Acetaminophen; Chlorpheniramine Maleate; Phenylpropanolamine (0048)
| Ingredients: |
Acetaminophen; Chlorpheniramine Maleate; Phenylpropanolamine |
| Indications: |
Fever, secondary to upper respiratory infection; Pain, secondary to upper respiratory infection; Rhinitis, allergic; Rhinitis, vasomotor |
| Pregnancy Category: |
C |
| FDA Approved: |
pre- 1938 |
| Classes: |
Analgesics, non- narcotic; Antihistamines, H1; Decongestants, nasal |
| Brand Names: |
Acetacol
-
Thailand
;
Contracol
-
Indonesia
;
Dupagen
-
Indonesia
;
Fortaflu
-
Indonesia
;
Neo-Bromexan Forte
-
Philippines
;
Procold
-
Indonesia
;
|
| DEA schedules: |
(none)
|
DESCRIPTION
|
| |
- The FDA is taking steps to remove phenylpropanolamine hydrochloride from all drug products due to the risk of hemorrhagic
stroke. The FDA has significant concerns because of the seriousness of stroke and the inability to predict who is at risk.
|
Each tablet contains:
- Acetaminophen: 500 mg
- Phenylpropanolamine Hydrochloride: 25 mg
- Chlorpheniramine Maleate: 4 mg
Acetaminophen, an analgesic and antipyretic, is N- (4- hydroxylphenyl)- acetamide.
Phenylpropanolamine HCl, an adrenergic agent, is μ- (1- aminoethyl)- benzenemethanol hydrochloride.
Chlorpheniramine maleate, an antihistamine, is 2- [p- chloro- μ- [2- (dimethylamino)- ethyl]benzyl]pyridine maleate (1:1).
Inactive Ingredients: Crospovidone, D&C red no. 27 (aluminum lake), FD&C blue no. 1 (aluminum lake), magnesium stearate, povidone, pregelatinized
starch, stearic acid.
|
CLINICAL PHARMACOLOGY
|
| |
Acetaminophen produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-
regulating center. Phenylpropanolamine HCl is a sympathomimetic and is a vasoconstrictor with decongestive action on nasal
and upper respiratory tract mucous membranes. Chlorpheniramine maleate is an alkylamine antihistamine which possesses anticholinergic
and sedative effects.
|
INDICATIONS AND USAGE
|
| |
Symptomatic relief and reduction of fever or relief of pain in common upper respiratory infections; allergic rhinitis; vasomotor
rhinitis.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
|
CONTRAINDICATIONS
|
| |
Hypersensitivity to any of the ingredients; cardiac disease; hypertension; patients receiving MAO inhibitors; hyper- thyroidism.
|
WARNINGS
|
| |
Acetaminophen; chlorpheniramine maleate; phenylpropanolamine HCl tablets may increase the effects of alcohol and other CNS
depressants. Do not take simultaneously with other products containing phenylpropanolamine HCl.
|
PRECAUTIONS
|
| |
General
|
| |
Use cautiously in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, bladder
neck obstruction, diabetes. Withdraw medication if restlessness or nervousness occurs or if high fever persists.
|
Information for the Patient
|
| |
Because this product may cause drowsiness or blurring of vision, patients should be cautioned against driving or operating
machinery. Also caution patients of the added effects of alcohol and other CNS depressants.
|
Pregnancy Category C
|
| |
It is not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. The product should be given to a pregnant woman only if clearly needed.
|
Nursing Mothers
|
| |
It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should
be exercised when this product is administered to a nursing woman.
|
|
ADVERSE REACTIONS
|
| |
- General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat.
- Cardiovascular: Hypotension, hypertension, headache, palpitations, tachycardia, extrasystoles and angina pain.
- Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis, leukopenia.
- CNS: Sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability,
insomnia, euphoria, paresthesias, blurred vision, diplopla, vertigo, tinnitus, acute labyrinthitis, hysteria neuritis and
convulsions.
- GI: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
- GU: Urinary frequency, urinary difficulty or retention, early menses.
- Respiratory: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
|
OVERDOSAGE
|
| |
The stomach should be emptied promptly by lavage or by induction of emesis.
|
DOSAGE AND ADMINISTRATION
|
| |
Adults: Two tablets initially, then 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours.
|
HOW SUPPLIED
|
| |
Alumadrine tablets are flat, quadri- scored, emobssed "107", purple tablets, 6 mm thick, 10 mm in diameter.
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PRODUCT IDENTIFICATION
|
| |
None Available |
|