Uniphyl (Oral)

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

Theophylline is part of a group of medicines called bronchodilators. Bronchodilators relax the muscles in the bronchial tubes (air passages) in the lungs. They help reduce cough, wheezing, shortness of breath, and difficulty breathing by allowing more air to flow through the bronchial tubes.

You can get this medicine only with a prescription from your doctor.

It is very important for your doctor to check how you or your child are doing during regular visits, especially in the first few weeks after starting this medicine. Blood tests might be needed to look for side effects.

Changes in your usual behavior or health can affect how this medicine works in your body. Tell your doctor if you or your child:

• Have had a fever of 102 degrees F or higher for 24 hours or more.
• Have started or stopped smoking tobacco or marijuana in the last few weeks.
• Have started or stopped taking another medicine in the last few weeks.
• Have changed your diet in the last few weeks.

Stop using this medicine and contact your doctor immediately if you or your child experience any of the following symptoms while using this medicine: ongoing nausea or vomiting, headaches, trouble sleeping, seizures, or irregular heartbeats.

Do not stop or change the dose of this medicine without first checking with your doctor.

Before any medical tests, inform the medical doctor in charge that you or your child are using this medicine. The results of some tests may be influenced by this medicine.

This medicine may increase the central nervous system (CNS) stimulant effects of foods or drinks that contain caffeine, like chocolate, cocoa, tea, coffee, and cola drinks. Avoid consuming large amounts of these foods or drinks while using this medicine. If you have questions about this, consult your doctor.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus issues, as well as herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. For this medicine, please consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare 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

Studies done so far have not shown any specific problems that would limit the use of theophylline in children. However, children younger than 1 year old are more likely to experience serious side effects, which may require careful monitoring and possible dose adjustments for patients taking theophylline.

Geriatric

Studies done so far have not shown any specific problems that would limit the use of theophylline in older adults. However, older patients might be more sensitive to the effects of theophylline than younger adults and are more likely to have kidney, liver, heart, or lung issues, which may require careful monitoring and possible dose adjustments for patients taking theophylline.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines can be used together even if an interaction might happen. In these cases, your doctor may want to change the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are based on their potential significance and may not include all possible interactions.

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.

• Riociguat
• Viloxazine

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

• Abametapir
• Adalimumab
• Adenosine
• Amifampridine
• Bupropion
• Capmatinib
• Ceritinib
• Cimetidine
• Ciprofloxacin
• Deferasirox
• Desogestrel
• Dienogest
• Dihydroartemisinin
• Donepezil
• Drospirenone
• Enoxacin
• Erythromycin
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etintidine
• Etonogestrel
• Febuxostat
• Fluconazole
• Fluvoxamine
• Fosphenytoin
• Gestodene
• Givosiran
• Halothane
• Idrocilamide
• Imipenem
• Ketamine
• Leniolisib
• Levofloxacin
• Levonorgestrel
• Medroxyprogesterone
• Mestranol
• Methacholine
• Mexiletine
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Paroxetine
• Pefloxacin
• Peginterferon Alfa-2a
• Peginterferon Alfa-2b
• Phenytoin
• Pixantrone
• Regadenoson
• Ritlecitinib
• Rofecoxib
• Segesterone
• Taurursodiol
• Thiabendazole
• Tocilizumab
• Troleandomycin
• Vemurafenib
• Zileuton

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtimes or with certain types of foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on their potential significance and may not include all possible interactions.

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

• Tobacco

Using this medicine with any of the following may increase the risk of certain side effects but may be necessary in some cases. If used together, your doctor may adjust the dose or how often you take this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Caffeine
• food

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform 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
• Severe infection (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 due to slower removal of the medicine from the body.

• Heart rhythm problems (e.g., arrhythmia) or
• Seizures, or a history of or
• Stomach ulcer—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Chest pain or discomfort
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• increase in urine volume
• lightheadedness
• persistent vomiting
• pounding or rapid pulse
• seizures
• shakiness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach pain
• blurred vision
• confusion
• confusion about identity, place, and time
• dark-colored urine
• decrease in frequency of urination
• decreased urine
• diarrhea
• difficulty in passing urine (dribbling)
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• fever
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle cramps or spasms
• muscle pain or stiffness
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, back, or neck
• painful urination
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• sweating
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Headache
• irritability
• restlessness
• sleeplessness
• trouble sleeping
• unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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:

• Tablet, Extended Release
• Tablet, Extended Release, 12 HR
• Capsule, Extended Release, 24 HR
• Solution
• Elixir
• Tablet, Extended Release, 24 HR

Therapeutic Class: Bronchodilator

Chemical Class: Methylxanthine

Take this medicine exactly as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep the blood level constant, take this medicine at the same time each day and do not miss any doses.

After you or your child begin taking theophylline, it is very important that your doctor check the level of the medicine in the blood at regular intervals to decide if the dose needs to be changed. Keep all appointments for testing the blood level.

Take the extended-release capsule or tablet every morning at the same time each day. You may take your second dose 10 to 12 hours after the morning dose and before the evening meal, unless your doctor tells you otherwise.

Swallow the extended-release tablet whole. Do not break, crush, or chew it. You may take the extended-release tablet with or without food.

It is best to take the extended-release capsule one hour before a high-fat meal or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• To treat symptoms of asthma, bronchitis, and emphysema: For oral dosage form (elixir or tablets): Adults, teenagers, and children above 1 year of age weighing more than 45 kilograms (kg)—At first, 300 milligrams (mg) per day, divided and given every 6 to 8 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day. Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day, divided and given every 6 to 8 hours. Children and teenagers 1 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day, divided and given every 4 to 6 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day. Infants younger than 1 year of age—Dose is based on body weight and age and must be determined by your doctor. For oral dosage form (extended-release capsules): Adults, teenagers, and children 12 years of age and older weighing more than 45 kilograms (kg)—At first, 300 to 400 milligrams (mg) as a single dose, usually in the morning, or divided and given two times per day. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day. Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day as a single dose, usually in the morning, or divided and given two times per day. Children and teenagers 12 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day as a single dose, usually in the morning, or divided and given two times per day. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day. Children younger than 12 years of age—Use and dose must be determined by your doctor. For oral dosage form (extended-release tablets): Adults, teenagers, and children 6 years of age and older weighing more than 45 kilograms (kg)—At first, 300 milligrams (mg) per day, divided and given every 12 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day. Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day, divided and given every 12 hours. Children and teenagers 6 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day, divided and given every 12 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day. Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.