Details
DICLAC Indications
The drug for intramuscular is intended for the treatment of:
• inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain, non-articular rheumatism;
• acute attacks of gout;
• renal and biliary colic;
• pain and swelling after injuries and operations;
• severe migraine attacks.
The drug when administered as an intravenous infusion is intended for the treatment or prevention of postoperative pain.
Dosage & Application
The general recommendation is individual dose determination. The drug should be used in the lowest effective doses for the shortest period of time, taking into account the objectives of treatment in each individual patient.
Adults
Do not use Diclac® solution for injection for more than 2 days. If necessary, treatment can be continued with Diclac® tablets.
Intramuscular injection.
The following rules should be followed to prevent damage to nerve or other tissues at the site of intramuscular injection, as such damage can lead to muscle weakness, muscle paralysis, hypostasis, and drug-induced skin embolism (Nicolau syndrome).
The daily dose is usually 75 mg (1 ampoule), which is injected by deep injection into the upper outer sector of the gluteus maximus. In severe cases (such as colic), the daily dose can be increased to 2 injections of 75 mg, with an interval of several hours (1 injection in each buttock). Alternatively, 75 mg of solution for injection can be combined with other Diclac® formulations (eg tablets) up to a maximum total daily dose of 150 mg diclofenac sodium.
In migraine attacks, clinical experience suggests that 75 mg of diclofenac sodium should be administered intramuscularly as soon as possible and, if necessary, 75 mg suppositories should be used on the same day. The total daily dose should not exceed 175 mg on the first day. There are no data available on the use of Diclax® for the treatment of migraine attacks for more than one day. If necessary, in the following days, treatment can be continued with suppositories up to a maximum daily dose of 150 mg (in divided doses).
Intravenous infusions.
Immediately before the start of the intravenous infusion, Diclac® should be diluted in 100-500 ml of 0.9% sodium chloride solution or 5% glucose solution. Both solutions should be buffered with sodium bicarbonate solution (0.5 ml of 8.4% solution or 1 ml of 4.2%). Only clear solutions can be used.
Diclac®, a solution for injection, should not be given as an intravenous bolus injection.
Recommended alternative dosing regimens for Diclac®, solution for injection:
- for the treatment of moderate and severe postoperative pain, 75 mg should be administered continuously from 30 minutes to 2 hours; if necessary, treatment can be repeated in a few hours, but the dose should not exceed 150 mg per day;
- to prevent postoperative pain after 15 minutes - 1 hour after surgery, you need to enter a loading dose of 25-50 mg, then you need to use a continuous infusion of approximately 5 mg / hour up to a maximum daily dose of 150 mg.
Special groups of patients
Elderly patients (over 65 years of age)
For elderly patients, no adjustment of the starting dose is usually required. However, caution is advised based on the condition of the patients, especially in debilitated elderly patients or people with low body weight (see section "Special precautions for use").
Pediatric population (aged 18 years).
Diclac® in the form of a solution for injection is contraindicated for use in children and adolescents.
Confirmed cardiovascular disease or serious cardiovascular risk factors
Treatment with Diclac® is generally not recommended for patients with cardiovascular disease or uncontrolled hypertension. If necessary, patients with cardiovascular disease, uncontrolled hypertension or significant risk factors for cardiovascular disease should be treated with Diclac® only after careful evaluation and only at doses up to 100 mg per day for more than 4 weeks (see section "Features"). application").
Renal failure
Diclac® is contraindicated in patients with renal insufficiency (GFR 2; see section "Contraindications").
No special studies have been performed in patients with renal impairment, so dose adjustment recommendations cannot be made. Diclac® should be used with caution in patients with impaired renal function (see section "Special warnings and precautions for use").
Hepatic failure
Diclac® is contraindicated in patients with hepatic insufficiency (see section "Contraindications").
No special studies have been performed in patients with hepatic impairment, so no dose adjustment is recommended. Diklak® should be used with caution in patients with mild to moderate hepatic impairment (see section 4.4).
Children.
Diclac in the form of a solution for injection is contraindicated in children.
Contradictions
· Hypersensitivity to the active substance or to any other components of the drug.
· Bleeding or perforation of the gastrointestinal tract in the anamnesis associated with previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs).
· Active form of peptic ulcer / bleeding or history of recurrent peptic ulcer / bleeding (two or more separate episodes of established ulcer or bleeding).
· Active form of gastric and / or duodenal ulcer, gastrointestinal bleeding or perforation.
· III trimester of pregnancy.
· Like other NSAIDs, diclofenac is also contraindicated in patients in whom ibuprofen, acetylsalicylic acid, or other NSAIDs provoke asthma attacks, bronchospasm, angioneurotic edema, urticaria, or acute rhinitis / nasal polyps, or symptoms, or symptoms,
· Inflammatory bowel disease (eg Crohn's disease or ulcerative colitis).
· Hepatic insufficiency (Child-Pugh class C), liver cirrhosis and ascites.
· Renal failure (glomerular filtration rate (GFR) 2).
· Congestive heart failure (NYHA II – IV).
· High risk of postoperative bleeding, non-coagulation, haemostasis, haematopoietic disorders or cerebrovascular haemorrhage.
· Treatment of postoperative pain during coronary artery bypass grafting (or use of an artificial circulation device).
· Ischemic heart disease in patients with angina, myocardial infarction.
· Cerebrovascular disease in patients who have suffered a stroke or have episodes of transient ischemic attacks.
· Diseases of peripheral arteries.
· In this dosage form the drug is contraindicated in children.
For intravenous use only.
· Concomitant use of NSAIDs or anticoagulants (including low doses of heparin).
· Presence of a history of hemorrhagic diathesis, confirmed or suspected history of cerebrovascular hemorrhage.
· Surgery with a high risk of bleeding.
· History of bronchial asthma.
· Moderate or severe renal impairment (serum creatinine> 160 μmol / l).
· Hypovolemia or dehydration for any reason.
