Paralgin/Paralgin Forte

Paralgin/Paralgin Forte Special Precautions

paracetamol + codeine

Manufacturer:

GoodScience

Distributor:

Mederis
Full Prescribing Info
Special Precautions
Do not exceed the recommended dose. At high doses codeine has most of the disadvantages of morphine, including respiratory depression. Codeine can produce drug dependence and therefore has the potential of being abused. Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blister or rash. These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.
Caution is advised when codeine is used in patients with underlying respiratory conditions, including those with asthma and other chronic breathing problems.
Parents and caregiver of paediatric patients should be advised on the possible sign and symptom of respiratory depression in their children such as unusual sleepiness, confusion and difficult or noisy breathing and to seek immediate medical attention if these are observed.
Nursing mothers should also be advised to exercise caution when taking codeine, since codeine's metabolite (morphine) subsequently be found in the breast milk. If the infant shows sign of increased sleepiness, difficulty breastfeeding, breathing difficulties and limpness, immediate medical attention should be sought.
Risks from Concomitant Use with Benzodiazepines: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Paralgin/Paralgin Forte with benzodiazepines. Observational studies have demonstrated that concomitant use of opioids and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
If the decision is made to newly prescribe a benzodiazepine and an opioid together, prescribe the lowest effective dosages and minimum durations of concomitant use.
If the decision is made to prescribe a benzodiazepine in a patient already receiving an opioid, prescribe a lower initial dose of benzodiazepine than indicated in the absence of an opioid, and titrate based on clinical response.
Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Paralgin/Paralgin Forte is used with benzodiazepines. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepines have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of benzodiazepines (see Interactions).
CYP2D6 metabolism: Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking these enzymes an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.
General symptoms of opioids toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. Estimates of prevalence of ultra- rapid metabolizers in different populations are summarized below: (see table).

Click on icon to see table/diagram/image

Post-operative use in children: There have been reports in the published literature that codeine given post-operatively in children after tonsillectomy or adenoidectomy for obstructive sleep apnoea, led to rare, but life-threatening adverse events including death. All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolizers in their ability to metabolize codeine to morphine.
Children with compromised respiratory function: Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.
Serotonin Syndrome with Concomitant Use of Serotonergic Drugs: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concurrent use of Paralgin/Paralgin Forte with serotonergic drugs (See Interactions). This may occur within the recommended dosage range.
Serotonin syndrome symptoms may include mental-status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) and can be fatal (See Interactions). The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that. Discontinue Paralgin/Paralgin Forte if serotonin syndrome is suspected.
Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, decreased appetite, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement dosing of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Sexual Function/Reproduction: Long term use of opioids may be associated with decreased sex hormone levels and symptoms such as low libido, erectile dysfunction, or infertility (See Postmarketing Experience under Adverse Reactions.)
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