How can I increase the isotretinoin effect?

Ciscutan 20 mg capsules

Prescription required:Yes
Active ingredient:Isotretinoin
Marketing authorization holderPELPHARMA HANDELS GMBH, VIENNA

How does the remedy work?

The cause of acne is a disease of the sebum glands. The increased cornification (hyperkeratinization of the epithelial lining) of the hair follicle and sebum glands leads to the desquamation of the corneal cells (keratinocytes) in the gland ducts. This leads to the gland ducts being blocked by keratin from the corneal cells and excess sebum that remains stuck in the duct. Isotretinoin inhibits the development of sebum-producing cells (sebocytes) and thus normalizes sebum production. In people with acne, the skin is mostly colonized by the bacterium Propionibacterium acnes. This germ can develop well in an environment where there is a lot of sebum. A reduced sebum production therefore inhibits the bacterial colonization of the gland duct.

In which areas of application is the product used?

Severe forms of acne that are not sufficiently treatable compared to standard adequate antibiotic treatment and topical treatment of the skin.

how do you apply the product?

  • The capsules should be taken with food once or twice a day.
  • Adults including adolescents from the age of 12 and the elderly:
    Isotretinoin treatment should be started at a dose of 0.5 mg / kg daily. Because the therapeutic response to isotretinoin and some of the side effects are dose-dependent and vary from patient to patient, individual dose adjustments must be made during treatment. For most patients, the dose will be in the range of 0.5-1.0 mg / kg per day.
  • The duration of treatment depends on the individual daily dose. Usually 16 to 24 weeks of treatment is enough to achieve a decrease. For the majority of patients, a complete elimination of acne is achieved in a single treatment phase. If the relapse is certain, a further phase of treatment with isotretinoin at the same daily dose and the same tolerable treatment dose can be considered. Since further improvement of the acne can only be seen up to eight weeks after discontinuation of therapy, a further treatment phase should not be considered before this period has elapsed.
  • Patients with severe kidney failure:
    In patients with severe kidney failure, treatment must be started at a lower dose (e.g. 10 mg / day). The dose should then be increased up to 1 mg / kg / day or up to the maximum dose tolerated by the patient. In people with severe intolerance to the recommended dose, treatment can be continued at a lower dose. This results in a longer duration of treatment and a higher risk of relapse. In order to be most effective in these people, treatment should normally be continued at the highest possible tolerated dose.

When should the product not be used?

  • Isotretinoin should not be used by children under 12 years of age
  • Isotretinoin is prohibited in pregnant and breastfeeding women
  • Isotretinoin is forbidden in women of childbearing potential unless it is sure to prevent pregnancy.
  • be used in case of hypersensitivity to isotretinoin, soy, peanuts or to any of the other ingredients of the drug.
  • Isotretinoin is also forbidden in people with liver failure, severely increased blood lipid levels, too high a level of vitamin A in the blood (hypervitaminosis) and with simultaneous treatment with tetracyclines (certain antibiotics)

Can the product be used by pregnant and breastfeeding women?

Isotretinoin can cause severe deformities in the fetus. Isotretinoin must not be used during pregnancy. If pregnancy occurs, the affected person should go to a gynecological center with a focus on child malformations. Isotretinoin must also not be taken during breastfeeding, as it can be absorbed by the child through breast milk and lead to serious illnesses in the child.

Which side effects can occur?

  • Increase in blood lipid levels and blood sugar levels
  • Elimination of blood and / or protein in the urine (hematuria, proteinuria)
  • Anemia
  • increased sedimentation rate
  • Decrease or increase in the amount of platelets in the blood (thrombocytopenia or thrombocytosis)
  • Reduction of certain immune cells (neutrophils) in the blood (neutropenia)
  • Strong headache
  • Inflammation of the conjunctiva and eyelids
  • dry eye, eye irritation
  • Nosebleeds, dry nose, inflammation of the nasopharynx (nasopharyngitis)
  • Inflammation of the lips
  • Hair loss, male hair type in women (hirsutism)
  • Inflammation of the inner zone of the skin (dermatitis), dry skin, local flaking (exfoliation), itching, reddish (erythematous) rash, increased vulnerability of the skin (risk of abrasions)
  • Joint pain (arthralgia), muscle pain (myalgia), back pain (especially in adolescents)
  • Increase in serum creatinine phosphokinase (muscle / liver value), especially in people who are exposed to significant physical exertion.
  • Increase in liver values ​​GOT and GPT (transaminases)
  • increased light / UV sensitivity
  • cramps

Psychological side effects and sometimes severe allergic reactions also occur rarely.

Interactions are known with the following substances:

Combination not possible:

  • other viramin A preparations: tretinoin, acitretin, alitretinoin
  • Tetracycline
  • locally applied acne preparations that affect the top layer of skin
  • Carbamazepine (epilepsy)

Warning notices

This medicine can cause serious malformations of the embryo. Isotretinoin is contraindicated in women of childbearing potential unless all of the following conditions of the pregnancy prevention program are met:

  • She has severe acne that does not improve adequately with standard appropriate antibiotic tablet treatment and topical treatment of the skin.
  • She is aware of the risk of serious malformations.
  • She understands the need for consistent monitoring on a monthly basis.
  • She understands and accepts the need for effective contraception without interruption, starting one month before treatment begins, for the entire duration of treatment and up to one month after treatment has ended. At least one, preferably two, complementary methods of contraception including a barrier method (e.g. condom) should be used.
  • Even in women without a menstrual period (amenorrhea), she must follow the recommendations for effective contraception.
  • She must be able to use effective contraception methods.
  • She is informed and understands the possible consequences of pregnancy and the need to see a doctor immediately if there is a risk that pregnancy may have occurred.
  • She understands the need for pregnancy tests before, during, and five weeks after treatment is finished and is ready to do so.
  • She stated that she understood the dangers and precautions needed to use isotretinoin.
  • These conditions also apply to women who are currently not sexually active, unless the prescribing physician sees compelling reasons that there is no risk of pregnancy occurring.
  • The prescribing physician should ensure that the patient is following the contraceptive conditions listed above, including confirmation that she has sufficiently understood them.
  • The date and results of the pregnancy tests must be documented.
  • Check-ups should take place every 28 days.
  • Because of the potential risk to the fetus of a pregnant woman receiving a transfusion, people should not donate blood while being treated with isotretinoin and for one month after stopping treatment.

Depression, worsening pre-existing depression, anxiety, aggressive behavior, mood changes, psychotic symptoms and, very rarely, thoughts of suicide, attempted suicide, and suicide have been reported in people treated with isotretinoin. Particular caution is required with people who have suffered from or are currently suffering from depression.
Stopping isotretinoin treatment, however, cannot relieve the symptoms either, so further psychiatric or psychological evaluation may be required.

  • Exposure of the skin to intense sunlight or UV rays should be avoided. If necessary, a sunscreen with a high protection factor of at least SPF 15 should be used.
  • Serious skin diseases (e.g. Erythema multiforme (EM), Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)) can occur.
  • Aggressive chemical treatments of the skin (dermabrasion and skin laser treatment) must be avoided in patients five to six months after the end of therapy, as there is a risk of scarring and less often of pigment changes in the skin in the treated areas. Wax depilation should be avoided for those with isotretinoin for a period of at least six months after the end of therapy due to the risk of removing skin with it.
  • Since isotretinoin can dry out the skin and lips, measures should be taken at the start of treatment (moisturizing ointment or cream and a lip balm).
  • Dry eyes, clouding of the cornea, night blindness, and inflammation of the cornea (keratitis) usually resolve after treatment is discontinued. Dry eyes can be relieved by using an eye ointment to moisturize or by using a tear substitute.
  • Since contact lenses can be intolerant, the patient should wear glasses during treatment.
  • Night blindness has also been reported and occurred suddenly in some people. Impairment of the ability to drive and use machines cannot be ruled out.
  • People who have vision problems should see an ophthalmologist. It may also be necessary to stop isotretinoin.
  • Bone changes, including premature epiphyseal closure (completion of bone growth), bone growths (hyperostosis) and calcification of tendons and ligaments have been observed after several years of use in very high doses for the treatment of cornification disorders of the skin (keratinization disorders). The dosages and the duration of treatment for these sufferers were generally well above the recommendations for the treatment of acne.
  • Certain liver values ​​(tansaminases) must be checked before treatment, one month after starting treatment and then every three months, unless more frequent monitoring is indicated. The increases in transaminases can recede again.
  • However, if there are persistent increases in liver enzymes that are dangerous to the body, the dose should be reduced or discontinuation of the drug should be considered.
  • Blood lipid levels should be checked prior to treatment, one month after starting treatment, and then every three months thereafter unless more frequent monitoring is indicated. Elevated fat levels in the blood usually return to normal after reducing the dose or stopping therapy and may also respond to dietary measures.
  • In particular, isotretinoin can greatly increase triglycerides, which can lead to inflammation of the pancreas.
  • Isotretinoin has been linked to inflammatory bowel disease in people with no known bowel disorders. If severe (bloody) diarrhea occurs, isotretinoin treatment should be stopped immediately.
  • People with diabetes, obesity, alcoholism, or lipid metabolism disorders who are being treated with isotretinoin may need more frequent blood lipid and / or blood sugar checks. Increased fasting blood sugar levels have been reported and new cases of diabetes have been diagnosed during treatment with isotretinoin.
  • Cases of benign intracranial hypertension (increased pressure) have been reported. Patients who develop benign intracranial hypertension should immediately discontinue isotretinoin treatment.

Note: The list of drugs in no way represents a recommendation, sales promotion or advertising of the individual drugs in any way.

The information is by no means conclusive and is not a substitute for medical or other specialist advice.

The attending physician or pharmacist should be consulted, particularly with regard to side effects, contraindications and other information.

Status of information: July 2019