MINOPHYLLINE SR TAB; theophylline, respiratory tract agents .
ACTIVE-INGREDIENT OF MINOPHYLLINE SR TAB
EACH tablet contains : theophylline anhydrous 300 mg .
INDICATION OF MINOPHYLLINE SR TAB
for relief and / or prevention of symptoms from asthma and reversible bronchospasm associated with chronic bronchitis and emphysema .
DOSAGE OF MINOPHYLLINE SR TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
as directed by the physician or as follows : chronic therapy : a initiating therapy with an immediate – release product : it is recommended that the appropriate dosage be established using an immediate – release preparation . A dosage form which allows small incremental doses is desirable for children to permit easier and more accurate dosage adjustment . slow clinical titration is generally preferred to help assure acceptance and safety of the medication and to allow the patient to develop tolerance to transient caffeine like side – effects . then if the total 24 – hour dose can be given by use of the available strengths of this product , the patient can usually be switched to minophylline SR tablets givining one-half of the daily doses at 12 – hour intervals or one – third daily dose at 8-hour intervals . patients metabolize theophylline rapidly , such as the young , smokers and some non-smoking adults , are the most likely candidates for dosing at 8-hour intervals . such patients can generally be identified as having trough serum concentrations lower than desired or repeately exhibiting symptoms near the end of a dosing interval . B. inintiating therapy with mino phylline SR tablets . alternatevely , therapy can be inintiated with minophylline S.R. tablets since it is available in dosage as outlined in the following dosing guidelines . it is recommended that for children under 25 kg proper dosage be established with a liquid preparation to permit titration in small increments . initial dose : 16 mg /kg/23 hours or 400 mg/24 hours ( whichever is less ) of theophylline in divided doses at 12 hours intervals increasing dose : the above dosage may be increased in approximately 25 percent increments at 3-day intervals so long as the – drug is tolerated . following each adjustment , if the clinical response is satisfactory and serum levels can be measured then such measurements should be obtained then that dosage level should be maintained . dosage increases may be made in this manner until the maximum dose indicated below is reached . it is important that no patient be maintained on any dosage that is not tolerated . when instructing patients to increase dosage according to the schedule above , they should be told not to take a subsequent dose if apparent side effects occur and to resume therapy at a lower dose once adverse effects have disappeared adjustment and chronic maintainance : maximum dose of theophylline where the serum concentration is not measured : warning : do not attempt to maintain any dose that is not tolerated not to exceed the following ( or 900 mg , whichever is less ) age 6 to under 9 years 24 mg/kg/day . age 9 to under 12 years 20 mg / kg / day . age 12 to under 16 years 18 mg /kg/day . age 16 to years and older 13 mg /kg/day . measurement of serum theophylline concentrations during chronic therapy : if the above maximimum doses are to be maintained or exceeded serum theophylline measurement is essential . final adjustment after serum theophylline if serum theophylline as : directions : within range maintain dosage if tolerated . too high 20 to 25 µg / ml decrease doses by about 10 % and recheck serum level after 3 days . 25 to 30 µg / ml skip the next dose and decrease subsequent doses by 25 % recheck serum level after 3 days . over 30 µg / ml skip the next 2 doses and decrease subsequent doses by 50 % recheck serum level 3 days . too low increase dosage by 25 % at 3-day intervals until either the desired serum concentration and / or clinical response is achieved . the total daily dose may need to be administered at more frequent intervals if symptoms occur repeately at the end of a dosing intervals . the serum concentration may be rechecked at appropriate intervals but at least at the end of any adjustment period when the pateint’s condition is otherwise clinically stable and none of the recognized factors which after elimination are present , measurment of serum levels need be repeated only every 6 to 12 months . dosage adjustment based on serum theophylline concentration measurements when these instructions have not been followed may result in recommendations that present risk of toxicity to the patient . once daily dosing : the slow absorption rate of this preparation may allow once-daily administeration in adult non-smokers with appropriate total body clearance and other with low dosage requirements once – daily dosing should be cosidered only after the patient has been gradually and satisfactoily titrated to therapeutic levels with q 12 h dosing ,. if symptoms recur or signs of toxicity appear during the once-daily dosing interval , dosing on the q 12 h basis should be reinstituted .
OVER-DOSAGE OF MINOPHYLLINE SR TAB
CONTRA-INDICATION OF MINOPHYLLINE SR TAB
this product is contraindicated in individuals who have shown hypersensitivity to its components . It is also contraindicated in patients with active peptic ulcer disease , and in individuals with underlying seizure disorders ( unless receiving appropriate anticonvulsant medication ) .
STORAGE OF MINOPHYLLINE SR TAB
store at temperature not exceeding 30 °C . Keep in dry place protect from light .
PACK OF MINOPHYLLINE SR TAB
pack contains plastic jar of 30 tablets .
MINOPHYLLINE SR TAB MANUFACTURED BY
ALEXANDARIA CO. for pharmaceuticals & chemical industries – Alex – egypt .