Medicinal Products

ACETRATE 40 mg

Generic drug of the therapeutic class: Dermatology
active ingredients: Isotretinoin
laboratory: Teva Sante

Soft capsule
Box of 30
All forms

Indication

Severe acne (such as nodular acne, acne conglobata or acne that may lead to permanent scarring) resistant to appropriate cures of conventional treatment involving systemic antibiotics and topical treatment.

Dosage ACNETRAIT 40 mg soft capsule Box of 30

Isotretinoin should only be prescribed by or under the supervision of physicians experienced in the use of systemic retinoids in the treatment of severe acne and a thorough knowledge of the risks of isotretinoin and the monitoring of she imposes.

The capsules should be swallowed during meals, once or twice a day.

Teenagers, adults and seniors

Treatment with isotretinoin should be initiated at 0.5 mg / kg / day.

The therapeutic response to isotretinoin and some of the side effects are dose dependent and vary from patient to patient. This requires an individual adjustment of the dose during treatment. For most patients, the dose is between 0.5 and 1 mg / kg / day.

The rates of prolonged remission and relapse after isotretinoin therapy depend more on the total cumulative dose than on the duration of treatment or daily dosage. Continued treatment above a cumulative dose in the range of 120 to 150 mg / kg has been shown to produce no significant additional benefit. The duration of treatment depends on the individual daily dose. A course of treatment lasting 16 to 24 weeks is usually sufficient to achieve remission.

In the majority of patients, a complete cure of acne is obtained after a single cure. In case of confirmed relapse, a new course of isotretinoin may be considered with the same daily dosage and the same cumulative therapeutic dose. As the improvement of acne can continue until 8 weeks after stopping treatment, a new cure before the end of this period should not be considered.

Patients with severe renal insufficiency

In patients with severe renal impairment, treatment should be initiated at a lower dose (eg 10 mg / day). The dosage will then be gradually increased to 1 mg / kg / day or to the maximum tolerated dose by the patient. (see section Warnings and precautions for use ).

children

Isotretinoin is not indicated for the treatment of prepubertal acne and is not recommended for children under 12 years of age.

Intolerant patients

In patients with severe intolerance at the recommended dose, treatment may be continued at a lower dose, thus exposing the patient to a longer duration of treatment and an increased risk of relapse. In order to ensure the best possible efficacy in these patients, treatment should normally be continued at the maximum tolerated dose.

Against indications

Isotretinoin is contraindicated in pregnant or breastfeeding women (see section Pregnancy and breastfeeding ).

Isotretinoin is contraindicated in women of childbearing age unless all conditions of the Pregnancy Prevention Program are met (see Warnings and Precautions ).

Isotretinoin is also contraindicated in case of:

· Hepatic insufficiency.

· Hyperlipidemia.

· Hypervitaminosis A.

· Combination with tetracyclines (see section Interactions with other medicinal products and other forms of interaction ).

Isotretinoin is contraindicated in patients with hypersensitivity to isotretinoin or any of the excipients.

Due to the presence of soybean oil, this medicine is contraindicated in case of peanut or soy allergy.

Adverse effects Acnetrait

The most common side effects observed during treatment with isotretinoin are dryness of the mucous membranes, especially the labial (cheilitis), nasal (epistaxis) and ocular (conjunctivitis); and a dry skin. These side effects, as well as some others, are dose-dependent. In general, most adverse effects are reversible after decreasing dosage or discontinuing treatment; some, however, persist after stopping treatment.

infections:

Very rare (≤ 1/10 000)

Gram-positive bacterial (mucocutaneous) infection

Blood and lymphatic system disorders:

Very common (≥ 1/10)

Anemia, Increased Sedimentation Rate, Thrombocytopenia, Thrombocythemia

Frequent (≥ 1/100, <1/10)

neutropenia

Very rare (≤ 1/10 000)

lymphadenopathy

Immune system disorders:

Rare (≥ 1/10 000, <1/1000)

Skin allergic reactions, Anaphylactic reactions, Hypersensitivity

Metabolism and nutrition disorders:

Very rare (≤ 1/10 000)

Diabetes, Hyperuricemia

Psychiatric disorders:

Rare (≥ 1/10 000, <1/1000)

Depression, aggravated depression, aggressive tendency, anxiety and mood changes.

Very rare (≤ 1/10 000)

Behavioral disorders, psychotic manifestations, suicidal ideation, suicide attempt, suicide.

Nervous system disorders:

Frequent (≥ 1/100, <1/10)

headaches

Very rare (≤ 1/10 000)

Benign Intracranial Hypertension, Seizures, Drowsiness, Dizziness

Eye disorders:

Very common (≥ 1/10)

Blepharitis, Conjunctivitis, Dry eye, Eye irritation

Very rare (≤ 1/10 000)

Blurred vision, Visual disturbances, Cataract, Achromatopsia (impaired color vision), Intolerance in contact lens wear, Corneal opacity, Decreased night vision, Keratitis, Papilledema (evidence of benign intracranial hypertension), Photophobia

Ear and ear canal disorders:

Very rare (≤ 1/10 000)

Decreased auditory acuity

Vascular disorders:

Very rare (≤ 1/10 000)

Vasculitis (eg Wegener's disease, allergic vasculitis)

Respiratory, thoracic and mediastinal disorders:

Frequent (≥ 1/100, <1/10)

Epistaxis, Nasal dryness, Rhinopharyngitis

Very rare (≤ 1/10 000)

Bronchospasm (especially in asthmatic patients), hoarseness

Gastrointestinal disorders:

Very rare (≤ 1/10 000)

Colitis, Ileitis, Dryness of the throat, Digestive haemorrhage, Bloody diarrhea and inflammatory bowel disease, Nausea, Pancreatitis (see Warnings and precautions for use )

Hepatobiliary disorders:

Very common (≥ 1/10)

Elevation of transaminases (see section Warnings and precautions for use )

Very rare (≤ 1/10 000)

Hepatitis

Skin and subcutaneous tissue disorders:

Very common (≥ 1/10)

Cheilitis, dermatitis, skin dryness, localized scarring, pruritus, erythematous rash, skin fragility (friction lesions)

Rare (≥ 1/10 000, <1/1000)

Alopecia

Very rare (≤ 1/10 000)

Acne fulminans, Aggravation of acne, Erythema (facial), Exanthema, Hair texture abnormalities, Hirsutism, Nail dystrophies, Peri-onyxis, Photosensitivity reaction, Botriomyoma, Hyperpigmentation, Hypersudation

Not known (can not be estimated from the available data):

Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis.

Musculoskeletal and connective tissue effects:

Very common (≥ 1/10)

Arthralgia, Myalgia, Back pain (especially in adolescents)

Very rare (≤ 1/10 000)

Arthrites, Calcifications (ligaments and tendons), Premature welding of epiphyses, Exostoses (hyperostosis), Reduction of bone density, Tendonitis

Renal and urinary disorders:

Very rare (≤ 1/10 000)

glomerulonephritis

General disorders and accidents related to the site of administration:

Very rare (≤ 1/10 000)

Increased granulomatous tissue formation, Malaise

investigations:

Very common (≥ 1/10)

Elevation of blood triglycerides, Decrease of circulating HDL

Frequent (≥ 1/100, <1/10)

Elevation of blood cholesterol, Elevation of blood sugar, Hematuria, Proteinuria

Very rare (≤ 1/10 000)

Increased blood levels of creatine phosphokinase

The incidence of adverse events was calculated from pooled clinical trial data that included 824 patients and from post-marketing data.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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