Isotretinoin Orifarm

This medicine treats severe acne when other treatments haven't helped.

Form
kapseli, pehmeä
Strength
20 mg
Active Ingredient
Isotretinoin
Manufacturer
Orifarm Generics A/S

How to Use

Dosage

The usual starting dose is 0.5 mg per kg of body weight daily. Most patients take 0.5–1.0 mg per kg daily.

Method

Take capsules whole with about 1.5 dl of water. Take them with food, once or twice a day. Do not chew or suck them.

Important

The maximum daily dose is usually 1.0 mg per kg of body weight, unless your doctor tells you otherwise.

Possible Side Effects

COMMON
  • Anemia (low red blood cells) and other changes in blood tests
  • Inflammation of the eyes (conjunctivitis) and eyelids
  • Dry and irritated eyes
  • Inflamed skin and lips
  • Dry, peeling, itchy skin, rashes, and fragile skin that can crack
  • Pain in the back, joints, and muscles
  • Changes in blood fat levels (triglycerides and HDL cholesterol)
  • Higher levels of liver enzymes in blood tests
  • More platelets in the blood
  • Headache
  • Nosebleeds and a runny nose
  • Dry nose
  • Higher cholesterol and blood sugar levels
  • Blood or protein in your urine
RARE
  • Allergic skin reactions, very strong allergic reactions (anaphylaxis), and other reactions
  • Hair loss
  • Feeling sad, anxious, or moody (depression or mood changes)
  • Worsening of depression
  • Aggression or violent behavior
  • Thoughts of self-harm or trying to commit suicide
  • Strange behavior
  • Psychosis (when you lose touch with reality, like hearing or seeing things that aren't real)
  • Infections in moist body areas (mucous membranes) and skin
  • More white blood cells in blood tests
  • Swollen glands (lymph nodes)
  • Diabetes (high blood sugar)
  • Higher uric acid levels in blood
  • Increased pressure inside the head, fits (seizures), and feeling very sleepy
  • Poor night vision, blurry vision, sensitivity to light, and problems seeing colors
  • Swelling in the eye
  • Not being able to wear contact lenses
  • Cataracts, clouding of the cornea (front of the eye), and inflammation of the cornea
  • Hearing loss
  • Swelling of blood vessels (vasculitis)
  • Tightening of muscles in the airways (bronchospasm)
  • Hoarse voice and dry throat
  • Inflammation of the large and small intestines
  • Bleeding in the digestive system, bloody diarrhea, and inflammatory bowel disease
  • Feeling sick (nausea)
  • Pancreas inflammation (pancreatitis)
  • Liver inflammation (hepatitis)
  • Sudden, severe, or worsening acne, red face, and skin rash
  • Hair problems
  • Increased body hair growth in women
  • Changes to nails and inflammation around the nail bed
  • Sensitivity to light
  • Increased sweating
  • Darkening of skin color
  • Benign (harmless) cauliflower-like skin growths, usually around nails
  • Joint inflammation (arthritis)
  • Bone problems like slow growth, extra bone, or changes in bone density
  • Hardening of ligaments and tendons, and tendon inflammation
  • Breakdown of muscle tissue (rhabdomyolysis)
  • Kidney inflammation
  • Increased growth of new tissue (granulation tissue)
  • Feeling generally unwell
  • Higher levels of a muscle enzyme (creatine phosphokinase) in blood
  • Difficulty getting or keeping an erection
  • Decreased sexual desire
  • Swelling of breasts in men, sometimes painful
  • Dryness in the vagina
  • Sacroiliitis (a type of inflammatory back pain in the lower back and buttocks)
  • Inflammation of the tube that carries urine out of the body (urethritis)
  • Very severe skin rashes (like erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) which can be life-threatening
  • Feeling drowsy, dizzy, and having problems with vision

Important Warnings

  • This medicine can severely harm an unborn baby. Women must use effective birth control during treatment and for one month after. Do not use if you are pregnant, think you might be, or are breastfeeding.
  • Do not use if you are allergic to isotretinoin, soy, peanuts, or any other ingredients in this medicine.
  • Do not use if you have severe liver problems.
  • Do not use if you have very high blood fat levels, very high Vitamin A levels, or are taking tetracycline antibiotics.
  • Tell your doctor if you have ever had mental health issues like depression, mood changes, aggression, or thoughts of harming yourself, as this medicine can affect your mood.
Show 6 more warnings
  • Do not donate blood during treatment or for one month after, as it could harm an unborn baby if a pregnant woman receives your blood.
  • Never give this medicine to anyone else. Return any unused capsules to the pharmacy after treatment.
  • Your skin may be more sensitive to sunlight. Avoid too much sun and use sunscreen (SPF 15 or higher).
  • Avoid skin resurfacing (dermabrasion), laser treatment, and waxing during treatment and for 5-6 months after, as your skin may be fragile.
  • If you are very active, you may experience muscle and joint pain. Tell your doctor if you have lasting lower back or buttock pain.
  • Be careful when driving at night as your night vision might worsen suddenly. If your eyes become dry while wearing contact lenses, you may need glasses.