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Basic Drug Info
Drug Name:Theophylline
Manufacturer:Actavis Mid Atlantic LLC
Other Info:



Clinical Trials:


Indications and Usage
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.
Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Pathological accumulation of air in tissues -- A pathological accumulation of air in tissues or organs.

Pulmonary Emphysema -- Enlargement of air spaces distal to the TERMINAL BRONCHIOLES where gas-exchange normally takes place. This is usually due to destruction of the alveolar wall. Pulmonary emphysema can be classified by the location and distribution of the lesions.

CHRONIC BRONCHITIS -- condition characterized by persistent coughing, increased secretion from the bronchial mucosa, obstruction of the respiratory passages, scanty or profuse expectoration, and necrosis and fibrosis of the respiratory tract.

Contraindications
Theophylline Elixir is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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 diseaseSeizure disordersCardiac 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:AgeNeonates (term and premature)Children <1 yearElderly (>60 years)Concurrent DiseasesAcute pulmonary edemaCongestive heart failureCor-pulmonaleFever; >102ยบ for 24 hours or more; or lesser temperature elevations for longer periodsHypothyroidismLiver disease; cirrhosis, acute hepatitisReduced renal function in infants <3 months of ageSepsis with multi-organ failureShockCessation Of SmokingDrug 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 corticosteroids 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).
Branded Drugs
The following US Branded drugs contain Theophylline


MERSALYL-THEOPHYLLINE -- WATSON LABORATORIES INC

DICURIN PROCAINE -- ELI LILLY AND CO

AEROLATE III -- FLEMING AND CO PHARMACEUTICALS INC

AEROLATE JR -- FLEMING AND CO PHARMACEUTICALS INC

AEROLATE SR -- FLEMING AND CO PHARMACEUTICALS INC

ELIXOPHYLLIN SR -- FOREST LABORATORIES INC

SLO-BID -- SANOFI AVENTIS US LLC

SLO-PHYLLIN -- SANOFI AVENTIS US LLC

SOMOPHYLLIN-CRT -- DM GRAHAM LABORATORIES INC

THEO-24 -- UCB INC

THEOBID -- WHITBY PHARMACEUTICALS INC

THEOBID JR. -- WHITBY PHARMACEUTICALS INC

THEOCLEAR L.A.-130 -- SCHWARZ PHARMA INC

THEOCLEAR L.A.-260 -- SCHWARZ PHARMA INC

THEO-DUR -- SCHERING CORP

THEOPHYLLINE-SR -- RP SCHERER NORTH AMERICA DIV RP SCHERER CORP

THEOPHYL-SR -- ORTHO MCNEIL PHARMACEUTICAL INC

THEOVENT -- SCHERING CORP SUB SCHERING PLOUGH CORP

BRONKODYL -- SANOFI AVENTIS US LLC

ELIXOPHYLLIN -- FOREST LABORATORIES INC

SOMOPHYLLIN-T -- FISONS CORP

ELIXOMIN -- HR CENCI LABORATORIES INC

LANOPHYLLIN -- LANNETT CO INC

THEOLIXIR -- PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC

THEOPHYL-225 -- ORTHO MCNEIL PHARMACEUTICAL INC

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER -- HOSPIRA INC

AEROLATE -- FLEMING AND CO PHARMACEUTICALS INC

THEOLAIR -- 3M PHARMACEUTICALS INC

ELIXICON -- FOREST LABORATORIES INC

ACCURBRON -- SANOFI AVENTIS US LLC

AQUAPHYLLIN -- FERNDALE LABORATORIES INC

THEOCLEAR-80 -- CENTRAL PHARMACEUTICALS INC

THEOPHYL -- ORTHO MCNEIL PHARMACEUTICAL INC

DURAPHYL -- FOREST LABORATORIES INC

LABID -- PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO

QUIBRON-T/SR -- MONARCH PHARMACEUTICALS INC

SUSTAIRE -- ROERIG DIV PFIZER INC

THEOCHRON -- INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC

THEOLAIR-SR -- 3M PHARMACEUTICALS INC

T-PHYL -- PHARMACEUTICAL RESEARCH ASSOC INC

UNI-DUR -- SCHERING CORP SUB SCHERING PLOUGH CORP

UNI-DUR -- SCHERING CORP

UNIPHYL -- PURDUE PHARMACEUTICAL PRODUCTS LP

QUIBRON-T -- MONARCH PHARMACEUTICALS INC

THEOCLEAR-100 -- CENTRAL PHARMACEUTICALS INC

THEOCLEAR-200 -- CENTRAL PHARMACEUTICALS INC

THEOLAIR -- GRACEWAY PHARMACEUTICALS LLC


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