Oratane

Oratane

isotretinoin

Manufacturer:

Douglas

Distributor:

United Italian
Full Prescribing Info
Contents
Isotretinoin.
Action
Who gets acne: Acne is common. It affects most people during their teenage years. 80% of people have suffered from acne at some time in their lives. 5% of these people suffer from very severe acne.
Acne is a skin disease and it should be treated as one.
What causes acne: The exact cause of acne is unknown. Acne is not caused by dirty skin and acne is not a problem suffered only by teenagers.
Some people find that their acne seems to get worse when they eat certain foods like chocolates, fried food and chillies. If the patient finds that this is the case, avoid the foods that appear to make the acne worse.
One idea about the cause of acne is that as the changes due to puberty occur, the skin of an acne prone person reacts to these changes by making excess sebum. This extra sebum causes a plug to form, blocking the pore and resulting in the development of a pimple. When this occurs in several places at the same time, the result is acne.
Emotional stress, fatigue and cosmetics can make acne worse.
Acne most commonly first appears at the beginning of puberty when the production of hormones (called androgens) is increased. The sebaceous glands also become more active at this time. Many people outgrow acne when they reach adulthood, as the sebaceous glands settle into a normal cycle. Some people never outgrow acne and they may be bothered by it their whole lives.
Sometimes women tend to break out in a pattern that follows the course of their menstrual cycle.
Family history is a factor in determining if the patient will get acne. If one or both of the parents had acne, chances are that the patient may also get acne.
Outside factors can affect acne, either causing acne or making existing acne worse. Grease and oils or the use of some cosmetics and hair products can cause or irritate acne. Besides being irritants these products can act like sebum and block pores.
If the patient finds break out with acne around the hairline, at the temples and in front of the ears, the hair products may be to blame. For instance, the shampoo used, or the hair gel the patient used, or hairspray may be blocking the pores. Another area that can be affected by outside factors is the jawline. Breakouts in this area can be the result of resting the head in the hand or even resting the telephone on the shoulder for long periods of time.
Although acne is not caused by dirt, it is helpful to keep the face clean. Gentle cleansing twice daily can help by cutting down on the amount of common bacteria on the skin, and by reducing the amount of other materials on the skin that can also act like sebum and contribute to the blocking of the pores. This cleansing can be accomplished by washing the face twice daily with warm (not hot) water and a mild antibacterial soap. The fingers are actually the best washcloth can use. If the patient does use a facecloth, be gentle. Scrubbing irritates pimples already present and can increase inflammation, it can also contribute to the formation of cysts.
Types of Acne: This section provides some technical information about types of acne and it should be very useful for anyone wanting to learn more about acne. The patient could also visit the website at www.oratane.co.nz or www.oratane.com.hk
The technical term for a pimple is "comedone".
A "closed comedone" is one in which the contents of the pore have not escaped from the skin and are attacked by a bacteria. The bacteria is called Propionibacterium acnes, these bacteria are normally found on the skin. The result of the bacteria attacking the pore is inflammation.
A blackhead is a pimple that is open to the air. The pore opening has expanded, or dilated, to allow the plug of sebum and skin cells to move to the top of the pore. The exposure to the air causes a component of the contents of the pimple, called melanin, to turn dark.
A pustule, or whitehead, forms when the pore opening remains closed and bacteria accumulates, this is a closed comedone.
Cystic acne is the most severe type of acne. It occurs when material from the pimple escapes from the pore under the skin. Swelling and pain occur as the body's defence systems send bacteria-fighting white cells to the area in response. Cystic acne can result in scarring. A doctor's care is required to treat this type of acne. A doctor will treat the acne in order to reduce inflammation and to try to reduce the possibility of scarring.
Cystic acne can occur on its own, sometimes it can be the result of "picking" at existing pimples. The pressure of squeezing a pimple can cause the contents of the pimple to escape from the pore under the skin, resulting in a cyst.
Why has Oratane been prescribed: The doctor has probably prescribed Oratane for the patient because other treatments for acne have been unsuccessful.
The patient probably hasn't been prescribed Oratane earlier because it is considered to be a good idea to try other treatments, such as creams and antibiotics, for the acne first.
While taking Oratane, advise the patient to follow very carefully all the instructions given by the doctor. Advise the patient to also follow the advice given in this monograph, as it will help the patient to look after the skin during Oratane treatment.
Indications/Uses
Oratane capsules contain a medication known as isotretinoin. Isotretinoin is indicated for acne treatment. It is a similar substance to Vitamin A, but the action of isotretinoin is very different.
Oratane works by reducing the amount of oily substances produced by the oil making glands in the skin. This reduces the amount of bacteria in the skin. These bacteria are the cause of the 'pus' and inflammation found with acne. Oratane may help reduce the inflammation of the skin.
Dosage/Direction for Use
Advise the patient that it is very important to follow the instructions given by the doctor. These instructions will help to make sure the patient is getting the right dose of Oratane. In determining the exact dosage the patient needs, the severity of acne and body mass should be considered.
It is important not to miss any of the Oratane capsules, or to take too many Oratane capsules. If the patient does miss a dose, a double dose should not be taken to make up for it, wait until it is time for the next dose and Oratane should be taken as normal, then taking Oratane should be continued in the usual way.
If the patient ever needs to check what the dose is, refer to the previously mentioned information.
The doctor has prescribed a particular dose of Oratane for a specific reason. Advise the patient that it is important not to change the amount of Oratane being taken. If the patient thinks it is too strong or too weak, advise the patient to speak to the doctor. The dose of Oratane may be varied, depending on how the body responds to the treatment. Advise the patient that only the doctor should change the dose of Oratane.
Advise the patient should continue taking the Oratane for as long as the doctor instructs to.
While taking Oratane the patient must: Take the Oratane capsules with meals; Not chew or suck the capsules; Swallow the capsules whole with water or another non-alcoholic drink; Take each dose of Oratane when it is due.
Advise the patient to follow the doctor's instructions.
If the patient follows the previously mentioned instructions as closely as possible the Oratane will work better.
What to expect from Oratane: When the patient first starts taking Oratane the patient may find that the acne starts to get worse. This does not mean that the medication is not working. If this happens, advise the patient not to be discouraged and to keep taking the Oratane, as prescribed by the doctor. The worsening of acne nearly always stops within the first few weeks, and then the acne will start to clear. If the patient has any worries or concerns about this, advise the patient to contact a doctor. Within the first four weeks of starting Oratane the patient will notice that the skin is much drier than before. This is because the Oratane is starting to work by reducing the amount of oil being produced by the skin. The patient may also find the need to wash the hair less often. By the second month the acne will be showing signs of improving. The improvement should continue throughout the Oratane treatment.
Finishing intake of Oratane: If the patient has any Oratane capsules left when the treatment is finished, advise the patient that it is very important to return them to the doctor.
Oratane should never be given to anyone else, even if they have acne. Oratane is a prescription only medicine. Advise the patient that Oratane should only be used under the supervision of a doctor.
At the conclusion of the Oratane treatment, acne should have significantly cleared. The skin should continue clearing, possibly for one or two months, after the Oratane treatment has ceased. The side effects associated with Oratane treatment will begin to clear at the conclusion of the treatment.
Stopping intake of Oratane: The course of Oratane treatment will vary from patient to patient. The patient must be advised on how long to take Oratane. In most cases the treatment lasts for around 16 weeks, but could last up to six months or more. Advise the patient should follow the doctor's instructions carefully.
In over 80% of cases Oratane will completely clear the acne by the end of one treatment. The healing process that is started with Oratane may continue after the treatment has ceased. Advise the patient to keep taking Oratane for as long as the doctor has told to, if the patient stops sooner it may not get the full benefits of Oratane.
If the acne has not been completely cured, a second course of Oratane may be considered.
Contraindications
Oratane is suitable for almost everyone with acne, regardless of sex or age. People who can't take Oratane include pregnant women or women who are breast feeding and people suffering from certain medical conditions. Advise the patient to inform the doctor if the patient has any other conditions or takes any other medications.
Special Precautions
Laboratory Tests: Sometimes the patient may be asked to have blood tests done. These establish a baseline for the liver function, blood lipids, and for females can also confirm that the patient is not pregnant. Advise the patient to follow the doctor's advice before having blood taken.
Skin Care: While taking Oratane the patient will have to take a little extra care of the skin as Oratane will make the skin drier and more fragile. The information in this section will help to look after the skin and keep the side effects of Oratane under control. It is a good idea to follow the skin care advice given in this section even before starting to notice any of the side effects related to Oratane. Prevention is always better than cure.
What not to do while taking Oratane: It is important to follow this list of things not to do so that the skin remains in good condition.
Do not squeeze any pimples. This can make the pimples worse and can damage the skin, resulting in skin infections.
Do not remove any scaly or peeling skin. Since the skin is fragile it can damage the skin by trying to remove scaly and peeling skin, this could lead to skin infections.
Do not have facials. Because the skin is fragile the potentially harsh treatments involved in a facial can cause damage to the skin.
Do not have waxes. Waxing while the skin is fragile can actually remove skin as well as hair.
Do not use other acne medication. Oratane is a strong medication and should not use any other medication unless the doctor has specifically told the patient to do so.
Do not have any part of the body pierced. There can be a serious risk of infection of any new piercing while on Oratane.
Do not have electrolysis. Because the skin is fragile, electrolysis has the potential to damage the skin.
Do not use hair colouring containing peroxide and do not have a perm or use hair rollers. If the patient wants to get hair permed it is best to do so at least two weeks before starting Oratane. While taking Oratane the patient's scalp will be more sensitive and hair will be more fragile, because of this it is important to avoid harsh hair treatments such as colours and perms.
Do not use solariums and sunbeds. Solariums and sunbeds can burn the skin just like the sun, the skin is more sensitive to the sun while taking Oratane and it is also too sensitive to use a solarium and sun bed.
Do not have overly hot showers. Very hot showers can irritate the skin.
Easing the side effects: The most common side effect of Oratane, dryness, is relatively easy to treat. The following section contains a list of products that can be used to relieve dryness. If the patient notices anything unusual about the skin or anything that concerns the patient, advise the patient to talk to a doctor or pharmacist about it. It is a good idea to write down anything the patient notices or any questions have for the doctor.
Products to use to ease the side effects: Dry Skin: Dry skin is the most common side effect of Oratane treatment. The patient can expect the skin to become drier all over the body. To help protect the skin it is best to keep the showers shorter than two minutes if possible and use luke warm water rather than hot water.
Face Cleansers: The patient should only use cleansers that are intended for use on sensitive skin.
Body Cleansers: Body cleansers should not be used on the face. It is better for the skin if the patient tries to avoid soaps and use one of the body cleansers recommended by the doctors.
Face Moisturisers: Using a moisturiser on the face regularly will help keep the dryness that may be seen with Oratane treatment under control. The best type of moisturiser is an oil free face moisturiser for sensitive skin, avoid greasy moisturisers.
Body Moisturisers: Body moisturisers should not be used on the face, unless they are also included in the face moisturisers section. To keep the skin in good condition the patient should use a moisturising lotion on the whole body, even if the patient doesn't seem to have any dryness, prevention is always better than cure. For extremely dry areas use a cream, rather than a lotion.
Dry Lips: Lips are particularly sensitive to the drying effects of Oratane. This makes it important to look after them well. This can be achieved very simply by applying a lip balm regularly. By applying a lip balm every one to two hours it can prevent the lips from becoming dry and cracked. Make sure the patient also pays attention to the corners of the mouth, this area is prone to racking. A lip balm that contains a sunscreen is best. The patient should carry a tube of lip balm during the day. Advise the patient should see a doctor if the lips become very cracked or begin bleeding.
Dry Nose: The inside of the nose can also become dry while taking Oratane. If this becomes severe it can result in nosebleeds. To keep the inside of the nose moist the patient should apply a small amount of petroleum jelly a few times a day using a cotton bud. If the patient suffers from persistent nose bleeds or the nose bleeds are difficult to stop, advise the patient that they will need to see a pharmacist or doctor. Severe nose bleeds can be treated with prescription products.
Dry Eyes: If the patients find that the eyes feel dry or sore then the patient may need to use eyedrops to keep them moist. Dry eyes can be a particular problem for people who wear contact lenses or people who work in air-conditioned areas. If the patient wears contact lenses and may find that the patient cannot wear contact lenses for as long as the patient did before starting on Oratane. For dry eyes, check with an optometrist to make sure that products are suitable.
Cosmetics: Makeup can sometimes aggravate the acne but if products are chosen carefully, the patient can still wear makeup if patient wants to.
Foundations: The patient will need to use an oil free foundation, preferably one with a sunscreen.
Powders: Most powders are suitable for use while taking Oratane.
Cover Sticks: The patient should use a medicated cover stick.
Lipsticks: All lipsticks are suitable for use while taking Oratane. The best lipsticks to use are those that contain sunscreens. It is also a good idea to wear a lip balm under lipstick, because this will provide better protection for the lips.
Lip Balms: A lip balm that contains a sunscreen is best. The patient should carry a tube of lip balm during the day.
Blushers: The patient should only use powder blushes while taking Oratane.
Dry Hair and Dandruff: If the patient finds that the scalp and hair are drier than usual the patient may need to use a mild shampoo designed for dry hair. The patient should use a conditioner to help protect the hair and scalp. The patient should avoid using hair dyes, especially dyes containing peroxide, as they may make the hair and scalp drier and can cause irritation. If dandruff becomes a problem, use a medicated anti-dandruff shampoo. The patient could try shampoo products for dry hair and dandruff.
Dry Vagina: The patient may find that the vagina is dry and this may cause pain during sexual intercourse. The patient can use Lubricating Gel to help relieve this problem.
Dry Anus: The patient may experience some dryness and irritation around the anus. The patient can help relieve and reduce this problem by applying petroleum jelly several times a day.
While taking Oratane the patient can do most things patients normally do unless have been told not to by the doctor or this monograph advises against it. Some minor changes may need to be made to the lifestyle to make it easier to deal with the effect the medication has on the patient. The patient will have to make sure to look after by eating properly and caring for the skin. Advise the patient that it is important to read and understand about all the potential side effects, but remember that the patient will not get all of them. Once the patient has finished the Oratane treatment life will be back to normal, only without acne.
Oratane dos and don'ts: There are some other important things the patient needs to be careful of while taking Oratane. Advise patient to: wear a sunscreen, 30+ is best; not to drink a lot of alcohol; not to donate blood until at least four weeks after the patient has stopped taking Oratane; not to take any Vitamin A supplements (check the patient's multivitamins).
Use In Pregnancy & Lactation
Oratane should NEVER be used by pregnant women or by women who intend to become pregnant, during or for one month after, their Oratane treatment.
All possibility of pregnancy must be ruled out before the patient starts Oratane treatment. Strict birth control methods should be used for one month before starting Oratane, during the whole Oratane treatment and for one month after the patient stops taking Oratane.
One month after finishing Oratane, the patient can resume the normal practices.
Further information about Oratane and birth defects can be found as follows.
There is no known risk to males who wish to father children.
If the patient is female, it is extremely important that the patient reads and understands the information in this section.
Pregnancy Prevention: Even if the patient is not sexually active it is important to understand the effects that Oratane can have on the unborn child should the patient become pregnant while taking Oratane.
The medication in Oratane, isotretinoin, is teratogenic. This means that it can cause birth defects, that is, the unborn child can become deformed.
Birth defects can only be caused by Oratane if the patient uses it while pregnant, becomes pregnant while using Oratane or becomes pregnant within one month of stopping taking Oratane.
A pregnancy test may be given to the patient to ensure that patient is not pregnant before allowing to start taking Oratane. Should the patient become pregnant while taking Oratane or within one month after the end of Oratane treatment, advise the patient the need to discuss the action that may need to be taken with the doctor. This is a very serious situation.
For this reason, it is vitally important to advise the patient to follow strict birth control procedures.
All women of child bearing potential should be careful. This means any woman or girl, who is taking Oratane, who has started menstruating needs to follow a strict birth control procedure.
Before the patient can begin taking Oratane the patient may be required to take a pregnancy test.
The patient MUST use strict birth control for at least one month before starting Oratane treatment, during the entire Oratane treatment and for at least one month after stopping Oratane.
The patient should wait until the 2nd or 3rd day of the next menstrual period before starting Oratane. This is an extra check to make sure the patient is not pregnant.
If the patient does become pregnant while taking Oratane, the patient should immediately stop taking Oratane and advise the patient to inform the doctor straight away.
Oratane does not affect the fertility in the long term. So even after taking Oratane the patient can be able to become pregnant in the future.
The patient is responsible for making sure that she doesn't get pregnant. The only person who can make sure that she does not get pregnant while taking Oratane. It is relatively easy to prevent pregnancy. The details of the recommended strict birth control procedure are explained as follows.
Before the patient begins taking Oratane, the risks associated with Oratane and pregnancy should be gone through. A Consent form may be asked to sign. Signing this form means that the patient understands these risks and that will do everything possible to make sure not to become pregnant while taking Oratane or for one month after stopping Oratane.
Strict Birth Control: Strict birth control or contraception means carefully following a procedure to make sure the patient does not become pregnant. The most effective form of birth control or contraception is 'the pill' (oral contraceptive) plus a barrier method (condom or diaphragm). The patient should carefully follow all the directions for the use of these methods of contraception.
More information about contraception should be provided. The patient will need a prescription for 'the pill', which can be provided by the doctor or local family planning clinic.
When to stop being so careful: One month after the end of Oratane treatment the risk of birth defects is no greater than normal.
Should the patient wish to become pregnant, the patient can do so one month after stopping taking Oratane.
Where to get more help and information: For further information about contraception, advise the patient to contact a family doctor or local family planning clinic.
Side Effects
As with all medicines, there are side effects with Oratane. The side effects include dryness in several parts of the body, possible tiredness, and sometimes aching of the muscles and bones. More information on side effects can be found in this monograph.
All medicines have side effects. With Oratane the side effects are closely linked to Oratane actually working. If the patient is experiencing the side effects, then Oratane is working and it won't be long before the acne starts improving. The side effects of Oratane can range from mild to severe. Most of the side effects can be kept under control.
Everyone gets side effects. With Oratane everyone taking it will get some side effects. On the bright side, these side effects are a really good way to tell that Oratane is actually working and they can be kept under control with good skin care. Some advice on how to control the side effects that happen while using Oratane can be found in Skin Care under Precautions.
The intensity of the side effects will vary from patient to patient. Most of the common side effects are not very bad. It is important to be aware of the side effects that may occur while taking Oratane. It is also important to remember that the patient will not get all of the side effects mentioned in this section; the patient may only get one or two mild side effects. If the patient gets side effects while taking Oratane the patient may find that they wear off with time.
Common side effects: The patient may start to get some side effects with Oratane before the acne starts to clear. This will tell the patient that Oratane is working and it is just a matter of time before the acne starts to improve.
When the patient first starts taking Oratane, one of the first side effects the patient may notice is that the acne starts to get worse. This does not mean that Oratane is not working. Advise the patient to keep taking Oratane as prescribed by the doctor. Within seven to ten days the acne should stop getting worse and should then start to clear.
Dryness of the skin is the most common side effect with Oratane. Since Oratane works by drying up the oily glands in the skin the patient will find that the skin will become drier and more fragile. The patient may find that the lips become dry and cracked. The patient's face may look redder than usual and the skin may start to peel. It is important to look after the skin, the instructions in the Skin Care under Precautions will help the patient keep the side effects under control.
A less common side effect of Oratane treatment is drying of the inside of the nose and dry eyes. Drying of the nose can be uncomfortable and can lead to nose bleeds. There are ways to prevent and manage this. These are explained in the Skin Care under Precautions. Dry eyes can be a problem for people who wear contact lenses or people who work in air conditioned areas. The patient may find the need to use eyedrops to keep the eyes moist. The patient may also find the need to not wear contact lenses for as long as the patient did before starting on Oratane.
While taking Oratane the patient will find that the skin is more sensitive to the sun. The patient will need to take extra care to avoid sunburn. The patient should wear a sunscreen daily and try to avoid spending a long time in the sun.
Other side effects: Most patients will not experience the side effects listed in this section, these side effects are not very common.
There have been reports of people taking Oratane finding that their joints and muscles feel tender and stiff. This can be a problem if the patient is intending to do a lot of heavy exercise while taking Oratane. Advise the patient that it is a good idea to discuss this with a doctor.
Other serious but rarely experienced side effects of Oratane include skin infections especially around fingernails and toenails, peeling of the palms and soles of the feet, bleeding and inflammation of the gums, headaches, blurred vision, dizziness, weight loss, diarrhoea and an abnormal menstrual cycle. Thinning of the hair may also occur; this is more common in men. Advise the patient to immediately inform the doctor if the patient feels that the medication is making the patient unhappy or depressed.
It is important to remember that the side effects seen with Oratane treatment are reversible. They should disappear soon after the patient have stopped taking Oratane.
The only side effects that is not reversible are the birth defects that can be caused if the patient become pregnant while taking Oratane. There is detailed information about how and why the patient must prevent pregnancy while taking Oratane in Use in Pregnancy & Lactation.
Important information: Advise the patient that it is important to make sure to inform the doctor if any of the things listed as follows happen.
If the patient can't tolerate the side effects the patient is getting while taking Oratane, advise the patient to inform the doctor. The dose of Oratane may need to be changed.
If the patient gets any of the serious less common side effects previously mentioned.
If the patient feels unhappy or depressed.
When will the side effects go away: When the patient has finished the course of Oratane. Because Oratane is causing the side effects, when the patient has finished taking Oratane the side effects should go away.
More information: If the patient has any questions about the side effects, or will get while on Oratane, advise the patient to talk to a doctor.
Further information about acne can be found in Actions.
For even more information visit the website at www.oratane.co.nz or www.oratane.com.hk
Drug Interactions
While taking Oratane the patient should not take any tetracyclines, these are antibiotics, which the patient may have tried for the acne, in the past.
Oratane can also affect the patient if the patient does a lot of physical training or sport. The patient may experience muscle fatigue which can lead to reduced performance. The patient should also try to avoid contact sports while taking Oratane. If the patient is training for an upcoming event or playing a seasonal sport, the patient may wish to delay the Oratane treatment until a more convenient time. While using Oratane the patient should try to avoid using creams or gels that may irritate the skin. This includes products like sports gels and arthritis creams.
Acne is a common skin condition. Acne consists of blackheads, white heads, red spots, and sometimes deeper boil-like spots, these are called nodules or cysts. Acne affects most people during their teenage years. However, the problem sometimes continues into adulthood.
Acne develops in the oil-producing glands of the skin. These glands are called sebaceous glands. The oily substances produced by the sebaceous glands is called sebum. The sebaceous glands are present in large numbers on the face, chest, upper back and shoulders. The sebaceous glands are connected to the hairs that grow in the pores in these areas.
Normally, sebum flows on to the surface of the skin through the pores. As the sebum flows through the pore it gets rid of dead skin cells from the lining of the pores.
Acne occurs when an excess of sebum is made. The excess sebum mixes with the dead skin cells from the lining of the pore and forms a "plug". This plug blocks the pore. None of the sebum and dead skin cells that are still being produced can escape from the pore. This builds up and results in a pimple.
MIMS Class
Acne Treatment Preparations
ATC Classification
D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.
Presentation/Packing
Form
Oratane cap 10 mg
Packing/Price
60's
Form
Oratane cap 20 mg
Packing/Price
60's
Form
Oratane cap 5 mg
Packing/Price
60's
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