1. Name Of The Medicinal Product
Benylin Children's Dry Coughs
2. Qualitative And Quantitative Composition
Active ingredient: Pholcodine 2.0 mg/5ml
3. Pharmaceutical Form
Oral solution
4. Clinical Particulars
4.1 Therapeutic Indications
Cough Suppressant for the relief of acute non-productive (dry) cough associated with upper respiratory tract infection.
4.2 Posology And Method Of Administration
For oral use.
Children 6 -12 years:
Two to three 5 ml spoonfuls three times a day. Not to be used for more than 5 days without the advice of a Doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
Children under 6 years:
Benylin Children's Dry Coughs is contraindicated in children under the age of 6 years (see section 4.3).
Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
Not to be used in children under the age of 6 years.
Pholcodine should not be given to subjects in, or at risk of developing respiratory failure.
Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment (see section 4.5).
4.4 Special Warnings And Precautions For Use
Should be used with caution by patients with liver or renal disease.
Use of pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.
The label should state the following:-
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Keep all medicines out of the reach and sight of children.
Ask a doctor before use if your child suffers from a chronic or persistent cough, if he/she has asthma, is suffering from an acute asthma attack or where cough is accompanied by excessive secretions.
Not more than 3 doses should be given in any 24 hours.
Do not take with any other cough and cold medicine.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Not to be used by patients taking MAOIs or within 14 days of stopping treatment.
Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.
The reduction of blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have the same effect. Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).
4.6 Pregnancy And Lactation
The safety of pholcodine during pregnancy and lactation has not been established. Based on the available data for morphine, it would seem likely that use of pholcodine during pregnancy would not be associated with congenital defects and that use of pholcodine during lactation would not be contraindicated. However, its use should be carefully assessed by consideration of small benefits versus potential risk to the foetus or neonate.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
The following side effects may be associated with the use of pholcodine: Occasional drowsiness, dizziness, excitation, confusion, sputum retention, vomiting, gastrointestinal disturbances (nausea and constipation) and skin reactions including rash.
Immune system disorders have been noted including hypersensitivity reactions and anaphylaxis.
4.9 Overdose
Pholcodine is thought to be of low toxicity, but the effects in overdosage will be potentiated by a simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms: These include nausea, drowsiness, restlessness, excitement, ataxia and respiratory depression.
Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01 mg/kg body weight). Other treatment option is activated charcoal (1g/kg body weight) if more than 4 mg/kg has been ingested within 1 hour, provided the airway can be protected.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pholcodine is a cough suppressant with mild sedative but little analgesic activity.
5.2 Pharmacokinetic Properties
Maximum plasma concentrations are attained at 4 to 8 hours after an oral dose. The elimination of half-life ranges from 32 to 43 hours and volume of distribution is 36-49l/kg.
Pholcodine is protein bound to the extent of 23.5%.
Pholcodine is metabolised in the liver but undergoes little conjugation.
There is little or no metabolism of pholcodine to morphine and this may account for the lack of analgesic activity, morphine-like side effects and addictive potential.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lycasin 80/55
Sodium citrate
Citric acid monohydrate
Sodium benzoate
Blackcurrant flavour DA 13624
Vanilla bean extract AD17342
Water purified
Hydroxyethylcellulose
Glycerin
Acesulfame k
6.2 Incompatibilities
None stated.
6.3 Shelf Life
24 months.
6.4 Special Precautions For Storage
Store below 30°C.
6.5 Nature And Contents Of Container
150 ml amber PET bottle with a polypropylene cap fitted with an expanded polyethylene liner or a 125 ml amber glass bottle with a 3 piece plastic child resistant, tamper evident closure fitted with a polyethylene/polyvinylidene chloride/polyethylene laminate faced wad.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
Administrative Data
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
United Kingdom
8. Marketing Authorisation Number(S)
15513/0054
9. Date Of First Authorisation/Renewal Of The Authorisation
17th April 1997
10. Date Of Revision Of The Text
31 March 2009
No comments:
Post a Comment