Baclofen (Baclofen Tablets) Drug Information: Warnings and Precautions

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May 25, 2012

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For what conditions are pain medications used?

Virtually any disease as well as most injuries and surgical procedures involve some degree of pain. It's not surprising, then, that pain medications, also known as analgesics, are among the most commonly used drugs in the U.S. Pain can range from minor, acute complaints, such as a muscle sprain, to chronic, severe pain, such as that sometimes experienced by cancer patients. Some drugs used for other conditions also are effective at relieving certain types of pain. These drugs include certain drugs used for depression, epilepsy, and anxiety.

What are the differences among the types of pain medications?

Pain medications can be broadly classified into two categories: prescription and nonprescription. In the latter category are several mild anti-inflammatory drugs (ibuprofen, naproxen), as well as acetaminophen. These are mainly meant for use with short-term, acute pain -- menstrual cramps,...

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WARNINGS

Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) . Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.

Impaired Renal Function: Because baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.

Stroke: Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) has not significantly benefitted patients with stroke. These patients have also shown poor tolerability to the drug.

Pregnancy: Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits. There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 or 34 times the human daily dose. There are no studies in pregnant women. Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

PRECAUTIONS

Safe use of baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) in pediatric patients under age 12 has not been established, and it is, therefore, not recommended for use in pediatric patients.

Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) may be additive to those of alcohol and other CNS depressants.

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.

In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) .

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) .

Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.

Last reviewed on RxList: 11/20/2007
This monograph has been modified to include the generic and brand name in many instances.