ALUPENT^® Syrup

Each 5 ml contains orciprenaline sulphate 10 mg.

Syrup.

ALUPENT is indicated for the relief of reversible airways obstruction.

ALUPENT Syrup is suggested for maintenance therapy.

Adults: The usual dose is 2 x 5 ml four times daily. The maximum recommended daily dosage is 8 x 5 ml spoonfuls.

Children 3-12 years: The usual starting dose is 1 x 5 ml four times daily. This may be increased to 2 x 5 ml three times daily as necessary. The maximum recommended daily dosage is 6 x 5 ml spoonfuls.

Children 1-3 years: The usual starting dose is ½ x 5 ml four times daily. This may be increased to 1 x 5 ml four times daily as necessary. The maximum recommended daily dosage is 4 x 5 ml spoonfuls.

Children 0-1 year: The usual starting dose is ½ x 5 ml three times daily. This may be increased to 1 x 5 ml three times daily as necessary. The maximum recommended daily dosage is 3 x 5 ml spoonfuls.

Diluents: ALUPENT Syrup may be diluted with either Syrup BP or Sorbitol Solution BP

No specific information on the use of this product in the elderly is available.

Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

Hypertrophic obstructive cardiomyopathy, tachyarrhythmia. Hypersensitivity to any of the ingredients in ALUPENT Syrup.

A chronic requirement for treatment would suggest the need for clinical review of the management of the patient's asthma. The patient's need for anti-inflammatory therapy (e.g. corticosteroids), or the adequacy of such therapy in patients already receiving it should be assessed.

Patients must be warned not to exceed the prescribed dose. In the case of acute rapidly worsening dyspnoea a doctor should be consulted immediately.

Sympathomimetic agents can cause unwanted effects. The concomitant use of other sympathomimetic drugs should be avoided or only used under strict medical supervision. ALUPENT and anticholinergic bronchodilators have been administered concurrently in reversible airways obstruction. In some situations, co-administered sympathomimetic agents and anticholinergics have been shown to produce greater bronchodilatation than the use of either agent alone (but see Interactions).

In the following conditions ALUPENT should only be used after careful risk/benefit assessment, especially when doses higher than those recommended are used:

Insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, pheochromocytoma, hyperthyroidism.

Cardiovascular effects may be seen with sympathicomimetic drugs, including ALUPENT. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta-agonists. Patients with underlying severe heart disease (e.g.ischaemic heart disease, arrhythmia or severe heart failure) who are receiving ALUPENT, should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

Potentially serious hypokalaemia may result from excessive beta-agonist therapy. This effect may be potentiated by concomitant treatment with xanthine derivatives, glucocorticosteroids and diuretics.

Additionally, hypoxia may aggravate the effects of hypokalaemia on cardiac rhythm. It is recommended that serum potassium levels are monitored in such situations.

In view of the possible interaction between beta-adrenergics and monoamine oxidase inhibitors or tricyclic anti-depressants, care should be exercised if it is proposed to administer these compounds concurrently with ALUPENT.

Beta-adrenergics, anticholinergics and xanthine derivatives (such as theophylline) may enhance the bronchodilator effect of orciprenaline.

The concurrent administration of the other beta-adrenergics, systemically absorbed anticholinergics and xanthine derivatives (e.g. theophylline) may increase the frequency and severity of unwanted effects.

Beta₂-receptor blockers counteract the action of ALUPENT.

Potentially serious bronchospasm may occur during concurrent administration of beta-blockers to patients with reversible airways obstruction.

Inhalation of halogenated hydrocarbon anaesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility to the cardiovascular effects of beta-agonists.

Although orciprenaline sulphate has been in general use for several years, there is no definite evidence of ill-consequence following administration of the drug during human pregnancy. Only in doses far in excess of the equivalent maximum human dose were effects on foetal development seen in animals.

ALUPENT should only be used during pregnancy, especially the first trimester, if the potential benefit outweighs the potential risk to the foetus.

The inhibitory effect of orciprenaline sulphate on uterine contraction should be taken into account.

Safety in breast-fed infants has not been established.

None stated.

The most frequently reported undesirable effects observed with ALUPENT are tremor and nervousness, headache, dizziness, tachycardia, palpitations, gastro-intestinal discomfort, nausea and vomiting. Some patients have experienced a feeling of tightness of the chest.

Potentially serious hypokalaemia may result from beta₂-agonist therapy.

As with other beta-mimetics, sweating, weakness, myalgia/muscle cramps and myocardial ischaemia may occur. In rare cases decrease in diastolic blood pressure, increase in systolic blood pressure, arrhythmias, particularly after higher doses may occur.

In rare cases, local irritation, skin reactions or allergic reactions have been reported. There have been isolated cases of anaphylactic or anaphylactoid reactions.

In individual cases psychological alterations have been reported under inhalational therapy with beta-mimetics.

Symptoms

The expected symptoms of overdosage with ALUPENT are those of excessive beta-stimulation such as flushing, tremor, nausea, restlessness, tachycardia, palpitation, dizziness, headache, hypotension, hypertension, a feeling of pressure in the chest, excitation, angina, increased pulse pressure and arrhythmia. Hypokalaemia may occur following overdose with orciprenaline. Serum potassium levels should be monitored.

Therapy

Treatment of overdosage should primarily be supportive and symptom-oriented.

If specific therapy is considered necessary, cardioselective beta-blockers are to be preferred. These should be administered with extreme caution to patients with asthma because of the risk of precipitating severe bronchospasm.

ALUPENT is a sympathomimetic amine with bronchodilator properties.

Following oral administration, the effect is usually noted within 30 minutes. The peak effect of bronchodilator activity following orciprenaline sulphate generally occurs within 60-90 minutes, and lasts for 1 to 5 hours.

Following oral administration orciprenaline is absorbed from the GI tract and undergoes extensive first-pass metabolism; about 40% of an oral dose is reported to reach the circulation unchanged. It is excreted in the urine primarily as glucuronide conjugates.

Sodium metabisulphite

Disodium edetate dihydrate

Methyl parahydroxybenzoate

Propyl parahydroxybenzoate

Hydroxyethylcellulose

Saccharin

Sorbitol solution

Woodruff aroma

Sodium hydroxide

Purified water

None stated.

5 years

Do not store above 25°C. Keep container in the outer carton.

ALUPENT Syrup is available in pack sizes of 50ml, 250ml, 300ml and 2L in amber type III glass bottles with tamper-evident, child resistant polypropylene caps with expanded polyethylene liners. Not all pack sizes may be marketed.

No special requirements.

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

00015/0001R

21/2/96

February 2009

Prescription Only Medicine