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theophylline anhydrous

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Overview

What is Theo-24?



What does Theo-24 look like?



What are the available doses of Theo-24?

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What should I talk to my health care provider before I take Theo-24?

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How should I use Theo-24?

Theophylline is 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.


What interacts with Theo-24?

Theo-24 is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.



What are the warnings of Theo-24?

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Concurrent Illness:

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When Signs or Symptoms of Theophylline Toxicity Are Present:

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DOSAGE AND ADMINISTRATION

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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 , Table VI).


What are the precautions of Theo-24?

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General:

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WARNINGS

DOSAGE AND ADMINISTRATION

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  • When initiating therapy to guide final dosage adjustment after titration.
  • Before making a dose increase to determine whether the serum concentration is sub-therapeutic in a patient who continues to be symptomatic.
  • Whenever signs or symptoms of theophylline toxicity are present.
  • Whenever there is a new illness, worsening of a chronic illness or a change in the patient's treatment regimen that may alter theophylline clearance (e.g., fever >102° F sustained for ≥24 hours, hepatitis, or drugs listed in Table II are added or discontinued).


Monitoring Serum Theophylline Concentrations:

To guide a dose increase, the blood sample should be obtained at the time of the expected peak serum theophylline concentration; 12 hours after a dose at steady-state (expected peak serum theophylline concentration range is between 5 –15 mcg/mL). For most patients, steady-state will be reached after 3 days of dosing when no doses have been missed, no extra doses have been added, and none of the doses have been taken at unequal intervals. A trough concentration (i.e., at the end of the dosing interval) provides no additional useful information and may lead to an inappropriate dose increase since the peak serum theophylline concentration can be two or more times greater than the trough concentration with an extended-release formulation. If the serum sample is drawn more or less than twelve (12) hours after the dose, the results must be interpreted with caution since the concentration may not be reflective of the peak concentration. In contrast, when signs or symptoms of theophylline toxicity are present, the serum sample should be obtained as soon as possible, analyzed immediately, and the result reported to the healthcare professional without delay. In patients in whom decreased serum protein binding is suspected (e.g., cirrhosis, women during the third trimester of pregnancy), the concentration of unbound theophylline should be measured and the dosage adjusted to achieve an unbound concentration of 6 - 12 mcg/mL.

Saliva concentrations of theophylline cannot be used reliably to adjust dosage without special techniques.

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Effects on Laboratory Tests:

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Information for Patients:

Patients should be instructed to take this medication each morning at approximately the same time and not to exceed the prescribed dose.

Patients who require a relatively high dose of theophylline should be informed of important considerations relating to time of drug administration and meal content (see ; and ).

Drug Interactions:

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Table II. Clinically significant drug interactions with theophylline*.
 *     †    
Drug Type of Interaction Effect†
 Adenosine Theophylline 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 theophylline clearance for up to 24 hours. 30% increase
 Allopurinol Decreases theophylline clearance at allopurinol doses ≥600 mg/day. 25% increase
 Aminoglutethimide Increases theophylline clearance by induction of microsomal enzyme activity. 25% decrease
 Carbamazepine Similar to aminoglutethimide. 30% decrease
 Cimetidine Decreases theophylline 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 theophylline blocks adenosine receptors. Larger diazepam doses may be required to produce desired level of sedation. Discontinuation of theophylline without reduction of diazepam dose may result in respiratory depression.
 Disulfiram Decreases theophylline 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 theophylline clearance by inhibiting cytochrome P450 3A3. 35% increase. Erythromycin steady-state serum concentrations decrease by a similar amount.
 Estrogen Estrogen containing oral contraceptives decrease theophylline clearance in a dose- dependent fashion. The effect of progesterone on theophylline 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, theophylline increases release of endogenous catecholamines. Increased risk of ventricular arrhythmias.
 Interferon, human recombinant alpha-A Decreases theophylline clearance. 100% increase
 Isoproterenol (IV) Increases theophylline clearance. 20% decrease
 Ketamine Pharmacologic. May lower theophylline seizure threshold.
 Lithium Theophylline 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 theophylline 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 theophylline clearance. 25% decrease
 Pancuronium Theophylline 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 theophylline clearance. 30% increase
 Phenobarbital (PB) Similar to aminoglutethimide. 25% decrease after two weeks of concurrent PB.
 Phenytoin Phenytoin increases theophylline clearance by increasing microsomal enzyme activity. Theophylline decreases phenytoin absorption. Serum theophylline phenytoin concentrations decrease about 40%.
 Propafenone Decreases theophylline clearance and pharmacologic interaction. 40% increase. Beta blocking effect may decrease efficacy of theophylline
 Propranolol Similar to cimetidine and pharmacologic interaction. 100% increase. Beta blocking effect may decrease efficacy of theophylline
 Rifampin Increases theophylline clearance by increasing cytochrome P450 1A2 and 3A3 activity. 20-40% decrease
 St. John's Wort (Hypericum Perforatum) Decrease in theophylline plasma concentrations. Higher doses of theophylline may be required to achieve desired effect. Stopping St. John's Wort may result in theophylline toxicity.
 Sulfinpyrazone Increases theophylline clearance by increasing demethylation and hydroxylation. Decreases renal clearance of theophylline. 20% decrease
 Tacrine Similar to cimetidine, also increases renal clearance of theophylline. 90% increase
 Thiabendazole Decreases theophylline clearance. 190% increase
 Ticlopidine Decreases theophylline clearance. 60% increase
 Troleandomycin Similar to erythromycin. 33-100% increase depending on troleandomycin dose.
 Verapamil Similar to disulfiram. 20% increase
Table III. Drugs that have been documented not to interact with theophylline or drugs that produce no clinically significant interaction with theophylline.*
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 albuterol, systemic and inhaled hydrocortisone ofloxacin
 amoxicillin isoflurane omeprazole
 ampicillin, with or without isoniazid prednisone, prednisolone
   sulbactam isradipine ranitidine
 atenolol influenza vaccine rifabutin
 azithromycin ketoconazole roxithromycin
 caffeine, dietary ingestion lomefloxacin sorbitol
 cefaclor mebendazole   (purgative doses do
 co-trimoxazole (trimethoprim medroxyprogesterone   not inhibit theophylline
    and sulfamethoxazole) methylprednisolone   absorption)
 diltiazem metronidazole sucralfate
 dirithromycin metoprolol terbutaline,systemic
 enflurane nadolol terfenadine
 famotidine nifedipine tetracycline
 felodipine nizatidine tocainide
 finasteride norfloxacin


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The Effect of Other Drugs on Theophylline Serum Concentration Measurements:

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Carcinogenesis, Mutagenesis, and Impairment of Fertility:

Theophylline has been studied in Ames salmonella, and cytogenetics, micronucleus and Chinese hamster ovary test systems and has not been shown to be genotoxic.

In a 14 week continuous breeding study, theophylline, administered to mating pairs of B6C3F mice at oral doses of 120, 270 and 500 mg/kg (approximately 1.0 - 3.0 times the human dose on a mg/m 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, theophylline was administered to F344 rats and B6C3F mice at oral doses of 40 - 300 mg/kg (approximately 2.0 times the human dose on a mg/m basis). At the high dose, systemic toxicity was observed in both species including decreases in testicular weight.

Pregnancy:

CATEGORY C:

In studies with mice, a single intraperitoneal dose at and above 100 mg/kg (approximately equal to the maximum recommended oral dose for adults on a mg/m basis) during organogenesis produced cleft palate and digital abnormalities. Micromelia, micrognathia, clubfoot, subcutaneous hematoma, open eyelids, and embryolethality were observed at doses that are approximately 2 times the maximum recommended oral dose for adults on a mg/m basis. In a study with rats dosed from conception through organogenesis, an oral dose of 150 mg/kg/day (approximately 2 times the maximum recommended oral dose for adults on a mg/m basis) produced digital abnormalities. Embryolethality was observed with a subcutaneous dose of 200 mg/kg/day (approximately 4 times the maximum recommended oral dose for adults on a mg/m basis).

In a study in which pregnant rabbits were dosed throughout organogenesis, an intravenous dose of 60 mg/kg/day (approximately 2 times the maximum recommended oral dose for adults on a mg/m basis), which caused the death of one doe and clinical signs in others, produced cleft palate and was embryolethal. Doses at and above 15 mg/kg/day (less than the maximum recommended oral dose for adults on a mg/m basis) increased the incidence of skeletal variations.

There are no adequate and well-controlled studies in pregnant women. Theophylline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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Nursing Mothers:

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Pediatric Use:

INDICATIONS AND USAGE

CLINICAL PHARMACOLOGY

WARNINGS

DOSAGE AND ADMINISTRATION

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Geriatric Use:

PRECAUTIONS: Drug Interactions

PRECAUTIONS, Monitoring Serum Theophylline Concentrations

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION


What are the side effects of Theo-24?

Adverse reactions associated with theophylline are generally mild when peak serum theophylline concentrations are <20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum theophylline concentrations exceed 20 mcg/mL, however, theophylline produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal (see ). The transient caffeine-like adverse reactions occur in about 50% of patients when theophylline 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 theophylline therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of theophylline 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 (see , Table V). 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 theophylline 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 theophylline therapy and the potential therapeutic benefit of alternative treatment.

Other adverse reactions that have been reported at serum theophylline 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 theophylline concentrations ≥15 mcg/mL. There have been a few isolated reports of seizures at serum theophylline concentrations <20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum theophylline concentrations <20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum theophylline concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum theophylline concentrations <20 mcg/mL have generally been milder than seizures associated with excessive serum theophylline concentrations resulting from an overdose (i.e., they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua).

Table IV. Manifestations of theophylline toxicity.*
 *    These data are derived from two studies in patients with serum theophylline 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 theophylline 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 theophylline concentrations >30 mcg/mL among 6000 blood samples obtained for       measurement of serum theophylline concentrations in three emergency departments. Differences in the       incidence of manifestations of theophylline 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.
 Percentage of patients reported with sign or symptom
 Acute Overdose (Large Single Ingestion) Chronic Overdosage (Multiple Excessive Doses)
 Sign/Symptom Study 1 (n=157) Study 2 (n=14) Study 1 (n=92) Study 2 (n=102)
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
     tachycardias 2 21 12 14
   Ventricular premature beats 3 21 10 19
   Atrial fibrillation or flutter 1 NR† 12 NR†
   Multifocal atrial tachycardia 0 NR† 2 NR†
   Ventricular arrhythmias with
     hemodynamic instability 7 14 40 0
   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



What should I look out for while using Theo-24?

Theo-24 is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.


What might happen if I take too much Theo-24?


How should I store and handle Theo-24?

QUDEXY XR (topiramate) extended-release capsules should be stored in a tightly-closed container at 20 to 25°C (68 to 77°F). Excursions permitted 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Theo-24 (theophylline anhydrous)Theo-24 300 mg capsules are Swedish orange and natural, with markings Theo-24, 300 mg, AP, and 2852, supplied as:   NDC Number Size 52244-300-10               bottle of 100 NDC single dose pack with 1 capsule as Theo-24 (theophylline anhydrous)Theo-24 300 mg capsules are Swedish orange and natural, with markings Theo-24, 300 mg, AP, and 2852, supplied as:   NDC Number Size 52244-300-10               bottle of 100 NDC single dose pack with 1 capsule as Theo-24 (theophylline anhydrous)Theo-24 300 mg capsules are Swedish orange and natural, with markings Theo-24, 300 mg, AP, and 2852, supplied as:   NDC Number Size 52244-300-10               bottle of 100 NDC single dose pack with 1 capsule as Theo-24 (theophylline anhydrous)Theo-24 300 mg capsules are Swedish orange and natural, with markings Theo-24, 300 mg, AP, and 2852, supplied as:   NDC Number Size 52244-300-10               bottle of 100 NDC single dose pack with 1 capsule as


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Mechanism of Action:

Theophylline increases the force of contraction of diaphragmatic muscles. This action appears to be due to enhancement of calcium uptake through an adenosine-mediated channel.

Non-Clinical Toxicology
Theo-24 is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

General:

if tolerated,

WARNINGS

DOSAGE AND ADMINISTRATION

Adverse reactions associated with theophylline are generally mild when peak serum theophylline concentrations are <20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum theophylline concentrations exceed 20 mcg/mL, however, theophylline produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal (see ). The transient caffeine-like adverse reactions occur in about 50% of patients when theophylline 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 theophylline therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of theophylline 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 (see , Table V). 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 theophylline 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 theophylline therapy and the potential therapeutic benefit of alternative treatment.

Other adverse reactions that have been reported at serum theophylline 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 theophylline concentrations ≥15 mcg/mL. There have been a few isolated reports of seizures at serum theophylline concentrations <20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum theophylline concentrations <20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum theophylline concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum theophylline concentrations <20 mcg/mL have generally been milder than seizures associated with excessive serum theophylline concentrations resulting from an overdose (i.e., they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).