CODAMOL ® Paracetamol + Codeine

CODAMOL ® is a drug based on paracetamol + codeine

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

Indications CODAMOL ® Paracetamol + Codeine

CODAMOL ® is indicated in the treatment of painful states of various kinds and of different entities.

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 prostaglandins active on the hypothalamic thermoregulatory centers.
Codeine, the second active principle of CODAMOL ®, is an opiate alkaloid chemically similar to morphine, whose intake and subsequent metabolism allow the release of morphine itself, which acting at the central level on the opiate receptors, is able to carry out a sensitive sedating and analgesic action, thanks to the inhibition of nociceptive transmission and the raising of the pain threshold.
This last active principle is also associated with antitussive and muscle relaxant properties of smooth muscles.
The presence in CODAMOL ® of both active ingredients allows to enhance the pain-relieving properties, thus obtaining excellent results in the treatment of painful symptoms.
Both paracetamol and codeine, following oral administration, are absorbed in the intestine and distributed throughout the body.
At the end of their biological activity with half-lives between 2 and 3 hours, following an intense cytochrome-dependent hepatic metabolism, they are eliminated in the form of inactive catabolites mainly via the kidney.

Studies carried out and clinical efficacy

1.PARACETAMOL + CODEIN IN THE TREATMENT OF DENTAL PAIN
Clin Ther. 2012 Jan; 34: 138-48. Epub 2011 Dec 14.

Assessment of the efficacy and safety profiles of aspirin and acetaminophen with codeine: results from 2 randomized, controlled trials in individuals with tension-type headache and postoperative dental pain.

Gatoulis SC, Voelker M, Fisher M.

Randomized double-blind clinical trial that demonstrates how paracetamol and codeine 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 + CODEIN IN OSTEOARTHRITIC PAIN
Osteoarthritis Cartilage. 2011 Aug; 19: 930-8. Epub 2011 Apr 6.

Transdermal buprenorphine plus oral paracetamol vs an oral codeine-paracetamolcombination for osteoarthritis of hip and / or knee: a randomized trial.

Conaghan PG, O "Brien CM, Wilson M, Schofield JP.

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

3.PARACETAMOL + CODEIN IN THE TREATMENT OF POLITRAUMATIZED PATIENTS
Eur Rev Med Pharmacol Sci. 2010 Jul; 14: 629-34.

Acetaminophen plus codeine compared to ketorolac in polytrauma patients.

Franceschi F, Buccelletti F, Marsiliani D, Carroccia A, Giupponi B, De Marco G, Gilardi E, Merra G, Mancini F, Potenza A, Giannuzzi R, Calcinaro S, Marini M, Gentiloni Silveri N.

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

Method of use and dosage

CODAMOL ®
Effervescent tablets of 500 mg of paracetamol and 30 mg of codeine phosphate.
In adults, taking 1-2 tablets 1-3 times a day is generally sufficient to reduce painful symptoms, even severe ones.
The aforementioned dosage should instead be reviewed by your doctor for patients of childhood, adolescence, senile or kidney disease.

Warnings CODAMOL ® Paracetamol + Codeine

CODAMOL ® based therapy should be understood as a short-term therapy, given the increased risk of liver disease and kidney disease that is observed following prolonged intake of this drug.
Particular caution should be reserved for all those patients treated with CODAMOL ® and at the same time suffering from kidney and liver diseases, in which the incidence of side effects and the risk of overdose is significantly higher.
The possible occurrence of adverse reactions or the absence of symptomatic improvement should alarm the patient, who after consulting his doctor may consider the need to discontinue treatment.
Recent pharmacogenomic studies have shown the presence in the European territory of cytochromial enzymatic isoforms particularly active in the metabolism of codeine, therefore capable of significantly increasing the quantity of morphine catabolites, thus increasing the risk of toxicity.
CODAMOL ® contains:

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

The presence of codeine in CODAMOL ® could cause drowsiness, making it dangerous to drive and use machines.

PREGNANCY AND BREASTFEEDING

Although the data in the literature are controversial regarding the fetotoxicity of codeine, the second active ingredient present in CODAMOL ®, experimentally showing the risk of fetal respiratory depression following the assumption of high doses in the pre-birth stages, not confirmed by data clinical, the taking of this drug during pregnancy is however not recommended.
This contraindication also extends to the subsequent period of breastfeeding, 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, on the other hand, could 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 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 substance or to one of its excipients, hepatic and renal insufficiency, high degree haemolytic anemia, enzymatic glucose 6 phosphate dehydrogenase deficiency and respiratory failure.

Undesirable Effects - Side Effects

The intake of CODAMOL ® could determine the onset of side effects whose severity would be directly proportional to the duration of the therapy and the dosage used.
The presence of paracetamol could in fact determine the onset of thrombocytopenia, neutropenia and leukopenia with the relative consequences, diarrhea and abdominal pain, allergic reactions both of a skin nature (urticaria, erythema, rash) and vascular (hypotension), hepatic and nephrotoxicity.
Codeine, on the other hand, even when taken at therapeutic doses, could facilitate the onset of constipation, nausea, vomiting, sedation, euphoria, miosis, urinary retention, skin and vascular hypersensitivity reactions, drowsiness, dizziness, bronchospasm and respiratory depression.

Note

CODAMOL ® can be sold with a medical prescription.

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