COMPOSITION :
Dilatamol® Inhaler 100 mcg, each actuation contains : Salbutamol sulfate equivalent to 100 mcg Salbutamol.
DESCRIPTIONS :
Dilatamol® contains Salbutamol sulfate as active ingredient (equivalent to Salbutamol) is available in inhaler which contains at least 200 MDI. Dilatamol® is a type of an inhaler CFC free which are environmentally friendly.
INDICATION :
Salbutamol is a selective β2 adrenoceptor agonist. At therapeutic doses it acts on the β2 adrenoceptors of bronchial muscle, with little or no action on the β1 adrenoceptors of the heart. With its fast onset of action, it is particularly suitable for the management and prevention of attack in asthma.
Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (e.g. > 1 mg/day Beclomethasone dipropionate) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision.
Salbutamol is particularly valuable as relief medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and use of regular inhaled corticosteroid therapy.
DOSAGE AND ADMINISTRATIONS :
Dilatamol® Inhaler is administered by the oral inhaled route only.
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Increasing use of β2 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.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.
Dilatamol® is administered by the oral inhaled route only.
Babies and young children using Dilatamol® Inhaler CFC free may benefit from the use of a paediatric spacer device with a face mask.
Relief of acute bronchospasm :
Adults : 100 or 200 mcg.
Children : 100 mcg the dose may be increased to 200 mcg if required.
Prevention of allergen on exercise-induced bronchospasm :
Adults : 200 mcg before challenge.
Children : 100 mcg before challenge, the dose may be increased to 200 mcg if required.
Chronic therapy :
Adults : Up to 200 mcg, 4 times daily.
Children : Up to 200 mcg, 4 times daily.
On demand use of Dilatamol® should not exceed four times daily. Reliance on such supplementation use or a sudden increase in dose indicates deteriorating asthma (see WARNINGS AND PRECAUTIONS).
Instruction for use/handling
Testing your inhaler :
Before using for the first time remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well and release two puffs into the air to make sure that it works. If it has not been used for several days shake it well and release one puff into the air to make sure that it works.
Using your inhaler :
Remove the mouthpiece cover by gently squeezing the sides of the cover and check the mouthpiece inside and outside to see that it is clean.
Shake the inhaler well.
Hold the inhaler upright between fingers and thumb with your thumb on the base, below the mouthpiece.
Breathe out as far as is comfortable and then place the mouthpiece in your mouth between your teeth and close your lips around it but do not bite it.
Just after starting to breathe in through your mouth press down on the top of the inhaler to release Salbutamol while still breathing in steadily and deeply.
While holding your breath, take the inhaler from your mouth and take your finger from the top of the inhaler. Continue holding your breath for as long as is comfortable.
If you are to take further puffs keep the inhaler upright and wait about half a minute before repeating steps 2 – 6.
The mouthpiece cover is replaced by firmly pushing and snapping the cap into position.
Note :
Do not rush stages 4, 5 and 6. It is important that you start to breathe in as slowly as possible just before operating your inhaler.
Practise in front of a mirror for the first few times. If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth you should start again from stage 2.
If your doctor has been given you different instructions for using your inhaler, please follow them carefully. Tell your doctor if you have any difficulties.
Cleaning :
Your inhaler should be cleaned at least once a week.
Remove the metal canister from the plastic casing of the inhaler and remove the mouthpiece cover.
Rinse the actuator thoroughly under warm running water.
Dry the actuator thoroughly inside and out.
Replace the metal and mouthpiece cover.
OVERDOSAGE :
Hypokalaemia may occur following overdose with Salbutamol. Serum potassium levels should be monitored.
The most common signs and symptoms of overdose with Dilatamol® are transient beta agonist pharmacologically mediated events (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS).
Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardioselective beta-blocking agent in patients presenting with cardiac symptoms (e.g., tachycardia, palpitations).
Beta-blockings drugs should be used with caution in patients with a history of bronchospasm.
CONTRAINDICATIONS :
In patients with a history of hypersensitivity to any of its component. Although intravenous Salbutamol and occasionally Salbutamol tablets are used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, inhaled Salbutamol presentations are not appropriate for managing premature labour. Salbutamol preparations should not be used for threatened abortion.
WARNINGS AND PRECAUTIONS :
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 β2 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 flow monitoring may be instituted.
Salbutamol should be administered cautiously to patients with thyrotoxicosis.
Potentially serious hypokalaemia may result from β2 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.
In the event of a previously effective dose of inhaled Salbutamol failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.
The patient’s inhaler technique should be checked to make sure that aerosol actuation is synchronised with inspiration of breath for optimum delivery of the drug to the lungs.
Use during pregnancy and lactation :
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Rare case 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 mother were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be discerned and baseline rate for congenital 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 any potential risk. It is not known whether Salbutamol in breast milk has a harmful effect on the neonate.
Effects on ability to drive and use machines : None reported.
DRUG INTERACTIONS :
Salbutamol and non-selective β-blocking drugs, such as Propanolol, should not usually be prescribed together. Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
ADVERSE REACTIONS :
Immune system disorders
Very rare (< 1/10000) : Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and nutrition disorder
Rare : Hypokalaemia.
Potentially serious hypokalaemia may result from β2 agonist therapy.
Nervous system disorders
Common : Tremor, headache.
Very rare : Hyperactivity.
Cardiac disorders
Common : Tachycardia.
Very rare : Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
Vascular disorders
Rare : Peripheral vasodilation.
Respiratory, thoracic and mediastinal disorders
Very rare : Paradoxical bronchospasm.
As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. Inhaler should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted.
Gastrointestinal disorders
Uncommon : Mouth and throat irritation.
Musculoskeletal and connective tissue disorders
Uncommon : Muscle cramps.
PRESENTATION :
Dilatamol® Inhaler 100 mcg Box, 1 canister @ 200 MDI
Reg. No. DKI1850400139A1
STORAGE :
STORE BELOW 30°C, DO NOT FREEZE
The metal canister is pressurised. Do not use or store near heat or open flame. Exposure to temperatures above 50ºC may cause bursting. Never throw container into fire to incinerator even when apparently empty.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
MEDISOL LIFESCIENCE PVT. LTD.
Valsad – India
For :
BERNOFARM
Sidoarjo – Indonesia
