| Product Information: Phenytoin (Epanutin®/Dilantin®)
What we sell:
| Phenytoin 25 - Epanutin® / Dilantin®
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28 x 25mg |
Capsules |
| Phenytoin 100 - Epanutin® / Dilantin®
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100 x 100mg |
Capsules |
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Manufacturers Insert
PHENYTOIN/ EPANUTIN®
Composition:
Sodium Phenytoin, Lactose and magnesium stearate, s.q.
Information for the User:
Recommended for crises involving Grand Mal, temporal lobe epilepsy and
other convulsive states.
Directions:
The average dosage for adults and children over the age of six is 0.10
gram (one capsule) three times per day before meals. Should an additional
dose of 0.10 grams be necessary, this may be taken at bedtime. the total
adult dosage should not exceed 0.60 grams per day. Children between the
age of four and six should initially take a dose of 0.10 grams twice daily.
For younger children and nursing mothers, the initial dose is 0.05 grams
twice daily.
Guidelines for the Correct Use of this Product:
Following every dose of Epanutin, the patient should drink at least half
a glass of water. Should he suffer from nausea or gastric distress, these
doses may be taken during or after meals.
Contraindications:
Epanutin is not recommended for patients with a history of hypersensitivity
to hydantoins. Because the safety of this product during pregnancy has
not been proven, it’s use should be evaluated not only according
to the benefits involved, but also the possible danger to the foetus.
Recent studies suggest an increased risk of birth defects when the mother
receives treatment for epilepsy during pregnancy.
Caution:
This product contains Lactose. Cases have been reported of poor tolerance
to this product in children and adolescents. Although the amount of Lactose
in this product is probably not sufficient to cause intolerance symptoms.
Consult a doctor in the case of diarrhea.
Pregnant Women and Nursing Mothers:
With Epilepsy and it’s treatment there is a 4% risk of birth defects
in new-borns (approximately double that of the general population). We
recommend the following guidelines
1. Plan your pregnancies with the help of your specialist.
2. If you are already pregnant, do not interrupt treatment and consult
your neurologist.
3. If you are breast-feeding, consult your pediatrician.
Interaction:
Epanutin should not be taken with barbiturates, coumarinic anticoagulants,
Disulfiram, Phenylbutazone and Sulphaphenazol, Isoniazid, tricyclic antidepressants,
Methopyrone and theophilline derivatives.
Side Effects:
Central Nervous System- Nystagmus- Ataxia, slurring and speech alterations,
mental confusion, dizziness, insomnia, temporary nervousness and headaches.
The effects will most likely disappear with continued use of the product,
although a weaker dose is recommended. Digestive System- Possible nausea,
vomiting and constipation. Taking this product during or immediately after
meals may prevent gastrointestinal symptoms. Other Side Effects- Rash,
Morbiliform or scarlatiniform types have been seen in children and young
adults. Hematological alterations, Thrombocytopenia, leucopenia, granulcytosis,
agranulcytosis and pancytopenia. Frequent cases of gingival hyperplasia
have appeared but this problem may be avoided with good oral hygiene,
including gum massage, frequent cleaning and proper dental care.
Intoxication and its Treatment:
Intoxication is treated by stomach pumping. Oxygen therapy, vasopressors
and assisted ventilation may be necessary in the case of depression of
the central nervous, respiratory and cardiovascular systems. Blood replacement
therapy has been employed in cases of severe intoxication in children.
Storage Conditions:
Keep in a cool dry place.
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