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What is Phenobarbital ?
Phenobarbital is a barbiturate, nonselective central nervous system depressant that is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses.
Phenobarbital, also known as phenobarbitone or phenobarb, is a medication recommended by the World Health Organization for treating certain types of epilepsy in developing countries. Children as young as 6 years of age are commonly treated with it, whereas older individuals and adults are usually treated with other medications. When used for sleep problems, anxiety, withdrawal from drugs, and to ease surgery pain, phenobarbital is sometimes effective.
Indications and Dosage
- Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks.
- Long-term anticonvulsants for the treatment of generalized tonic-clonic and cortical local seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.
Dosage and Administration
Suggested doses of phenobarbital for specific indications are as follows:
- Pediatric Oral Dosage (as recommended by the American Academy of Pediatrics):
Preoperative: 1 to 3 mg/kg.
- Adult Oral Dosage:
1. Daytime sedative: 30 to 120 mg daily in 2 to 3 divided doses.
2. Bedtime hypnotic: 100 to 320 mg.
3. Anticonvulsant: 50 to 100 mg 2 to 3 times daily.
Phenobarbital 60mg Tablets dosage needs to be individualized according to the patient’s particular characteristics and recommended rate of administration. The patient’s age, weight, and health condition are important factors to consider. The parenteral route should be used only if oral administration is impractical or impossible.
Anticonvulsant use: A therapeutic anticonvulsant level of phenobarbital in serum is 10 to 25 µg/mL. To achieve the blood levels considered therapeutic in children, higher per-kilogram dosages are generally necessary for phenobarbital and most other anticonvulsants. In children and infants, phenobarbital at loading dose of 15 to 20 mg/kg produces blood levels of about 20 µg/mL shortly after administration.
In status epilepticus, it is imperative to achieve therapeutic blood levels of phenobarbital as rapidly as possible. Because a barbiturate-induced depression may occur along with a postictal depression once the seizures are controlled, it is important, therefore, to use the minimal amount required, and to wait for the anticonvulsant effect to develop before administering a second dose.
Phenobarbital has been used in the treatment and prophylaxis of febrile seizures. However, it has not been established that prevention of febrile seizures influences the subsequent development of epilepsy.
Special patient population: Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to phenobarbital. Dosage should be reduced for patients with impaired renal function or hepatic disease.
15 mg – Each white round tablet imprinted Þ 026 contains 15 mg of Phenobarbital. Tablets are supplied in bottles of 1000 (NDC 0228-2026-96).
30 mg – Each white, round, scored tablet imprinted Þ 028 contains 30 mg of Phenobarbital. Tablets are supplied in bottles of 1000 (NDC 0228-2028-96).
60 mg – Each white, round, tablet imprinted EP902 contains 60 mg of Phenobarbital. Tablets are supplied in bottles of 1000
100 mg – Each white, round, scored tablet imprinted Þ 030 contains 100 mg of Phenobarbital. Tablets are supplied in bottles of 1000 (NDC 0228-2030-96).
Dispense in well-closed containers as defined in the USP. Store at controlled room temperature 15º- 30º C (59º- 86º F).
Based on the monitoring of thousands of hospitalized patients, these adverse reactions and their incidence are listed below.
More than 1 in 100 patients:The most common adverse reaction estimated to occur at a rate of 1 to 3 patients per 100 is:
- Nervous system: Somnolence.
Less than 1 in 100 patients:Adverse reactions estimated to occur at a rate of less than 1 in 100 patients listed below, grouped by organ system, and by decreasing order of occurrence are:
- Nervous system: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality.
- Respiratory system: Hypoventilation, apnea.
- Cardiovascular system: Bradycardia, hypotension, syncope.
- Digestive system: Nausea, vomiting, constipation.
- Other reported reactions: Headache, injection site reactions, hypersensitivity reactions (angioedema skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic phenobarbital use.