Phenobarbital 20 mg/5mL
phenobarbital · ELIXIR · Strides Pharma Science Limited
Phenobarbital is a elixir containing phenobarbital at 20 mg/5mL, taken oral. Manufactured by Strides Pharma Science Limited.
Key Facts
- Brand Name
- Phenobarbital
- Generic Name
- phenobarbital
- NDC Code (Product)
64380-166- Manufacturer
- Strides Pharma Science Limited
- Strength
- 20 mg/5mL
- Dosage Form
- ELIXIR
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Marketing Start
- 04/04/2022
Recall History
West-Ward Pharmaceutical Corp.
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
Aidapak Services, LLC
Labeling: Label Mixup: PHENobarbital, Tablet, 64.8 mg may have potentially been mislabeled as the following drug: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD73518_4, EXP: 5/31/2014.
Physicians Total Care, Inc.
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
West-Ward Pharmaceuticals Corp.
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Aidapak Services, LLC
Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the following drug: PHENobarbital, Tablet, 64.8 mg, NDC 00603516721, Pedigree: AD73518_7, EXP: 5/31/2014.
C. O. Truxton
Labeling: Label Mixup; potentially mislabeled
Aidapak Services, LLC
Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the following drug: EFAVIRENZ, Capsule, 200 mg, NDC 00056047492, Pedigree: AD46312_31, EXP: 5/16/2014.
Vitae Enim Vitae Scientific, Inc.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Lohxa LLC
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Sedative Anticonvulsant- For the treatment of generalized and partial seizures.
Dosage & Administration
DOSAGE AND 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. 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 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- Respirat…
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…
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.
Drug Interactions
Drug Interactions Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However, the application of these data to other barbiturates appears valid and warrants serial blood level determinations of the relevant drugs when there are multiple therapies. 1. Anticoagulants Phenobarbital lowers the plasma levels of dicumarol and causes a decrease in anticoagulant activity as measured by the prothrombin time. Barbiturates can induce hepatic microsomal enzymes resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (eg, warfarin, acenocoumarol, dicumarol, and phenprocoumon). Patients stabilized on anticoagulant therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen. 2. Corticosteroids Barbiturates appear to enhance the metabolism of exogenous corticosteroids, probably through the induction of hepatic microsomal enzymes. Patients stabilized on corticosteroid therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen. 3. Griseofulvin Phenobarbital appears to interfere with the absorption of or…
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 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, urticar…
Frequently Asked Questions
What is Phenobarbital used for?
Phenobarbital contains phenobarbital. It is a elixir taken oral. Consult your doctor for specific uses.
Is Phenobarbital a controlled substance?
Yes, Phenobarbital is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Phenobarbital?
The generic name for Phenobarbital is phenobarbital. There are 2 other brand versions of phenobarbital.
What is the NDC code for Phenobarbital 20 mg/5mL?
The NDC (National Drug Code) for Phenobarbital 20 mg/5mL is 64380-166, listed by Strides Pharma Science Limited.
Other Phenobarbital Dosages
- Phenobarbital97.2 mg/172162-1574
- Phenobarbital30 mg/172162-1582
- Phenobarbital100 mg/175826-143
- Phenobarbital16.2 mg/10603-5165
- Phenobarbital64.8 mg/182804-984
- Phenobarbital100 mg/182804-999
- Phenobarbital16.2 mg/113517-625
- Phenobarbital20 mg/5mL13811-299
- Phenobarbital16.2 mg/113811-304
- Phenobarbital30 mg/116571-672
Other Phenobarbital Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)