Dyphylline

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]

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Overview

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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

• Hypersensitivity to dyphylline or related xanthine compounds.

Warnings

• LUFYLLIN 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

• General: Use LUFYLLIN 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.

Adverse Reactions

Clinical Trials Experience

Adverse reactions with the use of LUFYLLIN 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.

Central nervous system: headache, irritability, restlessness, insomnia, hyperexcitability, agitation, muscle twitching, generalized clonic and tonic convulsions.

Cardiovascular: palpitation, tachycardia, extrasystoles, flushing, hypotension, circulatory failure, ventricular arrhythmias.

Respiratory: tachypnea.

Renal: albuminuria, gross and microscopic hematuria, diuresis.

Other: hyperglycemia, inappropriate ADH syndrome.

Postmarketing Experience

There is limited information regarding Dyphylline Postmarketing Experience in the drug label.

Drug Interactions

• 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 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.
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 LUFYLLIN is administered to a nursing woman.

Pediatric Use

• Safety and effectiveness in children have not been established.

Geriatic Use

• 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.

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 the compatibility of Dyphylline and IV administrations.

Overdosage

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.

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

There is limited information regarding Dyphylline Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Dyphylline Mechanism of Action in the drug label.

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.

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:

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Pharmacodynamics

There is limited information regarding Dyphylline Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Dyphylline Pharmacokinetics in the drug label.

Nonclinical Toxicology

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

Clinical Studies

There is limited information regarding Dyphylline Clinical Studies in the drug label.

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

There is limited information regarding Dyphylline Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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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

There is limited information regarding Dyphylline Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Dyphylline Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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