Symptomatic treatment of low or moderate fever and pain, when oral Ibuprofen is not possible or causes vomiting.
Composition:
1 suppository contains 60 mg or 125 mg ibuprofen.
Action:
A drug from the group of non-steroidal anti-inflammatory drugs. It has anti-inflammatory, analgesic and antipyretic properties by inhibiting prostaglandin cyclooxygenase. After rectal administration, it is absorbed quickly and almost completely, reaching a maximum blood concentration of 45 min (suppositories 60 mg) and after 1 hour 25 min (suppositories 125 mg). It penetrates into the synovial fluid. It is highly bound to plasma proteins. It is metabolised in the liver to inactive metabolites. T0,5 It is about 2 hours. It is excreted in the urine in the form of metabolites.
Contraindications:
Hypersensitivity to the preparation ingredients and other NSAIDs. Asthma, bronchospasm, rhinitis, urticaria - after Acetylsalicylic acid or other NSAIDs. Active or peptic ulcer of the stomach and / or duodenum. Bleeding from the gastrointestinal tract. Severe hepatic or renal failure. Severe heart failure. Third trimester of pregnancy. 60 mg suppositories: infants with an ≤6 kg. 125 mg suppositories: systemic lupus erythematosus; uncontrolled heart failure.
Precautions:
Caution should be exercised in patients with connective tissue diseases - mixed connective tissue disease and systemic lupus erythematosus (125 mg suppositories are contraindicated for patients with systemic lupus erythematosus); with diseases of the gastrointestinal tract, including chronic inflammatory bowel diseases (ulcerative duodenitis, Crohn's disease) and anal diseases; with hypertension and / or heart failure (risk of fluid retention, hypertension and edema due to NSAID therapy); with impaired renal and / or liver function; with bronchial asthma or other allergic reactions currently or in history (taking the preparation may cause bronchospasm) and in patients after major surgery. In patients with heart failure, kidney or liver failure receiving diuretic therapy or significant fluid loss due to major surgery, close monitoring of diuresis and renal function should be considered. The use of NSAIDs in combination with selective COX-2 enzyme inhibitors should be avoided. In case of bleeding from the gastrointestinal tract or ulcer, and after the occurrence of hypersensitivity symptoms, the drug should be immediately discontinued. The risk of bleeding, ulceration or perforation of the gastrointestinal tract increases with the increase in the dose of NSAID, in patients with a history of peptic ulcer disease, particularly associated with hemorrhage or perforation. For those patients and patients requiring combined use of low-dose acetylsalicylic acid or other medications that increase the risk of gastrointestinal reactions, combination therapy with barrier medicines should be considered. Long-term patients should be monitored for renal, hepatic and hematopoietic function. It is recommended to avoid the use of ibuprofen in patients with chickenpox.
Pregnancy and lactation:
The drug is intended for use in children. In the third trimester of pregnancy, ibuprofen is contraindicated (it may delay or prolong the duration of labor and cause severe fetal disorders). In the first and second trimester of pregnancy, ibuprofen can only be used if clearly necessary. Ibuprofen and its metabolites may in small amounts penetrate into breast milk - in the doses recommended for the above-mentioned indications, with short-term use, there is no need to stop the infant from breasts. Ibuprofen may affect fertility in women. This effect is transient and disappears after discontinuation of the preparation - the drug is not recommended for women planning pregnancy.
Side effects:
Suppositories 60 mg. Uncommon: indigestion, abdominal pain, nausea, headache, urticaria, pruritus. Rare: diarrhea, bloating, constipation, vomiting.Very rare: peptic ulcer of the stomach and / or duodenum, sometimes with bleeding and perforation, oliguria, edema, acute renal failure, renal papillary necrosis, increased urea in the blood, liver dysfunction, anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, severe skin reactions (including erythema multiforme), severe skin and soft tissue infections (as complications in chickenpox), swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension, shock, worsening asthma symptoms, symptoms of aseptic meningitis cerebrospinal fluid: stiff neck, headache, nausea, vomiting, fever, disorientation, especially in patients with existing autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease). In addition, edema, hypertension and heart failure have been reported.Suppositories 125 mg. Common: gastrointestinal disorders (dyspepsia, abdominal pain, nausea). Uncommon: diarrhea, bloating, constipation, vomiting; peptic ulcer disease, perforation or gastrointestinal bleeding sometimes with fatal outcome; tarry stools, bloody vomiting, ulcerative oral mucositis, exacerbation of colitis and Crohn's disease; gastritis; local irritation of the anus; headache, dizziness, insomnia, tinnitus and fatigue; hypersensitivity reactions with urticaria and pruritus. Very rare: swelling, hypertension, heart failure; reduction of urea excretion, edema, interstitial nephritis, nephrotic syndrome, acute renal failure; necrosis of the renal papilla (especially during prolonged use); increase in the concentration of urea in the serum; impaired liver function, liver damage (especially during long-term use), acute hepatitis; liver dysfunction (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis); bullous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis; severe skin reactions (including erythema multiforme), severe skin and soft tissue infections (as complications in chickenpox), swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension, shock, worsening asthma symptoms, symptoms of aseptic meningitis cerebrospinal fluid: stiff neck, headache, nausea, vomiting, fever, disorientation, especially in patients with existing autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease). The intake of ibuprofen in long-term and high doses (2400 mg / day) may be associated with a small increase in the risk of blockages.
Dosage:
Rectally. The maximum daily dose: 20-30 mg ibuprofen / kg body weight. in 3-4 single doses. Children about the month of 6-8 kg (3-9 months): 1 suppository (60 mg) every 6-8 h, do not use more than 3 suppositories (180 mg) per day; mc. 8-12.5 kg (9 months-2 years): 1 suppository (60 mg) every 6 hours, do not use more than 4 suppositories (240 mg) per day; mc. 12.5-17 kg (2-4 years): 1 suppository (125 mg) every 6-8 h, do not use more than 3 suppositories (375 mg) per day; mc. 17-20.5 kg (4-6 years): 1 suppository (125 mg) every 6 h, do not use more than 4 suppositories (500 mg) per day. Do not give more than 3 days.