Composition

Each 100 ml contains: 
Acefylline piperazine ........................................................................... 2 g
Phenobarbitone sodium ........................................................... 0.066 g

Inactive Ingredients: 

Methyl paraben sodium, glycerol, sorbitol 70% solution, menthol, orange oil, rose oil, propyl paraben sodium, brilliant blue no, 1, quinoline Yellow El 04, ethyl alcohol 95%, purified water.  

Therapeutic Indications              

Bronchial asthma.

Chronic obstructive pulmonary disease associated with anxiety and insomnia.

Dosage and Administration        

Adults: 1-2 tablespoonfuls three times daily.
Children: 1-2 teaspoonfuls three times daily.

Hypersensitivity to the product.

Severe respiratory depression.

Prophyria.

EPICOPHYLLINE PHENOBARBITONE should be given cautiously to patients with peptic ulceration, porphyria, hyperthyroidism, hypertension, cardiac arrhythmias, epilepsy, impaired hepatic, renal, or respiratory function, elderly or debilitated patients, in those in acute pain, and in those with depressive disorders. 

EPICOPHYLLINE PHENOBARBITONE contains small amounts of ethanol (alcohol), less than 100 mg per dose.

EPICOPHYLLINE PHENOBARBITONE contains sorbitol that may cause softening of the stool.

Concomitant use with other xanthine medications should be avoided. 

EPICOPHYLLINE PHENOBARBITONE requires a reduction of dose if co-administered with drugs that may reduce its clearance, e.g. allopurinol, contraceptive pills, cimetidine, macrolides, quinolones or propranolol.

EPICOPHYLLINE PHENOBARBITONE requires an increase of dose if co-administered with drugs that may increase its clearance, e.g. phenytoin, rifampicin, ritonavir or sulphinpyrazone.

The phenobarbital sedative effect may be enhanced if EPICOPHYLLINE PHENOBARBITONE is co-administered with antidepressants, hypnotics or tranquilizers.

The effects of phenobarbital and other barbiturates are enhanced by other CNS depressants including alcohol. 

Phenobarbital and other barbiturates may reduce the activity of many drugs by increasing the rate of metabolism through induction of drug-metabolising enzymes in liver microsomes. 

EPICOPHYLLINE PHENOBARBITONE is contraindicated during pregnancy, and lactation.

EPICOPHYLLINE PHENOBARBITONE is well tolerated. Transient side effects may occur including GI disturbance such as nausea, vomiting, diarrhea, abdominal pain; sedation and drowsiness. 

EPICOPHYLLINE PHENOBARBITONE may produce subtle mood changes and impairment of cognition and memory that may not be apparent without testing. Depression may occur.

Pharmacological Properties                 

EPICOPHYLLINE PHENOBARBITONE contains acephylline piperazine and phenobarbital sodium.

Acephylline piperazine is a theophylline derivative which is used as a bronchodilator similarly to theophylline. It relaxes smooth muscles of the bronchial airways and therefore it relieves bronchospasm. Phenobarbital sodium produces sedative and hypnotic effects. 

Pharmacokinetics: 

Acephylline is rapidly and completely absorbed; the rate, but not the extent, of absorption is decreased by food, and food may also affect acephylline clearance. Peak serum- acephylline concentrations occur 1 to 2 hours after ingestion. Acephylline is about 40 to 60% bound to plasma proteins, but in neonates, or adults with liver disease, binding is reduced. Acephylline is metabolised in the liver. The metabolites are excreted in the urine. In adults, about 10% of a dose of is excreted unchanged in the urine, but in neonates around 50% is excreted unchanged, and a large proportion is excreted as caffeine. The serum half-life of Acephylline may be increased in patients with heart failure or liver disease. Steady state is usually achieved within 48 hours with a consistent dosing schedule. Acephylline crosses the placenta; it is also distributed into breast milk. 

Phenobarbital is readily absorbed from the gastrointestinal tract, although it is relatively lipid-insoluble; peak concentrations are reached in about 2 hours after oral doses. 

Phenobarbital is about 45 to 60% bound to plasma proteins and is only partly metabolised in the liver. About 25% of a dose is excreted in the urine unchanged. The plasma half-life is about 75 to 120 hours in adults but is greatly prolonged in neonates, and shorter (about 21 to 75 hours) in children. Phenobarbital crosses the placental barrier and is distributed into breast milk. 

Storage

Store at temperature not exceeding 30^˚C.

Packaging                      

EPICOPHYLLINE PHENOBARBITONE Syrup: Bottle of 125 ml.