ACCUTANE
As listed in the register: ACCUTANE
40 mg · capsule
- Prescription only
- Skin
- Active substance
- Isotretinoin
- Used in
- Skin
- Made by
- Cheplapharm Schweiz Gmbh
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (ISOTRETINOIN). It describes the substance, not this exact product.
The exact mechanism of action of isotretinoin in the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater who are unresponsive to conventional therapy, including systemic antibiotics is unknown.
Isotretinoin is a retinoid, which inhibits sebaceous gland function and keratinization.
Isotretinoin is primarily metabolized by CYP2C8, 2C9, 3A4, and 2B6 in vitro.
Following oral administration of an 80 mg dose of radiolabeled-isotretinoin as a liquid suspension, the metabolites of isotretinoin were excreted in feces and urine in relatively equal amounts (total of 65% to 83%).
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-09-07
Safety of the active substance
From the US prescribing label for the same active substance (ISOTRETINOIN). It describes the substance, not this exact product.
WARNING: EMBRYO-FETAL TOXICITY - CONTRAINDICATED IN PREGNANCY Isotretinoin can cause life-threatening birth defects and is contraindicated in pregnancy.
- Isotretinoin capsules are contraindicated in: Pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ].
- Patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see Warnings and Precautions (5.14) ].
Most common adverse reactions (incidence ≥ 5%) are: dry lips, dry skin, back pain, dry eye, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips, dermatitis, increased creatine kinase, cheilitis, musculoskeletal discomfort, upper respiratory tract infection, reduced visual acuity.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United States12 matching products
Spain5 matching products
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Cheplapharm Schweiz Gmbh |
|---|---|
| Active substance | Isotretinoin |
| Used in | Skin |
| Strength | 40 mg |
| Form | capsule |
| Classification | D10BA01 · Skin |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 00582352 |
| DPD drug code | 5129 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Other strengths and forms
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- capsule2 products
- 10 mg
- 40 mg
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.