Mialdex solution for injections 25 mg/ml. ampoules 2 ml. №5

Description

Mialdex composition
active substance: dexketoprofen trometamol;
1 ml solution for injection contains 25 mg dexketoprofen (as dexketoprofen trometamol);
Excipients: 96% ethanol, sodium chloride, sodium hydroxide and / or hydrochloric acid, water for injections.

Dosage form
Solution for injection.

Pharmacological properties
Mialdex 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 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
Mialdex is a non-steroidal anti-inflammatory drug used for the symptomatic treatment of moderate to severe pain 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;
• ulcers of the stomach and duodenal ulcer in the acute phase;
• gastrointestinal, other bleeding, history of perforation;
• Crohn’s disease, ulcerative colitis;
• severe heart failure;
• renal and / or hepatic insufficiency 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 administration and dosage
Mialdex is intended for intramuscular or intravenous administration (bolus or infusion, as determined by a physician).
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 (in the same recommended average dosage as monotherapy) is acceptable.
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 the 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 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.

Storage conditions and periods
Shelf life is 3 years. Store in a dry place out of direct sunlight.
The finished solution retains its properties during the day at a storage temperature of 2 to 8 ° C.