Aknill(Isotretinoin)

Therapeutic Group: Topical Retinoid

Presentation

Aknill 10 Soft Gelatin Capsule: Each soft gelatin capsule contains Isotretinoin USP 10 mg.

Aknill 20 Soft Gelatin Capsule: Each soft gelatin capsule contains Isotretinoin USP 20 mg.

Description

Chemically, Isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). Isotretinoin is a highly lipophilic molecule. Isotretinoin is the only therapy that affects all four pathogenic mechanisms of acne. It suppresses sebaceous gland function & thus reduces sebum production. Isotretinoin reduces comedogenesis by decreasing proliferation, hyperkeratinization and shedding of follicular epithelium. It decreases Propionibacterium acnes by depriving it of one of its main sources of nutrients. It also reduces inflammation by increasing host defense mechanism and modifying monocyte chemotaxis.

Indications

Severe forms of acne (such as nodular or conglobate acne, acne that is at risk of causing permanent scarring, or acne that is unresponsive to an adequate course of conventional treatment).

Dosage & Administration

Adults and children (? 12 years of age): The recommended dosage is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks.
To decrease the risk of esophageal irritation, patients should swallow the capsules with a full glass of water. The patients should not lie down for at least 10 minutes after taking this medication. A single course of Isotretinoin therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course.

Side Effects

Very common side effects of isotretinoin are dryness of the skin, especially of the lips and face; inflamed skin, chapped and inflamed lips; rash; mild itching; and slight peeling. Use a moisturizing cream from the start of treatment. Skin becomes more fragile and redder than usual, especially the face
Back pain; muscle pain; joint pain, particularly in children and teenagers.
Other Common side effects are Pruritus, erythematous, dermatitis, localized exfoliation, etc. (related to skin and subcutaneous tissue)
Anemia, an increased red blood cell sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, etc. (related to blood and lymphatic systems) Headache, blepharitis, conjunctivitis, dry eye, eye irritation, nasal dryness, nasopharyngitis, transaminase increased, arthralgia, myalgia, etc.
Possible rare or very rare side effects may be serious skin rashes, depression, suicidal thoughts, unusual behavior, anaphylactic reactions, hepatitis, benign intracranial hypertension, muscle weakness, abdominal pain, blurred vision, etc.

Precautions

Warnings and precautions
Isotretinoin must only be prescribed to female patients who are confirmed to not be pregnant by a pregnancy test.
Female patients should be provided with complete information on how to prevent pregnancy. If they are not using effective contraception, they should be referred for contraceptive counseling.
Before beginning treatment with isotretinoin, female patients of childbearing potential must avoid pregnancy by using effective contraception (two forms of contraception simultaneously, including barrier contraception) for one month before treatment, during treatment, and for one month after treatment ends. As a minimum requirement, they must use at least one effective contraceptive.
After stopping isotretinoin treatment, contraception should be continued for at least 1 month, even in patients with amenorrhea.
If woman has unprotected sexual intercourse at any time 1 month before, during, or 1 month after therapy, she must stop taking isotretinoin immediately and start using 2 forms of effective contraception simultaneously.
If pregnancy occurs during isotretinoin treatment, treatment must be discontinued immediately. Isotretinoin should be carefully prescribed to adolescents and young adults with psychiatric disorders, as it may cause depression, psychosis, etc.
Marked elevations of serum triglycerides had been reported in patients treated with Isotretinoin in clinical trials. So, special consideration must be given to patients with diabetes, obesity, increased alcohol intake, lipid metabolism disorder, or a familial history of lipid metabolism disorder. Isotretinoin must only be prescribed by a registered physician.

Use in Pregnancy & Lactation

Pregnancy category X.
You must not take isotretinoin if you are pregnant, or think you may be pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for short periods of time. Potentially, any fetus exposed during pregnancy can be affected. There is an increased risk of spontaneous abortion, and premature births have been reported.
It is not known whether isotretinoin is excreted in human milk. Because of the potential for adverse effects, lactating mothers should not receive isotretinoin.

Drug Interaction

Additional adverse reactions have been reported due to the interaction of isotretinoin with vitamin A or its derivatives. Concomitant treatment with isotretinoin and tetracyclines should be avoided. The effectiveness of micro-dosed progesterone is reduced when it is used concomitantly with isotretinoin (two forms of effective contraception must be used).

Over Dose

Isotretinoin overdose has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolve without apparent residual effects. An overdose would be expected to result in higher levels of isotretinoin in semen. Male patients should use a condom or avoid reproductive sexual activity with a female patient who is or might
become pregnant, for 1 month after the overdose. All patients with isotretinoin overdose should not donate blood for at least 1 month.

Storage

Do not store above 30 ºC. Keep away from light and out of the reach of children.

Commercial Pack

Aknill 10 Soft Gelatin Capsule: Each box contains 1 blister strip of 10 soft gelatin capsules.
Aknill 20 Soft Gelatin Capsule: Each box contains 1 blister strip of 10 soft gelatin capsules.