Chlorphen Mal, Pseudoeph HCl
Name: Chlorphen Mal, Pseudoeph HCl
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Chlorphen Mal, Pseudoeph HCl - Clinical Pharmacology
Antihistaminic 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 allergic response (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.
Pseudoephedrine Hydrochloride
Pseudoephedrine hydrochloride is an oral sympathomimetic 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.
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 allergic response (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.
Pseudoephedrine Hydrochloride
Pseudoephedrine hydrochloride is an oral sympathomimetic 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.
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.
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.
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.
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.
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.
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.
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.
Precautions
General
Because Chlorphen Mal/Pseudoeph HCl 0.8/9 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/Pseudoeph HCl 0.8/9 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. MAO inhibitor drugs prolong and intensify the anticholinergic effects of antihistamines. (MAO) inhibitor drugs may enhance the effect of pseudoephedrine HCl.
Sympathomimetic agents may reduce the effects of antihypertensive drugs. The effects of sympathomimetic amines, such a pseudoephedrine, are increased by beta-adrenergic blockers.
Antihistamines have additive effects with alcohol and other CNS (Central Nervous System) depressants such as hypnotics, sedatives, tranquilizers, and anti-anxiety agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed to assess the carcinogenic and mutagenic potential of Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Drops or its effect on fertility.
Pregnancy,Teratogenic Effects –Pregnancy Category C
Animal reproductive studies have not been performed with Chlorphen Mal/Pseudoeph HCl 0.8/9 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/Pseudoeph HCl 0.8/9 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/Pseudoeph HCl 0.8/9 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.
Because Chlorphen Mal/Pseudoeph HCl 0.8/9 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/Pseudoeph HCl 0.8/9 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. MAO inhibitor drugs prolong and intensify the anticholinergic effects of antihistamines. (MAO) inhibitor drugs may enhance the effect of pseudoephedrine HCl.
Sympathomimetic agents may reduce the effects of antihypertensive drugs. The effects of sympathomimetic amines, such a pseudoephedrine, are increased by beta-adrenergic blockers.
Antihistamines have additive effects with alcohol and other CNS (Central Nervous System) depressants such as hypnotics, sedatives, tranquilizers, and anti-anxiety agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed to assess the carcinogenic and mutagenic potential of Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Drops or its effect on fertility.
Pregnancy,Teratogenic Effects –Pregnancy Category C
Animal reproductive studies have not been performed with Chlorphen Mal/Pseudoeph HCl 0.8/9 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/Pseudoeph HCl 0.8/9 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/Pseudoeph HCl 0.8/9 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.
Packaging
Sample labeling:
68032-457-01
Rx Only
Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Drops
Sugar Free • Alcohol Free
Each dropperful (1mL) contains:
Chlorpheniramine Maleate, USP, 0.8 mg
Pseudoephedrine HCl, USP, 9 mg.
Cherry Flavor
1 fl oz (30 mL)
USUAL DOSAGE:
6-12 months: 1/2 dropperful (1/2 mL) 4 times a day.
12-24 months: ¾ dropperful (3/4 mL) 4 times a day.
24-36 months: 1 dropperful (1 mL) 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.
See package insert for full prescribing information.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Tamper Evident by foil seal under cap. Do not use if foil seal is broken or missing.
Manufactured for:
River’s Edge Pharmaceuticals LLC.
Suwanee, GA 30024
Rev. 10/09 457-20
Sample carton:
Revised: 01/2010 River's Edge Pharmaceuticals
68032-457-01
Rx Only
Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Drops
Sugar Free • Alcohol Free
Each dropperful (1mL) contains:
Chlorpheniramine Maleate, USP, 0.8 mg
Pseudoephedrine HCl, USP, 9 mg.
Cherry Flavor
1 fl oz (30 mL)
USUAL DOSAGE:
6-12 months: 1/2 dropperful (1/2 mL) 4 times a day.
12-24 months: ¾ dropperful (3/4 mL) 4 times a day.
24-36 months: 1 dropperful (1 mL) 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.
See package insert for full prescribing information.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Tamper Evident by foil seal under cap. Do not use if foil seal is broken or missing.
Manufactured for:
River’s Edge Pharmaceuticals LLC.
Suwanee, GA 30024
Rev. 10/09 457-20
Sample carton:
| CHLORPHEN MAL PSEUDOEPH HCL chlorpheniramine maleate, pseudoephedrine hydrochloride solution/ drops | ||||||||||||||||||||
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| Labeler - River's Edge Pharmaceuticals (133879135) |
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.