Theophylline description, usages, side effects, indications, overdosage, supplying and lots more!

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Theophylline

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

THEOPHYLLINE DESCRIPTION


Theophylline






DOSAGE AND ADMINISTRATION


PHARMACOKINETICS

Overview

Table ITable IIPRECAUTIONS, Laboratory Tests

Table I. Mean and range of total body clearance and half-life of theophylline related to age and altered physiological states.*
PopulationTotal body clearanceHalf-life mean (range)Characteristicsmean (range)Age(mL/kg/min)(hr)Premature neonatespostnatal age 3 - 15 days 0.29 (0.09 to 0.49)30 (17 to 43)postnatal age 25 - 27days 0.64 (0.04 to 1.2)20 (9.4 to 30.6)Term infantspostnatal age 1 - 2 daysNR25.7 (25 to 26.5)postnatal age 3 - 30weeksNR11 (6 to 29)Children1 to 4 years1.7 (0.5 to 2.9)3.4 (1.2 to 5.6)4 to 12 years1.6 (0.8 to 2.4)NR13 to 5 years0.9 (0.48 to 1.3)NR6 to 17 years1.4 (0.2 to 2.6)3.7 (1.5 to 5.9)Adults (16 to 60 years)otherwise healthynonsmoking asthmatics0.65 (0.27 to 1.03)8.7 (6.1 to 12.8)Elderly (>60 years)nonsmokers with normalcardiac, liver and renalfunction0.41 (0.21 to 0.61)9.8 (1.6 to 18)Concurrent illness or altered physiological stateAcute pulmonary edema0.33(0.07 to 2.45)19(3.1 to 82)COPD->60 years, stablenonsmoker > 1 year0.54 (0.44 to 0.64)11 (9.4 to 12.6)COPD with corpulmonale0.48 (0.08 to 0.88)NRCystic fibrosis(14 to 28 years)1.25 (0.31 to 2.2)6.0 (1.8 to 10.2)Fever associated with acuteviral respiratory illness(children 9 - 15 years)NR.0 (1.0 to 13)Liver disease - cirrhosis0.31(0.1 to 0.7)32(10 to 56)acute hepatitis0.35 (0.25 to 0.45)19.2 (16.6 to 21.8)cholestasis0.65 (0.25 to 1.45)14.4 (5.7 to 31.8)Pregnancy - 1st trimesterNR8.5 (3.1 to 13.9)2nd trimesterNR8.8 (3.8 to 13.8)3rd trimesterNR13.0 (8.4 to 17.6)Sepsis with multi-organ18.8 (6.failure0.47 (0.19 to 1.9)18.8 (6.3 to 21.4)Thyroid disease-hypothyroid0.38 (0.13 to 0.57)11.6 (8.2 to 25)hyperthyroid0.8 (0.68 to 0.97)4.5 (3.7 to 5.6)*For various North American patient populations from literature reports. Different rates of elimination and consequent dosage requirements have been observed among other peoples.

Reported range or estimated range (mean +/- 2 SD) where actual range not reported.
NR = not reported or not reported in a comparable format.
Median.


NOTE: In addition to the factors listed above, theophylline clearance is increased and half-life
decreased by low carbohydrate/high protein diets, parenteral nutrition, and daily consumption
of charcoal-broiled beef. A high carbohydrate/low protein diet can decrease the clearance and
prolong the half-life of theophylline.

Absorption


Single-Dose Study






Multiple-Dose Study











Once-a-Day Dosing



Distribution


Metabolism


DOSAGE AND ADMINISTRATIONTable VI

Excretion
WARNINGS

Serum Concentrations at Steady-State


Special Populations (see Table I for mean clearance and half-life values)

Geriatric
WARNINGS

Pediatrics
WARNINGSWARNINGSDOSAGE AND ADMINISTRATION

Gender


Race


Renal Insufficiency
WARNINGS

Hepatic Insufficiency
WARNINGS

Congestive Heart Failure (CHF)
WARNINGS

Smokers
WARNINGS

Fever
WARNINGS

Miscellaneous
WARNINGS

Clinical Studies



INDICATIONS & USAGE



THEOPHYLLINE CONTRAINDICATIONS



WARNINGS

Concurrent Illness




Cardiac arrhythmias (not including bradyarrhythmias).



Age


Concurrent Diseases


Cessation of Smoking

Drug Interactions
PRECAUTIONS, Drug Interactions, Table II

DOSAGE AND ADMINISTRATIONDosing Guidelines,Table VI

Dosage Increases
PRECAUTIONS, Laboratory Tests
DOSAGE AND ADMINISTRATIONTable VI

PRECAUTIONS

General
WARNINGSDOSAGE AND ADMINISTRATIONTable V

Monitoring Serum Theophylline Concentrations








Effects on Laboratory Tests


INFORMATION FOR PATIENTS




DRUG INTERACTIONS

Drug-Drug Interactions





Table II. Clinically significant drug interactions with theophylline.*
DrugType of InteractionEffect*


Table III. Drugs that have been documented not to interact with theophylline or drugs that produce no clinically significant interaction with theophylline.*
*

Drug-Food Interactions


The Effect of Other Drugs on Theophylline Serum Concentration Measurements


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Category C


CLINICAL PHARMACOLOGY

Mechanism of Action



Serum Concentration-Effect Relationship


NURSING MOTHERS



PEDIATRIC USE

CLINICAL PHARMACOLOGYTable IWARNINGSDOSAGE AND ADMINISTRATIONTable V

GERIATRIC USE

DOSAGE AND ADMINISTRATION

THEOPHYLLINE ADVERSE REACTIONS

OVERDOSAGEDOSAGE AND ADMINISTRATIONTable V


Table IV. Manifestations of theophylline toxicity.*Percentage of patients reported with sign or symptom
Acute OverdoseChronic Overdosage(Large Single(Multiple ExcessiveIngestion)Doses)Sign/SymptomStudy 1 Study 2Study 1 Study 2Asymotomatic(n=157)(n=14)(n=92) (n=102)GastointestinalNR0NR6Vomiting73 9330 61Abdominal PainNR21NR12DiarrheaNR0NR14HematemesisNR0NR2Metabolic/OtherHypokalemia85 7944 43Hyperglycemia98 NR18 NRAcid/base disturbance34 219 5RhabdomyolysisNR7NR0CardiovascularSinus tachycardia100 86100 62Other supraventricular2 2112 14tachycardiasVentricular premature beats3 2110 19Atrial fibrillation or flutter1 NR12 NRMultifocal atrial tachycardia0 NR2 NRVentricular arrhythmias7 1440 0hemodynamic instabilityHypotension/shockNR21NR8NeurologicNervousnessNR64NR21Tremors38 2916 14DisorientationNR7NR11Seizures5 1414 5Death3 2110 4
*
NR = Not reported in a comparable manner.

OVERDOSAGE

General



Table IV



Overdose Management







OVERDOSAGEExtracorporeal Removal

Specific Recommendations

Acute Overdose









OVERDOSAGEExtracorporeal Removal




OVERDOSAGEExtracorporeal Removal












OVERDOSAGEExtracorporeal Removal




OVERDOSAGEExtracorporeal Removal



Extracorporeal Removal


DOSAGE & ADMINISTRATION

CLINICAL PHARMACOLOGYDrug InteractionsDrug-Food Interactions


General Considerations

Table VPRECAUTIONSLaboratory TestsDOSAGE AND ADMINISTRATIONTable VIWARNINGS
WARNINGSPRECAUTIONS

Table VTable VI

Table V. Dosing initiation and titration (as anhydrous theophylline).*
A.Children (6 to 15 years) and adults (16 to 60 years)without risk factors for impaired clearance.******B.Patients With Risk Factors For Impaired Clearance, The Elderly (>60 Years), And Those In Whom It Is Not Feasible To Monitor Serum Theophylline Concentrations:WARNINGSWARNINGS*

Table VI. Dosage adjustment guided by serum theophylline concentration.
Peak SerumDosage AdjustmentConcentration***WARNINGS

Once-Daily Dosing




HOW SUPPLIED

















PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION















Theophylline


Theophylline














Theophylline




Theophylline

Theophylline TABLET, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-223(NDC:50111-482)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
THEOPHYLLINE ANHYDROUS THEOPHYLLINE ANHYDROUS 200 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSE 2208 (100 MPA.S)
HYPROMELLOSE 2208 (100000 MPA.S)
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
povidone

Product Characteristics

Color Size Imprint Code Shape
white 12 mm PLIVA;482 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-223-02 30 in 1 BLISTER PACK
2 NDC:49349-223-20 100 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089808 2011-04-27


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