Tilade (nedocromil inhalation aerosol) Inhaler is indicated for maintenance therapy in the management of adult and pediatric patients 6 years and older with mild to moderate asthma. Tilade (nedocromil inhalation aerosol) is not indicated for the reversal of acute bronchospasm.
DOSAGE AND ADMINISTRATION
The recommended dosage for adult and pediatric patients 6 years of age and
older is two inhalations four times a day at regular intervals, which provides
a dose of 14 mg per day. In patients whose asthma is well controlled on this
dosage (e.g., patients who only need occasional inhaled or oral beta2-agonists
and who are not experiencing serious exacerbations), less frequent administration
may be effective.
Each Tilade (nedocromil inhalation aerosol) Inhaler canister must be primed with 3 actuations prior
to the first use. If a canister remains unused for more than 7 days, then it
should be reprimed with 3 actuations. Tilade (nedocromil inhalation aerosol) Inhaler may be added to
the patient's existing treatment regimen (e.g., bronchodilators). When a clinical
response to Tilade (nedocromil inhalation aerosol) Inhaler is evident and if the patient's asthma is
under good control, an attempt may be made to decrease concomitant medication
usage gradually. Proper inhalational technique is essential (see Patient
Instructions for Use). Patients should be advised that the optimal effect
of Tilade (nedocromil inhalation aerosol) therapy depends upon its administration at regular intervals,
even during symptom-free periods.
Tilade (nedocromil inhalation aerosol) Inhaler is available in 16.2 g canisters providing at least 104
metered inhalations. Each Tilade (nedocromil inhalation aerosol) canister contains 210 mg nedocromil
sodium. Each pack is supplied with patient instructions, a tan-colored rubber
valve cover, and white plastic mouthpiece and cover, bearing the Tilade (nedocromil inhalation aerosol)
logo. The Tilade (nedocromil inhalation aerosol) mouthpiece should not be used with other aerosol medications
and the Tilade (nedocromil inhalation aerosol) canister should not be used with other mouthpieces. Each
actuation meters 2.00 mg nedocromil sodium from the valve and delivers 1.75
mg nedocromil sodium from the mouthpiece.
NDC 0585-0685-02 One 16.2 g Canister (104 Metered Inhalations)
The canister should be discarded after the labeled number of actuations have
been used. The amount of medication in each actuation cannot be assured after
Store between 2 to 30°C (36 to 86°F). Do not freeze. Avoid spraying in eyes.
Contents under pressure. Do not puncture, incinerate, place near sources of
heat, or use with other mouthpieces. Exposure to temperatures above 120°F may
cause bursting. Never throw canister into fire or incinerator. Keep out of
the reach of children. For best results, the canister should be at room
temperature before use.
Shake well before using.
Note: The indented statement below is required by the Federal government's
Clean Air Act for all products containing or manufactured with chlorofluorocarbons
WARNING: Contains CFC-12 and CFC-114, substances which harm public health
and the environment by destroying ozone in the upper atmosphere.
A notice similar to the above WARNING has been placed in the "Patient
Instructions for Use" portion of this package insert under the Environmental
Protection Agency's (EPA's) regulations. The patient's warning states that the
patient should consult his or her physician if there are questions about alternatives.
Distributed by: King Pharmaceuticals™, Inc. Bristol, TN
37620. Manufactured by: Aventis Pharma LTD, Holmes Chape,l Cheshire CW48B3,
United Kingdom. FDA rev date: