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Introduction and mechanism of action of Roaccutane
Roaccutane (also know as Accutane in some countries) is member of a class of medicines known as retinoids, which are similar to vitamin A. The Accutane brand name has been discontinued in the U.S. different generic versions of this product have been approved by the FDA, and there are various generic equivalents available in the market.
This medication is used to treat severe acne called cystic acne (also known as nodular acne) that has not been treated with other medicines (e.g., benzoyl peroxide or clindamycin applied topically on the skin or tetracycline or minocycline taken orally). Nodules are inflammatory lesions of 5 mm diameter or greater. The nodules may become suppurative or bleeding may occur depending on the severity of acne.
Nodular acne causes redness, swelling, and tenderness of lumps in the skin. Roaccutane works by decreasing oil production (sebum secretions) made by glands in your skin, reducing bacterial load on the skin, inflammation at acne site and open the clogged pores. High sebum production can lead to severe acne and if not treated on time, severe acne can cause permanent scarring.
Different types of medicines are used for acne treatment. Roaccutane is one of them and used for the treatment of more severe acne. It works through different mechanisms, blocking different factors that produce acne including the production of sebum (an oily substance produced by sebaceous glands in the skin) and the formation of keratin (outer scales of skin) that block the pores of the hair follicle.
Since Roaccutane is the only helping medication we aim to serve patients to buy Roaccutane online UK easily.
How to buy Roaccutane UK safe?
It is very hard to find a real Roaccutane supplier on web. The most of the medications are made in China or India which are generic forms and has no active ingredients. Most customers on web claimed most of the medications they bought does not even work on their skin. That is because this medication has to be original brand which produced by Roche itself.
Composition of Roaccutane
Active ingredients inside Roaccutane
10 mg and 20 mg Isotretinoin is present in each Roaccutane capsule.
Inactive ingredients inside Roaccutane
Roaccutane capsules contain soya oil, yellow beeswax, hydrogenated soy oil, and partially hydrogenated soy oil. The capsule shell is composed of gelatin, glycerol, sorbitol, mannitol titanium dioxide, maize starch product, and iron oxide.
Printing ink contains black iron oxide and shellac.
Manufacturer of Roaccutane
Roaccutane is manufactured by Roche Company.
Availability and outlook of Roaccutane
Roaccutane is available in the form of 10 mg and 20 mg soft gelatin capsule in a packing of 30 capsules per pack. It is soft oval in shape, half brown-red, and half opaque with white color. It has “ROA 10” or "ROA 20" imprinting on it.
Indications of Roaccutane
Roaccutane is used for the treatment of nodular acne. Scarring and pitting on the face, relapsing acne, and acne which is unresponsive to at least two antibiotic therapy. It is also indicated for the treatment of
Safety information for using Roaccutane capsules
Side effects of Roaccutane
In general, dryness of the skin, lips, and eyes is the most common side effect. Using a moisturizer that does not block the skin pores) and lip balm regularly will help dryness of lips. In can lead to more severe form and can turn into eczema that may require additional medication.
Change in skin color and peeling off palms of hands and feet may occur. Nosebleeds may occur if the inside of the nose becomes very dry. Dryness of eyes may make it difficult to wear contact lenses and may be helped by using artificial tears eye drops provided with your contact lenses. As a result of the skin dryness and cracking, the risk of skin infection is increased. It may take a long time to heal the wounds and the skin may feel fragile and peel upper layers with friction.
Whilst taking Roaccutane, and for six months afterward, your skin will be more fragile than usual; hair removal using waxing, epilation, dermabrasion, or laser treatment, as well as tattoos and piercings should be avoided. Shaving is normally tolerated, but the use of a moisturizer afterward is recommended.
Roaccutane may increase your skin’s sensitivity to the sun. You should, therefore, avoid direct sun exposure whilst taking this medication. Where necessary a sun-protection product with a high sun protection factor of at least SPF 30 should be used. Muscles and joints may ache especially after exercise.
Temporary hair thinning may occasionally occur with Roaccutane use. Immediately contact your doctor if you have any serious side effects, including mental/mood changes (such as depression, anxiety, thoughts of suicide), tingling feeling in the skin, back/joint/muscle pain, any sort of skin bacterial infection (e.g., fever, persistent sore throat), difficulty in swallowing, peeling skin on palms/soles.
Sexual side effects include erectile dysfunction, vaginal dryness, and decreased sexual desire may also occur; these are proven to be rare but may continue after completion of treatment. Neurological changes may occur including pseudotumor cerebral, lethargy, dizziness, drowsiness, lack of sleep, nervousness, seizures, and weakness.
The reproductive system may be affected causing abnormal menstruation. Respiratory adverse effects include bronchoconstriction, respiratory system infections, and altered voice. Roaccutane may affect the hearing system causing impairment and tinnitus.
The musculoskeletal system is also affected by the treatment of severe nodular acne with Roaccutane/Accutane. The effects of multiple courses of Roaccutane (isotretinoin) on the growth of the musculoskeletal system are not clear. There is some evidence that treatment for prolonged periods of time with high dosing and multiple courses of treatment with isotretinoin have more severe side effects on the musculoskeletal system than a single course of treatment.
FDA pregnancy category for Roaccutane
In 1982, Isotretinoin was first approved by USFDA with the brand name Accutane for the treatment of severe nodular acne. However, after one and a half years of its approval 29 cases of adverse reproductive consequences in women taking Isotretinoin during first trimester were reported. Isotretinoin causes serious fetal harm in first trimester of pregnancy. The fetal abnormalities were called Accutane embryopathy or fetal isotretinoin syndrome.
On the basis of these adverse outcomes it has been called teratogenic and FDA pregnancy category X which means that there are no research studies to prove its use in pregnancy. Because of its teratogenicity, Isotretinoin must be marketed and distributed under a special restriction distribution program approved by the FDA called iPLEDGE. All doctors and dispensing pharmacists must be registered with this program.
Precautions for Roaccutane
Stop taking Roaccutane/Accutane or consult your Doctor/pharmacist/health care provider
- If you are breastfeeding
- If you have allergies to Roaccutane or Vitamin A. This medicine may contain inactive ingredients and preservatives (such as soybean, parabens), which have the probability to cause allergies or other health issues. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details #buy Roaccutane online.
- Discuss your medical history with your healthcare provider before using Roaccutane/Accutane, especially if u have diabetes, family or personal history of high blood cholesterol (triglycerides), mental/mood problems (such as depression), liver disease, obesity, eating disorders (e.g., anorexia nervosa), alcohol abuse, liver disease, bone loss problems (e.g., osteoporosis/osteomalacia, decreased bone density).
- If you are fighting with liver disease
- If you are on antibiotic therapy (Tetracyclines)
- If your blood cholesterol levels are higher than the normal
- If you have high levels of Vitamin A in the body
- Bloody stool or diarrhea
- Severe headache
- Difficulty to see at night or blurred vision
- Severe skin bruises
- If you are depressed, irritated
- If you have red patchy areas on lips, mouth, nose, genitals
- If you are feeling fever, chills and muscle fatigue
- If your stomach is upset and feeling pain in the upper area
- Simultaneous administration with topical keratolytic agents as it may cause irritation of the skin
Interactions of Roaccutane
Roaccutane has drug interactions with
- Some medicines may interact with Roaccutane. These include:
- Vitamin A or products containing vitamin supplements
- Tetracyclines antibiotics (also used for acne treatment) simultaneous treatment with Accutane/Roaccutane and tetracyclines should be avoided because concomitant Roaccutane use has been associated with a number of cases of pseudotumor cerebri.
- Hormone (progesterone) containing mini pills Micro-dosed progesterone containing products (“minipills” that do not contain an estrogen) may be an insufficient method of contraception during Roaccutane course of therapy. Various other hormonal contraceptives preparations are highly effective; there has been evidence of pregnancy from female patients who have been using a combination of oral contraceptives along with transdermal patch/injectable/implantable/vaginal ring hormonal birth control products. However, these evidences are more reported for childbearing women using only a single method of contraception. There is no evidence of hormonal contraceptives difference in their effectiveness when used with Roaccutane/Accutane. Therefore, it is very important for female patients of childbearing potential to choose and commit to use 2 forms of effective contraception strategies simultaneously, at least one of which must be a primary form of contraception.
- Anti-epilepsy drug (phenytoin)
- Corticosteroids (prednisone) Systemic corticosteroids have the potential to cause bone abnormalities namely osteoporosis. No proper clinical investigations have been carried out to evaluate drug interaction between corticosteroids and Roaccutane/Accutane and an interactive effect on bone loss between systemic corticosteroids and Accutane. Therefore, care should be exercised when using these medicines concomitantly.
- St. John’s wort (herbal product) Patients should be advised not to take medication themself with the herbal supplement St. John's Wort there is an interaction with hormonal contraceptives based on evidence of breakthrough bleeding on oral contraceptives shortly after starting St. John's Wort. It may cause more likely women to get pregnant. Pregnancies have been reported by patients taking combined hormonal contraceptives who also used some form of St. John's Wort as herbal remedy.
- Phenytoin (anti-epilepsy medicine) there is no clinical evidence that pharmacokinetics of phenytoin is altered by concomitant administration with Roaccutane/Accutane. These findings are consistent with the in vitro result that neither isotretinoin nor its metabolites cause induction or inhibition of CYP 2C9 human hepatic P450 enzyme activity in the body. Phenytoin use is associated with bone deformation namely osteomalacia. No formal clinical studies have been conducted to evaluate any sort of interaction on bone loss between phenytoin and Roaccutane/Accutane. Therefore, precautionary measures should be exercised when using these drugs together.
- Norethindrone/Ethinyl estradiol, a research study has been conducted on 31 premenopausal female patients suffering from recalcitrant nodular acne and taking OrthoNovum® Tablets as an oral contraceptive drug, Roaccutane/Accutane at the prescribed dose of 1 mg/kg/day, did not produced clinically significant changes in the pharmacokinetics of Ethinyl estradiol and norethindrone and also in the plasma concentrations of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Prescribers are recommended to consult the leaflet of medicine for medication administration simultaneously with hormonal contraceptives, since some drugs may decrease the effectiveness of these birth control hormonal products.
Frequently asked questions for Roaccutane
How should I take Roaccutane(Isotretinoin)?
Carefully follow the instructions provided by your doctor or pharmacist. As Roaccutane/Accutane shows good absorption with fatty meals, take it with food rich in fats. Always take Roaccutane/Accutane with a full glass of water to avoid the capsule from melting in your esophagus (food pipe) that will cause irritation of the gastrointestinal tract.
Do not chew or suck on the capsule. Swallow it as fast as possible to avoid irritation. Do not crush or split the capsule rather swallow it whole. Keep the capsules in a cool (5 to 25°C) dark place away from the reach of children.
What dose should I take Roaccutane and for which time period?
Roaccutane may be taken once or twice a daily with food for 6-20 weeks. At future appointments, the dose of Roaccutane may be changed depending on the side effects and your outcomes after taking medication. At the start of treatment, your acne may get worse but you have not to worry because it is an indication that Roaccutane has started its working.
After a few weeks, you will see improvement in your symptoms. It works even after you stop treatment with Roaccutane. Female patients should wait for the 2nd or 3rd day of the next normal menstrual cycle before starting Roaccutane treatment. This helps ensure that you aren't pregnant before you start taking Roaccutane.
If the total nodule number present on skin has been decreased by more than 70% before completion of 15 to 20 weeks of treatment, the medicine use may be stopped. After a break period of 2 months or more, and if nodular acne is persistent or recurring, the second course of treatment may be started after discussion with your dermatologist.
Are there any other precautions whilst taking Roaccutane?
You must never share your tablets with other people. Do not donate blood when taking Roaccutane and for at least one month after stopping the medication in case blood acceptor is a pregnant woman.
Does acne ever fail to clear on Roaccutane?
Normally Roaccutane is effective against the severe form of nodular acne, but in certain cases treatment failure occurs in case of whiteheads, smoking, secondary infection, polycystic ovarian syndrome, and age less than 14 years of age. It is very important you buy Roaccutane UK from a licensed online pharmacy.
If your acne is not responding to Isotretinoin you must:
- take additional antibiotic therapy,
- prolong the Roaccutane therapy,
- do electrocautery for whiteheads.
Can I drink alcohol whilst taking Roaccutane?
Yes, but in a limited quantity because excess as alcohol can also cause inflammation of the liver. You should not cross the government recommended limit guidelines for alcohol consumption (no more than 14 units per week).
Can I take other medications at the same time as Roaccutane?
Most drugs have no interaction with Roaccutane but some medications may interact and can cause side effects. It is important that you should tell your doctor and pharmacist about the medicine you are currently taking before starting any new prescription or over-the-counter medications (including herbal remedies). Medications to avoid while taking Roaccutane/Accutane include:
- Tetracycline antibiotics (also used for acne treatment)
- Anti-rheumatic drug (Methotrexate)
- Vitamin A supplements (including multivitamins containing vitamin A)
- it is important that you always inform your doctor and pharmacist that you are taking isotretinoin and read the in-pack leaflet
Will Roaccutane affect future pregnancies?
Roaccutane can cause serious birth defects in early pregnancy so, it has contraindication in the case of pregnant women. The use of Roaccutane/Accutane in women of childbearing age should be under the guidelines of the pregnancy prevention programs. One month after finishing a course of Roaccutane/Accutane, you may get pregnant with no side effects to the fetus. There has been no known additional risk on the pregnancy if a man taking Roaccutane fathers a child even though small concentrations of Roaccutane is found in semen.
What is pregnancy prevention program?
Under this program, rules are made by the Government body to, the medicine and health care product regulatory for the women of childbearing potential to enter into safe pregnancy while taking Roaccutane. These rules are following;
- At least one month before taking Roaccutane, you must take at least one or two contraception measures. Discuss the methods and consequences of contraception with your doctor and nurse.
- Combined contraceptive pills are considered effective in birth control. Keep in mind that certain antibiotics and herbal products can interact with hormone-based contraceptive medicines. They may make them less effective and increase the chances of conception during acne treatment with Roaccutane.
- Oral mini-pills (progestin-only) are not sufficient alone as a contraceptive and must be combined with other contraceptive means.
- Physical methods of birth control such as condoms and caps should not be used alone and must be combined with other methods.
- You must perform your pregnancy test and it should be negative before starting treatment with Roaccutane.
- It is best to start treatment on day 2 or 3 of your menstrual cycle to ensure that you are not pregnant.
- Every month you must go to the clinic for pregnancy testing and the final should be 1 month after finishing the course of treatment.
- Only 30 days of medicine will be given to you after a negative pregnancy test on each visit.
- Contraceptive measures should be taken for 1 month after completion of acne treatment with Roaccutane.
Can Roaccutane be used during breastfeeding?
Roaccutane is highly lipophilic and can appear in the milk of feeding mothers. It can cause adverse effects in children exposed through mother’s milk. So, it is not recommended to use Roaccutane during breastfeeding.
What are the consequences of overdose of Roaccutane?
If you have taken an overdose of Roaccutane accidentally, immediately contact your doctor or poisons Information Centre for advice, or go to Accident and Emergency at your nearest hospital. Contact your health care provider if you have no signs of discomfort or poisoning. You may need urgent medical attention. Signs of overdose include severe headache; vomiting; facial flushing; reddened, cracked lips; stomach pain; headache; dizziness, and loss of balance.
What should I do if I missed the dose?
If you have skipped a dose and its time for the next dose then continue your regular dosing schedule and do not take a double dose.
Can Roaccutane / Accutane cause lack of sleep?
Few literature studies are available that indicates that Roaccutane disturbs sleep pattern, it was found that Roaccutane therapy improves nighttime sleep without affecting stages of sleep and day time sleep.
Can I expect frequent urination with Roaccutane?
Roaccutane may cause blood sugar problems mainly diabetes that can cause frequent urination. If you have such symptoms of frequent urination contact your doctor/pharmacist immediately #order Roaccutane online.
Can I have mental health issues while taking Roaccutane?
It is very rare that Roaccutane causes serious mental health problems like depression, anxiety, suicide temptation. If you feel any such symptoms contact your doctor
- social disconnecting
- increased sadness of mood
- irritable or aggressive behavior
- feeling laziness
- changes in appetite and weight
- difficulty in concentrating things
Does it really cure acne for most people who take Roaccutane?
Roaccutane is the only acne medicine that is effective against all four causes of acne: excess skin oil, clogged pores, too much bacteria on the skin, and nodular inflammation. In most cases, acne is treated permanently. But, in some cases, acne relapse occurs when the treatment period is over
Why does acne comeback after Roaccutane treatment?
In most cases, acne is treated permanently. But, in some cases, acne relapse occurs when the treatment period is over. When acne reappears after treatment with Roaccutane, you have to continue treatment again with Roaccutane after consulting your doctor.
Will Roaccutane make my skin dry?
Yes, it will make your skin very dry that is how it works to treat acne. You will also get dry lips, cracked feet, nosebleed, and skin rashes.
Will taking Roaccutane to make me more sensitive to sun exposure?
Most people taking Roaccutane feel this effect. This is due to the fact that it causes shedding of the upper skin layer and exposing more sensitive new skin layers.
You can protect yourself by
- wearing sunshades
- using sunblock SPF 30 or greater
- use sunscreen on exposed areas of your body
Will Roaccutane causes my hair loss?
Hair loss is the most common problem among current Roaccutane patients. The good thing is that it won’t last long and you will get your normal hairs back despite some hair thinning. It is the most-talked but poorly documented in the proof side effect of Roaccutane. It is also important you buy Roaccutane UK from a trusted supplier.
Will Roaccutane affect my vision?
As this medicine is structurally related to Vitamin A and a high dose of this vitamin can cause night blindness (inability to see at night). So, Yes Roaccutane can affect your vision temporarily. If you are unable to see at night or in dark conditions you should avoid driving and/or operating heavy machinery. It can also cause dryness and irritation of the eyes. Once you stop taking this medicine, your eyesight will become normal. If you observe these changes in your vision then contact your doctor as soon as possible.
Is it more likely to cause skin dryness in winter?
Yes. Weather affects the level of skin dryness. So in winters, you should increase the use of a moisturizer. However, as there is less sunny weather in winters so it is another brighter side of the story.
Can children take this medicine (Roaccutane)?
The use of Roaccutane is restricted under the age of 12 years because it causes stunting of growth (slowing of growth) before puberty. Currently, no research studies are available on the effectiveness of this medicine in children.
Will Roaccutane cause stomach problems or inflammatory bowel disease?
Some studies mentioned that Roaccutane causes inflammation of the gastrointestinal tract especially large intestine and causes inflammatory bowel disease. To be more specific, it causes ulcerative colitis. But, a large study conducted in France showed that Roaccutane does not cause severe inflammatory bowel disease, and chances of severity re very less.
What are the storage conditions of Roaccutane?
Store Roaccutane at room temperature (25 degrees). Stay protected from heat, light, and moisture. Do not store in the bathroom cabinets. Keep out of the reach of children and pets.
Where can I find out more information about Roaccutane?
If you want to know any further information about Roaccutane, or if you have any queries about your treatment, you should talk over this with your doctor or pharmacist. For complete information, please see the drug information leaflet that comes with your medicine pack online. Your doctor will assess your medical conditions and inform you about the side effects that are particularly related to your case.
Can I start treatment with Roaccutane on my own?
No, you cannot start using it without consulting a doctor. This is not over the counter medicine (OTC).