Piroxicam-ratiopharm – description of the drug, instructions for use, reviews

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Manufacturers: Ratiopharm Gmbh

Active ingredients

• Piroxicam

Disease class

• Acute upper respiratory tract infection of multiple and unspecified localization
• Rheumatoid arthritis, unspecified
• Gout
• Arthritis, unspecified elsewhere
• Polyarthrosis
• Other arthrosis
• Ankylosing spondylitis
• Enthesopathy, unspecified
• Rheumatism, unspecified
• Myalgia
• Neuralgia and neuritis, unspecified
• Constant, unrelieved pain
• Other constant pain
• Superficial trauma to an unspecified area of ​​the body
• Unspecified injury
• Primary dysmenorrhea

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Anti-inflammatory
• Antipyretic
• Analgesic (non-narcotic)
• Antiaggregation

Pharmacological group

• NSAIDs - Oxycams

Description

Capsule-shaped tablets of white or almost white color with a score.

Pharmacotherapeutic group:

antibiotic - semisynthetic penicillin

ATX code:

J01CA04

Pharmacological properties

Pharmacodynamics

Amoxicillin is an aminobenzyl penicillin, a semisynthetic broad-spectrum antibiotic that has a bactericidal effect due to inhibition of bacterial cell wall synthesis. Minimum inhibitory concentration (MIC) thresholds for different sensitive microorganisms vary. The prevalence of resistant strains varies geographically and over time, so it is advisable to rely on local resistance information, especially when treating severe infections.

Pharmacokinetics

Suction

Absorption is fast, high (93%), food intake does not affect absorption, and is not destroyed in the acidic environment of the stomach. When taken orally at a dose of 250 mg and 500 mg, the maximum concentration in blood plasma is 5 mcg/ml and 10 mcg/ml, respectively. The time to reach maximum concentration after oral administration is 1-2 hours.

Distribution

It has a large volume of distribution - high concentrations are found in blood plasma, bronchial secretions (in purulent bronchial secretions the distribution is weak), liver, lymph nodes, uterus, ovaries, paranasal sinuses, pleural and peritoneal fluid, saliva and tear fluid, urine, contents of skin blisters , lung tissue, intestinal mucosa, middle ear fluid and paranasal sinuses, bones, adipose tissue, gall bladder (the concentration in bile is 10 times higher than the concentration in blood plasma - with normal patency of the bile ducts), fetal tissues. When the dose is doubled, the concentration also doubles. In the amniotic fluid and umbilical cord vessels, the concentration of amoxicillin is about 50% of the concentration in the blood plasma of a pregnant woman. It penetrates poorly through the blood-brain barrier; with inflammation of the meninges (meningitis), the concentration in the cerebrospinal fluid increases to 20% of the concentration in the blood plasma. Bonding with blood plasma proteins is 15-25%.

Metabolism

Partially (10-20%) is metabolized to form inactive metabolites.

Removal

The half-life (T1/2) is 1-1.5 hours. It is excreted 50-70% unchanged by the kidneys through tubular excretion (80%) and glomerular filtration (20%), and 10-20% by the liver. A small amount is excreted in breast milk. If renal function is impaired (creatinine clearance [CC] ≤ 15 ml/min), T1/2 is extended to 8.5 hours.

Amoxicillin is removed by hemodialysis.

Special patient groups

Age

T1/2 of amoxicillin in children aged 3 months to 2 years is similar to T1/2 in older children and adults.

Since in elderly patients the likelihood of decreased renal function increases, dose selection is carried out with caution, and monitoring of renal function is also necessary.

Floor

When administered orally to healthy men and women, the gender of the patients does not have a significant effect on the pharmacokinetics of amoxicillin.

Kidney failure

The total serum clearance of amoxicillin increases in proportion to the decrease in renal function. If renal function is impaired (creatinine clearance < 15 ml/min), T1/2 lengthens and can reach 8.5 hours in anuria.

Liver failure

In patients with impaired liver function, dose selection should be carried out with caution, and regular monitoring of liver function is necessary.

Compound

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• upper respiratory tract infections (tonsillopharyngitis, sinusitis, acute otitis media);
• lower respiratory tract infections (acute bacterial bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia);
• infections of the genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis, endometritis, cervicitis, gonorrhea);
• abdominal infections (cholangitis, cholecystitis);
• eradication of Helicobacter pylori
  in patients with duodenal or gastric ulcers (always in combination with other drugs);
• infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses);
• leptospirosis, listeriosis;
• Lyme disease;
• infections of the gastrointestinal tract (enterocolitis, typhoid fever, dysentery, salmonellosis (caused by Salmonella typhi
  , sensitive to ampicillin), salmonella carriage;
• prevention of bacterial endocarditis during surgical procedures in the oral cavity and upper respiratory tract.

Solution for injection Piroxicam-ratiopharm (Piroxicam-ratiopharm)

Instructions for medical use of the drug

Description of pharmacological action

Inhibits the activity of cyclooxygenase (COX-1 and COX-2), reduces the synthesis of PG, incl. PGE1, PGE2, PGE2alpha and thromboxanes. Suppresses phagocytosis and platelet aggregation.

Indications for use

Inflammatory and degenerative diseases of the joints and spine, accompanied by pain, incl. rheumatoid arthritis, rheumatism, ankylosing spondylitis (ankylosing spondylitis), osteoarthritis, juvenile chronic arthritis, tendinitis, tendovaginitis, brachial syndrome, glenohumeral periarthritis, acute attack of gout; pain syndrome of various origins: neuralgia, myalgia, primary dysmenorrhea, postoperative and post-traumatic pain, incl. for sports injuries (bruise, dislocation, sprain), pain and swelling in joints, tendons and muscles caused by overexertion, etc.; acute infectious and inflammatory diseases of the upper respiratory tract.

Release form

Solution for injection 20 mg/ml; dark glass ampoule 1 ml contour cell packaging 10 cardboard pack 1;

Pharmacodynamics

Helps relieve pain and symptoms of inflammation with any method of use. In case of articular syndrome, it weakens or relieves inflammation and pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints.

Pharmacokinetics

Equilibrium concentration in the blood is established within 7–12 days. Plasma protein binding is 97–99%. Metabolized in the liver (oxidized and conjugated), the main metabolites - 5-hydroxypiroxicam, N-methyl-benzenesulfonamide, etc. - are pharmacologically inactive. T1/2 is about 50 hours, may increase with liver diseases. It is excreted by the kidneys and gastrointestinal tract (in urine the amount is determined 2 times more than in feces), mainly in the form of glucuronides (5% is excreted unchanged). Passes through the placenta and enters breast milk. Does not accumulate.

Use during pregnancy

Contraindicated during pregnancy. FDA category of effect on the fetus is C. Breastfeeding should be discontinued during treatment.

Contraindications for use

Hypersensitivity, incl. to other NSAIDs, erosive and ulcerative lesions of the gastrointestinal tract (in the acute stage), “aspirin” asthma, severe dysfunction of the liver and/or kidneys, hemorrhagic diathesis, changes in the blood picture of unknown origin (including in history), inflammatory changes or bleeding in the rectum and anus, incl. proctitis (when using suppositories); pregnancy, breastfeeding, childhood and adolescence (injection solution - up to 18 years; gel, ointment, suppositories - up to 14 years).

Side effects

From the nervous system and sensory organs: dizziness, headache, irritability, drowsiness or insomnia, weakness, depression, hallucinations, tinnitus, blurred vision, eye irritation. From the cardiovascular system and blood (hematopoiesis, hemostasis): increased or decreased blood pressure, palpitations, anemia, thrombopenia, leukopenia, eosinophilia, decreased hemoglobin and hematocrit, hemorrhages. From the genitourinary system: renal failure, acute interstitial nephritis. Other: allergic reactions (itching, redness of the skin; swelling, including of the face, hands; Stevens-Johnson syndrome, Lyell's syndrome, very rarely - anaphylactic reactions, bronchospasm, photosensitivity, rash), swelling (mainly of the lower extremities in patients with impaired cardiac function), sweating, increased urea levels, hyperkalemia, hypo- or hyperglycemia, increased or decreased body weight. Local reactions: irritation of the rectal mucosa, tenesmus, pain and an unpleasant feeling of heaviness in the anal area (suppositories); when applied to the skin - irritation, incl. itching, redness, rash, burning (with long-term use).

Directions for use and doses

IM: 1 time per day, for severe pain - 40 mg, for moderate pain - 20 mg, maximum daily dose - 40 mg. Injections are carried out for 1–2 days, after stopping the acute stage of the process, they switch, if possible, to maintenance therapy using other dosage forms (tablets, capsules, etc.).

Overdose

Symptoms: drowsiness, blurred vision, at very high doses - loss of consciousness, coma. Treatment: gastric lavage, taking activated charcoal, antacids (to reduce absorption), symptomatic therapy.

Interactions with other drugs

Displaces other drugs from binding to blood proteins. Reduces the effectiveness of antihypertensive drugs. In combination with other NSAIDs and corticosteroids, the risk of ulcerogenic effects increases. Increases the risk of hyperkalemia when combined with potassium-sparing diuretics and other potassium-containing drugs. Increases the concentration of phenytoin and lithium in the blood. Anticoagulants increase the risk of bleeding. Acetylsalicylic acid reduces the concentration of piroxicam in the blood to 80% of the original.

Precautions for use

Before use, patients with bronchial asthma, allergic rhinitis, polyps of the nasal mucosa, chronic obstructive respiratory diseases should consult a doctor. During the treatment period, it is necessary to monitor the cellular composition of the blood, kidney and liver function. During the treatment period, you should not drink alcoholic beverages.

Storage conditions

List B: Under normal conditions.

Best before date

60 months

ATX classification:

M Musculoskeletal system

M01 Anti-inflammatory and antirheumatic drugs

M01A Non-steroidal anti-inflammatory drugs

M01AC Oxycams

M01AC01 Piroxicam

Use during pregnancy and breastfeeding

Results from animal studies do not indicate direct or indirect effects on reproductive toxicity. Limited data on the use of amoxicillin during human pregnancy do not indicate an increased risk of congenital malformations. Amoxicillin can be used during pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

Amoxicillin is excreted into breast milk in small quantities; if necessary, the drug can be used during breastfeeding. A breastfed baby may develop diarrhea, sensitization and fungal infection of the mucous membranes, so it may be necessary to stop breastfeeding. Amoxicillin should be used during breastfeeding only after the attending physician has assessed the benefit/risk ratio.

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Piroxicam-ratiopharm, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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Directions for use and doses

Inside, before or after meals.

The dose of Amoxicillin depends on the sensitivity of the infectious agent, the severity of the disease and the localization of the infectious process.

Adults and children over 13 years of age and/or weighing more than 40 kg

Usually prescribed 250 mg - 500 mg 3 times a day or 500 mg - 1000 mg 2 times a day. For sinusitis, community-acquired pneumonia and other severe infections, it is recommended to prescribe 500 mg - 1000 mg 3 times a day. The maximum daily dose is 6 g.

Children from 3 to 5 years old and/or weighing from 15 kg to 19 kg

Usually prescribed 250 mg 2 times a day. In cases where there is a high likelihood of infection caused by resistant Streptococcus
pneumoniae
, higher doses of 500 mg 2-3 times daily are recommended.

Children from 5 to 13 years old and/or weighing from 19 kg to 40 kg

Usually recommended is 250 mg 3 times a day. In cases where there is a high likelihood of infection caused by resistant Streptococcus
pneumoniae
, higher doses are recommended - 500-1000 mg 3 times a day.

The maximum daily dose for children is 100 mg/kg/day.

Lyme disease (borreliosis)

—
early stage
Adults and children over 13 years of age and/or weighing more than 40 kg

500 mg - 1000 mg 3 times a day up to a maximum daily dose of 4 g, divided into several doses, for 14 days (10-21 days).

Children from 3 to 5 years old and/or weighing from 15 kg to 19 kg

250 mg 3 times a day.

Children from 5 to 13 years old and/or weighing from 19 kg to 40 kg

500 mg 2-3 times a day (at the rate of 50 mg/kg/day, divided into 3 doses).

Eradication of
Helicobacter pylori in patients with duodenal or gastric ulcers
(always in combination with other drugs)

Adults: 1000 mg twice daily in combination with a proton pump inhibitor (eg, omeprazole, lansoprazole) and another antibiotic (eg, clarithrominin, metronidazole) for 7 days.

Children over 13 years old and/or weighing more than 40 kg -

1000 mg 2 times as part of combination therapy.

Children from 3 to 5 years old and/or weighing from 15 kg to 19 kg

250-500 mg 2 times a day.

Children from 5 to 13 years old and/or weighing from 19 kg to 40 kg

500-1000 mg 2 times a day (at the rate of 50 mg/kg/day, divided into 2 doses).

Prevention of bacterial endocarditis

Adults and children over 13 years of age and/or weighing more than 40 kg

It is recommended 2 g (or at the rate of 50 mg/kg/day) 0.5-1 hour before surgery.

Children from 3 to 5 years old
u /or body weight from 15 kg to 19 kg
750-1000 mg (at the rate of 50 mg/kg/day) before the procedure.

Children from 5 to 13 years old and/or with a body weight of 19 kg and up to 40 kg

1000-2000 mg (at the rate of 50 mg/kg/day) before the procedure.

For renal failure

In patients with CC > 30 ml/min, there is no need for dose adjustment. When CC < 30 ml/min, it is recommended to increase the interval between doses or reduce subsequent doses.

Nosological classification (ICD-10)

• M06.9 Rheumatoid arthritis, unspecified
• M10 Gout
• M19.9 Arthrosis, unspecified
• M45 Ankylosing spondylitis
• M47 Spondylosis
• M54 Dorsalgia
• M54.3 Sciatica
• M65 Synovitis and tenosynovitis
• M71 Other bursopathies
• M79.1 Myalgia
• M79.2 Neuralgia and neuritis, unspecified
• N94.6 Dysmenorrhea, unspecified
• R52.9 Pain, unspecified
• R68.8.0* Inflammatory syndrome
• T14.9 Injury, unspecified