Phenobarbital Sodium

Indications

INDICATIONS AND USAGE A. Sedative B. Anticonvulsant- For the treatment of generalized and partial seizures.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION The dose of phenobarbital must be individualized with full knowledge of it particular characteristics. Factors of consideration are the patients age, weight, and condition. Sedation For sedation, the drug may be administered in single doses of 30 to 120 mg repeated at intervals; frequency will be determined by the patient's response. It is generally considered that no more than 400 mg of phenobarbital should be administered during a 24-hour period. Adults Daytime Sedation: 30 to 120 mg daily in 2 to 3 divided doses.

Contraindications

CONTRAINDICATIONS Phenobarbital is contraindicated in patients who are hypersensitive to barbiturates, in patients with a history of manifest or latent porphyria, and in patients with marked impairment of liver function or respiratory disease in which dyspnea or obstruction is evident.

Warnings and precautions

WARNINGS 1. Habit Forming Phenobarbital may be habit forming. Tolerance and psychological and physical dependence may occur with continued use ( see DRUG ABUSE AND DEPENDENCE and Pharmacokinetics under CLINICAL PHARMACOLOGY). Patients who have psychologic dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates.

Pregnancy

Usage in Pregnancy 1. Teratogenic Effects Pregnancy Category D See Usage in Pregnancy under WARNINGS. 2. Nonteratogenic Effects Reports of infants suffering from long-term barbiturate exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days ( see DRUG ABUSE AND DEPENDE…

Storage and supply

Shake well before use. Keep tightly closed. Store at 20° - 25°C (68° - 77°F) .

Source: Phenobarbital (Phenobarbital) — US FDA prescribing information, 2023-10-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.