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Guaifenesin + pseudoephedrine oral solution

Presentation

Oral liquid containing guaifenesin and pseudoephedrine hydrochloride

Drugs List

  • BENYLIN MUCUS COUGH PLUS DECONGESTANT syrup
  • guaifenesin 100mg/5ml and pseudoephedrine 30mg/5ml oral solution
  • ROBITUSSIN CHESTY COUGH WITH CONGESTION liquid
  • Therapeutic Indications

    Uses

    Catarrh
    Nasal congestion
    Sinus congestion
    Symptomatic relief of chesty cough

    Dosage

    Adults

    10 ml up to four times a day.

    Elderly

    (See Dosage; Adult)

    Contraindications

    Children under 12 years
    Within 2 weeks of discontinuing MAOIs
    Cardiovascular disorder
    Diabetes mellitus
    Hereditary fructose intolerance
    Hypertension
    Hyperthyroidism
    Narrow angle glaucoma
    Phaeochromocytoma
    Pregnancy
    Severe renal impairment

    Precautions and Warnings

    Restricted sodium intake
    Benign prostatic hyperplasia
    Breastfeeding
    Glucose-galactose malabsorption syndrome
    Moderate renal impairment
    Severe hepatic impairment
    Urinary retention

    Some formulations contain more than 1mmol (23mg) sodium per dose
    Exclude chronic, persistent cough such as occurs with asthma or emphysema
    Contains alcohol
    Oral solution with maltitol unsuitable in hereditary fructose intolerance
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some brands contain Sunset Yellow (E110) - can trigger allergic reactions
    Some formulations contain amaranth (E123) - may cause allergic reactions
    Some formulations contain sucrose
    May affect results of some laboratory tests
    Advise patient to see doctor if symptoms persist for 7 days with treatment

    Pregnancy and Lactation

    Pregnancy

    Guaifenesin with pseudoephedrine is contraindicated in pregnancy.

    At the time of writing there is limited published information regarding the use of guaifenesin with pseudoephedrine during pregnancy. The manufacturer states that this drug should be used if the benefit of the treatment to the mother outweighs the potential risks to the foetus.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Use guaifenesin with pseudoephedrine with caution in breastfeeding.

    At the time of writing there is limited published information regarding the use of pseudoephedrine during breastfeeding. The manufacturer states that a very small amount, 0.5 to 0.7% of a single 60 mg dose, is excreted in breast milk and the effect of this on the infant is not known.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Agitation
    Anxiety
    CNS excitation
    Dizziness
    Hallucinations
    Headache
    Hypersensitivity reactions
    Increased blood pressure
    Insomnia
    Irritability
    Nausea
    Nervousness
    Palpitations
    Psychomotor hyperactivity
    Rash
    Restlessness
    Skin irritation
    Sleep disturbances
    Sleeplessness
    Tachycardia
    Urinary retention
    Urticaria
    Vomiting

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: January 2017

    Reference Sources

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press [Accessed on 09 January 2017].

    Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications [Accessed on 09 January 2017].

    Summary of Product Characteristics: Robitussin Chesty Cough with Congestion, Wyeth Consumer Healthcare, revised February 2014.

    Summary of Product Characteristics: Benylin Mucus Cough plus Decongestant Syrup, McNeil Products Ltd, revised June 2020.

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