Consumer medicine information

1 Name of Medicine

Beclometasone dipropionate and formoterol fumarate dihydrate.

2 Qualitative and Quantitative Composition

Fostair 100/6. Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate.
Each delivered dose (the dose leaving the mouthpiece) contains 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
Fostair 200/6. Each metered dose (the dose leaving the valve) contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate.
Each delivered dose (the dose leaving the mouthpiece) contains 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
Excipient with known effect. Ethanol absolute.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pressurised inhalation.
Colourless to yellowish solution.
The inhalation solution is contained in a pressurised aluminium container sealed with a metering valve (pressurised metered dose inhaler (pMDI)). The canister is inserted into a polypropylene plastic actuator which incorporates a mouthpiece and is fitted with a plastic protective cap. The actuator is light purplish-red with a dark purplish-red cap (Fostair 100/6) or dark green cap (Fostair 200/6). The actuator has a dose counter.

4 Clinical Particulars

4.9 Overdose

Inhaled doses of Fostair up to twelve cumulative actuations (total beclometasone dipropionate 1200 micrograms, formoterol 72 micrograms) have been studied in asthmatic patients. The cumulative treatments did not cause abnormal effect on vital signs and neither serious nor severe adverse events were observed.
Excessive doses of formoterol may lead to effects that are typical of beta₂-adrenergic agonists: nausea, vomiting, headache, tremor, somnolence, palpitations, tachycardia, ventricular arrhythmias, prolongation of QTc interval, metabolic acidosis, hypokalaemia, hyperglycaemia.
In case of overdose of formoterol, supportive and symptomatic treatment is indicated. Serious cases should be hospitalised. Use of cardioselective beta-adrenergic blockers may be considered, but only subject to extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm. Serum potassium should be monitored.
Acute inhalation of beclometasone dipropionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function recovers in a few days, as verified by plasma cortisol measurements. In these patients, treatment should be continued at a dose sufficient to control asthma.
Chronic overdose of inhaled beclometasone dipropionate: risk of adrenal suppression (see Section 4.4 Special Warnings and Precautions for Use). Monitoring of adrenal reserve may be necessary. Treatment should be continued at a dose sufficient to control asthma.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Beclometasone dipropionate and formoterol fumarate dihydrate, tested in combination, were not mutagenic in bacterial reverse mutation assays, and not clastogenic in vitro in human lymphocytes or in vivo in the rat bone marrow micronucleus test.
Carcinogenicity. No carcinogenicity studies have been performed with beclometasone dipropionate and formoterol fumarate dihydrate in combination. Data for the individual active components are described below.
Beclometasone dipropionate. The potential carcinogenicity of beclometasone dipropionate has not been adequately investigated in animal studies. Other glucocorticoids (budesonide, prednisolone and triamcinolone acetate) have been shown to increase the incidence of hepatocellular tumours in rats by a non-genotoxic mechanism.
Formoterol fumarate. In 2-year studies in mice and rats, treatment with formoterol fumarate, given via the diet or drinking water at very high doses, was associated with increases in several tumour types. In mice, these included hepatocellular adenoma and carcinomas (≥ 2 mg/kg/day), leiomyomas and leiomyosarcomas in the female reproductive tract (≥ 2 mg/kg/day) and adrenal subcapsular cell tumours (≥ 66 mg/kg/day). In rats, treatment was associated with benign granulosa/theca cell tumours in the ovaries (≥ 0.5 mg/kg/day), mesovarian leiomyomas (≥ 18 mg/kg/day), mammary adenocarcinomas (≥ 36 mg/kg/day) and thyroid C-cell neoplasms (46 mg/kg/day). A mesovarian leiomyoma was also observed in a female rat dosed by inhalation at 130 micrograms/kg/day for two years (approximately 30 times the maximum recommended human dose for Fostair, adjusted for body surface area).
Mammary adenocarcinomas, smooth muscle tumours in the female reproductive tract and effects on the ovary have been reported in rats and mice treated with other β₂-adrenergic agonists and are likely to be secondary to prolonged stimulation of β₂-adrenoceptors in these tissues.
Pre-clinical data on the CFC-free propellant HFA-134a reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBEDIPR.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFOFUMD.gif CAS number. Beclometasone dipropionate: 5534-09-8.
Formoterol fumarate dihydrate: 183814-30-4.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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