Bomitis 20mg Phil treat acne (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Isotretinoin
Ingredient Phil

Ingredient

Composition information	Content
Isotretinoin	20mg

Uses

Indications

Bomitis drug indicated in the following cases:

Treatment of acne is severe form (such as acne, acne, acne or acne that is at risk of leaving scars) not responding to conventional treatment therapy using body antibiotics in combination with topical applied drugs.

Pharmacology

Pharmacological Group: Acne Preparation for Systemic Sugar

ATC code: D10BA01

Mechanism of action

isotretinoin is a stereopedomatic isomers of All - Trans retinoic acid (tretinoin). The exact mechanism of isotretinoin is not well known, but has determined to improve the clinical improvement of severe acne -prone acne due to inhibiting sebaceous glands and reduces the size of sebaceous glands - proven to be historical. In addition, isotretinoin has been shown to have anti -inflammatory effects.

Effect

Excessive horny horns of the pores leading to drops of horny layers (comeocytes) into the pores and are retained in it due to excess keratin and sebum. Next is the formation of acne and finally inflammatory lesions.

Isotretinoin inhibits the growth of sebaceous cells and works on acne by re -establishing a chemical program in order. Sebum is the main substrate for the growth of acne bacteria Propionibacterium acnes, reducing sebum secretion that limits bacteria to penetrate into the pores.

Pharmacokinetics

absorption

The absorption of isotretinoin through the gastrointestinal tract changes and linearly according to the dose exceeds the medication concentration.

Absolutely unprofitable bioavailability, because isotretinoin is not used as an intravenous preparation for humans, but external from dog studies shows that the bioavailability is quite low and changing. When using Isotretinoin with food, bioavailability will double compared to hunger.

Distribution

Isotretinoin binds a lot of plasma proteins, mainly albumin (99.9%). The distribution volume has not been identified and isotretinoin is not used as an intravenous preparation for humans. In humans, there is very little information about the distribution of isotretinoin into the tissue. Plasma isotretinoin levels double the concentration of the epidermis. Plasma plasma isotretinoin concentration is about 1.7 times higher than the blood concentration in isotretinoin penetrates low red blood cells.

Metabolism

After taking isotretinoin, three main metabolites have been determined in plasma: 4 - Oxo - Isotretinoin, tretinoin (All - trans retinoic acid), and 4 - Oxo - tretinoin. These metabolites have shown biological activity in some in vitro tests. 4 - Oxo - Isotretinoin in a clinical study has shown significant contributions to the effects of isotretinoin (reducing her greasy secretion, though it does not affect the concentration of isotretinoin and tretinoin in plasma). Other auxiliary metabolites include the form combined with glucuronid. The plasma concentration of the main metabolite, 4 - Oxo - Isotretinoin, reaches a stable state 2.5 times higher than the original compound.

isotretinoin and tretinoin (all - trans retinoic acid) are metabolized inversely metabolized, and thus convert tretinoin associated with isotretinoin metabolism. It is estimated at 20 - 30% of the dose of isotretinoin is metabolized by isomer.

The intestinal circulation plays an important role in human pharmacokinetics in humans. In vitro studies have shown that some CYP enzymes are associated with the conversion of isotretinoin into 4 - Oxo - Isotretinoin and tretinoin. There is no individual isoform that has a prominent role.

Isotretinoin and its metabolites do not significantly affect the activity of CYP.

Elimination

After taking isotretinoin marking radioactive, the initial approximation ratio is found in urine and feces. After drinking, the disposal time of the drug in a constant form in patients with an average acne is 19 hours. The sale time of 4 - Oxo - Isotretinoin is longer, the average is 29 hours.

isotretinoin

is a physiological retinoid and endogenous retinoid levels for about two weeks after the end of the treatment.

Special subjects

Because isotretinoin is contraindicated in patients with liver failure, Isotretinoin's dynamics are limited in this group of patients. Renal failure does not significantly reduce the clearance of Isotretinoin or 4 - Oxo - Isotretinoin.

Before taking Bomitis 20mg Phil treat acne (3 blisters x 10 tablets)

How to use

oral tablets, often used during meals.

Dosage

isotretinoin is only prescribed by or under the supervision of a doctor in the use of systemic retinoids to treat severe acne and fully understand the risks when treated with Isotretinoin and monitoring requirements.

Should take medicine 1 to 2 times a day during meals.

Adults include teenagers and the elderly

start using isotretinoin at a dose of 0.5 mg/kg daily. Treatment response and some adverse effects often depend on the dose and there are differences between patients. During treatment, the dose should be adjusted for each patient. For most patients, the treatment dose is 0.5 - 1.0 mg/kg/day.

The level of boats decreases and the rate of recurrence is often closely related to the total amount of drugs used rather than related to daily treatment or dosage time. When using the accumulated dose up to 120 - 150 mg/kg, there is no significant benefit. Treatment time depends on daily dose. Each treatment lasts 16 - 24 weeks is often enough to relieve the symptoms.

In most patients, acne will be completely lost after a treatment. In case of recurrence, one more treatment is required, daily dose and accumulated dose may be used as in the previous treatment. Because the condition can still be improved up to 8 weeks after stopping treatment, do not conduct the next treatment before this time.

Patients with severe renal failure

Patients with severe renal failure should start at lower doses (for example 10 mg/day). Then increase the dose to 1 mg/kg/day or until the patient reaches the maximum tolerance.

Isotretinoin is not indicated for acne treatment before puberty and is not recommended for children under 12 years old.

Patients with intolerance

For patients who are intolerant to the offered dose, they may continue to treat with lower dose but the treatment time is longer and the risk of recurrence is higher. To achieve the maximum treatment effect in these patients, it is advisable to continue using the highest tolerance.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

Vitamin A poisoning includes: headache, nausea or vomiting, drowsiness, irritation or itching. Signs and symptoms of Isotretinoin overdose due to accidental or intentional can be similar to vitamin A overdose.

These symptoms will gradually decrease and recover without treatment.

Using isotretinoin, overdose or normal doses, are all harmful to pregnant women, as the drug can cause teratogenic or miscarriage. Women of reproductive age overdose isotretinoin must not be pregnant about 1 month after the overdose (must use two effective methods of contraception). Male patients with overdose isotretinoin must use condoms or avoid sex with a pregnant woman or may be about 1 month pregnant, because the level of isotretinoin in the province is high. In addition, all patients who use Isotretinoin overdose should not donate blood for at least 30 days.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

The most unwanted effects when treating with isotretinoin are the symptoms:

Dry skin, dry mucosa such as lips (lipitis), nasal mucosa (nosebleeds) and eyes (conjunctivitis). Some of the adverse effects when using isotretinoin are related to the dose. Adverse effects often recover after changing the dose or stopping treatment, but some may exist after the drug stopped.

Very common (≥ 1/10)

Blood and lymphatic system: Anemia, speeding up red blood cell deposits, platelets, platelets. - Bone and connective tissue: joint pain, muscle pain, back pain (especially in children and adolescents).

Blood and lymphatic system: neutral leukopenia.

The immune system: skin allergies, anaphylactic reactions, hypersensitivity.

Bacterial infection: Gram -positive bacteria infection (mucosa). Sleep, dizziness. ). Fish, red rash (face), rash, hair disease, him, nail nourishing, infection around the nail, sensitive to light, pus seeds, hyperpigmentation, sweat increasing. Kidney.

Skin and subcutaneous tissue: Diverse erythema, Stevens - Johnson syndrome, poisoned epidermal necrosis.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Contraindicated Bomitis in the following cases:

Isotretinoin is contraindicated for pregnant women or nursing women. Human:

Liver failure.

Caution when using

pregnancy

Isotretinoin's teratogenicity is very high. Therefore, doTretinoin is not used for pregnant women or may be pregnant during treatment. Although not all fetuses in contact with Isotretinoin are deformed, but there is a very high risk of fetal deformities if pregnant women use Isotretinoin with any content even in a short time.

It is necessary to check to ensure that the patient is not pregnant at the beginning of treatment with isotretinoin. Contraceptive measures should continue to be taken for at least one month after stopping treatment with Isotretinoin, even in menstrual patients need to do it.

Five weeks after stopping treatment, the patient should last for the last time to ensure no pregnancy.

Patients should not donate blood during treatment and within a month after stopping treatment because of the risk of affecting the fetus if the blood recipient is pregnant.

This drug should be prescribed by a physician who has the ability to diagnose and treat severe cases of severe lumpy acne that is hard to cure and has experience in using whole body retinoid, and understands the risk of teratogenicity if taking this medication during pregnancy.

Mental disorders

There have been a report of depression, serious depression, anxiety, aggression, mental change, mental symptoms and very rare patients who intend to commit suicide, try to commit suicide and suicide in patients with isotretinoin treatment. Special care should be performed in patients with a history of depression; Should monitor depression signs in all patients and apply appropriate treatment when needed.

Skin and tissue disorders

Acute acne outbreak occasionally occurs in the early stages of treatment, but will gradually decrease when continued treatment, usually within 7-10 days and do not need to adjust the dose.

Should avoid exposure to the sun or UV rays. If necessary, use sunscreen products with high SPFs from 15 or more.

Treatment of skin abrasion with chemicals and laser treatment should be avoided in patients with isotretinoin for 5-6 months after the end of the treatment because of the risk of hypertrophy of scars. Wax wax should also avoid at least 6 months after treatment for the risk of epidermal peeling.

Avoid using isotretinoin simultaneously with horn pepper or skin acne medications because it can increase local irritation.

Patients should use cream or ointment to keep skin warm and lip balm at the beginning of treatment and isotretinoin can cause dry skin and lips.

There have been after -skin reports of serious skin reactions such as diverse roses (Em), Stevens Johnson (SJS) syndrome and poisoned epithelial necrosis (Ten) when using isotretinoin. If one is suspected, one of the above reactions should be suspected.

Eye disorders

dry eyes, corneal blurring, night vision and corneal inflammation are usually gone after stopping treatment. Can help reduce symptoms of dry eyes with eye or artificial tear ointment. Patients should wear glasses during treatment if not tolerated in contact lenses. Night vision reduction has also been reported and this situation usually occurs in some patients. Stop taking the drug if necessary.

Muscle - bone and connective tissue disorders

Muscle pain, joint pain and increased serum creatine phosphokinase have been reported in patients using isotretinoin, especially in heavy physical activists.

Change bone includes early bone head, bone thickness, close calcification and ligaments that have occurred after a few years of high doses to treat keratin chemical disorders. Dosage, treatment time and total dosage accumulated in these patients often exceed the recommended dose for acne treatment.

Hurry up the benign intracranial pressure

There have been cases of benign intracranial pressure reported, some of which are related to medication and tetracyclin simultaneously. Signs and symptoms of benign intracranial pressure include headache, nausea and vomiting, visual disorders and thorns. When the patient shows signs of increased intracranial pressure, the drug should be stopped immediately.

Liver disorders

It is necessary to check the liver before treatment. 1 month after the beginning of treatment and continue every 3 months unless there is more frequent monitoring. There has been a transient and recovery report. Most of these cases are within normal limits and the indicators will return to the original level during treatment. However, in case the transaminase level is prolonged, it is advisable to consider reducing the dose or stopping the drug.

kidney failure

Renal failure does not affect the pharmacokinetics of isotretinoin. Therefore, isotretinoin can be used for patients with renal failure. However, these patients should start with low doses and gradually increase to maximum tolerance.

Lipid metabolic disorders

serum lipid (hungry time) should be tested before treatment, 1 month after the beginning of treatment, and then every 3 months unless the indications are more often monitored. High serum lipid concentration will return to normal when reducing the dose or stopping treatment and may also have a suitable diet.

Isotretinoin is associated with increased serum triglyceride concentration. If the serum triglyceride concentration increases in excess of uncontrollable or symptoms of pancreatitis, the drug should be discontinued. The concentration exceeds 800 mg/dl or 9 mmol/l sometimes combined with acute pancreatitis can be fatal.

Gastrointestinal disorders

Isotretinoin is associated with intestinal inflammation (including ileitis) in patients without a history of intestinal disorders. Patients with serious diarrhea (with hemorrhage) should stop the drug immediately.

Allergic reaction

Hypersensitivity reactions are rare in several patients after exposure to retinoids first. Less skin allergies. There have been cases of severe allergic vasculitis, which are usually hemorrhagic (bruises and red spots) in the limbs, may also be the whole body of the erythema. When serious allergic reactions occur. Must stop the drug and monitor carefully.

Fructose intolerance

The drug contains sorbitol. Do not use drugs for patients with rare genetic diseases in non -tolerance fructose.

Patients with high risk

In patients with diabetes, obesity, alcoholism or lipid metabolic disorders when treated with isotretinoin, regular healing of serum lipids and/ or blood glucose. There have been reports of hyperglycemia at hunger and some cases of diabetes are diagnosed with isotretinoin treatment.

Use drugs for women during pregnancy and lactation

pregnancy

Isotretinoin is contraindicated for pregnant women. Women of reproductive age must use effective contraceptive measures during treatment and prolong 1 month after treatment with Isotretinoin. If pregnant during treatment or within 1 month after treatment, the risk of serious defects in the fetus is very large.

If pregnant during treatment with Isotretinoin, the treatment must be stopped and the patient needs to be consulted by a specialized or experienced doctor about the risk of fetal defects.

Breastfeeding period

Isotretinoin is easy to excrete through breast milk due to lipid preference. Do not use isotretinoin for breastfeeding women, because of the possibility of unwanted effects for children.

Birth ability

In the treatment dose, Isotretinoin does not affect the number, movement and shape of the condition and does not harm the formation and development of embryos from the sperm of these men.

The effect of the drug on driving and operating machinery

isotretinoin may affect the ability to drive and operate machinery. Some cases of night vision loss during treatment with isotretinoin and this condition rarely lasts after stopping the drug. In some patients, reduced vision at night on the start suddenly, so patients should know this condition and are warned to be cautious when driving or operating machinery.

Sleep, dizziness and visual disorders rarely occur. However, patients need to be cautious when driving and operating machinery.

Interactive drug

avoid simultaneous use of isotretinoin and vitamin A because it can lead to an overdose of vitamin A.

Some cases of increased internal pressure compared to simultaneous use of isotretinoin and tetracyclin are reported, so avoid simultaneous use of these two drugs.

Avoid simultaneous use of isotretinoin with horn pepper or skin -based acne medications because it can increase local irritation.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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