Duo-Medihaler (Isoproterenol Hydrochloride / Phenylephrine Bitartrate Inhalation) - Indications and Dosage

Indications And Usage

DUO-MEDIHALER is indicated for the treatment of bronchospasm associated with acute and chronic asthma and reversible broncho­spasm which may be associated with chronic bronchitis or emphysema.

DOSAGE AND ADMINISTRATION

Adults: The usual dose for the relief of dyspnea caused by acute bronchospasm is one or two inhalations. Start with a single inhalation. If no relief is evident after two to five minutes, a second inhalation may be taken. For daily maintenance, use one or two inhalations four to six times daily or as directed by the physician. The physician should be careful to instruct the patient in the proper technique of administration so that the number of inhalations per treatment and the frequency of retreatment may be titrated to the patient's response.

No more than two inhalations should be taken at any one time, nor more than six inhalations in any one hour during a 24-hour period, unless advised by the physician. Lower doses in elderly patients may be required due to increased sympathomimetic sensi­tivity. Each depression of the valve delivers through the oral adapter 0.16 mg isoproterenol hydrochloride and 0.24 mg phenylephrine bitartrate.

Children: Safety and effectiveness for children under 12 years have not yet been established (see Pediatric Use).

DIRECTIONS FOR USE

Before each use, remove dust cap and inspect mouthpiece for foreign objects. Shake DUO-MEDIHALER.

1. Breathe out fully and place mouthpiece well into the mouth aimed at the back of the throat.
2. As you begin to breathe in deeply, press the vial firmly down into the adapter with the index finger. This releases one dose.
3. Release pressure on vial and remove unit from mouth. Hold your breath as long as possible, then breathe out slowly.

Replace dust cap after each use.

How supplied

DUO-MEDIHALER is an aerosol device which delivers 0.16 mg of isoproterenol hydrochloride and 0.24 mg of phenylephrine bitar­trate through the oral adapter with each depression of the valve.

15-ml vial and oral adapter, containing 21.0 gm, a minimum of 300 actuations

NDC 0089-0735-21).

15-ml refill vial only, containing 21.0 gm, a minimum of 300 actu­ations (NDC 0089-0735-11).

Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manu­factured with chlorofluorocarbons (CFC's).

WARNING: Contains trichloromonofluoromethane, dichlorodifluoromethane, and dichlorotetrafluoroethane, substances which harm public health and environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the "Patient Instructions for Use" of this product pursuant to EPA regulations.

CAUTION

Federal law prohibits dispensing without prescription. CONTENTS UNDER PRESSURE. Do not puncture or incinerate container Store at controlled room temperature between 15°C and 30°C. (59°F and 86°F). KEEP OUT OF THE REACH OF CHILDREN.

3M Pharmaceuticals
Northridge, CA 91324
DUO-20
NOVEMBER 1993
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