Active ingredients: Theophylline
Theo-Dur 200 mg prolonged-release tablets
Theo-Dur 300 mg prolonged release tablets
Indications Why is Theo-dur used? What is it for?
Theo-Dur contains the active ingredient theophylline, which belongs to a class of medicines called xanthine derivatives, which works by dilating the bronchi.
Theo-Dur is used to treat:
- bronchial asthma;
- lung diseases characterized by narrowing of the bronchi
Contraindications When Theo-dur should not be used
Do not take Theo-Dur
- if you are allergic to the active substance or any of the other ingredients of this medicine
- if you are allergic to medicines of the same class as theophylline (xanthine derivatives).
Precautions for use What you need to know before taking Theo-dur
Talk to your doctor or pharmacist before taking Theo-Dur:
If you have heart problems (myocardial infarction, cor pulmonale, congestive heart failure) and / or severe lack of oxygen in the blood (hypoxemia),
- If you have lung disease (chronic obstructive pulmonary disease), - if you have high blood pressure (hypertension)
- If you have high thyroid activity (hyperthyroidism)
- If you have liver and kidney disease
- If you have a stomach injury (ulcer)
- If you are an elderly person (especially if you are male).
Tell your doctor if you use other medicines at the same time (see Other medicines and Tefamin).
Cigarette smoking can decrease the effects of Theo-Dur.
Follow your doctor's instructions carefully to avoid toxic effects due to high theophylline levels (see "How to take Theo-Dur").
Children
Your doctor will prescribe Theo-Dur with caution in infants and younger children.
Interactions Which drugs or foods can modify the effect of Theo-dur
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important that your doctor know if you are taking any of the following medicines:
- epinephrine and other medicines called 'bronchodilators' as they can increase the effect of TheoDur;
- medicines containing active ingredients belonging to the same category as theophylline (xanthine derivatives), the active ingredient of Theo-Dur; These medicines can worsen existing heart rhythm abnormalities (cardiac arrhythmias).
- allopurinol (in high doses), cimetidine, ciprofloxacin, clinafloxacin, flutamide, levofloxacin, erythromycin, clarithromycin, disulfiram, enoxacin, fluvoxamine, recombinant human interferon alpha A, methotrexate, mexiletine, propamacyclopene, tactidloxate, tactidloxin, tetacyclopene, tactidloxin, tactidloxin, verapiabine , norfloxacin, troleandomycin, oral contraceptives containing estrogen, TAO (Oral Anticoagulant Therapy), lincomycin, clindamycin, influenza vaccine. If these medicines and Theo-Dur are administered simultaneously, the doctor may reduce the dose of Theo-Dur;
- rifampin, aminoglutethimide, moricizine, isoprenaline, ritonavir, barbiturates, carbamazepine and sulfinpyrazone, since, when these medicines and Theo-Dur are administered simultaneously, it may decrease the effect of Theo-Dur;
- products based on St. John's Wort (Hypericum perforatum), since in case of simultaneous administration of these products and Theo-Dur, the effect of The-Dur may decrease. The effect may persist for at least 2 weeks after discontinuation treatment with St John's Wort products. If you are taking St John's Wort products at the same time as Theo-Dur, your doctor will order blood tests, stop taking St John's Wort and may prescribe a different dosage of Theo-Dur;
- furosemide, as it leads to an increase in the elimination of urine (increased diuresis);
- reserpine, as it causes your heart to beat faster (tachycardia);
- sucralfate, as it diminishes the Theo-Dur effect;
- phenytoin, other medicines used to treat seizures called 'anticonvulsants', as they reduce the effect of Theo-Dur. In these cases, your doctor may increase the dose of Theo-Dur and order blood tests;
- pentoxifylline, as convulsions may occur when administered simultaneously with Theo-Dur;
- propranolol and medicines called 'beta-blockers', as they reduce the effect of Theo-Dur;
- adenosine, diazepam, flurazepam, lorazepam, midazolam, lithium and pancuronium, since in case of co-administration with Theo-Dur, it is necessary to increase the dose of these medicines;
- halothane, as in case of simultaneous administration with Theo-Dur, the risk of having abnormal heartbeat (ventricular arrhythmias) increases;
- ketamine, as in case of concomitant administration with Theo-Dur, it can make convulsions more likely;
- medicines that reduce the elimination of theophylline, the active ingredient of Theo-Dur.
If you need to carry out any laboratory tests, please inform that you are taking Theo-Dur, especially if you have kidney problems (kidney dysfunction).
Theophylline should not be combined with other treatments of the same type.
Theo-Dur with food, drink and alcohol
In the morning, the medicine can be taken on an empty stomach or immediately after breakfast. It is recommended not to take Theo-Dur in the evening as food intake affects the activity of TheoDur.
Drinking alcohol at the same time can increase the effects of Theo-Dur.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. During pregnancy and breastfeeding, your doctor will prescribe the medicine only in cases of real need.
Driving and using machines
The medicine does not affect the ability to drive and use machines.
Theo-Dur contains sugars
Theo-Dur contains sucrose and lactose. If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.
Dosage and method of use How to use Theo-dur: Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist. The recommended dose is: Children:
- of 15-20 kg: 100 mg (1/2 tablet of Theo-Dur 200 mg prolonged-release tablets every 12 hours)
- of 20-25 kg: 150 mg (1/2 tablet of Theo-Dur 300 mg prolonged-release tablets every 12 hours)
- over 25 kg: 200 mg (1 tablet of Theo-Dur 200 mg prolonged-release tablets every 12 hours).
If a sufficient result is not achieved within 3 days and there are no side effects, the daily dose can be increased by adding 100 mg per day (50 mg every 12 hours). Theo-Dur should be used with caution in younger children as they are unable to report minor side effects.
Adults:
- 200 mg (1 tablet of Theo-Dur 200 mg prolonged-release tablets every 12 hours). If a sufficient result is not achieved within 3 days and there are no side effects, the daily dose can be increased to 1 tablet of Theo-Dur 300 mg prolonged-release tablets every 12 hours.
If the medicine is well tolerated, if a sufficient result is still not achieved, your doctor may prescribe a higher dose. In this case you will have to carry out some blood tests carefully following the times and methods indicated by the doctor to avoid the risk of toxicity and the appearance of unwanted effects.
Your doctor may decide to prescribe once daily dosing if you have gradually achieved a satisfactory therapeutic response with dosing every 12 hours. Once-a-day administration should commence at the end of 12 hours after the last administration.
If your symptoms worsen or signs of toxicity appear, your doctor will re-prescribe one dose every 12 hours. Your doctor will order blood tests before and after switching to the once daily dose. If your doctor prescribes a once daily dose of Theo-Dur, you should take the tablet whole, without breaking it.
Use in the elderly
If you are elderly and have heart disease (cor pulmonale, heart failure) and liver disease (liver disease), in case of toxic effects due to the maximum recommended dose of Theo-Dur, your doctor will prescribe a lower dose.
Theo-Dur tablets should not be chewed or crushed (they can only be divided in half to allow the required dose to be administered).
If you forget to take Theo-Dur
Do not take a double dose to make up for a forgotten dose.
If you stop taking Theo-Dur
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Overdose What to do if you have taken too much Theo-dur
In case of overdose the first symptoms are: agitation, tremors, confusion, vomiting, increased heart rate (tachycardia). Later appear: blood in vomit (haematemesis), convulsions, altered heart rhythm (cardiac arrhythmia), dehydration, fever.
In case of overdose contact your doctor or the nearest hospital.
Side Effects What are the side effects of Theo-dur
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The undesirable effects are those typical of theophylline and are generally due to too high doses and require a dose reduction.
- increased blood sugar (hyperglycaemia)
- irritability
- headache
- restlessness
- insomnia
- accentuation of reflexes (hyperreflexia)
- seizures (grand mal, generalized tonic-clonic seizures)
- irregular or strong heartbeat (palpitations)
- increased heart rate (tachycardia)
- abnormal heart contractions extrasystoles)
- low blood pressure (hypotension)
- severe changes in the rhythm of the heart (severe ventricular arrhythmias)
- hot flashes
- circulatory failure (shock)
- increased breathing rate (tachypnea)
- nausea
- He retched
- upper abdominal pain (epigastric pain)
- presence of blood in the vomit (haematemesis)
- diarrhea
- muscle cramps
- high concentration of a substance called albumin in the urine (albuminuria)
- increased urine output (polyuria)
- presence of cells in the urine (tubular cells in the urine)
- increase in red blood cells in the urine (laboratory test positive red blood cells in urine).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Expiry". The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other Information
What Theo-Dur contains
- The active ingredient is theophylline.
Prolonged-release tablets 200 mg: One prolonged-release tablet contains 200 mg of theophylline anhydrous. Prolonged-release tablets 300 mg: One prolonged-release tablet contains 300 mg of anhydrous theophylline.
- The other ingredients are: Sucrose, starch, lactose, hydroxypropylmethylcellulose, magnesium stearate, glyceryl monostearate, white wax, cetyl alcohol, myristyl alcohol, cellulose acetophthalate, diethyl phthalate.
What Theo-Dur looks like and contents of the pack
Theo-Dursi comes in the form of extended-release tablets. The contents of the pack are 30 tablets of 200 mg or 300 mg.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
THEO-DUR PROLONGED RELEASE TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Theo-dur 200 mg
Each prolonged-release tablet contains 200 mg of anhydrous theophylline
Excipient with known effects:
Each prolonged-release tablet contains 62.53 mg of lactose and 52.65 mg of sucrose.
Theo-dur 300 mg
Each prolonged-release tablet contains 300 mg of anhydrous theophylline
Excipient with known effects:
Each prolonged-release tablet contains 93.8 mg of lactose and 79 mg of sucrose
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Prolonged-release tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Bronchial asthma, pulmonary affections with bronchial spastic component.
04.2 Posology and method of administration
It is recommended to start therapy with the following doses:
• children weighing 15-20 kg: 100 mg (½ tablet of Theo-dur 200 mg prolonged-release tablets every 12 hours)
• children weighing 20-25 kg: 150 mg (½ tablet of Theo-dur 300 mg prolonged-release tablets every 12 hours)
• children over 25 kg and adults: 200 mg (1 tablet of Theo-dur 200 mg prolonged-release tablets every 12 hours)
If a sufficient therapeutic response has not been achieved within 3 days and there are no side effects, the daily dose can be increased:
• in children by adding 100 mg per day (50 mg every 12 hours);
• in adults by switching to 1 tablet of Theo-dur 300 mg prolonged-release tablets every 12 hours
In the event that a sufficient therapeutic response is not achieved and the product is well tolerated, it is possible to further increase the doses, while controlling the serum concentrations of theophylline.
This control will be carried out between 3 and 8 hours after the administration of a dose and after a treatment period, carried out faithfully following the dosage schedule, of at least three days.
• If serum theophylline levels are between 10 and 20 mcg / ml and tolerability is good, the dosage should not be changed and the serum theophylline concentration should be rechecked at 6-12 month intervals.
• If the serum concentration of theophylline is too high or too low, it will be necessary to gradually vary the dosage until reaching the optimal levels.
Single daily dose
Once daily dosing should be considered only after the patient treated with every 12 hour dosing is gradually and satisfactorily brought to therapeutic levels.
Once-a-day dosing should be considered on the basis of double the dose at 12 hours, and should commence at the end of 12 hours after the last administration.
The trough concentration (Cmin.) Obtained following once daily dose conversion may be lower (especially in patients with high clearance) and the peak concentration (C max) could be higher (especially in patients with low clearance) than those obtained with the dose every 12 hours.
If symptoms reappear, or if signs of toxicity occur during the once daily dose interval, dosing should be resumed every 12 hours.
Serum concentrations of theophylline should be checked before and after switching to the once daily dose.
Food intake and position, together with associated changes in the circadian rhythm, could affect the absorption and / or clearance of theophylline in the controlled-release forms administered in the evening.
The exact correlation of these and other factors with nocturnal serum concentrations and the clinical significance of these results require further study. Therefore it is recommended that Theo-Dur once daily not be administered in the evening.
Theo-Dur given once a day should be taken whole without being broken.
Dosage adjustment based on assessments of serum theophylline concentration, when these instructions have not been followed, may result in recommendations that may present a risk of patient toxicity.
It should be used with caution in younger children who are unable to report minor side effects.
Elderly patients, suffering from: cor pulmonale, heart failure, liver disease should rarely need lower dosages and therefore may manifest toxic phenomena at the maximum therapeutic dosages recommended above.
It is important that no patient is kept on an intolerable dosage. In the instructions for increasing doses to patients according to the above scheme, it should be advised not to take repeated doses if evident side effects appear, and to resume therapy at the lower dose once the side effects have disappeared.
04.3 Contraindications
Hypersensitivity to the active substance, to xanthine derivatives or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
Theo-dur tablets should not be chewed or crushed (they can only be divided in half for dosage requirements).
Theophylline should be used with caution in patients with severe heart disease and / or hypoxemia, hypertension, hyperthyroidism, myocardial infarction, cor pulmonale, congestive heart failure, liver and kidney disease, in the elderly (especially males) and in neonates.
Hypericum perforatum preparations should not be taken concomitantly with medicinal products containing theophylline due to the risk of decreased plasma levels and decreased therapeutic efficacy of theophylline (see Section 4.5 Interactions).
Even in patients with a history of gastric ulcer theophylline should be used with caution.
Theophylline drugs can worsen pre-existing cardiac arrhythmias.
The toxic effects of theophylline are usually linked to too high serum levels (above 20 mcg / ml).
Above average blood levels may occur at conventional doses due to slowed plasma clearance, in cases of hepatic dysfunction, chronic obstructive pulmonary disease and in patients older than 55 years, especially males.
The medicine contains sucrose therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicine; in addition, the medicine contains lactose so patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency should not take it.
04.5 Interactions with other medicinal products and other forms of interaction
Drug / drug interactions
Toxic synergism with epinephrine has been documented and may occur with other sympathomimetic bronchodilators. Theophylline should not be used concomitantly with other xanthine derivatives.
The addition of a drug that inhibits theophylline metabolism, or the discontinuation of a concomitant drug that increases theophylline metabolism, may cause an increase in serum theophylline concentration which may result in toxicity.
Increased serum levels of theophylline have been reported with concomitant administration of allopurinol (high doses), cimetidine, ciprofloxacin, clinafloxacin, flutamide, levofloxacin, erythromycin, clarithromycin, disulfiram, enoxacin, fluvoxamine, interferon alpha-A, recombinant human alpha-A. propafenone, pentoxifylline, tacrine, thiabendazole, ticlopidine, verapamil, ofloxacin, norfloxacin, troleandomycin, alcohol, estrogen-containing oral contraceptives, TAO, lincomycin, clindamycin, influenza vaccine.
In case of concomitant administration it may be necessary to reduce the theophylline dosage.
Reduced serum levels of theophylline have been reported upon co-administration with rifampin, aminoglutethimide, moricizine, isoprenaline, ritonavir, barbiturates, carbamazepine and sulfinpyrazone.
Plasma concentrations of theophylline may be decreased by concomitant administration of Hypericum perforatum preparations. This is due to the induction of the enzymes responsible for drug metabolism by preparations based on Hypericum perforatum which, therefore, should not be administered concomitantly with theophylline. The induction effect may persist for at least 2 weeks after the discontinuation of the drug. treatment with products based on Hypericum perforatum.
If a patient is concurrently taking Hypericum perforatum products the plasma levels of theophylline should be monitored and therapy with Hypericum perforatum products discontinued.
Plasma levels of theophylline may increase with discontinuation of Hypericum perforatum. The theophylline dosage may need to be adjusted.
Interaction with furosemide leads to potentiation of diuresis. Concomitant administration of reserpine results in tachycardia.
Absorption of theophylline is reduced when given together with sucralfate.
Phenytoin, other anticonvulsants and cigarette smoking may increase theophylline clearance with reduced plasma half-life. In these cases it may be necessary to increase the theophylline dosage.
In the case of administration of drugs that may affect the theophylline clearance, monitoring of the blood level concentration is recommended to control the therapeutic range of theophylline.
Seizures have been reported in some patients due to concomitant administration of pentoxifylline and theophylline.
It is preferable to avoid non-selective beta-blockers (eg propranolol) in patients requiring theophylline due to an antagonistic pharmacological action. Furthermore, theophylline clearance may be decreased.
Higher than normal doses of adenosine, diazepam, flurazepam, lorazepam, midazolam, lithium and pancuronium are required to achieve the desired effects when these drugs are administered with theophylline.
Taking halothane with theophylline increases the risk of ventricular arrhythmias. Taking ketamine together with theophylline can lower the seizure threshold.
Drugs that inhibit cytochrome P450 1A2 may reduce theophylline clearance, resulting in increased serum concentrations.
Drug / laboratory test interactions
Metabolites and other drugs generally have no effect on the results of currently available analytical methods for measuring serum levels of theophylline, including high pressure liquid chromatography and immunoassay techniques. Other new analytical methods are currently in use. The physician should inquire about the dosing method used, and whether other drugs may interfere with the assay.
Caffeine and xanthine metabolites in patients with renal dysfunction may cause readings of some outpatient methods using dry reagents that are higher than the actual serum concentration of theophylline.
Drug / food interactions
The extent of theophylline absorption was similar under fasting conditions or immediately following a high fat breakfast. Time to peak concentration is delayed after hyperlipid breakfast, but without any clinical implications.
04.6 Pregnancy and breastfeeding
Although no negative effects of theophylline on fetal development have been found, its use in pregnancy should be limited only to cases in which the physician believes that failure to control asthma constitutes a real risk for the mother.
Similar caution should also be used during breastfeeding.
04.7 Effects on ability to drive and use machines
The product does not affect the ability to drive and use machines.
04.8 Undesirable effects
The side effects are those typical of theophylline; they are generally due to too high doses and require a dose reduction.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "Street address www.aifa.gov.it/responsabili
04.9 Overdose
The first signs of alarm are agitation, tremors, confusion, vomiting, tachycardia; later appear haematemesis, convulsions, cardiac arrhythmia, dehydration, fever.
Emergency interventions and antidotes.
• If there are no convulsions: induce vomiting, administer a cathartic and activated charcoal.
• In case of convulsions: ensure respiratory assistance and administer oxygen, diazepam i.v., rehydrate and control blood pressure.
• In case of coma: intubate and perform gastric lavage in place of induction of vomiting.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other drugs for obstructive respiratory tract syndromes for systemic use; xanthine derivatives
ATC code: R03DA04
Theophylline causes the smooth muscle of the bronchi to relax. Theophylline also possesses the other pharmacological properties of xanthine derivatives, such as vasodilation in the pulmonary circulation.
05.2 Pharmacokinetic properties
The kinetics of absorption of theophylline from Theo-dur tablets approach "zero order: gastrointestinal absorption of theophylline occurs gradually over a period of 12 hours and plasma rates remain constant over time within the therapeutic range (10- 20 mcg / ml). The subsequent phases of Theo-dur's kinetics are identified with those of theophylline; metabolization occurs by oxidation at the level of hepatic microsomes and excretion occurs mainly via the kidneys.
05.3 Preclinical safety data
Acute toxicity: oral LD50 in mice is 332 mg / kg.
Chronic toxicity: 60 days of treatment with 34 mg / kg / day orally did not cause toxic effects in the rat.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sucrose, starch, lactose, hydroxypropylmethylcellulose, magnesium stearate, glyceryl monostearate, white wax, cetyl alcohol, myristyl alcohol, cellulose acetophthalate, diethyl phthalate
06.2 Incompatibility
None.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
PVC and aluminum blisters.
Box of 30 tablets
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
RECORDATI Chemical and Pharmaceutical Industries S.p.A. - via Civitali, 1 - MILAN
Exclusive dealership for sale: ALMIRALL S.p.A. - Via Messina, 38 - Tower C - 20154 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Theo-dur 300 mg prolonged-release tablets 30 tablets AIC n. 025267016
Theo-dur 200 mg prolonged-release tablets 30 tablets AIC n. 025267028
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization 10 March 1984
Date of renewal of the most recent authorization: 31 May 2010
10.0 DATE OF REVISION OF THE TEXT
09/06/2015
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