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DRUGS & SUPPLEMENTS
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Albuterol:
Bronko Plus is a beta adrenoagonists with a predominant effect on beta2-adrenergic receptors (localized, particularly in the bronchi, myometrium, blood vessels).
This medication prevents and reduces or eliminates bronchospasm, reduces the resistance in the airways, increases the vital capacity. It prevents the release of histamine, slow reacting substance from mast cells and factors chemotaxis of neutrophils. Compared with other drugs of this group has a less pronounced positive chrono-and inotropic effect on myocardium. It widen of coronary arteries, practically does not reduce blood pressure. Has tocolytic effect, lowering the tone and the contractile activity of the myometrium.
When using an aerosol there is a rapid absorption of Bronko Plus (Albuterol) (salbutamol) in the blood, but its concentration in plasma when used in recommended doses are very low or below detection limit.
After oral administration Bronko Plus (Albuterol) is well absorbed from the gastrointestinal tract. Plasma protein binding is 10%. Metabolised with "first pass" through the liver and possibly in the wall of the intestine, the main metabolite - inactive sulfate conjugate. salbutamol is not metabolised in the lungs, thus its ultimate metabolism and excretion following inhalation depends on the method of application, which defines the relationship between inhaled salbutamol and unintentionally swallowed.
T1/2 from plasma is 2-7 hours. Bronko Plus (Albuterol) (salbutamol) is rapidly excreted in the urine as metabolites and unchanged substance, in small amounts excreted in the feces.
The prevention and relief of bronchospasm in all forms of bronchial asthma. Reversible airway obstruction in chronic bronchitis and emphysema, bronchial obstruction in children.
Threatening preterm labor with uterine contractions; birth to 37-38 weeks of pregnancy; isthmic-cervical insufficiency, decrease in fetal heart rate, depending on uterine contractions during opening of the cervix and expulsion. As a preventive measure during surgery on the pregnant uterus (the imposition of a circular suture with the lack of internal os of the uterus).
Bronko Plus for oral use as a means of extending the broncho adults and children over 12 years - 2.4 mg 3-4 times / day; if necessary, the dose may be increased to 8 mg 4 times / day. Children aged 6-12 years - 2 mg 3-4 times / day; children 2-6 years - 1-2 mg 3 times / day.
Bronko Plus (Albuterol) for inhalation use dose depends on the applied dosage form, frequency of use depends on the testimony and the clinical situation.
As a tocolytic agent used as IV infusion in dose of 1-2 mg.
Cardiovascular system: a transient expansion of peripheral blood vessels, a moderate tachycardia.
Central nervous system: headache, dizziness, nausea, vomiting.
Metabolic: hypokalaemia.
Allergic reactions: in a few cases - angioedema, allergic reactions in the form of skin rashes, urticaria, hypotension, collapse.
Other: Tremor of hands, inner trembling, tension, rarely - paradoxical bronchoconstriction, muscle cramps.
The threat of miscarriage in I and II trimesters of pregnancy, premature placental abruption, bleeding or toxemia in the III trimester of pregnancy, infancy to 2 years; hypersensitivity to salbutamol.
Category of the fetus by FDA - C.
Bronko Plus is contraindicated in threatened miscarriage in I and II trimesters of pregnancy, premature detachment of the placenta, bleeding, or toxicosis in the III trimester of pregnancy. If necessary, the use of salbutamol during pregnancy should be related to the expected benefits of treatment for the mother and the potential risk to the fetus. Currently is insufficient data on the safety of salbutamol in early pregnancy. salbutamol is excreted in breast milk, so if you need to use during lactation should also assess the potential benefits of treatment for the mother and the potential risk to the child.
With caution used Bronko Plus (Albuterol) when tachyarrhythmia and other cardiac arrhythmias, arterial hypertension, myocarditis, heart defects, aortic stenosis, diabetes, thyrotoxicosis, glaucoma, acute heart failure (with careful medical supervision).
Increase doses or frequency of receiving Bronko Plus (Albuterol) (salbutamol) should be under the supervision of a doctor. Reducing the interval may be only in exceptional cases and should be strictly justified.
In the application of salbutamol there was a risk of hypokalemia, so the period of treatment in patients with severe asthma should monitor the flow levels of potassium in the blood. The risk of hypokalemia increases with hypoxia.
To increase the effectiveness of therapy the patient should be trained in the proper use of inhalers and the beginning of treatment to use an inhaler under the supervision of medical personnel. Receiving high doses of salbutamol in patients with acute asthma leads to the fact that each subsequent attack of breathlessness becomes more intense the previous syndrome. In severe asthma interval between inhalations should be at least 20 minutes. In the absence of the minimal effect of inhalation or the appearance of pronounced tremor, tachycardia, cardiac arrhythmias continued uncontrolled use of the inhaler is contraindicated, and should appeal to the doctor. The risk of complications increases as in the long duration of treatment, and at a sharp lifting of the drug.
With simultaneous use of Bronko Plus (Albuterol) (salbutamol) with not cardioselective beta-blockers may suppress mutual therapeutic effects; with theophylline - increases the risk of tachycardia and arrhythmia, in particular, supraventricular extrasystoles.
With simultaneous use of salbutamol and xanthine derivatives, SCS or diuretics increases the risk of hypokalemia.
Symptoms: tachycardia (heart rate to 200 bpm), ventricular flutter, reducing blood pressure, increased cardiac output, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremors, headache, agitation, hallucinations, convulsions.
Treatment: removal of preparation and holding of symptomatic therapy of beta-blockers (selective) in patients with bronchial asthma requires extreme caution because of the risk of severe bronchospasm reaction.
Theophylline Anhydrous:
Bronko Plus (Theophylline Anhydrous) Extended-release capsules are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
Bronko Plus (Theophylline Anhydrous) Extended - release capsules is contraindicated in patients with a history of hypersensitivity to Bronko Plus (Theophylline Anhydrous) or other components in the product.
Bronko Plus should be used with extreme caution in patients with the following clinical conditions due to the increased risk of exacerbation of the concurrent condition:
There are several readily identifiable causes of reduced Bronko Plus (Theophylline Anhydrous) clearance. If the total daily dose is not appropriately reduced in the presence of these risk factors, severe and potentially fatal Bronko Plus (Theophylline Anhydrous) toxicity can occur. Careful consideration must be given to the benefits and risks of Bronko Plus (Theophylline Anhydrous) use and the need for more intensive monitoring of serum Bronko Plus (Theophylline Anhydrous) concentrations in patients with the following risk factors:
Drug Interactions Adding a drug that inhibits Bronko Plus metabolism (e.g., cimetidine, erythromycin, tacrine) or stopping a concurrently administered drug that enhances Bronko Plus (Theophylline Anhydrous) metabolism (e.g., carbamazepine, rifampin)..
Whenever a patient receiving Bronko Plus (Theophylline Anhydrous) develops nausea or vomiting, particularly repetitive vomiting, or other signs or symptoms consistent with Bronko Plus (Theophylline Anhydrous) toxicity (even if another cause may be suspected), additional doses of Bronko Plus (Theophylline Anhydrous) should be withheld and a serum Bronko Plus (Theophylline Anhydrous) concentration measured immediately. Patients should be instructed not to continue any dosage that causes adverse effects and to withhold subsequent doses until the symptoms have resolved, at which time the clinician may instruct the patient to resume the drug at a lower dosage.
Increases in the dose of Bronko Plus (Theophylline Anhydrous) should not be made in response to an acute exacerbation of symptoms of chronic lung disease since Bronko Plus (Theophylline Anhydrous) provides little added benefit to inhaled beta2-selective agonists and systemically administered corticosteroids in this circumstance and increases the risk of adverse effects. A peak steady-state serum Bronko Plus (Theophylline Anhydrous) concentration should be measured before increasing the dose in response to persistent chronic symptoms to ascertain whether an increase in dose is safe. Before increasing the Bronko Plus (Theophylline Anhydrous) dose on the basis of a low serum concentration, the clinician should consider whether the blood sample was obtained at an appropriate time in relationship to the dose and whether the patient has adhered to the prescribed regimen.
As the rate of Bronko Plus (Theophylline Anhydrous) clearance may be dose-dependent (i.e., steady-state serum concentrations may increase disproportionately to the increase in dose), an increase in dose based upon a sub-therapeutic serum concentration measurement should be conservative. In general, limiting dose increases to about 25% of the previous total daily dose will reduce the risk of unintended excessive increases in serum Bronko Plus (Theophylline Anhydrous) concentration.
Careful consideration of the various interacting drugs and physiologic conditions that can alter Bronko Plus clearance and require dosage adjustment should occur prior to initiation of Bronko Plus (Theophylline Anhydrous) therapy, prior to increases in Bronko Plus (Theophylline Anhydrous) dose, and during follow up. The dose of Bronko Plus (Theophylline Anhydrous) selected for initiation of therapy should be low and, if tolerated, increased slowly over a period of a week or longer with the final dose guided by monitoring serum Bronko Plus (Theophylline Anhydrous) concentrations and the patient's clinical response.
Serum Bronko Plus (Theophylline Anhydrous) concentration measurements are readily available and should be used to determine whether the dosage is appropriate. Specifically, the serum Bronko Plus (Theophylline Anhydrous) concentration should be measured as follows:
As a result of its pharmacological effects, Bronko Plus at serum concentrations within the 10-20 mcg/mL range modestly increases plasma glucose (from a mean of 88 mg% to 98 mg%), uric acid (from a mean of 4 mg/dl to 6 mg/dl), free fatty acids (from a mean of 451 μεq/l to 800 μεq/l, total cholesterol (from a mean of 140 vs 160 mg/dl), HDL (from a mean of 36 to 50 mg/dl), HDL/LDL ratio (from a mean of 0.5 to 0.7), and urinary free cortisol excretion (from a mean of 44 to 63 mcg/24 hr). Bronko Plus (Theophylline Anhydrous) at serum concentrations within the 10-20 mcg/mL range may also transiently decrease serum concentrations of triiodothyronine (144 before, 131 after one week and 142 ng/dl after 4 weeks of Bronko Plus (Theophylline Anhydrous)). The clinical importance of these changes should be weighed against the potential therapeutic benefit of Bronko Plus (Theophylline Anhydrous) in individual patients.
The patient (or parent/care giver) should be instructed to seek medical advice whenever nausea, vomiting, persistent headache, insomnia or rapid heart beat occurs during treatment with Bronko Plus (Theophylline Anhydrous), even if another cause is suspected. The patient should be instructed to contact their clinician if they develop a new illness, especially if accompanied by a persistent fever, if they experience worsening of a chronic illness, if they start or stop smoking cigarettes or marijuana, or if another clinician adds a new medication or discontinues a previously prescribed medication. Patients should be instructed to inform all clinicians involved in their care that they are taking Bronko Plus (Theophylline Anhydrous), especially when a medication is being added or deleted from their treatment. Patients should be instructed to not alter the dose, timing of the dose, or frequency of administration without first consulting their clinician. If a dose is missed, the patient should be instructed to take the next dose at the usually scheduled time and to not attempt to make up for the missed dose.
When prescribing administration by the sprinkle method, details of the proper technique should be explained to the patient.
Bronko Plus interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to Bronko Plus (Theophylline Anhydrous) or another drug or occurrence of adverse effects without a change in serum Bronko Plus (Theophylline Anhydrous) concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of Bronko Plus (Theophylline Anhydrous) clearance is altered by another drug resulting in increased or decreased serum Bronko Plus (Theophylline Anhydrous) concentrations. Bronko Plus (Theophylline Anhydrous) only rarely alters the pharmacokinetics of other drugs.
The drugs listed in Table II have the potential to produce clinically significant pharmacodynamic or pharmacokinetic interactions with Bronko Plus (Theophylline Anhydrous). The information in the “Effect” column of Table II assumes that the interacting drug is being added to a steady-state Bronko Plus (Theophylline Anhydrous) regimen. If Bronko Plus (Theophylline Anhydrous) is being initiated in a patient who is already taking a drug that inhibits Bronko Plus (Theophylline Anhydrous) clearance (e.g., cimetidine, erythromycin), the dose of Bronko Plus (Theophylline Anhydrous) required to achieve a therapeutic serum Bronko Plus (Theophylline Anhydrous) concentration will be smaller. Conversely, if Bronko Plus (Theophylline Anhydrous) is being initiated in a patient who is already taking a drug that enhances Bronko Plus (Theophylline Anhydrous) clearance (e.g., rifampin), the dose of Bronko Plus (Theophylline Anhydrous) required to achieve a therapeutic serum Bronko Plus (Theophylline Anhydrous) concentration will be larger. Discontinuation of a concomitant drug that increases Bronko Plus (Theophylline Anhydrous) clearance will result in accumulation of Bronko Plus (Theophylline Anhydrous) to potentially toxic levels, unless the Bronko Plus (Theophylline Anhydrous) dose is appropriately reduced. Discontinuation of a concomitant drug that inhibits Bronko Plus (Theophylline Anhydrous) clearance will result in decreased serum Bronko Plus (Theophylline Anhydrous) concentrations, unless the Bronko Plus (Theophylline Anhydrous) dose is appropriately increased. The drugs listed in Table III have either been documented not to interact with Bronko Plus (Theophylline Anhydrous) or do not produce a clinically significant interaction (i.e., <15% change in Bronko Plus (Theophylline Anhydrous) clearance).The listing of drugs in Tables II and III are current as of February 9, 1995. New interactions are continuously being reported for Bronko Plus (Theophylline Anhydrous), especially with new chemical entities. The clinician should not assume that a drug does not interact with Bronko Plus (Theophylline Anhydrous) if it is not listed in Table II. Before addition of a newly available drug in a patient receiving Bronko Plus (Theophylline Anhydrous), the package insert of the new drug and/or the medical literature should be consulted to determine if an interaction between the new drug and Bronko Plus (Theophylline Anhydrous) has been reported.
* Refer to PRECAUTIONS, Drug Interactions for further information regarding table. | ||
** Average effect on steady state Bronko Plus (Theophylline Anhydrous) concentration or other clinical effect for pharmacologic interactions. Individual patients may experience larger changes in serum Bronko Plus (Theophylline Anhydrous) concentration than the value listed. | ||
Drug | Type of Interaction | Effect** |
---|---|---|
Adenosine | Bronko Plus (Theophylline Anhydrous) blocks adenosine receptors. | Higher doses of adenosine may be required to achieve desired effect. |
Alcohol | A single large dose of alcohol (3 mL/kg of whiskey) decreases Bronko Plus (Theophylline Anhydrous) clearance for up to 24 hours. | 30% increase |
Allopurinol | Decreases Bronko Plus (Theophylline Anhydrous) clearance at allopurinol doses ≥600 mg/day. | 25% increase |
Aminoglutethimide | Increases Bronko Plus (Theophylline Anhydrous) clearance by induction of microsomal enzyme activity. | 25% decrease |
Carbamazepine | Similar to aminoglutethimide. | 30% decrease |
Cimetidine | Decreases Bronko Plus (Theophylline Anhydrous) clearance by inhibiting cytochrome P450 1A2. | 70% increase |
Ciprofloxacin | Similar to cimetidine. | 40% increase |
Clarithromycin | Similar to erythromycin. | 25% increase |
Diazepam | Benzodiazepines increase CNS concentrations of adenosine, a potent CNS depressant, while Bronko Plus (Theophylline Anhydrous) blocks adenosine receptors. | Larger diazepam doses may be required to produce desired level of sedation. Discontinuation of Bronko Plus (Theophylline Anhydrous) without reduction of diazepam dose may result in respiratory depression. |
Disulfiram | Decreases Bronko Plus (Theophylline Anhydrous) clearance by inhibiting hydroxylation and demethylation. | 50% increase |
Enoxacin | Similar to cimetidine. | 300% increase |
Ephedrine | Synergistic CNS effects. | Increased frequency of nausea, nervousness, and insomnia. |
Erythromycin | Erythromycin metabolite decreases Bronko Plus (Theophylline Anhydrous) clearance by inhibiting cytochrome P450 3A3. | 35% increase. Erythromycin steady-state serum concentrations decrease by a similar amount. |
Estrogen | Estrogen containing oral contraceptives decrease Bronko Plus (Theophylline Anhydrous) clearance in a dose-dependent fashion. The effect of progesterone on Bronko Plus (Theophylline Anhydrous) clearance is unknown. | 30% increase |
Flurazepam | Similar to diazepam. | Similar to diazepam. |
Fluvoxamine | Similar to cimetidine. | Similar to cimetidine. |
Halothane | Halothane sensitizes the myocardium. to catecholamines, Bronko Plus (Theophylline Anhydrous) increases release of endogenous catecholamines. | Increased risk of ventricular arrhythmias. |
Interferon, human recombinant alpha-A | Decreases Bronko Plus (Theophylline Anhydrous) clearance. | 100% increase |
Isoproterenol (IV) | Increases Bronko Plus (Theophylline Anhydrous) clearance. | 20% decrease |
Ketamine | Pharmacologic seizure threshold. | May lower Bronko Plus (Theophylline Anhydrous) |
Lithium | Bronko Plus (Theophylline Anhydrous) increases renal lithium clearance. | Lithium dose required to achieve a therapeutic serum concentration increased an average of 60%. |
Lorazepam | Similar to diazepam. | Similar to diazepam. |
Methotrexate (MTX) | Decreases Bronko Plus (Theophylline Anhydrous) clearance. | 20% increase after low dose MTX, higher dose MTX may have a greater effect. |
Mexiletine | Similar to disulfiram. | 80% increase |
Midazolam | Similar to diazepam. | Similar to diazepam. |
Moricizine | Increases Bronko Plus (Theophylline Anhydrous) clearance. | 25% decrease |
Pancuronium | Bronko Plus (Theophylline Anhydrous) may antagonize non-depolarizing neuromuscular blocking effects; possibly due to phosphodiesterase inhibition. | Larger dose of pancuronium may be required to achieve neuromuscular blockade. |
Pentoxifylline | Decreases Bronko Plus (Theophylline Anhydrous) clearance. | 30% increase |
Phenobarbital (PB) | Similar to aminoglutethimide. | 25% decrease after two weeks of concurrent PB. |
Phenytoin | Phenytoin increases Bronko Plus (Theophylline Anhydrous) clearance by increasing microsomal enzyme activity. Bronko Plus (Theophylline Anhydrous) decreases phenytoin absorption. | Serum Bronko Plus (Theophylline Anhydrous) and phenytoin concentrations decrease about 40%. |
Propafenone | Decreases Bronko Plus (Theophylline Anhydrous) clearance and pharmacologic interaction. | 40% increase. Beta-2 blocking effect may decrease efficacy of Bronko Plus (Theophylline Anhydrous). |
Propranolol | Similar to cimetidine and pharmacologic interaction. | 100% increase. Beta-2 blocking effect may decrease efficacy of Bronko Plus (Theophylline Anhydrous). |
Rifampin | Increases Bronko Plus (Theophylline Anhydrous) clearance by increasing cytochrome P450 1A2 and 3A3 activity. | 20-40% decrease |
Sulfinpyrazone | Increases Bronko Plus (Theophylline Anhydrous) clearance by increasing demethylation and hydroxylation. Decreases renal clearance of Bronko Plus (Theophylline Anhydrous). | 20% decrease |
Tacrine | Similar to cimetidine, also increases renal clearance of Bronko Plus (Theophylline Anhydrous). | 90% increase |
Thiabendazole | Decreases Bronko Plus (Theophylline Anhydrous) clearance. | 190% increase |
Ticlopidine | Decreases Bronko Plus (Theophylline Anhydrous) clearance. | 60% increase |
Troleandomycin | Similar to erythromycin. | 33-100% increase depending on troleandomycin dose. |
Verapamil | Similar to disulfiram. | 20% increase |
* Refer to PRECAUTIONS, Drug Interactions for information regarding table. | |||
albuterol, | diltiazem | medroxyprogesterone | roxithromycin |
systemic and inhaled | dirithromycin | methylprednisolone | sorbitol |
amoxicillin | enflurane | metronidazole | (purgative doses |
ampicillin, | famotidine | metoprolol | do not inhibit |
with or without | felodipine | nadolol | theophylline |
sulbactam | finasteride | nifedipine | absorption) |
atenolol | hydrocortisone | nizatidine | sucralfate |
azithromycin | isoflurane | norfloxacin | terbutaline, systemic |
caffeine, | isoniazid | ofloxacin | terfenadine |
dietary ingestion | isradipine | omeprazole | tetracycline |
cefaclor | influenza vaccine | prednisone, | tocainide |
co-trimoxazole | ketoconazole | prednisolone | |
(trimethoprim and | lomefloxacin | ranitidine | |
sulfamethoxazole) | mebendazole | rifabutin |
The Effect of Other Drugs on Bronko Plus (Theophylline Anhydrous) Serum Concentration Measurements: Most serum Bronko Plus (Theophylline Anhydrous) assays in clinical use are immunoassays which are specific for Bronko Plus (Theophylline Anhydrous). Other xanthines such as caffeine, dyphylline, and pentoxifylline are not detected by these assays. Some drugs (e.g.,cefazolin, cephalothin), however, may interfere with certain HPLC techniques. Caffeine and xanthine metabolites in neonates or patients with renal dysfunction may cause the reading from some dry reagent office methods to be higher than the actual serum Bronko Plus (Theophylline Anhydrous) concentration.
Drug-Food: Taking Bronko Plus (Theophylline Anhydrous) Extended-release Capsules immediately after a high-fat content meal such as 8 ounces whole milk, one fried egg, one slice of Canadian bacon, one English muffin with butter, 4 ounces hash brown potatoes, one slice of American cheese (about 240 calories, including approximately 27 g of fat) may result in an increase in the Cmax, but with no significant difference in the extent of absorption. The influence of the type and amount of other foods, as well as the time interval between drug and food, has not been studied.
Long term carcinogenicity studies have been carried out in mice (oral doses 30-150 mg/kg) and rats (oral doses 5-75 mg/kg). Results are pending.
Bronko Plus (Theophylline Anhydrous) has been studied in Ames salmonella, in vivo and in vitro cytogenetics, micronucleus and Chinese hamster ovary test systems and has not been shown to be genotoxic. In a 14 week continuous breeding study, Bronko Plus (Theophylline Anhydrous), administered to mating pairs of B6C3F1 mice at oral doses of 120, 270 and 500 mg/kg (approximately 1.0- 3.0 times the human dose on a mg/m2 basis) impaired fertility, as evidenced by decreases in the number of live pups per litter, decreases in the mean number of litters per fertile pair, and increases in the gestation period at the high dose as well as decreases in the proportion of pups born alive at the mid and high dose. In 13 week toxicity studies, Bronko Plus (Theophylline Anhydrous) was administered to F344 rats and B6C3F1 mice at oral doses of 40-300 mg/kg (approximately 2.0 times the human dose on a mg/m2 basis). At the high dose, systemic toxicity was observed in both species including decreases in testicular weight.
CATEGORY C : There are no adequate and well controlled studies in pregnant women. Additionally, there are no teratogenicity studies in non-rodents. Bronko Plus (Theophylline Anhydrous) was not shown to be teratogenic in CD-1 mice at oral doses up to 400 mg/kg, approximately 2.0 times the human dose on a mg/m2 basis or in CD-1 rats at oral doses up to 260 mg/kg, approximately 3.0 times the recommended human dose on a mg/m2 basis. At a dose of 220 mg/kg, embryotoxicity was observed in rats in the absence of maternal toxicity.
Bronko Plus (Theophylline Anhydrous) is excreted into breast milk and may cause irritability or other signs of mild toxicity in nursing human infants. The concentration of Bronko Plus (Theophylline Anhydrous) in breast milk is about equivalent to the maternal serum concentration. An infant ingesting a liter of breast milk containing 10-20 mcg/mL of Bronko Plus (Theophylline Anhydrous) day is likely to receive 10-20 mg of Bronko Plus (Theophylline Anhydrous) per day. Serious adverse effects in the infant are unlikely unless the mother has toxic serum Bronko Plus (Theophylline Anhydrous) concentrations.
Bronko Plus is safe and effective for the approved indications in pediatric patients (See, INDICATIONS AND USAGE). The maintenance dose of Bronko Plus (Theophylline Anhydrous) must be selected with caution in pediatric patients since the rate of Bronko Plus (Theophylline Anhydrous) clearance is highly variable across the age range of neonates to adolescents.
Elderly patients are at significantly greater risk of experiencing serious toxicity from Bronko Plus (Theophylline Anhydrous) than younger patients due to pharmacokinetic and pharmacodynamic changes associated with aging. Bronko Plus (Theophylline Anhydrous) clearance is reduced in patients greater than 60 years of age, resulting in increased serum Bronko Plus (Theophylline Anhydrous) concentrations in response to a given Bronko Plus (Theophylline Anhydrous) dose. Protein binding may be decreased in the elderly resulting in a larger proportion of the total serum Bronko Plus (Theophylline Anhydrous) concentration in the pharmacologically active unbound form. Elderly patients also appear to be more sensitive to the toxic effects of Bronko Plus (Theophylline Anhydrous) after chronic overdosage than younger patients. For these reasons, the maximum daily dose of Bronko Plus (Theophylline Anhydrous) in patients greater than 60 years of age ordinarily should not exceed 400 mg/day unless the patient continues to be symptomatic and the peak steady state serum Bronko Plus (Theophylline Anhydrous) concentration is <10 mcg/mL. Bronko Plus (Theophylline Anhydrous) doses greater than 400 mg/d should be prescribed with caution in elderly patients.
Adverse reactions associated with Bronko Plus (Theophylline Anhydrous) are generally mild when peak serum Bronko Plus (Theophylline Anhydrous) concentrations are <20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum Bronko Plus (Theophylline Anhydrous) concentrations exceed 20 mcg/mL, however, Bronko Plus (Theophylline Anhydrous) produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal. The transient caffeine-like adverse reactions occur in about 50% of patients when Bronko Plus (Theophylline Anhydrous) therapy is initiated at doses higher than recommended initial doses (e.g.,>300 mg/day in adults and >12 mg/kg/day in children beyond >1 year of age). During the initiation of Bronko Plus (Theophylline Anhydrous) therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of Bronko Plus (Theophylline Anhydrous) therapy at a low dose with subsequent slow titration to a predetermined age-related maximum dose will significantly reduce the frequency of these transient adverse effects. In a small percentage of patients (<3% of children and <10% of adults) the caffeine-like adverse effects persist during maintenance therapy, even at peak serum Bronko Plus (Theophylline Anhydrous) concentrations within the therapeutic range (i.e., 10-20 mcg/mL). Dosage reduction may alleviate the caffeine-like adverse effects in these patients, however, persistent adverse effects should result in a reevaluation of the need for continued Bronko Plus (Theophylline Anhydrous) therapy and the potential therapeutic benefit of alternative treatment.
Other adverse reactions that have been reported at serum Bronko Plus (Theophylline Anhydrous) concentrations <20 mcg/mL include diarrhea, irritability, restlessness, fine skeletal muscle tremors, and transient diuresis. In patients with hypoxia secondary to COPD, multifocal atrial tachycardia and flutter have been reported at serum Bronko Plus (Theophylline Anhydrous) concentrations ≥15 mcg/mL. There have been a few isolated reports of seizures at serum Bronko Plus (Theophylline Anhydrous) concentrations <20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum Bronko Plus (Theophylline Anhydrous) concentrations <20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum Bronko Plus (Theophylline Anhydrous) concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum Bronko Plus (Theophylline Anhydrous) concentrations <20 mcg/mL have generally been milder than seizures associated with excessive serum Bronko Plus (Theophylline Anhydrous) concentrations resulting from an overdose (i.e. they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua).
Percentage of patients reported | ||||||
with sign or symptom | ||||||
Acute Overdose | Chronic Overdosage | |||||
(Large Single Ingestion) | (Multiple Excessive Doses) | |||||
Sign/Symptom | Study 1 | Study 2 | Study 1 | Study 2 | ||
(n=157) | (n=14) | (n=92) | (n=102) | |||
* These data are derived from two studies in patients with serum Bronko Plus (Theophylline Anhydrous) concentrations >30 mcg/mL. In the first study (Study #1 - Shanon, Ann Intern Med 1993;119:1161-67), data were prospectively collected from 249 consecutive cases of Bronko Plus (Theophylline Anhydrous) toxicity referred to a regional poison center for consultation. In the second study (Study #2 - Sessler, Am J Med 1990;88:567-76), data were retrospectively collected from 116 cases with serum Bronko Plus (Theophylline Anhydrous) concentrations >30 mcg/mL among 6000 blood samples obtained for measurement of serum Bronko Plus (Theophylline Anhydrous) concentrations in three emergency departments. Differences in the incidence of manifestations of Bronko Plus (Theophylline Anhydrous) toxicity between the two studies may reflect sample selection as a result of study design (e.g., in Study #1, 48% of the patients had acute intoxications versus only 10% in Study #2) and different methods of reporting results. | ||||||
** NR = Not reported in a comparable manner. | ||||||
Asymptomatic | NR** | 0 | NR** | 6 | ||
Gastrointestinal | ||||||
Vomiting | 73 | 93 | 30 | 61 | ||
Abdominal Pain | NR** | 21 | NR** | 12 | ||
Diarrhea | NR** | 0 | NR** | 14 | ||
Hematemesis | NR** | 0 | NR** | 2 | ||
Metabolic/Other | ||||||
Hypokalemia | 85 | 79 | 44 | 43 | ||
Hyperglycemia | 98 | NR** | 18 | NR** | ||
Acid/base disturbance | 34 | 21 | 9 | 5 | ||
Rhabdomyolysis | NR** | 7 | NR** | 0 | ||
Cardiovascular | ||||||
Sinus tachycardia | 100 | 86 | 100 | 62 | ||
Other supraventricular | 2 | 21 | 12 | 14 | ||
tachycardias | ||||||
Ventricular premature beats | 3 | 21 | 10 | 19 | ||
Atrial fibrillation or flutter | 1 | NR** | 12 | NR** | ||
Cardiovascular (continued) | ||||||
Multifocal atrial tachycardia | 0 | NR** | 2 | NR** | ||
Ventricular arrhythmias with | 7 | 14 | 40 | 0 | ||
hemodynamic instability | ||||||
Hypotension/shock | NR** | 21 | NR** | 8 | ||
Neurologic | ||||||
Nervousness | NR** | 64 | NR** | 21 | ||
Tremors | 38 | 29 | 16 | 14 | ||
Disorientation | NR** | 7 | NR** | 11 | ||
Seizures | 5 | 14 | 14 | 5 | ||
Death | 3 | 21 | 10 | 4 |
The chronicity and pattern of Bronko Plus overdosage significantly influences clinical manifestations of toxicity, management and outcome. There are two common presentations: (1) acute overdose, i.e., ingestion of a single large excessive dose (>10 mg/kg) as occurs in the context of an attempted suicide or isolated medication error, and (2) chronic overdosage, i.e., ingestion of repeated doses that are excessive for the patient's rate of Bronko Plus (Theophylline Anhydrous) clearance. The most common causes of chronic Bronko Plus (Theophylline Anhydrous) overdosage include patient or care giver error in dosing, clinician prescribing of an excessive dose or a normal dose in the presence of factors known to decrease the rate of Bronko Plus (Theophylline Anhydrous) clearance, and increasing the dose in response to an exacerbation of symptoms without first measuring the serum Bronko Plus (Theophylline Anhydrous) concentration to determine whether a dose increase is safe.
Severe toxicity from Bronko Plus (Theophylline Anhydrous) overdose is a relatively rare event. In one health maintenance organization, the frequency of hospital admissions for chronic overdosage of Bronko Plus (Theophylline Anhydrous) was about 1 per 1000 person-years exposure. In another study, among 6000 blood samples obtained for measurement of serum Bronko Plus (Theophylline Anhydrous) concentration, for any reason, from patients treated in an emergency department, 7% were in the 20-30 mcg/mL range and 3% were >30 mcg/mL. Approximately two-thirds of the patients with serum Bronko Plus (Theophylline Anhydrous) concentrations in the 20-30 mcg/mL range had one or more manifestations of toxicity while >90% of patients with serum Bronko Plus (Theophylline Anhydrous) concentrations >30 mcg/mL were clinically intoxicated. Similarly, in other reports, serious toxicity from Bronko Plus (Theophylline Anhydrous) is seen principally at serum concentrations >30 mcg/mL.Several studies have described the clinical manifestations of Bronko Plus (Theophylline Anhydrous) overdose and attempted to determine the factors that predict life-threatening toxicity. In general, patients who experience an acute overdose are less likely to experience seizures than patients who have experienced a chronic overdosage, unless the peak serum Bronko Plus (Theophylline Anhydrous) concentration is >100 mcg/mL. After a chronic overdosage, generalized seizures, life-threatening cardiac arrhythmias, and death may occur at serum Bronko Plus (Theophylline Anhydrous) concentrations >30 mcg/mL. The severity of toxicity after chronic overdosage is more strongly correlated with the patient's age than the peak serum Bronko Plus (Theophylline Anhydrous) concentration; patients >60 years are at the greatest risk for severe toxicity and mortality after a chronic overdosage. Pre-existing or concurrent disease may also significantly increase the susceptibility of a patient to a particular toxic manifestation, e.g., patients with neurologic disorders have an increased risk of seizures and patients with cardiac disease have an increased risk of cardiac arrhythmias for a given serum Bronko Plus (Theophylline Anhydrous) concentration compared to patients without the underlying disease. The frequency of various reported manifestations of Bronko Plus (Theophylline Anhydrous) overdose according to the mode of overdose are listed in Table IV.Other manifestations of Bronko Plus (Theophylline Anhydrous) toxicity include increases in serum calcium, creatine kinase, myoglobin and leukocyte count, decreases in serum phosphate and magnesium, acute myocardial infarction, and urinary retention in men with obstructive uropathy. Seizures associated with serum Bronko Plus (Theophylline Anhydrous) concentrations >30 mcg/mL are often resistant to anticonvulsant therapy and may result in irreversible brain injury if not rapidly controlled. Death from Bronko Plus (Theophylline Anhydrous) toxicity is most often secondary to cardiorespiratory arrest and/or hypoxic encephalopathy following prolonged generalized seizures or intractable cardiac arrhythmias causing hemodynamic compromise.
General Recommendations for Patients with Symptoms of Bronko Plus (Theophylline Anhydrous) Overdose or Serum Bronko Plus (Theophylline Anhydrous) Concentrations >30 mcg/mL (Note: Serum Bronko Plus (Theophylline Anhydrous) concentrations may continue to increase after presentation of the patient for medical care.
Increasing the rate of Bronko Plus (Theophylline Anhydrous) clearance by extracorporeal methods may rapidly decrease serum concentrations, but the risks of the procedure must be weighed against the potential benefit. Charcoal hemoperfusion is the most effective method of extracorporeal removal, increasing Bronko Plus (Theophylline Anhydrous) clearance up to six fold, but serious complications, including hypotension, hypocalcemia, platelet consumption and bleeding diatheses may occur. Hemodialysis is about as efficient as multiple-dose oral activated charcoal and has a lower risk of serious complications than charcoal hemoperfusion. Hemodialysis should be considered as an alternative when charcoal hemoperfusion is not feasible and multiple-dose oral charcoal is ineffective because of intractable emesis. Serum Bronko Plus (Theophylline Anhydrous) concentrations may rebound 5-10 mcg/mL after discontinuation of charcoal hemoperfusion or hemodialysis due to redistribution of Bronko Plus (Theophylline Anhydrous) from the tissue compartment. Peritoneal dialysis is ineffective for Bronko Plus (Theophylline Anhydrous) removal; exchange transfusions in neonates have been minimally effective.
Taking Bronko Plus Extended-release Capsules immediately after a high-fat content meal may alter its rate of absorption. However, the differences are usually small and Bronko Plus (Theophylline Anhydrous) Extended-release Capsules may normally be administered without regard to meals.
The steady-state peak serum Bronko Plus (Theophylline Anhydrous) concentration is a function of the dose, the dosing interval, and the rate of Bronko Plus (Theophylline Anhydrous) absorption and clearance in the individual patient. Because of marked individual differences in the rate of Bronko Plus (Theophylline Anhydrous) clearance, the dose required to achieve a peak serum Bronko Plus (Theophylline Anhydrous) concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter Bronko Plus (Theophylline Anhydrous) clearance (e.g., 400-1600 mg/day in adults <60 years old and 10-36 mg/kg/day in children 1-9 years old). For a given population there is no single Bronko Plus (Theophylline Anhydrous) dose that will provide both safe and effective serum concentrations for all patients. Administration of the median Bronko Plus (Theophylline Anhydrous) dose required to achieve a therapeutic serum Bronko Plus (Theophylline Anhydrous) concentration in a given population may result in either sub-therapeutic or potentially toxic serum Bronko Plus (Theophylline Anhydrous) concentrations in individual patients. For example, at a dose of 900 mg/d in adults <60 years or 22 mg/kg/d in children 1-9 years, the steady-state peak serum Bronko Plus (Theophylline Anhydrous) concentration will be <10 mcg/mL in about 30% of patients, 10-20 mcg/mL in about 50% and 20-30 mcg/mL in about 20% of patients. The dose of Bronko Plus (Theophylline Anhydrous) must be individualized on the basis of peak serum Bronko Plus (Theophylline Anhydrous) concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects. Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, if judged to be clinically indicated, in small increments. Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum Bronko Plus (Theophylline Anhydrous) concentrations to reach the new steady state. Dosage adjustment should be guided by serum Bronko Plus (Theophylline Anhydrous) concentration measurement. Health care providers should instruct patients and care givers to discontinue any dosage that causes adverse effects, to withhold the medication until these symptoms are gone and to then resume therapy at a lower, previously tolerated dosage. If the patient's symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements, serum Bronko Plus (Theophylline Anhydrous) concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum Bronko Plus (Theophylline Anhydrous) concentrations should be monitored at frequent intervals, e.g., every 24 hours. Theophylline distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight. Table V contains Bronko Plus (Theophylline Anhydrous) dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for Bronko Plus (Theophylline Anhydrous) dosage adjustment based upon serum Bronko Plus (Theophylline Anhydrous) concentrations. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, these recommendations should serve as the upper limit for dosage adjustments in order to decrease the risk of potentially serious adverse events associated with unexpected large increases in serum Bronko Plus (Theophylline Anhydrous) concentration.
* Patients with more rapid metabolism, clinically identified by higher than average dose requirements, should receive a smaller dose more frequently to prevent breakthrough symptoms resulting from low trough concentrations before the next dose. A reliably absorbed slow-release formulation will decrease fluctuations and permit longer dosing intervals. | |||
A. Children (1-15 years) and adults (16-60 years) without risk factors for impaired clearance. | |||
Titration Step | Children < 45 kg | Children > 45 kg and adults | |
1 Starting Dosage | 12-14 mg/kg/day up to a maximum | 300 mg/day divided | |
of 300 mg/day divided Q8-12 hrs* | Q8-12 hrs* | ||
2 After 3 days, | 16 mg/kg/day up to a maximum | 400 mg/day divided | |
if tolerated, | of 400 mg/day divided Q8-12 hrs* | Q8- 12 hrs* | |
increase dose to: | |||
3 After 3 more days, if | 20 mg/kg/day up to a maximum | 600 mg/day divided | |
tolerated and if needed, | of 600 mg/day divided Q8-12 hrs* | Q8-12 hrs* | |
increase dose to: | |||
B. | Once-Daily Dosing: | ||
The slow absorption rate of this preparation may allow once-daily administration in adult nonsmokers with appropriate total body clearance and other patients with low dosage requirements. Once-daily dosing should be considered only after the patient has been gradually and satisfactorily treated to therapeutic levels with q12h dosing. Once-daily dosing should be based on the dosing guidelines in Table V and Table VI, and should be initiated at the end of the last q12h dosing interval. The trough concentration (Cmin) obtained following conversion to once-daily dosing may be lower (especially in high clearance patients) and the peak concentration (Cmax) may be higher (especially in low clearance patients) than that obtained with q12h dosing. If symptoms recur, or signs of toxicity appear during the once-daily dosing interval, dosing on the q12h basis should be reinstituted. It is essential that serum Bronko Plus (Theophylline Anhydrous) concentrations be monitored before and after transfer to once-daily dosing. Food and posture, along with changes associated with circadian rhythm, may influence the rate of absorption and/or clearance rates of Bronko Plus (Theophylline Anhydrous) from extended-release dosage forms administered at night. The exact relationship of these and other factors to nighttime serum concentrations and the clinical significance of such findings require additional study. Therefore, it is not recommended that Bronko Plus (Theophylline Anhydrous) Extended-release Capsules when used as a once-a-day product, be administered at night. | |||
C. | Patients With Risk Factors For Impaired Clearance, The Elderly (>60 Years), And Those In Whom It Is Not Feasible To Monitor Serum Bronko Plus (Theophylline Anhydrous) Concentrations: | ||
In children 1-15 years of age, the final Bronko Plus (Theophylline Anhydrous) dose should not exceed 16 mg/kg/day up to a maximum of 400 mg/day in the presence of risk factors for reduced Bronko Plus (Theophylline Anhydrous) clearance or if it is not feasible to monitor serum Bronko Plus (Theophylline Anhydrous) concentrations. In adolescents ≥16 years and adults, including the elderly, the final Bronko Plus (Theophylline Anhydrous) dose should not exceed 400 mg/day in the presence of risk factors for reduced Bronko Plus (Theophylline Anhydrous) clearance or if it is not feasible to monitor serum Bronko Plus (Theophylline Anhydrous) concentrations. |
Peak Serum Concentration | Dosage Adjustment |
---|---|
¶ Dose reduction and/or serum Bronko Plus (Theophylline Anhydrous) concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce Bronko Plus (Theophylline Anhydrous) clearance occur (e.g., sustained fever), or a drug that interacts with Bronko Plus (Theophylline Anhydrous) is added or discontinued. | |
<9.9 mcg/mL | If symptoms are not controlled and current dosage is tolerated, increase dose about 25%. Recheck serum concentration after three days for further dosage adjustment. |
10 to 14.9 mcg/mL | If symptoms are controlled and current dosage is tolerated, maintain dose and recheck serum concentration at 6-12 month intervals.¶ If symptoms are not controlled and current dosage is tolerated consider adding additional medication(s) to treatment regimen. |
15-19.9 mcg/mL | Consider 10% decrease in dose to provide greater margin of safety even if current dosage is tolerated.¶ |
20-24.9 mcg/mL | Decrease dose by 25% even if no adverse effects are present. Recheck serum concentration after 3 days to guide further dosage adjustment. |
25-30 mcg/mL | Skip next dose and decrease subsequent doses at least 25% even if no adverse effects are present. Recheck serum concentration after 3 days to guide further dosage adjustment. If symptomatic, consider whether overdose treatment is indicated. |
>30 mcg/mL | Treat overdose as indicated. If Bronko Plus (Theophylline Anhydrous) is subsequently resumed, decrease dose by at least 50% and recheck serum concentration after 3 days to guide further dosage adjustment. |
Bronko Plus (Theophylline Anhydrous) Extended-release Capsules may be administered by carefully opening the capsule and sprinkling the beaded contents on a spoonful of soft food such as applesauce or pudding; the soft food should be swallowed immediately without chewing and followed with a glass of cool water or juice to ensure complete swallowing of the beads. It is recommended that the food used should not be hot and should be soft enough to be swallowed without chewing. Any bead/food mixture should be used immediately and not stored for future use. SUBDIVIDING THE CONTENTS OF A CAPSULE IS NOT RECOMMENDED.
Bronko Plus (Theophylline Anhydrous) Extended-release Capsules USP are available as 125 mg, 200 mg, or 300 mg and have the following identification characteristics:
Bronko Plus (Theophylline Anhydrous) Extended-release 125 mg clear/clear capsule, with off-white seeds, and imprint: IL/3638.
Available in bottles of 100 (NDC 0258-3638-01).Theophylline Extended-release 200 mg clear/opaque white capsule, with off-white seeds, and imprint: IL/3634.
Available in bottles of 100 (NDC 0258-3634-01).Theophylline Extended-release 300 mg opaque white/clear capsule, with off-white seeds, and imprint: IL/3625.
Available in bottles of 100 (NDC 0258-3625-01).
STORAGE: Store at controlled room temperature 15° - 30°C (59°- 86°F).
Dispense in a tight container as defined in the USP.
Keep this and all medications out of the reach of children. Inwood Laboratories, Inc.
Subsidiary of FOREST LABORATORIES, INC.
Inwood, New York 11096MG #9933 (06)
Rev. 03/05
Depending on the reaction of the Bronko Plus after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Bronko Plus not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Bronko Plus addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology