Chemical formula: C₁₀H₁₄N₂O₄S₂ Molecular mass: 290.359 g/mol PubChem compound: 5356
Sultiame interacts in the following cases:
Sultiame is Pregnancy Category D – Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
The risk of a mother with epilepsy giving birth to a baby with an abnormality is about three times that of the normal population. Some of this risk is due to the anticonvulsant drugs taken. Mothers taking more than one anticonvulsant drug might have a higher risk of having a baby with a malformation than mothers taking one drug. There is a lack of data permitting any statement that women taking sulthiame are at any different risk of having a baby with an abnormality from women taking other anticonvulsants. Overall, the risk of having an abnormal child is far outweighed by the dangers to the mother and fetus of uncontrolled convulsions. If administered during pregnancy the dose of sulthiame must be kept as low as possible, particularly between days 20 and 40 of gestation.
It is not known whether sulthiame is excreted in breast milk or whether it has a harmful effect on the newborn. Therefore, it is not recommended for breastfeeding mothers, unless the expected benefits outweigh any potential risk.
The following frequency categories are used for the evaluation of adverse effects:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (≥1/10,000)
Not known (frequency cannot be estimated from the available data)
Very common: anorexia
Common: weight loss
Uncommon: hallucinations, anxiety, lack of drive, psychic changes, depression, behavioral anomaly
Common: ataxia, paraesthesias in the extremities and in the face (dose dependent), dizziness (giddiness)
Uncommon: headache, myasthenic phenomena, grand-mal status, increased seizure activity, drooling, insomnia
Not known: polyneuritis
Common: double vision
Common: stenocardia, tachycardia
Very common: hyperpnoea, dyspnoea
Common: tachypnoea, singultus
Very common: gastric complaints (in about 10% of patients)
Uncommon: abdominal pain, nausea
Not known: hepatotoxic reactions, increase of liver enzymes
Uncommon: Stevens-Johnson syndrome,
Not Known: Rash, Lyell’s syndrome
Uncommon: joint pain
Not known: acute renal failure
Uncommon: leucopenia
In one case, administration of Ospolot led to progressive weakness of the limbs, hypersalivation, slurred speech, increasing drowsiness up to coma. The symptoms abated within hours of Ospolot being discontinued.
Sulthiame is a carbonic anhydrase inhibitor. Therefore, undesirable effects of carbonic anhydrase inhibition, such as renal stone formation, metabolic acidosis, haemodilution and changes in serum electrolyte values, cannot be excluded during administration of sulthiame.
Disturbances in calcium and Vitamin D metabolism have been occasionally reported in association with long-term anticonvulsant therapy.
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