What is Isotretinoin: How to use, Side Effects, Dosage

What is Isotretinoin: How to use, Side Effects, Dosage

What is Isotretinoin

Isotretinoin, a retinoid, is available as Accutane in for oral administration. Each capsule includes beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules includes glycerin and parabens, with the following dye systems: 10 mg — iron oxide (red) and titanium dioxide; 20 mg — FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg — FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.

Chemical name: 13-cis-retinoic acid

Color: yellow to orange crystalline powder

Molecular weight: 300.44

Type: 10-mg, 20-mg and 40-mg soft gelatin capsules

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How to use Isotretinoin

As isotretinoin is best absorbed into the body with food containing some dietary fat, it should ideally be taken after a meal or a snack with milk rather than on an empty stomach. The capsules need to be swallowed whole and should not be crushed or split open. Keep the capsules in a cool (5 to 25°C) dark place away from children.

Dosage of Isotretinoin

The recommended dosage range for Accutane is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1.0 mg/kg/day,8. it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2.0 mg/kg/day, as tolerated. Failure to take Accutane with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.

The safety of once daily dosing with Accutane has not been established. Once daily dosing is not recommended. If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Accutane, even in low doses, has not been studied, and is not recommended. It is important that Accutane be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Accutane on bone loss is unknown.

Overdosage of Isotretinoin

Isotretinoin is a derivative of vitamin A. Although the acute toxicity of isotretinoin is low, signs of hypervitaminosis A could appear in cases of accidental overdose. Manifestations of acute vitamin A toxicity include severe headache, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with isotretinoin would probably be similar. These symptoms would be expected to be reversible and to subside without the need for treatment.

Isotretinoin

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Side effects of Isotretinoin

In general the side effects of isotretinoin are mild and settle later in the course of treatment. Dryness of the skin, lips, eyes and throat is common. An increased risk of skin infections accompanies the skin becoming dry and cracked, and nosebleeds may occur if the inside of the nose becomes very dry. Using a moisturiser and lip balm regularly will help to prevent these symptoms. Dry eyes may interfere with the wearing of contact lenses. The skin may also peel and become fragile, with wounds taking longer to heal. Whilst taking isotretinoin, and for six months afterwards, your skin will be more delicate than usual; waxing, epilation, dermabrasion and laser treatment should be avoided.

There is an increased risk of sunburn and you should use a sunscreen when appropriate. Muscles and joints may ache especially after exercise.Temporary hair thinning may occasionally occur. Isotretinoin can affect night vision and it should be used with care in people whose job requires good night vision, such as airline pilots and drivers.

Increased fat levels in the blood, and mild liver inflammation, are common and not usually of clinical significance; these will be monitored by blood tests during the course of treatment. If you have had problems with your liver or kidneys, or suffer from high cholesterol or diabetes, you should discuss this with your doctor prior to starting the medication.

Some brands of isotretinoin contain soya (e.g. Beacon brand) and peanut oil (e.g. Roaccutane (Roche brand)), and you should inform your doctor if you think you may have an allergy to these.

Drug interactions to Isotretinoin

Most drugs can be taken safely with isotretinoin but some medications may interact. It is important that you tell your doctor and pharmacist what you are currently taking before taking any new prescription or over-the-counter medications.

Drugs that adversely interact with isotretinoin include:

•             Tetracycline antibiotics (only if taken at the same time as isotretinoin)

•             Methotrexate

This is not an exhaustive list and it is important that you always inform your doctor and pharmacist that you are taking isotretinoin. Vitamin supplements containing vitamin A should be avoided during a course of isotretinoin.

Warnings of Isotretinoin

Before taking isotretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as tretinoin); or if you have any other allergies. This product may contain inactive ingredients (such as soybean, parabens), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, family or personal history of high blood fats (triglycerides), family or personal history of psychiatric disorders (including depression), liver disease, obesity, eating disorders (e.g., anorexia nervosa), alcohol abuse, pancreatitis, bone loss conditions (e.g., osteoporosis/osteomalacia, decreased bone density).Do not donate blood while you are taking isotretinoin and for at least 1 month after you stop taking it.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Isotretinoin can affect your night vision. Do not drive, use machinery, or do any activity that requires clear vision after dark until you are sure you can perform such activities safely.

If you wear contact lenses, you may not tolerate them as well as usual while using this medication. Contact your doctor for more information.

Do not have cosmetic procedures to smooth your skin (e.g., waxing, laser, dermabrasion) during and for 6 months after isotretinoin therapy. Skin scarring may occur.

Avoid the use of alcohol while taking this medication because it may increase the risk of certain side effects (e.g., pancreatitis).

Limited information suggests isotretinoin may cause some bone loss effects. Therefore, playing contact or repetitive impact sports (e.g., football, basketball, soccer, tennis) may result in bone problems, including an increased risk of broken bones. Limited information also suggests isotretinoin may stop normal growth in some children (epiphyseal plate closure). Consult your doctor for more details.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially the effects on bones.

Caution is advised when using this drug in children because they may be more sensitive to its effects, especially back/joint/muscle pain.

This drug must not be used during pregnancy or by those who may become pregnant during treatment. If you become pregnant or think you may be pregnant, inform your doctor right away. See also Warning section.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

You must have two negative pregnancy tests before starting this medication. You must have a monthly pregnancy testduring treatment with isotretinoin. If the test is positive, you must stop taking this medication and consult your doctor right away.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Isotretinoin

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