Reviparin interacts in the following cases:
Caution must be used when reviparin is administered concomitantly with non-steroidal antiinflammatory agents, salicylates, medicinal products affecting platelet function or plasma expanders (dextran) because of the potentiation of the risk of haemorrhage.
Caution must be used when reviparin is administered concomitantly with oral anticoagulants, cephalosporin-type antibiotics or medicinal products that raise serum potassium levels.
The effects of heparin may be reduced by nitroglycerin infusions.
Reviparin should be used in caution in patients with cerebral stroke, cerebral aneurysm or cerebral neoplasma.
Controlled clinical studies on the use of low molecular weight heparin in pregnancy have not been performed. In studies during the second and third trimesters, passage of low molecular weight heparin over the placental barrier could not be identified. In ex vivo experiments performed on an unknown number of perfused human placentas, passage of reviparin through the placenta could not be demonstrated even if the doses administered were much higher than those in therapeutic use.
In a clinical study in more than 50 pregnant women with repeated miscarriages, reviparin in prophylactic dosages during the entire pregnancy appeared to be safe.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, partutition or postnatal development.
Caution should be exercised when prescribing to pregnant women.
Information on passage of reviparin into breast milk is not available. Oral absorption of reviparin is unlikely. However, the use of reviparin during breast-feeding is not advised.
No studies on the effects on the ability to drive and use machines have been performed.
Adverse reactions with reviparin which occurred in more than 1% of 1273 patients receiving reviparin injection in the two phase III studies (COLUMBUS and/or CORTES), other clinical trials or from Postmarketing Surveillance are shown in the following list. The events considered at least possibly related to reviparinare ranked by organ class and under headings of frequency, using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Not Known: Thrombocytopenia
Not Known: Hypersensitivity
Common: Headache
Common: Haematoma (subcutaneous) Thrombosis
Common: Epistaxis
Common: Constipation
Common: Pain in extremity
Not Known: Osteoporosis
Common: Fever, Injection site haemorrhage
Not Known: Local tissue reactions
Common: Liver function test abnormal
The following are adverse reactions from Postmarketing Surveillance or other Clinical Trials with this or other formulations ofreviparin. Estimates of frequency cannot be made since such events are reported voluntarily from a population of unknown size.
Mild thrombocytopenia may occur.
Severe thrombocytopenia conditioned by an immunologic response may infrequently occur accompanied by paradoxical tendency for thrombosis (heparin induced thrombocytopenia type II). Skin necrosis may occur at the subcutaneous injection site.
Allergic reactions may occur with symptoms such as nausea, aching limbs, urticaria, vomiting, pruritus, dyspnoea and hypotension. Hypersensitivity and anaphylactic reactions to reviparin are rare.
Dose-dependent side effects include an increased incidence of bleeding, particularly from the skin, mucosa, wounds, gastrointestinal tract and urogenital tract. Slight bleeding at the injection site may occur with normal doses.
After fairly long term use of standard heparin (months) osteoporosis may develop, particularly in predisposed patients. This adverse drug reaction cannot be ruled out in the case of reviparin. Clinical trials with other low molecular weight heparins and also with reviparin have shown that the risk of osteoporosis probably is lower as compared to standard heparin.
Local tissue reactions (induration, reddening, discoloration and small haematomas) have been seen at the injection site.
Elevated serum transferases (ALT, AST and gamma-GT) are observed.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
