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Buy Phenobarbital 60 mg Tablets

PubChem CID:  4763

IUPAC:  5-ethyl-5-phenyl-1,3-diazinane-2,4,6-trione

Synonyms: Acid Phenylethylbarbituric, Gardenal, Hysteps, Luminal, Monosodium Salt Phenobarbital, Phenemal, Phenobarbital, Phenobarbital Sodium, Phenobarbital Monosodium Salt, Phenobarbitone, Phenylbarbital, Phenylethylbarbituric Acid, Sodium Phenobarbital,

CAS#: 50-06-6

Molecular Mass: 232.239 g/mol

Molecular Formula:  C12H12N2O3

Form: Tablets

Administration: Oral

Storage: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20-25°C (68-77°F), however, brief excursions are permitted between 15-30°C (59-86°F).


Each Bottle contains 1000 tablets and each tablet 60 mg of Phenobarbital as active ingredient.

Phenobarbital is a barbiturate that is widely used as a sedative and an antiseizure medication. 

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What is Phenobarbital ?

Phenobarbital is a barbiturate, nonselective central nervous system depressant which 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 the treatment of certain types of epilepsy in developing countries. In the developed world it is commonly used to treat seizures in young children, while other medications are generally used in older children and adults. Phenobarbital is occasionally used to treat trouble sleeping, anxiety, and drug withdrawal and to help with surgery.

Indications and Dosage

Indications

a. Sedatives.

b. Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks.

c. Preanesthetics.

d. 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:

a. Pediatric Oral Dosage (as recommended by the American Academy of Pediatrics):

Preoperative: 1 to 3 mg/kg.

b. 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.

Dosages of phenobarbital must be individualized with full knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient’s age, weight, and condition. Parenteral routes should be used only when oral administration is impossible or impractical.

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.

HOW SUPPLIED

Oral Tablets

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).

SIDE EFFECTS

The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients.

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.

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