COMPOSITION :
Inhavent® Inhalation fluid, each ampoule contains : Ipratropium bromide monohydrate equivalent to Ipratropium bromide 0.5 mg and Salbutamol sulfate equivalent to Salbutamol 2.5 mg.
DESCRIPTIONS :
Inhavent® with active ingredient Ipratropium bromide monohydrate equivalent to Ipratropium bromide 0.5 mg and Salbutamol sulfate equivalent to Salbutamol 2.5 mg are available in inhaler solution.
INDICATIONS :
Inhavent® is indicated for the management of reversible bronchospasm associated with obstructive pulmonary diseases and acute asthma attack in patient who require more than a single bronchodilator.
DOSAGE AND ADMINISTRATIONS :
Inhavent® has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.
Patients should be advised to consult a physician or the nearest hospital immediately in the case of acute or rapidly worsening dyspnoea if additional inhalations of Inhavent® do not produce an adequate improvement.
If higher than recommended doses of Inhavent® are required to control symptoms, the patients therapy plan should be reviewed.
The following doses of Inhavent® are recommended for adults (including elderly patients) :
Inhavent® solution for inhalation in ampoule
Inhavent® inhalation solution in ampoule may be administrated from a suitable nebulizer or an intermittent positive pressure ventilator.
Treatment should be initiated and administered under medical supervision, e.g. in the hospital setting. Home based treatment can be recommended on exceptional cases (severe symptoms or experienced patients requiring higher doses) when a low dose rapid acting β-agonist bronchodilator has been insufficient in providing relief after consultation with an experienced physician.
The treatment with the nebulizer solution in ampoule should always be started with the lowest recommended dose (1 ampoule). In very severe cases two ampoules may be required for symptom relief. Administration should be stopped when sufficient symptoms relief is achieved.
Treatment of acute attacks :
1 ampoule is sufficient for prompt symptom relief in many cases.
In severe cases if an attack has not been relieved by one ampoule, two ampoules may be required.
In these cases, patients should consult the doctor or the nearest hospital immediately.
Maintenance treatment :
1 ampoule three or four time daily.
Instruction for use
Ampoule are intended only for inhalation with suitable nebulising devices and must not be taken orally or administered parenterally. The content of the ampoule does not need to be diluted for nebulization.
| Turn down the content from the neck of ampoule by tapping a finger on ampoule or ampoule being shaken in a circular motion downward.
Protect your fingers with gauze if ampoule is made of glass. Break the top of the ampoule carefully. Remove the liquid into the nebulizer and use as directed. Assemble the nebulizer and use as directed. After use throw away any solution left in the reservoir and clean the nebulizer, following the manufacturer’s instructions. |
Since the ampoule contain no preservative, it is important that the contents are used soon after opening and that a fresh ampoule is used for each administration to avoid microbial contamination.
Partly used, opened or damaged ampoule should be discarded.
It is strongly recommended not to mix Inhavent® solution for inhalation with other drugs in the same nebulizer.
OVERDOSAGE :
Symptoms
The effect of overdosage are expected to be primarily related to Salbutamol. The expected symptoms with overdosage are those of excessive β-adrenergic-stimulation, the most prominent being tachycardia, palpitation, tremor, hypertension, hypotension, widening of the pulse pressure, angina pain, arrhythmias and flushing. Metabolic acidosis has also been observed with overdosage of Salbutamol.
Expected symptoms of overdosage with Ipratropium bromide (such as dry mouth, visual accommodation disorder) are mild and transient in nature in view of the wide therapeutic range and topical administration.
Therapy
Administration of sedative, tranquillizers, in severe cases intensive therapy. β-receptor blocker, preferably β1-selective, are suitable as specific antidotes; however, a possible increase in bronchial obstruction must be taken into account and the dose should be adjusted carefully in patients suffering from bronchial asthma.
CONTRAINDICATIONS :
Hypertrophic obstructive cardiomyopathy, tachyarrhythmia, hypersensitivity to any of the components of the product, to atropine or its derivatives.
WARNINGS AND PRECAUTIONS :
Hypersensitivity
Immediate hypersensitivity reaction may occur after administration of Inhavent® solution for inhalation, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal oedema.
Paradoxical bronchospasm
As with other inhaled medicines Inhavent® may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs Inhavent® should be discontinued immediately and substituted with an alternative therapy.
Ocular complications
There have been isolated reports of ocular complications (i.e., mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye pain) when aerosolised Ipratropium bromide either alone or in combination with an adrenergic β2-agonist, has come in contact with the eyes.
Eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of this symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Patient must be instructed in the correct administration of Inhavent®. Care must be taken not to expose the eyes to the solution of Inhavent®. Its recommended that the nebulizer solution be administered via mouth piece. If this is not available and a nebulizer mask is used, it must fit properly. Patient who may be predisposed to glaucoma should be warned specifically to protect their eyes.
Systemic effects
In the following condition, Inhavent® should only be used after careful risk/benefit assessment, especially when doses higher than recommended are used :
Insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorder, hyperthyroidism, phaeochromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.
Cardiovascular effects
Cardiovascular effect may be seen with sympatomimetic drugs, including Inhavent®.
There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with Salbutamol. Patient with underlying severe heart disease (e.g., ischaemic heart disease, tachyarrhythmia or severe heart failure) who are receiving Salbutamol for respiratory disease, should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
Hypokalaemia
Potentially serious hypokalaemia may result from β2-agonist therapy. Additionally, hypoxia may aggravate the effect of hypokalaemia on cardiac rhythm. In such situations, monitoring of serum potassium levels is recommended.
Gastrointestinal motility disturbances
Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.
Dyspnoea
In the case of acute, rapidly worsening dyspnoea patients should be advised to consult a physician immediately.
The result of animal experiments indicates that high dosage of some sympathomimetic agents may cause cardionecrosis. In view of this evidence, the possibility of cardiac lesions occurring in humans cannot be excluded. The administrations of Inhavent® by inhalation results in only low plasma concentrations of Salbutamol so the risk of this effect is lower than for some other routes of administration.
Patients must be instructed in the correct administration of Inhavent®.
Prolonged use :
If bronchial obstruction deteriorates it is inappropriate and possibly hazardous to simply increase the use of Inhavent® beyond the recommended dose over extended period of time.
Interference with laboratory test or other diagnostic measures
The use of Inhavent® may lead to positive result with regards to Salbutamol in tests for non clinical substance abuse, e.g., in the context of athletic performance enhancement (doping).
Fertility, pregnancy and lactation
Pregnancy
The safety of Inhavent® during human pregnancy has not been established. The inhibitory effect of Inhavent® on uterine contraction should be taken into account. The benefits of using Inhavent® during a confirmed or suspected pregnancy must be weighed against possible hazards to the unborn child. The usual precautions regarding the use of drugs in pregnancy, especially during the first trimester, should be observed.
For Ipraptropium bromide, nonclinical studies have shown no embryotoxic of teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.
Lactation
It is not known whether Ipraptropium bromide and Salbutamol sulphate are excreted in breast milk. It is considered unlikely that Ipraptropium bromide would reach the infant to an important extent, especially when administered by inhalation. However, caution should be exercised when Inhavent® is administered to nursing mothers.
Fertility
No studies on the effect on human fertility have been conducted for Inhavent®. Clinical data on fertility are neither available for the combination of Ipraptropium bromide and Salbutamol sulphate not for each of the two components of the combination.
Nonclinical studies performed with Ipraptropium bromide and Salbutamol showed no adverse effect on fertility.
Effect on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have beeen performed. However, patients should be advised that they may experience undesirable effects such as dizziness, accomodation disorder, mydriasis and blurred vision during treatment with Inhavent®. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.
INTERACTIONS :
The chronic co-administration of Inhavent® with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration of Inhavent® with other anticholinergic drugs is not recommended.
The concurrent administration of xanthine derivates as well as other β-adrenergics and anticholinergics may increase the side effects.
β2-agonist induced hypokalemia may be increase by concomitant treatment with xanthine derivates, glucocorticosteroids and diuretics. This should be taken into account particularly in patients with severe airway obstruction.
Hypokalemia may result in an increased susceptibility to arrhythmias in patients receiving digoxin. It is recomended that serum potassium levels are monitored in such situations.
A potentially serious reduction in bronchodilator effect may occur during concurrent administration of β-blockers.
β2-adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of β2-adrenergic agonist may be enhanced.
Inhalation of halogenated hydrocarbon anaesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility to the cardiovascular effects of β2-agonists.
ADVERSE REACTIONS :
Many of the listed undesirable effects can be assigned to the anticholinergic and β2-sympathomimetic properties of Inhavent®. As with all inhalation therapy Inhavent® may show symptoms of local irritation. Adverse drug reactions were identified from data obtained in clinical trials and pharmacovigilance during post approval use of the drug.
The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastrointestinal motility disorders (including constipation, diarrhea and vomiting), nausea, and dizziness.
Immune system disorders :
Anaphylactic reaction, hypersensitivity.
Metabolism and nutrition disorder :
Hypokalaemia.
Psychiatric disorders :
Nervousness, mental disorder.
Nervous system disorders :
Headache, tremor, dizziness.
Eye disorders :
Accommodation disorder, corneal oedema, glaucoma, intraocular pressure increased, mydriasis, vision blurred, eye pain, conjunctival hyperaemia, halo vision.
Cardiac disorders :
Arrhythmia, atrial fibrillation, myocardial ischaemia, palpitations, supraventricular tachycardia, tachycardia.
Respiratory, thoracic and mediastinal disorders :
Cough, dysphonia, dry throat, bronchospasm, bronchospasm paradoxical, laryngospasm, pharyngeal oedema.
Gastrointestinal disorders :
Dry mouth, nausea, throat irritation, diarrhea, vomiting, constipation, gastrointestinal motility disorder, oedema mouth, stomatitis.
Skin and subcutaneous tissue disorders :
Skin reaction (such as rash, pruritus and urticaria), angioedema and hyperhidrosis.
Musculoskeletal and connective tissue disorders :
Muscle spasms, muscular weakness, myalgia.
Renal and urinary disorder :
Urinary retention.
General disorders and administration site conditions :
Asthenia.
Investigation :
Blood pressure diastolic decreased, blood pressure systolic increased.
PRESENTATION :
Inhavent® Inhalation fluid Box, 5 ampoules @ 2.5 ml Reg. No. DKL2002362668A1
STORAGE :
STORE BELOW 25°C AND DRY PLACE, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
