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Possible Adverse Effects(unusual, unexpected and infrequent reactions) If any of the following develop, consult your physician promptly for guidance




Inform Your Physician Before Taking This Drug If

This Drug Should Not Be Taken If

Usual Adult Dosage Range:As sedative: 15 to 30 mg 2 to 4 times/day. As hypnotic: 100 to 200 mg at bedtime. As anticonvulsant: 100 to 200 mg given as a single dose at bedtime. The total daily dosage should not exceed 600 mg. Note: Actual dosage and administration schedule must be determined by the physician for each patient individually.

Available Dosage Forms and Strengths

Capsules — 16 mg

Elixir — 15 mg, 20 mg per 5-ml teaspoonful Tablets — 8 mg, 16 mg, 32 mg, 65 mg, 100 mg

Dosing Instructions: May be taken with or after food to reduce stomach

irritation. Regular tablets may be crushed and capsules opened for administration. Prolonged-action dosage forms should be swallowed whole without alteration.

Usual Duration of Use: Continual use on a regular schedule for 3 to 5 days is usually necessary to determine this drug's effectiveness in relieving anxiety and tension, and for 4 to 6 weeks to determine its ability to control seizures. If used to treat anxiety-tension states, its use should not exceed 4 weeks without reappraisal of continued need. Long-term use for seizure control (months to years) requires supervision and periodic evaluation by your physician. Consult your physician on a regular basis.

• you have had an allergic reaction to it previously.

• you are subject to acute intermittent porphyria.

• you are allergic or overly sensitive to any barbiturate drug (see Drug
Class, Section Four).

• you are pregnant or planning pregnancy.

• you have a history of alcohol or drug abuse.

• you are taking any drugs with sedative effects.

• you have any type of seizure disorder.

• you have myasthenia gravis.

• you have impaired liver, kidney or thyroid gland function.

• you plan to have surgery under general anesthesia in the near future.

Possible Side-Effects (natural, expected and unavoidable drug actions) Drowsiness, impaired concentration, mental and physical sluggishness.

Mild Adverse Effects Allergic Reactions: Skin rashes, hives, localized swellings of face, drug

fever (see Glossary).

Dizziness, unsteadiness, impaired vision, double vision. Nausea, vomiting, diarrhea. Shoulder-hand syndrome: pain and stiffness in the shoulder, pain and swelling in the hand.

Serious AdverseEffects

Allergic Reactions: Drug-induced hepatitis with jaundice (see Glossary). Idiosyncratic Reactions: Paradoxical excitement and delirium (instead of

sedation).

Mental depression, abnormal involuntary movements. Blood cell disorders: deficiencies of all blood cell types causing fatigue,

weakness, fever, sore throat, abnormal bleeding or bruising.




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