Urapidil Stragen i.v. should not be used if there is hypersensitivity (allergy) to the active substance or to any of the ingredients. Urapidil Stragen i.v. should not be used in cases of aortic isthmus stenosis and arteriovenous shunt (except where the dialysis shunt is not haemodynamically active).
If urapidil is not being administered as the first-line antihypertensive agent, a sufficiently long time must be allowed to pass for the effect of the previously administered antihypertensive drug(s) to be observed. The dose of urapidil chosen should be correspondingly lower. A too rapid fall in blood pressure can lead to bradycardia or cardiac arrest.
Due to the presence of propylene glycol, symptoms similar those of alcohol may be observed when administering Urapidil Stragen i.v.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free.
The antihypertensive action of urapidil can be exacerbated by concomitant administration of alphareceptor blockers including those given for urological conditions, vasodilators and other blood pressure lowering drugs, and in conditions involving hypovolaemia (diarrhoea, vomiting) and alcohol.
The combination of urapidil with baclofen should be considered cautiously, as baclofen can increase the antihypertensive effect.
Cimetidine administered concomitantly inhibits the metabolism of urapidil. Urapidil serum concentration is likely to increase by 15%, so that dosage reduction should be considered
Consideration should be given to the following concomitant administration:
As no adequate experience yet exists of combining treatment with ACE inhibitors, this is not at the moment recommended.
Urapidil Stragen i.v. during pregnancy is not recommended. There is no adequate data from the use of urapidil in pregnant women.
Studies in animals have shown reproductive toxicity without teratogenicity (section 5.3). Because of the limitations of the studies, the potential risk for humans is unknown.
In the absence of data on excretion into mother’s milk, breast-feeding is not recommended in case of treatment with urapidil.
This medicinal product has minor influence on the ability to drive and use machines. The response to treatment may vary from one patient to another. This applies most particularly at the start of treatment, after changes to treatment, or in the event of concomitant alcohol intake.
In the majority of cases the following undesirable effects can be attributed to too rapid a fall in blood pressure; however, experience shows that they disappear within minutes, even during slow infusion, so that interrupting the treatment must be decided depending on the degree of severity of the undesirable effect.
Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,1000, Very rare (<1/10,000), Not known (cannot be estimated from the available data)
Very rare: Thrombocytopenia
Uncommon: Palpitations; Tachycardia; Bradycardia; Chest pressure sensation; Respiratory distress; Cardiac dysrhythmias
Common: Nausea
Uncommon: Vomiting
Uncommon: Fatigue
Very rare: Asthenia
Common: Dizziness, Headaches
Very rare: Restlessness
Rare: Priapism
Rare: Nasal congestion
Uncommon: Sweating
Rare: Symptoms of cutaneous allergic reactions (pruritus, rashes, exanthema)
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
The following active substance(s) [or solution for reconstitution/dilution] should not be administered simultaneously: alkaline injection and infusion solutions. This may cause turbidity or flocculation.
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