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Phenytoin (Phenytoin)

Trade Name : Phenytoin

VistaPharm, Inc.

SUSPENSION

Strength 125 mg/5mL

PHENYTOIN Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Phenytoin (Phenytoin) which is also known as Phenytoin and Manufactured by VistaPharm, Inc.. It is available in strength of 125 mg/5mL per ml. Read more

Phenytoin (Phenytoin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions ()u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 7/2019
  • Warnings and Precautions ()u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 10/2018
  • Warnings and Precautions ()u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a07/2019
  • Phenytoin is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.
  • Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. ()
  • No data
  • Phenytoin is available as a 125 mg phenytoin/5 mL oral suspension of opaque orange color with an orange flavor.
  • Phenytoin oral suspension is available as a 125 mg phenytoin/5 mL oral suspension.()
  • Phenytoin is contraindicated in patients with:
  • No data
  • Withdrawal Precipitated Seizuren- 5.1
  • Suicidal Behavior and Ideation:n- 5.2
  • Serious Dermatologic Reactions:n- 5.3
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity:n- 5.4
  • Array
  • Array
  • Arrayn- Array
  • Hematopoietic Complications:n- 5.9
  • The following serious adverse reactions are described elsewhere in the labeling:
  • The following adverse reactions associated with the use of phenytoin were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Body as a Whole:n- Warnings and Precautions (, , )n- .
  • There have also been reports of coarsening of facial features, systemic lupus erythematosus, periarteritis nodosa, and immunoglobulin abnormalities.
  • Digestive System:
  • Hematologic and Lymphatic System:n- [see n
  • Laboratory Test Abnormality:n- [see n n
  • Nervous System:n- [see n n
  • A predominantly sensory peripheral polyneuropathy has been observed in patients receiving long-term phenytoin therapy.
  • Skin and Appendages:n- [see n
  • Special Senses:
  • Urogenital:
  • The most common adverse reactions are nervous system reactions, including nystagmus, ataxia, slurred speech, decreased coordination, somnolence, and mental confusion. ()
  • Phenytoin is extensively bound to plasma proteins and is prone to competitive displacement. Phenytoin is metabolized by hepatic cytochrome P450 enzymes CYP2C9 and CYP2C19 and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity. Monitoring of phenytoin serum levels is recommended when a drug interaction is suspected.
  • Phenytoin is a potent inducer of hepatic drug-metabolizing enzymes.
  • Multiple drug interactions because of extensive plasma protein binding, saturable metabolism and potent induction of hepatic enzymes (, ).
  • No data
  • The lethal dose in pediatric patients is not known. The lethal dose in adults is estimated to be 2 to 5 grams. The initial symptoms are nystagmus, ataxia, and dysarthria. Other signs are tremor, hyperreflexia, lethargy, slurred speech, blurred vision, nausea, and vomiting. The patient may become comatose and hypotensive. Bradycardia and cardiac arrest have been reported [see ]. Death is caused by respiratory and circulatory depression.
  • There are marked variations among individuals with respect to phenytoin serum levels where toxicity may occur. Nystagmus, on lateral gaze, usually appears at 20 mcg/mL, ataxia at 30 mcg/mL, dysarthria and lethargy appear when the serum concentration is over 40 mcg/mL, but as high a concentration as 50 mcg/mL has been reported without evidence of toxicity. As much as 25 times the therapeutic dose has been taken to result in a serum concentration over 100 mcg/mL with complete recovery. Irreversible cerebellar dysfunction and atrophy have been reported.
  • Treatment:
  • The adequacy of the respiratory and circulatory systems should be carefully observed and appropriate supportive measures employed. Hemodialysis can be considered since phenytoin is not completely bound to plasma proteins. Total exchange transfusion has been used in the treatment of severe intoxication in pediatric patients.
  • In acute overdosage the possibility of other CNS depressants, including alcohol, should be borne in mind.
  • Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula:
  • Each 5 mL of the oral suspension contains 125 mg of phenytoin, USP; anhydrous citric acid, carboxymethylcellulose sodium, FD&C yellow no. 6, flavor orange, glycerin, magnesium aluminum silicate, polysorbate 80, purified water, sodium benzoate, and sucrose.
  • No data
  • Carcinogenesisu00a0
  • [see n
  • In carcinogenicity studies, phenytoin was administered in the diet to mice (10, 25, or 45 mg/kg/day) and rats (25, 50, or 100 mg/kg/day) for 2 years. The incidences of hepatocellular tumors were increased in male and female mice at the highest dose. No increases in tumor incidence were observed in rats. The highest doses tested in these studies were associated with peak serum phenytoin levels below human therapeutic concentrations.
  • In carcinogenicity studies reported in the literature, phenytoin was administered in the diet for 2 years at doses up to 600 ppm (approximately 160 mg/kg/day) to mice and up to 2400 ppm (approximately 120 mg/kg/day) to rats. The incidences of hepatocellular tumors were increased in female mice at all but the lowest dose tested. No increases in tumor incidence were observed in rats.
  • Mutagenesis
  • Phenytoin was negative in the Ames test and in the in vitro clastogenicity assay in Chinese hamster ovary (CHO) cells.
  • In studies reported in the literature, phenytoin was negative in the in vitro mouse lymphoma assay and the in vivo micronucleus assay in mouse. Phenytoin was clastogenic in the in vitro sister chromatid exchange assay in CHO cells.
  • Fertility
  • Phenytoin has not been adequately assessed for effects on male or female fertility.
  • No data
  • Advise patients to read the FDA-approved patient labeling ().
  • Administration Information
  • Advise patients taking phenytoin of the importance of adhering strictly to the prescribed dosage regimen, and of informing the physician of any clinical condition in which it is not possible to take the drug orally as prescribed, e.g., surgery, etc.
  • Instruct patients to use an accurately calibrated measuring device when using this medication to ensure accurate dosing.
  • Withdrawal of Antiepileptic Drugs
  • Advise patients not to discontinue use of phenytoin oral suspension without consulting with their healthcare provider. Phenytoin oral suspension should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus n
  • Suicidal Ideation and Behavior
  • Counsel patients, their caregivers, and families that AEDs, including phenytoin oral suspension, may increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare n
  • Serious Dermatologic Reactions
  • Advise patients of the early signs and symptoms of severe cutaneous adverse reactions and to report any occurrence immediately to a physician n
  • Potential Signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Other Systemic Reactions
  • Advise patients of the early toxic signs and symptoms of potential hematologic, dermatologic, hypersensitivity, or hepatic reactions. These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy, facial swelling, and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. Advise the patient that, because these signs and symptoms may signal a serious reaction, that they must report any occurrence immediately to a physician. In addition, advise the patient that these signs and symptoms should be reported even if mild or when occurring after extended usen
  • Cardiac Effectsn
  • Counsel patients that cases of bradycardia and cardiac arrest have been reported, both at recommended phenytoin doses and levels, and in association with phenytoin toxicity. Patients should report cardiac signs or symptoms to their healthcare provider [see ].
  • Angioedema
  • Advise patients to discontinue Phenytoin and seek immediate medical care if they develop signs or symptoms of angioedema, such as facial, perioral, or upper airway swelling [see ].
  • Effects of Alcohol Use and Other Drugs and Over-the-Counter Drug Interactions
  • Caution patients against the use of other drugs or alcoholic beverages without first seeking their physicianu2019s advice n
  • Inform patients that certain over-the-counter medications (e.g., antacids, cimetidine, and omeprazole), vitamins (e.g., folic acid), and herbal supplements (e.g., St. Johnu2019s wort) can alter their phenytoin levels.
  • Hyperglycemia
  • Advise patients that phenytoin oral suspension may cause an increase in blood glucose levels n
  • Gingival Hyperplasia
  • Advise patients of the importance of good dental hygiene in order to minimize the development of gingival hyperplasia and its complications.
  • Neurologic Effects
  • Counsel patients that phenytoin oral suspension may cause dizziness, gait disturbance, decreased coordination and somnolence. Advise patients taking phenytoin oral suspension not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with phenytoin oral suspension.
  • Use in Pregnancy
  • Inform pregnant women and women of childbearing potential that use of phenytoin oral suspension during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate (oral clefts), cardiac defects, dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits. When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options. Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using phenytoin oral suspension, keeping in mind that there is a potential for decreased hormonal contraceptive efficacy n
  • Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they are breastfeeding or intend to breastfeed during therapy n
  • Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy n
  • Manufactured by:
  • Largo, FL 33771, USA
  • VP2055R9
  • 07/2019
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0
  • Distributed by:
  • u00a0
  • Largo, FL 33771, USA
  • VP2098R5
  • 10/2018
  • Phenytoin
  • Oral Suspension, USP
  • 100 mg per 4 mL
  • PHARMACIST: Dispense the enclosed Medication Guide to each patient.u00a0
  • Delivers 4 mL
  • SHAKE WELL. Do not freeze. Protect from light.u00a0
  • Store at 20u00b0u201325u00b0C (68u00b0u201377u00b0F); see USP CRT conditions.u00a0
  • Manufactured by:
  • VistaPharm, Inc.
  • Largo, FL 33771, USA
  • Xactdose
  • Rx Only
  • VP2054R2
  • 06/18
  • NDC 66689-036-01

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