Interactions

Active ingredient Baclofen interacts in the following cases:

Renal failure

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Oral baclofen increases the incidence of omphaloceles (ventral hernias) in the foetuses of rats at high doses. No teratogenic effects have been noted in mice or rabbits.

A dose related increase in the incidence of ovarian cysts, and a less marked increase in enlarged and/or haemorrhagic adrenals have been observed in female rats treated for 2 years. The clinical relevance of these findings is not known.

During pregnancy, especially in the first 3 months, oral baclofen should only be employed if its use is of vital necessity. The benefits of the treatment for the mother must be carefully weighed against the possible risks for the child.

Baclofen intrathecal should not be used during pregnancy unless the potential benefit is judged to outweigh the potential risk to the foetus.

Baclofen crosses the placental barrier.

Nursing Mothers

Intrathecal administration

In mothers taking oral baclofen in therapeutic doses the active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected. It is not known whether detectable levels of drug are present in the breast milk of nursing mothers receiving baclofen intrathecal.

Oral administration

In mothers taking baclofen in therapeutic doses, the active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.

Carcinogenesis, Mutagenesis and Fertility

One case of suspected withdrawal reaction (generalised convulsions) has been reported in a week-old infant whose mother had taken oral baclofen 80 mg daily throughout her pregnancy. The convulsions, which were refractory to standard anticonvulsant treatment, ceased within 30 minutes of giving baclofen to the infant.

Effects on Ability to Drive and Use Machines

Central nervous system (CNS) depressant effects such as somnolence and sedation have been reported in some patients receiving intrathecal baclofen, and patients should be advised to exercise due caution. Other listed events include ataxia, hallucinations, vision blurred, diplopia and withdrawal symptoms. Operating equipment or machinery may be hazardous.