Advisability of Use During Pregnancy. Possible Effects on Laboratory Tests

Possible Effects on Laboratory Tests

Natural Diseases or Disorders That May Be Activated by This Drug

Adverse Effects That May Mimic Natural Diseases or Disorders

Possible Effects on Sexual Function

Decreased libido and/or impotence (16%).

Decreased effectiveness of oral contraceptives taken concurrently (71%).

Liver reactions may suggest viral hepatitis.

Acute intermittent and/or cutaneous porphyria, systemic lupus ery­thematosus.

Complete blood cell counts: decreased red cells, hemoglobin, white cells and platelets.

Blood lupus erythematosus (LE) cells: positive.

Prothrombin time: decreased (when taken concurrently with warfarin).

Blood calcium level: decreased (with long-term use).

Blood thyroxine (T⁴) level: decreased.

Liver function tests: increased liver enzymes (ALT/GPT, AST/GOT and alkaline phosphatase), increased bilirubin.

Urine sugar tests: no effect with TesTape; false low results with Clinistix and Diastix.

Urine screening tests for drug abuse: may be positive. (Test results depend upon amount of drug taken and testing method used.)

CAUTION

1. Anticonvulsant drug therapy must be carefully individualized. Accu­rate diagnosis and classification of the seizure pattern are essential to the correct selection of the most appropriate drug for seizure control.

2. Emotional stress or physical trauma (including surgery) may require
increased anticonvulsant dosage to control seizures.

3. Prolonged-action dosage forms of this drug are not appropriate for
the treatment of seizures and should not be used.

Precautions for Use

By Infants and Children: This drug should not be given to the hyperkinetic child. Observe for possible paradoxical stimulation and hyperactivity; this can occur in 10% to 40% of children. Changes associated with puberty characteristically slow the metabolism of this drug and permit its gradual accumulation. Blood levels of this drug in young adoles­cents should be monitored every 3 months to detect rising concentra­tions and early toxicity. Adjust dosage as necessary.

By Those over 60 Years of Age: It is advisable to avoid all barbiturates in the elderly. If use of this drug is attempted, start with small doses until tolerance has been determined. Observe for confusion, delirium, agita­tion and excitement. Do not use this drug concurrently with other drugs for mental disorders. This drug is conducive to the development of hypothermia (see Glossary).

Pregnancy Category: D (tentative). See Pregnancy Code inside back cover.

Animal studies: Conflicting reports of cleft palate and skeletal defects in mouse, rat and rabbit studies.

Human studies: Information from studies of pregnant women indicates no increase in birth defects in 8037 exposures to this drug. However, it is reported that barbiturates can cause fetal damage when taken during pregnancy.

Avoid use of drug during entire pregnancy if possible. If it is clearly needed to control seizures, the mother should receive vitamin К prior to delivery and the infant should receive it at birth.

Дата добавления: 2015-06-25