Senophylline
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS
Concurrent Illness
Theophylline should be used with extreme caution in patients with the following clinical conditions due to the increased risk of exacerbation of the concurrent condition:
Active peptic ulcer disease
Seizure disorders
Cardiac arrhythmias (not including bradyarrhythmias).
Conditions that Reduce Theophylline Clearance
There are several readily identifiable causes of reduced theophylline clearance.If the total daily dose is not appropriately reduced in the presence of these risk factors, severe and potentially fatal theophylline toxicity can occur. Careful consideration must be given to the benefits and risks of theophylline use and the need for more intensive monitoring of serum theophylline concentrations in patients with the following risk factors:
Age
Neonates (term and premature), children less than 1 year, elderly (greter than 60 years).
Concurrent Diseases
Acute pulmonary edema, congestive heart failure, cor-pulmonale, fever (greater than or equal to 102° for 24 hours or more; or lesser temperature elevations for longer periods), reduced renal function in infants less than 3 months of age, sepsis with multi-organ failure, and shock.
Cessation of Smoking
Drug Interactions
Adding a drug that inhibits theophylline metabolism (e.g., cimetidine, erythromycin, tacrine) or stopping a concurrently administered drug that enhances theophylline metabolism (e.g., carbamazepine, rifampin). (see PRECAUTIONS, Drug Interactions, Table II).
When Signs or Symptoms of Theophylline Toxicity Are Present
Whenever a patient receiving theophylline develops nausea or vomiting, particularly repetitive vomiting, or other signs or symptoms consistent with theophylline toxicity (even if another cause may be suspected), additional doses of theophylline should be withheld and a serum theophylline 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 (see DOSAGE AND ADMINISTRATION, Dosing Guidelines,Table VI).
Dosage Increases
Increases in the dose of theophylline should not be made in response to an acute exacerbation of symptoms of chronic lung disease since theophylline provides little added benefit to inhaled beta2-selective agonists and systemically administered cortico-steroids in this circumstance and increases the risk of adverse effects. A peak steady-state serum theophylline 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 theophylline 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 (see PRECAUTIONS, Laboratory Tests).
As the rate of theophylline 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 theophylline concentration (see DOSAGE AND ADMINISTRATION, Table VI).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS AND USAGE
Theophylline extended-release tablets 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.
INDICATIONS FOR USE Sentra AM is intended for the clinical nutritional management of the metabolic processes associated with fatigue and cognitive disorders. - Chronic fatigue - Cognitive impairment - Fibromyalgia
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION
Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, and is represented by the following structural formula:
This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations).
Each extended-release tablet for oral administration contains either 100 mg, 200 mg, 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, anhydrous lactose, magnesium stearate and povidone.
PRODUCT DESCRIPTION Primary Ingredients Sentra AM consists of a proprietary blend of amino acids, cocoa, and flavonoids in specific proportions. These ingredients fall into the category of “Generally Regarded as Safe” (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the U.S. Food and Drug Administration (FDA) to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186. Amino Acids Amino Acids are the building blocks of protein. All amino acids are GRAS listed as they have been ingested by humans for thousands of years. The doses of the amino acids, particularly choline, in Sentra AM are equivalent to those found in the usual human diet; however the formulation uses specific ratios of the key ingredients to elicit a therapeutic response. Patients with fatigue and cognitive disorders may require an increased amount of certain amino acids that cannot be obtained from normal diet alone. Choline, for example, is an obligatory amino acid. The body cannot make choline and must obtain choline from the diet. Choline is needed to produce acetylcholine. Acetylcholine is required to reduce fatigue and improve cognitive function. Patients with fatigue and cognitive disorders have altered choline metabolism. Some patients with fatigue and cognitive disorders have a resistance to the metabolism of choline that is similar to the mechanism found in insulin resistance. Patients with fatigue and cognitive disorders cannot acquire sufficient choline from the diet without ingesting a prohibitively large amount of calories, particularly calories from protein. Flavonoids Flavonoids are a group of phytochemical compounds found in all vascular plants including fruits and vegetables. They are a part of a larger class of compounds known as polyphenols. Many of the therapeutic or health benefits of colored fruits and vegetables, cocoa, red wine, and green tea are directly related to their flavonoid content. The specially formulated flavonoids found in Sentra AM cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response. Physical Description Sentra AM is a yellow to light brown powder. Sentra AM contains L-Glutamic Acid, Choline Bitartrate, Cocoa, Acetylcarnitine, and Hawthorn Berry. Other Ingredients Sentra AM contains the following inactive or other ingredients as fillers, excipients, and colorings: magnesium stearate, microcrystalline cellulose, Maltodextrin NF, gelatin (as the capsule material).
Sources
Senophylline Manufacturers
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Physician Therapeutics Llc
![Senophylline (Theophylline Anhydrous, Choline) Kit [Physician Therapeutics Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Senophylline | Physician Therapeutics Llc
DOSAGE AND ADMINISTRATION
Taking theophylline extended-release tablets immediately after a high-fat content meal may result in a somewhat higher Cmax and delayed Tmax, and somewhat greater extent of absorption. However, the differences are usually not great and this product may normally be administered without regard to meals (see CLINICAL PHARMACOLOGY, Drug Interactions, Drug-Food Interactions).
Theophylline extended-release tablets are recommended for chronic or long-term management and prevention of symptoms, and not for use in treating acute symptoms of asthma and reversible bronchospasm.
General Considerations
The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10 to 20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400 to 1600 mg/day in adults less than 60 years old and 10 to 36 mg/kg/day in children 1 to 9 years old). For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either subtherapeutic or potentially toxic serum theophylline concentrations in individual patients. For example, at a dose of 900 mg/d in adults less than 60 years or 22 mg/kg/d in children 1 to 9 years, the steady-state peak serum theophylline concentration will be less than 10 mcg/mL in about 30% of patients, 10 to 20 mcg/mL in about 50% and 20 to 30 mcg/mL in about 20% of patients. The dose of theophylline must be individualized on the basis of peak serum theophylline 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 (see Table V). 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 theophylline concentrations to reach the new steady state. Dosage adjustment should be guided by serum theophylline concentration measurement (see PRECAUTIONS, Laboratory Tests and DOSAGE AND ADMINISTRATION, Table VI). 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 (see WARNINGS).
If the patient’s symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements (see WARNINGS and PRECAUTIONS), serum theophylline concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum theophylline 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 theophylline dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for theophylline dosage adjustment based upon serum theophylline 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 theophylline concentration.A. Children (6-15 years) and adults (16-60 years) without risk factors for impaired clearance.
Table V. Dosing initiation and titration (as anhydrous theophylline).* Titration Step
1. Starting Dosage
Children less than 45 kg
12-14 mg/kg/day up
to a maximum of
300 mg/day divided
Q12 hrs*
Children >45 kg and adults 300 mg/day
divided Q12 hrs*
2. After 3 days,
if tolerated.
increase dose to:
16 mf/kg/day up
to a maximum of
400 mg/day divided
Q12 hrs*
400 mg/day divided
Q12 hrs*
3. After 3 more days,
if tolerated.
increase dose to:
20 mg/kg/day up to
a maximum of
600 mg/day
divided Q12 hrs*
600 mg/day divided
Q12 hrs*
B. Patients With Risk Factors For Impaired Clearance, The Elderly (greater than 60 Years), And Those In Whom It Is Not Feasible To Monitor Serum Theophylline Concentrations:
In children 6-15 years of age, the final theophylline dose should not exceed 16 mg/kg/day up to a maximum of 400 mg/day in the
presence of risk factors for reduced theophylline clearance (see WARNINGS) or if it is not feasible to monitor serum theophylline
concentrations.
In adolescents ³16 years and adults, including the elderly, the final theophylline dose should not exceed 400 mg/day in the presence of
risk factors for reduced theophylline clearance (see WARNINGS) or if it is not feasible to monitor serum theophylline concentrations.
*Patients with more rapid metabolism, clinically identified by higher than average dose requirements, should receive a smaller dose
more frequently (every 8 hours) to prevent breakthrough symptoms resulting from low trough concentrations before the next dose
Table VI. Dosage adjustment guided by serum theophylline concentration. Peak Serum
Concentration
Dosage Adjustment
less than 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 (see recommendations for chronic overdosage).
greater than 30 mcg/mL
Treat overdose as indicated (see recommendations for chronic overdosage). If theophylline is
subsequently resumed, decrease dose by at least 50% and recheck serum concentration after 3 days to
guide further dosage adjustment.
* Dose reduction and/or serum theophylline concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce theophylline clearance occur (e.g., sustained fever), or a drug that interacts with theophylline is added or discontinued (see WARNINGS).
Once-Daily Dosing
The slow absorption rate of this preparation may allow once-daily administration in adult non-smokers 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 titrated to therapeutic levels with q12h dosing. Once-daily dosing should be based on twice the q12h dose 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 theophylline 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 theophylline 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 theophylline extended-release once-daily dosing be administered at night.
DOSAGE AND ADMINISTRATION Recommended Administration For the nutritional management of the metabolic processes in patients with fatigue and cognitive disorders. Take (2) capsules one to three times daily or as directed by physician. As with most amino acid formulations Sentra AM should be taken between meals without food to increase the absorption of key ingredients.
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