Phenobarbital Oral Solution 20 mg/5mL
Phenobarbital Oral · SOLUTION · Kesin Pharma Corporation
Phenobarbital Oral Solution is a solution containing phenobarbital oral at 20 mg/5mL, taken oral. Manufactured by Kesin Pharma Corporation.
Key Facts
- Brand Name
- Phenobarbital Oral Solution
- Generic Name
- Phenobarbital Oral
- NDC Code (Product)
81033-164- Manufacturer
- Kesin Pharma Corporation
- Strength
- 20 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Marketing Start
- 11/05/2025
Recall History
Lohxa LLC
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS USAGE A. Sedative B. Anticonvulsant - For the treatment of generalized and partial seizures.
Dosage & Administration
DOSAGE & ADMINISTRATION The dose of phenobarbital must be individualized with full knowledge of its particular characteristics. Factors of consideration are the patient’s 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. Oral Hypnotic: 100 to 200 mg. Anticonvulsant Use Clinical laboratories reference values should be used to determine the therapeutic anticonvulsant level of phenobarbital in the serum. To achieve the blood levels considered therapeutic in pediatric patients, higher per-kilogram dosages are generally necessary for phenobarbital and most other anticonvulsants. In pediatric patients and infants, phenobarbital at a loading dose of 15 to 20 mg/kg produces blood levels of about 20 mcg/mL shortly after administration. Phenobarbital has been used in the treatment and prophylaxis of febrile seizures. However, it has not been established that prevention …
Warnings
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. In order to minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in a person who is dependent on the drug may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive doses over long periods of time (see DRUG ABUSE AND DEPENDENCE ). 2. Acute or Chronic Pain Caution should be exercised when barbiturates are administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could b…
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.
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been reported: CNS Depression - Residual sedation or “hangover”, drowsiness, lethargy, and vertigo. Emotional disturbances and phobias may be accentuated. In some persons, barbiturates such as phenobarbital repeatedly produce excitement rather than depression, and the patient may appear to be inebriated. Irritability and hyperactivity can occur in children. Like other nonanalgesic hypnotic drugs, barbiturates such as phenobarbital, when given in the presence of pain, may cause restlessness, excitement, and even delirium. Rarely, the use of barbiturates results in the localized or diffuse myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia. The pain may appear in paroxysms, is most intense in the early morning hours, and is most frequently located in the region of the neck, shoulder girdle, and upper limbs. Symptoms may last for days after the drug is discontinued. Respiratory/Circulatory - Respiratory depression, apnea, circulatory collapse. Allergic - Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, …
Frequently Asked Questions
What is Phenobarbital Oral Solution used for?
Phenobarbital Oral Solution contains Phenobarbital Oral. It is a solution taken oral. Consult your doctor for specific uses.
Is Phenobarbital Oral Solution a controlled substance?
Yes, Phenobarbital Oral Solution is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Phenobarbital Oral Solution?
The generic name for Phenobarbital Oral Solution is Phenobarbital Oral. There are no other listed brand versions of Phenobarbital Oral.
What is the NDC code for Phenobarbital Oral Solution 20 mg/5mL?
The NDC (National Drug Code) for Phenobarbital Oral Solution 20 mg/5mL is 81033-164, listed by Kesin Pharma Corporation.
Other Phenobarbital Oral Solution Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)