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Etaphylline Phenobarbital Papaverine

To the Medical and Pharmaceutical Professions.

Composition:
Each suppository contains:
Acefylline piperazine                       400 mg
Phenobarbital                                 100 mg
Papaverine hydrochloride               100 mg


Pharmacological properties:
Acefylline piperazine is a theophylline derivative which is used as a bronchodilator similarly to theophylline.
It relaxes bronchial smooth muscles, relieves bronchospasm and has a stimulant effect on respiration.
It stimulates the myocardium and CNS, decreases peripheral resistance and venous pressure and causes diuresis.
Phenobarbital is a non-selective CNS depressant that is primarily used as sedative hypnotic.
Papaverine hydrochloride acts directly on the heart muscle to depress conduction and prolong the refractory period, also it relaxes various smooth muscles.


Indications:
Etaphylline Phenobarbital Papaverine suppositories are indicated in the relief of:
-  Asthma, bronchospasm associated with chronic bronchitis and emphysema.
-  Cerebral and peripheral ischemia associated with arterial spasm and myocardial ischemia complicated by arrhythmias.


Contraindications:
Etaphylline Phenobarbital Papaverine suppositories are contraindicated in persons with hypersensitivity to any of the components of the product.


Warnings:
-  Psychological and physical dependence may occur with continued use of the drug.
-  Caution should be exercised in patients with acute or chronic pain, because important symptoms could be masked.


Precautions:
The drug should be given with caution to patients with hyperthyroidism, hypertension, heart failure, hepatic dysfunction, chronic alcoholism or glaucoma.

Pregnancy:
The drug is used during pregnancy only if clearly needed.

Lactation:
Caution should be exercised when the drug is administered to a nursing woman.


Drug interactions:
-    Allopurinol, some antiarrhythmic drugs, cimitidine, disulfiram, macrolide antibacterials and quinolones, oral contraceptives, tiabendazole may reduce clearance of the drug, while phenytoin, rifampicin and sulfinpyrazone may increase clearance of the drug.

-    The drug may potentiate hypokalemia caused by hypoxia or associated with the administration of beta-2 agonists and diuretics.

-    There is a risk of synergistic toxicity if the drug is given with halothane or ketamine, and it may antagonize the effects of adenosine and of competitive neuromuscular blockers.

-    The drug may increase the metabolism of anticoagulants and of estradiol.

-    The concomitant use of the drug with CNS depressants may produce additive depressant effects.

-    Monoamine oxidase inhibitors prolong the effect of the drug.


Side effects:
Nausea, vomiting, abdominal pain, gastro-oesophageal reflux, insomnia, headache, palpitations, precipitation of sinus tachycardia and supraventricular pre-mature contractions, lethargy and vertigo.

Overdosage:
Overdosage may lead to agitation, cardiac arrhythmias, convulsions, CNS depression, hypotension and respiratory depression.

Treatment:
Elimination of the drug by repeated oral doses of activated charcoal.
Protection of the patient’s airway with assisted respiration and oxygen administration.
Fluid therapy and other standard treatment for shock, if needed.

Dosage and administration:
1-3 suppositories daily or as directed by the physician.

Therapeutic category:
Bronchodilator and anti-asthmatic drug.

Legal category:
Prescription only medicine (POM).

Storage:
Store below 30° C, protect from light.

Package:
Boxes of 10 suppositories.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.