Generic drug from Surgam
Therapeutic class: Anti-inflammatories
Active ingredients: Tiaprofenic acid
laboratory: IVAX PHARMACEUTICALS SAS
Box of 30
They arise from the anti-inflammatory activity of tiaprofenic acid, the importance of the manifestations of intolerance to which the drug results and its place in the range of anti-inflammatory products currently available.
They are limited, in adults and children from 15 kg (about 4 years old), to:
- long-term symptomatic treatment:
. chronic inflammatory rheumatism, including rheumatoid arthritis,
. some painful and disabling arthroses;
- symptomatic treatment of short duration:
. acute attacks of osteoarthritis, low back pain,
. acute post-traumatic benign conditions of the musculoskeletal system;
- dysmenorrhea after etiological research;
- symptomatic treatment of pain during inflammatory manifestations in ENT and stomatological fields. In this indication, the risks involved, in particular the extension of a concomitant septic process, are those of NSAIDs. They must be evaluated in relation to the expected analgesic benefit.
Dosage TIAPROFENIC ACID IVAX 100 mg Breakable tablet Box of 30
Administration mode :
The tablets are swallowed as is with a large glass of water or dissolved in a large glass of water.
- Adult :
. attack treatment : 2 tablets at 100 mg, 3 times daily, ie 600 mg maximum per day;
. maintenance treatment : from the 4th day, it is possible to reduce the dosage to 3 or 4 tablets to 100 mg, or 300 mg or 400 mg per day.
- Child from 15 kg: the dosage is 10 mg / kg per day.
For information :
. from 15 to 20 kg (approximately 4 to 6 years) : 1/2 100 mg tablet, 3 times daily to 1 100 mg tablet, 2 times daily, or 150 to 200 mg per day;
. from 20 to 30 kg (approximately 6 to 10 years) : 1 tablet to 100 mg, 2 to 3 times a day, or 200 to 300 mg per day;
. from 30 kg (approximately from 10 years) : 1 tablet to 100 mg, 3 times a day, or 300 mg per day.
Approximate ages by weight are indicative.
Frequency of administration:
The tablets should be taken preferably during meals.
The dosage is to be divided into 2 to 3 doses per day.
This medicine is contraindicated in the following situations:
- History of allergy or asthma triggered by taking tiaprofenic acid or substances of similar activity such as other NSAIDs, aspirin,
- a history of allergy to the other constituents of the tablet,
- evolving gastroduodenal ulcer,
- severe hepatocellular insufficiency,
- severe renal insufficiency,
- severe uncontrolled heart failure,
- child under 15 kg, ie under 4 years of age (because of the inadequacy of the unit dosage),
- beyond 24 weeks of amenorrhea (5 months of pregnancy completed):
the administration during the 2nd and 3rd trimesters exposes to:
. renal functional impairment in utero that can be observed as early as 12 weeks of amenorrhea (initiation of fetal diuresis): oligoamnios (most often reversible at the end of treatment), even anamnios especially during prolonged exposure ; at birth, renal insufficiency (reversible or not) may persist especially in case of late and prolonged exposure (with a risk of delayed severe hyperkalemia);
. a risk of cardiopulmonary involvement: partial or complete constriction in utero of the arterial canal. The constriction of the arterial duct may occur after 5 months and may lead to fetal or neonatal right heart failure or even fetal death in utero . This risk is even more important that the catch is close to the term (less reversibility). This effect exists even for a punctual catch;
. a risk of increased bleeding time for the mother and the child.
As a result, beyond 24 weeks of amenorrhea (5 months): any take even punctual is contraindicated. An inadvertent intake beyond 24 weeks of amenorrhea (5 months) justifies cardiac and renal, fetal and / or neonatal monitoring according to the exposure term. The duration of this monitoring will be adapted to the elimination half-life of the molecule.
Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
NOT RECOMMENDED :
- Chicken pox can exceptionally be the cause of serious infectious skin and soft tissue complications. To date, the role promoting NSAIDs in worsening these infections can not be ruled out. It is therefore prudent to avoid the use of tiaprofenic acid in chickenpox (see side effects).
- Breast-feeding: NSAIDs passing into breast milk, as a precaution, should be avoided in women who are breastfeeding.
- Associations advised against : other NSAIDs (including aspirin and other salicylates); oral anticoagulants; heparins in curative doses or in the elderly; lithium; methotrexate, used at doses greater than 15 mg / week.
Adverse effects Tiaprofenic acid Ivax
- Gastrointestinal effects:
Gastrointestinal disorders such as nausea, diarrhea, vomiting, epigastric pain, transit disorders, ulcers, perforations, haemorrhagic colitis, digestive ulcerations with or without haemorrhage, occult or non-occult haemorrhage have usually been reported. These are all the more frequent as the dosage used is high and the duration of treatment extended and require the immediate cessation of treatment.
- Hypersensitivity reactions:
. Dermatological : rash, urticaria and aggravation of chronic urticaria, pruritus, purpura. Rare cases of erythema multiforme and bullous eruptions (Stevens-Johnson syndrome, Lyell syndrome) require immediate discontinuation of treatment. Exceptional opportunity for photosensitization.
. Respiratory : the onset of asthma attack may be related in some subjects to an allergy to aspirin or NSAID (see contraindications).
. General : general malaise with hypotension, angioedema, anaphylactic shock.
- Effects on the central nervous system:
- Kidney effects:
. Hydrosoduced retention, hyperkalemia (see warnings and precautions for use and interactions).
. Functional acute renal failure (ARF) in patients with risk factors (see warnings and precautions for use).
. Organic kidney disease that may result in ARI: isolated cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, papillary necrosis have been reported.
. Urinary: Urinary disorders (cystalgia, dysuria and pollakiuria), hematuria or cystitis may occur. Serious cases were exceptionally reported when treatment was continued. These disorders are reversible when the treatment is stopped.
Exceptionally, severe infectious skin and soft tissue complications occur during chickenpox (see warnings and precautions for use).
- Biological modifications:
. exceptionally, liver test abnormalities,