CODAMOL ® Paracetamol + Codeine

CODAMOL ® is a drug based on paracetamol + codeine

THERAPEUTIC GROUP: CODAMOL ® is indicated in the treatment of painful states of various nature and of different entity

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications CODAMOL ® Paracetamol + Codeine

CODAMOL ® is indicated in the treatment of painful conditions of various kinds and of different magnitudes.

Mechanism of action CODAMOL ® Paracetamol + Codeine

CODAMOL ® is a particularly effective medicine in the treatment of painful states even of severe entity, given the contextual presence of two different active ingredients with marked analgesic activities.

In fact, paracetamol, by inhibiting neuronal cyclooxygenases and reducing the production of chemical mediators such as PGE 2 and Bradykinin involved in the genesis of pain, is able both to avoid the stimulation of peripheral nociceptors and to increase, at the central level, the pain threshold .

This activity is also associated with a marked antipyretic action, linked to the reduction of the synthesis of active prostaglandins on hypothalamic thermoregulatory centers.

Codeine, the second active ingredient of CODAMOL ®, is an opiate alkaloid chemically similar to morphine, whose assumption and subsequent metabolism allow the release of morphine, which acts at the central level on opiate receptors and is able to carry out a sensitive sedative and analgesic action, thanks to the inhibition of nociceptive transmission and the raising of the pain threshold.

The latter active ingredient is also associated with antitussive and muscle relaxant properties of smooth muscles.

The presence of both active ingredients in CODAMOL ® enhances the pain-relieving properties, thus achieving excellent results in the treatment of pain symptoms.

Both paracetamol and codeine, after oral administration, are absorbed at the intestinal level, and distributed in the body.

After their biological activity with half-lives of between 2 and 3 hours, following an intense cytochrome-dependent hepatic metabolism, they are eliminated in the form of inactive catabolites mainly through the kidneys.

Studies carried out and clinical efficacy

1.PARACETAMOL + CODEINE IN THE TREATMENT OF DENTAL PAIN

Clin Ther. 2012 Jan; 34 (1): 138-48. Epub 2011 Dec 14.

Double-blind randomized clinical trial that demonstrates how paracetamol and codeine-based therapy can be effective both in the treatment of post-operative dental pain (extraction of the third molar) and in tension-type headache.

2 .PARACETAMOL + CODEINE IN OSTEOARTRITIC PAIN

Osteoarthritis Cartilage. 2011 Aug; 19 (8): 930-8. Epub 2011 Apr 6.

Work conducted on approximately 200 patients over the age of 60 with osteoarthritis, which demonstrates how the use of CODAMOL can be effective in reducing the inflammatory pain present in the knee and hip.

3.PARACETAMOL + CODEINE IN THE TREATMENT OF POLYRAUMATIZED PATIENTS

Eur Rev Med Pharmacol Sci. 2010 Jul; 14 (7): 629-34.

Very interesting Italian work that shows how the intake of paracetamol + codeine can be effective in controlling pain in patients with multiple traumatization, representing a valid alternative to NSAIDs, especially in all those cases of increased bleeding risk.

Method of use and dosage

CODAMOL ®

500 mg effervescent tablets of paracetamol and 30 mg of codeine phosphate.

In adults the intake of 1-2 tablets 1-3 times a day is generally sufficient to reduce the painful symptoms even of severe entity.

The aforementioned dosage should instead be reviewed by your doctor for patients in childhood, adolescence, age or suffering from kidney disease.

Warnings CODAMOL ® Paracetamol + Codeine

CODAMOL ® -based therapy should be considered as short-term therapy, given the increased risk of liver disease and nephropathy that is observed following the prolonged intake of this drug.

Particular caution should be reserved for all those patients treated with CODAMOL ® and contextually suffering from renal and hepatic diseases, in which the incidence of side effects and the risk of overdose is significantly higher.

The possible appearance of adverse reactions or the absence of a symptomatic improvement, should alarm the patient, who after consulting his doctor, could consider the need to suspend the treatment.

Recent pharmacogenomic studies have shown the presence in the European territory of cytochromial enzymatic isoforms particularly active in the codeine metabolism, thus able to significantly increase the amount of morphine catabolites, thus increasing the risk of toxicity.

CODAMOL ® contains:

aspartame as a source of phenylalanine, therefore being contraindicated in patients with phenylketonuria;
sodium, therefore being contraindicated in patients receiving hyposodic diets;
sorbitol, potentially dangerous in patients with rare hereditary forms of fructose intolerance.

The presence of codeine in CODAMOL ® could cause drowsiness, thus making the driving of vehicles and the use of machinery dangerous.

PREGNANCY AND BREASTFEEDING

Despite the data in the literature are controversial regarding the fetus-toxicity of codeine, the second active ingredient present in CODAMOL ®, showing experimentally the risk of fetal respiratory depression following the assumption of high doses in the pre-birth phases not confirmed then by data clinical, the assumption of this drug in pregnancy turns out however not advised.

This contraindication also extends to the subsequent breastfeeding period, given the ability of codeine to accumulate in significant concentrations in breast milk.

Interactions

The presence in CODAMOL ® of both paracetamol and codeine significantly increases the risk of pharmacologically relevant interactions, such as to vary both the therapeutic profile and the safety profile of the drug.

Particular attention should be paid to the simultaneous intake of alcohol, diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate given the ability of these active ingredients to increase the hepatic and renal toxicity of paracetamol.

Phenytoin, probenencid, inducers of monooxygenases and active ingredients capable of altering gastric motility could on the other hand cause significant variations in the pharmacokinetics of paracetamol.

The sedating effects of codeine, on the other hand, could be enhanced by the simultaneous intake of other sedative-acting drugs such as morphine derivatives, neuroleptics, barbiturates, benzodiazepines and anxiolytics in general.

Contraindications CODAMOL ® Paracetamol + Codeine

The use of CODAMOL ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, hepatic and renal insufficiency, high-grade haemolytic anemia, glucose deficiency of glucose 6 phosphate dehydrogenase and respiratory failure.

Undesirable effects - Side effects

Taking CODAMOL ® could determine the occurrence of side effects whose severity would be directly proportional to the duration of the therapy and to the dosage used.

The presence of paracetamol could in fact determine the appearance of thrombocytopenia, neutropenia and leucopenia with the related consequences, diarrhea and abdominal pain, allergic reactions both of cutaneous nature (urticaria, erythema, rash) and vascular (hypotension), hepatic and nephrotoxicity.

Codeine, on the other hand, even when taken at therapeutic doses, could facilitate the appearance of constipation, nausea, vomiting, sedation, euphoria, miosis, urinary retention, cutaneous and vascular hypersensitivity reactions, drowsiness, dizziness, bronchospasm and respiratory depression.