A fixed-dose combination analgesic-antihistamine primarily used for symptomatic relief of fever, pain, and associated irritability/restlessness in pediatric patients. Paracetamol provides central antipyresis and analgesia, while promethazine, a first-generation phenothiazine antihistamine, provides sedative and anti-emetic effects, aiding in calming the child and facilitating sleep during illness.
Adult: Not typically recommended as a first-line combination for adults in India. If used, consult a physician. Approximate dose: Paracetamol 500mg + Promethazine 10-25mg, but separate components are preferred.
Note: Shake the syrup well before use. Use the measuring cup or dropper provided. Can be taken with or without food. Taking with food may slightly delay absorption. Do not crush/chew dispersible tablets; dissolve in water. Maintain adequate hydration.
Paracetamol acts centrally by inhibiting cyclooxygenase (COX), particularly the COX-2 variant, and modulating the endogenous cannabinoid system in the brain and spinal cord, reducing prostaglandin synthesis and elevating pain threshold. Its antipyretic action is mediated in the hypothalamic heat-regulating center. Promethazine is a potent antagonist of histamine H1 receptors. Its sedative effect is due to antagonism of central H1 and muscarinic receptors. It also has antiemetic properties via antagonism of D2 receptors in the chemoreceptor trigger zone.
Pregnancy: Paracetamol: Category A (considered safe in all trimesters for short-term use at recommended doses). Promethazine: Category C. Use only if potential benefit justifies potential fetal risk. Avoid near term due to possible neonatal adverse effects (respiratory depression, extrapyramidal symptoms).
Driving: STRONGLY DISCOURAGED. Promethazine causes significant drowsiness and impairs cognitive and motor functions. Patients should not drive or operate heavy machinery for at least 8-12 hours after a dose.
| CNS Depressants (Alcohol, Benzodiazepines, Opioids) | Potentiated sedation, respiratory depression, impaired psychomotor performance. | Major |
| Enzyme Inducers (Carbamazepine, Phenytoin, Rifampicin, Barbiturates) | Increased metabolism of paracetamol to toxic NAPQI metabolite, raising hepatotoxicity risk even at therapeutic doses. | Major |
| Warfarin and other Coumarins | Paracetamol may potentiate anticoagulant effect, increasing INR and bleeding risk, especially with chronic high-dose use. | Moderate |
| Anticholinergics (Atropine, TCAs) | Additive anticholinergic effects (dry mouth, urinary retention, constipation, blurred vision). | Moderate |
| MAO Inhibitors (Phenelzine, Tranylcypromine) | Exaggerated anticholinergic and CNS depressant effects of promethazine; can cause hypertensive crisis. | Major |
| Metoclopramide, Domperidone | Antagonistic effect on GI motility; may reduce efficacy. | Moderate |
| Selective Serotonin Reuptake Inhibitors (SSRIs) | Increased risk of serotonin syndrome (theoretical, rare with promethazine). | Moderate |
Same composition (Paracetamol (125mg) + Promethazine (2.5mg)), different brands: