Omni (Codeine – Chlorpheniramine – Ephedrine – Phenyltoloxamine)

OMNI-TUSS®

Rh´ne-Poulenc Rorer

Codeine – Chlorpheniramine – Ephedrine – Phenyltoloxamine (Resin Complex)

Antitussive – Decongestant – Expectorant

Indications And Clinical Uses: To facilitate expectoration and control cough associated with inflamed mucosa and tenacious sputum which does not respond to products of lesser potency.

Contra-Indications: Hypertension, cardiac disease, hyper- thyroidism, prostatic hypertrophy, sensitivity to any of the components, patients receiving MAO inhibitors.

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.

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 codeine crosses the placental barrier, its use in pregnancy is not recommended.

As codeine may inhibit peristalsis, patients with chronic constipation should be given Omni-Tuss only after weighing the potential therapeutic benefit against the hazards involved.

Omni-Tuss contains codeine: may be habit forming.

Use with caution in patients with glaucoma or diabetes mellitus.

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.

See also guaifenesin and codeine phosphate monographs.

Adverse Reactions: Rarely: jitteriness, nausea, drying of mouth, insomnia, drowsiness, constipation, which disappear upon adjustment of the dose or discontinuance of treatment.

Symptoms And Treatment Of Overdose: Symptoms: May include nausea, dry mouth, sedation, respiratory depression.

Treatment: Gastric emptying by lavage or emesis, intubation measures aimed at supporting respiration and the administration of a narcotic antagonist, e.g., naloxone. (Adults: 0.4 mg/kg i.v., i.m. or s.c. repeated at 2-3 minute intervals. If no response after 2 or 3 doses, the condition may be due partly or totally to other disease processes or nonopiate drugs. Children: 0.01 mg/kg i.v., im. or s.c. Dose may be repeated as for the adult administration.)

Dosage: Orally, every 12 hours: Adults, 5 mL; children 6 to 12 years, 2.5 mL.

Availability And Storage: Each 5 mL of green, mint-flavored liquid contains: codeine 10 mg, phenyltoloxamine 5 mg, chlorpheniramine 3 mg, ephedrine 25 mg, all as cation exchange resin complexes, and guaiacol carbonate 20 mg. Nonmedicinal ingredients: D&C Yellow No 10, FD&C Blue No 1, flavor of limes, flavor menthol cream, methylparaben, polacrilin potassium, propylparaben, purified water and sorbitol. Energy: 18 kJ (4.4 kcal)/5 mL. Sodium:

OMNI-TUSS® Rh´ne-Poulenc Rorer Codeine – Chlorpheniramine – Ephedrine – Phenyltoloxamine (Resin Complex) Antitussive – Decongestant – Expectorant

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