Consists of bromhexine hydrochloride, guaiphenesin, terbutaline sulphate
Overdose of Bromhexine hydrochloride (Bro-ZEDEX-SF EXP) in details
No symptoms of overdosage have been reported in man to date. If they occur, symptomatic treatment should be provided.
Bromhexine hydrochloride (Bro-ZEDEX-SF EXP) warnings
Bromhexine hydrochloride should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics, as it may induce ventricular fibrillation. An increased risk of arrhythmias may also occur if given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Hypokalaemia may be induced by higher than recommended doses of beta-agonists, especially in patients receiving digitalis glycosides or diuretics or are prone to cardiac dysrrhythmias.
Caution should be exercised in patients suffering from hyperthyroidism due to sympathomimetic effects of orciprenaline sulphate.
Caution should be observed in patients with gastric ulcer due to the bromhexine hydrochloride mucolytic action.
In addition, care should be observed in patients suffering from cardiovascular diseases i.e. ischaemic heart disease; arrhythmias or tachycardia; occlusive vascular disorders including arteriosclerosis, hypertension or aneurysms. Anginal pain may be precipitated in patients suffering from angina pectoris.
Care is also required when Bromhexine hydrochloride SYRUP is given to patients with diabetes mellitus or closed angle glaucoma.
Caution is also needed in patients with convulsive disorders.
Bromhexine hydrochloride (Bro-ZEDEX-SF EXP) precautions
Use in pregnancy & lactation: Available preclinical studies as well as clinical experience to date have shown no evidence of ill-effects during pregnancy. Nonetheless, the usual precautions regarding the use of drugs during pregnancy, especially during the 1st trimester, should be observed.
Bromhexine hydrochloride (Bro-ZEDEX-SF EXP) is expected to enter breast milk and thus should be avoided during lactation.
Guaiphenesin (Bro-ZEDEX-SF EXP) precautions
Do not exceed the recommended dosage. Stop use & consult a physician if the patient has a cough that persists for >1 wk, tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition. In case of accidental overdose, discontinue use & seek professional assistance immediately. Cough associated w/ smoking or chronic lung disease eg, asthma or emphysema. Pregnancy & lactation.
What happens if I overdose Terbutaline sulphate (Bro-ZEDEX-SF EXP)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include anxiety; chest pain; drowsiness; dry mouth; fainting; fast or irregular heartbeat; gasping; muscle cramps; nervousness; seizures; severe or persistent dizziness, headache, or nausea; sweating; tremor; unconsciousness; vomiting.
Proper storage of Terbutaline sulphate (Bro-ZEDEX-SF EXP):
Store Terbutaline sulphate (Bro-ZEDEX-SF EXP) at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Terbutaline sulphate (Bro-ZEDEX-SF EXP) out of the reach of children and away from pets.
Overdose of Terbutaline sulphate (Bro-ZEDEX-SF EXP) in details
There is a potential for progressive accumulation of dry powder in the mouthpiece of the Terbutaline sulphate (Bro-ZEDEX-SF EXP) Turbuhaler that could be released if dropped (for example, from a table) towards the end of inhaler life. To minimize unnecessary systemic exposure to terbutaline, the patients should be advised to, when possible, rinse their mouth after each use.
Symptoms: Headache, anxiety, tremor, nausea, tonic muscle cramps, palpitations, tachycardia and cardiac arrhythmias. A fall in blood pressure sometimes occurs.
Treatment: Usually no treatment is required. If it can be suspected that significant amounts of terbutaline have been swallowed, the following measures should be considered: Gastric lavage, activated charcoal. Determine acid-base balance, blood glucose and electrolytes. Monitor heart rate and rhythm and blood pressure. The preferred antidote for overdosage with Terbutaline sulphate (Bro-ZEDEX-SF EXP) 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.
Laboratory Findings: Hyperglycaemia and lactacidosis sometimes occur. β2-agonists may cause hypokalemia as a result of redistribution of potassium.
What should I avoid while taking Terbutaline sulphate (Bro-ZEDEX-SF EXP)?
Avoid situations that may worsen your respiratory condition such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet fur.
Terbutaline sulphate (Bro-ZEDEX-SF EXP) warnings
Patient Information
Tell you doctor if you have unusual reaction to albuterol, ephedrine, epinephrine, isoproterenol, metaproterenol, or terbutaline. Also let the doctor know if you are pregnant or breast-feeding
Older patients maybe more sensitive to Terbutaline sulphate (Bro-ZEDEX-SF EXP) than the patients of other age groups. If yo experience signs or symptoms, such as trambling, high bllod pressure, or fast/irregular heartbears you should contact you doctor as soon as possible
Some medical conditions may affect the use of terbutaline. Tell you doctor if you have any of th following medical problems - seizur - diabetes mellitu - gastrointestinal narrowin - enlarged prostat - glaucom - high bllod pressur - overactive thyroi - Parkinsons diseas - psychiatric problem - reduced blood fow to the brain or hear - arrhythmia
What should I discuss with my healthcare provider before taking Terbutaline sulphate (Bro-ZEDEX-SF EXP)?
Some medical conditions may interact with Terbutaline sulphate (Bro-ZEDEX-SF EXP). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have heart disease, an irregular heartbeat, high blood pressure, an overactive thyroid, diabetes, a history of seizures, or an adrenal gland tumor
Some MEDICINES MAY INTERACT with Terbutaline sulphate (Bro-ZEDEX-SF EXP). Tell your health care provider if you are taking any other medicines, especially any of the following:
- Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), droxidopa, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as life-threatening irregular heartbeat, may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) or other sympathomimetic medicines (eg, pseudoephedrine, albuterol) because the risk of their side effects may be increased by Terbutaline sulphate (Bro-ZEDEX-SF EXP). Ask your doctor or pharmacist if you are unsure if any of your medicines may be a sympathomimetic
- Beta-blockers (eg, propranolol) because they may decrease Terbutaline sulphate (Bro-ZEDEX-SF EXP)'s effectiveness
- Insulin because its effectiveness may be decreased by Terbutaline sulphate (Bro-ZEDEX-SF EXP)
This may not be a complete list of all interactions that may occur. Ask your health care provider if Terbutaline sulphate (Bro-ZEDEX-SF EXP) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Terbutaline sulphate (Bro-ZEDEX-SF EXP) precautions
Hypokalaemia: Potentially serious hypokalaemia may result from β2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatments. It is recommended that serum potassium levels are monitored in such situations.
Cardiovascular Diseases and Hyperthyroidism: Caution is advised when terbutaline is administered to patients with thyrotoxicosis.
Diabetes: Due to the hyperglycaemic effects of β2-stimulants, additional blood glucose controls are initially recommended when diabetic patients are commenced on terbutaline.
Terbutaline sulphate has not been approved for and should not be used for acute or maintenance tocolysis (beyond 48-72 hrs). In particular, terbutaline sulphate should not be used for maintenance tocolysis in the outpaitent or home setting.
Patients with chronic asthma who require maintenance therapy with β2-agonists must also have optimal anti-inflammatory treatment with corticosteroids. These patients should be advised to continue taking their anti-inflammatory treatment after starting Terbutaline sulphate (Bro-ZEDEX-SF EXP) controlled release tablets even when symptoms reduce. If the symptoms persist or if treatment with β2 agonists needs to be increased, this indicates a worsening in the underlying condition and justifies reassessment of the treatment.
Turbuhaler/Injection: Cardiovascular effects may be seen with sympathomimetic drugs, including Terbutaline sulphate (Bro-ZEDEX-SF EXP). There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with β-agonists. Patients with underlying severe heart disease (eg, ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Terbutaline sulphate (Bro-ZEDEX-SF EXP), 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 eg, dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
Arrhythmogenic Potential: β2-stimulants have an arrhythmogenic potential which must be considered for each patient when receiving treatment for bronchospasm.
Sensitivity to Sympathomimetic Amines: Some patients may be unusually sensitive to β-adrenergic stimulants. Terbutaline should be used with caution when an increased susceptibility to sympathomimetic amines can be expected for instance in other patients with hyperthyroidism not yet adequately controlled.
Pulmonary Conditions: Positive pressure delivery system (IPPB) for respiratory drugs should not be used in pulmonary conditions involving pneumothorax, air cyst or mediastinal emphysema unless special drainage is carried out.
Lack of Response: If the usual dose does not provide the usual relief, a nonresponsive state may be developing. If a previously effective dose lasts less than usual, patients should be instructed to consult a doctor. This could also be the sign of worsening asthma and repeated inhalations of β2-antagonists must then not then delay reassessment of the asthma therapy.
Acute Asthma: If patients with an acute attack of asthma fail to respond to a dry powder inhaler of β2-agonist, they should be advised to follow their personal asthma action plan. Failure to respond to β2-agonists in general can be due to various reasons related to drug administration or the disease itself. Particularly in children ≤5 years and exceptionally in other cases, inspiratory flow through a dry powder inhaler may not be sufficient for optimal drug delivery. If a nonresponse occurs, medical help should be sought while a β2-agonist treatment is continued. In such a situation and if available, a pressurised metered-dose inhaler with spacer should be used.
Cardionecrosis: Animal studies suggest that cardionecrotic lesions may occur with high doses of some sympathomimetic amines. On this evidence, it is not possible to exclude myocardial lesions as a possible hazard resulting from long-term treatment.
Impaired Hepatic Function: Hepatic failure has not been shown to influence the metabolism of terbutaline. However, caution should be exercised in patients with impaired liver function.
Impaired Renal Function: As terbutaline is largely excreted in urine, caution should be exercised in patients with renal impairment.
Effects on the Ability to Drive or Operate Machinery: Terbutaline sulphate (Bro-ZEDEX-SF EXP) does not affect the ability to drive or use machines.
Use in pregnancy: Pregnancy Category A: No teratogenic effects have been observed in animals or in patients. However, caution is recommended during the 1st trimester of pregnancy.
Oral β2 agonists with slow release must be used with caution in the final stage of pregnancy because of the tocolytic effect.
During pregnancy, serious adverse reactions, including death, have been reported after administration of terbutaline sufate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycaemia, hypokalaemia, cardiac arrhythmias, pulmonary edema, and myocardial ischaemia. Increased fetal heart rate and neonatal hypoglycaemia may occur as a result of maternal administration.
Use in lactation: Terbutaline passes over to breast milk but an influence on the child is unlikely with therapeutic doses.
Although terbutaline is secreted into breast milk, and milk concentrations are approximately those in maternal plasma, 2 individual case studies indicate that the infant is likely to receive 0.2-0.7% of the maternal dose (0.4 mcg/kg/day and 0.7 mcg/kg/day, respectively), depending (for example) on the time of feeding in relation to administration of the drug. In the 4 infants studied, this did not result in any signs of β-adrenoceptor stimulation.
Transient hypoglycaemia has been reported in newborn pre-term infants after maternal β2-agonist treatment.
What happens if I miss a dose of Terbutaline sulphate (Bro-ZEDEX-SF EXP)?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Get your prescription refilled before you run out of medicine completely.
References
- DailyMed. "TERBUTALINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "Bromhexine". http://www.drugbank.ca/drugs/DB09019 (accessed September 17, 2018).
- DrugBank. "terbutaline". http://www.drugbank.ca/drugs/DB00871 (accessed September 17, 2018).
Reviews
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
