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Sildec PE DM
Overview
What is Sildec PE DM?
CPM/PE/DM Syrup is a sugar-free, alcohol-free, grape flavored syrup for oral administration for adults and for pediatric patients 2 years and older.
Each teaspoonful (5 mL) contains:Chlorpheniramine maleate ………………. 4.0 mgPhenylephrine hydrochloride ……………. 12.5 mgDextromethorphan hydrobromide ……….. 15.0 mg
Inactive ingredients
Chlorpheniramine maleate is an antihistamine with the chemical name: 2-Pyridinepropanamine, y -(4-chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1). Its chemical structure is as follows:
Phenylephrine hydrochloride is a mydriatic and a decongestant with the chemical name: ()-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride. Its chemical structure is as follows:
Dextromethorphan hydrobromide is an antitussive with the chemical name 3-Methoxy-17-methyl-9α, 13α, 14α - morphinan hydrobromide monohydrate. Its structure is as follows:
What does Sildec PE DM look like?
What are the available doses of Sildec PE DM?
Sorry No records found.
What should I talk to my health care provider before I take Sildec PE DM?
Sorry No records found
How should I use Sildec PE DM?
For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
CHLORPHENIRAMINE / PHENYLEPHRINE/ DEXTROMETHORPHAN Syrup (CPM/PE/DM Syrup) Adults and Children 12 years of age and older
Children 6 to under 12 years of age
Children 2 to under 6 years of age
Not recommended for use in children under 2 years of age.
In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.
What interacts with Sildec PE DM?
Patients with hypersensitivity or idiosyncrasy to any of its ingredients.
Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines are contraindicated in patients with narrow angle glaucoma, urinary retention, peptic ulcer and during an asthma attack. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.
What are the warnings of Sildec PE DM?
The antianabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired renal function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia and acidosis.
Do not exceed recommended dosage.
Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure or prostatic hypertrophy (See CONTRAINDICATIONS). Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Administration of dextromethorphan may be accompanied by histaminerelease and should be used with caution in atopic children.
What are the precautions of Sildec PE DM?
General
Information for Patients
Drug Interactions
CONTRAINDICATIONS
Use in Pregnancy: Pregnancy Category C
Nursing Mothers
What are the side effects of Sildec PE DM?
Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and dysuria and, rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy. Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmia, respiratory difficulties, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, pallor and dysuria. Dextromethorphan may cause drowsiness, dizziness and GI disturbance.
What should I look out for while using Sildec PE DM?
Patients with hypersensitivity or idiosyncrasy to any of its ingredients.
Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines are contraindicated in patients with narrow angle glaucoma, urinary retention, peptic ulcer and during an asthma attack. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.
Do not exceed recommended dosage.
Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure or prostatic hypertrophy (See CONTRAINDICATIONS). Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Administration of dextromethorphan may be accompanied by histaminerelease and should be used with caution in atopic children.
Drug Interactions
CONTRAINDICATIONS
What might happen if I take too much Sildec PE DM?
No information is available as to specific results of an overdose of CPM/PE/DM Syrup. The signs, symptoms and treatments described below are those of H antihistamine, ephedrine, and dextromethorphan overdose.
Symptoms
Should sympathomimetic symptoms predominate, central effects include 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.
Dextromethorphan may cause respiratory depression with a large overdose.
Treatment
How should I store and handle Sildec PE DM?
Store the oral suspension between 20°-25°C (68°-77°F). [See USP]. Dispense in a tight container. Protect from heat.CHLORPHENIRAMINE / PHENYLEPHRINE/ DEXTROMETHORPHAN Syrup (CPM/PE/DM Syrup) CPM/PE/DM SyrupIt is available in bottles of 16 fluid ounce (473 mL) bottles - .Dispense in a tight, light-resistant container as defined in USP with a child resistant closure. CHLORPHENIRAMINE / PHENYLEPHRINE/ DEXTROMETHORPHAN Syrup (CPM/PE/DM Syrup) CPM/PE/DM SyrupIt is available in bottles of 16 fluid ounce (473 mL) bottles - .Dispense in a tight, light-resistant container as defined in USP with a child resistant closure. CHLORPHENIRAMINE / PHENYLEPHRINE/ DEXTROMETHORPHAN Syrup (CPM/PE/DM Syrup) CPM/PE/DM SyrupIt is available in bottles of 16 fluid ounce (473 mL) bottles - .Dispense in a tight, light-resistant container as defined in USP with a child resistant closure.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Antihistaminic, decongestant and antitussive actions.
Chlorpheniramine maleate possesses H antihistaminic activity and mild anticholinergic and sedative effects. Peak plasma concentration is reached in 5 hours. Urinary excretion is the major route of elimination. The liver is assumed to be the major site of metabolic transformation.
Phenylephrine 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, phenylephrine has less pressor effect in normotensive adults. Serum half-life for phenylephrine 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.
Dextromethorphan hydrobromide is a non-narcotic 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. At usual doses, it will not depress respiration or inhibit ciliary 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.
Non-Clinical Toxicology
Patients with hypersensitivity or idiosyncrasy to any of its ingredients.Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines are contraindicated in patients with narrow angle glaucoma, urinary retention, peptic ulcer and during an asthma attack. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.
Do not exceed recommended dosage.
Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure or prostatic hypertrophy (See CONTRAINDICATIONS). Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Administration of dextromethorphan may be accompanied by histaminerelease and should be used with caution in atopic children.
Array
General
Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and dysuria and, rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy. Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmia, respiratory difficulties, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, pallor and dysuria. Dextromethorphan may cause drowsiness, dizziness and GI disturbance.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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