النشرة الداخلية

1. RIAPHYLLIN® SYRUP100ML
COMPOSITION:
Syrup: Each5 ml contains 60 mg Theophylline BP.
CUNICALPHARMACOLOGY:
Riaphyllin pharmacologically acts as a bronchodilator, pulmonary
vasodilator and smooth muscle relaxant. Since it directly relaxes
the smooth muscles of bronchial airways and pulmonary blood
vessels,its actions are believed to be mediated through inhibition
of phosphodiesterase and a resultant increase in intracellular cyclic
-AMP.
INDICATIONS:
Riaphyllin is indicated for the treatment of the symptoms and
reversible airflow obstruction associated with chronic asthma and
other chronic lung diseases, e.g., emphysema and chronic bronchitis.
CONTRAINDICATIONS:
Riaphyllin is contraindicated in patients with hypersensitivity
(allergic) to theophylline or any of the other ingredients of this
product.
Riaphyllin is contraindicated in children taking ephedrine (found in
some cough medicines and decongestants).
PRECAUTIONS:
Theophylline should be used with caution in patients with severe
cardiac disease, hypertension, hyperthyroidism, acute myocardial
injury, congestive heart failure, hepatic impairment and epilepsy.
It should be used with caution in patients with peptic ulcer and in
patients who are sensitive to Xanthine derivatives.
Smoking may increase theophylline clearance and increased doses of
theophylline might therefore be required.
WARNING:
Contains Sulphites: Can cause allergic type reactions including
anaphylactic symptoms, or severe asthmatic episodes in susceptible
persons.
The herbal remedy St. Johns wort (Hypericum perforatum) should
not be taken at the sametime asthis medicine. If you alreadytake St.
Johnswort, consult your doctor before stopping the St. Johns wort
preparations.
Xanthines can potentiate hypokalemia resulting from Beta-2 agonist
therapy, steroids, diuretics, and hypoxia. Particular caution is advised
in severe asthma. It is recommended that serum potassium levels are
monitored in such situations.
ADVERSEREACTIONS:
The most common side effects with Theophylline are nau
vomiting....diardw-ea headache.Lrestlessness insomnia, mu
twitching and reflex hyper-excitability.
Drug interaction:
- Cimetidine, Allopurinol, Corticosteroids or Steroids, Frusem
Isoprenaline, oral Contraceptives, Thiabendazole, Cipnofloxa
Erythromydn or other antibiotics and Calcium Cha
Blockers, Diltiazem and Verapamil, Nizatidine, Norfloxa
Isoniazid, Fluconazole, Carbimazole, Mexiletine, Propafen
Oxpentifylline, Disulfram, Viloxazine, Interferon Alfa and Influe
vaccine increase plasma theophylline concentrations, A reducti
of the theophylline dosageis recommended.
Phenytoin, Carbamazepine, Barbiturates, Rifamp
Sulphinpyrazone, Ritonavir, Primidone and Aminoglutethim
mayreduce.plasma.theoobsume oncentration.and therefore.th
theophylline dosagemay need to be increased.
- Theophylline can increase Uthium excretion.
- The concomitant use of Theophylline and Fluvoxamine should
usually be avoided. Where this is not possible, patients should
have their theophylline dose halved and plasma theophylline
should be monitored closely.
- Theophylline should not be administered concurrently with other
Xanthine medications.
Plasma concentration of theophylline can be reduced by
concomitant useof the herbal remedy StJohn'swort (hypericum
perforatum).
USEDURINGPREGNANCYAND LACTATION:
UseofTheophylline in pregnant women should be balancedagainst
the risk of uncontrolled asthma. Excretionof Theophylline in breast
milk may cause irritability in the infant. For both cases, Theophylline
Should be prescribed only under doctor's supervision.
DOSAGE:
Majntenance Dose Acute Symptoms
Population Group
Oral Theophytline
(MG/KG/DAYI
Premature inhmts newbom 6 weeks (for apnea/
bradycardia)
6 weeks - 6 months 10
Infants 6 months - 1 year 12 ·18
Children 1-9~ars 20-24
Children 9 - 12 years and a~nt daily smokers
d~ othHwbe adulttYnOlcrr5
so years.
16
Adol~scents 12 - 16 years. 13
Ot~ise healthy nonsmoking adults (includil'l8
elderly patients)
10 (not to elCC~ 900
"'IId..,1
cardiac decompensation Of Ptllmonary and/Of nve-
dysfunction
S(notlOexc~400
"'IIday)
OVERDOSAGE:
Overdoseis characterised by nausea,vomiting (often
severe), epigastric pain, haematemesis, restlessness, hypertonia,
impaired consciousness, exaggerated limb reflexes and convulsions,
and arrhythmias. In addition, hypokalemia, hyperglycaemia,
hypomagnesaemia and metabolic acidosis may occur.
Activated charcoal or gastr1c lavage should be considered ,f
a significant overdose has been ingested within 1-2 hours.
Management is followed by symptomatic relief.
STORAGE:
Store below 25·C,protect from t,
Do not use the drug after the expiry date printed on the package.
PRESENTAnON:
Syrup: 100 ml bottles.
Do Not Freeze
sea, To Report any side eff&et(s) or Quality Problems:
scle National Phannacovigilance Center (NPC)- ~~-,-
o t-ax :+!lt5o-1-<'U!>-f0t5<'
o E-mail: npc.drug@sfda.gov.sa
ide,
o websrte: www.sfda.gov_sa/npc
cin,
This is a medicament
nnel
cin, A medicament js a product. ~ d«:ts 'JOAI t.aIlh. and r.s ~
contrary to instructJons is ~ tar)'OO..
one, Follow strictly the doc:;tgr's pra5Q'lpbDn. the method of use and the Inn'Ucbons of
nza
the pharmacist who sold the ~
• The doctor and the phamacist en expertS In medcine, ItS beoeftts and nsks.
on 00 not by yoOOlelf nt8l'TUpt the penod of tncnenl pn!5CI'bed ror you
00 not repeat the same pn!J5CnPbOnwtthout c:::onsUbngyou- doctor
K_ medicaments
icin, out of the rea<:h of chUdren
ide CouncH of Arab Health Ministers
Union of Arab Phannacists
'-C. '=-oi.
Manufactured by Riyadh Pharma
Medical and Cosmetic Products Co. Ltd.
Riyadh, Saudi Arabia.
RIY~
Revised October. 2012 AIAPHYlLiN is a trademark
ITEM CODE: PIL0469
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