LAURO [Lornoxicam] 8 mg Lyophilized powder for solution
instructions for the medical use of
the medicinal product
LAURO
Tradename:
Lauro, Лауро
International non-proprietary name
or generic name:
Lornoxicam, Лорноксикам
Composition
1 vial contains:
active
substance: lornoxicam 8
mg;
excipients: mannitol, tromethamine, disodium
edetate, water for injection.
Dosage form:
Lyophilized powder for
solution preparation.
Pharmacotherapeutic
group:
Nonsteroidal anti-inflammatory drugs
(NSAIDs).
Code АТХ: М01АС05
Pharmacological
properties
Pharmacodynamics
Lornoxicam
belongs to the oxicam class. It has pronounced analgesic and anti-inflammatory
effects. Its mechanism of action is based on the suppression of prostaglandin
synthesis (inhibition of the COX enzyme), leading to the suppression of
inflammation.
Lornoxicam
does not affect vital signs: body temperature, respiratory rate, heart rate,
blood pressure, ECG data, or spirometry.
The
analgesic effect of lornoxicam is not associated with a narcotic effect.
Lornoxicam does not have an opiate-like effect on the central nervous system
and, unlike narcotic analgesics, does not depress respiration or cause drug
dependence.
Due to
local gastrointestinal irritation and systemic ulcerogenic effects associated
with the suppression of prostaglandin synthesis, gastrointestinal disturbances
are common adverse effects of NSAID therapy.
Pharmacokinetics
Following
intramuscular administration, peak plasma concentrations of lornoxicam are
reached in approximately 0.4 hours. Absolute bioavailability (calculated based
on the area under the concentration-time curve) after intramuscular
administration is 97%. The half-life averages 3-4 hours. Lornoxicam is present
in plasma unchanged and as a hydroxylated metabolite that lacks pharmacological
activity. Plasma protein binding is 99% and is concentration-independent.
Lornoxicam is completely metabolized, with approximately 1/3 of the metabolites
excreted via the kidneys and 2/3 via the liver. No significant changes in
lornoxicam pharmacokinetics were observed in the elderly or in patients with
impaired liver or kidney function.
Indications for use
Short-term symptomatic treatment of
mild to moderate acute pain syndrome: rheumatoid arthritis, osteoarthritis,
ankylosing spondylitis, articular syndrome during exacerbation of gout,
bursitis, tendovaginitis, arthralgia, myalgia, neuralgia, lumbago, sciatica,
migraine, toothache and headache, algomenorrhea, pain in injuries and burns,
fever syndrome in colds and infectious diseases.
Contraindications
-
Hypersensitivity to lornoxicam or any of the components of the drug;
- Complete
or partial combination of bronchial asthma, recurrent nasal polyposis or
paranasal sinus polyposis, and intolerance to acetylsalicylic acid and other
NSAIDs (including history);
-
Thrombocytopenia;
-
Hemorrhagic diathesis or bleeding disorders, as well as those who have undergone
surgeries associated with the risk of bleeding or incomplete hemostasis;
-
Post-coronary artery bypass grafting;
- Erosive
and ulcerative changes in the gastric or duodenal mucosa, active
gastrointestinal bleeding; cerebrovascular or other bleeding;
- Recurrent
gastric ulcer or repeated gastrointestinal bleeding;
- History
of previous gastrointestinal bleeding associated with NSAID use;
-
Inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute
phase;
-
Decompensated heart failure;
- Liver
failure or active liver disease;
- Severe
renal impairment (serum creatinine level greater than 300 μmol/L, progressive
kidney disease, confirmed hyperkalemia,
hypovolemia,
or dehydration);
-
Pregnancy, breastfeeding;
- Children
and adolescents under 18 years of age.
Method of
administration and dosage
IM, IV.
The solution for IM and IV administration is
prepared immediately before administration by dissolving the contents of one
vial (8 mg lornoxicam) in 2 ml of water for injection.
The duration of IV administration should be at
least 15 seconds, and IM administration should be at least 5 seconds.
Lauro lyophilisate for the preparation of IM and
IV solution is used only for the relief of acute pain when oral administration
is not possible.
The recommended single dose is 8 mg. The daily
dose should not exceed 16 mg. Some patients may require an additional 8 mg dose
within the first 24 hours.
The lowest effective dose should be used for the
shortest possible course.
For all patients, the dose and administration
regimen should be based on the individual response to treatment. The risk of
adverse events can be significantly reduced by using the lowest effective dose
for the shortest duration necessary to relieve symptoms. Patients with impaired
renal and hepatic function may require dosage adjustment.
Special instructions and precautions
Before using this medication,
consult a doctor.
Use with caution in patients with
erosive and ulcerative lesions, gastrointestinal bleeding (history), moderate
renal insufficiency, post-surgical conditions, in elderly patients (over 65
years of age), and in patients weighing less than 50 kg.
Lauro should only be used after a
careful assessment of the expected benefit and potential risk in the following
cases: mild renal impairment (serum creatinine level 150-300 μmol/L); heart failure and other conditions associated with decreased
circulating blood volume and renal blood flow; liver dysfunction; arterial
hypertension and conditions associated with fluid retention and edema; patients
who have undergone major surgery.
In patients with renal impairment,
regular monitoring of renal function is necessary during treatment. Elderly
patients, as well as those with arterial hypertension, require blood pressure
monitoring while using the drug.
For peptic ulcers and duodenal
ulcers, therapy should be administered concomitantly with histamine H2 receptor
antagonists or omeprazole.
With long-term use, peripheral blood
counts, as well as liver and renal function tests, should be periodically
monitored.
Effect on the ability to drive and
operate machinery
Since lornoxicam reduces psychomotor
speed, particular caution should be exercised when driving or engaging in other
potentially hazardous activities during treatment.
Interaction
with other medicinal products
Concomitant use of lornoxicam
and:
- cimetidine - increases
plasma concentrations of lornoxicam. No interactions with ranitidine or
antacids have been identified;
- Anticoagulants or platelet
aggregation inhibitors - may increase bleeding time (increased risk of
bleeding, international normalized ratio (INR) monitoring is necessary);
- Phenprocoumon - decrease in
the effect of phenprocoumon treatment;
- Concomitant use of NSAIDs
and heparin in combination with spinal/epidural anesthesia increases the risk
of spinal or epidural hematomas.
- Beta-blockers and
angiotensin-converting enzyme inhibitors may reduce their hypotensive effect;
- Diuretics - reduces the
diuretic effect and hypotensive effect;
- Digoxin - decreases renal
clearance of digoxin.
- Quinolone antibiotics -
increases the risk of developing convulsions;
- Other NSAIDs or
glucocorticoids - increases the risk of gastrointestinal bleeding;
- Methotrexate - increases
the concentration of methotrexate in serum;
- Selective Selective
serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine,
sertraline) increase the risk of gastrointestinal bleeding.
- lithium salts: may increase
peak plasma lithium concentrations and thereby enhance the known side effects
of lithium;
- cyclosporine: increases the
nephrotoxicity of cyclosporine.
- sulfonylurea derivatives:
may enhance the hypoglycemic effect of sulfonylureas;
- alcohol, corticotropin, and
potassium supplements increase the risk of gastrointestinal side effects;
- cefamandole, cefoperazone,
cefotetan, and valproic acid increase the risk of bleeding.
- tacrolimus: increases the
risk of nephrotoxicity.
Side
effect
Gastrointestinal: abdominal pain, diarrhea, dyspepsia, nausea, vomiting,
heartburn, flatulence, dry mouth, gastritis, esophagitis, erosive and
ulcerative lesions of the gastric and intestinal mucosa, gastrointestinal
bleeding (including rectal), and liver dysfunction.
Central nervous system: dizziness, headache, drowsiness, agitation, sleep
disturbances, depression, tremor, aseptic meningitis.
Hematopoietic system: leukopenia, thrombocytopenia, agranulocytosis.
Hematopoietic system: with prolonged use in high doses - bleeding
(gastrointestinal, gingival, uterine, nasal, rectal, hemorrhoidal), anemia.
Metabolic: increased sweating, chills, weight change.
Cardiovascular: hypertension, tachycardia, development or worsening of
heart failure.
Urinary: dysuria,
decreased glomerular filtration rate, interstitial nephritis,
glomerulonephritis, papillary necrosis, nephrotic syndrome, peripheral edema,
acute renal failure.
Allergic reactions: skin rash, itching, urticaria, angioedema,
bronchospasm.
Other: edema,
tinnitus, weight change.
If any of the side effects listed in the instructions
worsen, or you notice any other side effects not listed in the instructions,
please inform your doctor.
Overdose
There are currently no data on overdose that
would allow us to assess its consequences or recommend specific treatment.
Symptoms: In case of overdose with Lauro, nausea and
vomiting, cerebral symptoms (dizziness, visual disturbances, ataxia progressing
to coma, and seizures) may occur. Changes in liver and kidney function, and
blood clotting disorders are possible.
Treatment: In case of overdose or suspected overdose,
discontinue therapy immediately. Due to the half-life of lornoxicam, which is
approximately 4 hours, it is rapidly eliminated from the body. Dialysis is
ineffective. A specific antidote is currently unknown. Standard emergency
measures and symptomatic treatment should be administered.
Storage conditions
Store in a dry place at temperatures not exceeding 25°C.
Keep out of reach of children.
Shelf life
3 years. Do not use after the expiration date printed
on the package.
Vacation conditions
By prescription.
Release form
A tubular glass bottle sealed with a bromobutyl stopper and aluminum combination cap. One bottle and instructions for use are packaged in a cardboard box.