Lufyllin

For relief of acute bronchial asthma and for reversible bronchospasm associated with chronic bronchitis and emphysema.

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), 1000 (NDC 0037-0521-97), and 5000 (NDC 0037-0521-98).

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), 1000 (NDC 0037-0731-97), and 2500 (NDC 0037-0731-99).

Storage:   Store at controlled room temperature 20°-25°C (68°-77°F).

Dispense in a tight container.

WALLACE LABORATORIES
Division of
Carter-Wallace, Inc.
Cranbury, New Jersey 08512

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© Lufyllin Patient Information is supplied by Cerner Multum, Inc. and Lufyllin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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

Use of other bronchodilator medicines is preferred.

Geriatric

As in younger patients, use of other bronchodilator medicines is preferred. Also, older patients with kidney disease may require a lower dose of dyphylline than do older adults without kidney disease.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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.

• 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
• Regadenoson

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Heart or blood vessel disease or
• Stomach ulcer (or history of) or other stomach problems—May make these conditions worse.

• Heart failure or
• Kidney disease—The effects of the medicine may be increased.

This section provides information on the proper use of a number of products that contain dyphylline. It may not be specific to Lufyllin. Please read with care.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, dyphylline must be taken at regularly spaced times, as ordered by your doctor. Do not miss any doses.

This medicine also works best when taken with a glass of water on an empty stomach (either 30 minutes to 1 hour before meals or 2 hours after meals). However, in some cases your doctor may want you to take this medicine with meals or right after meals to lessen stomach upset.

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.

• For oral dosage forms (elixir or tablets):
  • For asthma, bronchitis, or emphysema:
    • Adults—Dose is based on body weight. The usual dose is 15 milligrams (mg) per kilogram (kg) of body weight up to four times per day.
    • Children—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. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

• It is used to treat breathing problems.

• If you have an allergy to dyphylline or any other part of Lufyllin (dyphylline).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are having a breathing attack.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Lufyllin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

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.