Novahistex DM (Hydrocodone / Phenylephrine)

NOVAHISTEX® DH

Hoechst Marion Roussel

Hydrocodone Bitartrate – Phenylephrine HCl

Antitussive – Decongestant

Indications And Clinical Uses: The treatment of adults with cough associated with inflamed mucosa, which does not respond to products of lesser potency.

Contra-Indications: Patients undergoing therapy with MAO inhibitors, hypersensitivity to any of the components.

Precautions: Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiologic complications and that appropriate therapy for the primary disease is provided.

Continuous dosage over extended periods of time may cause a hydrocodone bitartrate dependent state.

In young children the respiratory centre is especially susceptible to the depressant action of narcotic cough suppressants. Benefit to risk ratio should be carefully considered, especially in children with respiratory embarrassment, e.g., croup. Estimation of dosage relative to the child’s age and weight is of great importance.

Pregnancy: Since hydrocodone crosses the placental barrier, its use in pregnancy is not recommended.

As hydrocodone may inhibit peristalsis, patients with chronic constipation should be given the drug only after weighing the potential therapeutic benefit against the hazards involved.

Administer with caution to patients hypersensitive to sympathomimetic preparations, patients with severe hypertension, hyperthyroidism, diabetes mellitus, glaucoma, cardiac or peripheral vascular disease.

Occupational Hazards: Patients should be cautioned not to operate vehicles or hazardous machinery until their response to the drug has been determined.

Since the depressant effects of antihistamines are additive to those of other drugs affecting the CNS, patients should be cautioned against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant effects during antihistaminic therapy.

Adverse Reactions: Occasional drowsiness, dry mouth, dizziness, blurred vision, mild mental stimulation and gastric irritation may occur rarely.

Symptoms And Treatment Of Overdose: Symptoms: Symptoms are similar to those caused by overdosage of hydrocodone. Narcosis is usually present, sometimes associated with convulsions. Tachycardia, pupillary constriction, nausea and vomiting or respiratory depression can occur.

Treatment: If respiration is severely depressed, administer the narcotic antagonist, naloxone. Adults: 400 g by i.v., i.m. or s.c. routes and repeated at 2 to 3 minute intervals if necessary. Children: 10 g/kg by i.v., i.m. or s.c. routes. Dosage may be repeated as for the adult administration. Failure to obtain significant improvement after 2 to 3 doses suggests that causes other than narcotic overdosage may be responsible for the patient’s condition.

If naloxone is unsuccessful, institute intubation and respiratory support or conduct gastric lavage in the unconscious patient.

Dosage: Adults and children over 12 years, 5 mL every 4 hours.

Availability And Storage: Each 5 mL of red, raspberry flavored liquid contains: hydrocodone bitartrate 5 mg and phenylephrine HCl 20 mg. Nonmedicinal ingredients: artificial flavor (raspberry and others), citric acid, glucose, glycerin, menthol, propylene glycol, purified water, Red #2, sodium benzoate, sodium chloride, sodium citrate, sodium cyclamate and xylitol. Alcohol- and sucrose-free. Bottles of 100 mL and 2 L.

NOVAHISTEX┬« DH Hoechst Marion Roussel Hydrocodone Bitartrate – Phenylephrine HCl Antitussive – Decongestant

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