Salbutamol 4mg tablets

The expected signs and symptoms with overdosage of albuterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis).[Label] In particular, the signs of salbutamol overdosage are significant tachycardia and/or significant muscle tremor.[F3265,F3268]

Hypokalaemia may occur following overdosage with salbutamol.F3265 Serum potassium levels should be monitored.F3265

Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.[F3265,F3268]

Salbutamol is categorized as Pregnancy Category C.[Label] There are no adequate and well-controlled trials with salbutamolc or albuterol sulfate in pregnant women.[Label] During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with salbutamol.[Label] Some of the mothers were taking multiple medications during their pregnancies.[Label] No consistent pattern of defects can be discerned, and a relationship between salbutamol use and congenital anomalies has not been established.[Label] Animal reproduction studies in mice and rabbits revealed evidence of teratogenicity.[Label] Salbutamol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetusLabel]. Women should be advised to contact their physicians if they become pregnant while taking salbutamol.[Label]

Since there exists a potential for beta-agonist interference with uterine contractility, the use of salbutamol during labour should be restricted to those patients in whom the benefits clearly outweigh the risk.[Label]

Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of salbutamol are excreted in human milk.[Label] Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of salbutamol by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.[Label] Caution should be exercised when salbutamol is administered to a nursing woman.[Label]

The safety and effectiveness of salbutamol in children younger than 4 years of age has not yet been established.[Label]

Clinical trials of VENTOLIN HFA did not include sufficient numbers of subjects aged 65 years and older to determine whether older subjects respond differently than younger subjects.[Label] Other reported clinical experience has not identified differences in responses between the elderly and younger patients.[Label] In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.[Label]

The LD₅₀ value was determined to be 1100 mg/kg (orally in mice).