Benylin Dry Coughs 7.5mg/5ml Syrup
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BENYLIN DRY COUGHS 7.5mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
BENYLIN DRY COUGHS 7.5mg/5ml Syrup contains -Dextromethorphan hydrobromide Ph Eur 7.5 mg in each 5 ml
3. PHARMACEUTICAL FORM
Pale brown coloured, peach flavoured syrup.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
BENYLIN DRY COUGHS 7.5mg/5ml Syrup is indicated as an antitussive, for the relief of persistent, dry, irritating cough.
4.2 Posology and method of administration
Adults and Children aged 12 years and over:
Oral. 10 ml syrup (15 mg dextromethorphan) 4 times a day. Maximum daily dose: 40 ml syrup (60 mg dextromethorphan)
Children under 12 years:
BENYLIN DRY COUGHS 7.5mg/5ml Syrup is contraindicated in children under the age of 12 years (see section 4.3).
The Elderly (over 65 years)
As for adults above.
Hepatic/renal dysfunction
Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of moderate to severe hepatic impairment (see Pharmacokinetics).
Do not exceed the stated dose.
Keep out of the sight and reach of children.
4.3 Contraindications
BENYLIN DRY COUGHS 7.5mg/5ml Syrup is contraindicated in individuals with known hypersensitivity to the product or any of its components.
BENYLIN DRY COUGHS 7.5mg/5ml Syrup is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of a dextromethorphan-containing product and monoamine oxidase inhibitors, can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma.
Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to subjects in, or at risk of developing respiratory failure.
Not to be used in children under the age of 12 years.
4.4 Special warnings and precautions for use
BENYLIN DRY COUGHS 7.5mg/5ml Syrup should not be administered to patients with chronic or persistent cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.
There have been no specific studies of BENYLIN DRY COUGHS 7.5mg/5ml Syrup in renal or hepatic dysfunction. Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of hepatic impairment.
Interaction with other Medicinal Products and other Forms of Interaction
4.5.
The concomitant use of a dextromethorphan-containing product and monoamine oxidase inhibitors can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma.
4.6 Fertility, pregnancy and lactation
Although dextromethorphan has been in widespread use for many years without apparent ill consequence, there is insufficient information on the effects of administration during human pregnancy. In addition, it is not known whether dextromethorphan or its metabolites are excreted in breast milk.
BENYLIN DRY COUGHS 7.5mg/5ml Syrup should therefore only be used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing foetus or suckling infant.
4.7 Effects on ability to drive and use machines
Unlikely to produce an effect.
This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When taking this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called ‘statutory defence’) if:
o The medicine has been taken to treat a medical or dental problem and o You have taken it according to the information provided with the medicine and
o It was not affecting your ability to drive safely.
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law
4.8. Undesirable Effects
Side effects attributed to dextromethorphan are uncommon; occasionally dizziness, nausea, vomiting, or gastro-intestinal disturbance may occur.
Overdose
4.9
Signs and symptoms
The effects of acute toxicity from BENYLIN DRY COUGHS 7.5mg/5ml Syrup overdose may include drowsiness, lethargy, nystagmus, ataxia, respiratory depression, nausea, vomiting, hyperactivity.
Treatment
Treatment should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
ATC Code: R05DA09 Pharmacotherapeutic Group: Cough Suppressant, Opium alkaloids and derivatives
Dextromethorphan is the dextrorotatory isomer of 3-methoxy-N-methyl-morphinan. It is a synthetic morphine derivative that, in contrast to its levorotatory isomer, has no significant analgesic, respiratory depressant or physical dependency properties at recommended doses.
Dextromethorphan is a non-opioid antitussive drug. It exerts its antitussive activity by acting on the cough centre in the medulla oblongata, raising the threshold for the cough reflex. The onset of antitussive effects are realised within 15 to 30 minutes of oral administration, lasting for approximately 3 to 6 hours.
The major metabolite of dextromethorphan, dextrorphan, binds with high affinity to a-receptors to produce its antitussive activity without exhibiting the classic opiate effects that occur from binding into p- and 5-receptors. Dextrorphan also exhibits binding activity at serotonergic receptors and was shown to enhance serotonin activity by inhibiting the reuptake of serotonin. In larger than therapeutic doses, dextrorphan is also an antagonist of N-methyl-D-aspartate (NMDA) receptors.
5.2. Pharmacokinetic properties
Absorption
Dextromethorphan is rapidly absorbed from the gastrointestinal tract with peak plasma concentrations reached in approximately 2 to 2.5 hours. The low plasma levels of dextromethorphan suggest low oral bioavailability secondary to extensive first-pass (pre-systemic metabolism) in the liver. The maximum clinical effects occur 5 to 6 hours after ingestion of dextromethorphan.
Distribution
Dextromethorphan is widely distributed in the human body.
Dextromethorphan and its active metabolite, dextrorphan, are actively taken up and concentrated in brain tissue. It is not known if dextromethorphan or dextrorphan are excreted in breast milk or cross the placenta.
Metabolism
Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration. As the hepatic metabolism of dextromethorphan is genetically determined, individuals vary in their ability to metabolise dextromethorphan and have been classified as either poor or extensive metabolisers. Dextromethorphan undergoes O-demethylation via CYP2D6 to dextrorphan; N-demethylation to 3-methoxymorphinan via CYP3A4/3A5; which is further metabolised to 3-hydroxy-morphinan via CYP2D6.
Excretion
Dextromethorphan is primarily excreted via the kidney as unchanged parent drug and its active metabolite, dextrorphan. Dextrorphan and 3-hydroxy-morphinan are further metabolised by glucuronidation and are eliminated via the kidneys.
The elimination half-life of the parent compound is between 1.4 to 3.9 hours; dextrorphan is between 3.4 to 5.6 hours. The half-life of dextromethorphan in poor metabolisers is extremely prolonged, in the range of 45 hours
5.3. Preclinical safety data
General toxicology
Acute oral toxicity studies conducted with Dextromethorphan report the following LD values (mg/kg): mouse, 210 and rat, 116. Acute subcutaneous
toxicity with Dextromethorphan reports the LD value (mg/kg): mouse, 112.
Acute intravenous toxicity with Dextromethorphan reports the LD value
(mg/kg): rat, 16.3.
Repeat dose toxicity studies conducted in rats for 13 weeks duration at doses up to 100 mg/kg and 27 weeks at 10 mg/kg, and of 14 weeks in dogs by oral gavage at doses up to 4 mg/kg on five days per week. The only effect recorded was of reduced body weight gain in the rat 13-week study at the highest dose.
Genetic Toxicology
Dextromethorphan hydrobromide was negative in the bacterial reverse mutation assay (Ames test). Dextromethorphan 39 mg/kg is reported to be negative in in-vivo mouse micronucleus test and comet assay.
Dextromethorphan was reported to be negative in in vitro chromosome aberration assay tested up to 200 pg/ml.
Carcinogenicity
There are no known reports of animal carcinogenicity studies for Dextromethorphan. The overall weight of evidence for Dextromethorphan and its structural analogues, support the conclusion that this class of phenanthrene-based chemicals, and Dextromethorphan, in particular, are not genotoxic in vitro or in vivo
Teratogenicity
There was no association between dextromethorphan and malformations. Fertility
Mating, gestation, fertility, littering and lactation were studied in rats at doses up to 50 mg/kg and no adverse effects were found.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Liquid Glucose Sucrose
Sorbitol solution 70% (non crystallising)
Ethanol 96%
Glycerol
Saccharin sodium Citric acid monohydrate Sodium benzoate Caramel T12 Imitation peach flavour Levomenthol Carbomer Purified Water
6.2. Incompatibilities
None known
6.3. Shelf-Life
3 Years
6.4. Special Precautions for Storage
Do not store above 300C
6.5 Nature and contents of container
125 or 150 ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyterephtalate ethylene faced aluminium/expanded polyethylene laminated wad
6.6 Special precautions for disposal
None applicable
7 MARKETING AUTHORISATION HOLDER
McNeil Products Limited Foundation Park Roxborough Way Maidenhead Berkshire SL6 3UG United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 15513/0051
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
16 June 1997
10 DATE OF REVISION OF THE TEXT
30/06/2015