Quibron-T

Name: Quibron-T

Quibron-T Overview

Theophylline is a prescription medication used to treat chronic (ongoing) lung diseases such as asthma, emphysema, and chronic bronchitis. This medication belongs to a group of drugs called methylxanthines. It works by relaxing the muscles of the airways, which opens airway passages and allows more air to get into the lungs. This action relieves wheezing, shortness of breath, and chest tightness.

Theophylline comes in a sustained-release tablet. It is usually taken once or twice daily. Take this medication on an empty stomach, unless your doctor tells you otherwise. Swallow tablets whole. Do not crush or chew theophylline sustained-release tablets.

Common side effects include nausea, headache, and insomnia.

Uses of Quibron-T

Theophylline is a prescription medication used to treat chronic (ongoing) lung diseases such as asthma, and chronic obstructive pulmonary disease (COPD) which includes emphysema, and chronic bronchitis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Monarch Pharmaceuticals, Inc.

Quibron-T Drug Class

Quibron-T is part of the drug class:

  • Xanthines

Side Effects of Quibron-T

Common side effects include:

  • nausea
  • vomiting
  • headache
  • insomnia

This is not a complete list of theophylline side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Commonly used brand name(s)

In the U.S.

  • Elixophyllin
  • Norphyl
  • Phyllocontin
  • Quibron-T
  • Quibron-T/SR
  • Theo-24
  • TheoCap
  • Theochron
  • Theo-Dur
  • Theo-Time
  • Truxophyllin
  • Uniphyl

Available Dosage Forms:

  • Elixir
  • Solution
  • Tablet, Extended Release, 12 HR
  • Tablet
  • Capsule, Extended Release, 24 HR
  • Capsule, Extended Release
  • Tablet, Extended Release
  • Capsule, Extended Release, 12 HR
  • Syrup
  • Capsule
  • Tablet, Extended Release, 24 HR
  • Tablet, Enteric Coated

Therapeutic Class: Bronchodilator

Chemical Class: Methylxanthine

Uses For Quibron-T

Theophylline is used together with other medicines to treat the symptoms of asthma, bronchitis, emphysema, and other lung diseases.

Theophylline belongs to a group of medicines known as bronchodilators. Bronchodilators are medicines that relax the muscles in the bronchial tubes (air passages) of the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Before Using Quibron-T

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of theophylline in children. However, children younger than 1 year of age are more likely to have serious side effects, which may require caution and an adjustment in the dose for patients receiving theophylline.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of theophylline in the elderly. However, elderly patients may be more sensitive to the effects of theophylline than younger adults, and are more likely to have kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving theophylline.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Riociguat

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenosine
  • Blinatumomab
  • Bupropion
  • Ceritinib
  • Cimetidine
  • Ciprofloxacin
  • Deferasirox
  • Desogestrel
  • Dienogest
  • Dihydroartemisinin
  • Donepezil
  • Drospirenone
  • Enoxacin
  • Erythromycin
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etintidine
  • Etonogestrel
  • Fluconazole
  • Fluvoxamine
  • Fosphenytoin
  • Golimumab
  • Guselkumab
  • Halothane
  • Idelalisib
  • Idrocilamide
  • Imipenem
  • Levofloxacin
  • Levonorgestrel
  • Medroxyprogesterone Acetate
  • Mestranol
  • Mexiletine
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Pefloxacin
  • Peginterferon Alfa-2a
  • Peginterferon Alfa-2b
  • Phenytoin
  • Pixantrone
  • Regadenoson
  • Rofecoxib
  • Secukinumab
  • Thiabendazole
  • Troleandomycin
  • Vemurafenib
  • Zileuton

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adinazolam
  • Alprazolam
  • Aminoglutethimide
  • Amiodarone
  • Azithromycin
  • Brotizolam
  • Cannabis
  • Carbamazepine
  • Chlordiazepoxide
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Diazepam
  • Disulfiram
  • Estazolam
  • Febuxostat
  • Flunitrazepam
  • Flurazepam
  • Halazepam
  • Interferon Alfa-2a
  • Ipriflavone
  • Isoproterenol
  • Ketazolam
  • Lorazepam
  • Lormetazepam
  • Medazepam
  • Methotrexate
  • Midazolam
  • Nilutamide
  • Nitrazepam
  • Oxazepam
  • Pancuronium
  • Pentoxifylline
  • Phenobarbital
  • Piperine
  • Prazepam
  • Propafenone
  • Quazepam
  • Rifampin
  • Rifapentine
  • Riluzole
  • Ritonavir
  • Secobarbital
  • St John's Wort
  • Tacrine
  • Telithromycin
  • Temazepam
  • Ticlopidine
  • Triazolam
  • Viloxazine
  • Zafirlukast

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Caffeine
  • food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Congestive heart failure or
  • Cor pulmonale (heart condition) or
  • Fever of 102 degrees F or higher for 24 hours or more or
  • Hypothyroidism (underactive thyroid) or
  • Infection, severe (e.g., sepsis) or
  • Kidney disease in infants younger than 3 months of age or
  • Liver disease (e.g., cirrhosis, hepatitis) or
  • Pulmonary edema (lung condition) or
  • Shock (serious condition with very little blood flow in the body)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Heart rhythm problems (e.g., arrhythmia) or
  • Seizures, or history of or
  • Stomach ulcer—Use with caution. May make these conditions worse.

Adverse Reactions

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 OVERDOSAGE). 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 (seeDOSAGE AND ADMINISTRATION, 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.*
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
Cardiovascular (cont.)
   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
* 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.

How Supplied

Quibron®-T Tablets: Bottles of 100, ivory, in the ACCUDOSE® Tablet design with “M 020” debossed on one side, containing 300 mg of anhydrous theophylline.

NDC 61570-020-01

Store from 15°-25°C (59°-77°F)

Rx only.

Manufactured for Monarch Pharmaceuticals®, Inc., Bristol, TN 37620

Manufactured by Bristol-Myers Squibb, Princeton, NJ 08543

Quibron-T 
theophyllin, anhydrous tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61570-020
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
theophylline, anhydrous (theophylline) theophylline 300 mg
Inactive Ingredients
Ingredient Name Strength
cellulose  
yellow ferric oxide  
hydroxypropyl methylcellulose 2910  
lactose monohydrate  
magnesium stearate  
silicon dioxide  
sodium starch glycolate  
Product Characteristics
Color WHITE Score no score
Shape RECTANGLE Size 17mm
Flavor Imprint Code M;020
Contains     
Coating false Symbol false
Packaging
# Item Code Package Description
1 NDC:61570-020-01 100 TABLET (100 TABLET) in 1 BOTTLE
Labeler - Monarch Pharmaceuticals, Inc.
Revised: 11/2006   Monarch Pharmaceuticals, Inc.
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