Each 5 rnl Bronchoterol syrup contains:
Salbutamol as Sulfata 2 mg
Sucrose, methyl paraben sodium, propyl paraben sodium, ponceau 4R 85%. citric acid anhydrous, sodium citrate dihydrate,
tutti flavour , purified water.
– Salbutamol is aselective beta-2 adrenoceptor agonist providing short-acting (4-6 hours) bronchodilatation In reversible airways
obstruction. Bronchoterol syrup can be used in the management of asthma, bronchospasm and/or reversible airways obstruction.
– Relief of bronchospasm in bronchial asthma of all types.
– Bronchotetol syrup is suitable oral therapy for children and adults who are unable to used an inhaler device .
DOSAGE AND ADMINISTRATION :
Salbutamol has a duration 0f action of 4 to 6 hours in mast petients.
Increasing use of B2 agonists may be sign of worsening asthma. Under these conditions a reassessment of the patient’s therapy plan may be required and concomitant glucocorticosteroid therapy should be considerad as there may be adverse effects associated with excessive dosing, the dosage or frequency 0f admnistration should only be Increased on medical advice .
The usual effective dose is 4 milligrams three or four times per day. If adequate bronchodilation is not obtained each single dose may be gradually Increased to as much as 8 milligrams.
Some patients obtain adequate relief with 2 milligrams three or four times daily. In the management of premature labour after uterine contractions have been controlled by intravenous infusion 0f
Salbutamol and the infusion hat been withdrawn, maintenance therapy can be continued with oral salbutamol. The usual dosage is 4 milligrams, three or four limes daily .
2·6 years: 110 2 mg three or four times daily (or 2.5-5 mI of syrup)
6·12 years: 2 mg three or four times daily. (5 mlayrup)
Over 12 yean: 2·” mg tine or four times daily.
Special patient groups :
In elderly patients or in those known to be unusualy sensitive to B.adrenergic stimulant drugs. It is advisable to initiate treatment with 2 milligrams salbutamol three or four times per day.
bronchoterol Is contraindicated in patients with a history of hypersensitivity to any of their components.
WARNINGS AND PRECAUTIONS :
– Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma severe asthma requires regular medical asessment including lung function testing as patients are at risk of severe attacks and even death. Physicians should consider using oral corticosteroid therapy and/or themaximum recommended dose of inhaled corticosteroid in those patients
– Patients should seek medical advice if treatment with Bronchoterol syrup becomes less effectivt
– The dosage or frequency of administration should only be increased on medical advice.
– Patients taking Bronchoterol syrup any also be receiving short acting inhaled brnnchoditatorl to relieve symptoms.
-lncreasing use of bronchodilators in particular short-ecting Inhaled bronchodilators to releve symptoms incllcates deterionition of asthma control. The patient should be instruacted to seek medical advice if short acting relife bronchodilator treatment becoment less effctive or they need more inhalations than usual in this situation petients should be reassessed and consideration given 110 the need for increased anti inflaammatory therapy (eg Higher doses of inhaled corticisteroids or acourse of oral corticosteroid severe exacerbations of asthma must be treated in the normal way
– Patients should be wamed that if either the usual relief with bronchoterol oralpreparations is diminished or the usual duration
of action reduced, they should not increase the dose or its frequency of administrtion, but should seek medical advica. – Bronchoterol syrup and non-selecIlve beta-blocklng drugs, such 8S pmpranoIoI, should not usually be prescr1bed togethef.
– Cardiovascular effects may be seen with sympathomimetic drugs, Including salbutamol. There Is some evidence from post marketing data and published literature auociated with salbutamot Patients with undeftying severe heart disease. Attention should be pelcllo asseument of symptDms sucf’1 as dyspnoea and c:hHt pein, as they may be of either respiratory or cardiac origin.
– Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis. – Potentially serious hypokalaemia may rasult from beta-2 agonist therapy mainly from parenteral and nebulised administration. Particulaf caution is advised in increased asthma as effect may be potentieted by hypoxia end by concomitant treatment with xantNnra derivatives, steroids. Its recomended that serum potassum levels are monitored is such situations.
– In common with other agonists. salbutamol can induce stie metabolic changes such as increased blood glucosediabetic patients may be untile to compenute for It. may in blood glucose and development reported concurent administration of corticosteroid can exaggerate this effect.
– salbutamol and non-selective b-blocking drugs, such as propran0lol should not usually be pretcfib8d together.
– Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
PREGNANCY AND LACTATION :
– Administration of drugs during pregnancy should only be conaidered if the expected benefit to the mother is greater than
eny possible risk to the foetus . during worldwide marketing experience rare cases of various congenital anomalies including cleft palate and limb defects have been reported in the offspring of patients being treated with salbutamol. Some of the
mothers were taking multiple medications during theirpregnancies Because no consistent pattem of defects can be discemed, and baseline rate for congential anomalies is 2-3%, a relationship with salbutamol use cannot be established.
– As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected benefits outweigh the potential risk. It is not known whether salbulamol in breast milk has a harmful effect on the neonate.
ABILITY TO DRIVE AND USE MACHINES :
ADVERSE REACTIONS :
Adverse events ere bled below by system organ class and frequency. Frequr.ciea ere defined as: very common ~1/10).
common (iZ:1f100 and <1/10), uncommon (iZ:1f1ooo and <1/100), rare ~1f10,ooo and <1/1000) and very rare «1/10.000)
including Isolated report&. Very common and common evenla weN! generally determined from clinical trial deta. Rare and
very rare events were generally determined from spontaneous data.
Immune system dI$c:lrdIn
Very rare: Hypersenaltmty.-.actions 1nckJding~. urticaria. bronchoapum. hypotension and collapse.
Metabolism and nutrition disofders
Rare: Hypokalaemia, potentially serious hypokalaemia may result from beta2 agonist thenipy.
Nervous system disorders
Vwy common: Tremor.
Common: Tachycardia, palpitations.
Rare: Peripheral vuodKatation.
Musculoskeletal and connectlve tissue dlsorde,.
Common: Muscle cramps.
Very rare: Feeling of muscle tension.
The preferred antidote for 0verd0sage with salbutamol is a cardioselective b-blocking agent. However b-blocking drugs
should be used with caution im patients with ahistory of bronchospasm. Hypokalaemia may occur following overdose with salbutamol Serum potassium levels should be monitored.
Salbutamol is a selective b2 adrenoceptor agonist. At thefapeutic doses it ads on the b2 adrenocaptors of bronchial muscle,
with little or no action on the b-1 adrenoceptora of cardiac muscle.
carton box containing brown round glass bottile (Type 111) of 120 ml with aluminum cap and inner leaflet
Keep at atemperature not exceeding 30 c keep all medications out of reach of children.
Produced by :
PHARAONIA PHARMACEUTICALS (PHARO PHARMA)
NEW BORG EL-ARAB CITY ALEXANDRIA – Egypt