Phenytoin Infatabs

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Overview

What is Phenytoin Infatabs?

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 Phenytoin Infatab, chewable tablet for oral administration, contains 50 mg phenytoin, USP. Also contains: D&C yellow No. 10, Aluminum Lake; FD&C yellow No. 6, Aluminum Lake; flavor; saccharin sodium, USP; confectioner's sugar, NF; talc, USP; magnesium stearate, NF; and purified water, USP.

What does Phenytoin Infatabs look like?

What are the available doses of Phenytoin Infatabs?

Phenytoin Infatabs are available as 50 mg phenytoin scored chewable tablets. ()

What should I talk to my health care provider before I take Phenytoin Infatabs?

How should I use Phenytoin Infatabs?

Phenytoin Infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.

NOT FOR ONCE-A-DAY DOSING. Phenytoin Infatabs can be either chewed thoroughly before being swallowed or swallowed whole.

What interacts with Phenytoin Infatabs?

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What are the warnings of Phenytoin Infatabs?

Sorry No Records found

What are the precautions of Phenytoin Infatabs?

Sorry No Records found

What are the side effects of Phenytoin Infatabs?

Sorry No records found

What should I look out for while using Phenytoin Infatabs?

Phenytoin is contraindicated in patients with:

What might happen if I take too much Phenytoin Infatabs?

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. 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.

How should I store and handle Phenytoin Infatabs?

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.

Non-Clinical Toxicology

Phenytoin is contraindicated in patients with:

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Oxycodone Hydrochloride and Acetaminophen Tablets.

If concomitant use is necessary, consider dosage reduction of Oxycodone Hydrochloride and Acetaminophen Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Oxycodone Hydrochloride and Acetaminophen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

If concomitant use is necessary, consider increasing the Oxycodone Hydrochloride and Acetaminophen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Oxycodone Hydrochloride and Acetaminophen Tablets dosage reduction and monitor for signs of respiratory depression.

Benzodiazepines and Other CNS Depressants

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see ].

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxycodone Hydrochloride and Acetaminophen Tablets if serotonin syndrome is suspected.

The use of Oxycodone Hydrochloride and Acetaminophen Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics

Advise patient to avoid concomitant use of these drugs.

Muscle Relaxants

If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Oxycodone Hydrochloride and Acetaminophen Tablets and/or the muscle relaxant as necessary.

Diuretics

If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.

Anticholinergic Drugs

If concomitant use is warranted, monitor patients for signs of urinary retention or reduced gastric motility when Oxycodone Hydrochloride and Acetaminophen Tablets are used concomitantly with anticholinergic drugs.

Alcohol, ethyl

Oral Contraceptives

Charcoal (activated)

Beta Blockers (Propranolol)

Loop Diuretics

Lamotrigine

Probenecid

Zidovudine

Abrupt withdrawal of phenytoin in epileptic patients may precipitate status epilepticus. When, in the judgment of the clinician, the need for dosage reduction, discontinuation, or substitution of alternative anticonvulsant medication arises, this should be done gradually. However, in the event of an allergic or hypersensitivity reaction, more rapid substitution of alternative therapy may be necessary. In this case, alternative therapy should be an anticonvulsant not belonging to the hydantoin chemical class.

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:

[see , ]

There have also been reports of coarsening of facial features, systemic lupus erythematosus, periarteritis nodosa, and immunoglobulin abnormalities.

Digestive System:

Hematologic and Lymphatic System:

[see ]

Laboratory Test Abnormality:

[see ]

Nervous System:

[see ]

A predominantly sensory peripheral polyneuropathy has been observed in patients receiving long-term phenytoin therapy.

Skin and Appendages:

[see ]

Special Senses:

Urogenital:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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