Paracetamol with other ingredients for cough & colds
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Cough and cold medicines are readily available in different presentations for the patient to purchase for self-medication according to their preferred ingredient list and formulation.
Such medicines typically contain paracetamol in combination with one or more of the following types of ingredient:
Cough suppressants: pholcodine, dextromethorphan
Antihistamines: promethazine, diphenhydramine
Sympathomimetic decongestants: pseudoephedrine, ephedrine, phenylephrine
Expectorants: guaifenesin
Other ingredients: ascorbic acid, caffeine, levomenthol or cetylpyridinium may also be included in the product.
Drugs List
Therapeutic Indications
Uses
For relief of symptoms associated with the common cold and influenza, including aches and pains, sore throat, headache, nasal congestion, feverishness and chills.
Dosage
Consult product literature for specific advice on dose in the different presentations.
Adjust dose in accordance with the manufacturer's directions. Patients should not to take more than 1 product containing paracetamol at a time. Paracetamol containing products should not be taken more frequently than 4 to 6 hours or more than 4 doses of paracetamol in 24 hours.
Adults
500mg to 1g of paracetamol every 4 to 6 hours as required.
Maximum of 4g daily.
Children
Children should not be given more than one cough or cold preparation at a time because different brands may contain the same active ingredient; care should be taken to give the correct dose.
Children 6 to 12 years
Some products in this class are available from pharmacies where the patient's carer may obtain professional advice.
The recommended dose on paracetamol in this age group ranges from:
250mg to 500mg every 4 to 6 hours when necessary. Maximum of 1g to 2g in 24 hours, depending on the age.
Children under 6 years
The CHM has advised that products containing cough suppressants, expectorants, antihistamines or nasal decongestants are contraindicated in children in this age group (See Precautions and warnings: CSM warning).
For advice on paracetamol dosing as a single ingredient, refer to the monograph for paracetamol oral liquid preparations.
Patients with Renal Impairment
Paracetamol
Caution is advised in patients with renal impairment.
The Renal Drug Handbook suggests that patients with a glomerular filtration rate (GFR) of less than 10ml/min should not exceed 500mg - 1g every 6 to 8 hours.
Other ingredients
Pholcodine - avoid or reduce the dose in patients with mild to moderate renal impairment due to increased and prolonged effect and increased cerebral sensitivity to pholcodine.
Promethazine, diphenhydramine and ephedrine should be used with caution in renal impairment.
Guaifenesin should be used with caution in severe renal impairment.
Patients with Hepatic Impairment
Caution is advised in patients with hepatic impairment.
Paracetamol - should be given with care to patients with severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Paracetamol has dose-related hepatic toxicity.
Other ingredients
Pholcodine - avoid or reduce the dose in patients with mild to moderate hepatic impairment as pholcodine may precipitate a coma.
Caution is also advised for preparations containing: dextromethorphan, promethazine, diphenhydramine or guaifenesin.
Administration
For oral use.
Contraindications
Children under 6 years (see 'CSM Warnings' section)
Pregnancy (see 'Pregnancy' section)
Breastfeeding (see 'Lactation' section)
Additional contraindications for each ingredient are as follows:
Sympathomimetics (pseudoephedrine, ephedrine and phenylephrine):
Ischaemic heart disease including severe hypertension
Within 14 days of stopping MAOIs
Pholcodine:
Respiratory failure
Chronic obstructive pulmonary disease
Bronchiectasis
Chronic bronchitis
Within 14 days of stopping MAOIs
Dextromethorphan:
Severe hepatic disease
Respiratory failure or predisposition to respiratory failure
Within 14 days of stopping MAOIs
Promethazine:
Coma
Central nervous system depression
Within 14 days of stopping MAOIs
Diphenhydramine:
Asthma
Stenosing peptic ulcer
Obstruction of neck of bladder
Within 14 days of stopping MAOIs
Guaiphenesin:
None known
Ascorbic acid:
Hyperoxaluria
Precautions and Warnings
Paracetamol should be used with caution in patients with:
Severe hepatic impairment
Severe renal impairment
Alcohol dependence
Non-cirrhotic alcoholic liver disease
Additional precautions for each different ingredient are as follows:
Pholcodine, dextromethorphan and guaifenesin:
Respiratory disease including asthma
Pseudoephedrine, ephedrine and phenylephrine:
Heart disease including mild to moderate hypertension
Arrhythmias
Occlusive vascular disease including Raynaud's syndrome
Diabetes mellitus
Phaeochromocytoma
Glaucoma
Benign prostatic hyperplasia
Renal impairment
Hyperthyroidism
Promethazine:
Severe coronary artery disease
Narrow angle glaucoma
Epilepsy
Hepatic disease
Renal impairment
Bladder neck or pyloroduodenal obstructions
Prostatic hypertrophy
Urinary retention: may exacerbate the symptoms of prostatism
Elderly
Reye's syndrome or Reye like symptoms in children or adolescents
Porphyria
Diphenhydramine:
Prostatic hypertrophy
Epilepsy
Narrow angle glaucoma
Hepatic impairment
CNS depression
Hypotension in the elderly
Myasthenia gravis
Pyloroduodenal obstruction
Urinary retention
Porphyria
Bronchitis
Chronic obstructive pulmonary disease
Within 14 days of stopping MAOIs
Caffeine:
History of peptic ulcer
General warnings for these preparations are:
Prolonged excessive use of analgesics can produce renal nephropathy.
Prolonged use and excessive doses may cause hepatic necrosis.
Patients should be advised:
to avoid alcohol during treatment.
not to exceed the stated dose.
not to use this or similar products for longer than 7 days except on the advice of a doctor.
to consult a doctor if symptoms persist despite treatment.
Remind patients that they should not take any other flu, cold or decongestant products whilst taking this medication.
Different formulations contain different excipients. Check the product label for details in each case. The most common excipients and the conditions where they should be given with caution are:
Aspartame (E951): a source of phenylalanine. It may be harmful for patients with phenylketonuria.
Glucose should not be used by patients with glucose-galactose malabsorption. The glucose content should also be taken into consideration when used by patients with diabetes.
Fructose should not be given in hereditary fructose intolerance.
Sucrose should not be given in hereditary fructose intolerance and given with caution in glucose-galactose malabsorption syndrome. The content of sucrose should also be taken into account by patients with diabetes mellitus.
Maltitol and sorbitol are unsuitable in hereditary fructose intolerance.
Lactose should not be used by patients with galactosaemia and caution should be used in patients with glucose-galactose malabsorption syndrome and lactose intolerance.
Sodium content should be taken into account by patients on a controlled sodium diet.
Care should be taken when given to children or patients suffering from alcoholism. The hepatotoxicity of paracetamol is increased.
Propylene glycol is metabolised to alcohol and may cause alcohol like symptoms.
Pregnancy and Lactation
Pregnancy
Combination preparations are not generally recommended in pregnancy since the toxic risk increases with the number of ingredients. However, inadvertent use of a combination analgesic preparation does not justify a termination of pregnancy or invasive diagnostic preparations.
The individual ingredients in these preparations are discussed below:
Paracetamol: in single-ingredient preparations is the analgesic and antipyretic of choice during pregnancy, and is well tolerated. It can be used during all stages of pregnancy, and at usual doses. Some studies have raised the possibility of teratogenic potential or as a possible cause for asthma in later childhood, but others do not indicate any developmental risk. It appears to be safe for short-term use in therapeutic doses, but should not be used in continuous high daily doses.
Sympathomimetics (pseudoephedrine, phenylephrine and ephedrine): are known to slow uterine blood flow, but the effect has not been sufficiently studied in relation to human reproduction. Studies have shown the possibility of ventricular septal defects due to vasoconstrictive effects, as well as possible increased risk of gastroschisis, small intestinal atresia and hemifacial microsomia, primarily from exposure in the first trimester and probably only when in combination with other products. It should therefore be avoided in the first trimester, and is not recommended for use in pregnancy. Inadvertent use is not an indication for termination.
Pholcodine: is thought to have greater depressant effects than codeine on the respiratory and cardiovascular systems in animals, but these results are not reproducible in man. It appears less addictive, and is metabolised and eliminated more slowly than codeine.
Promethazine: although used as an antihistamine in these products, is also commonly used to treat nausea and vomiting in pregnancy. It crosses the placenta readily and elimination is slower in the foetus and neonate than in the adult. No evidence of teratogenicity has been demonstrated in studies, and it is not thought to be embryo- or foetotoxic. However, some studies have shown significant neonatal respiratory depression following use during labour, and there are other reports of maternal tachycardia, persistent sedation, fatal shock and uterine activity changes.
Dextromethorphan: is widely used as a cough suppressant. It is considered safe for use during pregnancy, and can be given during all trimesters. However, higher does for longer periods of time, or use near delivery may cause neonatal withdrawal and respiratory depression. No increased incidence of congenital malformations or human teratogenicity have been found. It is not known if it crosses the placenta, but this is likely, given its low molecular weight.
Diphenhydramine: Animal data and most published human experience suggest that diphenhydramine does not cause complications in pregnancy. There is one report of a statistical association with cleft palate following first trimester exposure. Premature infants exposed within two weeks of birth may be at risk of toxicity.
Lactation
Combination preparations are not generally recommended during breastfeeding since the toxic risk increases with the number of ingredients.
The majority of coughs and colds will get better on their own, and medicines may not help. Consider measures such as rest and increased fluid intake in preference to medicine whilst breastfeeding.
The individual ingredients in these preparations are discussed below:
Paracetamol: as a single ingredient preparation is the analgesic of choice during breastfeeding. No undesirable effects have been reported and no side effects have been observed in studies, save one case of maculopapular rash. Calculations show that the amount of paracetamol ingested by an infant through breast milk, even at peak levels, is significantly smaller than the minimum therapeutic dose for a pre-term infant, and hence risk to the infant is low. There is a possibility of accumulation in long term treatment, due to metabolism and renal excretion in the neonate not being fully developed. Evidence suggests that the amount secreted into milk is too small to be hazardous and hence paracetamol is the analgesic of choice.
Sympathomimetics (pseudoephedrine, phenylephrine and ephedrine): are excreted in breast milk in amounts small enough to be considered safe in occasional doses. It is unlikely that it will harm the infant, but may cause occasional irritability, restlessness or mild sedation. Some data suggests that it may inhibit milk production significantly, and repeated use may interfere with lactation. It is therefore not recommended for use in cases where lactation is not yet well established or where mothers are having difficulties producing sufficient milk.
Pholcodine: is not generally recommended in breastfeeding mothers due to a lack of data available.
Promethazine: is likely to be excreted into breast milk in small amounts, which may cause drowsiness, irritability or sleep disturbance in the infant and hence is not generally recommended. There is the possibility of links with Sudden Infant Death Syndrome, and it should not be used in infants inclined to apnoea. All infants should be closely observed for signs of sedation and apnoea, particularly if repeated doses are used. Promethazine lowers basal prolactin secretion so may interfere with the establishment of lactation if given early postpartum.
Dextromethorphan: has less sedative action than codeine. There is little data available on use during breastfeeding, but single doses are considered safe. Careful observation is required for repeated doses in case of somnolence. It is not known whether it is excreted in breast milk, but it is thought unlikely that transfer would occur in clinically significant amounts.
Diphenhydramine: Diphenhydramine should be used with caution during lactation as small amounts of antihistamines are excreted in breast milk. Data is limited in humans but expected breast milk concentrations are not thought to be sufficiently high to affect a nursing infant. Drug and Lactation Database (LactMed) states that small, occasional doses of diphenhydramine would not be expected to cause any adverse effects in the breastfed infants. Larger doses or more prolonged use may cause effects in the infant or decrease the milk supply. The non-sedating antihistamines are preferred alternatives.
Effects on Ability to Drive and Operate Machinery
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.
Counselling
Do not take with any other paracetamol containing products
Do not exceed the stated dose
Seek advice immediately in the event of an overdose, even if the patient seems well because of the risk of delayed, serious liver damage
Do not take any other flu, cold or decongestant products whilst taking this medication
Avoid alcohol during treatment
Do not use this or similar products for longer than 7 days except on the advice of a doctor
Consult a doctor if symptoms persist despite treatment
For products containing sedating antihistamines, advise patients not to drive or operate machinery if affected by drowsiness.
Side Effects
Paracetamol:
Rash
Allergic reaction
Blood dyscrasias
Thrombocytopenia
Agranulocytosis
Papillary necrosis
Leucopenia
Neutropenia
Anaphylactic reaction
Angioedema
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Bronchospasm
Hepatic dysfunction
Sympathomimetics (pseudoephedrine, ephedrine, phenylephrine):
Tachycardia
Restlessness
Insomnia
Sleep disturbances
Hallucinations
Fix drug eruption
Anxiety
Rash
CNS excitation
Closed angle glaucoma
Palpitations
Hypertension
Irritability
Nausea,
Vomiting
Headache
Urinary retention
Nervousness
Promethazine:
Anorexia
Headache
Drowsiness
Dizziness
Restlessness
Tiredness
Disorientation
Confusion
Arrhythmias
Hypotension
Urinary retention
Dry mouth
Blurred vision
Constipation
Rash
Photosensitivity
Blood dyscrasias
Haemolytic anaemia
Hypersensitivity reactions
Gastro-intestinal symptoms
Gastric irritation
Jaundice
Bronchospasm
Tremor
Angioedema
Palpitations
Sleep disturbances
Nightmares
Sedation
Depression
Extrapyramidal effects
Anaphylaxis
Hepatic impairment
Excitement (paradoxical)
Psychomotor impairment
Muscle spasm
Tics
Anticholinergic effects
Difficulty in lacrimation
Convulsions
Urticaria
Pruritus
Dextromethorphan:
Dizziness
Gastro-intestinal symptoms
Nausea
Vomiting
CNS excitation
Confusion
Respiratory depression
Hypersensitivity reactions
Rash
Convulsions
Diphenhydramine:
Sedation
Headache
Antimuscarinic effects
Alopecia
Gastroesophageal reflux
Excitement (paradoxical)
Psychomotor impairment
Nervousness
Rash
Photosensitivity
Palpitations
Arrhythmias
Hypersensitivity reactions
Anaphylaxis
Convulsions
Sweating
MyalgiaParaesthesia
Blood disorders
Extrapyramidal effects
Tremor
Hepatic impairment
Sleep disturbances
Depression
Hypotension
Drowsiness
Confusion
Dry mouth
Dizziness
Nausea
Difficulty in micturition
Allergic reaction
Thrombocytopenia
Blurred vision
Gastro-intestinal symptoms
Bronchospasm
Angioedema
Grogginess
Urinary retention
Lassitude
Incoordination
Tinnitus
Haemolytic anaemia
Agranulocytosis
Leucopenia
Vomiting
Epigastric pain
Constipation
Thickening of bronchial secretions
Diarrhoea
Fatigue
Urticaria
Dyspnoea
Increased energy
Restlessness
Attention disturbances
Unsteady gait
Dyskinesia
Tachycardia
Muscle twitch
Weight gain
Anorexia
Erythema
Guaifenesin:
Allergic reactions
angioedema
anaphylactic reactions
dyspnoea
rash
urticaria
Nausea
Vomiting
Abdominal discomfort
Pholcodine:
Constipation
Nausea
Drowsiness
Sputum retention
Rash
Hypersensitivity reactions
Respiratory depression
Anaphylaxis
Dizziness
Excitation
Confusion
Vomiting
Gastrointestinal disorder
Caffeine:
GI irritation
Nausea
Vomiting
Insomnia
Restlessness
Nervousness
Delirium
Effects on Laboratory Tests
If urine is collected within 24hours of a dose of guaifenesin a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
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 ).
The MHRA have produced 'generic' overdose sections for the top ten drugs for which the NPIS received the greatest number of queries about management of overdose in 2002. This information is represented below:
Liver damage is possible in patients who have taken 75mg/kg or more of paracetamol in less than an hour, and these patients should be referred to hospital. To avoid underestimating the potentially toxic paracetamol dose ingested by obese patients who weigh more than 110kg, a bodyweight of 110kg (rather than the actual bodyweight) should be used to calculate the total dose of paracetamol ingested in mg/kg.
Further Information
Last Full Review Date: January 2012
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