Butalin Tablets
Salbutamol
2mg
Julphar (Gulf Pharmaceutical Industries)
| Pack size | 20's Blister |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | JULPHAR |
| Retail Price | 5.00 AED |
Available as:
Indications
Butalin Tablets is used for:
Acute severe asthma, Severe bronchospasm
Adult Dose
Oral
Acute bronchospasm
Adult: 2-4 mg 3 or 4 times daily, up to 8 mg 3 or 4 times daily.
As modified-release tab: 8 mg bid.
Not to exceed 32 mg/day
Elderly: 2 mg 3 or 4 times daily.
Inhalation
Acute bronchospasm, Intermittent episodes of asthma
Adult: As metered-dose aerosol or dry powd inhaler (90 or 100 mcg/actuation): 1 or 2 inhalations (1 ConviCap) as a single dose when required.
Not to exceed 12 inhalations/24 hr
Chronic maintenance or prophylactic therapy
Adult: As metered-dose aerosol or dry powd inhaler (90 or 100 mcg/actuation): 2 inhalations (1 ConviCap) 3-4 times daily. Max: 800 mcg daily.
Acute severe asthma
Adult: As metered-dose inhaler (100 mcg/actuation) via spacer device: Initially, 4-8 puffs inhaled every 20min for up to 4 hr and then 1-4hrly as required. Max: 10 inhalations.
Prophylaxis of exercise-induced bronchospasm
Adult: As metered-dose aerosol or dry powd inhaler (90 or 100 mcg/actuation): 2 inhalations (1 ConviCap) 10-15 min prior to exercise.
Nebuliser Solution
Severe bronchospasm
Adult: Via nebuliser: 2.5-5 mg, up to 4 times daily, alternatively, may be given continuously at a rate of 1-2 mg/hr.
Reconstitution: Dilute 0.5 mL of soln to a total of 3 mL w/ NaCl 0.9% to prepare a 2.5 mg dose.
Respirator Solution
0.5-1.0 ml should be diluted to final volume of 3-4 ml with normal saline for injection. The resulting solution is inhaled from a suitably driven nebulizer until aerosol generation ceases. Should take about 10 minutes.
Parenteral
Severe bronchospasm
Adult: IM/SC: 500 mcg (8 mcg/kg) and repeated 4 hrly as required.
Intravenous
Severe bronchospasm
Adult: As 50 mcg/mL soln: 250 mcg (4 mcg/kg) injected slowly. May be repeated if necessary.
As 10 mcg/mL soln: Usual rate of 3-20 mcg/min (0.3-2 mL/min), adjusted according to patient needs. Higher doses may be used in resp failure.
Reconstitution: Dilute 5 mL of soln w/ 500 mL NaCl or dextrose inj or other suitable diluents to provide a 10 mcg/mL soln.
Child Dose
Oral
Children
Acute bronchospasm
Tablet
Child: 2-6 yr 1-2 mg;
>6-12 yr 2 mg;
>12 yr 2-4 mg 3 or 4 times daily, up to 8 mg 3 or 4 times daily.
Syrup
2 - 6 years: 2.5 ml syrup, 3-4 times daily
6-12 years: 5 ml syrup, 3-4 times daily
Over 12 years: 5-10 ml syrup, 3-4 times daily (2-4 mg tablet, 3-4 times daily)
Inhalation
Acute bronchospasm
Child: 4-12 yr 1 inhalationas a single dose, may be increased to 2 inhalations as necessary. Max: 400 mcg daily.
Prophylaxis of exercise-induced bronchospasm
Child: 4-12 yr 1 inhalation 10-15 min prior to exercise.
Nebuliser Solution
Severe bronchospasm
Child> 4 years: Via nebuliser: 2.5-5 mg, up to 4 times daily, alternatively, may be given continuously at a rate of 1-2 mg/hr.
Reconstitution: Dilute 0.5 mL of soln to a total of 3 mL w/ NaCl 0.9% to prepare a 2.5 mg dose.
Respirator Solution
0.5-1.0 ml should be diluted to final volume of 3-4 ml with normal saline for injection. The resulting solution is inhaled from a suitably driven nebulizer until aerosol generation ceases. Should take about 10 minutes.
Parenteral
Severe bronchospasm
Child >12 years: IM/SC: 500 mcg (8 mcg/kg) and repeated 4 hrly as required.
Intravenous
Severe bronchospasm
Child >12 years: As 50 mcg/mL soln: 250 mcg (4 mcg/kg) injected slowly. May be repeated if necessary.
As 10 mcg/mL soln: Usual rate of 3-20 mcg/min (0.3-2 mL/min), adjusted according to patient needs. Higher doses may be used in resp failure.
Reconstitution: Dilute 5 mL of soln w/ 500 mL NaCl or dextrose inj or other suitable diluents to provide a 10 mcg/mL soln.
Renal Dose
Administration
Tablet/Syrup: Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals.
Aerosol Metered-Dose Inhaler
Prime the inhaler before using for the first time and in cases where the inhaler has not been used for >2 weeks by releasing 4 “test sprays” into the air, away from the face
Patient instructions for administration
Shake well before each use
Breathe out fully through the mouth, expelling as much air from your lungs as possible; place the mouthpiece fully into the mouth, holding the inhaler in its upright position and close the lips around it
While breathing in deeply and slowly through the mouth, fully depress the top of the metal canister with your index finger
Hold your breath as long as possible, up to 10 seconds; before breathing out, remove the inhaler from your mouth and release your finger from the canister
If your physician has prescribed additional puffs, wait 1 minute, shake the inhaler again, and repeat steps listed above; replace the cap after use
Cleaning
To maintain proper use of this product, it is important that the mouthpiece be washed and dried thoroughly at least once a week
Keeping the plastic mouthpiece clean is very important to prevent medication buildup and blockage
The inhaler may cease to deliver medication if not properly cleaned and air dried thoroughly
If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage
Powder Metered-Dose Inhaler
Does NOT require priming
Do not use with a spacer or volume holding chamber
Cleaning
Keep clean and dry at all times
Never wash or put any part of inhaler in water
Routine maintenance not required
If the mouthpiece needs cleaning, gently wipe with a dry cloth or tissue as needed
Contra Indications
Salbuatmol inhaler is contraindicated in patients with a history of hypersensitivity to any of its components. Although intravenous Salbutamol, and occasionally Salbutamol tablets, is used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, Salbutamol inhaler preparations are not appropriate for managing premature labour. Salbutamol preparation should not be used for threatened abortion during the first or second trimesters of pregnancy.
Precautions
Hyperthyroidism, myocardial insufficiency, arrhythmias, susceptibility to QT-interval prolongation, HTN, DM, glaucoma, hypokalaemia, seizure disorder. Renal impairment. Elderly. Pregnancy and lactation. Monitoring Parameters Monitor BP, heart rate, electrolyte and fluid balance; glucose, lactate and K levels.
Lactation: Unknown whether drug is excreted in milk; not recommended
Pregnancy-Lactation
Pregnancy
There are no randomized clinical studies of use during pregnancy
Available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage
In animal reproduction studies, when administered SC to pregnant mice there was evidence of cleft palate at ?9x the maximum recommended human daily inhalation dose (MRHDID)
Clinical considerations
Disease-associated maternal and/or embryo/fetal risk
In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate
Closely monitor pregnant women and adjust medications as necessary to maintain optimal control
Labor or delivery
Because of potential for beta-agonist interference with uterine contractility, restrict use for relief of bronchospasm during labor to those patients in whom the benefits clearly outweigh the risk
Lactation
There are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Interactions
Diuretics, corticosteroids and xanthines may augment hypokalaemia. CV effects potentiated by MAOIs, TCAs, sympathomimetics. Increases absorption of sulfamethoxazole when used together. May markedly increase heart rate and BP when used with atomoxetine. Reduces serum levels of digoxin. Hypokalaemia induced by salbutamol increases the risk of digitalis toxicity. BP should be closely monitored if linezolid is used concurrently with salbutamol.
Adverse Effects
Side effects of Salbutamol :
>10%
Tremor (20%), Nervousness in children aged 2-6 years (20%), Insomnia in children aged 6-12 years receiving 4-12 mg q12hr (11%)
1-10%
Nausea (10%), Fever (1.6-9%), Bronchospasm (8%), Vomiting (7%), Headache (4-7%), Dizziness (1-7%), Cough (5%), Allergic reactions (4%), Otitis media (3.3%), Epistaxis in children (3%), Increased appetite (3%), Urinary tract infection (3%), Dry mouth (<3%), Eructation or flatulence (<3%), Increased sweating (<3%), Pain (2.7%), Dyspepsia (1-2%), Hyperactivity (1-2%), Chills (<2%), Lymphadenopathy (<2%), Ocular pruritus (<2%), Sweating (<2%), Conjunctivitis in children aged 2-6 years (1%), Dysphonia (>1%), Flu syndrome, Nervousness
<1%
Epigastric pain, Epistaxis in adults, Hyperactivity in children
Frequency Not Defined
Adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, metabolic acidosis, and drying or irritation of oropharynx
Hypersensitivity, Hypokalemia, Increased blood glucose levels, Prolonged QT interval and ST-segment depression, Sleeplessness, Tachycardia (incidence varies with formulation)
Urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema (rare)
Potentially Fatal: Potentially serious hypokalaemia after large doses.
Mechanism of Action
Salbutamol is a direct-acting sympathomimetic with beta-adrenergic activity and selective action on ?2 receptors, producing bronchodilating effects. It also decreases uterine contractility.
Note
Butalin 2mg Tablets manufactured by Julphar (Gulf Pharmaceutical Industries). Its generic name is Salbutamol. Butalin is availble in United Arab Emirates.
Farmaco UAE drug index information on Butalin Tablets is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.