Indomethacin rectal suppositories 100mg N10 Berlin-Chemie
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Active ingredients
Indomethacin
Release form
Suppositories
Composition
1 supp. contains: Active ingredient: indomethacin 100 mg. Auxiliary substances: solid fat - 1.7 g, corn starch - 100 mg.
Pharmacological effect
NSAIDs, indole acetic acid derivative. It has anti-inflammatory, analgesic and antipyretic effects. The mechanism of action is associated with inhibition of the COX enzyme, which leads to inhibition of the synthesis of prostaglandins from arachidonic acid. Inhibits platelet aggregation. range of motion. The anti-inflammatory effect develops by the end of the first week of treatment. When applied topically, it eliminates pain, reduces swelling and erythema. When applied topically, it also helps reduce morning stiffness and increase the volume of movements.
Pharmacokinetics
After oral administration, indomethacin is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is reached in 2 hours. Metabolized in the liver. Subjected to enterohepatic recirculation. Indomethacin is determined in blood plasma as an unchanged substance and unbound metabolites - desmethyl, desbenzoyl, desmethyl-disbenzoyl. in the form of metabolites.
Indications
For systemic use: articular syndrome (including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), pain in the spine, neuralgia, myalgia, traumatic inflammation of soft tissues and joints, rheumatism, diffuse diseases of the connective tissue, dysmenorrhea. As an adjuvant in infectious and inflammatory diseases of the upper respiratory tract, adnexitis, prostatitis, cystitis. including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), back pain, neuralgia, myalgia, traumatic inflammation of the soft tissues and joints.
Contraindications
Hypersensitivity to indomethacin, erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, aspirin triad, hematopoietic disorders, marked disorders of the liver and / or kidneys, severe forms of chronic heart failure, hypertension, pancreatitis, III trimester of pregnancy, children under 14 for rectal use: proctitis, recent rectal bleeding.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
Indomethacin is contraindicated in the third trimester of pregnancy. In the I and II trimesters of pregnancy, as well as during lactation (breastfeeding) use is not recommended. Indomethacin in small quantities is excreted in breast milk.
Dosage and administration
Set individually, taking into account the severity of the disease. For adults with oral intake, the initial dose is 25 mg 2-3 times / day. With insufficient severity of the clinical effect, the dose is increased to 50 mg 3 times / day. Dosage forms of prolonged action used 1-2 times / day. Maximum daily dose: 200 mg. When effect is achieved, treatment is continued for 4 weeks in the same or reduced dose. With prolonged use, the daily dose should not exceed 75 mg. It is taken after a meal. For the treatment of acute conditions or the relief of an exacerbation of a chronic process, i / m is administered in 60 mg 1-2 times a day. The duration of the / m introduction - 7-14 days. Then indomethacin is used inside or rectally in 50-100 mg 2 times / day, while the maximum daily dose should not exceed 200 mg. For maintenance treatment, rectal 50-100 mg is used 1 time / day for the night. For local use in ophthalmology, the dose frequency and duration of use are determined individually. Topically used 2 times / day.
Side effects
On the part of the digestive system: nausea, anorexia, vomiting, pain and discomfort in the stomach, constipation or diarrhea, erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract; rarely - intestinal strictures, stomatitis, gastritis, flatulence, bleeding from the sigmoid colon or diverticulum, jaundice, hepatitis. On the side of the central nervous system and peripheral nervous system: dizziness, headache, depression, feeling tired; rarely - anxiety, fainting, drowsiness,convulsions, peripheral neuropathy, muscle weakness, involuntary muscle movements, sleep disorders, mental disorders (depersonalization, psychotic episodes), paresthesias, dysarthria, parkinsonism. For cardiovascular system: edema, increased blood pressure, tachycardia, chest pain, arrhythmia , palpitation, arterial hypotension, congestive heart failure, hematuria. Allergic reactions: rarely - itching, urticaria, angiitis, erythema nodosum, skin rash, exfoliative dermatitis, Stevens-Johnson syndrome, erythema goformal, toxic epidermal necrolysis, hair loss, acute respiratory distress, a sharp drop in blood pressure, anaphylactic reactions, angioedema, dyspnea, bronchial asthma, pulmonary edema. anemia, thrombocytopenia, DVS syndrome. On the part of the senses: rarely - impaired visual perception, diplopia, orbital and periorbital pains, tinnitus, hearing impairment, deafness. From the urine of the positive system: rarely - proteinuria, nephrotic syndrome, interstitial nephritis, renal dysfunction, renal failure. Metabolism: rarely - hyperglycemia, glycosuria, hyperkalemia. Others: rarely - vaginal bleeding, flushing, increased sweating, nasal bleeding, increase and tension mammary glands, gynecomastia. Local reactions: in the place of i / m administration in some cases - the formation of infiltration, abscess; with rectal use, irritation of the rectal mucosa, tenesmus, exacerbation of chronic colitis is possible. When applied externally: itching, redness, rash at the site of application.
Overdose
Overdose cases have not yet been reported.
Interaction with other drugs
With simultaneous use of indomethacin can reduce the effects of saluretik, beta-blockers; to enhance the effects of indirect anticoagulants. With simultaneous use of indomethacin and diflunisal, there is a risk of severe bleeding from the gastrointestinal tract. When used simultaneously with probenecid, plasma levels of indomethacin may increase.which leads to an increase in its toxicity. With simultaneous use with NSAIDs, cyclosporine toxicity increases. Idometacin in a dose of 50 mg 3 times / day increases the concentration of lithium in the blood plasma and reduces lithium clearance in patients with mental diseases. possible increase in the concentration of digoxin in the blood plasma and an increase in the half-life of digoxin.
special instructions
Used with caution in elderly patients, as well as in diseases of the liver, kidney, gastrointestinal tract in history, with dyspeptic symptoms at the time of use, hypertension, heart failure, immediately after serious surgical interventions, with Parkinson's disease, epilepsy. reactions to NSAIDs are used only in emergency cases. During the period of treatment, systematic monitoring of liver and kidney function, peripheral blood picture is necessary. Simultaneous use is not recommended. with acetylsalicylic acid and other NPVS. Indomethacin should not be used simultaneously with diflunisal. When using indomethacin with lithium preparations at the same time, you should bear in mind the possibility of the onset of symptoms of the toxic effect of lithium. eyes or mucous membranes. Impact on the ability to drive motor vehicles and control mechanisms. During the period of treatment, you should refrain from potentially dangerous types of activities. Related to the need for concentration and increased speed of psychomotor reactions.