Prescription required. A licensed provider determines eligibility and treatment; kit contents may vary. Use only as directed and do not share medications. Amble does not provide medical care or dispense medications; care and prescriptions are provided by licensed providers and pharmacies. Compounded medications, if prescribed, are not FDA approved or reviewed for safety, effectiveness, or quality.
Just in Case Kit
Just in Case Kit
Amble’s Just in Case Kit was designed as your first line of defense when illness or emergency strikes. Packed with nine essential prescription medications — antibiotics, antivirals, anti-parasitics, antifungals, and anti-nausea treatments — this kit is designed to give you options when access to care might be limited.
- Nearly 100 illnesses covered in just one kit
- Prescribed by a licensed medical provider
- Includes nine essential prescription medications designed for common illnesses and unexpected situations.
- Covers a range of needs including bacterial infections, viral illnesses, parasites, fungal infections and nausea.
Prescription required. A licensed provider determines eligibility and treatment; kit contents may vary. Use only as directed and do not share medications. Amble does not provide medical care or dispense medications; care and prescriptions are provided by licensed providers and pharmacies. Compounded medications, if prescribed, are not FDA approved or reviewed for safety, effectiveness, or quality.
How do I order?
Click Get Started to begin the process. Next you will answer some questions about your health history, medical allergies, and lifestyle via our online medical intake. A licensed medical provider will then review your information and determine if the Kit is right for you. If prescribed, your Kit is shipped directly to your door at no extra cost.
Can I order refills?
You can order an Amble Med Kit annually for each person in your household that meets our requirements. You can order an additional Med Kit to keep at a different location. This will allow you to order up to 4 full Med Kits per year, per person, providing they are kept at different locations. Important Note: We do not condone the stockpiling of medications. Medications purchased through Amble are for the sole purpose of having the appropriate emergency medications on hand when and where you need them, and only should be used in the event you cannot access medical help.
Can I order multiple kits?
Yes. You are eligible to purchase an Amble Med Kit for additional locations. For those who have a legitimate reason to own an additional Med Kit, you can apply for approval during the standard checkout process.
Example of eligible situations:
• Store in your vehicle
• Second home address
• RV or Motorhome
• Cabin
• Boat or Houseboat
• Office/Work
What amount of ivermectin is included, and is it compounded?
Where ivermectin is included in an Amble Med Kit and prescribed for you, Amble provides Ivermectin 18mg, 30 tablets. Note: Amble offers both compounded and non-compounded ivermectin options. Final form and availability are confirmed during provider review and fulfillment.
Whats included
How it works
Free assessment, 100% online
Answer some questions about your health history, lifestyle, and goals via our online medical intake.
Prescription
A licensed medical provider will review your information and determine if the medication is right for you.
Free delivery
If prescribed, your medication is cold-shipped directly to your door at no extra cost.
Emergency Readiness
Stay prepared for unexpected illnesses and situations.
Broad Coverage
Addresses a wide range of common health concerns.
Peace of Mind
Have essential medications available when needed.
Provider Reviewed
Prescribed based on your health history and needs.
Why Amble?
Doctor-trusted medication
Licensed physicians
On-going support
Your questions, answered.
Who can order an Amble Med Kit?
This is an RX product. To ensure compliance, orders are limited to you or a dependent using your verified email. To order for others, please purchase a gift card or contact Customer Service.
How do I store my kit?
It is recommended to store medications in air-tight containers in a cool and dry environment. However, storage requirements can vary for different medications, so we recommend consulting with your healthcare professional regarding proper storage conditions.
How long can the medications be stored?
Regulations require a pharmacist to place an expiration date of one year on most medications that they dispense. Remember to always store your medication in a cool dry place to maximize its viability.
Does Amble encourage stockpiling medications?
No, Amble does not encourage or condone the stockpiling of medications. Our emergency Med Kits are intended solely for limited and responsible preparedness in case of unexpected emergencies or disasters where access to medical care may be limited.
How often can I reorder my medications
You can order an Amble Med Kit annually for each person in your household that meets our requirements. You can order an additional Med Kit to keep at a different location. This will allow you to order up to 4 full Med Kits per year, per person, providing they are kept at different locations.
What if I have an allergy to a specific medication in the kit?
If you have a known allergy to medication, you can note that during the enrollment process. Based on the medical history and allergy information provided during the enrollment process, one or more medications may not be prescribed in your kit without substitution.
Can I share my kit with other family members?
Amble only offers individual kits that are prescribed to the individual who filled out the order form. The physicians prescribe based upon the answers to the questions on that form. If there is an allergy notated on the form, we need to account for that allergy and make sure that others are not using the medications that could potentially be harmful to them. These are emergency medications and should be treated the same way as any other prescription that is prescribed by a physician.
Can I order multiple kits?
Yes. You are eligible to purchase an Amble Med Kit for additional locations. For those who have a legitimate reason to own an additional Med Kit, you can apply for approval during the standard checkout process.
Example of eligible situations:
• Store in your vehicle
• Second home address
• RV or Motorhome
• Cabin
• Boat or Houseboat
• Office/Work
Can I order refills?
You can order an Amble Med Kit annually for each person in your household that meets our requirements. You can order an additional Med Kit to keep at a different location. This will allow you to order up to 4 full Med Kits per year, per person, providing they are kept at different locations. Important Note: We do not condone the stockpiling of medications. Medications purchased through Amble are for the sole purpose of having the appropriate emergency medications on hand when and where you need them, and only should be used in the event you cannot access medical help.
Do I need insurance?
No, Amble does not require insurance. We provide transparent, all-inclusive pricing for your care. This includes comprehensive clinical support — ongoing provider oversight, direct access to your care team through secure messaging, and regular medication shipments. Our goal is to ensure you receive continuous medical guidance and support throughout your treatment.
Medication Information Guide
General Disclaimer
These medications should always be used responsibly and after consultation with a qualified healthcare professional or primary care provider for diagnosis and treatment instructions before utilizing any medications in your kit. If you have any questions, Amble offers a team of licensed medical professionals to help.
Storage Information
Most solid oral drugs have a longer shelf life when stored at room temperature (68–77°F / 20–25°C) and shielded from UV radiation in airtight containers. The FDA's Shelf-Life Extension Program showed that many solid form medications stayed potent beyond their expiration date.
Legal Disclaimer:
Medication Information
AMOXICILLIN-CLAVULANATE 875 mg/125 mg
(generic Augmentin™)
Pharmacologic Category: Antibiotic, Penicillin
FDA-Approved Uses:
- Lymphadenitis (lymph node inflammation)
- Mastitis (breast tissue inflammation)
- Otitis Media (inner ear infection)
- Acute Pharyngitis, Group A streptococcus (strep throat)
- Tonsilitis (tonsil inflammation)
- Urinary tract infection (UTI)
Common Off-Label Uses:
- Acute bacterial rhinosinusitis (nasal passage & sinus infection)
- Lung abscess
- Empyema
- Pyomyositis (bacterial infection of skeletal muscle)
- Bite wound (human, dog, cat)
- Dental infections
- Community-acquired pneumonia, mild
- Diabetic foot infection
- Chronic obstructive pulmonary disease (COPD), acute exacerbation
Typical Adult Dosing:
Community-acquired pneumonia, mildTake Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 5–10 daysCan be used in combination with Azithromycin or Doxycycline
Bite wounds (human, dog, cat), prophylaxis (asymptomatic exposure)Take Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 3–5 days
Bite wounds (human, dog, cat), treatment (symptomatic infection)Take Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 7–14 days
Urinary Tract Infection (UTI), uncomplicatedTake Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 3–7 days
Acute bacterial rhinosinusitis (nasal passage & sinus infection)Take Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 5–7 days
Acute pharyngitis, group A streptococcus (strep throat)Take Amoxicillin-Clavulanate 875 mg/125 mg (1 tablet) by mouth TWICE A DAY for 10 days
Pregnancy: Pregnancy Risk Category B (see Appendix A). Consult with a medical provider.
Breastfeeding: Present in breastmilk, considered compatible with breastfeeding when used in usual recommended doses.
Notes: While Amoxicillin-Clavulanate may be taken with food or on an empty stomach, the risk of gastrointestinal side effects is decreased when taken with meals.
Common Side Effects: Gastrointestinal including diarrhea, nausea, vomiting, and rash.
Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Amoxicillin, clavulanic acid, or other beta-lactam antibacterial drugs (e.g. PENICILLINS, CEPHALOSPORINS) or any other component of the formulation. DO NOT TAKE if history of cholestatic jaundice or hepatic dysfunction with amoxicillin/clavulanate potassium therapy. Avoid use in suspected or confirmed mononucleosis infection.
Caution: Significant drug interactions exist and may require dose/frequency adjustment or avoidance. Prolonged use (>28 days) of antibiotics may result in fungal or bacterial superinfection.
Please review the full package insert and consult with a medical provider for additional information.
AZITHROMYCIN 250 mg
(generic Zithromax™, Z-Pak™)
Pharmacologic Category: Antibiotic, Macrolide
FDA-Approved Uses:
- Community-acquired pneumonia, mild severity
- Acute Pharyngitis, Group A streptococcus (strep throat)
- Acute bacterial sinusitis (sinus infection)
- Acute otitis media (inner ear infection)
- Acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD)
- Uncomplicated skin infections
- Urethritis and cervicitis (caused by Chlamydia trachomatis)
Common Off-Label Uses:
- Babesiosis (malaria-like parasitic disease)
- Bartonella (cat scratch disease)
- Infectious traveler's diarrhea
- Pertussis (whooping cough)
- Bronchiectasis
Typical Adult Dosing:
Community-acquired pneumonia, mild severityTake Azithromycin 500 mg (2 tablets) by mouth DAILY on day 1, then 250 mg (1 tablet) by mouth DAILY on days 2–5orTake Azithromycin 500 mg (2 tablets) by mouth DAILY for 3 days
Infectious traveler's diarrheaTake Azithromycin 500 mg (2 tablets) by mouth DAILY for 3 days
Viral upper respiratory infection, Bronchitis, Pertussis; Take Azithromycin 500 mg (2 tablets) by mouth DAILY on day 1, then 250 mg (1 tablet) by mouth DAILY on days 2–5
Sexually transmitted infection (STI), chlamydiaTake Azithromycin 1,000 mg (4 tablets) by mouth ONE TIME, repeat after 1 week if needed
Acute bacterial pharyngitis, Sinusitis, TonsillitisTake Azithromycin 500 mg (2 tablets) by mouth DAILY on day 1, then 250 mg (1 tablet) by mouth DAILY on days 2–5
Babesiosis, BartonellaTake Azithromycin 500 mg (2 tablets) by mouth DAILY on day 1, then 250 mg (1 tablet) by mouth DAILY on days 2–5
Pregnancy: Pregnancy Risk Category B (see Appendix A).
Breastfeeding: Present in breastmilk, use caution. Consult with a medical provider.
Notes: While Azithromycin may be taken with food or on an empty stomach, the risk of gastrointestinal side effects is decreased when taken with meals.
Common Side Effects: Gastrointestinal including diarrhea and nausea.
Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Azithromycin (Zithromax™, Z-Pak™), Clarithromycin (Biaxin™), Erythromycin (Erythrocin™, Ery-Tab™, or E.E.S.™), or any other Macrolide. DO NOT TAKE if history of cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use. Azithromycin is listed as a contraindication in the manufacturer's labeling for pimozide.
Caution: Significant drug interactions exist and may require dose/frequency adjustment or avoidance. Azithromycin may affect the efficacy of blood thinners, like warfarin, which could increase the risk of bleeding. Medical supervision may be necessary to monitor clotting times and, if necessary, adjust the dosage of anticoagulants during Azithromycin treatment. Prolonged use (>28 days) of antibiotics may result in fungal or bacterial superinfection.
Please review the full package insert and consult with a medical provider for additional information.
VALACYLOVIR HCL
(generic Valtrex™) — kit strength typically 500 mg tabletsSource: DailyMed Valacyclovir hydrochloride tablets (FDA label)
Pharmacologic Category: Antiviral; nucleoside analogue DNA polymerase inhibitor (prodrug of acyclovir)
FDA-Approved Uses:
- Cold sores (herpes labialis)
- Genital herpes — initial episode, recurrent episodes, and chronic suppression (immunocompetent adults; HIV-infected adults for suppression when indicated)
- Reduction of genital herpes transmission (with safer sex practices)
- Herpes zoster (shingles) in immunocompetent adults
Common Off-Label Uses:
- Herpes simplex virus (HSV) prophylaxis in selected settings as directed by a medical provider
- Varicella (chickenpox) in selected adult cases as directed by a medical provider
Typical Adult Dosing:
Cold sores (herpes labialis)Take Valacyclovir 2 grams (e.g., four 500 mg tablets) by mouth every 12 hours for 1 day (2 doses total). Start at the earliest symptom (tingling, itching, or burning).
Genital herpes — initial episodeTake Valacyclovir 1 gram (two 500 mg tablets) by mouth twice daily for 10 days. Most effective when started within 48 hours of symptom onset.
Genital herpes — recurrent episodeTake Valacyclovir 500 mg by mouth twice daily for 3 days. Start at the first sign or symptom.
Genital herpes — suppression (immunocompetent)Take Valacyclovir 1 gram by mouth once daily; or 500 mg once daily if ≤9 recurrences/year (provider-directed).
Herpes zoster (shingles)Take Valacyclovir 1 gram by mouth 3 times daily for 7 days. Start as early as possible; most effective within 48 hours of rash onset.
Dose adjustments are required for reduced kidney function — consult a medical provider.
Pregnancy: Pregnancy Risk Category B (see Appendix A). Use only if potential benefit justifies potential risk. Discuss with a medical provider.
Breastfeeding: Acyclovir (active metabolite) is present in breast milk. Discuss with a medical provider whether benefits outweigh risks.
Notes: Valacyclovir does not cure herpes infections. It does not prevent all transmission — use safer sex practices. Start therapy as early as possible for best effect. Maintain adequate hydration. Not a substitute for medical evaluation of severe, disseminated, or ocular herpes.
Common Side Effects: Headache, nausea, and abdominal pain are most common. Other effects may include dizziness, vomiting, diarrhea, fatigue, rash, and menstrual symptoms. Serious reactions can include acute kidney injury, central nervous system effects (confusion, agitation, hallucinations, seizures — higher risk in elderly or reduced kidney function), and thrombotic thrombocytopenic purpura / hemolytic uremic syndrome (TTP/HUS) reported with very high doses in immunocompromised patients.
Contraindications: Clinically significant hypersensitivity (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation.
Caution: Use with caution and dose-adjust in kidney impairment; elderly patients are at higher risk of CNS adverse effects. Seek urgent care for decreased urine output, severe confusion, unusual bruising/bleeding, severe rash, or swelling of face/lips/tongue.
Please review the full package insert and consult with a medical provider for additional information.
DOXYCYCLINE HYCLATE 100 mg
Pharmacologic Category: Antibiotic, Tetracycline Derivative
FDA-Approved Uses:
- Acne vulgaris
- Anthrax due to Bacillus anthracis (bioterror)
- Amebiasis (parasite infection caused by Entamoeba histolytica)
- Sexually transmitted infections (caused by Chlamydia trachomatis)
- Malaria prophylaxis
- Rickettsia infections
- Rocky Mountain spotted fever (caused by Rickettsia rickettsii)
- Q Fever (caused by Coxiella burnetii)
- Typhus
Common Off-Label Uses:
- Lyme disease (vector-borne disease caused by Borrelia bacteria)
- Community-acquired pneumonia
- Acute bacterial rhinosinusitis (nasal passage & sinus infection)
- Skin and soft tissue infections due to Staph aureus
- Tularemia (Rabbit fever caused by bacterium Francisella tularensis, bioterror)
- Plague (caused by Yersinia pestis, bioterror)
Typical Adult Dosing:
Anthrax (bioterror), inhalation, postexposure prophylaxisTake Doxycycline 100 mg (1 capsule) by mouth TWICE A DAY for 42 to 60 days***Consult with a local expert for more information**Some experts favor longer durations (3–4 months)
Lyme disease, prophylaxis (asymptomatic exposure & Ixodes spp. tick attached for > 36 hours)Take Doxycycline 200 mg (2 capsules) by mouth ONCE
Lyme disease, treatment (symptomatic infection)Take Doxycycline 100 mg (1 capsule) by mouth TWICE A DAY for 10 to 28 days****Duration based on symptom presentation
- Treatment, erythema migrans: 10 days
- Treatment, acute neurological disease: 14–21 days
- Treatment, carditis: 14–21 days
- Treatment, arthritis with neurological involvement: 28 days
Rocky Mountain Spotted FeverTake Doxycycline 100 mg (1 capsule) by mouth TWICE A DAY for 5 to 7 days****or for at least 3 days after fever subsides, whichever is longer
Q fever, acute symptomatic infectionTake Doxycycline 100 mg (1 capsule) by mouth TWICE A DAY for 14 days
Bite wound (human and animal), prophylaxis (asymptomatic exposure)Take Doxycycline 100 mg (1 capsule) by mouth TWICE A DAY for 3–5 days
Bite wound (human and animal), treatment (symptomatic infection)Take Doxycycline 100 mg (1 capsule) by mouth TWICE A DAY for up to 14 days
Plague (Yersinia pestis), Tularemia (bioterror)Take Doxycycline 100 mg (1 capsule) by mouth TWICE A DAY for 7 days*Consult with a local expert for more information
Sexually transmitted infection (STI), caused by Chlamydia trachomatisTake Doxycycline 100 mg (1 capsule) by mouth TWICE A DAY for 7 days
Pregnancy: Pregnancy Risk Category D (see Appendix A). Many guidelines consider Doxycycline to be a relative contraindication in pregnant women. Consult with a medical provider.
Breastfeeding: Present in breastmilk, use caution. Consult with a medical provider.
Notes: Doxycycline is most effective when taken on an empty stomach. If stomach disturbance is a concern, may be taken with a meal, however, absorption may be decreased.
Common Side Effects: Gastrointestinal including diarrhea and nausea.
Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Doxycycline, other tetracyclines, or any other component of the formulation; concurrent use of isotretinoin.
Caution: Significant drug interactions exist and may require dose/frequency adjustment or avoidance. Prolonged use (>28 days) of antibiotics may result in fungal or bacterial superinfection. Doxycycline use may exacerbate the neuromuscular disorder myasthenia gravis.
Please review full package insert and consult with a medical provider for additional information.
METRONIDAZOLE 500 mg
(generic Flagyl™)
Pharmacologic Category: Antibiotic, Amebicide, Antiprotozoal, Nitroimidazole
FDA-Approved Uses:
- Anaerobic infections (intra-abdominal, skin, bone, & joint)
- Endocarditis (caused by Bacteroides spp.)
- Bacterial septicemia (blood poisoning)
- Gynecological infections
- Helicobacter pylori (adjunct therapy)
- Meningitis and brain abscess
- Amebiasis and amebic liver abscess (parasitic dysentery)
- Trichomoniasis (parasitic sexually transmitted infection)
Common Off-Label Uses:
- Colitis, including Clostridioides difficile (C. diff)
- Tetanus (caused by Clostridium tetani)
- Bacterial vaginosis
- Periodontal disease
- Crohn's disease
- Giardiasis (parasitic disease caused by Giardia duodenalis)
- Dracunculiasis (Guinea-worm disease)
Typical Adult Dosing:
Colitis, including Clostridioides difficile (C. diff) infection, mild-moderate severityTake Metronidazole 500 mg (1 tablet) by mouth THREE TIMES A DAY for 10 to 14 days
GiardiasisTake Metronidazole 500 mg (1 tablet) by mouth TWICE A DAY for 5–7 days
Tetanus (caused by Clostridium tetani)Take Metronidazole 500 mg (1 tablet) by mouth THREE TIMES A DAY for 7–10 days
Trichomoniasis
- Females: Take Metronidazole 500 mg (1 tablet) by mouth TWICE A DAY for 7 days
- Males: Take Metronidazole 2,000 mg (4 tablets) by mouth ONCE
Bacterial VaginosisTake Metronidazole 500 mg (1 tablet) by mouth TWICE A DAY for 7 days
Pregnancy: Pregnancy Risk Category B (see Appendix A). Relative contraindications exist. Consult with a medical provider.
Breastfeeding: Present in breastmilk in quantities that could be harmful to the newborn. If Metronidazole is required, nursing should be discontinued during and for 24 hours following therapy. Consult with a medical provider.
Notes: Metronidazole is recommended to be taken with a meal to reduce the risk of gastrointestinal side effects. Do not take it with alcohol (see below).
Common Side Effects: Headache, nausea, vaginitis, metallic taste.
Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Metronidazole (Flagyl™), Nitroimidazole derivatives, or any other component of the formulation. Do not take during the first trimester of pregnancy in patients with trichomoniasis; use of Disulfiram within the past 3 weeks; use of alcohol or propylene glycol-containing products during therapy or within 3 days of discontinuation.
Caution: US BOXED WARNING – Metronidazole has been shown to be carcinogenic in mice and rats. Avoid unnecessary use of Metronidazole. Recommended use reserved for trichomoniasis, amebiasis, and anaerobic bacterial infections. Significant drug interactions exist and may require dose/frequency adjustment or avoidance. DO NOT take with alcohol. DO NOT consume alcohol within 3 days of the last dose of Metronidazole. Prolonged use (>28 days) of antibiotics may result in fungal or bacterial superinfection. Additional considerations in persons with hepatic (liver) impairment, renal (kidney) impairment, or seizure disorder.
Please review the full package insert and consult with a medical provider for additional information.
TRIMETHOPRIM/SULFAMETHOXAZOLE 160 mg/800 mg
(generic Bactrim™ DS)
Pharmacologic Category: Antibiotic, Sulfonamide (Sulfa drug)
FDA-Approved Uses:
- Infectious traveler's diarrhea
- Shigella infection (Shigellosis)
- Otitis media (caused by S. pneumoniae)
- Urinary tract infections (UTI)
- Pneumocystis jiroveci pneumonia (PCP)
Common Off-Label Uses:
- Bite wounds (human & animal)
- Skin and soft tissue infections
- Diabetic foot infection
- Intra-abdominal infection
- Spontaneous bacterial peritonitis, prophylaxis
- Toxoplasma gondii encephalitis
- Bartonella (cat scratch disease)
- Nocardiosis
- Plague (caused by Yersinia pestis)
- Q fever (caused by Coxiella burnetii)
Typical Adult Dosing:
Infectious traveler's diarrhea, ShigellosisTake Trimethoprim/Sulfamethoxazole 160 mg/800 mg (1 tablet) by mouth TWICE A DAY for 5 to 7 days
- Females: Take Trimethoprim/Sulfamethoxazole 160 mg/800 mg (1 tablet) by mouth TWICE A DAY for 3 days
- Males: Take Trimethoprim/Sulfamethoxazole 160 mg/800 mg (1 tablet) by mouth TWICE A DAY for 7 days
Take Trimethoprim/Sulfamethoxazole 160 mg/800 mg (1 tablet) by mouth TWICE A DAY for 14 days
Take Trimethoprim/Sulfamethoxazole 160 mg/800 mg (1 tablet) by mouth TWICE A DAY for 7 to 14 days****Some experts recommend a dosage of 2 tablets TWICE A DAY for persons who weigh >70kg
Bite wound (human & animal), prophylaxis (asymptomatic exposure)Take Trimethoprim/Sulfamethoxazole 160 mg/800 mg (1 tablet) by mouth TWICE A DAY for 3 to 5 days
Bite wound (human & animal), treatment (symptomatic infection)Take Trimethoprim/Sulfamethoxazole 160 mg/800 mg (1 tablet) by mouth TWICE A DAY for 5 to 14 days
Take Trimethoprim/Sulfamethoxazole 320 mg/1,600 mg (2 tablets) by mouth TWICE A DAY for 7 to 14 days
Pregnancy: Pregnancy Risk Category C (see Appendix A). While the FDA indicates Trimethoprim/Sulfamethoxazole may be used in pregnancy if the benefits outweigh the risks, certain countries (e.g. Canada) have designated pregnancy as a contraindication for use due to established risks of congenital malformations (birth defects). Consult with a medical provider.
Breastfeeding: Present in breastmilk, women should avoid breastfeeding when taking Trimethoprim/Sulfamethoxazole. Consult with a medical provider.
Notes: While Trimethoprim/Sulfamethoxazole may be taken with food or on an empty stomach, the risk of gastrointestinal side effects is decreased when taken with meals. It is recommended to increase water intake for therapy duration.
Common Side Effects: Side effect frequency is undefined. However, some common side effects include diarrhea, nausea, vomiting, stool discoloration, dizziness, headache, and sunburn (see below).
Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Trimethoprim/Sulfamethoxazole (Bactrim™), SULFA DRUG allergy, or any other component of the formulation. DO NOT TAKE if pregnant, history of drug-induced immune thrombocytopenia with use of sulfonamides or trimethoprim; megaloblastic anemia due to folate deficiency; significant unmonitored hepatic (liver) or renal (kidney) disease.
Caution: Significant drug interactions exist and may require dose/frequency adjustment or avoidance. Prolonged use (>28 days) of antibiotics may result in fungal or bacterial superinfection. Additional consideration for persons of advanced age, hepatic (liver) impairment, renal (kidney) impairment, thyroid dysfunction, folate deficiency, or porphyria.
Please review the full package insert and consult with a medical provider for additional information.
IVERMECTIN 12 mg
(generic Stromectol™)
Pharmacologic Category: Anthelmintic
FDA-Approved Uses:
- Onchocerciasis (River blindness caused by the parasite Onchocerca volvulus)
- Strongyloidiasis (parasitic worm Strongyloides stercoralis)
- Lice
- Acne rosacea
Common Off-Label Uses:
- Scabies (skin infection caused by Sarcoptes scabiei)
- Ascariasis (parasitic roundworm Ascaris lumbricoides)
- Lymphatic filaria (filarial roundworms)
- Strongyloides stercoralis
- Loa loa (African eye worm)
- Hookworm-related cutaneous larva migrans
- Trichuriasis (whipworm infection caused by Trichuris trichiura)
Typical Adult Dosing:
ScabiesTake Ivermectin 0.2 mg/kg body weight by mouth ONCE; repeat dose after 1 week
Lice, refractory, after insufficient response to topical therapyTake Ivermectin 0.2–0.4 mg/kg body weight by mouth ONCE; repeat dose after 1 week
Hookworm-related cutaneous larva migransTake Ivermectin 0.2 mg/kg body weight by mouth DAILY for 1 to 2 days
Table 1. Approximate Ivermectin Dose by Body Weight (based on 0.6 mg/kg using 12 mg capsules)
Note: In the source document, the body-weight ranges for this table were not legible/extractable (OCR artifacts only). The dose column read as approximately 24 mg daily (2 capsules), 36 mg daily (3 capsules), 48 mg daily (4 capsules), 60 mg daily (5 capsules), and 72 mg daily (6 capsules), but I can't confirm the corresponding weight bands without the original file. Flagging rather than guessing, since this is dosing information — let me know if you can send a cleaner copy of that table and I'll drop it in exactly.
Pregnancy: Pregnancy Risk Category C (see Appendix A). Consult with a medical provider.
Breastfeeding: Present in breastmilk, use caution. Consult with a medical provider.
Notes: Ivermectin is typically dosed based on a person's body weight. While the manufacturer recommends taking on an empty stomach, studies have shown bioavailability increases when taken with a high-fat meal.
Common Side Effects: Itchiness, fever, swelling, rash, hives, joint pain, and diarrhea. Some patients report temporary visual aura.
Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Ivermectin (Stromectol™), or any other component of the formulation.
Caution: Significant drug interactions exist and may require dose/frequency adjustment or avoidance. Additional considerations in persons with immunocompromised status (e.g. HIV).
Please review the full package insert and consult with a medical provider for additional information.
FLUCONAZOLE 150 mg
(generic Diflucan™)
Pharmacologic Category: Antifungal, Azole Derivative
FDA-Approved Uses:
- Vulvovaginal candidiasis (vaginal yeast/fungal infection caused by Candida species)
- Oropharyngeal candidiasis
- Esophageal candidiasis
- Cryptococcal meningitis
Common Off-Label Uses:
- Candida species infections
- Blastomycosis (caused by Blastomyces dermatitidis)
- Coccidioidomycosis (Valley fever caused by fungus Coccidioides)
- Histoplasmosis (caused by Histoplasma capsulatum)
- Pityriasis versicolor (skin yeast infection)
- Tinea infections
Typical Adult Dosing:
Vulvovaginal Candidiasis, infection, mild-moderate severityTake Fluconazole 150 mg (1 capsule) by mouth ONCE; repeat dose 3–7 days later if needed
Pregnancy: Pregnancy Risk Category C (see Appendix A). Oral fluconazole for the treatment of vaginal candidiasis is NOT recommended during pregnancy due to risk of fetal harm. Consult with a medical provider.
Breastfeeding: Present in breast milk. Considered compatible with breastfeeding when used in usual recommended doses.
Notes: Fluconazole may be taken with food or on an empty stomach. Recommended to take Fluconazole 2 hours before any medications used for GERD or acid reflux.
Common Side Effects: Headache, dizziness.
Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Fluconazole (Diflucan™), or any other component of the formulation. DO NOT TAKE in combination with CYP3A4 substrates (e.g. erythromycin, pimozide, quinidine).
Caution: Significant drug interactions exist and may require dose/frequency adjustment or avoidance. May affect the efficacy of blood thinners (e.g. warfarin) and oral hypoglycemics. May cause dizziness, advise caution while driving. Additional considerations in persons with renal (kidney) impairment.
Please review the full package insert and consult with a medical provider for additional information.
ONDANSETRON 4 mg
(generic Zofran™)
Pharmacologic Category: Antiemetic; Selective 5-HT₃ Receptor Antagonist
FDA-Approved Uses:
- Cancer chemotherapy-induced nausea and/or vomiting
- Postoperative nausea and/or vomiting
- Radiotherapy-associated nausea and/or vomiting
Common Off-Label Uses:
- Nausea and/or vomiting, acute, severe
- Pregnancy-associated nausea and/or vomiting
- Vertigo-associated nausea and/or vomiting
Typical Adult Dosing:
Nausea and/or vomiting, acute, severeTake Ondansetron 4 mg (1 tablet) by mouth EVERY 4 to 8 HOURS, as needed for nausea or vomiting****Do not exceed 16 mg (4 tablets) in a 24-hour period
Pregnancy: Pregnancy Risk Category B (see Appendix A). Consult with a medical provider.
Breastfeeding: Presence in human breast milk is unknown. Potential harm to breastfeeding infants is unknown. Consult with a medical provider.
Notes: Ondansetron may be taken with food or on an empty stomach. Take with a full glass of water.
Common Side Effects: Headache, constipation, diarrhea, dizziness, drowsiness, fatigue, and malaise.
Contraindications: DO NOT TAKE if known allergy or hypersensitivity to Ondansetron (Zofran™), or any other component of the formulation; DO NOT TAKE with apomorphine.
Caution: Significant drug interactions exist and may require dose/frequency adjustment or avoidance. Additional considerations in persons taking other serotonergic agents (e.g. SSRIs, SNRIs, MAOIs) or with a history of Serotonin syndrome. May cause dizziness/drowsiness, advise caution while driving.
Please review the full package insert and consult with a medical provider for additional information.
VALACYCLOVIR HCL
Appendix A: Pregnancy, Lactation, and Reproductive Potential Labeling
Purpose of This Appendix
This appendix summarizes how pregnancy, breastfeeding, and reproductive potential information should be interpreted in medication education materials. This appendix is based on the FDA Pregnancy and Lactation Labeling Rule (PLLR) framework for prescription drug labeling.
The FDA no longer uses the pregnancy letter categories A, B, C, D, and X in current prescription drug labeling. These categories were removed because they were considered confusing and overly simplistic and did not adequately communicate medication risk during pregnancy, lactation, or reproductive decision-making.
Current FDA labeling uses narrative risk information to help healthcare providers assess benefit and risk and counsel pregnant patients, breastfeeding patients, and patients of reproductive potential.
8.1 Pregnancy
Under current FDA labeling, the Pregnancy subsection may include the following elements when applicable:
Pregnancy Exposure RegistryIf a pregnancy exposure registry exists for a medication, labeling may include information about the registry and how pregnant patients may enroll or obtain additional information.
Risk SummaryThe pregnancy risk summary provides a concise summary of what is known about medication use during pregnancy. It may include available human data, animal data, and pharmacologic information when relevant.
The risk summary may address whether available data identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Clinical ConsiderationsThis section may include clinically relevant information such as:
- Disease-associated maternal and/or embryo/fetal risk
- Dose adjustments during pregnancy and postpartum period
- Maternal adverse reactions
- Fetal/neonatal adverse reactions
- Labor or delivery considerations when applicable
DataThis section may summarize the human and/or animal data supporting the risk summary.
8.2 Lactation
Under current FDA labeling, the Lactation subsection may include the following elements when applicable:
Risk SummaryThe lactation risk summary may describe:
- Whether the medication is present in human milk
- Whether the medication affects the breastfed child
- Whether the medication affects milk production
- Relevant human or animal lactation data, if available
When human lactation data are available, FDA labeling gives priority to human data over animal data. If breastfeeding is contraindicated, that information should be stated first in the risk summary.
Clinical ConsiderationsThis section may include recommendations for minimizing exposure, monitoring the breastfed child, or managing potential adverse reactions when applicable.
DataThis section may summarize available human or animal lactation data, including measured drug levels in milk or infant exposure estimates when available.
8.3 Females and Males of Reproductive Potential
Under current FDA labeling, this subsection may include information about:
- Pregnancy testing
- Contraception
- Infertility
This section is included when a medication may affect pregnancy status, fertility, embryo-fetal development, or reproductive decision-making.
Legacy Pregnancy Letter Categories
The FDA has removed the pregnancy letter categories A, B, C, D, and X from prescription drug labeling. These categories may still appear in older reference materials, older product labels, or legacy clinical documents, but they are not the current FDA labeling standard.
When a legacy category appears in this medication guide, it should be interpreted only as historical labeling language. Current prescribing information should be reviewed for the most up-to-date pregnancy risk summary.
Legacy Category AAdequate and well-controlled studies in pregnant women failed to demonstrate a risk to the fetus in the first trimester, and there is no evidence of risk in later trimesters.
Legacy Category BAnimal reproduction studies failed to demonstrate fetal risk, but there are no adequate and well-controlled studies in pregnant women.orAnimal studies showed an adverse effect, but adequate and well-controlled studies in pregnant women failed to demonstrate fetal risk.
Legacy Category CAnimal reproduction studies showed an adverse effect on the fetus, and there are no adequate and well-controlled studies in humans.orNo animal reproduction studies and no adequate and well-controlled studies in humans are available.
Potential benefits may warrant use in pregnant women despite potential risks.
Legacy Category DThere is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans.
Potential benefits may warrant use in pregnant women despite potential risks.
Legacy Category XStudies in animals or humans demonstrated fetal abnormalities.orThere is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans.
The risks involved in use during pregnancy clearly outweigh potential benefits.
Standard Pregnancy Language for Medication Sheets
Use one of the following FDA-aligned language structures when drafting medication sheets:
When current labeling provides a clear pregnancy risk statementPregnancy: Current labeling states [insert label-based risk summary]. Consult with a medical provider before use during pregnancy.
When human pregnancy data are limitedPregnancy: Available human data are limited and are not sufficient to establish a drug-associated risk. Use during pregnancy only if the potential benefit justifies the potential risk. Consult with a medical provider.
When medication should be avoided at a specific pregnancy stagePregnancy: Avoid use during [insert trimester/week range] unless specifically advised by a medical provider due to [insert label-supported risk]. Consult with a medical provider.
When medication is contraindicated in pregnancyPregnancy: Use is contraindicated during pregnancy. Do not use if pregnant or planning to become pregnant unless labeling or a medical provider specifically indicates otherwise.
Standard Breastfeeding Language for Medication Sheets
Use one of the following FDA-aligned language structures when drafting medication sheets:
When medication presence in human milk is unknownBreastfeeding: It is not known whether this medication is present in human milk, whether it affects the breastfed infant, or whether it affects milk production. Consult with a medical provider before use while breastfeeding.
When medication is present in human milkBreastfeeding: This medication is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for treatment and any potential adverse effects on the breastfed child. Consult with a medical provider.
When medication is expected to produce low infant exposureBreastfeeding: Available data suggest infant exposure through breastmilk is expected to be low. Consult with a medical provider before use while breastfeeding, especially when nursing a newborn or preterm infant.
When breastfeeding is not recommendedBreastfeeding: Breastfeeding is not recommended during treatment with this medication and for [insert duration, if specified in labeling] after the last dose. Consult with a medical provider for individualized guidance.
When breastfeeding is contraindicatedBreastfeeding: Use is contraindicated during breastfeeding. Do not breastfeed during treatment unless current prescribing information or a medical provider specifically indicates otherwise.
Standard Disclaimer
This appendix is for medication education and labeling consistency only. It does not provide medical advice, diagnose any condition, recommend treatment, or replace the full prescribing information, product label, FDA-approved labeling, or guidance from a licensed medical provider. Current prescribing information should be reviewed because pregnancy, lactation, and reproductive-risk information may change as new data become available.
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