Contraindications for use
The use of the drug is contraindicated in the following cases:
- third trimester of pregnancy and lactation (see section 4.6)
- children and adolescents under 18 years of age
- hypersensitivity to meloxicam or to any of the excipients listed in section 6.1, or to a substance with a similar effect, for example, to drugs from the NSAID group (non-steroidal anti-inflammatory drugs), acetylsalicylic acid. Meloxicam should not be used in patients with asthma symptoms, nasal polyps, angioedema and urticaria associated with the administration of acetylsalicylic acid or other NSAIDs.
- history of gastrointestinal bleeding or gastrointestinal perforation that has been associated with NSAID use
- active gastric and/or duodenal ulcer or history of recurrent ulcers and bleeding (two or more cases of confirmed ulceration or bleeding)
- severe liver dysfunction
- severe renal impairment in patients not on hemodialysis
- history of gastrointestinal bleeding and cerebral hemorrhage or other bleeding conditions
- hemostasis disorders or simultaneous use of anticoagulants (contraindications related to the method of drug administration)
- severe heart failure
- perioperative treatment of pain during vascular bypass surgery (by-pass surgery).
Instructions for use MELOXIPOL
Before starting to use Meloxipol, you must make sure that the patient does not currently have an exacerbation of esophagitis, gastritis or gastric ulcer.
The drug is prescribed with caution to patients with a history of gastrointestinal diseases, as this may worsen the condition. Medical supervision should be established to check for the appearance of symptoms of relapse of gastrointestinal diseases in such patients, especially signs of bleeding from the gastrointestinal tract.
If peptic ulcers or gastrointestinal bleeding occur, Meloxipol should be discontinued.
The risk of gastrointestinal bleeding, ulceration and perforation increases with increasing dose of NSAIDs in patients with a history of ulcers, especially those complicated by bleeding or perforation, as well as in elderly patients. In these patients, therapy should be started with the lowest possible doses. In this group of patients and in patients who require concomitant therapy with low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal bleeding, combination therapy with drugs that have a protective effect on the gastric mucosa (such as misoprostol) should also be considered. or proton pump inhibitors).
Caution should be exercised in patients receiving concomitant therapy with drugs that can increase the risk of ulceration or bleeding (corticosteroids, anticoagulants, selective serotonin reuptake inhibitors and antiplatelet agents).
There are extremely rare reports of serious skin reactions associated with NSAID therapy, some of which have been fatal. The maximum risk of developing these reactions in patients is observed at the initial stage of treatment; in most cases, these reactions developed in the first month of therapy. When the first signs of skin rash, damage to the mucous membranes or any other signs of hypersensitivity appear, treatment with Meloxipol must be interrupted.
In rare cases, NSAIDs may cause interstitial nephritis, glomerulonephritis, renal medulla necrosis, or nephrotic syndrome.
In rare cases, increased levels of serum transaminases or changes in other indicators of liver function have been reported. In most cases, deviations from the norm were minor and transient. If the disturbances in liver function indicators are more pronounced or permanent, you should stop taking Meloxipol and carry out control laboratory tests.
NSAIDs may promote sodium, potassium and water retention and reduce the natriuretic effect of diuretics. As a result, in the presence of predisposing factors, the administration of NSAIDs can lead to the progression of heart failure and hypertension.
NSAIDs inhibit the synthesis of renal prostaglandins, which are involved in maintaining sufficient levels of renal blood flow. Therefore, there is a risk of developing renal decompensation when prescribing NSAIDs to patients with reduced renal blood flow or volume (as a rule, renal function is restored after discontinuation of therapy). However, this fact should be taken into account when prescribing Meloxipol to patients with dehydration, congestive heart failure, liver cirrhosis, nephrotic syndrome, severe kidney disease, as well as patients taking diuretics who have undergone surgery leading to hypovolemia. In such patients, diuresis and renal function should be monitored from the very beginning of treatment.
Weakened and debilitated patients, as well as elderly patients, may tolerate side effects worse; such patients require careful monitoring. Meloxipol should be used with caution in elderly patients, who are more likely to have impaired renal, hepatic or cardiac function.
In case of insufficient therapeutic effect, the recommended maximum daily dose should not be exceeded, nor should another NSAID, including selective COX-2 inhibitors, be added to treatment. Adverse events can be minimized by using the minimum effective dose for the minimum period necessary to control the corresponding symptoms.
Use in pediatrics
Safety and effectiveness of Meloxipol in children under 15 years of age
have not been determined.
Impact on the ability to drive vehicles and operate machinery
No special studies have been conducted. However, in the event of impaired visual acuity, drowsiness, dizziness or other disorders of the central nervous system, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Side effects
System-organ classes | Frequency of occurrence |
| Blood and lymphatic system disorders | |
| Anemia | Infrequently |
| Blood morphology disorders (including leukocyte formula): leukopenia, thrombocytopenia | Rarely |
| Cases of agranulocytosis have been very rarely reported (see part c). | |
| Immune system disorders | |
| Allergic reactions other than anaphylactic or anaphylactoid | Infrequently |
| Anaphylactic shock, anaphylactic reactions, anaphylactoid reactions | Unknown |
| Mental disorders | |
| Mood disorders, nightmares | Rarely |
| Confusion, disorientation | Unknown |
| Nervous system disorders | |
| Headache | Often |
| Dizziness, drowsiness | Infrequently |
| Visual disorders | |
| Visual impairment, including decreased visual acuity, conjunctivitis | Rarely |
| Hearing and labyrinth disorders | |
| Dizziness of labyrinthine origin | Infrequently |
| Noise in ears | Rarely |
| Heart disorders | |
| Cardiopalmus | Rarely |
| *Heart failure has been reported with the use of NSAIDs. | |
| Vascular disorders | |
| Increased blood pressure (see section 4.4), sudden facial flushing | Infrequently |
| Respiratory, thoracic and mediastinal disorders | |
| Development of asthma attacks with hypersensitivity to aspirin or another NSAID drug | Rarely |
| Gastrointestinal disorders | |
| Gastrointestinal disorders such as dyspepsia, nausea and vomiting, abdominal pain, diarrhea, flatulence, constipation | Often |
| Gastrointestinal bleeding (including hidden), gastritis, inflammation of the oral mucosa, gastroesophageal reflux | Infrequently |
| Colitis, gastric and/or duodenal ulcers, esophagitis | Rarely |
| Perforation of the gastrointestinal tract | Very rarely |
| Pancreatitis | Unknown |
| *Gastrointestinal bleeding, ulceration or perforation can sometimes be severe and fatal, especially in older patients (see section 4.4). | |
| Disorders of the liver and biliary tract | |
| Liver dysfunction (eg, increased transaminase activity or bilirubin concentrations) | Infrequently |
| Hepatitis | Very rarely |
| Skin and subcutaneous tissue disorders | |
| Angioedema, itching, rash | Infrequently |
| Stevens–Johnson syndrome, toxic epidermal necrolysis, urticaria | Rarely |
| Bullous reactions, erythema multiforme | Very rarely |
| Photophobia | Unknown |
| Renal and urinary tract disorders | |
| Sodium and water retention in the body, hyperkalemia (see sections 4.4. and 4.5), renal dysfunction (increased serum creatinine and/or urea concentrations) | Infrequently |
| Acute renal failure, especially in patients with risk factors (see section 4.4) | Very rarely |
| Disorders of the reproductive system and mammary glands | |
| Female infertility, delayed ovulation | Unknown |
| General and administration site disorders | |
| Lump at the injection site, pain at the injection site | Often |
| Edema, including of the lower extremities | Infrequently |
Mode of application
Doses
Single administration of 15 mg per day.
MAXIMUM RECOMMENDED DAILY DOSE – 15 mg.
Treatment should be limited to a single dose of the drug; in exceptional cases, the course of treatment can be extended to 2-3 days (for example, when the drug cannot be administered orally or rectally). Adverse reactions can be minimized by using the lowest effective dose for the shortest period necessary to relieve symptoms (see section 4.4).
It is necessary to periodically monitor the patient's response to treatment and determine the degree of demand for symptomatic therapy.
Elderly patients and patients at increased risk of adverse reactions
The recommended daily dose for elderly patients is 7.5 mg. In patients at increased risk of adverse reactions, treatment should be started with a dose of 7.5 mg per day (½ 1.5 ml ampoule) (see section 4.4).
Patients with impaired renal function
In patients with severe renal impairment undergoing hemodialysis, the daily dose of the drug should not exceed 7.5 mg (½ 1.5 ml ampoule).
In patients with mild or moderate renal impairment and creatinine clearance above 25 ml/min, no dose adjustment is required.
Use in patients with severe renal impairment not on hemodialysis is contraindicated (see section 4.3).
Patients with liver dysfunction
In patients with mild or moderate liver dysfunction, no dose adjustment is required.
Use in patients with severe hepatic impairment is contraindicated (see section 4.3).
Children and teenagers:
Meloxipol 15 mg/1.5 ml injection solution is contraindicated for use in children and adolescents under 18 years of age (see section 4.3).
Intramuscularly.
The drug is administered slowly through a deep intramuscular injection into the upper outer quadrant of the buttock under strict aseptic conditions. If it is necessary to re-administer the drug, it is recommended to perform an injection into the second buttock. Before administering the drug, you need to make sure that the needle does not enter a blood vessel.
If severe pain occurs during injection, administration of the drug should be stopped immediately.
In patients with a hip joint endoprosthesis, the drug must be administered in the opposite direction.
To continue treatment, you should use the oral route (tablets).
Instructions for use of Meloxicam tablets and suppositories
Tablets are taken once a day in an amount of 7.5-15 mg with meals. This dosage is intended for adults and adolescents. In this case, the tablets can only be used for the first few days, after which it is possible to replace them with another drug.
If the patient is on hemodialysis and has severe kidney pathologies, he can use no more than 7.5 mg per day. However, daily and single dosages of other drugs in the same series (for example, Meloxicam Prana) may differ. The norm depends on the person’s age, condition, concomitant diseases and other factors.
Suppositories are administered rectally once a day - regardless of the time of day or meal. One suppository corresponds to a daily dosage of 15 mg.
Attention!
In case of overdose, the side effects described above may occur. Immediate gastric lavage is indicated; treatment is symptomatic. A specific antidote for Meloxicam has not been developed.
