Orfiril
Orfiril 100 mg/ml solution for injection is an epilepsy medication used to treat epileptic seizures.
Form
injektioneste, liuos
Strength
100 mg/ml
Active Ingredient
Sodium valproate
Manufacturer
Desitin Arzneimittel GmbH
How to Use
Dosage
The starting dose is 5-10 mg/kg given as a slow intravenous injection. The dose can be increased by 5 mg/kg every 4-7 days.
Method
The medication is given intravenously (into a vein) either as a slow injection over 3-5 minutes or as an infusion.
Important
The recommended maximum daily dose for adults is 2400 mg.
Possible Side Effects
COMMON
- •Increased ammonia levels in the blood
- •Stomach pain, nausea, vomiting
- •Tremors
- •Seizures
- •Bruising or bleeding
- •Changes in blood counts (decrease in platelets, red and white blood cells)
- •Weight changes (increase or decrease), changes in appetite
- •Increased insulin levels in the blood
- •Headache, dizziness, drowsiness
- •Skin sensations (burning, prickling, itching, tingling)
- •Decreased level of consciousness (stupor)
- •Muscle stiffness, reduced movement, muscle tremors
- •Aggression, agitation, difficulty concentrating
- •Confusion, hallucinations, loss of appetite
- •Memory impairment, involuntary eye movements, dizziness
- •Hypersensitivity
- •Temporary hair loss, hair discoloration and curling
- •Missed periods (amenorrhea)
- •Diarrhea
- •Gum disorders (such as gum overgrowth), gingivitis
- •Low sodium levels in the blood
- •Changes in liver function tests
- •Decreased HDL cholesterol levels
- •Nail and nail bed disorders
- •Involuntary urination
RARE
- •Decrease in all blood cell types (pancytopenia)
- •Severe liver damage, including liver failure
- •Severe allergic reaction causing swelling of hands, feet, face, lips, tongue, and throat (angioedema)
- •Pancreatitis, which can be fatal
- •Kidney failure (decreased urine output)
- •Irritability, hyperactivity
- •Coordination disorders (ataxia), jerky muscle movements
- •Mental disorders and other brain disorders (e.g., encephalopathy)
- •Temporary coma (sometimes associated with increased seizures)
- •Worsening of seizures
- •Parkinsonism (resolves after treatment cessation)
- •Change in taste perception
- •Syndrome of inappropriate antidiuretic hormone (SIADH) (weight gain, nausea, vomiting, muscle cramps, confusion, and seizures)
- •Vasculitis
- •Menstrual pain (dysmenorrhea)
- •Increased male hormones (hirsutism, acne, male-pattern hair loss in women)
- •Low body temperature
- •Rash
- •Decreased number and quality of blood-forming cells in the bone marrow (myelodysplastic syndrome)
- •Bone marrow dysfunction
- •Enlarged red blood cells (macrocytosis) or decreased red blood cells (macrocytic anemia)
- •Absence of red blood cell formation
- •Significant decrease in certain white blood cells (agranulocytosis)
- •Low levels of certain proteins (insulin-like growth factor binding protein I) in the blood
- •Underactive thyroid gland
- •Swelling of legs and/or arms, abnormal behavior, learning difficulties, psychomotor hyperactivity
- •Difficulty falling asleep
- •Brain dysfunction with brain shrinkage, which resolves after stopping treatment
- •Impaired understanding, memory or thinking (cognitive disorder)
- •Double vision, speech disorder, coordination disorders
- •Severe muscle breakdown (rhabdomyolysis)
- •Increased salivation
- •Severe blistering skin and mucous membrane reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- •Skin redness (erythema multiforme)
- •Drug rash with increased white blood cells (eosinophilia), swollen lymph nodes, fever, and possible organ damage (DRESS syndrome)
- •Immune system disorder causing joint pain, rash, and fever (SLE)
- •Polycystic ovary syndrome with cysts forming in ovaries
- •Male infertility (usually reversible after stopping treatment)
- •Injection site inflammation and pain
- •Frequent urination and thirst (Fanconi syndrome)
- •Bedwetting
- •Kidney tissue inflammation
- •Obesity
- •Decreased levels of at least one clotting factor and changes in clotting tests
- •Decreased Vitamin B8 (biotin) levels
- •Changes in blood composition (decrease or increase in white blood cells, reduced platelet aggregation, decrease in clotting factors)
- •Prolonged bleeding time
- •Psychosis, anxiety, depression, hearing loss (reversible and irreversible) and ringing in the ears
Important Warnings
- Orfiril can seriously harm an unborn baby if used during pregnancy.
- Women of childbearing age must use effective contraception throughout the entire treatment period.
- Contact your doctor immediately if you are planning to get pregnant or suspect you are pregnant.
- Do not stop taking this medication without first talking to your doctor, as your condition may worsen.
- Tell your doctor immediately if you or your child suddenly develop general unwellness, nausea, vomiting, upper abdominal pain, tiredness, swollen legs, yellow skin or eyes, or weakness, as these could be signs of liver damage.
Show 3 more warnings
- Seek immediate medical attention if you develop severe skin reactions, such as blistering, peeling skin, or sores.
- Tell your doctor if you have thoughts of harming yourself or suicide.
- If your child is taking several epilepsy medications at the same time, talk to your doctor.
Use in Elderly Patients
Category C
Suitable for older adults, with specific precautions. Low serum albumin levels increase the response. Consider potential adverse effects, such as hyponatraemia och hematological changes. Monitor liver function. (updated 10.11.2025)