SKUDEXA 1 Tablet - Tramadol / Dexketoprofen 75mg / 25mg

Indications / Uses

SKUDEXA is used for the management of acute moderate to severe pain, particularly when a rapid onset of analgesic action is required. It is an effective combination of tramadol, an opioid analgesic, and dexketoprofen, a non-steroidal anti-inflammatory drug (NSAID). This formulation is beneficial for conditions such as musculoskeletal pain, postoperative pain, or pain resulting from injury. By targeting pain through different mechanisms, SKUDEXA provides comprehensive pain relief.

Side-effects

SKUDEXA common side effects include nausea, dizziness, and somnolence. Some individuals may also experience gastrointestinal issues such as indigestion or abdominal pain. These side effects are generally mild but may vary between individuals. Serious side effects are rare but require immediate attention if experienced. Monitoring for any adverse reactions is advisable.

Dosage / Direction

Adults: The recommended dosage is one tablet (corresponding to 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen). Additional doses can be taken as needed, with a minimum dosing interval of 8 hours. The total daily dose should not exceed three tablets per day (corresponding to 225 mg of tramadol hydrochloride and 75 mg of dexketoprofen).
Skudexa is intended for short term use only and the treatment must be strictly limited to the symptomatic period and in any case not more than 5 days. Switching to a single agent analgesia should be considered according to pain intensity and response of the patient.
Undesirable effects may be minimised by using the lowest number of doses for the shortest duration necessary to control symptoms (see Precautions).
Elderly: In elderly patients the starting recommended dosage is one tablet; additional doses can be taken as needed with the minimum dose interval of 8 hours and not exceeding the total daily dose of 2 tablets (corresponding to 150 mg of tramadol hydrochloride and 50 mg of dexketoprofen). The dosage may be increased to a maximum of 3 daily tablets as recommended for the general population only after good general tolerance has been ascertained.
Limited data are available in patients over 75 years, therefore SKUDEXA should be used with caution in these patients (see Precautions).
Hepatic impairment: Patients with mild to moderate hepatic dysfunction should start therapy at reduced number of doses (total daily dose 2 tablets) and be closely monitored.
It should not be used in patients with severe hepatic dysfunction (see Contraindications).
Renal impairment: The initial total daily dosage should be reduced to 2 tablets Skudexa in patients with mildly impaired renal function (creatinine clearance 60-89 ml/min) (see Precautions).
It should not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml / min) (see Contraindications). 
Paediatric population: The safety and efficacy of it in children and adolescents have not been established. No data are available. It should not be used in children and adolescents.

Method of administration: Oral use.
Tramadol / Dexketoprofen (Skudexa) should be swallowed with a sufficient amount of fluid (e.g. one glass of water). Concomitant administration with food delays the absorption rate of the drug (see Pharmacology: Pharmacokinetics under Actions), for a faster effect the tablets may be taken at least 30 minutes before meals.

Contraindications

SKUDEXA should not be used in individuals with known hypersensitivity to tramadol, dexketoprofen, or any of its components. It is contraindicated in patients with severe renal or hepatic impairment. Reviewing patient history is crucial to avoid contraindicated use.

Special Precautions

Special precautions should be taken for patients with a history of substance abuse or dependence, as it contains an opioid component. Caution is also advised for individuals with gastrointestinal disorders or cardiovascular conditions. Monitoring for any signs of misuse or adverse effects is essential during treatment.

Is it safe to take it with other drugs?

Caution is necessary when considering the use of SKUDEXA with other medications, as interactions may occur. Some drugs may enhance the effects of tramadol or dexketoprofen, leading to increased risk of side effects. Evaluating all concurrent medications is important to avoid potential interactions.

How should I store it?

Store at temperatures not exceeding 30°C. Store in the original package in order to protect from light.