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Indications and usage:
Dilantin (Phenytoin Sodium) is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Dosage and administration:
Overdosage:
The lethal dose of phenytoin 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. 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:
Treatment is nonspecific since there is no known antidote.
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 by Dilantin (Phenytoin Sodium) pills the possibility of other CNS depressants, including alcohol, should be borne in mind.
Dosage forms and strengths:
Dilantin (Phenytoin Sodium) is available as 30 mg and 100 mg extended-release capsules.
Contraindications:
Warnings and precautions:
Adverse reactions, side effects:
The most common adverse reactions of this medication are nervous system reactions, including nystagmus, ataxia, slurred speech, decreased coordination, somnolence, and mental confusion.
To report suspected side effects of Dilantin (Phenytoin Sodium) capsules contact Pfizer, Inc. pharmaceutical company or your local FDA.
Drug interactions:
Multiple drug interactions because of extensive plasma protein binding, saturable metabolism and potent induction of hepatic enzymes.
Use in specific populations:
Pregnancy
Prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes.
Lactation
Phenytoin is secreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dilantin and any potential adverse effects on the breastfed infant from this medicine or from the underlying maternal condition.
Pediatric use
Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years and adolescents may require the minimum adult dosage (300 mg/day).
Geriatric use
Phenytoin clearance tends to decrease with increasing age. Lower or less frequent dosing may be required.
Renal and/or hepatic impairment or hypoalbuminemia
Monitor unbound phenytoin concentrations in these patients.
Information for patients:
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.
Advise patients not to use capsules which are discolored.
Withdrawal of antiepileptic drugs
Advise patients not to discontinue use of Dilantin without consulting with their healthcare provider. This drug should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus.
Suicidal ideation and behavior
Counsel patients, their caregivers, and families that AEDs, including phenytoin sodium capsules, 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 providers.
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.
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 use.
Cardiac effects
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.
Angioedema
Advise patients to discontinue Dilantin and seek immediate medical care if they develop signs or symptoms of angioedema, such as facial, perioral, or upper airway swelling.
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 physician's advice.
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. John's wort) can alter their phenytoin levels.
Hyperglycemia
Advise patients that this medication may cause an increase in blood glucose levels.
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 may cause dizziness, gait disturbance, decreased coordination and somnolence. Advise patients taking Dilantin not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with this medicine.
Use in pregnancy
Inform pregnant women and women of childbearing potential that use of Dilantin (Phenytoin Sodium) pills 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 Dilantin, keeping in mind that there is a potential for decreased hormonal contraceptive efficacy.
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.
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.
Where to buy phenytoin online:
To purchase Dilantin (Phenytoin Sodium) 100 mg capsules or tablets from reliable online pharmacies and drugstores at low prices please use resources described above on this webpage.
Here is a list of popular medications containing phenytoin as a main active pharmaceutical ingredient; their trade names, forms, doses, companies - manufacturers, distributors, suppliers, researchers and developers:
| Trade name of the drug | Pharmaceutical forms and doses | Companies |
| Dilantin | ||
| Epamin | ||
| Epanutin | ||
| Eptoin |