PULMO-NEB 4
-
Chemical Name:
Salbutamol -
Therapeutic Category:
Respiratory tract drugs -
Pharmacologic Category:
Beta2 Agonist -
Pharmaceutical Form:
Tablets -
Composition:
Salbutamol 4mg
PULMO-NEB
Tablet
Salbutamol (Sulphate)
1-COMPOSITION:
PULMO-NEB 2 Tablets: Each tablet contains Salbutamol (Sulphate)2mg.
PULMO-NEB 4 Tablets: Each tablet contains Salbutamol (Sulphate) 4mg.
Excipient
PULMO-NEB 2
Lactose monohydrate, magnesium stearate, maize starch.
PULMO-NEB 4
Lactose monohydrate, magnesium stearate, maize starch, iron oxide yellow.
2-PHARMACOLOGY:
Mechanism of Action:
Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2
adrenoceptors of bronchial muscle, with little or no action on the beta-1 adrenoceptors of cardiac muscle.
Pharmacokinetics:
The majority of a dose of salbutamol given orally is excreted within 72h.
Salbutamol is bound to plasma proteins to the extent of 10%.
After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes
considerable first-pass metabolism to the phenolic Sulphate.
Both unchanged drug and conjugate are excreted primarily in the urine.
The bioavailability of orally administered salbutamol is about 50%.
3-INDICATIONS:
PULMO-NEB Tablets are indicated for the treatment of reversible airways obstruction of all types of
asthma, chronic bronchitis and emphysema.
4-CONTRAINDICATIONS:
Salbutamol tablets are contra-indicated in patients with a history of hypersensitivity to any of their
Components.
5-SIDE EFFECTS:
-The most common side effect are a tremor , muscle cramps, headache ,tachycardia, palpitations.
- Few side effects have been reported rarely including:
hypersensitivity reactions, urticaria, bronchospasm, hypotension , collapse, hypokalaemia , hyperactivity , cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia, extrasystoles , peripheral vasodilatation and feeling of muscle tension.
6-WARNINGS:
- The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.
Increasing use of short-acting inhaled beta-2 agonists to control symptoms indicates deterioration of
asthma control. Under these conditions, the patient's therapy plan should be reassessed.
Sudden and progressive deterioration in asthma control is potentially life-threatening and
consideration should be given to starting or increasing corticosteroid therapy. In patients considered
at risk, daily peak expiratory flow monitoring may be instituted.
- Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and
nebulised administration. Particular caution is advised in acute severe asthma as this effect may be
potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is
recommended that serum potassium levels are monitored in such situations.
- Salbutamol should be administered cautiously to patients with thyrotoxicosis.
- Salbutamol can induce reversible metabolic changes, The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported.
- Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or
severe heart failure) who are receiving salbutamol 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.
- Patients should be warned that if either the usual relief is diminished or the usual duration of action
reduced, they should not increase the dose or its frequency of administration, but should seek medical
advice.
7-DRUG INTERACTIONS:
- Salbutamol and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
- Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors
(MAOIs).
8-PREGNANCY AND LACTAION:
Pregnancy:
PULMO-NEB should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactaion:
salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless
the expected benefits outweigh any potential risk.
9-DOSAGE & ADMINISTRATION:
-Adults:
The usual effective dose is 4mg, three or four times per day.
If adequate bronchodilation is not obtained, each single dose may be gradually increased to as much as 8mg.
Some patients obtain adequate relief with 2 mg three or four times daily.
- Children:
2- 6 years: The minimum starting dose is 1mg (1/2 tablet), three times daily. This may be increased
to 2mg , three or four times daily.
6 - 12 years: The minimum starting dose is 2mg , three times daily. This may be increased
to four times daily.
Over 12 years: The minimum starting dose is 2mg three times daily. This may be increased to 4mg three or four times daily.
- Elderly:
In elderly patients or in those known to be usually sensitive to beta-adrenergic stimulant drugs, it is
advisable to initiate treatment with 2 mg salbutamol three or four times per day.
10-OVERDOSAGE:
hypokalaemia may occur following overdose with salbutamol. Serum Potassium levels should be monitored.
Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Treatment:
Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such
as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia,
palpitations). Beta-blocking drugs should be used with caution in patients with a history of
bronchospasm.
11-PACKAGING :
PULMO-NEB 2 Tablets: carton package of 20 Tablets.
PULMO-NEB 4 Tablets: carton package of 20 Tablets.
12-STORAGE:
Store PULMO-NEB at temperature below 25°C, Protect from moisture.
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