Oftacril

Uses

Oftacril inhaler is used for maintenance therapy in the management of adult and pediatric patients 6 years and older with mild to moderate asthma. Oftacril inhaler is not used for the reversal of acute bronchospasm.

Oftacril is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Asthma, Eye pruritus

How Oftacril works

Oftacril has been shown to inhibit the in vitro activation of, and mediator release from, a variety of inflammatory cell types associated with asthma, including eosinophils, neutrophils, macrophages, mast cells, monocytes, and platelets. Oftacril inhibits activation and release of inflammatory mediators such as histamine, prostaglandin D2 and leukotrienes c4 from different types of cells in the lumen and mucosa of the bronchial tree. These mediators are derived from arachidonic acid metabolism through the lipoxygenase and cyclo-oxygenase pathways. The mechanism of action of nedocromil may be due partly to inhibition of axon reflexes and release of sensory neuropeptides, such as substance P, neurokinin A, and calcitonin-geneñrelated peptides. The result is inhibition of bradykinin-induced bronchoconstriction. Oftacril does not posess any bronchodilator, antihistamine, or corticosteroid activity.

Dosage

Oftacril dosage

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 Oftacril 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. Oftacril Inhaler may be added to the patient's existing treatmentregimen(e.g., bronchodilators). When a clinical response to Oftacril 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 isessential(seePatient Instructionsfor Use). Patients should be advised that the optimal effect of Oftacril therapydepends upon its administration at regular intervals, even during symptom-free periods.

Side Effects

Unpleasant taste, headache, fatigue, nausea, vomiting, dyspepsia, diarrhoea, abdominal pain, conjunctivitis, cough, pharyngitis, rhinitis, upper respiratory infection.

Toxicity

Side effects include headache, nasal congestion, ocular burning, irritation and stinging, unpleasant taste, cough, difficulty breathing, noisy breathing, shortness of breath, tightness in chest, wheezing, conjunctivitis, blurred vision, change in color vision, difficulty seeing at night, increased sensitivity of eyes to sunlight.

Precaution

Pregnancy and lactation. Not for use in acute asthma attacks; acute bronchospasm. Children <6 yr; monitor closely.

Interaction

In clinical studies, Oftacril inhalation aerosol has been co-administered with other anti-asthma medications, including inhaled and oral bronchodilators, and inhaled corticosteroids, with no evidence of increased frequency of adverse events or laboratory abnormalities. No formal drug-drug interaction studies, however, have been conducted.

Food Interaction

Elimination Route

Low

Half Life

~3.3 hours

Elimination Route

It is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).

Pregnancy & Breastfeeding use

Pregnancy Category B. Reproduction studies performed in mice, rats, and rabbits using a subcutaneous dose of 100 mg/kg/day (approximately 30 times, 60 times, and 116 times, respectively, the maximum recommended human daily inhalation dose on a mg/m2 basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oftacril inhalation aerosol is administered to a nursing woman.

Contraindication

Oftacril inhalation aerosol inhaler is contraindicated in patients who have shown hypersensitivity to nedocromil sodium or other ingredients in Oftacril Sodium.

Special Warning

Pediatric Use: The safety and effectiveness of Oftacril inhalation aerosol in patients below the age of 6 years have not been established.

Geriatric Use: Clinical studies of Oftacril inhalation aerosol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Storage Condition

Store at 2-30° C. Do not freeze.

Innovators Monograph

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