Efavirenz

The recommended adult dose of efavirenz is 600 mg once daily taken in combination with other anti-HIV (antiretroviral) drugs. The recommended dose of efavirenz for children age 3 to 17 years of age is based on body weight and will be determined by your doctor.

The efavirenz capsules or tablets should be swallowed whole with a full glass of water. The daily dose is best taken before bedtime to reduce problems associated with potential nervous system side effects.

should ideally be taken on an empty stomach (i.e., 2 hours after a meal). Food can increase how much efavirenz your stomach absorbs, which can increase your risk of side effects.

Your doctor may decide on a different dosing pattern. Do not change your dose unless instructed by your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause diarrhea; it may cause spots or redness of the skin; it may cause drowsiness or dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause nausea and vomiting; you may have difficulty concentrating. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each yellow, capsule-shaped, film-coated tablet, debossed with "TEVA" on one side and "7541" on the other side, contains 600 mg of efavirenz. Nonmedicinal ingredients: hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, poloxamer, sodium lauryl sulfate and sodium starch glycolate and purified water; Film coating: hypromellose, lactose monohydrate, titanium dioxide, polyethylene glycol, triacetin and iron oxide yellow.

Do not take efavirenz if you:

• are allergic to efavirenz or any ingredients of
• are taking cisapride, midazolam, Triazolam, Pimozide, St. John's wort, or ergot derivatives

Do not give to children less than 3 years of age or those weighing less than 13 kg.

There are life-threatening interactions that can occur between efavirenz and many other medications. For your safety, if you are thinking about or using any other medication, prescription or non-prescription, you should check with your doctor or pharmacist first. See the "What other medications could interact with ?" section for more details.

There may be an interaction between efavirenz and any of the following:

• Abiraterone
• alcohol
• alpha blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• amantadine
• Amiodarone
• anti-cancer medications (e.g., Cabazitaxel, Docetaxel, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Vincristine)
• antihistamines (e.g,. cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apixaban
• atovaquone
• azelastine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., butalbital, Phenobarbital)
• benzodiazepines (e.g., Clobazam, Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam)
• birth control
• Bosentan
• brimonidine
• Bupropion
• Buspirone
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• cannabis
• Carvedilol
• Celecoxib
• chloral hydrate
• chloroquine
• Cobicistat
• conivaptan
• Cyclosporine
• Dantrolene
• Dapsone
• Darifenacin
• Deferasirox
• Dexamethasone
• Disopyramide
• dofetilide
• Domperidone
• Dronedarone
• Entacapone
• Enzalutamide
• methylergonovine)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Famotidine
• Flecainide
• formoterol
• Galantamine
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• Guanfacine
• Hepatitis C antivirals (e.g., daclatasvir, dasabuvir, ledipasvir, paritaprevir, ombitasvir, simeprevir, sofosbuvir)
• other HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• Indacaterol
• Ivabradine
• ketamine
• Leuprolide
• lidocaine
• lithium
• Loperamide
• Losartan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Maprotiline
• maraviroc
• Mefloquine
• Methadone
• Metoclopramide
• Metronidazole
• mifepristone
• Mirtazapine
• Modafinil
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• nefazodone
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Octreotide
• Orlistat
• pentamidine
• Piroxicam
• Pramipexole
• praziquantel
• Primaquine
• procainamide
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• proguanil
• Propafenone
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• protein kinase inhibitors (e.g., Crizotinib, Dasatinib, imatinib, Nilotinib)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• Repaglinide
• rifabutin
• rifampin
• rilpivirine
• Rivaroxaban
• Romidepsin
• Ropinirole
• St. John's wort
• salmeterol
• seizure medications (e.g., clobazam, Ethosuximide, felbamate, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Selegiline
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Sildenafil
• siltuximab
• Sirolimus
• sodium oxybate
• Solifenacin
• Sotalol
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• sulfonamide antibiotics (‘sulfas'; e.g., sulfisoxazole, sulfamethoxazole)
• sulfonylureas (e.g., Gliclazide, Glyburide, Tolbutamide)
• Tacrolimus
• Tapentadol
• Tetrabenazine
• tetracyclinethiazolidinediones (e.g., Pioglitazone, Rosiglitazone)
• Ticagrelor
• Ticlopidine
• Tocilizumab
• Tofacitinib
• tolcapone
• Tolterodine
• Tolvaptan
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Trimethoprim
• Ulipristal
• Vardenafil
• Venlafaxine
• vilanterol
• Warfarin
• Zafirlukast
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with . Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use .

Birth control: Methods of birth control that use hormones, such as a birth control pill, patch or injection, may not be fully reliable as efavirenz interacts with many medications and may change the way that your body uses the hormones. At least 2 forms of non-hormonal birth control (condom, diaphragm) should be used while you are taking . It is recommended that a woman not attempt to become pregnant until at least 12 weeks after stopping , to give the medication time to leave the body.

Depression: Anti-retroviral medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how may affect your medical condition, how your medical condition may affect the dosing and effectiveness of , and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking contact your doctor as soon as possible.

Drowsiness/reduced alertness: Side effects of efavirenz may include dizziness, drowsiness, and trouble concentrating. You should not undertake activities requiring mental alertness or physical coordination until you determine that efavirenz does not affect you in this way.

Fat redistribution: Over time, may change how fat is distributed in your body and may change your body shape. You may notice increased fat in the upper back and neck, breast, around the back, chest, and stomach area; or loss of fat from the legs, arms, and face. The long-term effects of this are not known.

Heart rhythm: Efavirenz can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), discuss with your doctor how may affect your medical condition, how your medical condition may affect the dosing and effectiveness of , and whether any special monitoring is needed.

Immune reconstitution syndrome: may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes or Tuberculosis). Report any new symptoms to your doctor immediately.

Liver function: Liver disease or reduced liver function may cause to build up in the body, causing side effects. Efavirenz can also cause decreased liver function. If you have liver problems, discuss with your doctor how may affect your medical condition, how your medical condition may affect the dosing and effectiveness of , and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking .

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Pancreatitis: Efavirenz can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how may affect your medical condition, how your medical condition may affect the dosing and effectiveness of , and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

If you have a history of pancreatitis, gallstones, Alcoholism, or high triglycerides, you may be more at risk of experiencing this.

Seizures: There have been occasional reports of seizures occurring when taking efavirenz. If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how may affect your medical condition, how your medical condition may affect the dosing and effectiveness of , and whether any special monitoring is needed.

Stopping the medication: If you stop taking , your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: Women should avoid becoming pregnant while taking efavirenz as may cause harm to a developing baby if it is taken during the first trimester of pregnancy. Your doctor should test you for pregnancy before starting . If you become pregnant while taking , talk with your doctor before stopping the medication. After assessing the risks and benefits of efavirenz in your particular situation, your doctor may recommend that you continue the medication.

Breast-feeding: It is not known if efavirenz passes into breast milk. Women who have HIV infection are cautioned against breast-feeding because of the risk of passing HIV to a baby who does not have the infection.

Children: The safety and effectiveness of using have not been established for children less than 3 years of age or weighing less than 13 kg.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. This medication should be swallowed whole. It should not be split, crushed or chewed. This medication may be taken with or without food. Avoid consuming alcohol or alcohol-containing products while taking this medication.