Roaccutan Drug Information [ Roche; F. Uhlmann-Eyraud ]

Table of content

Roaccutan category:

• Human
• Miscellaneous Skin and Mucous Membrane Agents

Active ingredients:

• Isotretinoin

Roaccutan companies and manufacturers:

• Roche

• F. Uhlmann-Eyraud

General Information

Roaccutan forms, composition and dosages:

• Capsule; Oral; Isotretinoin 10 mg
• Capsule; Oral; Isotretinoin 20 mg
• Capsule; Oral; Isotretinoin 5 mg
• Gel; Local Oral; Isotretinoin 0.05%

Indications, usages and classification codes:

• D10BA01 - Isotretinoin

There is an additional general information about this medication active ingredient isotretinoin:

Pharmacological action

Isotretinoin is an pharmaceutical agent for the treatment of acne. Contributes to the normalization of terminal cell differentiation, inhibits the hyperproliferation of the epithelium of excretory ducts of the sebaceous glands, the formation of detritus and makes it easier to evacuate. Due to this reduced production of sebum and facilitates its isolation, normal structure, decreasing the inflammatory reaction around the glands. For external and systemic application isotretinoin has antiseborrhea, sebostatic, anti-inflammatory, keratitis and immunomodulatory actions, strengthens the processes of regeneration in the skin.

Pharmacokinetics

When administered orally isotretinoin is absorbed from the gastrointestinal tract, absorption may increase when taken with food. C_max plasma levels reached after 1-4 hours after ingestion.
Oral bioavailability is low which may be caused by parietal metabolism in the intestinal wall and the effect of "first passage" through the liver.
Isotretinoin is highly bound to plasma proteins. Metabolized in the liver with the formation of the main metabolite 4-oxo-isotretinoin, also there is some isomerization of isotretinoin in tretinoin.
Isotretinoin, tretinoin and its metabolites are enterohepatic recycling.
The end of T1/2 of tretinoin is 10-20 hours. An equivalent amount is determined in the feces, mostly unchanged, and urine in the form of metabolites.

Why is Roaccutan prescribed?

For oral administration: severe nodular-cystic acne especially with the localization on the body.
For rectal administration: severe relapsing forms of acne, rashes associated with seborrheic process.
For external use: papule-pustular acne, seborrhea, rosacea, perioral dermatitis.

Dosage and administration

For oral administration initial dose is 500 mcg / kg / day; the maximum daily dose used for a limited time and is 1 mg / kg; the maintenance dose is 0.1-1 mg / kg / day; duration of treatment is 16 weeks, a second course conducted at intervals of 8 days. Isotretinoin is taken with meals in one or more receptions.
Rectal - 0.5-1 mg / kg / day, one time at night (in the supine position); course of treatment - 8-12 weeks, the intervals between courses - 1-2 months.
Ointment applied thinly to the affected areas of skin 2 times / day. Duration of treatment - 4-6 weeks.

Roaccutan side effects

Dermatological reactions: dry mucous membranes, skin rashes, dermatitis, pruritus, cheilitis, erythema (especially on the face), sweating, palmar-plantar desquamation and paronychia, nail dystrophy, increased proliferation of granulation tissue in the affected area, rarely - thinning hair, vasculitis, photosensitivity.
Senses: conjunctivitis, photophobia, decreased night vision, corneal opacity, weakening of the hearing.
CNS and peripheral nervous system: headache, rarely - depression, seizures, suicide, and in rare cases - intracranial hypertension.
Digestive system: nausea, rarely - colitis, bleeding from the gastrointestinal tract, transient elevation of liver transaminases and in rare cases - hepatitis.
Hematopoietic system: anemia, neutropenia, changes in platelet count, increased erythrocyte sedimentation rate.
Metabolism: increased concentrations of TG and glucose.
Musculoskeletal system: pain in muscles and joints, rarely - hyperostosis.
Other: nasal bleeding.
Rectal and topical using: 1-2 weeks of treatment may cause new eruptions, itching, swelling and redness.

Contraindications

Pregnancy, established and planned lactation, hypersensitivity to isotretinoin, the simultaneous use of tetracycline antibiotics.
For oral administration: severe liver and/or kidney damage, hypervitaminosis A, significantly elevated levels of lipids in blood plasma, neoplasms.
For rectal use - diseases of the rectum.

Using Roaccutan during pregnancy and lactation

Isotretinoin has a pronounced teratogenic and embryotoxic action.
Contraindicated in established and planned pregnancy.
Contraindicated during lactation.

Special instructions

Rectally and topically applied with caution in liver disease, kidney disease, chronic pancreatitis, decompensation of heart function, chronic intoxication (including alcohol).
Rectal and external use in a pronounced exacerbation of the reaction (on 1-2-week treatment) is recommended to cancel the medication for a few days before its decline, then therapy can be resumed.
For oral administration requires regular monitoring of liver function and lipid levels in blood plasma before treatment, 1 month after initiation of therapy and then every 3 months.
In diabetes, obesity, alcoholism or lipid metabolism violations recommended more frequent monitoring of laboratory parameters. In diabetes mellitus or suspected it is necessary to strictly control glucose levels in plasma.
With prolonged use may develop symptoms of chronic hypervitaminosis A.
During treatment or within a certain time after its completion can not be donors for women of childbearing age.
During the treatment, patients should not be given UV treatment, patients should avoid direct exposure to sunlight.
In the course of treatment may occur intolerance of contact lenses.
Safety of children and prepubertal patients has not been established.
Should avoid the simultaneous use of isotretinoin and 19-nortestosterone derivatives, particularly in patients with gynecological / endocrine diseases.
Not recommended for concurrent use of other drugs with keratolytic or exfoliative properties (including other retinoids), and progesterone in the microdose (including drugs "mini-pilly").

Roaccutan drug interactions

The action of isotretinoin is weakened by the simultaneous application of progesterone in the microdose.
With the simultaneous application of isotretinoin and vitamin A may increase toxic effects.
With the simultaneous application of isotretinoin and aminoglycoside antibiotics is at risk of developing intracranial hypertension.

• Roaccutan analogs
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