Barnidipine

Chemical formula: C₂₇H₂₉N₃O₆  Molecular mass: 491.544 g/mol  PubChem compound: 443869

Interactions

Barnidipine interacts in the following cases:

Alcohol

In a specific interaction study alcohol led to an increase of barnidipine plasma levels (40%), which increase may be considered clinically not relevant. As with all vasodilating and antihypertensive agents, caution should be exercised when alcohol is taken concomitantly as it may potentiate their effect.

Grapefruit juice

Although barnidipine kinetics was not significantly altered by administration with grapefruit juice, a modest effect was observed.

Mild CYP3A4 inhibitors, mild CYP3A4 inducers

Care should be taken with concomitant use of mild CYP3A4 inhibitors or inducers. In case of concomitant use of CYP3A4 inhibitors it is discouraged to increase the dosage of barnidipine to 20 mg.

Mild to moderate renal impairment (creatinine clearance between 10 and 80 ml/min)

Barnidipine should be used with caution in patients with mild to moderate renal impairment (creatinine clearance between 10 and 80 ml/min).

Antihypertensives

The concurrent administration of barnidipine and other antihypertensive drugs may result in an additional antihypertensive effect.

Cyclosporin

In vitro data show that cyclosporin may inhibit the metabolism of barnidipine.

Cimetidine

Concurrent dosing of cimetidine in a specific interaction study led on average to a doubling of barnidipine plasma levels. Care should therefore be exercised when using barnidipine concomitantly with cimetidine.

Phenytoin, carbamazepine, rifampicin

A higher dose of barnidipine may be necessary when barnidipine is administered concomitantly with enzyme inducing drugs, such as phenytoin, carbamazepine and rifampicin. Should a patient stop using an enzyme inducing drug, lowering the dosage of barnidipine should be considered.

Sick sinus

Caution is recommended also when barnidipine is administered to patients with sick sinus (if a pacemaker is not in situ).

Left ventricular dysfunction, obstruction of the outflow channel of the left ventricle

As with all other dihydropyridines, Vasexten should be used with caution in patients with left ventricular dysfunction, in patients suffering from obstruction of the outflow channel of the left ventricle and patients with isolated right-sided cardiac decompensation, e.g. cor pulmonale. Barnidipine has not been studied in NYHA class III or IV patients.

Pregnancy

No clinical experience with barnidipine in pregnancy or lactation is present. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal or postnatal development. Only indirect effects are observed. The class of dihydropyridines has shown the potential to prolong delivery and parturition, which was not observed with barnidipine. As a consequence, barnidipine could be used in pregnancy only if the benefit justifies the potential risk to the fetus.

Nursing mothers

The results of animal tests have shown that barnidipine (or its metabolites) is excreted in human milk. Therefore, breast feeding is not advised during use of barnidipine.

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed barnidipine. However, caution should be exercised because dizziness/vertigo may occur during antihypertensive treatment.

Adverse reactions


System organ class10 mg dosage20 mg dosage
Immune system disorders
Anaphylactoid reactionNot known (frequency cannot be estimated from the available data)Not known (frequency cannot be estimated from the available data)
Nervous system disorders
HeadacheCommon (≥1/100 to <1/10)Very common (≥1/10)
Dizziness/vertigoCommon (≥1/100 to <1/10)Common (≥1/100 to <1/10)
Cardiac disorders
PalpitationsCommon (≥1/100 to <1/10)Common (≥1/100 to <1/10)
Tachycardia, sinus tachycardia, heart rate increasedNot known (frequency cannot be estimated from the available data)Not known (frequency cannot be estimated from the available data)
Vascular disorders
FlushingCommon (≥1/100 to <1/10)Very common (≥1/10)
Hepato-biliary disorders
Liver function test abnormalNot known (frequency cannot be estimated from the available data)Not known (frequency cannot be estimated from the available data)
Skin and subcutaneous tissue disorders
RashNot known (frequency cannot be estimated from the available data)Not known (frequency cannot be estimated from the available data)
General and administration site conditions
Peripheral oedemaCommon (≥1/100 to <1/10)Very common (≥1/10)

The symptoms tend to diminish or disappear during treatment (within one month for peripheral oedema and two weeks for flushing, headache and palpitations).

Although never observed, the following adverse event may be of interest, as it is in the use of other dihydropyridines: gingival hyperplasia.

Some dihydropyridines may rarely lead to precordial pain or angina pectoris. Very rarely patients with preexisting angina pectoris may experience increased frequency, duration or severity of these attacks. Isolated cases of myocardial infarction may be observed.

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