Novahistex DM (Dextromethorphan)

NOVAHISTEX® DM NOVAHISTEX® DM Decongestant NOVAHISTEX® DM Decongestant Expectorant NOVAHISTINE® DM NOVAHISTINE® DM Decongestant NOVAHISTINE® DM Decongestant Expectorant

Hoechst Marion Roussel

Dextromethorphan HBr

Dextromethorphan HBr – Pseudoephedrine HCl

Dextromethorphan HBr – Pseudoephedrine HCl – Guaifenesin

Dextromethorphan HBr

Dextromethorphan HBr – Pseudoephedrine HCl

Dextromethorphan HBr – Pseudoephedrine HCl – Guaifenesin

Antitussive

Antitussive – Decongestant

Antitussive – Decongestant – Expectorant

Antitussive

Antitussive – Decongestant

Antitussive – Decongestant – Expectorant

Action And Clinical Pharmacology: Dextromethorphan (DM) suppresses the cough reflex by a direct effect on the cough centre in the medulla of the brain. The drug acts centrally to elevate the threshold for coughing. Although it is chemically related to morphine, it has no analgesic or addictive properties. Its antitussive activity is about equal to that of codeine.

Pseudoephedrine is a stereoisomer of ephedrine that is less potent than ephedrine in producing tachycardia, increased blood pressure and CNS stimulation. The medication shrinks swollen nasal mucous membranes; reduces tissue hyperemia, edema and nasal congestion; and increases nasal airway patency.

It is a sympathomimetic amine with peripheral effects similar to ephedrine and central effects similar to, but less intense than amphetamines. Patients taking pseudoephedrine orally have not been reported to experience the rebound congestion sometimes experienced with frequent, repeated use of topical decongestants. Pseudoephedrine is not known to produce drowsiness.

Guaifenesin acts as an expectorant by increasing the volume of respiratory tract fluid excreted from the bronchial airways, which reduces the viscosity of tenacious secretions, making expectoration of sputum (phlegm) and bronchial secretions easier.

Indications And Clinical Uses: DM: For the symptomatic relief of nonproductive coughs associated with colds.

DM Decongestant: For the symptomatic relief of nonproductive coughs and nasal sinus congestion associated with colds, bronchitis, influenza, and sinusitis.

DM Decongestant Expectorant: For the symptomatic relief of nonproductive coughs, nasal sinus congestion, and to facilitate the expectoration of mucus/phlegm associated with colds, bronchitis, influenza, and sinusitis.

Contra-Indications: Novahistex: DM: In patients with hypersensitivity to dextromethorphan. Dextromethorphan preparations should not be used in patients receiving monoamine oxidase (MAO) inhibitors.

DM Decongestant and DM Decongestant Expectorant: In patients with severe hypertension, severe coronary artery disease, and in patients on MAO inhibitor therapy.

Hypersensitivity: This product is contraindicated in patients with hypersensitivity to dextromethorphan and in patients with hypersensitivity or idiosyncrasy to sympathomimetic amines. Patient idiosyncrasy to adrenergic agents may be manifested by insomnia, dizziness, weakness, tremor or arrhythmias.

Lactation: Pseudoephedrine is excreted in breast milk and therefore use by nursing mothers is not recommended because of the risk of side effects to the nursing child.

Novahistine: DM: In patients with hypersensitivity to dextromethorphan. Dextromethorphan preparations should not be used in patients receiving monoamine oxidase (MAO) inhibitors.

DM Decongestant and DM Decongestant Expectorant: In patients with severe hypertension, severe coronary artery disease, and in patients on MAO inhibitor therapy.

Hypersensitivity: This product is contraindicated in patients with hypersensitivity to dextromethorphan. In patients with hypersensitivity or idiosyncrasy to sympathomimetic amines. Patient idiosyncrasy to adrenergic agents may be manifested by insomnia, dizziness, weakness, tremor or arrhythmias.

Manufacturers’ Warnings In Clinical States: DM: If cough persists after medication has been used for 7 days or if high fever, skin rash, or continuing headache is present with cough, consult a physician.

DM Decongestant and DM Decongestant Expectorant: If cough persists after medication has been used for 7 days or if high fever, skin rash, or continuing headache is present with cough, consult a physician. At dosages higher than the recommended dose, nervousness, dizziness, sleeplessness, nausea, or headache may occur.

Precautions: Novahistex: DM: Dextromethorphan should not be taken for persistent or chronic cough (e.g., with smoking, emphysema, asthma) or when coughing is accompanied by excessive secretions, unless directed by a physician. Concurrent use of CNS depressant medications may potentiate the CNS depressant effect of these medications or dextromethorphan. This product should not be used by patients taking a prescription drug for depression without the advice of a physician. Pregnancy and Lactation: Pregnant or nursing patients, consult a physician before using this product. Diabetes: Diabetic patients should take note of the presence of glucose in this preparation (see Supplied for glucose and energy contents).

DM Decongestant: Dextromethorphan should not be taken for persistent or chronic cough (e.g., with smoking, emphysema, asthma) or when coughing is accompanied by excessive secretions, unless directed by a physician. Concurrent use of CNS depressant medications may potentiate the CNS depressant effect of these medications or dextromethorphan. Pseudoephedrine should be used with caution in patients with diabetes mellitus, hypertension, cardiovascular disease, coronary artery disease (severe), glaucoma, hyperthyroidism, prostatic hypertrophy, severe organic disease, asthma, urinary retention and hypersensitivity to ephedrine. MAO inhibitors and beta-adrenergic blockers potentiate the sympathomimetic effect of pseudoephedrine. This product should not be used by patients taking a prescription drug for hypertension or depression without the advice of a physician. Pregnancy and Lactation: Pregnant or nursing patients, consult a physician before using this product. Diabetes: Diabetic patients should take note of the presence of glucose in this preparation (see Supplied for glucose and energy contents).

DM Decongestant Expectorant: Dextromethorphan should not be taken for persistent or chronic cough (e.g., with smoking, emphysema, asthma) or when coughing is accompanied by excessive secretions, unless directed by a physician. Concurrent use of CNS depressant medications may potentiate the CNS depressant effect of these medications or dextromethorphan. Pseudoephedrine should be used with caution in patients with diabetes mellitus, hypertension, cardiovascular disease, coronary artery disease (severe), glaucoma, hyperthyroidism, prostatic hypertrophy, severe organic disease, asthma, urinary retention and hypersensitivity to ephedrine. MAO inhibitors and beta-adrenergic blockers potentiate the sympathomimetic effect of pseudoephedrine. Guaifenesin interferes with the colorimetric determination of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). This product should not be used by patients taking a prescription drug for hypertension or depression without the advice of a physician. Pregnancy and Lactation: Pregnant or nursing patients, consult a physician before using this product. Diabetes: Diabetic patients should take note of the presence of glucose in this preparation (see Supplied for glucose and energy contents).

Novahistine: DM: Dextromethorphan should not be taken for persistent or chronic cough (e.g., with smoking, emphysema, asthma) or when coughing is accompanied by excessive secretions, unless directed by a physician. Concurrent use of CNS depressant medications may potentiate the CNS depressant effect of these medications or dextromethorphan. This product should not be used by patients taking a prescription drug for depression without the advice of a physician. Diabetes: Diabetic patients should take note of the presence of glucose in this preparation (see Supplied for glucose and energy contents).

DM Decongestant: Dextromethorphan should not be taken for persistent or chronic cough (e.g., with smoking, emphysema, asthma) or when coughing is accompanied by excessive secretions, unless directed by a physician. Concurrent use of CNS depressant medications may potentiate the CNS depressant effect of these medications or dextromethorphan. Pseudoephedrine should be used with caution in patients with diabetes mellitus, hypertension, cardiovascular disease, coronary artery disease (severe), glaucoma, hyperthyroidism, severe organic disease, asthma, urinary retention and hypersensitivity to ephedrine. MAO inhibitors and beta-adrenergic blockers potentiate the sympathomimetic effect of pseudoephedrine. This product should not be used by patients taking a prescription drug for hypertension or depression without the advice of a physician. Diabetes: Diabetic patients should take note of the presence of glucose in this preparation (see Supplied for glucose and energy contents).

DM Decongestant Expectorant: Dextromethorphan should not be taken for persistent or chronic cough (e.g., with smoking, emphysema, asthma) or when coughing is accompanied by excessive secretions, unless directed by a physician. Concurrent use of CNS depressant medications may potentiate the CNS depressant effect of these medications or dextromethorphan. Pseudoephedrine should be used with caution in patients with diabetes mellitus, hypertension, cardiovascular disease, coronary artery disease (severe), glaucoma, hyperthyroidism, severe organic disease, asthma, urinary retention and hypersensitivity to ephedrine. MAO inhibitors and beta-adrenergic blockers potentiate the sympathomimetic effect of pseudoephedrine. Guaifenesin interferes with the colorimetric determination of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). This product should not be used by patients taking a prescription drug for hypertension or depression without the advice of a physician. Diabetes: Diabetic patients should take note of the presence of glucose in this preparation (see Supplied for glucose and energy contents).

Adverse Reactions: DM: Adverse effects with dextromethorphan are rare, but nausea and/or other gastrointestinal disturbances, slight drowsiness, and dizziness sometimes occur.

DM Decongestant and DM Decongestant Expectorant: Adverse effects with dextromethorphan are rare, but nausea and/or other gastrointestinal disturbances, slight drowsiness, and dizziness sometimes occur.

Adverse effects with pseudoephedrine: Individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness or nausea. Sympathomimetic drugs have been associated with reactions such as confusion, fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS stimulation, arrhythmias and cardiovascular collapse with hypotension. Children and the elderly may be more susceptible to systemic effects of the drug than are adults.

Symptoms And Treatment Of Overdose: Symptoms: Manifestations of Acute Overdosage: DM: Dextromethorphan has a low order of toxicity with the potential for toxic effects following acute overdosage being extremely low. Drowsiness or dizziness; nausea or vomiting; blurred vision; shallow respiration; urinary retention; stupor; toxic psychosis; coma. Consult with a physician as soon as possible if any of these symptoms occur.

DM Decongestant and DM Decongestant Expectorant: Dextromethorphan has a low order of toxicity with the potential for toxic effects following acute overdosage being extremely low. Drowsiness or dizziness; nausea or vomiting; blurred vision; shallow respiration; urinary retention; stupor; toxic psychosis; coma. Pseudoephedrine may cause convulsions, hallucinations, increase in blood pressure, irregular heartbeat, troubled breathing, nervousness, restlessness, excitement, following acute overdosage. Consult with a physician as soon as possible if any of these symptoms occur.

Treatment: Treatment of Acute Overdosage: DM Decongestant and DM Decongestant Expectorant: Treatment is symptomatic and directed towards supporting the various bodily systems. Gastric lavage should be performed at the discretion of the attending physician. Assisted respiration may be required. Acidify the urine to enhance elimination and institute general supportive measures. If CNS stimulation is prominent, an anticonvulsant may be administered. Heart signs and electrolytes should be monitored.

Dosage And Administration: Novahistex: Adults and Children over 12 years: DM: 10 mL every 6 to 8 hours. Maximum 4 doses in 24 hours.

DM Decongestant and DM Decongestant Expectorant: 10 mL every 4 to 6 hours. Maximum 4 doses in 24 hours.

Do not exceed recommended dose.

Novahistine: DM: Children 6 to 12 years: 10 mL every 6 to 8 hours. Maximum 4 doses in 24 hours; 2 to 5 years: 5 mL every 6 to 8 hours. Maximum 4 doses in 24 hours; under 2 years: consult a physician.

DM Decongestant and DM Decongestant Expectorant: Children 6 to 12 years: 10 mL every 4 to 6 hours. Maximum 4 doses in 24 hours; 2 to 5 years: 5 mL every 4 to 6 hours. Maximum 4 doses in 24 hours; under 2 years: consult a physician.

Do not exceed recommended dose.

Availability And Storage: Novahistex: DM: Each 5 mL of red-colored, raspberry-flavored liquid contains: dextromethorphan HBr 15 mg. Nonmedicinal ingredients: artificial raspberry flavor, citric acid, FD&C blue No. 1, FD&C red No. 2, FD&C yellow No. 6, glucose, glycerin, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium cyclamate, sorbitol and xylitol. Energy: 16.7 kJ (4 kcal)/5 mL. Glucose: 975 mg. Bottles of 100 mL.

DM Decongestant: Each 5 mL of red-colored, raspberry- flavored liquid contains: dextromethorphan HBr 15 mg and pseudoephedrine HCl 30 mg. Nonmedicinal ingredients: artificial raspberry flavor, citric acid, FD&C blue No. 1, FD&C red No. 2, FD&C yellow No. 6, glucose, glycerin, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium cyclamate, sorbitol and xylitol. Energy: 16.7 kJ (4 kcal)/5 mL. Glucose: 975 mg. Bottles of 100 mL.

DM Decongestant Expectorant: Each 5 mL of red-colored, cherry-flavored liquid contains: dextromethorphan HBr 15 mg, pseudoephedrine HCl 30 mg and guaifenesin 100 mg. Nonmedicinal ingredients: artificial and natural cherry flavors, citric acid, FD&C blue No. 1, FD&C red No. 2, FD&C yellow No. 6, glucose, menthol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium cyclamate and xylitol. Energy : 46 kJ (11 kcal )/5 mL. Glucose: 2 750 mg. Bottles of 100 mL.

Novahistine: DM: Each 5 mL of purple-colored, grape-flavored liquid contains: dextromethorphan HBr 7.5 mg. Nonmedicinal ingredients: artificial and natural grape flavors, citric acid, FD&C blue No. 1, FD&C red No. 2, glucose, glycerin, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium cyclamate, sorbitol and xylitol. Energy: 16.7 kJ (4 kcal )/5 mL. Glucose: 975 mg. Bottles of 100 mL.

DM Decongestant: Each 5 mL of purple-colored, grape- flavored liquid contains: dextromethorphan HBr 7.5 mg and pseudoephedrine HCl 15 mg. Nonmedicinal ingredients: artificial and natural grape flavors, citric acid, FD&C blue No. 1, FD&C red No. 2, glucose, glycerin, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium cyclamate, sorbitol and xylitol. Energy: 16.7 kJ (4 kcal )/5 mL. Glucose: 975 mg. Bottles of 100 mL.

DM Decongestant Expectorant: Each 5 mL of red-colored, raspberry-flavored liquid contains: dextromethorphan HBr 7.5 mg, pseudoephedrine HCl 15 mg and guaifenesin 50 mg. Nonmedicinal ingredients: artificial raspberry flavor, citric acid, FD&C red No. 2, glucose, glycerin, purified water, sodium benzoate, sodium citrate, sodium cyclamate, sorbitol and xylitol. Energy: 16.7 kJ (4 kcal )/5 mL. Glucose: 1 000 mg. Bottles of 100 mL.

All preparations are alcohol-, gluten-, lactose-, sulfite- and tartrazine-free. Store between 15 and 30°C.

NOVAHISTEX® DM NOVAHISTEX® DM Decongestant NOVAHISTEX® DM Decongestant Expectorant NOVAHISTINE® DM NOVAHISTINE® DM Decongestant NOVAHISTINE® DM Decongestant Expectorant Hoechst Marion Roussel Dextromethorphan HBr Dextromethorphan HBr – Pseudoephedrine HCl Dextromethorphan HBr – Pseudoephedrine HCl – Guaifenesin Dextromethorphan HBr Dextromethorphan HBr – Pseudoephedrine HCl Dextromethorphan HBr – Pseudoephedrine HCl – Guaifenesin AntitussiveAntitussive – Decongestant Antitussive – Decongestant – Expectorant Antitussive Antitussive – Decongestant Antitussive – Decongestant – Expectorant

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