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While Taking This Drug, Observe the Following. Advisability of Use if Breast-Feeding
Advisability of Use if Breast-Feeding Presence of this drug in breast milk: Yes, in small amounts. Monitor nursing infant closely and discontinue drug or nursing if adverse effects develop. Habit-Forming Potential: Psychological and physical dependence can occur with prolonged use of excessive doses—300 to 700 mg/day for 1 to 2 months. Dependence is not likely to occur with usual sedative or anticonvulsant doses. Effects of Overdosage: Behavior similar to alcoholic intoxication: confusion, slurred speech, physical incoordination, staggering gait, drowsiness, stupor progressing to coma. Possible Effects of Long-Term Use: Psychological and/or physical dependence; syndrome of chronic intoxication: headache, depression, impaired vision, dizziness, slurred speech, incoordination.Megaloblastic anemia due to folic acid deficiency. Rickets or osteomalacia due to deficiencies of vitamin D and calcium. Suggested Periodic Examinations While Taking This Drug (at physician's discretion) Complete blood cell counts, liver function tests. During long-term use: blood levels of folic acid, vitamin B-12, calcium and phosphorus; skeletal X-ray studies for demineralization of bone. Foods: No restrictions. Eat liberally of foods rich in folic acid: fortified breakfast cereals, liver, legumes, green leafy vegetables. Beverages: No restrictions. May be taken with milk or fruit juices. Alcohol: Avoid completely. Alcohol can increase greatly the sedative and depressant actions of this drug on brain functions. Tobacco Smoking: May enhance the sedative effects of this drug and increase drowsiness. Marijuana Smoking: Increased drowsiness, unsteadiness; significantly impaired mental and physical performance. Other Drugs Phenobarbital may increase the effects of • all other drugs with sedative effects, and cause excessive sedation. • anticoagulants (Coumadin, etc.), and require dosage adjustments.
• certain beta blockers (Inderal, Lopressor), and reduce their effective • cortisonelike drugs. • doxycycline (Vibramycin), and reduce its effectiveness. • griseofulvin (Fulvicin, etc.), and reduce its effectiveness. • oral contraceptives, and reduce their effectiveness in preventing preg • quinidine (Quinaglute, etc.), and reduce its effectiveness. • theophyllines (Aminophyllin, Theo-Dur, etc.), and reduce their an Phenobarbital taken concurrently with • phenytoin (Dilantin) may alter phenytoin blood levels: a high pheno The following drugs may increase the effects of phenobarbital • valproic acid (Depakene). Driving, Hazardous Activities: This drug may cause drowsiness and may impair mental alertness, judgment, physical coordination and reaction time. Restrict activities as necessary. Aviation Note: The use of this drug is a disqualification for piloting. Consult a designated Aviation Medical Examiner. Exposure to Sun: Use caution until sensitivity has been determined. This drug may cause photosensitivity. Exposure to Cold: Observe the elderly for possible hypothermia while taking this drug. Discontinuation: If used as an anticonvulsant, this drug must not be discontinued abruptly. Sudden withdrawal can precipitate status epilepticus (repetitive seizures). Gradual reduction in dosage should be made over a period of 3 months. Total drug withdrawal may be attempted after a period of 3 to 5 years without a seizure. However, seizures are likely to recur in 40% of adults and in 20% to 30% of children.
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