Tablet 100/50 mg

pharmacological class



Epilepsy, tonic-clonic seizure pattern, status epilepticus,seizures,seizures in neurosurgery.

Pregnancy Category

Phenytoin C, Phenobarbital D


hydantion & barbiturates anticonvulsants cross the placenta risk-benefit must be considered.


hydantion & barbiturates anticonvulsants are distributed into breast milk.


Cross-sensitivity, patients sensitive to one of the hydantion and barbiturates anticonvulsants may be sensitive to others also.



Children are more sensitive to side and adverse effects of phenytoin & Phenobarbital.


Geriatric patients may needs to reduced usual dose.

Contraindication & Drug interaction

Except under special circumstances, this medication should not be used when the following medical problem exists:

Cardiac function impairment, such as Adams-Stokes syndrome, second- and third-degree AV block, sino-atrial block, and sinus bradycardia, Porphyria, acute intermittent or variegata, or history .

Risk-benefit should be considered when the following medical problems exist:

Alcoholism active, Blood dyscrasias, Cardiovascular disease, Diabetes mellitus, Hepatic function impairment, Porphyria, Renal function impairment, Thyroid function impairment

Anemia, severe, Asthma, history of, Diabetes mellitus, especially with Phenobarbital, Drug abuse or dependence, history of, Hepatic coma, premonitory signs of, or, Hepatic function impairment

Hyperkinesis Hyperthyroidism Hypoadrenalism, borderline, Mental depression and/or,

Suicidal tendencies, Pain, acute or chronic, Renal function impairment, especially with intermediate- and long-acting barbiturates,Respiratory disease involving dyspnea or obstruction, particularly status asthmaticus,Sensitivity to barbiturate prescribed, Caution should be used also in debilitated patients because they may react to usual doses with marked excitement, mental depression, and confusion.

Drug interactions

Alcohol, CNS depression-producing medications, Amiodarone, Antacids, Anticoagulants, Chloramphenicol, Cimetidine, Isoniazid, Phenylbutazone, Sulfonamides, Anticonvulsants succinimide, Corticosteroids glucocorticoid, Cyclosporine, Digitalis glycosides, Disopyramide, Doxycycline, Furosemide, Levodopa, Mexiletine, Quinidine, Antidepressants tricyclic, Bupropion, Clozapine, Haloperidol, Loxapine, Maprotiline, Molindone, Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline or Phenothiazines, Pimozide, Thioxanthenes, Antidiabetic agents oral, Insulin, Antifungals, azole, including: Fluconazole ,Itraconazole , Ketoconazole ,Miconazole, Antineoplastic agents such as: Bleomycin , Carmustine (BCNU),Cisplatin,Dacarbazine ,Doxorubicin ,Ifosfamide , Methotrexate ,Vinblastine ,Barbiturates, Primidone, Calcium, Calcium channel blocking agents including:Diltiazam ,Nifedipine ,Verapamil, Carbamazepine, Carbonic anhydrase inhibitors, Chlordiazepoxide, Clonazepam, Diazepam, Contraceptives, estrogen-containing oral, Contraceptives progestin-containing , Diazoxide, Dopamine, Estrogens, Progestins, Felbamate, Fluoxetine, Leucovorin, Halothane (and possibly enflurane or methoxyflurane), Lamotrigine, Levothyroxine, Lidocaine, Methadone, Omeprazole, Paroxetine, Phenacemide, Praziquantel, Rifampin, Streptozocin, Sucralfate, Ticlopidine, Valproic acid, Vitamin D, Xanthines, such as:

Aminophylline, Caffeine ,Oxtriphylline, Theophylline

Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Acetaminophen, Addictive medications, other, especially CNS depressants with habituating potential, Adrenocorticoids, glucocorticoid and mineralocorticoid ,Chloramphenicol , Corticotropin,Dacarbazine, Metronidazole, Amphetamines, Anesthetics, Anticoagulants, coumarin- or indandione-derivative, Anticonvulsants, succinimide, Antidepressants, tricyclic , Carbonic anhydrase inhibitors, Cyclophosphamide, Disopyramide, Divalproex sodium, Valproic acid, Doxycycline, Fenoprofen, Griseofulvin, Guanadrel, Guanethidine, Haloperidol, Hypothermia-producing medications, Ketamine, Leucovorin, Levothyroxine, Loxapine, Phenothiazines, Thioxanthenes, Maprotiline, Methylphenidate, Mexiletine, , pargyline, Phenylbutazone, Posterior pituitary, Primidone.

Usual Adult Dose


Phenytoin- 100mg three times a day

Phenobarbital- 60 to 250 mg per day as a single dose in divided doses.

Usual Pediatric Dose



Initial: Oral, 5 mg per kg of body weight a day, divided into two or three doses, the dosage being adjusted as needed and tolerated.

Maintenance: Oral, 4 to 8 mg per kg of body weight or 250 mg per square meter of body surface area a day, divided into two or three doses.


Oral ,1 to 6 mg (base)per kg of body weight pr day ,as a single dose or in divided doses.

Side Effects

Those indicating need for medical attention:

Incidence rare

Blood dyscrasias, including agranulocytosis, leucopenia, pancytopenia, and thrombocytopenia, cholestatic jaundice or hepatitis, choreoathetoid movements, transient, cognitive impairment, periarteritis nodosa, Peyronie's disease, pulmonary infiltrates or fibrosis, vitamin D and/or calcium imbalance, Agranulocytosis, allergic reaction, exfoliative dermatitis, hallucinations; hypotension or megaloblastic anemia, Stevens-Johnson syndrome, hrombocytopenia, thrombophlebitis, Hepatic damage, osteopenia or rickets, Sensitivity to barbiturates, mental depression, paradoxical reaction

Those indicating need for medical attention only if they continue or are bothersome

Incidence more frequent

Constipation, mild dizziness, mild drowsiness, nausea and vomiting, Clumsiness or unsteadiness; dizziness or lightheadedness; drowsiness; "hangover" effect

Incidence less frequent

Diarrhea, enlargement of facial features, including thickening of lips, widening of nasal tip, and protrusion of jaw; gynecomastia, headache, hypertrichosis, insomnia, muscle twitching, Exfoliative dermatitis, Stevens-Johnson syndrome, Severe respiratory depression, apnea, laryngospasm, bronchospasm, Prolonged barbiturate therapy may result in osteopenia or rickets, Barbiturate dependence may occur, Anxiety or nervousness; constipation; feeling faint; headache; irritability; nausea or vomiting; nightmares or trouble in sleeping

Those indicating possible barbiturate withdrawal and need for medical attention if they occur after medication is discontinued:

Anxiety or restlessness; muscle twitching; trembling of hands; weakness; dizziness; vision problems; nausea; vomiting; trouble in sleeping, increased dreaming, or nightmares; orthostatic hypotension, Convulsions; hallucinations.


Store below 30°C (86°F). Protect from light and keep the medicine in the box.


Box of 100, Scored tablets Phenytoin/Phenobarbital 100/50mg.





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