B-ksikam
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
B-xicam is a non-steroidal anti-inflammatory drug (NSAID). It has anti-inflammatory, analgesic and antipyretic effects.
Release form and composition
Dosage forms:
- tablets: flat-cylindrical, light yellow (10 pcs. in a blister strip: 7.5 mg - in a cardboard box, 2 packs; 15 mg - in a cardboard box, 1 pack; 20 pcs. in a polymer can, in cardboard box 1 can);
- solution for intramuscular (intramuscular) injection: clear yellow liquid with a green tint [1.5 ml in glass ampoules without color (with or without a break point): in a cardboard box 3 or 5 pieces; in a contour acheikova packing 3 or 5 pieces, in a cardboard box complete with an ampoule knife or without it 1 pack of 3 or 5 pieces or 2 packages of 5 pieces].
1 tablet contains:
- active substance: meloxicam (in terms of 100% substance) - 7.5 mg or 15 mg;
- auxiliary components: lactopress (anhydrous lactose), sodium citrate dihydrate, microcrystalline cellulose, colloidal silicon dioxide (aerosil), povidone (polyvinylpyrrolidone 25,000, kollidone), magnesium stearate, crospovidone (polyplasdone IKS EL-10).
1 ampoule contains:
- active substance: meloxicam - 15 mg;
- auxiliary components: glycofurol, glycine, meglumin (N-methylglucamine), sodium chloride, pluronic F-68 (poloxamer 188), sodium hydroxide (1 M sodium hydroxide solution), water for injection.
Indications for use
The use of B-ksikam is indicated for the symptomatic treatment of inflammatory and degenerative diseases of the joints, accompanied by pain syndrome:
- osteoarthritis;
- rheumatoid arthritis;
- ankylosing spondylitis (ankylosing spondylitis).
Contraindications
- severe liver failure;
- severe renal failure [creatinine clearance (CC) less than 30 ml / min] in patients without hemodialysis;
- period of exacerbation of gastric ulcer and duodenal ulcer;
- severe heart failure;
- active gastrointestinal bleeding, cerebrovascular bleeding, or any other bleeding;
- the period of pregnancy and breastfeeding;
- individual intolerance to the components of the drug.
In addition, each of the forms has separate contraindications.
Pills
- aspirin bronchial asthma;
- syndrome of glucose-galactose malabsorption, lactose intolerance, lactase deficiency;
- age up to 15 years.
With caution: elderly patients, history of erosive and ulcerative lesions of the gastrointestinal tract (GIT), cirrhosis of the liver, hypovolemia after surgery.
Solution for i / m administration
- incomplete or complete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to other NSAIDs and acetylsalicylic acid (including history);
- period of exacerbation of ulcerative colitis, Crohn's disease;
- active liver pathologies;
- confirmed hyperkalemia and other progressive kidney disease;
- period after coronary artery bypass grafting;
- age up to 18 years.
It is recommended to prescribe a solution of the drug with caution in the presence of Helicobacter pylori infection, a history of gastrointestinal tract diseases, renal failure (CC 30-60 ml / min), cerebrovascular diseases, congestive heart failure, ischemic heart disease, dyslipidemia or hyperlipidemia, peripheral arterial disease, diabetes mellitus, severe somatic pathologies, frequent alcohol consumption, smoking, long-term use of NSAIDs, with the simultaneous use of anticoagulants, antiplatelet agents, oral glucocorticoids, selective serotonin reuptake inhibitors, in elderly patients.
Method of administration and dosage
Pills
The tablets are taken orally 1 time per day with meals.
Recommended daily dosage:
- rheumatoid arthritis: 15 mg, if necessary, the dose can be reduced to 7.5 mg;
- osteoarthritis: 7.5 mg, in the absence of a therapeutic effect, a single dose can be increased to 15 mg;
- ankylosing spondylitis: 15 mg.
The maximum daily dose is no more than 15 mg.
With an increased risk of developing undesirable effects, the initial daily dose should be 7.5 mg.
In renal failure with a CC of more than 25 ml / min, no dosage adjustment is required.
In patients on dialysis, the dose of the drug should not exceed 7.5 mg.
Solution for i / m administration
The solution is intended for deep intramuscular injection once a day.
Do not use the drug for intravenous administration!
Mixing in one syringe with other drugs is not allowed.
The use of the solution is indicated for the removal of severe pain syndrome or inflammation only during the first 2-3 days, then the patient is transferred to the oral form of B-xicam.
The doctor prescribes the dose and the period of treatment based on clinical indications, taking into account the severity of the inflammatory process and the intensity of pain.
Recommended dosage: 7.5 mg or 15 mg.
The maximum daily dose of meloxicam is no more than 15 mg.
The daily dose for severe renal failure in patients on hemodialysis, as well as with an increased risk of adverse reactions, should not exceed 7.5 mg.
Side effects
- digestive system: nausea, diarrhea, vomiting, belching, abdominal pain, constipation, flatulence, stomatitis, esophagitis, colitis, erosive and ulcerative lesions of the stomach and duodenum, latent or obvious gastrointestinal bleeding, hepatitis, transient changes in liver function indicators;
- nervous system: headache, dizziness, drowsiness, confusion, disorientation, emotional lability;
- organs of sight and hearing: conjunctivitis, visual impairment, tinnitus;
- genitourinary system: edema, hypercreatininemia and / or increased serum urea;
- cardiovascular system: increased blood pressure (BP), tachycardia, a feeling of flushing to the face;
- respiratory system: exacerbation or development of bronchial asthma in case of allergy to acetylsalicylic acid and other NSAIDs, cough;
- dermatological reactions: skin rash, itching, urticaria, photosensitivity, erythema multiforme exudative, toxic epidermal necrolysis;
- hematopoietic system: anemia, leukopenia, thrombocytopenia;
- allergic reactions: anaphylactoid or anaphylactic reactions, including anaphylactic shock.
In addition, each of the forms has additional side effects.
Pills
- nervous system: sleep disturbance;
- digestive system: dry mouth, bowel or stomach perforation;
- genitourinary system: proteinuria, hematuria, interstitial nephritis, renal medullary necrosis, urinary infection, renal failure;
- allergic reactions: allergic vasculitis, swelling of the tongue and lips;
- others: fever.
Solution for i / m administration
- organs of sight and hearing: vertigo;
- digestive system: gastritis;
- dermatological reactions: angioedema, erythema multiforme, bullous dermatitis;
- urinary system: impaired urination, acute urinary retention, acute renal failure;
- local reactions: pain and swelling at the injection site.
special instructions
It should be borne in mind that Bi-ksikam may hide the symptoms of an underlying infectious disease.
Patients with a history of gastrointestinal diseases should be carefully monitored, since the risk of erosive and ulcerative lesions or bleeding is very high, especially in elderly patients.
With the development of side effects from the skin and mucous membranes, you should consider discontinuing the drug.
It is necessary to monitor the indicators of renal function and diuresis when using tablets and solution in elderly patients with cirrhosis of the liver, nephrotic syndrome or acute impaired renal function, chronic heart failure with symptoms of circulatory insufficiency, in patients who are simultaneously taking diuretics, and patients with hypovolemia that has arisen as a result of surgical interventions.
While taking diuretics, the patient should drink a sufficient amount of liquid.
Against the background of long-term use of Bi-Xicam, the risk of developing myocardial infarction, serious cardiovascular thrombosis, angina attack (including fatal) increases, especially in predisposed patients.
Weak or malnourished patients should be carefully monitored, who may be less tolerant of the development of adverse events.
During the period of treatment, care must be taken when driving vehicles and mechanisms, since drowsiness, dizziness or headache may develop.
Drug interactions
With the simultaneous use of Bi-xicam:
- glucocorticoids, salicylates, other NSAIDs increase the risk of erosive and ulcerative formations in the gastrointestinal tract and gastrointestinal bleeding, therefore, it is not recommended to combine them with meloxicam;
- selective serotonin reuptake inhibitors increase the risk of gastrointestinal bleeding;
- lithium preparations reduce their renal secretion, which can lead to an increase in plasma lithium concentration to a dangerous toxic level, therefore, this combination should be avoided;
- angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, vasodilators, diuretics (antihypertensive drugs) reduce their effect;
- methotrexate reduces tubular secretion and the level of its concentration in the blood plasma increases, therefore, with concomitant therapy with methotrexate in a weekly dose of more than 15 mg, it is not recommended to prescribe B-ksikam;
- intrauterine contraceptives reduce their effectiveness;
- cyclosporine increases nephrotoxicity;
- diuretics should be accompanied by adequate fluid intake, as with dehydration, the risk of developing acute renal failure increases;
- angiotensin II receptor antagonists reduce the rate of glomerular filtration, which can cause the development of acute renal failure.
If combination therapy with lithium is necessary, the patient should be monitored for the lithium content in the blood plasma at the beginning of treatment and after discontinuation of meloxicam.
When combined with antacids, cimetidine, digoxin, furosemide, no clinically significant pharmacokinetic interactions have been established.
Possible interaction with hypoglycemic agents for oral administration and drugs that inhibit CYP2C9 and / or CYP3A4 (or their metabolism occurs with the participation of these enzymes).
Terms and conditions of storage
Keep out of the reach of children.
Store at temperature: tablets - up to 25 ° C, solution - up to 30 ° C.
The shelf life is 5 years.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
