Berdinal | 30 mg Tablet
Price: 0.00Generic: Phenobarbitone
Manufactured By: G. A. Company Ltd.Variant: Injection 200 mg/ml
Presentation
Berdinal 30: Each tablet contains Phenobarbital BP 30 mg.
Berdinal 60: Each tablet contains Phenobarbital BP 60 mg.
Berdinal Elixir: Each 100 ml or 50 ml bottle contains Phenobarbital BP 20 mg/5ml.
Berdinal Injection: Each 1 ml ampoule contains Phenobarbital Sodium BP 200 mg.
Description
Berdinal is a preparation of Phenobarbital which is a barbiturate, nonselective, central nervous system depressant which is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses.
Indications and Uses
Berdinal is indicated for the following conditions:
- Sedatives
- Hypnotics for the short-term treatment of insomnia
- Pre-anesthetics
- Long-term anticonvulsants for the treatment of generalized tonic-clonic and cortical local seizures. And, in the emergency control of certain acute convulsive episodes, (those associated with status epilepticus,
- eclampsia meningitis, tetanus, and toxic reactions to Strychnine or local anesthetics).
Dosage and administration
Suggested doses of Berdinal for specific indications are as follows:
a. Pediatric Oral Dosage:
- Preoperative: 1 mg to 3 mg/kg.
- Anticonvulsant: 1 mg to 6 mg/kg per day
b. Adult Oral Dosage:
- Daytime sedative: 30 mg to 120 mg daily in 2 to 3 divided doses.
- Bedtime hypnotic: 100 mg to 320 mg.
- Anticonvulsant: 50 mg to 100 mg 2 to 3 times daily.
c. Pediatric Injection Dosage:
- 15 to 20 mg/kg IV over 10 to 15 min.
- Preoperative Sedation:1 to 3 mg/kg IM/IV;
- Anticonvulsant: 4 to 6 mg/kg IM/IV per day, for 10 days.
- Alternatively, use 10 to 15 mg/kg IM/IV per day to reach therapeutic level more quickly.
- Maximum IV rate 60 mg/min.
d. Adult Injection Dosage:
- Insomnia: 100 to 320 mg IM/IV;
- Convulsions: 100 to 320 mg IV. Repeat if needed (maximum, 600 mg per day);
- Status Epilepticus: 10 to 20 mg/kg IV. Repeat if needed.
Contraindications
Phenobarbital is contraindicated in patients with known Phenobarbital sensitivity or a history of latent porphyria.
Precautions
Tolerance and psychological and physical dependence may occur with continuing use. Berdinal should be administered with caution to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. In patients with hepatic damage, Berdinal should be administered with caution and initially reduced doses.
Side-effects
The most common adverse reaction is somnolence. Other less frequent adverse reactions are agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality, apnea, bradycardia, hypotension, nausea, vomiting and constipation.
Use in pregnancy & lactation
Pregnancy Category D. Berdinal can cause fetal damage when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be in risk of the potential hazard to the fetus. Caution should be taken when Phenobarbital is administered to a nursing woman since small amounts of Phenobarbital are excreted in the milk.
Drug interactions
The concomitant use of Alcohol or other CNS depressants may produce additive CNS depressant effects.
Overdosage
The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturate. Acute overdosage with barbiturates is manifested by CNS and respiratory depression Treatment of overdosage is mainly supportive and immediate hospitalization is necessary.
Commercial Pack.
Berdinal 30: Each box contains 10 blister strips of 10 tablets.
Berdinal 60: Each box contains 10 blister strips of 10 tablets.
Berdinal Elixir: Each box contains 50 ml or 100 ml Elixir with a plastic dropper.
Berdinal Injection: Each box contains 1 blister strip of 5 ampoules of 1 ml.