Off-Label Use.Ivermectin is approved for and widely useful for the treatment of parasites such as for instance River Blindness. It has not been reviewed and approved by the US Food and Drug Administration (FDA) for use within COVID-19 or any other viral illness and its use is considered “off-label.”
Medical Controversies.This use of ivermectin has been the main topic of professional disagreement and substantial public misinformation. The medical literature includes a significant amount of clinical studies, meta-analyses, and reviews that analyze available studies, including epidemiological investigations following populations that have used ivermectin in the prevention or early treatment of COVID-19. Some meta-analyses have figured ivermectin is safe with moderate to strong, statistically significant effectiveness, particularly at early stages of the condition, while others evidence finds the evidence confirmed inconclusive. Conclusions vary partly as a result of the degree of dosing used and disagreements over the validity of study designs and rigor of some studies.
Section of a Protocol.The utilization of ivermectin is part of a protocol produced by FLCCC to deal with COVID-19 and works best when followed in its entirety rather than relying entirely on ivermectin.
There are some critical factors which be seemingly clear from studies and clinical experience about which patients should bear in mind:
Timing. Ivermectin has the best chance to work against COVID-19 when taken early in the disease. It should be started when possible.
Dosing. Concerns regarding Ivermectin arise partly because it takes higher dosing to reach antiviral and therapeutic impacts compared to doses originally approved for parasitic diseases. The prospect of negative effects is greater at higher doses; dose levels required vary by patient weight and the stage of disease.
Delta Variant. Lots of the studies done preceded the delta variant of the coronavirus, which creates higher viral loads than previous variants. Clinical connection with physicians treating with ivermectin is that it really has clinical effectiveness though it might be somewhat reduced such cases and therefore may require higher doses or additional medications.
Veterinary Forms of Ivermectin. Patients should just take what's prescribed and obtained from a pharmacy and not take veterinary ivermectin or purchase it on the web, as these forms may contain higher concentrations and impurities of unknown safety to humans.
Public Health Measures. Someone taking ivermectin, whether to cut back threat of contracting the condition or as treatment, cannot assume that they're therefore at any less threat of spreading the disease. All public health measures, including social distancing and wearing of masks along with vaccination should be strictly followed as appropriate.
Ivermectin; Notice of Public Health Agency Positions. The view of public health agencies, as expressed by the Centers for Disease Control and Prevention (CDC) is that:
Clinical trials and observational studies to gauge the usage of ivermectin to prevent and treat COVID-19 in humans have yielded insufficient evidence for the NIH COVID-19 Treatment Guidelines Panel to recommend its use. Data from adequately sized, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.” https://emergency.cdc.gov/han/2021/han00449.asp
The CDC has further issued a record that adverse effects associated with ivermectin misuse and overdose are increasing, shown by a rise in calls to poison control centers reporting overdoses and more folks experiencing adverse effects. Most of such reported cases have resulted from the usage of veterinary drugs and reports from human drugs are difficult to gauge from available information.
The FDA has warned consumers not to use ivermectin to prevent or treat COVID-19, a warning initially on the basis of the use of the pet version of the drug, which will be highly inadvisable, and more recently on the view that there is no evidence supporting its use within COVID-19. The FDA has not formally reviewed the evidence nor issued a guidance document but identifies the data at clinicaltrials.gov about which there's professional disagreement.
The National Institutes of Health (“NIH”) did review the evidence and in January of 2021 elevated ivermectin from a “do not use” to a “neither recommend for or against” policy, the exact same status as convalescent plasma and other treatments which can be in use. NIH discovered that the evidence for or against was inconclusive, which, especially given the possible lack of treatment alternatives Dr Pierre Kory , leaves the problem to the informed decision of physician and patient.
Potential Side Effects: Ivermectin has been administered in over 4 billion doses worldwide for parasitic disease and is generally considered to have excellent safety profile. All the significant negative effects caused by such use are because of the die-off of the parasite. Dosing for parasitic diseases is founded on weight up to maximum of five 3 mg pills each day for 5 days. Dosing for treatment of COVID-19 is higher to be able to achieve therapeutic levels.
Clinical ramifications of ivermectin are often mild and can include gastrointestinal symptoms such as for instance nausea, vomiting, and diarrhea; hypotension and neurologic effects such as for instance low blood pressure, headache, blurred vision, dizziness, tachycardia, visual hallucinations, altered mental status, confusion, loss of coordination and balance, orthostatic hypotension, central nervous system depression, and seizures. Cardiovascular negative effects have included tachycardia but are rare. EKG changes have been reported in rare cases including prolonged PR interval, flattened T -waves and peaked T-waves. Significant overdoses are associated with effects such as for instance decreased consciousness, confusion, hallucinations, seizures, coma, and death.
Get emergency medical help if you have signs of a hypersensitive reaction to Ivermectin: hives; difficult breathing; swelling of see your face, lips, tongue, or throat.
Drug interactions: Ivermectin has few major drug interaction, the most notable are with the anti-coagulant warfarin and immunosuppressive medications usually taken by organ transplant recipients. Some drugs can enhance or reduce the blood levels and ramifications of ivermectin. Make sure your physician has reviewed all other medicines that you're taking.
PROTOCOL DRUG INFORMED CONSENT ATTACHMENT - NITAZOXANIDE
Nitazoxanide. Nitazoxanide is definitely an antiprotozoal medicine usually used to deal with infections brought on by protozoa (single-cell parasites that reside in moist places such as for instance lakes, streams, and soil).
Possible contraindications: Make sure to tell your physician if you have liver or kidney disease; HIV or AIDS; or perhaps a weakened immune system.
Potential Adverse Effects: Nitazoxanide may cause abdominal pain, headache, abnormal urine color, nausea, and diarrhea. Additionally, it may cause dizziness, heartburn, hives or welts, itching, or skin rash, redness of your skin, trouble breathing or vomiting. These generally do not require immediate medical attention unless they are particularly bothersome or persist.
PROTOCOL DRUG INFORMED CONSENT ATTACHMENT - FLUOXETINE
Fluoxetine. Fluoxetine (Prozac) is just a selective serotonin reuptake inhibitor (SSRI) antidepressant. There has been evidence suggesting that use is significantly and substantially associated with reduced threat of intubation or death due to antiviral effects. SSRIs are often continued indefinitely and take up to 4 weeks to have an effect on mood. Use for COVID will likely be shorter-term and discontinued prior to obtaining psychiatric effects. Dosing and discontinuation should be performed under medical supervision.
Contraindications: Inform your physician invest the some of these medications, as you ought not use fluoxetine with thioridazine, linezolid, pimozide, or methylene blue injection. Patients already on an SSRI (such as Celexa, Lexapro, Paxil, or Zoloft) or if you have used an MAO inhibitor previously 14 days (such as Marplan, Nardil, Parnate, Emsam, Azilect or Eldepyrl) should not take fluoxetine. You should wait at the least 14 days after stopping an MAO inhibitor when you take fluoxetine. You should wait 5 weeks after stopping fluoxetine before you can take thioridazine or an MAOI.
Potential Adverse Effects: Many people, especially the young, have acute anxiety or thoughts about suicide when first taking an antidepressant. Stay alert to changes in mood or symptoms. Fluoxetine could impair judgment, thinking, or motor skills. Be careful when operating machinery. Report any new or worsening symptoms to your doctor, such as for instance: mood or behavior changes, anxiety, panic attacks, sleep disorders, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Alert your doctor simultaneously if you have blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); low degrees of sodium in the body – headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or a significant nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
Seek medical attention right away if you have apparent symptoms of serotonin syndrome, such as for instance: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common fluoxetine negative effects, which do not require immediate medical care may include insomnia issues (insomnia), strange dreams; headache, dizziness, drowsiness, vision changes; tremors or shaking, feeling anxious or nervous; pain, weakness, yawning, tired feeling;
upset stomach, loss of appetite, nausea, vomiting, diarrhea; dry mouth, sweating, hot flashes; changes in weight or appetite; stuffy nose, sinus pain, sore throat, flu symptoms; or decreased sexual drive, impotence, or difficulty having an orgasm.
PROTOCOL DRUG INFORMED CONSENT ATTACHMENT - SPIRONOLACTONE
Spironolactone. Spironolactone is just a potassium-sparing diuretic (water pill) that prevents the human body from absorbing an excessive amount of salt and keeps your potassium levels from getting too low. It's used to deal with heart failure, high blood pressure (hypertension) or hypokalemia (low potassium levels in the blood).
Contraindications: Patients should use spironolactone with caution with kidney, liver or heart problems, high degrees of potassium or any other electrolyte imbalance (such as low degrees of calcium, magnesium, or sodium in your blood), Addison's disease, difficulty urinating or if taking eplerenone.
Tell your doctor if you should be pregnant or want to become pregnant. Having congestive heart failure, cirrhosis, or uncontrolled high blood pressure during pregnancy may lead to medical problems in the mother or the baby. Your doctor should decide whether you take spironolactone if you should be pregnant.
Possible Adverse Events: Common spironolactone negative effects may include breast swelling or tenderness. Call your doctor simultaneously if you have: a light-headed feeling, like you might pass out; little if any urination; apparent symptoms of high potassium level such as for instance nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement or signs of other electrolyte imbalances such as for instance increased thirst or urination, confusion, vomiting, muscle pain, slurred speech, severe weakness, numbness, loss of coordination, feeling unsteady.
PROTOCOL DRUG INFORMED CONSENT ATTACHMENT - NIGELLA SATIVA
Nigella Sativa: Nigella sativa is just a popular medicinal plant for a variety of conditions including as an antihypertensive, liver tonic, diuretic, digestive aide, anti-diarrheal, appetite stimulant, analgesics, anti-bacterial and in skin disorders.
Possible Contraindications and Adverse Effects: Patients with kidney or liver disease should review the usage of this herb using their physician. It might lower blood pressure and should be used in combination with caution in patients with hypotension. It might slow blood clotting and increase the danger of bleeding disorders interviews and caution in patients on blood thinners and should be discontinued before surgery. In certain patients it may cause stomach upset, vomiting or constipation.