Rotalfen (dexketoprofen) solution for injections 50 mg/2 ml. 2 ml. ampoules №5

$24.00

Manufacturer: Romania

Symptomatic treatment of moderate to high intensity acute pain in cases where oral administration of the drug is not appropriate, for example, postoperative pain, renal colic and lower back pain.

Description

Rotalfen (dexketoprofen) solution for injections 50 mg/2 ml. 2 ml. ampoules №5

Composition

active substance: dexketoprofen;

1 ampoule (2 ml) contains dexketoprofen trometamol 73.8 mg, which is equivalent to dexketoprofen 50 mg;

excipients: ethanol 96%, sodium chloride, sodium hydroxide, water for injections.

Medicinal form

Solution for injection.

Main physicochemical properties: transparent colorless solution.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory and anti-rheumatic drugs. Derivatives of propionic acid. Dexketoprofen.
ATX code M01A E17.

Pharmacological properties

This drug belongs to the group of non-steroidal anti-inflammatory and antirheumatic drugs, and its main active ingredient, dexketoprofen trometamol, belongs to the derivatives of propionic acid.
The main active ingredient is the propionic acid salt, exhibiting the properties of an analgesic, anti-inflammatory and antipyretic effect.
The action of the drug is due to its ability to reduce the synthesis of prostaglandins due to inhibition of the enzyme, or, more precisely, the group of cyclooxygenase enzymes.
The property to inhibit the synthesis of prostaglandins also affects other mediators of the inflammatory process, in particular, kinins. It also affects the main mechanism of action of a given drug, in particular its analgesic (pain relieving) properties.

Indications

This drug is a non-steroidal anti-inflammatory drug that is used to treat symptomatic pain of moderate to high intensity when oral administration is not possible or desirable.

In particular, it is used if it is necessary to relieve pain in:

  • postoperative pain;
  • renal colic;
  • back pain.

The duration of the action of the drug is about 8 hours.
Using this drug can reduce the need for opiates.
If there is a need to take morphine, then if it is taken simultaneously with dexketoprofen, the dose of morphine is reduced by 30-45%.

Contraindications

Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
Also, use is contraindicated for:

  • attacks of bronchial asthma;
  • gastric ulcer and 12 duodenal ulcer in the acute phase;
  • gastrointestinal, other bleeding, history of perforation;
  • Crohn’s disease, ulcerative colitis;
  • severe heart failure;
  • renal and / or hepatic failure of moderate and severe degree;
  • hemorrhagic diathesis, other blood clotting disorders;
  • use for the purpose of neuraxial administration (intrathecal or epidural).

Application during pregnancy and lactation

This drug is contraindicated for use starting from the 6th month of pregnancy, as well as when planning a pregnancy.
During treatment with this drug, breastfeeding should be discontinued.

Method of application and dosage

The recommended dose is 50 mg with an interval of 8–12 hours.

If necessary, a second dose should be administered after 6 hours.

The maximum daily dose should not exceed 150 mg.

The drug is intended for short-term use, so it should be used only during acute pain (no longer than 2 days).

Patients should be switched to oral analgesics if possible.

Adverse reactions can be reduced by using the lowest effective dose for the shortest possible time needed to improve the condition.

For postoperative pain of moderate or severe severity, the drug can be used according to indications in the same recommended doses in combination with opioid analgesics.

  • Intramuscular administration
    The contents of one ampoule (2 ml of injection solution) should be slowly injected deep into the muscles.
  • Intravenous infusion
    The contents of the ampoule (2 ml of solution for injection) should be diluted in 30–100 ml of 0.9% sodium chloride solution, glucose solution or Ringer’s lactate solution.
    The solution for infusions should be prepared in aseptic conditions, avoiding exposure to natural daylight. The prepared solution should be transparent.
    The infusion should be administered intravenously slowly over 10–30 minutes.
    Avoid exposing the prepared solution to natural daylight.
    The drug diluted in 100 ml of 0.9% sodium chloride solution or in glucose solution can be mixed with dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.
    The medicinal product cannot be mixed in the infusion solution with promethazine and pentazocine.
  • Intravenous injection (bolus administration)
    The contents of the ampoule (2 ml of solution for injection) should be administered intravenously slowly for at least 15 seconds.
    The drug can be mixed in small volumes (for example, in a syringe) with solutions for injections of heparin, lidocaine, morphine and theophylline.
    The drug should not be mixed in small volumes (for example, in a syringe) with solutions of dopamine, promethazine pentazocine, pethidine and hydroxyzine because a white precipitate is formed.
    The medicinal product can be mixed only with the medicinal products specified above.

For intramuscular or intravenous bolus use, the drug should be administered immediately after it has been drawn from the ampoule. The solution for intravenous infusion should be used immediately after its preparation.

When storing diluted solutions of the medicinal product in polyethylene bags or in products prepared for injection from ethyl vinyl acetate, cellulose propionate, low-density polyethylene, and polyvinyl chloride, changes in the content of the active substance due to sorption were not observed.

The medicine is intended for one-time use, so the rest of the finished solution should be disposed of.

Before administering the medicine, it is necessary to visually check that the solution is transparent and colorless. A solution containing solid particles cannot be used.

Children

The drug should not be used in children and adolescents (under 18 years of age) due to the lack of data on its effectiveness and safety.

Overdose

The dosage has not been fixed at this time.
In case of an overdose, such drugs usually cause disorders of the digestive system, in particular:

  • nausea;
  • vomiting;
  • anorexia;
  • abdominal pain.

A disorder of the nervous system may also occur in the form of:

  • drowsiness;
  • dizziness;
  • disorientation;
  • headache.

Treatment of symptoms and dialysis are recommended.

Side effects

Therapy with this drug can cause:

  • headache, nausea, vomiting;
  • phlebitis;
  • chills, asthenia, dermatitis, rash, urticaria, vertigo, dermatitis;
  • arterial hypotension, arterial hypertension, thrombophlebitis, hot flashes;
  • stomach ulcer, hepatitis, laryngeal edema, perforation;
  • acne (acne), nephritis.