Nadroparin interacts in the following cases:
Moderate and severe renal impairment is associated with increasing exposure to nadroparin. These patients are at an increased risk of thromboembolism and haemorrhage.
If patients with renal impairment are treated for deep venous thrombosis, the laboratory test results should be monitored, preferably via anti-Xa level determination (amidolytic method with chromogenic substrate). The anti-Xa activity can be checked during the 2nd and the 4th day, 4 to 6 hours following subcutaneous application. Anti-Xa values above 1.8 I.U./ml may be an indication of an overdose and should lead to a dose reduction.
Nadroparin is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min).
Nadroparin should be administered with caution in patients who receive oral anticoagulants, systemic (gluco-) corticosteroids and dextrans.
The concomitant use of nadroparin with acetylsalicylic acid (or other salicylates), non-steroidal anti-inflammatory and anti-platelet drugs is not recommended, as they may increase the risk of bleeding.
Heparin may suppress adrenal secretion of aldosterone, which can lead to hyperkalaemia particularly in patients with elevated plasma potassium concentrations or in patients at risk for elevated plasma potassium concentrations, such as patients with diabetes mellitus, persistent renal function impairment, pre-existing metabolic acidosis, or in patients taking drugs that increase potassium plasma concentrations (for instance ACE inhibitors [angiotensin-converting enzyme], non-steroidal anti-inflammatory drugs [NSAIDs]). The risk of hyperkalaemia appears to increase with duration of treatment, but is generally reversible. Plasma potassium concentrations should therefore be monitored in patients at risk.
In very rare cases, cutaneous necrosis has been observed, typically at the injection site under treatment with standard or low-molecular weight heparin, that was preceded by purpura or infiltrated or painful erythematous skin, with or without general symptoms. In such cases, treatment should be discontinued immediately.
Animal studies have not shown any teratogenic or fetotoxic effects. However, there is only limited clinical data concerning transplacental passage of nadroparin. Experiences based on a limited number of applications of nadroparin calcium during pregnancy have shown no adverse effects on the pregnancy or the health of the foetus/new-born. Further epidemiological data are not available. Therefore, the use of nadroparin during pregnancy is not advised, unless the therapeutic benefits outweigh the possible risks.
There is insufficient information on the excretion of nadroparin calcium in breast milk. Therefore, the use of nadroparin during breast-feeding is not recommended.
There are no clinical studies on the effect of nadroparin on fertility.
There are no data on the effects on the ability to drive and use machines.
The most common adverse effects include haemorrhagic manifestations, minor hematomas at the injection site, open or hidden bleeding complications (particularly affecting the skin, mucous membranes, lesions, as well as the gastrointestinal tract region), elevated transaminase concentration, irritations at the injection site, elevated serum calcium concentrations and elevated aminotransferase, gamma-GT and lipase concentrations.
Adverse reactions are listed below by system organ class and frequency. The following conventions have been used for the classification of adverse reactions in terms of frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Clinical investigations comparing Nadroparin 19,000 I.U. with the conventional twice-daily administration of nadroparin calcium confirmed the established safety profile of the drug. In this study, 3.8% of the patients treated once daily with nadroparin calcium and 4.5% of the patients treated twice daily with nadroparin calcium experienced adverse effects.
Application experience with nadroparin calcium shows that about 3% of the prophylactically treated patients had adverse reactions.
Very common: Haemorrhagic manifestations on various sites (including cases of spinal hematomas), more frequent in patients with other risk factors
Common: Open or hidden bleeding complications (particularly affecting the skin, mucous membranes, lesions, as well as the gastrointestinal tract and urogenital tract regions) that can lead to haemorrhagic anaemia
Uncommon: Mild transient thrombocytope nia (Type I)
Rare: Thrombocytopenia (including antibodymediated heparin-induced thrombocytope nia (Type II)), thrombocytosis, Eosinophilia, which is reversible after discontinuation
Very rare: Thrombocytope nia above 1,000,000/mm³, primarily observed postoperatively
Rare: Anaphylactic shock, anaphylactoid reactions, angioedema
Very rare: Hypersensitivity reactions (including cutaneous reactions)
Not known: Headache, Migraine
Rare: Reversible hyperkalaemia
Very rare: Reversible hyperkalaemia in conjunction with heparininduced aldosterone suppression, particularly in patients at risk
Common: Elevated transaminases, usually transient
Very rare: Priapism
Rare: Rash, urticaria, erythema, pruritus alopecia, Skin necrosis, usually at the injection site
Very common: Minor hematomas at the injection site
In some cases, the occurrence of firm nodules, which do not indicate an encapsulation of heparin, may be observed. These nodules usually disappear after a few days.
Common: Reactions at the injection site.
Rare: Calcinosis at the injection site. Calcinosis occurs more frequently in patients with abnormal calcium phosphate product, such as in some cases of chronic renal insufficiency. Allergic reactions with symptoms such as nausea, vomiting, elevated body temperature, headache, urticaria, pruritis, dyspnoea, bronchospasm, hypotension
Common: Increases in serum potassium concentration. Elevated aminotransferas e, gamma-GT, LDH and lipase levels
Cases of serious adverse effects, such as intracranial bleeding and ocular bleeding have also been reported. Epidural bleeding in the lumbar region following catheterized spinal anaesthesia that can lead to paraplegia has been observed.
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