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|drugClass=bronchodilator
|drugClass=bronchodilator
|indicationType=treatment
|indicationType=treatment
|indication= relief of acute bronchial [[asthma]] and for reversible [[bronchospasm]] associated with chronic bronchitis and [[emphysema]].
|indication=acute bronchial [[asthma]] and for reversible [[bronchospasm]] associated with chronic [[bronchitis]] and [[emphysema]]
|adverseReactions=[[diarrhea]], [[nausea]], [[vomiting]], [[headache]], [[agitation]], feeling excited, [[irritability]]
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult====Indications===
|fdaLIADAdult====Indications===
*For relief of acute bronchial asthma and for reversible bronchospasm associated with chronic bronchitis and emphysema.
*For relief of acute bronchial asthma and for reversible bronchospasm associated with chronic [[bronchitis]] and [[emphysema]].


===Dosage===
===Dosage===
Line 17: Line 18:


*Appropriate dosage adjustments should be made in patients with impaired renal function
*Appropriate dosage adjustments should be made in patients with impaired renal function
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Dyphylline in adult patients.
|offLabelAdultGuideSupport=*There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Dyphylline in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Dyphylline in adult patients.
|offLabelAdultNoGuideSupport=*There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Dyphylline in adult patients.
|fdaLIADPed=*Safety and effectiveness in pediatric patients have not been established.
|fdaLIADPed=*Safety and effectiveness in pediatric patients have not been established.
|offLabelPedGuideSupport=*There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Dyphylline in pediatric patients.
|offLabelPedGuideSupport=*There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Dyphylline in pediatric patients.
|offLabelPedNoGuideSupport=*There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Dyphylline in pediatric patients.
|offLabelPedNoGuideSupport=*There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Dyphylline in pediatric patients.
|contraindications=*Hypersensitivity to dyphylline or related xanthine compounds.
|contraindications=*[[Hypersensitivity]] to dyphylline or related [[xanthine]] compounds.
|warnings=*LUFYLLIN is not indicated in the management of status asthmaticus, which is a serious medical emergency.
|warnings=*Dyphylline is not indicated in the management of [[status asthmaticus]], which is a serious medical emergency.


*Although the relationship between plasma levels of dyphylline and appearance of toxicity is unknown, excessive doses may be expected to be associated with an increased risk of adverse effects.
*Although the relationship between plasma levels of dyphylline and appearance of toxicity is unknown, excessive doses may be expected to be associated with an increased risk of adverse effects.


====Precautions====
====Precautions====
*General: Use LUFYLLIN with caution in patients with severe cardiac disease, hypertension, hyperthyroidism, acute myocardial injury, or peptic ulcer.
*General: Use dyphylline with caution in patients with severe [[cardiac disease]], [[hypertension]], [[hyperthyroidism]], acute myocardial injury, or [[peptic ulcer]].


*Concurrent administration of dyphylline and probenecid, which competes for tubular secretion, has been shown to increase the plasma half-life of dyphylline.
*Concurrent administration of dyphylline and [[probenecid]], which competes for tubular secretion, has been shown to increase the plasma half-life of dyphylline.
|clinicalTrials=*Adverse reactions with the use of dyphylline have been infrequent, relatively mild, and rarely required reduction in dosage or withdrawal of therapy.


*The following adverse reactions which have been reported with other xanthine bronchodilators, and which have most often been related to excessive drug plasma levels, should be considered as potential adverse effects when dyphylline is administered:


:*Gastrointestinal: [[nausea]], [[vomiting]], [[epigastric pain]], [[hematemesis]], [[diarrhea]].


|clinicalTrials=Adverse reactions with the use of LUFYLLIN have been infrequent, relatively mild, and rarely required reduction in dosage or withdrawal of therapy.
:*Central nervous system: [[headache]], [[irritability]], [[restlessness]], [[insomnia]], hyperexcitability, agitation, muscle twitching, generalized clonic and tonic convulsions.


The following adverse reactions which have been reported with other xanthine bronchodilators, and which have most often been related to excessive drug plasma levels, should be considered as potential adverse effects when dyphylline is administered:
:*Cardiovascular: [[palpitation]], [[tachycardia]], extrasystoles, [[flushing]], [[hypotension]], circulatory failure, [[ventricular arrhythmias]].


Gastrointestinal: nausea, vomiting, epigastric pain, hematemesis, diarrhea.
:*Respiratory: [[tachypnea]].


Central nervous system: headache, irritability, restlessness, insomnia, hyperexcitability, agitation, muscle twitching, generalized clonic and tonic convulsions.
:*Renal: albuminuria, gross and microscopic [[hematuria]], diuresis.


Cardiovascular: palpitation, tachycardia, extrasystoles, flushing, hypotension, circulatory failure, ventricular arrhythmias.
:*Other: [[hyperglycemia]], [[inappropriate ADH syndrome]].
|postmarketing=*There is limited information regarding <i>Postmarketing experience</i> of Dyphylline.
|drugInteractions=*Synergism between xanthine bronchodilators (e.g., [[theophylline]]), [[ephedrine]], and other sympathomimetic bronchodilators has been reported. This should be considered whenever these agents are prescribed concomitantly.
|FDAPregCat=C
|useInPregnancyFDA=*Animal reproduction studies have not been conducted with dyphylline. It is also not known if dyphylline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dyphylline should be given to a pregnant woman only if clearly needed.
|useInNursing=*Dyphylline is present in human milk at approximately twice the maternal plasma concentration. Caution should be exercised when dyphylline is administered to a nursing woman.
|useInPed=*Safety and effectiveness in children have not been established.
|useInGeri=*Clinical studies of dyphylline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
|administration=*Oral
|monitoring=*Monitoring and maintenance of vital signs, fluids, and electrolytes in overdosage.
|IVCompat=*There is limited information regarding <i>IV Compatibility</i>.
|overdose=*There have been no reports, in the literature, of overdosage with dyphylline. However, the following information based on reports of theophylline overdosage are considered typical of the xanthine class of drugs and should be kept in mind.


Respiratory: tachypnea.
*Signs and symptoms: Restlessness, [[anorexia]], [[nausea]], [[vomiting]], [[diarrhea]], [[insomnia]], irritability, and [[headache]]. Marked overdosage with resulting severe toxicity has produced agitation, severe [[vomiting]], [[dehydration]], excessive thirst, [[tinnitus]], [[cardiac arrhythmias]], hyperthermia, diaphoresis, and generalized clonic and tonic convulsions. Cardiovascular collapse has also occurred, with some fatalities. [[Seizures]] have occurred in some cases associated with very high theophylline plasma concentrations, without any premonitory symptoms of toxicity.


Renal: albuminuria, gross and microscopic hematuria, diuresis.
*Treatment: There is no specific antidote for overdosage with drugs of the xanthine class. Symptomatic treatment and general supportive measures should be instituted with careful monitoring and maintenance of vital signs, fluids, and electrolytes. The stomach should be emptied by inducing emesis if the patient is conscious and responsive, or by gastric lavage, taking care to protect against aspiration, especially in stuporous or comatose patients. Maintenance of an adequate airway is essential in case oxygen or assisted respiration is needed. Sympathomimetic agents should be avoided but sedatives such as short-acting barbiturates may be useful.


Other: hyperglycemia, inappropriate ADH syndrome.
*Dyphylline is dialyzable and, although not recommended as a routine procedure in overdosage cases, hemodialysis may be of some benefit when severe intoxication is present or when the patient has not responded to general supportive and symptomatic treatment.
|drugInteractions=*Drug interactions: Synergism between xanthine bronchodilators (e.g., theophylline), ephedrine, and other sympathomimetic bronchodilators has been reported. This should be considered whenever these agents are prescribed concomitantly.
|drugBox={{Drugbox2
|FDAPregCat=C
| Watchedfields = changed
|useInPregnancyFDA= Animal reproduction studies have not been conducted with LUFYLLIN. It is also not known if LUFYLLIN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. LUFYLLIN should be given to a pregnant woman only if clearly needed.
| verifiedrevid = 443716387
| IUPAC_name = 7-(2,3-dihydroxypropyl)-1,3-dimethyl-3,7-dihydro-1''H''-purine-2,6-dione
| image = Dyphylline.png


|useInNursing=*Dyphylline is present in human milk at approximately twice the maternal plasma concentration. Caution should be exercised when LUFYLLIN is administered to a nursing woman.
<!--Clinical data-->
|useInPed=*Safety and effectiveness in children have not been established.
| tradename = Lufyllin
| Drugs.com = {{drugs.com|CDI|dyphylline}}
| MedlinePlus = a682494
| pregnancy_US = C
| legal_US = Rx-only
| routes_of_administration =


|useInGeri=*Clinical studies of LUFYLLIN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
<!--Pharmacokinetic data-->
|administration=*Oral
| bioavailability =
|monitoring=*Monitoring and maintenance of vital signs, fluids, and electrolytes in overdosage.
| metabolism =
|overdose=There have been no reports, in the literature, of overdosage with LUFYLLIN. However, the following information based on reports of theophylline overdosage are considered typical of the xanthine class of drugs and should be kept in mind.
| elimination_half-life =
| excretion =


Signs and symptoms: Restlessness, anorexia, nausea, vomiting, diarrhea, insomnia, irritability, and headache. Marked overdosage with resulting severe toxicity has produced agitation, severe vomiting, dehydration, excessive thirst, tinnitus, cardiac arrhythmias, hyperthermia, diaphoresis, and generalized clonic and tonic convulsions. Cardiovascular collapse has also occurred, with some fatalities. Seizures have occurred in some cases associated with very high theophylline plasma concentrations, without any premonitory symptoms of toxicity.
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 479-18-5
| ATC_prefix = R03
| ATC_suffix = DA01
| PubChem = 3182
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB00651
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 3070
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 263T0E9RR9
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D00691
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 4728
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 1752


Treatment: There is no specific antidote for overdosage with drugs of the xanthine class. Symptomatic treatment and general supportive measures should be instituted with careful monitoring and maintenance of vital signs, fluids, and electrolytes. The stomach should be emptied by inducing emesis if the patient is conscious and responsive, or by gastric lavage, taking care to protect against aspiration, especially in stuporous or comatose patients. Maintenance of an adequate airway is essential in case oxygen or assisted respiration is needed. Sympathomimetic agents should be avoided but sedatives such as short-acting barbiturates may be useful.
<!--Chemical data-->
 
| C=10 | H=14 | N=4 | O=4
Dyphylline is dialyzable and, although not recommended as a routine procedure in overdosage cases, hemodialysis may be of some benefit when severe intoxication is present or when the patient has not responded to general supportive and symptomatic treatment.
| molecular_weight = 254.24 g/mol
|structure=LUFYLLIN (dyphylline), a xanthine derivative, is a bronchodilator available for oral administration as tablets containing 200 mg and 400 mg of dyphylline. Other ingredients: magnesium stearate, microcrystalline cellulose.
| smiles = O=C2N(c1ncn(c1C(=O)N2C)CC(O)CO)C
| InChI = 1/C10H14N4O4/c1-12-8-7(9(17)13(2)10(12)18)14(5-11-8)3-6(16)4-15/h5-6,15-16H,3-4H2,1-2H3
| InChIKey = KSCFJBIXMNOVSH-UHFFFAOYAI
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C10H14N4O4/c1-12-8-7(9(17)13(2)10(12)18)14(5-11-8)3-6(16)4-15/h5-6,15-16H,3-4H2,1-2H3
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = KSCFJBIXMNOVSH-UHFFFAOYSA-N
| synonyms = 7-(2,3-dihydroxy-propyl)theophylline
}}
|mechAction=Dyphylline is a xanthine derivative with pharmacologic actions similar to theophylline and other members of this class of drugs. Its primary action is that of bronchodilation, but it also exhibits peripheral vasodilatory and other smooth muscle relaxant activity to a lesser degree. The bronchodilatory action of dyphylline, as with other xanthines, is thought to be mediated through competitive inhibition of phosphodiesterase with a resulting increase in cyclic AMP producing relaxation of bronchial smooth muscle.
|structure=Dyphylline, a xanthine derivative, is a bronchodilator available for oral administration as tablets containing 200 mg and 400 mg of dyphylline. Other ingredients: magnesium stearate, microcrystalline cellulose.


Chemically, dyphylline is 7-(2,3-dihydroxypropyl)-theophylline, a white, extremely bitter, amorphous powder that is freely soluble in water and soluble in alcohol to the extent of 2 g/100 mL. Dyphylline forms a neutral solution that is stable in gas­trointestinal fluids over a wide range of pH.
Chemically, dyphylline is 7-(2,3-dihydroxypropyl)-theophylline, a white, extremely bitter, amorphous powder that is freely soluble in water and soluble in alcohol to the extent of 2 g/100 mL. Dyphylline forms a neutral solution that is stable in gas­trointestinal fluids over a wide range of pH.


The molecular formula for dyphylline is C10H14N4O4 with a molecular weight of 254.25. Its structural formula is:
The molecular formula for dyphylline is C10H14N4O4 with a molecular weight of 254.25. Its structural formula is:
[[File:XXXXX.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:Dyphylline1.jpeg|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|nonClinToxic=*Carcinogenesis, mutagenesis, impairment of fertility: No long-term animal studies have been performed with LUFYLLIN.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of Dyphylline.
|howSupplied=LUFYLLIN Tablets contain 200 mg dyphylline and are white, rectangular, scored on one side and imprinted WALLACE 521 on the other side. The tablets are available in bottles of 100 (NDC 0037-0521-92).
|PK=*Dyphylline is well tolerated and produces less [[nausea]] than aminophylline and other alkaline theophylline compounds when administered orally. Unlike the hydrolyzable salts of theophylline, dyphylline is not converted to free theophylline in vivo. It is absorbed rapidly in therapeutically active form and in healthy volunteers reaches a mean peak plasma concentration of 17.1 mcg/mL in approximately 45 minutes following a single oral dose of 1000 mg of dyphylline.
 
*Dyphylline exerts its bronchodilatory effects directly and, unlike the­ophylline, is excreted unchanged by the kidneys without being metabolized by the liver. Because of this, dyphylline pharmacokinetics and plasma levels are not influenced by various factors that affect liver function and hepatic enzyme activity, such as smoking, age, congestive heart failure, or concomitant use of drugs which affect liver function.


LUFYLLIN-400 Tablets contain 400 mg dyphylline and are white, capsule-shaped, scored on one side and imprinted WALLACE 731 on the other side. The tablets are available in bottles of 100 (NDC 0037-0731-92).
*The elimination half-life of dyphylline is approximately two hours (1.8-2.1 hr) and approximately 88% of a single oral dose can be recovered from the urine unchanged. The renal clearance would be correspondingly reduced in patients with impaired renal function. In anuric patients, the half-life may be increased 3 to 4 times normal.
|alcohol=Alcohol-Dyphylline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
*Dyphylline plasma levels are dose-related and generally predictable. The range of plasma levels within which dyphylline can be expected to produce effective bronchodilation has not been determined.
|nonClinToxic=*Carcinogenesis, mutagenesis, impairment of fertility: No long-term animal studies have been performed with dyphylline.
|clinicalStudies=*There is limited information regarding <i>Clinical Studies</i> of Dyphylline.
|howSupplied=*LUFYLLIN Tablets contain 200 mg dyphylline and are white, rectangular, scored on one side and imprinted WALLACE 521 on the other side. The tablets are available in bottles of 100 (NDC 0037-0521-92).
 
*LUFYLLIN-400 Tablets contain 400 mg dyphylline and are white, capsule-shaped, scored on one side and imprinted WALLACE 731 on the other side. The tablets are available in bottles of 100 (NDC 0037-0731-92).
|storage=*Store at controlled room temperature 20°-25°C (68°-77°F).
*Dispense in a tight container.
|packLabel=[[File:Dyphylline2.jpeg|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:Dyphylline3.jpeg|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:Dyphylline4.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|alcohol=*Alcohol-Dyphylline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=*LUFYLLIN ®<ref>{{Cite web | title =LUFYLLIN- dyphylline tablet  | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d7ed7c0-9646-11de-a404-0002a5d5c51b }}</ref>
|lookAlike=*There is limited information regarding <i>Look-Alike Drug Names</i>.
}}
}}
[[Category:Phosphodiesterase inhibitors]]
[[Category:Xanthines]]
[[Category:Drug]]

Latest revision as of 20:17, 18 August 2015

Dyphylline
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]

Disclaimer

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Overview

Dyphylline is a bronchodilator that is FDA approved for the treatment of acute bronchial asthma and for reversible bronchospasm associated with chronic bronchitis and emphysema. Common adverse reactions include diarrhea, nausea, vomiting, headache, agitation, feeling excited, irritability.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • For relief of acute bronchial asthma and for reversible bronchospasm associated with chronic bronchitis and emphysema.

Dosage

  • Dosage should be individually titrated according to the severity of the condition and the response of the patient.
  • Usual adult dosage: Up to 15 mg/kg every six hours.
  • Appropriate dosage adjustments should be made in patients with impaired renal function

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Dyphylline in adult patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Dyphylline in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • Safety and effectiveness in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Dyphylline in pediatric patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Dyphylline in pediatric patients.

Contraindications

Warnings

  • Dyphylline is not indicated in the management of status asthmaticus, which is a serious medical emergency.
  • Although the relationship between plasma levels of dyphylline and appearance of toxicity is unknown, excessive doses may be expected to be associated with an increased risk of adverse effects.

Precautions

  • Concurrent administration of dyphylline and probenecid, which competes for tubular secretion, has been shown to increase the plasma half-life of dyphylline.

Adverse Reactions

Clinical Trials Experience

  • Adverse reactions with the use of dyphylline have been infrequent, relatively mild, and rarely required reduction in dosage or withdrawal of therapy.
  • The following adverse reactions which have been reported with other xanthine bronchodilators, and which have most often been related to excessive drug plasma levels, should be considered as potential adverse effects when dyphylline is administered:
  • Renal: albuminuria, gross and microscopic hematuria, diuresis.

Postmarketing Experience

  • There is limited information regarding Postmarketing experience of Dyphylline.

Drug Interactions

  • Synergism between xanthine bronchodilators (e.g., theophylline), ephedrine, and other sympathomimetic bronchodilators has been reported. This should be considered whenever these agents are prescribed concomitantly.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Animal reproduction studies have not been conducted with dyphylline. It is also not known if dyphylline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dyphylline should be given to a pregnant woman only if clearly needed.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dyphylline in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dyphylline during labor and delivery.

Nursing Mothers

  • Dyphylline is present in human milk at approximately twice the maternal plasma concentration. Caution should be exercised when dyphylline is administered to a nursing woman.

Pediatric Use

  • Safety and effectiveness in children have not been established.

Geriatic Use

  • Clinical studies of dyphylline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Gender

There is no FDA guidance on the use of Dyphylline with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dyphylline with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dyphylline in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dyphylline in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dyphylline in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dyphylline in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

  • Monitoring and maintenance of vital signs, fluids, and electrolytes in overdosage.

IV Compatibility

  • There is limited information regarding IV Compatibility.

Overdosage

  • There have been no reports, in the literature, of overdosage with dyphylline. However, the following information based on reports of theophylline overdosage are considered typical of the xanthine class of drugs and should be kept in mind.
  • Signs and symptoms: Restlessness, anorexia, nausea, vomiting, diarrhea, insomnia, irritability, and headache. Marked overdosage with resulting severe toxicity has produced agitation, severe vomiting, dehydration, excessive thirst, tinnitus, cardiac arrhythmias, hyperthermia, diaphoresis, and generalized clonic and tonic convulsions. Cardiovascular collapse has also occurred, with some fatalities. Seizures have occurred in some cases associated with very high theophylline plasma concentrations, without any premonitory symptoms of toxicity.
  • Treatment: There is no specific antidote for overdosage with drugs of the xanthine class. Symptomatic treatment and general supportive measures should be instituted with careful monitoring and maintenance of vital signs, fluids, and electrolytes. The stomach should be emptied by inducing emesis if the patient is conscious and responsive, or by gastric lavage, taking care to protect against aspiration, especially in stuporous or comatose patients. Maintenance of an adequate airway is essential in case oxygen or assisted respiration is needed. Sympathomimetic agents should be avoided but sedatives such as short-acting barbiturates may be useful.
  • Dyphylline is dialyzable and, although not recommended as a routine procedure in overdosage cases, hemodialysis may be of some benefit when severe intoxication is present or when the patient has not responded to general supportive and symptomatic treatment.

Pharmacology

Template:Px
Dyphylline
Systematic (IUPAC) name
7-(2,3-dihydroxypropyl)-1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione
Identifiers
CAS number 479-18-5
ATC code R03DA01
PubChem 3182
DrugBank DB00651
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 254.24 g/mol
SMILES eMolecules & PubChem
Synonyms 7-(2,3-dihydroxy-propyl)theophylline
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

C(US)

Legal status

[[Prescription drug|Template:Unicode-only]](US)

Routes ?

Mechanism of Action

Dyphylline is a xanthine derivative with pharmacologic actions similar to theophylline and other members of this class of drugs. Its primary action is that of bronchodilation, but it also exhibits peripheral vasodilatory and other smooth muscle relaxant activity to a lesser degree. The bronchodilatory action of dyphylline, as with other xanthines, is thought to be mediated through competitive inhibition of phosphodiesterase with a resulting increase in cyclic AMP producing relaxation of bronchial smooth muscle.

Structure

Dyphylline, a xanthine derivative, is a bronchodilator available for oral administration as tablets containing 200 mg and 400 mg of dyphylline. Other ingredients: magnesium stearate, microcrystalline cellulose.

Chemically, dyphylline is 7-(2,3-dihydroxypropyl)-theophylline, a white, extremely bitter, amorphous powder that is freely soluble in water and soluble in alcohol to the extent of 2 g/100 mL. Dyphylline forms a neutral solution that is stable in gas­trointestinal fluids over a wide range of pH.

The molecular formula for dyphylline is C10H14N4O4 with a molecular weight of 254.25. Its structural formula is:

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dyphylline.

Pharmacokinetics

  • Dyphylline is well tolerated and produces less nausea than aminophylline and other alkaline theophylline compounds when administered orally. Unlike the hydrolyzable salts of theophylline, dyphylline is not converted to free theophylline in vivo. It is absorbed rapidly in therapeutically active form and in healthy volunteers reaches a mean peak plasma concentration of 17.1 mcg/mL in approximately 45 minutes following a single oral dose of 1000 mg of dyphylline.
  • Dyphylline exerts its bronchodilatory effects directly and, unlike the­ophylline, is excreted unchanged by the kidneys without being metabolized by the liver. Because of this, dyphylline pharmacokinetics and plasma levels are not influenced by various factors that affect liver function and hepatic enzyme activity, such as smoking, age, congestive heart failure, or concomitant use of drugs which affect liver function.
  • The elimination half-life of dyphylline is approximately two hours (1.8-2.1 hr) and approximately 88% of a single oral dose can be recovered from the urine unchanged. The renal clearance would be correspondingly reduced in patients with impaired renal function. In anuric patients, the half-life may be increased 3 to 4 times normal.
  • Dyphylline plasma levels are dose-related and generally predictable. The range of plasma levels within which dyphylline can be expected to produce effective bronchodilation has not been determined.

Nonclinical Toxicology

  • Carcinogenesis, mutagenesis, impairment of fertility: No long-term animal studies have been performed with dyphylline.

Clinical Studies

  • There is limited information regarding Clinical Studies of Dyphylline.

How Supplied

  • LUFYLLIN Tablets contain 200 mg dyphylline and are white, rectangular, scored on one side and imprinted WALLACE 521 on the other side. The tablets are available in bottles of 100 (NDC 0037-0521-92).
  • LUFYLLIN-400 Tablets contain 400 mg dyphylline and are white, capsule-shaped, scored on one side and imprinted WALLACE 731 on the other side. The tablets are available in bottles of 100 (NDC 0037-0731-92).

Storage

  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Dispense in a tight container.

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Dyphylline Patient Counseling Information in the drug label.

Precautions with Alcohol

  • Alcohol-Dyphylline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

  • There is limited information regarding Look-Alike Drug Names.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "LUFYLLIN- dyphylline tablet".
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