Contains the active ingredient of it. Chemically, it is 13-cis-retinoic acid and is related to both retinoic acid and retinol (Vitamin A).
Indicated for the treatment of:
1. Severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic anti-bacterials and topical therapy.
2. Skin disease caused by disorders of keratinization, such as pityriasis rubra pilaris, keratosis follicularis and ichthyosis, etc.
3.Local skin inflammatory and non-inflammatory acne.
It could suppress sebaceous gland activity and histologically reduce the size of the sebaceous glands, thus to inhibit the reproduction of propionibacterium acnes that grow depending on lipid environment.
It has the effects of ant-keratosis, inhibiting epidermal cell excessive proliferation and promoting their differentiation, could relieve the keratinization of follicular orifice and sebaceous
gland.
It could affect the function of monocyte and lymphocyte, and inhibit the chemotaxis of neutrophils, thus having the anti-inflammatory and anti-cancer activity..
The soft capsules should be taken with food once or twice daily.
Paediatric Population
Should not be used for the treatment of prepubertal acne and not recommended in children less than 12 years of age.
Adults including adolescents and the elderly:
It therapy should be started at a dose of 0.5 mg/kg daily.
The therapeutic response to isotretinoin and some of the adverse effects are dose-related and vary between patients. This necessitates individual dosage adjustment during the therapy. For most patients, the dose ranges from 0.5-1.0 mg/kg per day.
Long-term remission and relapse rates are more closely related to the total dose administered than to either duration of treatment or daily dose. The duration of treatment will depend on the individual daily dose. A treatment course of 16-24 weeks is normally sufficient to achieve remission.
In the majority of patient, complete clearing of the acne is obtained with a single treatment course. Inthe event of a definite relapse a further course of it therapy may be considered using the same daily dose and curmulative treatment dose. As further improvement of the acne can be observed up to 8 weeks after discontinuation of treatment, a further course of treatment should not be considered until at least this period has elapsed.
Possible side effects:
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using it and call
your doctor at once if you have any of these serious side effects: depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations. Thoughts of suicide or hurting yourself; sudden numbness or weakness , especially on one side of the body; blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting; hearing problem, hearing loss, or ringing in your ears, seizure (convulsions); severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; loss of appetite, dark urine, clay-colored stools. jaundice (yellowing of the skin or eyes); severe diarrhea, rectal bleeding, black, bloody, or tarry stools, fever, chills, body aches, flu symptoms, purple spot under your skin, easy bruising or bleeding; or joint stiffness, bone pain or fracture. Less serious it side effects may include: joint pain, back pain, feeling dizzy, drowsy, or nervous; dryness of the lips, mouth, nose, or skin; or cracking or peeling skin, itching, rash, changes in your fingernails or toenails. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
Warnings and Special Precautions:
It is contraindicated in:
- Women who are pregnant, may pregnant, or planning to become pregnant.
- Women who are breastfeeding.
- Patients with hypersensitivity to isotretinoin or to any of the excipients.
- Patients with excessively elevated blood lipid values.
- Patients with hypervitaminosis A.
- Patients with concomitant treatment with tetracyclines.
Before you start to take it, tell your doctor if
1. you have any allergies to any other medicines, foods, preservatives or dyes.
2. you have or have had any other health problems or issues including:
- diabetes, or a history of diabetes in your family
- depression
- liver disease
- kidney disease
- lipid (cholesterol or triglyceride) disorder
- hormone disorder
- stomach or bowel disease
3. You drink large amounts of alcohol.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get with or without a prescription.
Some medicines may interfere with it, these include:
- tetracycline antibiotics (Such as Akamin, Doxycycline Hydrochloride, Frakas, Vibramycin, Doryx, Minomycine)
- Vitamin A, or preparations containing vitamin A (including vitamin supplements)
- other medicine you are using to treat your acne
- The "mini-pill" , a progestogen only oral contraceptive pill
Keep this medicine out of the sight and reach of children.
Keep your soft capsules in the original package until it is time to take them.
Keep in a cool dry place where the temperature stays below 30 degree.
Protect from light.
Do not use this medicine after the expiry date that is stated on the outer carton and the label after "EXP", The expiry date refers to the last day of that month.