VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION 5 MG/5 ML [SIN02539P]

Product Info

VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION 5 MG/5 ML

[SIN02539P]

Indication

INDICATIONS

Respiratory

Salbutamol is a selective beta-₂ agonist indicated for the treatment or prevention of bronchospasm. It provides short acting bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema.

Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma unresponsive to VENTOLIN, treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failing to respond to treatment with VENTOLIN may signal a need for urgent medical advice or treatment.

VENTOLIN injection/solution for infusion is indicated for the relief of severe bronchospasm associated with asthma or bronchitis and for the treatment of status asthmaticus. It is suitable for the management of an asthma attack under the direction of a physician.

Obstetric

VENTOLIN injection/solution for infusion is a selective beta-₂ adrenoceptor agonist. At therapeutic doses, it acts on the beta-₂ adrenoceptors in the uterus, with little or no action on the beta-₁ adrenoceptors of the heart. It is indicated to arrest uncomplicated labour between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy, under the direction of a physician.

Dosing

DOSAGE AND ADMINISTRATION

Pharmaceutical form: Injection/Solution for Infusion.

VENTOLIN has a duration of action of 4 to 6 hours in most patients.

The dosage should be adjusted, depending on the clinical situation.

VENTOLIN parenteral preparations are to be used under the direction of a physician.

Note: The contents of the ampoules of VENTOLIN solution for intravenous infusion must not be injected undiluted. The concentration should be reduced by 50% before administration.

VENTOLIN parenteral preparations should not be administered in the same syringe or infusion as any other medication.

Increasing use of beta-₂ agonists may be a sign of worsening asthma. Under these conditions, a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.

In severe bronchospasm and status asthmaticus:
Adults

Subcutaneous Route:
500 mcg (8 mcg/kg bodyweight) and repeated every 4 hours as required.

Intramuscular Route:
500 mcg (8 mcg/kg bodyweight) and repeated every 4 hours as required.

Intravenous Route:
250 mcg (4 mcg/kg bodyweight) injected slowly. If necessary, the dose may be repeated.

If VENTOLIN Injection 500 mcg in 1 mL (500 mcg/mL) is used, the injection may be facilitated by dilution with water for injections.

Infusion:
In status asthmaticus, infusion rates of 3 to 20 mcg per minute are generally adequate but in patients with respiratory failure, higher dosage has been used with success. A starting dose of 5 mcg per minute is recommended with appropriate adjustment in dosage according to patient response.

A suitable solution for infusion may be prepared by diluting 5 mL of VENTOLIN solution for intravenous infusion in 500 mL of an infusion solution such as Sodium Chloride and Dextrose Injection BP to provide a salbutamol dose of 10 mcg/mL of solution.

Children

At present there is insufficient evidence to recommend a dosage regimen for routine use in children.

In the management of premature labour:

Treatment with VENTOLIN injection/solution for infusion should only be initiated by obstetricians/physicians experienced in the use of tocolytic agents. Ideally, it should be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetal health status.

Duration of treatment should not exceed 48 hours as data show that the main effect of tocolytic therapy is a delay in delivery of up to 48 hours. No statistically significant effect on perinatal mortality or morbidity has been observed in randomized, controlled trials. This delay may be used to administer glucocorticoids or to implement other measures known to improve perinatal health.

VENTOLIN injection/solution for infusion should be administered as early as possible after the diagnosis of premature labour, and after evaluation of the patient to eliminate any contraindications to the use of VENTOLIN (see Contraindications). This should include an adequate assessment of the patient’s cardiovascular status with continuous ECG monitoring throughout treatment (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For this indication, VENTOLIN solution for intravenous infusion is recommended using a solution prepared as above. Infusion rates of 10 to 45 mcg per minute are generally adequate to control uterine contractions but greater or lesser infusion rates may be required according to the strength and frequency of contractions. A starting rate of 10 mcg per minute is recommended, increasing the rate at 10-minute intervals until there is evidence of patient response shown by diminution in strength, frequency or duration of contractions. Thereafter the infusion rate may be increased slowly until contractions cease. Careful attention should be given to cardio-respiratory function, including increases in pulse rate and changes in blood pressure, electrolytes, glucose and lactate levels and fluid balance monitoring. A maximum sustained maternal heart rate of 120 beats/min should not be exceeded. Treatment should be discontinued should signs of pulmonary oedema or myocardial ischaemia develop (see Warnings and Precautions and Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Once uterine contractions have ceased, the infusion rate should be maintained at the same level for 1 hour and then reduced by 50% decrements at 6-hourly intervals.

As an alternative procedure or to counteract inadvertent overdosage with oxytocic drugs, VENTOLIN Injection may be administered as a single injection by the intravenous route. The usual recommended dose is 100 to 250 mcg of salbutamol. The dose may be repeated according to the response of the patient.

Contraindications

CONTRAINDICATIONS

VENTOLIN parenteral preparations are contra-indicated in patients with a history of hypersensitivity to any of their components.

Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or threatened abortion.

Obstetric

VENTOLIN injection/solution for infusion, when used in the management of premature labour, is contra-indicated in the following conditions:

• At a gestational age < 22 weeks.

• Intrauterine foetal death, known lethal congenital or lethal chromosomal malformation.

• Threatened abortion during 1^st and 2^nd trimester.

• Any condition of the mother or foetus in which prolongation of the pregnancy is hazardous e.g. severe toxaemia, intrauterine infection, vagina bleeding resulting from placenta previa, eclampsia or severe preeclampsia, placenta abruption, or cord compression.

• In patients with pulmonary hypertension, pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease.