Phenobarbital

Hikma Pharmaceuticals Usa Inc.
Human Prescription Drug
NDC 0143-1500

Phenobarbital is a human prescription drug labeled by 'Hikma Pharmaceuticals Usa Inc.'. National Drug Code (NDC) number for Phenobarbital is 0143-1500. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Phenobarbital drug includes Phenobarbital - 30 mg/1 . The currest status of Phenobarbital drug is Active.

Drug Information:

Drug NDC:	0143-1500
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Phenobarbital
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Phenobarbital
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hikma Pharmaceuticals Usa Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	PHENOBARBITAL - 30 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	05 Mar, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	20 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Hikma Pharmaceuticals USA Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	198083 198089 312357 312362
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0301431458010
UPC stands for Universal Product Code.
UNII:	YQE403BP4D
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
DEA Schedule:	CIV
This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0143-1500-01	100 TABLET in 1 BOTTLE (0143-1500-01)	05 Mar, 2020	N/A	No
0143-1500-05	500 TABLET in 1 BOTTLE (0143-1500-05)	05 Mar, 2020	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Phenobarbital phenobarbital phenobarbital phenobarbital calcium stearate silicon dioxide starch, corn microcrystalline cellulose ww;445 phenobarbital phenobarbital phenobarbital phenobarbital anhydrous lactose silicon dioxide starch, corn docusate sodium lactose monohydrate magnesium stearate cellulose, microcrystalline sodium starch glycolate type a potato ww;450 phenobarbital phenobarbital phenobarbital phenobarbital anhydrous lactose silicon dioxide starch, corn docusate sodium lactose monohydrate magnesium stearate cellulose, microcrystalline sodium starch glycolate type a potato ww;455 phenobarbital phenobarbital phenobarbital phenobarbital anhydrous lactose silicon dioxide starch, corn docusate sodium lactose monohydrate magnesium stearate cellulose, microcrystalline sodium starch glycolate type a potato ww;458 phenobarbital phenobarbital phenobarbital phenobarbital calcium stearate silicon dioxide starch, corn microcrystalline cellulose west;ward;445 phenobarbital phenobarbital phenobarbital phenobarbital anhydrous lactose silicon dioxide starch, corn docusate sodium lactose monohydrate magnesium stearate cellulose, microcrystalline sodium starch glycolate type a potato west;ward;450

Drug Interactions:

Drug interactions phenobarbital in combination with alcohol, tranquilizers, and other central nervous system depressants has additive depressant effects, and the patient should be so advised. patients taking this drug should be warned not to exceed the dosage recommended by their physician. toxic effects and fatalities have occurred following overdoses of phenobarbital alone and in combination with other central nervous system depressants. caution should be exercised in prescribing unnecessarily large amounts of phenobarbital for patients who have a history of emotional disturbances or suicidal ideation or who have misused alcohol and other cns drugs (see overdosage ).

Warnings:

Warnings in small doses, the barbiturates may increase the reaction to painful stimuli. taken by themselves, the barbiturates cannot be relied upon to relieve pain or even to produce sedation or sleep in the presence of severe pain.

General Precautions:

General precautions barbiturates induce liver microsomal enzyme activity. this accelerates the biotransformation of various drugs and is probably part of the mechanism of the tolerance encountered with barbiturates. phenobarbital, therefore, should be used with caution in patients with decreased liver function. this drug should also be administered cautiously to patients with a history of drug dependence or abuse (see drug abuse and dependence ). phenobarbital may decrease the potency of coumarin anticoagulants; therefore, patients receiving such concomitant therapy should have more frequent prothrombin determinations. as with other sedatives and hypnotics, elderly or debilitated patients may react to barbiturates with marked excitement, depression, or confusion. the systemic effects of exogenous hydrocortisone and endogenous hydrocortisone (cortisol) may be diminished by phenobarbital. thus, this product should be administered with caution to patients with borderline hypoadrenal funct Read more...

ion, regardless of whether it is of pituitary or of primary adrenal origin.

Dosage and Administration:

Dosage and administration oral sedative dose adults: 30 to 120 mg daily in 2 or 3 divided doses. children: 6 mg/kg of body weight daily in 3 divided doses. oral hypnotic dose adults: 100 to 320 mg. oral anticonvulsant dose, adults: 50 to 100 mg 2 or 3 times daily. children: 15 to 50 mg 2 or 3 times daily.

Contraindications:

Contraindications phenobarbital is contraindicated in patients who are hypersensitive to barbiturates. in such patients, severe hepatic damage can occur from ordinary doses and is usually associated with dermatitis and involvement of parenchymatous organs. a personal or familial history of acute intermittent porphyria represents one of the few absolute contraindications to the use of barbiturates. phenobarbital is also contraindicated in patients with marked impairment of liver function, or respiratory disease in which dyspnea or obstruction is evident. it should not be administered to persons with known previous addiction to the sedative/hypnotic group, since ordinary doses may be ineffectual and may contribute to further addiction.

Adverse Reactions:

Adverse reactions the following adverse reactions have been reported: cns depression residual sedation or âhangoverâ, 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. 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 diffused 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. Read more...

allergic acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions. hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. rarely, exfoliative dermatitis (e.g., stevens-johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. the skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. in a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital. other nausea and vomiting; headache. to report suspected adverse reactions, contact hikma pharmaceuticals usa inc. at 1-800-962-8364, or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Drug Interactions:

Overdosage:

Overdosage the signs and symptoms of barbiturate poisoning are referable especially to the central nervous system and the cardiovascular system. moderate intoxication resembles alcoholic inebriation. in severe intoxication, the patient is comatose, the level of reflex activity conforming in a general way to the intensity of the central depression. the deep reflexes may persist for some time despite coexistent coma. the babinski sign is often positive. the eeg may be of the âburst-suppressionâ type, with brief periods of electrical silence. the pupils may be constricted and react to light, but late in the course of barbiturate poisoning they may show hypoxic paralytic dilatation. respiration is affected early. breathing may be either slow or rapid and shallow; cheyne-stokes rhythm may be present. respiratory minute volume is diminished, and hypoxia and respiratory acidosis may develop. the blood pressure falls, owing partly to depression of medullary vasomotor centers; partly to a direct action of the drug on the myocardium, sympathetic ganglia, and vascular smooth muscle; partly to hypoxia. the patient thus develops a typical shock syndrome, with a weak and rapid pulse, cold and clammy skin, and a rise in the hematocrit. respiratory complications (atelectasis, pulmonary edema, and bronchopneumonia) and renal failure are much dreaded and not infrequent concomitant of severe barbiturate poisoning. there is usually hypothermia, sometimes with temperatures as low as 32Â°c. treatment general management should consist of symptomatic and supportive therapy, including gastric lavage, administration of intravenous fluids, and maintenance of blood pressure, body temperature and adequate respiratory exchange. dialysis will increase the rate of removal of barbiturates from the body fluids. antibiotics may be required to control pulmonary complications.

dependence:

Dependence prolonged, uninterrupted use of barbiturates (particularly the short-acting drugs), even in therapeutic doses, may result in psychic and physical dependence. withdrawal symptoms due to physical dependence following chronic use of large doses of barbiturates may include delirium, convulsions, and death.

Description:

Description phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. its saturated solution has a ph of about 5.6. chemically, it is 5-ethyl-5-phenylbarbituric acid with the molecular formula c 12 h 12 n 2 o 3 (232.24). the structural formula is as follows: each phenobarbital tablet usp contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, usp. inactive ingredients are as follows: anhydrous lactose, colloidal silicon dioxide, corn starch, docusate sodium with sodium benzoate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. phenobarbital-structural formula

Clinical Pharmacology:

Clinical pharmacology phenobarbital, a long-acting barbiturate, is a central nervous system depressant. in ordinary doses, the drug acts as a sedative and anticonvulsant. its onset of action occurs within 30 minutes, and the duration of action ranges from 5 to 6 hours. it is detoxified in the liver.

How Supplied:

How supplied phenobarbital tablets, usp 15 mg white, round tablet; debossed âww 445â on one side and plain on the other side. ndc 0143-1445-01: bottle of 100 tablets ndc 0143-1445-05: bottle of 500 tablets ndc 0143-1495-01: bottle of 100 tablets ndc 0143-1495-05: bottle of 500 tablets phenobarbital tablets, usp 30 mg white, round, scored tablet; debossed âww 450â on one side and scored on the other side. ndc 0143-1450-01: bottle of 100 tablets ndc 0143-1450-05: bottle of 500 tablets ndc 0143-1500-01: bottle of 100 tablets ndc 0143-1500-05: bottle of 500 tablets phenobarbital tablets, usp 60 mg white, round tablet; debossed âww 455â on one side and plain on the other side. ndc 0143-1455-01: bottle of 100 tablets ndc 0143-1455-05: bottle of 500 tablets phenobarbital tablets, usp 100 mg white, round, scored tablet; debossed âww 458â on one side and scored on the other side. ndc 0143-1458-01: bottle of 100 tablets ndc 0143-1458-05: bottle of 500 tabl Read more...

ets store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. protect from light and moisture. dispense in a tight, light-resistant container as defined in the usp using a child-resistant closure. distr. by: hikma pharmaceuticals usa inc. eatontown, nj 07724 c50000803/01 revised july 2019

Information for Patients:

Information for patients phenobarbital may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. the patient should be cautioned accordingly.

Package Label Principal Display Panel:

Principal display panel ndc 0143-1445-01 phenobarbital tablets usp 15 mg 100 tablets rx only ndc 0143-1445-01 phenobarbital tablets, usp 15 mg 100 tablets rx only

Principal display panel ndc 0143-1495-01 phenobarbital tablets usp 15 mg 100 tablets rx only ndc 0143-1495-01 phenobarbital tablets, usp 15 mg 100 tablets rx only

Principal display panel ndc 0143-1450-01 phenobarbital tablets usp 30 mg 100 tablets rx only ndc 0143-1450-01 phenobarbital tablets, usp 30 mg 100 tablets rx only

Principal display panel ndc 0143-1500-01 phenobarbital tablets usp 30 mg 100 tablets rx only ndc 0143-1500-01 phenobarbital tablets, usp 30 mg 100 tablets rx only

Principal display panel ndc 0143-1455-01 phenobarbital tablets usp 60 mg 100 tablets rx only ndc 0143-1455-01 phenobarbital tablets, usp 60 mg 100 tablets rx only

Principal display panel ndc 0143-1458-01 phenobarbital tablets usp 100 mg 100 tablets rx only ndc 0143-1458-01 phenobarbital tablets, usp 100 mg 100 tablets rx only

Comments/ Reviews:

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