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Meptin Syrup

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Meptin® syrup
Procaterol Hydrochloride syrup preparation

COMPOSITION AND DESCRIPTION
1.Composition
Each mL of Meptin syrup contains 5 μg of procaterol hydrochloride.
The formulation contains 3% ethyl alcohol used as a solvent.
2.Product Description
Meptin syrup is a colorless. clear and slight viscous liquid. It has an orange odor and a sweet taste.
pH: 3.5 - 4.5

INDICATIONS
Remission of various symptoms caused by respiratory obstructive disturbance in the following diseases bronchial asthma. chronic bronchitis. pulmonary emphysema. acute bronchitis, and asthma-like bronchitis.

CONTRAINDICATIONS
(Meptin syrup is contraindicated in the following patients)
Patients with a history of hypersensitivity to any ingredient of this drug.

DOSAGE AND ADMINISTRATION
The usual adult dosage is 10 mL of Meptin syrup (50 μg of procaterol hydrochloride) once before bed or twice (in the morning and before bed) a day by the oral route.
The dosage in children 6 years of age or older is 5 mL of Meptin syrup (25 μg of procaterol hydrochloride) once before bed or twice (in the morning and before bed) a day by the oral route.
The dosage in children less than 6 years of age is 0.25 mL of Meptin syrup (1.25 μg of procaterol hydrochloride) per kg body weight once before bed or twice (in the morning and before bed) a day by the oral route.
The dosage may be adjusted according to the patient's age and severity of symptoms. The recommended usual doses for children younger than 6 years old are listed below.
Children younger than 1 year old: 2-3 mL of Meptin syrup (10-15 μg of procaterol hydrochloride).
Children 1-3 years of age: 3-4 mL of Meptin syrup (15-20 μg of procaterol hydrochloride).
Children 3-6 years of age: 4-5 mL of Meptin syrup (20-25 μg of procaterol hydrochloride).

PHARMACOLOGY
1.Bronchodilatory Action
The bronchodilatory action of procaterol hydrochloride was comparable to or more potent than that of isoproterenol and more potent than that of salbutamol and orciprenaline, as determined by inhibition of increased pulmonary resistance, in dogs. cats, and guinea pigs.

2.Duration of Bronchodilatory Action
Procaterol hydrochloride had a longer duration of action than isoproterenol, trimetoquinol, orciprenaline, or salbutamol in dogs, cats, and guinea pigs.

3.Selectivity for β2-Adrenergic Receptors (Organ Selectivity)
The selectivity of procaterol hydrochloride for β2-adrenergic receptors in the respiratory system was greater than that for such receptors in the cardiovascular system, as compared to isoproterenol, trimetoquinol, orciprenaline, and salbutamol, in dogs, cats, and guinea pigs.

4.Anti-allergic Action
Procaterol hydrochloride exhibited a definite anti-allergic action by inhibiting antibody-induced increases in airway resistance, the PCA reaction, and histamine release from sensitized lung tissues in guinea pigs and rats, as well as allergen-induced skin reactions, and increases in asthmatic responses to antibody inhalation in bronchial asthma patients, as compared to isoproterenol, trimetoquinol, orciprenaline, and salbutamol. The drug also inhibited allergen induced delayed-type and immediate-type bronchial responses.

5.Effects on Airway Secretion
Procaterol hydrochloride accelerates ciliary activity in the airways of pigeons.

6.Inhibitory Effect on Exercise-Induced Asthma Episodes
The results of treadmill or ergometer exercise or methacholine loading tests suggest that procaterol hydrochloride suppresses exercise-induced asthma attacks in patients with bronchial asthma.

7.Effect on Accelerated Airway Hypersensitivity
Procaterol hydrochloride inhibited airway hypersensitivity accelerated by the inoculation of influenza virus C in dogs.

8.Inhibitory Effect on Accelerated Vascular Permeability
Procaterol hydrochloride inhibited the acceleration of vascular permeability and edema formation in dorsal subcutaneous air sacs in rats experimentally prepared using various inflammatory chemical agents. Its potency was similar to that of isoproterenol. Procaterol hydrochloride also inhibited pulmonary edema induced by histamine inhalation in guinea pigs. with greater potency than salbutarnol.

9.Effect on Cough
Procaterol hydrochloride inhibited cough in acute bronchitis induced by the inhalation of substance P.

PHARMACOKINETICS
1.Plasma Concentrations
When procaterol hydrochloride was administered orally to 6 healthy male subjects at single doses of 50 and 100 μg/ subject. the following plasma concentration curves and pharmacokinetic parameters were obtained.


Plasma kinetic data
Dose
Tmax
Cmax
Half-life
50 μg
1.1 hr
97 pg/mL
Not determined
100 μg
1.5 hr
226 pg/mL
3.6 hr

2.Urinary Excretion
When procaterol hydrochloride was administered orally as single doses of 50 and 100 μg/subject, 9.93% and 11.65% of the dose were excreted in the urine within 24 hours post-dosing, respectively.

PRECAUTIONS
1.Careful Administration (Meptin syrup should be administered with care in the following patients.)
  1. Patients with hyperthyroidism (The disease may be exacerbated.)
  2. Patients with hypertension (Blood pressure may further increase.)
  3. Patients with heart disease (Palpitation, arrhythmia exacerbation of heart disease, and other symptoms may occur.)
  4. Patients with diabetes mellitus (The disease may be exacerbated.)
  5. Patients during pregnancy or suspected pregnancy (See Use during Pregnancy, Delivery or lactation section.)
2.Important Precautions
  1. If the desired therapeutic effect of Meptin syrup cannot be achieved at the recommended dose, the drug should be discontinued.
  2. Continuous administration of excessive amounts of this drug may cause cardiac arrhythmia and cardiac arrest. Special care should therefore be taken not to exceed the recommended dosage of this drug.
3.Use in the Elderly
Dosage adjustment or other appropriate measures should be considered when prescribing Meptin syrup to elderly patients, because these patients may be physiologically more sensitive to the drug than younger patients.

4.Use during Pregnancy, Delivery, or Lactation
  1. This drug should be administered to pregnant or possibly pregnant women only If the expected therapeutic benefit is thought to outweigh any possible risk. (The safety of this drug during pregnancy has not been established.)
  2. Nursing should be interrupted before starting treatment with the drug. (Rat studies showed that procaterol hydrochloride is excreted in breast milk.)
5.Pediatric Use
The safety of this drug in premature babies and neonates has not been established. (Clinical experience in premature babies and neonates is insufficient.)

6.Effects on Laboratory Tests
This drug tends to inhibit skin reactions in allergen tests. The drug should be withdrawn 12 hours prior to such tests.

7.Other Precautions
  1. Tissue damage in cardiac muscle was noted at 30 and 10 mg/kg/day or higher in the sub-acute and chronic toxicity studies, respectively, using rats. The damage was also observed in dog studies. However, the damage has been reported for other β2-adrenergic stimulants in both rat and dogs.
  2. Administration of procaterol hydrochloride with diet for 104 weeks was reported to cause mesovarian leiomyoma in SD rats. The tumor, however, is rat species specific and tends to develop during the long-term use of β2-adrenergic stimulants.

ADVERSE REACTIONS
In clinical trials involving 22,757 subjects, a total of 644 patients (2.83%) showed adverse reactions, including abnormal laboratory values. The following summary of data includes adverse reactions reported after marketing without incidence. (Figures are total cases reported from the time to approval up to December 1999)
1.Clinically significant adverse reactions (*incidence unknown)
  1. Shock, anaphylactoid reaction: Shock or anaphylactoid reaction may occur. Patient should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
  2. Significant decreases in serum potassium levels have been reported in patients receiving procaterol hydrochloride. If xanthine derivatives, corticosteroids, or diuretics are co-administered with this drug in patients with severe potassium levels induced by β2-adrenergic agonists. Serum potassium levels should be closely monitored in hypoxic patients, in view of the possible aggravation of cardiac arrhythmias secondary to a decrease in serum potassium levels.
2.Other adverse reactions
5% › ≥ 0.1%
‹ 0.1%
* Incidence unknown
CardiovascularPalpitations and tachycardiaFacial flushing etc.Supraventricular extrasystoles, supraventricular tachycardia, ventricular extrasystoles. etc.,
Psychoneurologic Tremor and headacheDizziness, insomnia, numbness of limbs, etc.Finger spasticity, muscle cramps, muscular spasm, and nervousness
GastroIntestinalNausea and vomitingDry mouth, gastric discomfort, etc.
Hypersensitivity (note) Skin rash,  etcPruritus
HepaticIncreases in GOT, GPT, and LDH levels and other signs of hepatic dysfunction
OtherGeneralized  fatigue, weakness,  nasal obstruction, and tinnitusDecrease in serum potassium levels


Note:
1) If symptoms of hypersensitivity occur, the drug should be discontinued.
* The incidences rate of adverse reactions reported voluntarily after marketing and those reported outside Japan are not known.

DRUG INTERACTIONS
Precautions for co-administration (Meptin syrup should be administered with care when co-administered with the following drugs.)

DrugsSigns, Symptoms, and TreatmentMechanism and Risk Factors
catecholamines (e.g., epinephrine and isoproterenol)The combined use of this drug with catecholamines may cause arrhythmias or cardiac arrestEpinephrine, isoproterenol, and other catecholamines potentiate the adrenoreceptor stimulating action of this drug, possibly resulting in the induction of arrhythmias
Xanthine derivatives (e,g theophylline, aminophylline, and dipropylline)The combined use of this drug with xanthine derivatives may aggravate hypokalemia and cardiovascular adverse reactions (e.g., tachycardia, arrhythmias) due to adrenergic stimulation. If any of these abnormalities are observed, the dose should be reduced or treatment should be discontinued immediatelyXanthine derivatives potentiate the adrenoreceptor stimulating action of this drug, possibly resulting in a decrease in serum potassium levels and causing cardiac or vascular adverse reactions. The mechanism responsible for the induction of hypokalemia is not known
Corticosteroids (e.g. betamethasone, prednisolone, and hydrocortisone sodium succinate) and Diuretics (e.g. furosemide)The combined use of this drug with corticosteroids or diuretics may cause a decrease in serum potassium levels, resulting in arrhythmias. If any
of these abnormalities are observed. the dose should be reduced or treatment should be discontinued immediately
Corticosteroids and diuretics augment the excretion of potassium from the renal tubules, possibly resulting in an excessive decrease in serum potassium levels

PHYSICOCHEMISTRY
Nonproprietary name:
      Procaterol hydrochloride (JAN)
Chemical name:
8-hydroxy-5-[(1 RS,2SR)-1-hydroxy-2-isopropyl-aminobutyl)-2(1 H)quinolinone monohydrochloride hemihydrate.

Structural formula:


Molecular formula: C16H22N2O3 - HCl -1/2H20
Molecular weight: 335.83

STORAGE
Room temperature, protected from light

PACKAGING
Meptin syrup: 60 mL in bottles
Reg. No. : DKL 8618701437A1

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Manufactured by:
PT Otsuka Indonesia
Lawang, East Java
Indonesia

Ventolin Nebules

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Ventolin Nebules 2.5 mg
Salbutamol

1. TRADE NAME OF THE MEDICINAL PRODUCT
Ventolin Nebules.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventolin Nebules 2.5 mg: contain a concentration of salbutamol of 0.1% (1 mg salbutamol, as the sulphate, in 1 ml). Each Nebule contains 2.5 ml of solution equivalent to 2.5 mg salbutamol.

3. PHARMACEUTICAL FORM
Nebuliser solution.

4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
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 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 the 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 alter 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.
Routine management of chronic bronchospasm - unresponsive to conventional therapy.
Treatment of acute severe asthma (status asthmaticus).

4.2 Posology and Method of Administration
Salbutamol has a duration of action of 4 to 6 hours in most patients. Ventolin Nebules are intended to be used undiluted. However, if prolonged delivery time is desirable (more than 10 minutes) dilution using normal saline for injection as a diluent may be required. Ventolin Nebules are to be used with a nebuliser, under the direction of a physician. The solution must not be injected.
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.
Delivery of the aerosol may be by facemask, 'T' piece or via an endotracheal tube. Intermittent positive pressure ventilation may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.
As many nebulisers operate on a continuous flow basis, it is likely that nebulised drug will be released in the local environment. Ventolin Nebules should therefore be administered in a well ventilated room, particularly in hospitals when several patients may be using nebulisers at the same time.

Adults and Children:
A suitable starting dose of salbutamol by wet inhalation is
2.5 milligrams. This may be increased to 5 milligrams. Treatment may be repeated four times daily.

In adults higher dosing, up to
40 milligrams per day, can be given under strict medical supervision in hospital for the treatment of severe airways obstruction.

Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain.
As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.

4.3 Contra-indications
Ventolin Nebules are contra-indicated in patients with a history of hypersensitivity to any of their components. 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 preparations are not appropriate for managing premature labour.
Salbutamol presentations should not be used for threatened abortion during the first or second trimesters of pregnancy.

4.4.b Special Warnings and Special Precautions for Use
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.
Patients receiving treatment at home with Ventolin Nebules must 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. Ventolin Nebules should be used with caution in patients known to have received large doses of other sympathomimetic drugs. Salbutamol should be administered cautiously to patients with thyrotoxicosis.
A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol and ipratropium bromide. A combination of nebulised salbutamol with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.
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 common with other  β-adrenoceptor agonists, Ventolin can induce reversible metabolic changes, for example increased blood sugar levels.
The diabetic patient may be unable to compensate for this and the development of ketacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.

4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
Salbutamol and non-selective  β-blocking drugs, such as propranolol, should not usually be prescribed together. Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).

4.6 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.
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 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.

4.7 Effects on Ability to Drive and Use Machines 
None reported.

4.8 Undesirable Effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and ‹1/10), uncommon (≥1/1000 and ‹ 1/100), rare (≥l/l0,000 and ‹1/1000) and very rare ‹1/10,000) including isolated reports. Very common and common events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data.

Immune system disorders
Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.

Metabolism and nutrition disorders
Rare: Hypokalaemia.
Potentially serious hypokalaemia may result from beta, 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 vasodilatation.

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. Ventolin Nebules 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.

4.9 Overdose
The preferred antidote for overdosage with salbutamol is a cardioselective  β-blocking agent.  β-blocking drugs should be used with caution in patients with a history of bronchospasm. Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
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 cardiac muscle.

5.2 Pharmacokinetic Properties
Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally and partly by metabolism to the inactive 4'-O-sulphate (phenolic sulphate) which is also excreted primarily in the urine. The faeces are a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours. Salbutamol is bound to plasma proteins to the extent of 10%.
After administration by the inhaled route between 10 and 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The fraction deposited in the airways is absorbed into the pulmonary tissues and circulation but is not metabolised by the lung. On reaching the systemic circulation it becomes accessible to hepatic metabolism and is excreted, primarily in the urine, as unchanged drug and as the phenolic sulphate.
The swallowed portion of an inhaled dose 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.

5.3 Preclinical Safety Data
In common with other potent selective β2 receptor agonists, salbutamol has been shown to be teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5mg/kg, 4 times the maximum human oral. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial malformations in 37% of foetuses at 50mg/kg/day, 78 times the maximum human oral dose.

6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Sodium chloride, Sulphuric acid, Purified water.

6.2 Incompatibilities
None reported.

6.3 Shelf Life
3 years.

6.4 Special Precautions for Storage
Ventolin Nebules should be stored at a temperature below 30°C.
Protected from light.

6.5 Nature and Contents of Container
Ventolin Nebules are plastic ampoules containing a solution of salbutamol sulphate in normal saline. Each Nebule contains 2.5ml of solution.

6.6 Instructions for Use/ Handling
Dilution:-
Ventolin Nebules may be diluted with Sodium Chloride Injection BP. Any unused solution in the chamber of the nebuliser must be discarded.

6.7 Direction for Use
ONCE A NEBULE HAS BEEN DETACHED FROM THE PLASTIC BAR. IT IS OPEN AND SHOULD BE USED IMMEDIATELY.

1.Prepare your nebuliser for filling

2.Separate one Ventolin Nebule and detach by twisting it firmly.

3.The Nebule is now open.
Take care not to spill the contents.

4.Squeeze the contents of the Nebule into the reservoir of the nebuliser. Do not dilute the contents unless instructed to do so by your doctor.
5.Assemble the nebuliser and use it as directed
6.After use, discard any remaining solution and clear your nebuliser in the usual way.

If dilution is necessary this should be carried out only as prescribed by your doctor. The usual method of dilution is to empty the Ventolin Nebule into the nebuliser reservoir, as above, and then to add the prescribed amount of sterile normal saline. The reservoir should then be gently shaken to mix the contents.

Package Quantities and Registration Number
Ventolin Nebules 5mg are each available in boxes containing 20 Nebules in pack 4 x 5.
Reg No. DKI9282000368A1

HARUS DENGAN RESEP DOKTER

Manufactured by
GlaxoSmithKline Australia Pty Ltd, Boronia, Australia

Imported by
PT. Glaxo Wellcome Indonesia, Jakarta, Indonesia
Ventolin and Nebules are trade marks of the GlaxoSmithKline group of companies
Based an GCT issue number # 13 (16 May 2003)

Bricasma Injeksi

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Bricasma Injeksi
Bricasma® Injection
terbutaline sulphate
Selective Bronchodilator

Composition
Each ml of solution for injection contains Terbutaline sulphate 0.5 mg.

Characteristics
Pharmacodynamic properties
Terbutaline is a sympathomimetic bronchodilator with a degree of selective β2 stimulant activity on the respiratory system, thus producing relaxation of bronchial smooth muscle, inhibiton of the release of endogenous spasmogens, inhibition of edema caused by endogenous mediators, increased mucociliary clearance.
After subcutaneous injection of terbutaline the duration of onset regarding the bronchodilating effect is less than 5 minutes. Maximum effect is reached within 30 minutes.

Pharmacokinetic properties
Terbutaline is metabolized mainly by conjugation, with the sulphuric acid and excreted as the sulphate conjugate. No active metabolites are formed. The plasma half-life is about 16 hours. After intravenous and subcutaneous administration of terbutaline 90% is excreted renally during 48-96 hours. Of this, about 60% consists of unmetabolized terbutaline.

Indication
'Bricasma' is indicating for the relief of bronchospasm in bronchial asthma and other bronchopulmonary disorders in which bronchospasm is a complicating factor.

Dosage and administration
The dose may be given intravenously or subcutaneously.
'Bricasma' injection, 1 ml ampoule, is intended for subcutaneous and intravenous injection.
Dosage should be individual.

Bronchospasm:
Intravenous injection
Adult: 0.25-0.5 mg (0.5-1 ml) is injected slowly intravenously. The solution for injection is diluted with sterile physiological saline up to 10 ml and is given slowly intravenously during 5 minutes. The dose may have to be repeated with short intervals (a few hours). The dose should not exceed 2 mg in 24 hours.
Intravenous infusion
Adults: 1-2 mg (2-4 ml) is given during a 24 hour interval as a continuous infusion. An initial loading dose up to 0.10 mg (0.2 ml) can be given over 10 minutes.
Children: Up to 25 μg/kg b.w. (0.05 ml/kg b.w.) is given during a 24 hour interval as a continuous infusion. An initial loading dose up to 1.5 μg/kg b.w. (0.003 ml/kg b.w.) can be given over 10 minutes.

Subcutaneous injection
Adults: 1-2 mg (2-4) ml) is given during a 24 hour interval, split into at least 4 occasions.
Children: Up to 25 μg/kg b.w. (0.05 ml/kg b.w.) is given during a 24 hour interval, split into at least 4 occasions.

Contraindications
Patients with a history of hypersensitivity to any of its component or sympathomimetic amines.

Interaction with other medicaments and other forms of interaction
Beta-receptor blocking agent (including eye drops), especially those which are non selective may partly or totally inhibit the effect of β-receptor stimulants.
Hypokalemia may result from β2-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics (see 'Warning and Precautions').

Side effects
Potentially serious hypokalaemia may result from β2-agonist therapy (see in 'Warning and Precautions').
In common with other β2-agonist maternal pulmonary oedema has been reported in association with the use of terbutaline for the management of premature labour; in some cases this has proved fatal. Predisposing factors include fluid overload, multiple pregnancy, pre-existing cardiac disease and maternal infection. Close monitoring of the patient's state of hydration is essential. If signs of pulmonary oedema develop (e.g. cough, shortness of breath), treatment should be discontinued immediately and diuretic therapy instituted.
The intensity of the adverse reactions depends on dosage and route of administration. An initial dose titration will often reduce the adverse reactions. Adverse reaction which have been recorded e.g. tremor, headache, tonic muscle cramp and palpitations, are all characteristic of sympathomimetic amines. The majority of these effect have reversed spontaneously within the first 1-2 weeks
of treatment.
Urticaria and exanthema may occur.
Sleep disturbances and behavioural disturbances, such as agitation, hyperactivity and restlessness, have been observed.
Other commonly reported reactions include increased heart rate and dizziness.
Other reported reactions include headache, drowsiness, vomiting, nausea, sweating, and muscle cramps. These reactions are generally transient and usually do not require treatment.
There have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis.

Precaution
As for all β2-agonist caution should be observed in patient with thyrotoxicosis and in patients with severe cardiovascular disorder, such as ischemic heart disease, tachyarrhythmias or severe heart failure.
Due to the hyperglycemic effect of β2-agonist, additional blood glucose controls are recommended initially in diabetic patients. If treatment becomes less effective or shorter acting, the patient's general condition should be reviewed.

Due to the positive inotropic effect of β2-agonist these drugs should not be used in patients with hypertrophic cardiomyopathy.
As terbutaline sulphate is largely excreted in urine, caution should be exercised in patients with renal impairment.
Increased tendency to uterine bleeding has been reported in connection with Caesarean section. However, this can be effectively stopped by propanolol 1-2 mg injected intravenously.
Potentially serious hypokalemia may result from β2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia.
The hypokalemic effect may be potentiated by concomitant treatment (see Interactions). It is recommended that serum potassium levels are monitored in such situations.
Terbutaline is not indicated and should not be used for the management of preterm labor. Serious adverse reactions have been reported following administration of Terbutaline sulphate to women in labor.
These reports have included transient hypokalemia, pulmonary edema (sometimes after delivery), and hypoglycemia in the mother and / or neonatal child. Maternal death has been reported with terbutaline sulphate and other drugs of this class.
There have been rare reports of seizures occurring in patients receiving terbutaline, which do not recur when the drug is discontinued and have not been explained on any other basis.
Terbutaline sulphate is a sympathomimetic amine and such should be used with caution in patients with cardiovascular disorders (including arrythmias, coronary insufficiency and hypertension), in patients with hyperthyroidism or diabetes mellitus, history of seizures, or in patients who are unusually responsive to sympathomimetic amines.
Patients susceptible to hypokalemia should be monitored because transient early alls in serum potassium levels have been reported with β2-agonist.
Immediate hypersensitivity reactions and exacerbation of bronchospasm have been reported after terbutaline administration.
There are, however, no adequate and well controlled studies in pregnant women, this drug should be used during pregnancy only if clearly needed.
Terbutaline is excreted in breast milk. Caution should be exercised when this drug is administered to a nursing woman.
Safety and effectiveness in children below the age of 12 have not been established.

Overdosage
Too frequent administration, as with other sympathomimetic agents, may cause nausea, headaches, changes in blood pressure, anxiety, tension, insomnia, tremor. The symptoms and sign are those characteristic of excessive sympathetic stimulation.

Possible symptoms and signs: Headache, anxiety, tremor, tonic muscle cramps, palpitation, arrhythmia. A fall in blood pressure sometimes occurs.

Laboratory findings: Hyperglycemia and lactacidosis sometimes occur. β2-agonists may cause hypokalemia as a result of redistribution of potassium.

Treatment of overdosage:
Usually no treatment is required. In severe cases of overdosage, the following measures should be considered:
Determine acid-base balance, blood glucose and electrolytes. Monitor heart rate and rhythm and blood pressure. The preferred antidote for overdosage with 'Bricasma' is a cardioselective beta-receptor blocking agent, but beta-receptor blocking drugs should be used with caution in patients with a history of bronchospasm.
If the β2-mediated reduction in peripheral vascular resistance significantly contributes to the fall in blood pressure, a volume expander should be given.

Effect on ability to drive and use machines
'Bricasma' does not affect the ability to drive or use machines.

Incompatiilities
'Bricasma' solution for injection should not be mixed with alkaline solutions, i.e.: solution with the pH higher than 7.0.

Presentation
Box of 5 ampoules @ 1 ml
(Reg. No.: DKI0451302243A1)
The ampoules should be stored at temperatures not exceeding 25°C and be protected from light.

HARUS DENGAN RESEP DOKTER

Manufactured by:
AstraZeneca AB, Sodertalje, Sweden

Imported by:
PT AstraZeneca Indonesia
Jakarta - Indonesia

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Ventolin Tablet, Syrup

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Ventolin Tablet, Syrup
Ventolin™ oral preparations 
Salbutamol

Ventolin Tablet 2 mg
Ventolin Syrup

Presentation
Ventolin Tablet: White tablets each containing Salbutamol BP 2 mg as sulphate.
Ventolin Syrup: Salbutamol BP 2 mg as sulphate in each 5 ml of a fruit-flavoured, sugar-free syrup, which is devoid of artificial colouring agents.

Uses
Salbutamol BP is a beta-adrenergic stimulant which has a highly selective action on the receptors in bronchial muscle, and in therapeutic dosage, little or no action on the cardiac receptor.
Ventolin Tablet and Ventolin Syrup are indicated for the relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and emphysema. Ventolin Syrup is suitable oral therapy for children or for those adults who prefer liquid medicines.
Because of their selective action on the bronchi and their lack of effects on the cardiovascular system. Ventolin oral preparations are suitable for treating bronchospasm in patients with coexisting heart disease or hypertension.

Dosage and Administration
Posology and method of administration
Salbutamol has aduration of action of 4 to 6 hours in most patients. Increasing use of beta-2 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.
Adults: The usual effective dose is 4 milligrams Salbutamol (two tablets 2 mg or 10 ml of syrup) three or four times per day. If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 20 ml of syrup (8 milligram Salbutamol).
However, it has been established that some patients obtain adequate relief with 2 mg three or four time daily. In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with 2 mg three or four times per day.
Children: The following doses should be administered three or four times daily:
2 to 6 years : 1 to 2 mg as 2.5 to 5 ml of syrup or ½ to 1 tablet 2 mg.
6 to 12 years : 2 mg as 5 ml of syrup or 2 mg as 1 tablet 2 mg.
Over 12 years : 2 to 4 mg as 5 ml to 10 ml of syrup or 2 to 4 mg as 1 to 2 tablet 2 mg.
The drug is well tolerated by children so that, if necessary, these doses may be cautiously increased.

Contra-Indications
Ventolin oral preparations and beta-blocking drugs, such as propranolol, should not usually be prescribed together.
Ventolin oral preparations are contra-indicated in patients with a history of hypersensitivity to any of their components.

Precautions
Special warning and special precaution for use
The management of asthma should normally follow a stepwise programme, and patient's 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 flow monitoring may be instituted. 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.
Salbutamol should be administered cautiously to patients with thyrotoxicosis. Potentially serious hypokalaemia may result from beta-2 agonists 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.
As maternal pulmonary oedema has been reported during or following treatment of premature labour with beta-2 agonists, careful attention should be given to fluid balance and cardio-respiratory function monitored.
Interaction with other medicaments and other forms of interaction
Salbutamol and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
Salbutamol is not contra-indicated in patients under treatment with monoamine oxidase inhibitors (MAOIs)

Pregnancy and Lactation
Unnecessary administration of drugs during the first trimester of pregnancy is undesirable. 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. Salbutamol has been in widespread use for many years in human beings; this includes its well established use in the management of premature labour. However, as with the majority of drugs, there is little published evidence of its safety in the early stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the foetus.
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,

Side Effects
Ventolin oral preparations may cause a fine tremor of skeletal muscle, usually the hands are most obviously affected. This effect is dose related and is common to all beta-adrenergic stimulants. A few patients experience a feeling of tension; this is also due to the effects on skeletal muscle and not to direct CNS stimulation. Occasionally headaches have been reported.
In patients who are unusually sensitive to beta-adrenergic stimulants, peripheral vasodilatation and a compensatory small increase in heart rate may occur. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. There have been very rare reports of transient muscle cramps. Potentially serious hypokalaemia may result from beta-2 agonist therapy. As with other beta-2 agonists hyperactivity has been reported rarely in children.

Overdosage
The preferred antidote for overdosage with Salbutamol is a cardioselective beta-blocking agent.
However, beta-blocking drugs should be used with caution in patients with a history of bronchospasm.

Pharmaceutical Precautions
Storage : Ventolin Syrup and Ventolin Tablet 2 mg should be stored at a temperature not exceeding 30°C. Ventolin Syrup should be protected from light.
Dilution: Ventolin Syrup does not contain sugars. Ventolin Syrup may be diluted with Purified Water BP. The resulting mixture should be protected from light and used within 28 days. A 50% v/v dilution of Ventolin Syrup has been shown to be adequately preserved against microbial contamination. However, to avoid the possibility of introducing excessive microbial contamination, the Purified Water used for dilution should be recently prepared or alternatively it should be boiled and cooled immediately before use. Dilution of Ventolin Syrup with Syrup BP or Sorbitol solution is not recommended as this may result in precipitations of the cellulose thickening agent. Admixture of Ventolin Syrup with other liquid preparations is not recommended.

Legal Category
On medical prescription only.

Further Information
The syrup preparation does not contain sugars, so it is unlikely to predispose to dental caries with long term use.
Ventolin does not cause difficulty in micturition because, unlike sympathomimetic drugs such as ephedrine, it does not stimulate alpha-adrenoceptors.

Package Quantities and Registration Number
Ventolin Tablets 2 mg are supplied in cartons of 3 alufoil blisters of 10 tablets, Reg. No. DKL9232000610A1
Ventolin Syrup is supplied in bottles of 100 ml, Reg. No. DKL9232000537Al.

HARUS DENGAN RESEP DOKTER

Manufactured by
PT. Glaxo Wellcome Indonesia
Jakarta, lndonesia

™Ventolin is a trade mark of the GlaxoSmithKline group of companies

ICT #08, Rl01193 for Tablets 
ICT #09, R050494 for Syrup

Combivent UDV

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Combivent®
Ipratropium bromide
Salbutamol sulphate
Unit Dose Vials

Komposisi
1 unit dose vial (2,5 ml) larutan untuk inhalasi mengandung:
Ipratropium bromide0,52mg
yang setara dengan
Ipratropium bromide anhydrous0,5mg
Salbutamol sulphate3,01mg
yang setara dengan
Salbutamol base2,5mg
Zat tambahan: natrium klorida, HCl, akuades.

Khasiat
Ipratropium bromide adalah persenyawaan ammonium kuaterner yang mempunyai sifat antikolinergik (parasimpatolitik). Dalam studi preklinik, ipratropium bromide menghambat reflek vagus dengan melawan kerja asetilkolin, suatu zat transmiter yang dilepas oleh saraf vagus. Antikolinergik mencegah peningkatan konsentrasi siklik GMP intrasel yang disebabkan oleh interaksi antara asetilkolin dengan reseptor muskarinik di otot polos bronkus.
Bronkodilatasi yang terjadi setelah inhalasi ipratropium bromide adalah karena efek lokal yang spesifik di paru, bukan dari efek sistemik.
Salbutamol sulfat adalah obat adrenergik-beta2 yang bekerja merelaksasi otot polos saluran napas. Salbutamol merelaksasi semua otot polos dari trakea sampai bronkioli terminalis dan mencegah terjadinya bronkokonstriksi karena rangsangan.
COMBIVENT UDV memberikan pelepasan ipratropium bromide dan salbutamol sulphate secara bersamaan dimana efek aditif pada reseptor muskarinik dan adrenergik-beta2  pada paru menghasilkan bronkodilatasi yang lebih baik dari masing-masing obat.
Uji klinik terkontrol pada pasien dengan penyakit paru obstruktif kronik sedang sampai berat menunjukkan bahwa COMBIVENT UDV mempunyai efek bronkodilatasi yang lebih besar daripada masing-masing komponen dan tidak dijumpai potensiasi efek samping.

Indikasi
COMBIVENT UDV diindikasikan untuk pengobatan bronkospasme yang disebabkan karena penyakit paru obstruktif kronik pada pasien yang menjalani pengobatan dengan Ipratropium dan Salbutamol.

Dosis dan Cara Pemberian
Larutan inhalasi COMBIVENT UDV dapat diberikan melalui nebuliser yang sesuai atau "intermitten positive pressure ventilator".
Dewasa (termasuk orang tua): Isi dari 1 vial dosis unit, diberikan dengan nebulisasi dan inhalasi, tiga atau empat kali sehari.
Konseling untuk penghentian kebiasaan merokok harus menjadi tahap pertama dalam pengobatan pasien COPD yang merokok. Penghentian kebiasaan merokok memberikan manfaat simptomatik dan telah terbukti memberikan suatu keuntungan dengan memperlambat atau menghentikan memburuknya COPD.
Anak di bawah 12 tahun: belum ada  penelitian tentang penggunaan COMBIVENT UDV pada anak di bawah 12 tahun.

Cara Pemberian
UDV hanya digunakan untuk inhalasi dengan alat nebuliser yang sesuai dan tidak bisa digunakan per oral atau parenteral.

  1. Siapkan alat nebuliser untuk pengisian sesuai dengan instruksi dari pabrik atau dokter.
  2. Robek 1 UDV dari strip
  3. Buka UDV dengan memilin bagian atas dengan kuat
  4. Pijat vial agar isinya masuk kedalam reservoir
  5. Rakit nebuliser dan gunakan sesuai petunjuk
  6. Setelah penggunaan, buanglah larutan yang tertinggal di reservoir dan bersihkan nebuliser sesuai instruksi pabrik.

Karena UDV tidak mengandung pengawet, maka sangatlah penting larutan segera digunakan setelah dibuka dan gunakan vial yang baru pada setiap pemberian untuk mencegah kontaminasi bakteri. UDV yang telah digunakan sebagian, terbuka atau rusak harus dibuang.
Sangat dianjurkan untuk tidak mencampur larutan inhalasi COMBIVENT dengan obat lain dalam nebuliser yang sama.

Perhatian
Reaksi hipersensitif yang mungkin segera muncul setelah pemberian COMBIVENT inhalasi pada kasus yang jarang adalah urtikaria, angioedema, ruam kulit, bronkospasme dan edema orofaring.

Komplikasi Mata
Pada kasus tersendiri pernah dilaporkan terjadinya komplikasi mata (yaitu midriasis, kenaikan tekanan intraokuler, glaukoma, nyeri dimata) apabila semprotan ipratropium bromide baik dalam bentuk tunggal maupun kombinasi dengan agonis-beta2
adrenergik mengenai mata.Nyeri atau rasa tidak enak di mata, pandangan kabur, pandangan halos atau bayangan berwarna sehubungan dengan mata merah karena kongesti konjungtiva dan edema kornea adalah tanda-tanda dari glaukoma sudut sempit akut. Bila gejala-gejala ini timbul, pengobatan dengan tetes mata miotik harus diberikan dan segera mencari bantuan dokter spesialis.
Pasien harus diinstruksikan cara pemakaian COMBIVENT UDV dengan benar. Hati-hati agar larutan atau kabut tidak masuk mata. Dianjurkan agar nebulisasi larutan diberikan lewat corong hisap. Bila tidak tersedia corong hisap, maka topeng nebulisasi yang benar-benar cocok dapat digunakan. Pasien yang cenderung menderita glaukoma harus diberi peringatan secara khusus untuk melindungi mata mereka.
Untuk kondisi-kondisi dibawah ini, COMBIVENT hanya dapat digunakan secara hati-hati dengan mempertimbangkan manfaat risikonya, khususnya bila hendak diberikan pada dosis yang melebihi dosis yang dianjurkan.
Diabetes melitus yang tidak terkontrol dengan baik, infark baru pada miokardium, gangguan organik jantung yang berat atau pembuluh darah, hipertiroidisme, feokromositoma, risiko glaukoma sudut­ sempit, hipertropi prostat atau sumbatan leher kandung kencing.

Terapi agonis-beta2 dapat menyebabkan hipokalemia yang serius. Selain itu, kurangnya jumlah oksigen pada jaringan dapat memperberat efek hipokalemia pada irama jantung.
Pasien dengan cystic fibrosis cenderung untuk mendapatkan gangguan motilitas gastro-intestinal.
Pada kasus sesak napas yang mendadak atau memburuk dengan cepat, segeralah konsultasi dengan dokter.
Bila untuk mengontrol gejala diperlukan COMBIVENT dengan dosis yang lebih tinggi dari yang dianjurkan, maka rencana terapi pasien sebaiknya ditinjau ulang lagi oleh dokter.
Hasil percobaan pada binatang menunjukkan bahwa dosis tinggi dari beberapa agen simpatomimetika dapat menyebabkan kardionekrosis. Dalam hal ini, kemungkinan kerusakan jantung pada manusia mungkin terjadi. Pemberian COMBIVENT UDV dengan cara inhalasi menghasilkan konsentrasi plasma Salbutamol yang rendah sehingga risiko efek ini lebih rendah daripada cara pemberian yang lainnya.

Pasien harus diberitahukan cara pemakaian yang benar dari COMBIVENT UDV.

Penggunaan jangka panjang
Apabila obstruksi bronkial memburuk, adalah tidak tepat dan mungkin berbahaya untuk hanya meningkatkan penggunaan COMBIVENT UDV melebihi dosis yang dianjurkan dalam jangka waktu yang panjang.

Masa Kehamilan dan Menyusui
Keamanan selama kehamilan belum diketahui. Peringatan sehubungan dengan pemakaian obat pada kehamilan, terutama selama trismester pertama harus diperhatikan.

Efek penghambatan terhadap kontraksi rahim harus diperhitungkan.

Salbutamol sulphate dan ipratropium bromide mungkin diekskresikan lewat air susu ibu dan efeknya terhadap neonatus belum diketahui. Walaupun basa kuaterner yang tidak larut dalam lemak bisa melewati air susu ibu, tetapi ipratropium bromide tidak mencapai bayi terutama bila diberikan dengan inhalasi. Akan tetapi karena banyak obat yang dikeluarkan lewat air susu ibu, maka perhatian harus diberikan bila COMBIVENT diberikan pada wanita menyusui.

Efek Samping
Seperti pada agonis-beta2 yang lain, efek samping yang sering terjadi dari COMBIVENT adalah nyeri kepala, pusing, gelisah, takikardia, gemetar pada otot kerangka dan palpitasi, dan ini terjadi terutama pada pasien yang rentan.
Hipokalema berat mungkin terjadi karena agonis-beta2. Seperti pada pengobatan inhalasi lainnya, batuk, iritasi lokal dan yang jarang bronkokonstriksi karena inhalasi dapat dijumpai. Seperti pada betamimetik yang lain mungkin terjadi mual, muntah, berkeringat, kelemahan otot dan mialgia atau kejang otot. Pada kasus yang jarang mungkin terjadi penurunan tekanan darah diastolik, peningkatan tekanan darah sistolik. aritmia dan ini terjadi terutama setelah dosis yang lebih tinggi.
Pada kasus yang jarang pernah dllaporkan reaksi alergl dikulit terutama pada pasien yang hipersensitif.
Pada kasus yang sangat individual pernah dilaporkan gangguan psikologis setelah inhalasi dengan beta mimetik.
Efek samping dari penggunaan antikolinergik yang sering terjadi adalah mulut kering dan disfonia.
Pada kasus tersendiri pernah dilaporkan terjadinya komplikasi mata (yaitu midriasis, kenaikan tekanan intraokuler, glaukoma, nyeri di mata) apabila semprotan ipratropium bromide baik tunggal maupun kombinasi dengan agonis-beta2 adrenergik mengenai mata.
Efek samping mata, gangguan motilitas gastrointestinal dan retensi urin mungkin terjadi pada kasus yang jarang dan bersifat reversibel.

Kontraindikasi
Hipertrofi obstruksi kardiomiopati, takiaritmia. Hipersensitif terhadap salah satu komponen obat baik atropin ataupun derivatnya.

Interaksi Obat
Pemberian bersamaan dengan derivat xanthin, adrenergik-beta yang lain dan antikolinergik mungkin memperberat efek samping.
Hipokalemia yang disebabkan oleh agonis-beta mungkin diperberat oleh pemberian bersamaan dengan derivat xanthin, glukokortikosteroid dan diuretik. Ini harus diperhitungkan terutama pada pasien dengan obstruksi saluran napas yang berat.
Hipokalemia bisa meningkatkan kerentanan terhadap aritmia pada pasien yang minum digoksin. Dianjurkan untuk mengamati kadar kalium dalam serum.
Pengurangan efek bronkodilatasi yang serius mungkin terjadi bila diberikan bersamaan dengan beta bloker.

Agonis-beta2 harus diberikan secara hati-hati pada pasien yang diobati dengan monoamin-oksidase (MAO) atau antidepresan trisiklik karena kerja agonis-beta akan diperkuat.
Inhalasi anestesi golongan hidrokarbon halogen seperti halotan, trikloroetilen dan enfluran mungkin meningkatkan kerentanan terhadap efek kardiovaskuler dari agonis-beta.

Kelebihan Dosis
Gejala-gejala
Efek kelebihan dosis terutama karena salbutamol.

Gejala kelebihan dosis yang disebabkan rangsangan kelebihan adrenergik-beta adalah takikardia, palpitasi, tremor, hipertensi, hipotensi, peningkatan tekanan nadi, nyeri angina, aritmia dan kemerahan pada wajah.
Gejala kelebihan dosis ipratropium bromide (seperti mulut kering, gangguan pada akomodasi mata) diharapkan akan bersifat ringan dan sementara dengan melihat jangkauan terapi yang luas dan pemberian secara topikal.

Terapi
Pemberian sedatif, obat penenang dan terapi intensif pada kasus­ kasus berat.
Penghambat reseptor-beta, terutama beta1-selektif sesuai untuk antidotum spesifik; tetapi kemungkinan meningkatnya obstruksi bronkus harus diperhitungkan dan dosis harus disesuaikan dengan hati-hati pada pasien yang menderita asma bronkial.

Kemasan
Larutan inhalasi dalam unit dose vials
Dus berisi 10 vial @  2,5 ml, Reg. No. DKI0256900375A1

Simpan pada suhu 25- 30°C, terlindung dari cahaya.
Simpan di tempat yang aman, jauhkan dari jangkauan anak-anak .

Harus dengan resep dokter.

Diproduksi oleh:
Boehringer Ingelheim Limited
Bracknell, United Kingdom

Diimpor oleh :
PT. Boehringer Ingelheim Indonesia
Bogor, Indonesia
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