharmaceuticals
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Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg DropsDESCRIPTION
Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops is an antihistaminic, antitussive, and decongestant drop for oral administration.Each dropperful (1 mL) contains:
Chlorpheniramine Maleate, USP .............. 0.8 mg
Dextromethorphan HBr, USP ..................... 3 mg
Pseudoephedrine HCl, USP ........................ 9 mg
Inactive Ingredients
Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, Grape Flavor, FDC Blue #1, FDC Red #40, Purified Water.
Chlorpheniramine maleate is an antihistamine having the chemical name, 2-[p-Chloro- -[2-(dimethylamino)ethyl]benzyl]pyridine maleate(1:1).
Dextromethorphan hydrobromide is an antitussive having the chemical name, (Morphinan,3-methoxy-17-methyl-,(9,13 ,14 )-,hydrobromide, monohydrate).
Pseudoephedrine hydrochloride is a decongestant having the chemical name, (Benzenemethanol,-[1-(methylamino)ethyl]-, [S-(R*,R*)]-,hydrochloride).
CLINICAL PHARMACOLOGY
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.
INDICATIONS AND USAGE
Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops is indicated for symptomatic relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.CONTRAINDICATIONS
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.
WARNINGS
Antihistamines may diminish mental alertness, and may cause hyperexcitability, especially in children.At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed the recommended dosage.
Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.
Do not give this product to children who have a chronic pulmonary disease, breathing problems such as chronic bronchitis, glaucoma, or those who are taking sedatives or tranquilizers without first consulting with a doctor.
Considerable caution should be exercised in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure, renal impairment, and prostatic hypertrophy.
Do not give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
PRECAUTIONS
GeneralBefore 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.
ADVERSE REACTIONS
The most frequent adverse reactions to Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops include: sedation; drowsiness; dryness of mouth, nose, and throat; thickening of bronchial secretions; and dizziness.Other adverse reactions may include:
Dermatologic – urticaria, drug rash, photosensitivity, pruritus.
Cardiovascular System – hypotension, hypertension, cardiac arrhythmias, palpitation.
Central Nervous System (CNS) – disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria.
G.U. System – urinary frequency, difficult urination.
G.I. System – epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.
Respiratory System – tightness of chest and wheezing, shortness of breath.
Hematologic System – hemolytic anemia, thrombocytopenia, agranulocytosis.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
OVERDOSAGE
The definition of overdose has not been established for Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops. Individuals may exhibit overdose signs and symptoms to a range of administered doses.Signs and Symptoms
Potential toxic effects following acute overdosage with dextromethorphan are rare. Manifestations following acute overdosage have included nausea, vomiting, drowsiness,dizziness, blurred vision, ataxia, shallow respirations, and stupor.
Acute overdosage with antihistamines results primarily in central nervous system effects. In the small child, predominate symptoms are excitation, hallucination, ataxia, incoordination, tremors, flushed face and fever. Convulsions,fixed and dilated pupils, coma and death may occur in severe cases.
Acute overdosage with sympathomimetics include central nervous system effects such as restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmia, hypertension with subsequent hypotension and circulatory collapse.
Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea and abdominal cramps.
Treatment
In the event of overdose, induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Gastric lavage may be carried out. Precautions against aspiration must be taken, especially in infants and small children. For CNS hyperactivity or convulsive seizures, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids and other supportivemeasures should be used as indicated.
DOSAGE AND ADMINISTRATION
| AGE | DOSE* | FREQUENCY |
| 6-12 months: | 1/2 dropperful (1/2 mL) | QID (4 times a day) |
| 12-24 months: | 3/4 dropperful (3/4 mL) | QID (4 times a day) |
| 24-36 months: | 1 dropperful (1 mL) | QID (4 times a day) |
Do not exceed 4 doses during a 24-hour period.
*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.
HOW SUPPLIED
Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops is a purple, grape-flavored, sugar free, alcohol free solution for use with a calibrated, shatterproof dropper(enclosed in each carton).Each 1 mL contains Chlorpheniramine Maleate, USP, 0.8 mg; Dextromethorphan HBr, USP, 3 mg; and Pseudoephedrine HCl, USP, 9 mg.
NDC No.: 68032-458-01 ... 1 fl oz (30 mL) bottles
WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Tamper Evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispense in a tight, light-resistant container as defined in the USP.
Manufactured for:
River’s Edge Pharmaceuticals LLC.
Suwanee, GA 30024
Rev. 10/09 458-10
PACKAGING
| CHLORPHEN MAL DEX HBR PSEUDOEPH HCL
chlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride solution/ drops |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 02/15/2010 | 01/31/2011 | |
| Labeler - River's Edge Pharmaceuticals (133879135) |