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Given your age, Dr. Haider usually recommends an extended high-risk protocol which includes dutasteride and spironolactone (for those patients who are not already on them and don't have any other contraindications), which are thought to help with acute and long COVID, especially in higher-risk men, but also in higher-risk women. Dutasteride is commonly used for men's enlarged prostate and hair loss, and spironolactone is frequently used in both sexes for high blood pressure or as a water pill, and in women for acne. 

Both are androgen blockers that can interfere with fetal development, so should not be handled by women of childbearing age (unless they are on strict birth control or otherwise certain they are not and cannot get pregnant), should any women of that description be in the household. 

Spironolactone is a potassium-sparing diuretic (water pill), which means that it may raise your body's potassium levels. If you do not take a potassium supplement and you have normal functioning kidneys, then your body can usually handle this and remove any excess potassium. However, if you do take potassium supplementation (often recommended to patients who have chronically low levels due to other diuretics/water pills), and/or if you have low kidney function, then you may develop excessively high levels of potassium when you add spironolactone, which can be dangerous and cause heart arrhythmias in rare cases. Therefore, it is always recommended to get potassium levels checked a week after starting on spironolactone.

If you would like Dr. Haider to consider one or both of these meds for your protocol in case of developing an acute COVID infection, let us know that you have read the above and would like them added to your prescriptions. *

 

 

In order to offer medical advice, treatment and other patient services online we need to register you as a patient and get your medical history and confirm your identity, same as in any on-the-ground clinic. 

 

This intake form is HIPAA-compliant and your data is fully secure. Any private information shared with us is kept strictly confidential and is never shared with anyone.

Telemedicine Consent

INTRODUCTION

Telemedicine involves the use of electronic communications to enable health care providers at different locations to share individual patient medical information for the purpose of improving patient care. Providers may include primary care practitioners, specialists, and/or subspecialists. The information may be used for diagnosis, therapy, follow‐up and/or education, and may include any of the following:

• Patient medical records 
• Medical images
• Asynchronous messaging
• Live two‐way audio and video
• Output data from medical devices and sound and video files
• Electronic systems used will incorporate network and software security protocols to protect the confidentiality of patient identification and imaging data and will include measures to safeguard the data and to ensure its integrity against intentional or unintentional corruption.

EXPECTED BENEFITS

Improved access to medical care by enabling a patient to remain at a location of their choice while the physician consults with them, obtains test results and consults from healthcare practitioners at distant/other sites. 

More efficient medical evaluation and management.

Obtaining expertise of a distant specialist.

POSSIBLE RISKS

As with any medical procedure, there are potential risks associated with the use of telemedicine. 

These risks include, but may not be limited to:

In rare cases, information transmitted may not be sufficient (e.g. poor resolution of images) to allow for appropriate medical decision making by the physician and consultant(s);

Delays in medical evaluation and treatment could occur due to deficiencies or failures of the equipment; In very rare instances, security protocols could fail, causing a breach of privacy of personal medical information;

In rare cases, a lack of access to complete medical records may result in adverse drug interactions or allergic reaction or other judgment error;

REFILLS

Chronic medication refills are made available on a limited basis to keep on hand in case of a disruption in supply for reasons including but not limited to: loss of primary care, supply chain disruption, natural disaster, etc. These limited refills necessitate the care and monitoring of your own physician at all times and the provision of these refills by mygotodoc does not entail the formation of a primary care physician patient relationship. Informed consent around your chronic medications is expected to have been conducted by your primary care provider though we may reiterate some of it. Alternatives to your medications, risks associated with taking all of your chronic medications are assumed to have been discussed with your primary prescribing physician and all monitoring is assumed to be conducted by your primary care physician. Our service is similar to an urgent care refill offered when a patient cannot get in touch with their primary care doctor in time and is meant to bridge you briefly until you can reestablish regular primary care and medication access. 

BY SIGNING THIS FORM, I ATTEST TO AND UNDERSTAND THE FOLLOWING:

• I understand that the laws that protect privacy and the confidentiality of medical information also apply to telemedicine, and that no information obtained in the use of telemedicine which identifies me will be disclosed to researchers or other entities without my consent,
• I understand that I have the right to withhold or withdraw my consent to the use of telemedicine in the course of my care at any time, without affecting my right to future care or treatment,
• I understand that I have the right to inspect all information obtained and recorded in the course of telemedicine interaction, and may receive copies of this information for a reasonable fee,
• I understand that a variety of alternative methods of medical care may be available to me, and that I may choose one or more of these at any time. Mygotodoc and/or its associates have explained the alternatives to my satisfaction. 
• I understand that telemedicine may involve electronic communication of my personal medical information to other medical practitioners who may be located in other areas, including out of state. I understand that it is my duty to inform my doctor and/or his/her staff of electronic interactions regarding my care that I may have with other healthcare providers.
• I understand that I may expect the anticipated benefits from the use of telemedicine in my care, but that no results can be guaranteed or assured.
• I attest that I am currently located in the state indicated and will be present in the same state during all telehealth encounters with my physician.

PATIENT CONSENT TO THE USE OF TELEMEDICINE

This intake form is HIPAA-compliant and your data is fully secure. Any private information shared with us is kept strictly confidential and is never shared with anyone.

INFORMED CONSENT FOR ANTIBIOTICS

 

Our emergency Medkit prescriptions are meant to give patients under the active care of a physician access to life saving antibiotics when local supplies may have run out. 

They are not meant for self diagnosis or treatment, but for physician directed use at all times if at all possible, though it is understood that in certain extreme situations emergency physician services may not be available. 

We will provide guidance on typical conditions treated and protocols via a free ebook. 

Information presented therein on common infectious diseases and their treatment protocols is meant to help patients familiarize themselves with the conditions and protocols and help answer common questions, but should not serve as a substitute to proper diagnosis, medical advice or treatment recommendations from a physician. It is not possible to adequately cover these topics in such a short space and even if it was, without direct in person instruction it is not possible to teach the necessary diagnostic skills and clinical judgment required for proper evaluation and management of any medical condition. 

We will also endeavor to provide guidance on the typical conditions treated and protocols that may be used for various conditions via asynchronous medical chat, however the turnaround time for asynchronous medical chat may be hours to days and cannot be relied upon for urgent or emergency care. 

Benefits of Antibiotics

In the pre antibiotic era bacterial infections were one of the leading causes of death, though the exact extent to which poor hygiene played a role in morbidity and mortality is unknown. The age of antibiotics coincided with the widespread implementation of good hygiene practices and aseptic surgical techniques. Simple hand washing prevented many post surgical infections and deaths. 

However some infections like pneumonia can be transmitted even in hygienic surroundings and can be life threatening even in otherwise healthy patients. Also many patients nowadays are at high risk of deterioration from what would otherwise be mild infections due to comorbid conditions that depress their immunity, most commonly diabetes. 

Overall there are still many patients whose lives are saved in modern times by the judicious use of antibiotics. 

Alternatives to Antibiotics

The main alternative to antibiotic use is supportive care, allowing the immune system to fight off an infection on its own. This is recommended for mild self limited bacterial infections like paronychia (a cuticle infection).  

Inappropriate Use

Antibiotics are frequently over prescribed for viral infections and in some cases are not necessary for bacterial infections either. 

There is no good evidence that most people need antibiotics to treat: bronchitis (mostly viral), sinusitis (mostly viral), sore throat (including strep throat), middle ear infections, outer ear infections, or pink eye. Minor skin infections will also often resolve on their own. Many mild UTIs resolve on their own with increased fluid intake, cranberry juice or high dose cranberry extract (e.g. D-mannose 500 mg 5 times a day for 5 days). 

General Antibiotic Risks

Antibiotics can be lifesaving drugs, but their use and overuse is associated with many problems and diseases because of: unexpected adverse reactions, allergies, interactions with other drugs and foods, drug disease interactions, negative effects on our bodies' healthy bacteria, etc. 

All these issues are compounded by self administration of antibiotics without proper physician guidance e.g. in certain emergency settings when there is no physician available, but medications are on hand. 

General Adverse Effects

Prescription antibiotics, acid suppressing drugs and steroids along with some other medications that have antibiotic-like effects may reversibly or irreversibly kill some species of healthy bacteria which you may never recover even if you take probiotics (which just pass through your system in a couple weeks). 

Healthy bacteria are involved in a number of ways in our immune system function, for example by directly blocking invading pathogens. They also help us maintain a healthy weight, and metabolize some nutrients and make some vitamins for us. Changes in healthy gut bacteria have been associated with chronic diseases like heart disease, obesity, dementia, Parkinson's disease, diabetes, allergies, asthma, inflammatory bowel disease and Irritable bowel syndrome, to name just a few.  

Aside from eliminating good bacteria, antibiotics also have direct negative effects on the mammalian immune system, which have been documented in a number of studies. In one study of mice infected with the flu virus, only a third survived if they had been given antibiotics soon before compared to 80% survival of those not treated with antibiotics. The mechanism was interference with the production of a protein by cells lining the lungs via alterations of genetic activity. In a similar study on west nile virus infections in mice again 80% of normal mice survived, but only 20% survived that had been exposed to antibiotics beforehand. Experiments on mice with Dengue and Zika virus had similar results. 

https://www.sciencedaily.com/releases/2019/07/190702112834.htm

All antibiotics do have some rare severe side effects. For example fluoroquinolone (drugs ending in floxacin) like ciprofloxacin: 

https://www.nature.com/articles/d41586-018-03267-5

https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-fluoroquinolone-antibiotics

The combination drug Bactrim has been withdrawn from use in England, but not elsewhere after a reporter publicized deaths due to the drug:

https://briandeer.com/bactrim-septra.htm

Healthy Bacteria 

Healthy bacteria in and on your body are an important part of your immune system and also help you maintain a normal healthy weight and metabolize some nutrients for you and make some vitamins for you that you can't make yourself. They are involved in maintaining bone density, they produce neurotransmitters, steroid hormones, activate thyroid hormone and produce their own antibiotics to fight off invasive “bad bacteria” that can cause infections. They can also affect bile salt metabolism. 

If you lose them to antibiotics, acid suppressants, steroids or painkillers, you could gain weight, develop micronutrient deficiencies and have lower immunity to infectious diseases. Long term alterations in healthy gut bacterial populations are associated with a host of chronic diseases including cancers, heart disease, obesity, diabetes, autism, depression, allergies, asthma, autoimmune diseases, IBD, MS, Rheumatoid arthritis, Liver disease, Lupus, Alzheimer’s dementia, and Parkinson's disease. We don't know if changes in healthy bacterial are part of the cause of these diseases, an effect of them or both, but the safest course of action is to minimize antibiotics and other drugs with antibiotic like effects listed above, as much as possible, because current research suggests that you cannot always replace the important bacterial species you lose. 

Probiotic supplements contain just a handful of species, compared to thousands of species in a healthy human gut, so they are not meant to replace what is lost and anyway they simply travel through your system in a couple weeks and don't remain in your gut long term anyway. Also currently there are few if any probiotics designed for other areas of the body like the nose and sinuses or skin and upper airways.  

SPECIFIC WARNINGS AND PRECAUTIONS BY ANTIBIOTIC INCLUDING:

• Adverse Reactions
• Contraindications
• Warnings/Precautions
• Drug Interactions
• Food Interactions
• Reproductive Considerations
• Pregnancy Considerations
• Breastfeeding Considerations
• Dietary Considerations
• Monitoring Parameters

This intake form is HIPAA-compliant and your data is fully secure. Any private information shared with us is kept strictly confidential and is never shared with anyone.

INFORMED CONSENT FOR OFF-LABEL TREATMENT

 

I am prescribing medications "off-label" for the prevention and treatment of COVID-19.

Off-label means that a drug is FDA approved for one indication and then used for another. For example, Ivermectin is approved for certain parasite infections and used off-label for scabies. Aspirin has been widely used off-label for the primary prevention of cardiovascular disease.

Off-label drugs are used every day in the US and make up more than 20% of all out patient prescriptions, BUT they are usually widely affirmed by nearly all physicians and pharmacists to be safe and have enough data backing them up to argue for their off-label use.

This is NOT the case with off-label prescribing for COVID-19. It is a highly charged subject and most doctors and pharmacists DO NOT agree with using ANY off-label drugs for COVID-19 aside from over-the-counter medications for symptom control. This is because our official standard setting bodies like the FDA, NIH, CDC and FDA have recommended against most off-label medications for COVID-19 outside of clinical trials.

You can expect many pharmacists to REFUSE to fill any or all of these medications when they know or suspect they are being used for COVID-19 prevention or treatment. 

The evidence base for off-label medications in COVID-19 is overall graded moderate to poor quality depending on who you ask. Those who believe it to be of poor quality recommend further higher quality studies before deciding to use the medications in practice. Those who believe at least some of the research to be moderate quality recommend using some combination of off label medications now. There are no high quality studies (like double blind placebo controlled randomized controlled trials) yet on off-label medications for COVID-19. 

Also some recommended drugs (like pravastatin) may have no studies to back up their use, only a hypothesized beneficial mechanism of action based on our understanding of how they work in the body. 

The alternatives to off-label drugs for COVID-19 include vaccines, monoclonal antibodies, remdesevir, symptom management, and in some cases specific therapeutics like intubation, ECMO, steroids, etc. There are also many therapeutics in development and testing phases like oral antivirals.

IVERMECTIN (IVM):

Ivermectin is a generally safe medication and has been used in millions of people around the world for over 30 years.

There are a number of studies of poor to moderate quality that appear to suggest ivermectin works to prevent and treat COVID-19. However most qualified researchers and prominent standard setting bodies like the WHO, CDC, NIH and FDA publically state the studies are weak and of very poor quality and there is not yet enough evidence to recommend ivermectin use outside a clinical trial. 

There are other prominent researchers like professor of medicine Paul Marik and intensivist Pierre Kory who consider the research to be of moderate quality and strong enough to recommend ivermectin's use right now. 

The non-partisan British Ivermectin Recommendation Development Panel (BIRD) has recommended ivermectin for prevention and treatment. The FLCCC in the US recommends ivermectin for prevention and treatment. There have been some meta-analyses of 27 randomized controlled trials suggesting ivermectin decreases risk of death by more than 80%. Other meta-analyses that had different inclusion criteria for their studies suggest ivermectin does not work. 

Studies may be published in the future with poor trial design that appear to discredit ivermectin. It is also possible excellent quality studies are published in the future that prove ivermectin doesn't work.

IVM SAFETY

Ivermectin has a 30 year history of safe use in humans and the side effect profile appears mild for the most part. However the past use of ivermectin does not predict the safety and side effects seen when used for COVID-19 because we are using much higher doses when treating and preventing COVID-19. For scabies and parasite infections the usual dose is one time 0.2mg/kg. For COVID-19 prevention the dose is 0.2mg/kg twice a week indefinitely. For acute treatment the recommended dose is 0.4mg/kg daily until symptoms resolve and it may be continued for 7-14 days total. These doses are MUCH higher than any used in the past. Based on my experience they are still safe and in thousands of patients I have seen no lasting or serious reactions to high dose ivermectin use, but my data is imperfect and there may have been serious or severe side effects not reported to me. I do know that in the US many patients have called poison control centers after taking higher than usual doses of ivermectin. There are many reports in hospitals of patients with elevated liver function tests after ivermectin use.

Also when used on a new disease, side effects could be different than those recorded in the past. For example, the most severe side effects of ivermectin in the past were only seen in the setting of treatment for a certain parasitic disease. The other relatively common side effect that has been seen in the past is elevated liver function tests which could indicate liver damage, reported in 2% of patients. While on ivermectin you should get liver function tests done on a monthly basis. There are also a number of other more severe side effects seen less than 1% of the time. All that being said, Tylenol and Advil use has been shown to increase the risk of heart failure and death and those are available over the counter. All medications do carry some risk that you should be aware of and in our judgement the risk is acceptable given the disease, but others including the FDA, CDC, NIH and WHO STRONGLY disagree with this assessment.

IVM Interactions and safe usage notes:

Alcohol can increase the blood levels of ivermectin, so should be avoided when taking ivermectin.

Using alcohol with Ivermectin may increase the risk of side effects.

These are the common side effects reported with ivermectin in general:

Cardiovascular: Tachycardia (4%), peripheral edema (3%), facial edema (1%), orthostatic hypotension (1%)
Central nervous system: Dizziness (3%)
Gastrointestinal: Diarrhea (2%), nausea (2%)

Not to be used in pregnancy, or by those who might become pregnant - sexually active women should use contraception.

All Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Dermatologic: Pruritus (3%; Mazzotti reaction, associated with onchocerciasis: 28%), dermatological reaction (Mazzotti reaction, associated with onchocerciasis: 23%; includes edema, urticarial rash)

Hematologic & oncologic: Lymphadenitis (Mazzotti reaction, associated with onchocerciasis: 1% to 14%)

Neuromuscular & skeletal: Arthralgia (Mazzotti reaction, associated with onchocerciasis: ≤9%), synovitis (Mazzotti reaction, associated with onchocerciasis: ≤9%)

Miscellaneous: Fever (Mazzotti reaction, associated with onchocerciasis: 23%)

1% to 10%:

Cardiovascular: Tachycardia (4%), peripheral edema (3%), facial edema (1%), orthostatic hypotension (1%)

Central nervous system: Dizziness (3%)

Gastrointestinal: Diarrhea (2%), nausea (2%)

Hematologic & oncologic: Eosinophilia (3%), decreased white blood cell count (3%), increased hemoglobin (1%)

Hepatic: Increased serum ALT (2%), increased serum AST (2%)

Contraindications Hypersensitivity to ivermectin or any component of the formulation

Warnings/Precautions Concerns related to adverse effects:

• Cutaneous/systemic reactions: Data have shown that antihelmintic drugs like ivermectin may cause cutaneous and/or systemic reactions (Mazzoti reaction) of varying severity including ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with ivermectin for onchocerciasis may experience these reactions. Treatment of severe Mazzoti reactions is not definitive, but includes supportive care (eg, hydration and/or parenteral corticosteroids) to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate reactions.

Disease-related concerns:

• Loiasis: Pretreatment assessment and post-treatment follow up for Loa loa infection is recommended in any patient with significant exposure to endemic areas (West and Central Africa); serious and/or fatal encephalopathy has been reported (rarely) during treatment in onchocerciasis patients with concomitant loiasis.

Special populations:

• Immunocompromised patients: Repeated treatment may be required in immunocompromised patients (eg, HIV); control of extraintestinal strongyloidiasis may necessitate suppressive (once monthly) therapy.

Other warnings/precautions:

• Appropriate use: Onchocerca volvulus: Ivermectin has no activity against adult O. volvulus parasites.

Warnings: Additional Pediatric Considerations: Avoid use or use with extreme caution in pediatric patients 

FLUVOXAMINE 50mg twice a day for acute COVID-19

As of late April Fluvoxamine has been added to the FLCCC IMask protocol for acute COVID-19.

60 minutes report

A small number of studies show this may prevent progression to severe disease. 

Fluvoxamine is an old psychiatric drug that may work by blocking the COVID-19 cytokine storm in the brain and body by its action on the Sigma 1 receptor - this is helpful because Ivermectin does not work in the brain where much of the damage can occur, especially with long COVID. A number of studies and case series on Fluvoxamine suggest efficacy in preventing hospitalization with COVID-19 as well as long COVID symptoms beyond 2 weeks. See skirsch.io and: tinyurl.com/COVIDFluvox for more details. The 50 mg dose is smaller than that normally used for OCD and has no side effects for most patients. Also there are usually no psychiatric effects with a short 2 week course.

When taking fluvoxamine:

NO CAFFEINE ALLOWED (or very very little - 1/10 of a cup)

Fluvoxamine prevents the metabolism of caffeine so levels can build up and make you very uncomfortable after a while.

First, patients should avoid caffeine while taking fluvoxamine. It prevents the body from properly metabolizing caffeine, making it stay in the system 5 times as long as expected. This is not dangerous but can cause insomnia and jitteriness. If they must have caffeine, they should limit their intake to ½ of a small cup of coffee, or one can of soda, or one tea, in the morning. They can return to their regular caffeine intake once they have stopped taking fluvoxamine.

Side effects: Uncommon Side Effects of FLUVOXAMINE (1-10%)

Dizziness, Weight loss or loss of appetite, Agitation, nervousness, or anxiety, Yawning, Trouble sleeping or excessive sleepiness, Tremor, Headache, Palpitations (feeling your heart beating), High heart rate, Diarrhea or constipation, Sweating, Weakness or feeling of malaise, Dry mouth, Nausea, Vomiting, Sexual dysfunction (delayed orgasm or reduced libido)

Rare (< 1%) — painful joints, hallucinations, confusion, drop in blood pressure while standing, edema (build up of fluid), rash or itchy skin, main (elevated mood), seizures, abnormal liver function, light sensitivity.

BUDESONIDE steroid inhaler for acute COVID-19:

Trials have shown this may prevent progression to severe lung disease in COVID-19.

Adverse Reactions:

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequencies are for both formulations unless otherwise indicated.

>10%:

Otic: Otitis media (suspension: 12%; powder: 1%)
Respiratory: Respiratory infection (suspension: 38%; powder: ≥3%), rhinitis (5% to 12%)

1% to 10%:

Cardiovascular: Syncope (powder: 1% to 3%), chest pain (suspension: 1% to < 3%)
Central nervous system: Headache (powder: ≥3%; suspension: < 1%), pain (powder: ≥3%), hypertonia (powder: 1% to 3%), insomnia (powder: 1% to 3%), voice disorder (powder: 1% to 3%), emotional lability (suspension: 1% to < 3%), fatigue (suspension: 1% to < 3%)
Dermatologic: Skin rash (suspension: 4%; powder: < 1%), contact dermatitis (suspension: 1% to < 3%), eczema (suspension: 1% to < 3%), pruritus (suspension: 1% to < 3%), pustular rash (suspension: 1% to < 3%)
Endocrine & metabolic: Weight gain (1% to 3%)
Gastrointestinal: Dyspepsia (≥5%), nausea (2% to ≥5%), gastroenteritis (suspension: 5%), diarrhea (suspension: 4%), vomiting (1% to 4%), abdominal pain (1% to 3%), dysgeusia (powder: 1% to 3%), xerostomia (powder: 1% to 3%), anorexia (suspension: 1% to < 3%), viral gastroenteritis (powder: 2%), oral candidiasis (powder: 1%)
Hematologic & oncologic: Ecchymosis (powder: 1% to 3%), cervical lymphadenopathy (suspension: 1% to < 3%), purpura (suspension: 1% to < 3%)
Hypersensitivity: Hypersensitivity reaction (1% to < 3%)
Infection: Candidiasis (suspension: 4% to 5%), viral infection (suspension: 4% to 5%), infection (1% to 3%), herpes simplex infection (suspension: 1% to < 3%)
Neuromuscular & skeletal: Arthralgia (≥5%), weakness (≥5%), back pain (powder: ≥3%), bone fracture (1% to 3%), myalgia (1% to 3%), neck pain (powder: 1% to 3%), hyperkinesia (suspension: 1% to < 3%)
Ophthalmic: Conjunctivitis (suspension: 4%), eye infection (suspension: 1% < 3%)
Otic: Otic infection (suspension: 5%), otalgia (suspension: 1% to < 3%)
Respiratory: Nasopharyngitis (powder: 9%), cough (5% to 9%), epistaxis (suspension: 2% to 4%), respiratory tract infection (powder: ≥3%), sinusitis (powder: ≥3%; suspension: < 1%), nasal congestion (powder: 3%), pharyngitis (powder: 3%; suspension: < 1%), flu-like symptoms (suspension: 1% to < 3%), stridor (suspension: 1% to < 3%), allergic rhinitis (powder: 2%), viral upper respiratory tract infection (powder: 2%)
Miscellaneous: Fever (≥3%)

Postmarketing and/or case reports: Adrenocortical insufficiency, aggressive behavior, anxiety, avascular necrosis of femoral head, bronchitis, bruise, cataract, depression, glaucoma, growth suppression, hypercorticoidism, increased intraocular pressure, irritability, nervousness, osteopo

Contraindications

Hypersensitivity to budesonide or any component of the formulation; severe hypersensitivity to milk proteins (Pulmicort Flexhaler); primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Moderate-to-severe bronchiectasis, pulmonary tuberculosis (active or quiescent), untreated respiratory infection (bacterial, fungal, or viral)

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children, in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products or corticosteroids with lower systemic effect due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections (particularly gastroenteritis), or other conditions with severe electrolyte loss. Select surgical patients on long-term, high-dose, inhaled corticosteroid (ICS), should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; reaction should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue budesonide and institute alternative therapy.
• Hypersensitivity reactions: Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, rash, contact dermatitis and urticaria) may occur; discontinue use if reaction occurs.
• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use, if possible, in patients with ocular herpes, active or quiescent respiratory tuberculosis, or untreated viral, fungal, parasitic or bacterial systemic infections. Exposure to chickenpox and measles should be avoided; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled intramuscular immunoglobulin, respectively, may be indicated; if chickenpox develops, treatment with antiviral agents may be considered.
• Oral candidiasis: Local oropharyngeal Candida albicans infections have been reported; if this occurs, treat appropriately while continuing therapy. Patients should be instructed to rinse mouth with water without swallowing after each use.
• Vasculitis: Rare cases of vasculitis (eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) or other systemic eosinophilic conditions can occur; often associated with decrease and/or withdrawal of oral corticosteroid therapy following initiation of inhaled corticosteroid.

Disease-related concerns:

• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Use is contraindicated in status asthmaticus or during other acute episodes of asthma requiring intensive measures.
• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants or oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.
• Hepatic impairment: Use with caution in patients with hepatic impairment; budesonide undergoes hepatic metabolism; drug may accumulate with hepatic impairment.
• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; blurred vision, increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.

Special populations:

• Pediatric: Orally-inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally-inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Lactose: Pulmicort Flexhaler contains lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Discontinuation of therapy: A gradual tapering of dose may be required prior to discontinuing therapy; there have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.
• Transfer to oral inhaler: When transferring to oral inhalation therapy from systemic corticosteroid therapy, previously suppressed allergic conditions (rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions) may be unmasked. Withdraw systemic corticosteroid therapy by gradually tapering the dose. Monitor lung function, beta-agonist use, asthma symptoms and for signs and symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea/vomiting, hypotension) during withdrawal.

PRAVASTATIN

There are no studies on pravastatin in COVID-19. This has been recommended by Dr Ram Yogendra of incelldx. He hypothesizes that it may help prevent vascular inflammation caused by COVID-19 and has used it extensively in long COVID patients. It may help prevent progression and lower the incidence of long COVID. 

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As reported with adults.

>10%:

Neuromuscular & skeletal: Musculoskeletal pain (25%) (table 1)

Respiratory: Upper respiratory tract infection (21%)

1% to 10%:

Cardiovascular: Angina pectoris (4%), edema (< 2%), flushing (< 2%) 
Dermatologic: Alopecia (< 2%), urticaria (< 2%)
Endocrine & metabolic: Change in libido (< 2%), weight gain (4%)
Gastrointestinal: Dysgeusia (< 2%)
Genitourinary: Cystitis (interstitial; Huang 2015), sexual disorder (< 2%)
Hypersensitivity: Hypersensitivity reaction (< 2%)
Nervous system: Insomnia (< 2%), memory impairment (< 2%), myasthenia (< 2%), neuropathy (< 2%; including peripheral neuropathy), sleep disturbance (3%), vertigo (< 2%)
Respiratory: Cough (8%)

< 1%:

Neuromuscular & skeletal: Myopathy

Frequency not defined:

Cardiovascular: Increased serum creatine kinase
Hepatic:  Increased serum alanine aminotransferase, increased serum aspartate aminotransferase
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen:

Postmarketing:

Cardiovascular: Vasculitis
Dermatologic: Erythema multiforme, skin changes (including changes to hair/nails, discoloration, dryness of mucous membranes, nodules), skin photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis
Endocrine & metabolic: Gynecomastia, thyroid dysfunction
Gastrointestinal: Abdominal pain, constipation, pancreatitis (Tsigrelis 2006)
Genitourinary: Dysuria, nocturia, urinary frequency
Hematologic & oncologic: Eosinophilia, hemolytic anemia, increased erythrocyte sedimentation rate, positive ANA titer, purpuric disease
Hepatic: Acute hepatotoxicity (Hartleb 1999), cholestatic jaundice, fulminant hepatic necrosis, hepatic cirrhosis, hepatic failure, hepatic neoplasm, hepatitis, increased serum transaminases, liver steatosis
Hypersensitivity: Anaphylaxis, angioedema
Immunologic: Immune-mediated necrotizing myopathy
Nervous system: Chills, cognitive dysfunction (reversible; including amnesia, confusion), cranial nerve disorder (including facial paresis, impairment of extraocular movement), malaise, nightmares, peripheral nerve palsy
Neuromuscular & skeletal: Arthralgia, arthritis, asthenia, dermatomyositis, lupus-like syndrome, myalgia, polymyalgia rheumatica, polymyositis, rhabdomyolysis, tendinopathy
Respiratory:  Dyspnea, interstitial pulmonary disease

Contraindications

Hypersensitivity to pravastatin or any component of the formulation; active liver disease; unexplained persistent elevations of serum transaminases; pregnancy; breast-feeding

Warnings/Precautions

Concerns related to adverse effects:

Diabetes mellitus: Increases in HbA1c and fasting blood glucose have been reported with HMG-CoA reductase inhibitors; however, the benefits of statin therapy far outweigh the risk of dysglycemia.

Myopathy/rhabdomyolysis: Discontinue therapy in any patient in which CPK levels are markedly elevated (>10 times ULN) or if myopathy is suspected/diagnosed.

Disease-related concerns:

Hepatic impairment: Use with caution in patients who consume large amounts of ethanol and/or have a history of liver disease. May require dosage adjustment in some patients with hepatic impairment.

Myasthenia gravis: May rarely worsen or precipitate myasthenia gravis (MG); monitor for worsening MG if treatment is initiated (AAN [Narayanaswami 2021]).

Special Populations:

Elderly: Use with caution in patients with advanced age, these patients are predisposed to myopathy.

Surgical patients: Based on current research and clinical guidelines, HMG-CoA reductase inhibitors should be continued in the perioperative period for noncardiac and cardiac surgery (ACC/AHA [Fleisher 2014]; ACC/AHA [Hillis 2011]). Perioperative discontinuation of statin therapy is associated with an increased risk of cardiac morbidity and mortality.

Secondary Medications for patients who cannot take ivermectin and/or fluvoxamine

1. Nitazoxanide - An antiparasitic that has evidence of efficacy against COVID-19/

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%: 

Central nervous system: Headache (>2%)
Gastrointestinal: Abdominal pain (>2%), nausea (>2%)
Genitourinary: Urine discoloration (>2%)
< 1%, postmarketing, and/or case reports: Diarrhea (exacerbation), dizziness, dyspnea, gastroesophageal reflux disease, skin rash, urticaria

Contraindications

Hypersensitivity to nitazoxanide or any component of the formulation

2. DUTASTERIDE: an antiandrogen agent that may help fight COVID-19 also used for male pattern baldness and enlarged prostate. Must be avoided in pregnancy and in those who might become pregnant.

1% to 10%:

Endocrine & metabolic: Decreased libido (≤3%; incidence highest during first 6 months of therapy), gynecomastia (including breast tenderness, breast enlargement; ≤1%), increased luteinizing hormone, increased testosterone level, increased thyroid stimulating hormone level
Genitourinary: Impotence (≤5%; incidence highest during first 6 months of therapy), ejaculatory disorder (≤2%)
Hematologic & oncologic: Prostate cancer high grade (≤1%)
< 1%, postmarketing, and/or case reports: Angioedema, cardiac failure, depressed mood, dermatological reaction (serious), dizziness, hypersensitivity, localized edema, malignant neoplasm of breast (males), pruritus, skin rash, testicular pain, testicular swelling, urticaria

Contraindications

Clinically significant hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors (eg, finasteride), or any component of the formulation; pregnancy.

3. Spironolactone: - an antiandrogen agent that may help fight COVID-19 also used for hypertension and acne. Must be avoided in pregnancy and in those who might become pregnant.

Adverse Reactions (Significant): Considerations

Gynecomastia

Spironolactone may cause gynecomastia in patients of any age that may affect one or both breasts (typically both). Gynecomastia is usually reversible following discontinuation of therapy. Eplerenone, which is associated with a lower risk of gynecomastia, may be considered if continued aldosterone antagonist therapy is required.

Mechanism: Dose- and time-related; due to decreased androgen production, inhibition of androgen receptor binding, displacement of estradiol from sex hormone-binding globulin and enhanced peripheral conversion of testosterone to estradiol.

Onset: Delayed; may occur after 1 to 2 months to over a year of therapy

Risk factors:

• Higher doses (eg, ≥150 mg/day)
• Longer duration of therapy

Hyperkalemia

Spironolactone may cause reversible hyperkalemia, which may result in hospitalization and in some cases death.

Mechanism: Dose-related; related to the pharmacologic action. Competes with aldosterone for binding to the mineralocorticoid receptor, thereby inhibiting the exchange of sodium for potassium in the distal convoluted renal tubule and preventing potassium excretion.

Onset: Intermediate; usually occurs within 4 weeks of initiation or dose titration.

Risk factors:

• Older age
• Kidney impairment
• Excessive potassium intake (eg, potassium supplements, potassium-containing salt substitutes)
• Concomitant use of certain drugs (eg, angiotensin-converting enzyme [ACE] inhibitors, angiotensin-receptor blockers, drospirenone, nonsteroidal anti-inflammatory drugs). Concurrent use of larger doses of ACE inhibitors (eg, lisinopril ≥10 mg daily in adults) also increases risk.
• Heart failure (especially patients receiving higher doses and patients with diabetes mellitus, higher baseline serum potassium levels, and worse New York Heart Association functional class)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Endocrine & metabolic: Gynecomastia (9%; up to 52% in patients receiving high doses [eg, ≥150 mg/day]) (Haynes 2009; Jeunemaitre 1987; Nuttall 2015; Prisant 2005)

Frequency not defined:

Cardiovascular: Vasculitis
Dermatologic: Chloasma, erythematous maculopapular rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Endocrine & metabolic: Amenorrhea (Levitt 1970), decreased libido, hyperglycemia, hypocalcemia, hypomagnesemia, hyponatremia, hypovolemia
Gastrointestinal: Abdominal cramps, diarrhea, gastritis, gastrointestinal hemorrhage, gastrointestinal ulcer, nausea, vomiting
Genitourinary: Erectile dysfunction, irregular menses, mastalgia, postmenopausal bleeding
Hematologic & oncologic: Agranulocytosis (Whitling 1997), leukopenia, thrombocytopenia
Hepatic: Hepatotoxicity
Hypersensitivity: Anaphylaxis
Immunologic: Drug reaction with eosinophilia and systemic symptoms
Nervous system: Ataxia, confusion, dizziness, drowsiness, headache, lethargy, nipple pain
Neuromuscular & skeletal: Lower limb cramp
Renal: Renal failure syndrome, renal insufficiency
Miscellaneous: Fever
Postmarketing: Endocrine & metabolic: Gout (Ben Salem 2017), hyperkalemia (common: ≥10%) (Huang 2005; Shah 2005), hyperuricemia (Ben Salem 2017), metabolic acidosis (in patients with cirrhosis) (Feinfeld 1978; Gabow 1979), ovarian cyst (in a premature neonate) (Vachharajani 2001)

Contraindications

Hyperkalemia; Addison disease; concomitant use with eplerenone.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to spironolactone or any component of the formulation; acute renal insufficiency; severe renal impairment (eGFR < 30 mL/minute/1.73 m2); anuria; concomitant use with heparin or low molecular weight heparin; pregnancy; breastfeeding.

Warnings/Precautions

Concerns related to adverse effects:

Fluid/electrolyte imbalance: Fluid and electrolyte imbalance (eg, hypomagnesemia, hyponatremia, hypocalcemia, hyperglycemia, hyperkalemia) may occur. Patients with heart failure, renal disease, or cirrhosis may be particularly susceptible. Monitor and correct electrolyte disturbances; adjust dose to avoid dehydration.

Tumorigenic: Shown to be a tumorigen in chronic toxicity animal studies. Recent retrospective and observational studies do not suggest an increased risk of prostate or breast cancer (McKenzie 2016; Rozner 2020; Sabatier 2019).

Disease-related concerns:

• Adrenal vein catheterization: Discontinue use prior to adrenal vein catheterization.
• Heart failure: When evaluating a heart failure patient for spironolactone treatment, eGFR should be >30 mL/minute/1.73 m2 or creatinine should be ≤2.5 mg/dL (men) or ≤2 mg/dL (women) with no recent worsening and potassium < 5 mEq/L with no history of severe hyperkalemia (ACC/AHA [Yancy 2013]). Serum potassium levels require close monitoring and management if elevated. American College of Cardiology/American Heart Association recommends considering discontinuation upon the development of serum potassium >5.5 mEq/L or worsening renal function with careful evaluation of the entire medical regimen. Avoid triple therapy with the combined use of an ACE inhibitor, ARB, and spironolactone. Therapy may need to be modified during an episode of diarrhea or dehydration or when loop diuretic therapy is interrupted (ACC/AHA [Yancy 2013]).

Special populations:

• Elderly: Avoid use of tablets >25 mg/day in elderly patients with heart failure or with reduced renal function (eg, CrCl < 30 mL/minute or eGFR ≤30 mL/minute/1.73 m2 [ACC/AHA (Yancy 2013)]).

Other warnings/precautions:

• Suspension: Suspension is NOT therapeutically equivalent to tablets. In patients requiring > 100 mg/dose, use tablets (>100 mg/dose of suspension may result in spironolactone concentration higher than expected).

4. CALCITRIOL - a synthetic active vitamin D analogue that does not need to be activated in the body like over the counter vitamin D.

Adverse Reactions
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Endocrine & metabolic: Hypercalcemia

1% to 10%:

Central nervous system: Headache
Dermatologic: Skin rash
Endocrine & metabolic: Polydipsia
Gastrointestinal: Abdominal pain, nausea
Genitourinary: Urinary tract infection

Frequency not defined:

Cardiovascular: Cardiac arrhythmia, hypertension
Central nervous system: Apathy, drowsiness, hyperthermia, metallic taste, psychosis, sensory disturbance
Dermatologic: Erythema, erythema multiforme, pruritus, urticaria
Endocrine & metabolic: Albuminuria, calcinosis, decreased libido, dehydration, growth suppression, hypercholesterolemia, weight loss
Gastrointestinal: Anorexia, constipation, pancreatitis, stomach pain, vomiting, xerostomia
Genitourinary: Hypercalciuria, nocturia
Hepatic: Increased serum ALT, increased serum AST
Hypersensitivity: Hypersensitivity reaction
Local: Pain at injection site (mild)
Neuromuscular & skeletal: Dystrophy, myalgia, ostealgia, weakness
Ophthalmic: Conjunctivitis, photophobia
Renal: Calcium nephrolithiasis, increased blood urea nitrogen, increased serum creatinine, polyuria
Respiratory: Rhinorrhea
< 1%, postmarketing, and/or case reports: Agitation, anaphylaxis, apprehension, hypermagnesemia, hyperphosphatemia, hypervitaminosis D, increased hematocrit, increased hemoglobin, increased neutrophils, increased serum alkaline phosphatase, insomnia, limb pain, lymphocytosis

Contraindications

Hypersensitivity to calcitriol, other vitamin D analogues, or any component of the formulation; hypercalcemia, vitamin D toxicity

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INFORMED CONSENT FOR OFF-LABEL TREATMENT (Long Haul)

 

Off-label drugs are used every day in the US and make up more than 20% of all prescriptions. Still, they are usually widely affirmed by nearly all physicians and pharmacists to be safe. Moreover, they have enough data backing them up to argue for their off-label use.

This is NOT the case with off-label prescribing for COVID-19. It is a highly charged subject, and most doctors and pharmacists disagree with using ANY off-label drugs for COVID-19 aside from over-the-counter medications for symptom control.

You can expect some pharmacists to REFUSE to fill any or all of these medications when they suspect they are being used for COVID-19 prevention or treatment. However, so far, it has always been possible to find some nearby pharmacy to fill the prescriptions as some pharmacists either look the other way or are on board with our effort to treat COVID-19.

LONG COVID

Treatment generally starts with the cheapest drugs with the least side effects. At the top is ivermectin, then fluvoxamine, and later we may add low dose steroids or maraviroc depending on response. We can use those for the initial regimen if you already have recommendations based on the Incelldx blood panel (covidlonghaulers.com). Once your symptoms resolve, we can stop some meds quickly and taper others like fluvoxamine over a few weeks, depending on how long you have been on them.

Based on the experience of Bruce Patterson et al at incelldx:

If mostly brain fog - fluvoxamine with low dose steroid works best.

This is likely because 71% of their patients with brain fog had elevated VEGF, and ivermectin doesn’t help with that.

If mostly generalized fatigue, then ivermectin with fluvoxamine works best.

Some of Dr. Patterson’s patients respond well to ivermectin alone; others only respond when maraviroc is added. Maraviroc usually leads to faster improvement and earlier discontinuation of medications in those who respond to ivermectin independently.

IVERMECTIN (IVM):

You can learn more about ivermectin for COVID-19 here: covid19criticalcare.com

Ivermectin is a generally safe medication and has been used in millions of people around the world for over 30 years.

In one small study of 33 patients by Aguirre-Chang it was 94% effective for diminishing long COVID symptoms after 4 days.

In a larger case series using aspirin and ivermectin together up to 85% had resolution of symptoms, sometimes requiring longer treatment durations:

symptoms that respond best include anosmia, nasal congestion, tachycardia, chest pain, night sweats, low grade fever, shortness of breath, wheezing, brain fog, and poor memory.

IVM SAFETY NOTES

Based on data compiled by various physicians around the world, we believe Ivermectin is effective at preventing and treating COVID19 at every stage and can be safely used off-label in humans for this indication.

The NIH stance on Ivermectin is "neither for nor against" this is the same NIH stance on commonly used therapies for COVID19 like convalescent plasma and monoclonal antibodies.

NIH COVID19 treatment guidelines:

According to the FDA, it is allowed as an off-label drug. The main use of Ivermectin in the US is for scabies, and this is also an off-label indication.

Still, studies may be published in the future proving that Ivermectin doesn't work.

Ivermectin has a 30-year history of safe use in humans, and the side effect profile is very reassuring.

However, when used on a new disease, side effects could be different than those recorded in the past. For example, the most severe side effects of Ivermectin in the past were only seen in the setting of treatment for certain parasitic diseases.

Elevated liver function tests have been reported, but only one case of hepatitis. There are a number of other more severe side effects seen less than 1% of the time.

IVM Interactions and safe usage notes:

Alcohol can increase the blood levels of ivermectin which may increase the risk of mild to moderate side effects.

These are the common side effects reported with ivermectin in general:

Cardiovascular: Tachycardia (4%), peripheral edema (3%), facial edema (1%), orthostatic hypotension (1%)
Central nervous system: Dizziness (3%)
Gastrointestinal: Diarrhea (2%), nausea (2%)

At higher doses used for long covid, I have had a small percentage of patients complain of visual changes that quickly go away when the dose is reduced, or the medication is stopped. Eye exams in these patients have not shown any abnormalities, but inflammation of various parts of the eye is possible with ivermectin.

Not to be used in pregnancy, or by those who might become pregnant - sexually active women should use contraception.

MARAVIROC

An HIV drug. Dr. Bruce Patterson’s group reports that it is effective for many long-haul patients, especially as an adjunct to ivermectin. Adverse effects at first glance seem concerning as they include heart attacks, strokes, and cancers, but most of these showed up after many months to years of use in HIV patients with other preexisting conditions like heart disease; they are not expected to appear with short term use.

Adverse Effects

>10%: