Isocural capsules

Isocural

  • Active Ingredient: Isotretinoin
  • 40 mg, 30 mg, 20 mg, 10 mg, 5 mg
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What is Isocural?

The active ingredient of Isocural brand is isotretinoin. Isotretinoin is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

Used for

Isocural is used to treat diseases such as: Acne, Acute Nonlymphocytic Leukemia, Granuloma Annulare, Melanoma, Metastatic, Pityriasis rubra pilaris, Rosacea.

Side Effect

Possible side effects of Isocural include: joint pain, redness, stiffness, or swelling; irritation; bloody or cloudy urine; flushing; cough or hoarseness; dryness of the mouth or nose; swelling of the eyelids, face, lips, hands, lower legs, or feet.

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Drug interactions with Isocural

Care should be taken with the following medications:

  • Vitamin-A (retinoic ac >intracranial pressure.
  • Warfarin: monitor INR carefully.

i·so·tret·i·no·in

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Following oral administration of an 80 mg dose of 14C-Isocural as a liquid suspension, 14Cactivity in blood declined with a half-life of 90 hours. The metabolites of Isocural and any conjugates are ultimately excreted in the feces and urine in relatively equal amounts (total of 65% to 83%). After a single 80 mg oral dose of Accutane (Isocural) to 74 healthy adult subjects under fed conditions, the mean ± SD elimination half-lives (t½) of Isocural and 4-oxo-Isocural were 21.0 ± 8.2 hours and 24.0 ± 5.3 hours, respectively. After both single and multiple doses, the observed accumulation ratios of Isocural ranged from 0.90 to 5.43 in patients with cystic acne.

For how long is Isocural taken?

Most patients should be treated until their skin condition clears and then for a further few months. However, courses have often been restricted to 16–30 weeks (4–7 months) to minimise the risk of teratogenicity (risk of congenital abnormalities), and to comply with local regulatory authorities. Isocural may be prescribed for years, usually in low dose or intermittently.

8. Cautions with other medicines

Some medicines and Isocural capsules can interfere with each other, and make it more likely that you'll have side effects.

Tell your doctor if you're taking these medicines before you start treatment with Isocural capsules:

  • supplements that contain vitamin A
  • tetracycline antibiotics such as doxycycline, oxytetracycline, minocycline, and lymecycline
  • other acne medicines (using both together may make skin irritation worse)

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Isocural for patients with significant systemic disease.

Patients with significant systemic disease have been successfully treated with oral Isocural. It has been suggested that these patients fall into three subgroups and therefore three appropriate protocols have been recommended ( Table 3 ) aimed at minimizing adverse effects in the associated disorder. In all instances it is necessary that a careful check be made by the dermatologist and/or the relevant physician at monthly intervals to ensure that there are no significant clinical or laboratory changes in the systemic disease. 36 , 37

Common side effects

The common side effects of Isocural capsules happen in more than 1 in 10 people. Talk to your doctor or pharmacist if these side effects bother you or don't go away:

  • skin becoming more sensitive to sunlight
  • dry eyes
  • dry throat
  • dry nose and nosebleeds
  • headaches and general aches and pains

PATIENT INFORMATION

Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant)

To be completed by the patient (and her parent or guardian* if patient is under age 18) and signed by her doctor.

Read each item below and initial in the space provided to show that you understand each item and agree to follow your doctor's instructions. Do not sign this consent and do not take Isocural if there is anything that you do not understand.

*A parent or guardian of a minor patient (under age 18) must also read and initial each item before signing the consent.

1. I understand that there is a very high chance that my unborn baby could have severe birth defects if I am pregnant or become pregnant while taking Isocural. This can happen with any amount and even if taken for short periods of time. This is why I must not be pregnant while taking Isocural.

2. I understand that I must not get pregnant 1 month before, during the entire time of my treatment, and for 1 month after the end of my treatment with Isocural.

3. I understand that I must avoid sexual intercourse completely, o r I must use 2 separate, effective forms of birth control (contraception) at the same time. The only exceptions are if I have had surgery to remove the uterus (a hysterectomy) or both of my ovaries (bilateral oophorectomy), or my doctor has medically confirmed that I am post-menopausal.

4. I understand that hormonal birth control products are among the most effective forms of birth control. Combination birth control pills and other hormonal products include skin patches, shots, under-the-skin implants, vaginal rings, and intrauterine devices (IUDs). Any form of birth control can fail. That is why I must use 2 different birth control methods at the same time, starting 1 month before, during, and for 1 month after stopping therapy every time I have sexual intercourse, even if 1 of the methods I choose is hormonal birth control.

5. I understand that the following are effective forms of birth control:

Primary forms

  • tying my tubes (tubal sterilization)
  • partner's vasectomy
  • intrauterine device
  • hormonal (combination birth control pills, skin patches, shots, under-the-skin implants, or vaginal ring)

3. Who can and can't take Isocural capsules

Isocural capsules are for teenagers and adults with severe acne. Do not give Isocural capsules to children under the age of 12 years or before puberty.

Isocural capsules aren't suitable for some people.

Do not take Isocural capsules if you:

  • have had an allergic reaction to Isocural, soya (the capsules contain soya) or any other medicines in the past
  • have an inherited digestive disorder called fructose intolerance (the capsules contain sorbitol)

To make sure Isocural capsules are safe for you, tell your doctor if you:

  • have had a mental health illness like depression
  • are pregnant or think you could be, or you're breastfeeding
  • have ever had an allergic reaction to Isocural or any other medicine
  • have liver or kidney disease
  • have high levels of cholesterol or other fats in your blood
  • have high levels of vitamin A
  • have Crohn's disease or ulcerative colitis

If you have diabetes, talk to your doctor before beginning treatment with Isocural capsules. You may need extra monitoring while you take Isocural capsules as this medicine can cause a rise in blood sugar levels.

Like all medicines, Isocural capsules can cause side effects, although not everyone gets them. Side effects will usually go away when you stop treatment.

Dry skin and lips are very common side effects. For safety, do not have any waxing, dermabrasion, or laser skin treatment while you're taking this medicine and for at least 6 months after you stop, as this could cause scarring or skin irritation.

Corneal opacities have occurred in patients receiving Accutane (Isocural) for acne and more frequently when higher drug dosages were used in patients with disorders of keratinization. The corneal opacities that have been observed in clinical trial patients treated with Accutane (Isocural) have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation of the drug (see ADVERSE REACTIONS: Special Senses).

Serious side effects

Serious side effects are rare and happen in less than 1 in 1,000 people.

Stop taking Isocural capsules and call a doctor straight away if you get:

  • anxiety, aggression and violence, changes in mood, or suicidal thoughts - these can be signs of depression or other mental health problems
  • severe pain in your stomach with or without diarrhoea, feeling or being sick (nausea or vomiting) - these can be signs of a serious problem called pancreatitis
  • bloody diarrhoea – this may be a sign of gastrointestinal bleeding
  • a serious skin rash that peels or has blisters - the skin rash may come with eye infections, ulcers, a fever, and headaches
  • difficulty moving your arms or legs, and painful, swollen or bruised areas of the body, or dark pee - these can be signs of muscle weakness
  • yellow skin or the whites of your eyes turn yellow, difficulty peeing, or feeling very tired - these are signs of liver or kidney problems
  • a bad headache that doesn't go away and makes you feel sick or be sick
  • sudden changes in eyesight, including not seeing as well at night

It's very rare, but Isocural capsules can sometimes cause depression or make it worse, and even make people feel suicidal.

7. Advice for women

This medicine is likely to harm a baby. It also increases the risk of miscarriage.

If you become pregnant during treatment with Isocural capsules, stop taking the capsules and tell your doctor as soon as possible.

It's very important that you do not get pregnant while you're taking Isocural capsules. You'll be asked by your doctor to follow strict rules to prevent pregnancy during treatment and for 1 month afterwards.

Before starting treatment with Isocural capsules, women who are able to become pregnant must agree to:

  • use at least 1, and ideally 2, reliable methods of contraception for 1 month before starting Isocural capsules, and for 1 month after treatment has stopped - the second contraceptive should be a barrier method of contraception (for example, a condom), but you shouldn't use barrier methods on their own
  • have a pregnancy test before, during, and 5 weeks after the end of treatment - some doctors may ask you to have monthly pregnancy tests

Your doctor will give you a patient reminder card for Isocural. Read this card and the information leaflet that comes with your medicine before you start taking the capsules.

Do not breastfeed while you're using Isocural capsules. This medicine can get into breast milk and harm your baby.

Cutaneous and mucocutaneous side effects

Most of the side effects due to Isocural are cutaneous or mucocutaneous and relate to the mode of action of the drug. The most common are listed here. When side effects are troublesome, Isocural may need to be withheld or the dose reduced.

  • Acne flare-up (particularly if starting dose is > 0.5 mg/kg/day)
  • Dry lips, cheilitis (sore, cracked or scaly lips) (100% of patients on 1 mg/kg/day)
  • Dry skin, fragile skin, eczema / dermatitis (itchy, red patches of skin). Note: atopic eczema may improve.
  • Increased sweating
  • Dry nostrils, epistaxis (nose bleeds)
  • Dry, watery or irritable eyes (especially in contact lens wearers), conjunctivitis, keratitis
  • Dry anal mucosa , bleeding at the time of a bowel motion
  • Dry genitals, dyspareunia (discomfort during intercourse)
  • Facial erythema
  • Sunburn on exposure to the sun
  • Temporary hair loss
  • Brittle nails
  • Pyogenic granuloma
  • Skin infections: impetigo, acute paronychia

Lipids

Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with Accutane (Isocural) . Marked elevations of serum triglycerides were reported in approximately 25% of patients receiving Accutane (Isocural) in clinical trials. In addition, approximately 15% developed a decrease in high-density lipoproteins and about 7% showed an increase in cholesterol levels. In clinical trials, the effects on triglycerides, HDL, and cholesterol were reversible upon cessation of Accutane (Isocural) therapy. Some patients have been able to reverse triglyceride elevation by reduction in weight, restriction of dietary fat and alcohol, and reduction in dose while continuing Accutane (Isocural) . 5

Blood lipid determinations should be performed before Accutane (Isocural) is given and then at intervals until the lipid response to Accutane (Isocural) is established, which usually occurs within 4 weeks. Especially careful consideration must be given to risk/benefit for patients who may be at high risk during Accutane (Isocural) therapy (patients with diabetes, obesity, increased alcohol intake, lipid metabolism disorder or familial history of lipid metabolism disorder). If Accutane (Isocural) therapy is instituted, more frequent checks of serum values for lipids and/or blood sugar are recommended (see PRECAUTIONS: Laboratory Tests).

The cardiovascular consequences of hypertriglyceridemia associated with Accutane (Isocural) are unknown. Animal Studies: In rats given 8 or 32 mg/kg/day of Isocural (1.3 to 5.3 times the recommended clinical dose of 1.0 mg/kg/day after normalization for total body surface area) for 18 months or longer, the incidences of focal calcification, fibrosis and inflammation of the myocardium, calcification of coronary, pulmonary and mesenteric arteries, and metastatic calcification of the gastric mucosa were greater than in control rats of similar age. Focal endocardial and myocardial calcifications associated with calcification of the coronary arteries were observed in two dogs after approximately 6 to 7 months of treatment with Isocural at a dosage of 60 to 120 mg/kg/day (30 to 60 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area).

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Serious allergic reaction

In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to Isocural capsules.

DOSAGE AND ADMINISTRATION

Accutane (Isocural) should be administered with a meal (see PATIENT INFORMATION).

The recommended dosage range for Accutane (Isocural) 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 (Isocural) 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 (Isocural) 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 (Isocural) , even in low doses, has not been studied, and is not recommended. It is important that Accutane (Isocural) 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 (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure).

Contraceptive measures must be followed for any subsequent course of therapy (see PRECAUTIONS).

Table 4 : Accutane (Isocural) Dosing by Body Weight (Based on Administration With Food)

INFORMATION FOR PHARMACISTS

Access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866495-0654) to obtain an authorization and the “do not dispense to patient after” date. Accutane (Isocural) must only be dispensed in no more than a 30-day supply.

REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM.

An Accutane (Isocural) Medication Guide must be given to the patient each time Accutane (Isocural) is dispensed, as required by law. This Accutane (Isocural) Medication Guide is an important part of the risk management program for the patient.

What happens if a pregnant woman takes Isocural?

Isocural has a very high chance of resulting in a spontaneous miscarriage or a severe birth deformity if a fetus is exposed to it during the first half of pregnancy. The deformities affect the growth of tissues developing at the time of exposure to the drug:

  • Cranium (skull and brain)
  • Cardiac (heart)
  • Eye, ear
  • Limbs.

Pharmacology

Isocural is indicated to treat severe recalcitrant nodular acne and patients ≥12 years enrolled in the iPLEDGE program. Label,12

The pharmacodynamics of Isocural are poorly understood. Label

Mechanism of action

Isocural produces its effects through altering progress through the cell cycle, cell differentiation, survival, and apoptosis. 4 These actions reduce sebum production, preventing the blockage of pores, and growth of acne causing bacteria. 4 Isocural and 4-oxo-Isocural both significantly reduce the production of sebum. 4,Label Isocural has little to no affinity for retinol binding proteins (RBPs) and retinoic ac >4 Tretinoin and 4-oxo-tretinion bind to the RAR-γ receptor, which is suspected to be part of the action of acne treatment by Isocural. 4 Isocural induces apoptosis in sebocytes, leading to a decrease in sebum production. 4 Isocural also reduces the formation of comedones by reducing hyperkeratinization through an unknown mechanism. 4 Isocural does not directly kill bacteria but it does reduce the size of sebum ducts and makes the microenvironment less hospitable to acne causing bacteria. 4 It may also increase immune mechanisms and alter chemotaxis of monocytes to reduce inflammation. 4

There is preliminary ev >9

Target Actions Organism U Retinoic acid receptor alpha


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