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

Description

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

Composition

active substance: dexketoprofen;

1 ampoule (2 ml) of solution contains dexketoprofen (in the form of dexketoprofen trometamol) 50 mg;

1 ml of solution for injection contains dexketoprofen (in the form of dexketoprofen trometamol) 25 mg;

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

Medicinal form

Solution for injection.

Main physical and chemical 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 analgesic, anti-inflammatory and antipyretic properties.
The effect 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 Sertofen solution 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.
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 in:

• attacks of bronchial asthma;
• stomach 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 Sertofen solution 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 administration and dosage

Sertofen solution is intended for intramuscular or intravenous administration (bolus or infusion, as decided by the doctor).
The dose is selected by the attending physician, based on the individual characteristics of the body and the course of the disease of each patient.
Average dosage: – 50 mg, every 8-12 hours. If necessary, after 6 hours.
A maximum of 150 mg of dexketoprofen can be administered per day.
This drug is not intended for systemic use, it can be administered for no more than 2 days in a row, in case of acute pain. If possible, the transfer to the oral form should be carried out as early as possible. Simultaneous administration with opioid analgesics is acceptable (at the same recommended average dosage as monotherapy).
No dose adjustment is required in elderly patients. In case of impaired renal or liver function, the dose is reduced to 50 mg per day.
Intramuscular injection is performed deep into the gluteus muscle.
Intravenous bolus injection – 2 ml of solution is injected over a minimum of 15 seconds.
Intravenous drip – administered over 10-30 minutes. To prepare an infusion solution, sodium chloride solution, glucose, Ringer’s lactate solution are used. It can be mixed with dopamine, heparin, lidocaine, morphine, pethidine and theophylline.
Do not mix with promethazine or pentazocine.

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, dialysis is 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.