Chemical formula: C₂₆H₃₃N₂O₉P Molecular mass: 548.192 g/mol
Codeine and Paracetamol interacts in the following cases:
The dose should be reduced or the interval between doses should be increased in the presence of impaired liver and/or kidney function and in subjects suffering from Gilbert’s syndrome (Meulengracht’s disease). Patients with severe renal impairment (creatinine clearance <10 ml/min) must not exceed a dose interval of at least 8 hours.
The prolonged use of codeine may give rise to opioid dependence of the foetus. The repeated administration of codeine in the last three months of pregnancy has been reported to cause withdrawal symptoms in the newborn.
Use during pregnancy should be avoided, unless advised by a physician. This includes maternal use during labour because of the potential for respiratory depression in the neonate.
The safety of paracetamol-codeine during pregnancy has not been established relative to the possible adverse effects of foetal development.
Paracetamol/codeine combination should not be used during breastfeeding.
At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant. However, if the patient is an ultrarapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.
Even if used properly, the codeine component of the fixed-dose combination may modify the patient’s reaction to an extent that his/her ability to drive a car, operate machinery or perform hazardous activities is impaired.
In this section frequencies of undesirable effects are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
| System Organ Class | Very common | Common | Uncommon | Rare | Very rare |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Allergic thrombocytopenia, leucocytopenia | Agranulocytosis, pancytopenia | |||
| Nervous system disorders | Dizziness, mild headache, fatigue | Mild drowsiness | Sleep disturbances | ||
| Ear and labyrinth disorders | Tinnitus | ||||
| Respiratory, thoracic and mediastinal disorders | Shortness of breath | Bronchospasm (analgesic asthma syndrome) | |||
| Gastrointestinal disorders | Nausea, vomiting (initially), constipation | Dry mouth | |||
| Hepatobiliary disorders | Increase in liver‐specific laboratory findings (increase of liver transaminase level) | ||||
| Skin and subcutaneous tissue disorders | Pruritus, erythema, allergic exanthema, urticaria | Serious skin reactions (including Stevens‐Johnson syndrome) | |||
| Immune system disorders | Hypersensitivity reactions such as angioedema, shortness of breath, sweating, nausea, fall in blood pressure, including shock |
Note:
Patients should be instructed to stop treatment and immediately contact a doctor at the earliest signs of hypersensitivity reactions.
Allergic reactions caused by non‐fat phospholipids are very rare.
Pulmonary oedema: Patients on large doses may develop pulmonary oedema, especially those with pre‐existing disorders of lung function.
Cardiovascular diseases: Patients taking large amounts tend to develop fall in blood pressure and syncope.
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