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Isotretinoin Actavis

Isotretinoin Actavis is a medicine containing isotretinoin, used to treat severe forms of acne in adults and teenagers when other treatments have not worked.

Form
kapseli, pehmeä
Strength
20 mg
Active Ingredient
Isotretinoin
Manufacturer
Actavis Group PTC ehf

How to Use

Dosage

The usual starting dose is 0.5 mg per kilogram of body weight daily. For example, a 60 kg person usually starts with 30 mg per day. Your doctor may adjust this dose, with most patients taking between 0.5 mg and 1.0 mg per kg daily. If you have severe kidney problems, treatment may start with a lower dose like 10 mg per day.

Method

Take the capsules once or twice a day with food. Swallow them whole with a drink or food.

Important

The maximum daily dose for most patients is up to 1.0 mg per kilogram of body weight, as determined by your doctor. The treatment typically lasts 16 to 24 weeks.

Possible Side Effects

COMMON
  • •Dry skin, especially lips and face; skin inflammation; chapped and inflamed lips; rash; mild itching and slight peeling.
  • •Abnormal skin fragility and redness, especially on the face.
  • •Back pain; muscle pain; joint pain, especially in children and teenagers.
  • •Eye inflammation (conjunctivitis) or eyelid inflammation. Eyes feel dry and irritated.
  • •Increased liver enzyme levels seen in blood tests.
  • •Changes in blood fat levels (e.g., HDL cholesterol or triglycerides).
  • •Increased tendency to bruise, bleed, or clot – if treatment affects platelets.
  • •Anemia – weakness, dizziness, pale skin – if treatment affects red blood cells.
  • •Headache.
  • •Increased blood cholesterol levels.
  • •Presence of proteins or blood in urine.
  • •Increased susceptibility to infection – if treatment affects white blood cells.
  • •Dry nasal lining and crusting, which may cause minor nosebleeds.
  • •Soreness and inflammation of the throat and nose.
  • •Increased blood sugar levels.
RARE
  • •Severe skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) that can be life-threatening, possibly starting as round patches with blisters, especially on arms, hands, legs, and feet, progressing to widespread skin peeling. May also include eye inflammation and sores in the mouth, throat, or nose. Often preceded by headache, fever, and flu-like aches.
  • •Depression or similar disorders (sadness, mood swings, anxiety, emotional difficulties).
  • •Worsening of depression.
  • •Violence or aggression.
  • •Suicidal thoughts or attempts, some successful. These individuals may not have appeared depressed.
  • •Abnormal behavior.
  • •Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that are not there.
  • •Severe (anaphylactic) reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and mouth. Also sudden swelling of hands, feet, and ankles.
  • •Sudden tightness in the chest, shortness of breath, and wheezing (especially if you have asthma).
  • •Muscle weakness that can be life-threatening, making it difficult to move arms or legs; painful, swollen, and bruised areas on the body; dark urine; reduced or no urine output; confusion or dehydration. These are signs of rhabdomyolysis.
  • •Sacroiliitis, a type of inflammatory back pain causing buttock or lower back pain.
  • •Yellowing of skin or eyes and feeling tired. These can be signs of hepatitis (liver inflammation).
  • •Difficulty urinating, swollen and puffy eyelids, and feeling very tired. These can be signs of kidney inflammation.
  • •Persistent headache with nausea and vomiting, and vision changes like blurred vision. These can be signs of benign intracranial pressure increase, especially if Isotretinoin Actavis is used with tetracycline antibiotics.
  • •Severe abdominal pain, possibly with severe bloody diarrhea, nausea, and vomiting. These can be signs of serious bowel disease.
  • •Blurred vision.
  • •Allergic reactions, such as itching and rash.
  • •Hair loss (alopecia). This is usually temporary, and hair growth returns to normal after treatment.
  • •Worsening night vision; color blindness and worsening color vision.
  • •Increased sensitivity to light.
  • •Other vision disturbances, such as blurred vision, distorted vision, clouding of the eye surface (corneal opacity, cataracts), contact lens irritation, corneal inflammation (keratitis).
  • •Severe thirst, frequent urination. These can be signs of diabetes.
  • •Acne symptoms may worsen during the first weeks of treatment.
  • •Skin inflammation, swelling, and darkening, especially on the face, rash (exanthema), skin discoloration, red and raised skin growths that bleed easily (pyogenic granuloma).
  • •Excessive sweating or itching.
  • •Arthritis, bone disorders (slowed growth, excessive growth and changes in bone density), growing bones may stop growing.
  • •Soft tissue calcification; tendon tenderness; abnormally high levels of muscle breakdown products in blood, if strenuous exercise is done during treatment.
  • •Increased photosensitivity.
  • •Bacterial infections of the nail folds, nail changes.
  • •Swelling, pus formation.
  • •Severe scar formation after surgery.
  • •Increased body hair.
  • •Hair disorders.
  • •Seizures, drowsiness, dizziness.
  • •Possible swelling of lymph nodes.
  • •Dry throat, hoarseness.
  • •Hearing difficulties.
  • •General feeling of unwellness.
  • •Increased blood uric acid levels.
  • •Bacterial infections.
  • •Blood vessel inflammation (sometimes with bruises, red patches).
  • •Dark or cola-colored urine.
  • •Difficulty getting or maintaining an erection.
  • •Decreased libido.
  • •Swelling of male breasts, possibly with tenderness.
  • •Vaginal dryness.
  • •Urethritis (inflammation of the urethra).

Important Warnings

  • This medicine can cause serious harm to an unborn baby. Women must use effective contraception and must not be pregnant or become pregnant during treatment or for one month after stopping. Do not breastfeed.
  • Do not use this medicine for children under 12 years old or before puberty.
  • Do not take if you are allergic to isotretinoin, soy, peanuts, or any other ingredients in this medicine.
  • Tell your doctor if you have liver problems, very high blood fat levels (cholesterol or triglycerides), very high vitamin A levels in your blood, or kidney problems.
  • Do not take this medicine with tetracycline antibiotics, vitamin A supplements, or other acne skin treatments.
Show 6 more warnings
  • Isotretinoin Actavis can affect your mood. Tell your doctor if you have ever had mental health problems (like depression, aggressive behavior, mood swings, suicidal thoughts). It's important to tell friends and family so they can help notice changes.
  • Do not donate blood during treatment or for one month after, as it could harm an unborn baby if a pregnant person receives your blood.
  • This medicine can affect your night vision, sometimes suddenly. It can also cause drowsiness or dizziness. Do not drive or operate machines if you experience these symptoms.
  • Your skin will likely become dry. Use moisturizers and lip balm. Avoid harsh exfoliating or acne products, excessive sun exposure (use SPF 15+), sunlamps, tanning beds, and cosmetic skin treatments like waxing or laser.
  • Reduce strenuous exercise as this medicine can cause muscle and joint pain. Tell your doctor if you have prolonged lower back or buttock pain.
  • Never give this medicine to anyone else. Return unused capsules to the pharmacy.

Additional Information

ATC Code: D10BA01
→ View Professional Information (PDF)→ View Patient Leaflet (PDF)