Elox SOLOPHARM, 10 mg/ml 1.5 ml 3 pcs.

Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAIDs)

ATC code: M01AC06

Pharmacodynamics:

Indications

Active ingredient

Composition

How to take, the dosage

The drug is given by deep intramuscular injection.

The drug should not be given intravenously.

Osteoarthritis with pain syndrome: 75 mg per day. If necessary, this dose can be increased to 15 mg per day.

Rheumatoid arthritis: 15 mg per day. Depending on the therapeutic effect, this dose can be reduced to 75 mg per day.

Ankylosing spondylitis: 15 mg daily.

Depending on the therapeutic effect, this dose may be reduced to 75 mg per day.

In patients with an increased risk of adverse reactions (history of gastrointestinal disease, presence of cardiovascular risk factors), it is recommended to start treatment with a dose of 75 mg daily.

In patients with significant renal impairment who are on hemodialysis, the dose should not exceed 75 mg per day.

General recommendations

Because the potential risk of adverse reactions depends on the dose and duration of treatment, the lowest possible dose and duration of use should be used.

The maximum recommended daily dose is 15 mg.

Combined use

The drug should not be used concomitantly with other NSAIDs.

The total daily dose of the drug used in different dosage forms should not exceed 15 mg. Intramuscular administration of the drug is indicated only during the first few days of therapy. Thereafter, treatment is continued with oral dosage forms. The recommended dose is 75 mg or 15 mg once a day, depending on the intensity of pain and the severity of the inflammatory process.

With regard to possible incompatibilities, the drug should not be mixed in the same syringe with other medications.

The procedure for the polymer ampoule:

1. Take the ampoule and shake it by holding the neck.

2. squeeze the ampoule with your hand so that the product does not seep out and twist the valve and remove it.

3. immediately connect the syringe to the ampoule through the resulting opening.

4. Turn the ampoule over and slowly draw the contents into the syringe.

5. Slide the needle onto the syringe.

Interaction

– Other prostaglandin synthesis inhibitors including glucocorticoids and salicylates – concomitant use with meloxicam increases the risk of gastrointestinal ulcers and gastrointestinal bleeding (due to synergistic action). Simultaneous use with other NSAIDs is not recommended.

– Anticoagulants for oral heparin for systemic thrombolytic agents – concomitant use with meloxicam increases the risk of bleeding. In case of concomitant use, close monitoring of the clotting system is necessary.

– Antiplatelet drugs serotonin reuptake inhibitors – concomitant use with meloxicam increases the risk of bleeding due to inhibition of platelet function. In case of concomitant use, close monitoring of the clotting system is required.

Lithium drugs – NSAIDs increase plasma levels of lithium by reducing its excretion by the kidneys. Concomitant use of meloxicam with lithium drugs is not recommended. If concomitant use is necessary, it is recommended to carefully monitor the concentration of lithium in plasma throughout the course of the use of lithium drugs.

Methotrexate – NSAIDs decrease renal secretion of methotrexate, thus increasing its plasma concentrations. Concomitant use of meloxicam and methotrexate (in dose more than 15 mg per week) is not recommended. In case of concomitant use, careful monitoring of renal function and blood counts is required. Meloxicam may increase hematological toxicity of methotrexate especially in patients with impaired renal function.

– Contraception – There is evidence that NSAIDs may reduce the effectiveness of intrauterine contraceptive devices but this has not been proven.

Diuretics – The use of NSAIDs in patients who are dehydrated is accompanied by a risk of acute renal failure.

– Antihypertensives (beta-adrenoblockers angiotensin-converting enzyme inhibitors vasodilators diuretics). NSAIDs reduce the effect of antihypertensive drugs due to inhibition of prostaglandins with vasodilatory properties.

Angiotensin II receptor antagonists as well as angiotensin converting enzyme inhibitors when combined with NSAIDs increase decrease glomerular filtration and thus may lead to acute renal failure, particularly in patients with impaired renal function.

– Colestiramine binding meloxicam in the gastrointestinal tract leads to its faster excretion.

– Pemetrexed – when concomitant use of meloxicam and pemetrexed in patients with creatinine clearance of 45 to 79 ml/min, meloxicam should be discontinued 5 days before starting pemetrexed and possibly resumed 2 days after completion of administration. If there is a need for co-administration of meloxicam and pemetrexed such patients should be closely monitored especially with regard to myelosuppression and the occurrence of gastrointestinal side effects. In patients with creatinine clearance less than 45 mL/min, meloxicam should not be used with pemetrexed.

NSAIDs acting on renal prostaglandins may increase nephrotoxicity of cyclosporine.

When using with meloxicam the medicinal products with known ability to inhibit CYP2C9 and/or CYP3A4 (or metabolized with the participation of these enzymes) such as sulphonylurea derivatives or probenecid should be taken into account the possibility of pharmacokinetic interaction.

In co-administration with oral antidiabetic agents (e.g. sulfonylurea derivatives nateglinide) there may be CYP2C9-mediated interactions that can lead to increased blood concentrations of both these drugs and meloxicam.

Patients taking meloxicam concomitantly with sulfonylurea or nateglinide should carefully monitor blood sugar levels because of the possibility of hypoglycemia.

No significant pharmacokinetic interactions have been found with cimetidine digoxin and furosemide concomitantly.

Special Instructions

Patients suffering from gastrointestinal diseases should be monitored regularly. If gastrointestinal ulceration or gastrointestinal bleeding occurs, the drug should be discontinued.

Gastrointestinal perforations or bleeding may occur during use of NSAIDs at any time, with or without a history of alarming symptoms or serious gastrointestinal complications. The consequences of these complications are generally more serious in older adults.

Serious skin reactions such as exfoliative dermatitis Stevens-Johnson syndrome toxic epidermal necrolysis may develop when using the drug. Therefore, special attention should be paid to patients who report the development of adverse reactions of the skin and mucous membranes and hypersensitivity to the drug, especially if such reactions have been observed during the previous course of treatment. The development of such reactions is usually observed during the first month of treatment. In case of the first signs of skin rash, mucous membrane changes or other signs of hypersensitivity the discontinuation of the drug should be considered.

There have been described cases of increased risk of serious cardiovascular thrombosis myocardial infarction with possible fatal angina attacks when taking NSAIDs. This risk increases with long-term use of the drug, as well as in patients with a history of the above diseases and predisposition to such diseases.

NSAIDs inhibit the renal synthesis of prostaglandins that are involved in maintaining renal perfusion. Use of NSAIDs in patients with reduced renal blood flow or reduced circulating blood volume can lead to decompensation of latent renal failure. After discontinuation of NSAIDs, renal function usually recovers to baseline levels. Elderly patients with dehydration, congestive heart failure, cirrhosis, nephrotic syndrome or acute renal dysfunction, patients taking diuretics concomitantly, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists and patients undergoing serious surgical interventions leading to hypovolemia are at highest risk for this reaction. In such patients, diuresis and renal function should be carefully monitored at the beginning of therapy. The use of NSAIDs in conjunction with diuretics may lead to retention of potassium sodium and water, as well as to a decrease in the natriuretic effect of diuretics. As a result, in predisposed patients there may be increased signs of heart failure or hypertension. Therefore, close monitoring of such patients is necessary and they should be kept adequately hydrated. Prior to initiation of treatment renal function investigation is necessary.

In case of combined therapy, renal function should also be monitored.

When using meloxicam (as well as most other NSAIDs) there may be occasional increases in serum transaminase activity or other indicators of liver function. In most cases, this increase was small and transient. If the changes detected are significant or do not decrease with time, the drug should be discontinued and the laboratory changes detected should be monitored.

Patients who are frail or debilitated may have a poorer tolerance to adverse events, so these patients should be monitored closely.

Like other NSAIDs, meloxicam may mask the symptoms of an underlying infectious disease.

The use of meloxicam as well as other drugs inhibiting the synthesis of cyclooxygenase/prostaglandin may affect fertility so it is not recommended for women who have difficulty conceiving.

In patients with mild to moderate renal insufficiency (creatinine clearance greater than 25 ml/min), dosage adjustment is not required.

In patients with cirrhosis (compensated) no dose adjustment is required.

We should be careful during treatment because of possible cardiovascular and nervous system side effects when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and quick psychomotor reactions.

Synopsis

Contraindications

– Hypersensitivity to the active ingredient and excipients of the drug to acetylsalicylic acid or other NSAIDs.

– Complete or incomplete combination of bronchial asthma recurrent polyposis of the nose and sinuses angioedema or urticaria caused by intolerance to acetylsalicylic acid or other NSAIDs due to the existing possibility of cross-sensitivity (including a history).

– Erosive ulcerative lesions of the stomach and duodenum in the acute stage or recently suffered.

– Inflammatory bowel disease – Crohn’s disease or ulcerative colitis in the acute stage.

– Severe liver and heart failure.

– Severe renal failure (unless hemodialysis creatinine clearance less than 30 ml/min) progressive renal disease including confirmed hyperkalemia.

– Active liver disease.

– Active gastrointestinal bleeding recent cerebrovascular bleeding or established diagnosis of blood clotting disorders.

– Age under 18 years of age.

– Therapy of perioperative pain during coronary artery bypass grafting.

– Concomitant therapy with anticoagulants because of the risk of intramuscular hematomas.

– Pregnancy.

– Breast-feeding period.

– Diseases of the gastrointestinal tract (GIT) in the history (presence of Helicobacterpylori infection).

– Congestive heart failure.

– Renal insufficiency (creatinine clearance 30-60 ml/min).

– Coronary heart disease.

– Cerebrovascular disease.

– Dyslipidemia/hyperlipidemia.

– Diabetes mellitus.

– Concomitant therapy with the following drugs: anticoagulants oral glucocorticosteroids antiaggregants selective serotonin reuptake inhibitors.

– Peripheral arterial disease.

– Older age.

– Prolonged use of NSAIDs.

– Smoking.

– Frequent use of alcohol.

Side effects

The following are side effects that have been considered possible with the use of this drug. Side effects reported in post-marketing use that were considered to have a possible association with the use of the drug are marked*.

Within the systemic organ classes by frequency of side effects the following categories are used: very common (≥ 1/10) common (≥ 1/100 < 1/10) infrequent (≥ 1/1000 < 1/100) rare (≥ 1/10000 < 1/1000) very rare (< 1/10000) not identified.

Blood and lymphatic system disorders

Infrequent – anemia;

rare – leukopenia thrombocytopenia changes in blood cell count including changes in the leukocytic formula.

Immune system disorders

Infrequent – other immediate-type hypersensitivity reactions*;

not established – anaphylactic shock* anaphylactoid reactions*.

Mental disorders

Rarely – change in mood*;

not established – confusion* disorientation*.

Nervous system disorders

Often – headache;

infrequently – dizziness drowsiness.

Hearing and labyrinth disorders visual disorders

Infrequent – vertigo;

rarely – conjunctivitis* visual disturbances including blurred vision* tinnitus.

Cardiovascular disorders

Infrequent – increased blood pressure feeling of “rush” of blood to the face;

Rarely – feeling of palpitations.

Respiratory system disorders

Rarely – bronchial asthma in patients allergic to acetylsalicylic acid and other NSAIDs.

Gastrointestinal disorders

Often – abdominal pain dyspepsia diarrhea nausea vomiting;

Infrequent – hidden and overt gastrointestinal bleeding gastritis* stomatitis constipation abdominal bloating belching;

rarely – gastroduodenal ulcers colitis esophagitis;

very rare – gastrointestinal perforation.

Hepatic and biliary tract disorders

Infrequent – transient changes in liver function parameters (such as increased transaminases or bilirubin activity);

very rare – hepatitis*.

Skin and subcutaneous tissue disorders

Infrequent – angioedema* itching skin rash;

rarely – toxic epidermal necrolysis* Stevens-Johnson syndrome* urticaria;

very rarely – bullous dermatitis* erythema multiforme*;

not established – photosensitization.

Renal and urinary tract disorders

Infrequent – changes in renal function parameters (increased serum creatinine and/or urea levels) urinary disorders including acute urinary retention*;

very rare – acute renal failure*.

Gender and mammary gland disorders

Infrequent – late ovulation*;

not established – infertility in women*.

General disorders and disorders at the site of administration

Often – pain and swelling at the site of administration;

infrequently – edema.

The concomitant use with medications that suppress bone marrow (e.g., methotrexate) may provoke cytopenia.

Gastrointestinal bleeding ulcers or perforations can be fatal.

As with other NSAIDs, do not rule out the possibility of interstitial nephritis glomerulonephritis renal medullary necrosis nephrotic syndrome.

Overdose

Symptoms: nausea vomiting epigastric pain gastrointestinal bleeding acute renal failure liver failure respiratory arrest asystole lethargy sleepiness increased blood pressure coma seizures cardiovascular collapse cardiac arrest anaphylactoid reactions.

Treatment: there is no specific antidote. In case of drug overdose, symptomatic therapy should be carried out. Forced diuresis urine alkalinization hemodialysis is ineffective due to high binding of the drug to blood proteins.

Pregnancy use

The drug is contraindicated in pregnancy.

If it is necessary to prescribe the drug during breastfeeding, breastfeeding should be stopped.

The use of meloxicam is not recommended in women planning to become pregnant and in women participating in infertility or fertility studies. The safety of use during pregnancy of this drug has not been proven. The effect of delayed prostaglandin synthesis on embryogenesis during the first two trimesters of pregnancy is not clear. In the last trimester of pregnancy the mechanism of action of meloxicam is characterized by inhibition of labor activity by premature closure of Ductus arteriosus Botalli in fetus and increased susceptibility to bleeding in mother and child and increased risk of edema in mother.

Meloxicam penetrates maternal milk in small amounts and in the case of breastfeeding, meloxicam can be detected in the infant’s plasma.

As a drug which inhibits the synthesis of cyclooxygenase/prostaglandin meloxicam can affect fertility and therefore is not recommended for women with difficulties in conception. For this reason it is recommended to cancel the drug in women undergoing examination for this reason.

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