Ipanten 50 mg, 100 mg capsules – Phenytoin Sodium

Ipanten is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Ipanten is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Ipanten used to treat Epilepsy: Epilepsy is a disorder in which the electrical activity in the brain briefly becomes irregular. This abnormal electrical activity results in events called seizures. Seizures occur suddenly and usually lasts for seconds to minutes. During a seizure, a person can experience a change in behavior, body movements, and level of awareness (consciousness). There are many types of epilepsies and more than 30 types of seizures.

Ipanten has two common off-label uses:

  • It may be helpful in treating a kind of face pain called trigeminal neuralgia. The seizure medicine carbamazepine (Tegretol) is usually more effective, however.
  • Doctors sometimes use Ipanten to treat patients with certain psychiatric disorders, such as the mania of bipolar disorder. Few studies have shown a definite benefit, however. Another reason for caution in this kind of use is that phenytoin interacts with many of the medicines generally used to treat psychiatric disorders.

Composition

IPANTEN
IPANTEN
  • Ipanten 50 mg capsules: Each 1 Capsule contains 100 mg Phenytoin sodium.
  • Ipanten 100 mg capsules: Each 1 Capsule contains 50 mg Phenytoin sodium.

People who switch from Ipanten to other phenytoin preparation possibly risk having more seizures or side effects during the changeover, because the body does not absorb the different phenytoin preparation in the same way. All these risks are not fully known. For some people the effects of changing from one type to another are very small.

Dosage and Administration

  • The most important goal of treatment is the greatest possible reduction in seizures with respect to both frequency and severity – taking the tolerability of the medication into account. Single-dose quantities and dosing intervals will be determined according to each individual case and according to individual response to medication. Therefore, a general dosage scheme does not exist.
  • Take the capsule with liquid.
  • In every case of medical treatment of epilepsy, it is most important that dosage prescribed by the physician be strictly adhered to and that the patient, under no circumstances, change the dosage or stop the medication even if no further seizures occur.
  • Sudden withdrawal may cause accumulation of attacks or status epilepticus. Therefore, the dosage should be reduced gradually with gradual introduction of increased doses of a replacement antiepileptic medication.
  • In light of the narrow therapeutic spectrum and differing bioavailability of Ipanten and other phenytoin preparations, a switch should be made only under ,close monitoring of the plasma concentration of phenytoin.  A constant plasma concentration under steady-state is attained only after 5-14 days.
Unless otherwise prescribed, the following regimen is to be observed:
Adults: If not treated before with any other anticonvulsant: 300 mg phenytoin a day in 3 doses. This dose can be increased at weekly intervals by 100 mg daily. Adjustment and especially the higher doses should only be prescribed after clinical examination and monitoring plasma concentration. Normally, a daily maintenance dose of 300 to 400 mg is sufficient.
Rapid saturation in adults: The required saturation level should be performed under clinical conditions and under monitoring of the plasma concentration. Oral: 1 g/day, divided into 3 doses (400 mg, 300 mg, 300 mg) administered at 2 hour intervals. The maintenance dose on day 2 is a total of 300 mg.
General Dose for children: For gradual dose increases, children up to 12 years are given 2 mg/kg body weight/day . Dosage can be increased every 3 days by 1 mg/kg body weight /day according to plasma concentration.
For rapid saturation level, children up to 12 years are given 5-8 mg/kg body weight/ day, under monitoring of the plasma concentrations, children older than 6 years may be given 150-200 mg/day starting on day 2 as a maintenance dose: the dose for children under 6 is adjusted on the basis of the plasma concentration. The maintenance dose is determined individually according to seizure frequency, side effects and plasma concentration. The usual daily maintenance dose is 4-8 mg/kg body weight. The daily dose should be divided into 2-4 single doses.

Side Effects

Headache, nausea, vomiting, constipation, dizziness, feeling of spinning, drowsiness, trouble sleeping, or nervousness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Ipanten may cause swelling and bleeding of the gums. Massage your gums and brush and floss your teeth regularly to minimize this problem. See your dentist regularly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: slow heartbeat, unusual eye movements, loss of coordination, trouble speaking, confusion, muscle twitching, double or blurred vision, tingling of the hands/feet, facial changes (e.g., swollen lips, butterfly-shaped rash around the nose/cheeks), excessive hair growth, increased thirst or urination, unusual tiredness, bone or joint pain, easily broken bones.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

Get medical help right away if any of these rare but very serious side effects occur: uncontrolled muscle movements, signs of liver problems (such as nausea/vomiting that doesn’t stop, stomach/abdominal pain, yellowing eyes/skin, dark urine), easy bruising/bleeding.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Packaging

  • Pack of 50 Capsules 100 mg and Inner leaflet.
  • Pack of 50 Capsules 50 mg and Inner leaflet.
  • Manufactured By :Arab Company For Gelatine And Pharmaceutical Products (Arab Caps). for : ACDIMA International.
N03AB02 phenytoin ANTIEPILEPTICS Hydantoin derivatives ACDIMA International.

Ipanten – Information Leaflet

AR- Patient_Information_Leaflet
Ipanten – AR- Patient_Information_Leaflet
ENG-Patient-Information-Leaflet
Ipanten – ENG-Patient-Information-Leaflet
Council of Arab Health Ministers and Union of Arab pharmacists
Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sells the medicament.
The doctor and the pharmacist are experts in medicine, its benefits and risks.
Do not by yourself intenupt the period of treatment prescribed for you.
Do not repeat the same prescription without consulting your doctor.
Keep medicament out of children reach.

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