Efavirenz 50mg - What is a "Generic" medication/drug?

Resistant virus emerges rapidly when efavirenz 50mg administered as monotherapy. The choice of new antiretroviral agent s to be efavirenz in combination with efavirenz should take into consideration the potential for viral cross-resistance see section 5.

Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, 50mg tenofovir disoproxil fumarate efavirenz not recommended unless needed for dose adjustment for example, 50mg rifampicin. Concomitant 50mg of Ginkgo biloba extracts is not recommended see section 4. When prescribing medicinal products concomitantly with efavirenz, physicians should refer to the corresponding Summary of Product Characteristics. While effective viral suppression with antiretroviral therapy has been proven efavirenz substantially reduce the risk of sexual transmission, a residual risk 50mg be excluded, efavirenz 50mg.

Precautions to prevent transmission should be taken in accordance with national guidelines. If any antiretroviral medicinal product in efavirenz combination regimen is interrupted because of suspected intolerance, serious consideration should be given to simultaneous discontinuation of all antiretroviral medicinal products.

The antiretroviral medicinal products should be restarted at the same time upon resolution of the intolerance symptoms, efavirenz 50mg. Intermittent monotherapy and sequential reintroduction of antiretroviral agents is not advisable because efavirenz the increased potential for selection of resistant virus. Rash Mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves efavirenz continued therapy. 50mg incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.

Efavirenz 50mg be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever. If therapy with efavirenz is discontinued, efavirenz 50mg, consideration should also be given to interrupting therapy with other 50mg agents to avoid development of resistant efavirenz see section 4, efavirenz 50mg.

Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited see section 4. Efavirenz is not recommended efavirenz patients who have had a life-threatening cutaneous reaction e. Psychiatric symptoms Psychiatric adverse reactions have been reported in patients treated with efavirenz.

Patients with a prior history of psychiatric disorders appear to be at 50mg risk of these serious psychiatric adverse reactions, efavirenz 50mg. In particular, efavirenz 50mg, severe depression was more common in those with a history of depression. There have also been post-marketing efavirenz of severe depression, efavirenz 50mg, death by suicide, delusions, efavirenz 50mg, psychosis-like behaviour and catatonia.

Patients should be advised that if they experience symptoms such efavirenz severe depression, efavirenz 50mg, psychosis or suicidal ideation, they should contact their doctor immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risks of continued therapy outweigh the benefits see section 4.

50mg system symptoms Symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported adverse reactions in patients receiving efavirenz mg daily in clinical studies see section 4.

Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2 - 4 weeks. Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.

Seizures Convulsions have been observed in adult and paediatric patients receiving efavirenz, generally 50mg the presence of known medical history of seizures. Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.

In a drug interaction study, carbamazepine efavirenz concentrations were decreased when carbamazepine was co-administered with efavirenz see section 4. Caution must be taken in any patient with a history of seizures, efavirenz 50mg.

Sustiva 50 mg, 100 mg and 200 mg Hard Capsules

Hepatic events A 50mg of the postmarketing reports of hepatic failure occurred in efavirenz with no pre-existing hepatic disease or other identifiable risk factors see efavirenz 4.

Liver enzyme monitoring should be considered for patients without pre-existing hepatic dysfunction or other risk factors. QTc Prolongation QTc prolongation has been observed with the 50mg of efavirenz see sections 4, efavirenz 50mg.

Consider alternatives to efavirenz for coadministration with a drug with a known risk of Torsade de Pointes or when to be administered to patients at higher risk of Torsade de Pointes. Effect of food The administration of efavirenz with food may increase efavirenz exposure see section 5, efavirenz 50mg. It is recommended efavirenz efavirenz be taken 50mg an empty stomach, efavirenz 50mg, preferably at bedtime, efavirenz 50mg.

Immune Reactivation Syndrome In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy CARTan inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise efavirenz cause serious clinical conditions, efavirenz 50mg, or aggravation of symptoms.

Typically, such reactions have been observed efavirenz the first few weeks or months of initiation of CART. Any inflammatory symptoms should be evaluated and efavirenz instituted when necessary, efavirenz 50mg. Autoimmune disorders such as Graves' disease have also been reported 50mg occur in the setting of immune reactivation; however, the reported time misoprostol after mifepristone onset is more variable and these events can occur many months after initiation of treatment.

Weight and metabolic parameters Weight and levels of blood lipids and glucose 50mg increase during antiretroviral 50mg. Such changes may in part be linked to disease control and life style. For lipids, there is in some cases evidence for a treatment effect, efavirenz 50mg, while for weight gain there is no strong evidence relating this to any particular treatment.

For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines, efavirenz 50mg.

lopinavir ritonavir

Lipid disorders should be 50mg as clinically appropriate. Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement, efavirenz 50mg. Special populations Liver disease Efavirenz is contraindicated in patients with severe hepatic impairment see sections 4. Because of the extensive cytochrome Pmediated metabolism of efavirenz and limited clinical experience in patients with chronic liver disease, caution must be exercised in administering efavirenz to patients with mild hepatic impairment, efavirenz 50mg.

Patients should be monitored carefully for dose-related adverse reactions, efavirenz 50mg, especially nervous system symptoms, efavirenz 50mg. Laboratory tests should be performed to evaluate efavirenz liver disease at periodic intervals see section 4. The safety and efficacy of efavirenz has not been established in patients with significant underlying liver disorders, efavirenz 50mg. Patients with chronic hepatitis Efavirenz or C and treated with combination antiretroviral therapy are at increased risk for severe and potentially fatal hepatic adverse reactions.

Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice. If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, efavirenz 50mg, the benefit of continued therapy with efavirenz needs to be weighed against the potential risks of significant liver toxicity.

In 50mg patients, interruption or discontinuation 50mg treatment must be considered see section 4. In patients treated with other medicinal products associated with liver toxicity, efavirenz 50mg, monitoring of liver enzymes is also recommended.

In case of concomitant antiviral therapy for hepatitis B or C, efavirenz 50mg, please refer also to the relevant product information for these medicinal products. There is 50mg experience in patients with severe renal failure and close safety monitoring 50mg recommended in this population. Elderly patients Insufficient numbers of elderly efavirenz have been evaluated in clinical studies to determine whether they 50mg differently than younger patients.

Paediatric population Efavirenz has not been evaluated in children below 3 months of age or who weigh less than 3, efavirenz 50mg. Therefore, efavirenz should not be efavirenz to children less than 3 months of age. Prophylaxis with appropriate antihistamines prior to efavirenz therapy with efavirenz in children may be considered.

Efavirenz Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz, efavirenz 50mg.

Brand Name Sustiva

In vitro efavirenz is also an inhibitor of CYP3A4. Theoretically, efavirenz 50mg, efavirenz may therefore initially increase the exposure to CYP3A4 substrates and caution is warranted for CYP3A4 substrates with narrow therapeutic index see section 4.

Efavirenz may be an inducer of CYP2C19 and CYP2C9; however, inhibition has also been observed in vitro and efavirenz net effect of co-administration with substrates of these enzymes is not 50mg see section 5. Efavirenz exposure may be increased 50mg given with medicinal products for example, ritonavir or food for example, efavirenz 50mg, efavirenz juicewhich inhibit CYP3A4 or CYP2B6 activity.

Compounds or herbal preparations for example Ginkgo biloba extracts and St. John's wort which induce these enzymes may give efavirenz to decreased plasma concentrations of efavirenz. Concomitant use of St. John's wort 50mg contraindicated see section 4. Paediatric population Interaction studies have only been performed in adults. Contraindications of concomitant use Efavirenz must 50mg be administered concurrently with terfenadine, astemizole, efavirenz, midazolam, efavirenz 50mg, triazolam, pimozide, bepridil, efavirenz 50mg, or pristiq and topamax interaction alkaloids for example, efavirenz 50mg, ergotamine, dihydroergotamine, ergonovine, and methylergonovinesince inhibition of their metabolism may lead to serious, life-threatening events see section 4.

John's efavirenz Hypericum perforatum Co-administration of efavirenz and St. John's wort or herbal preparations containing St. John's wort is contraindicated.

Plasma levels of efavirenz can be reduced by concomitant use of St. If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible efavirenz levels. Efavirenz levels may increase on stopping St, efavirenz 50mg.

John's wort and the dose of efavirenz may need adjusting. The inducing effect of St. John's wort may persist for at least 2 weeks after 50mg of treatment. Studies were conducted in healthy subjects unless otherwise noted.