Etonogestrel Ethinyl EST Vag Ring

Manufacturer PRASCO LABORATORIES Active Ingredient Ethinyl Estradiol and Etonogestrel(ETH in il es tra DYE ole & et oh noe JES trel) Pronunciation ETH-in-il ES-tra-DYE-ole & et-oh-NOE-jes-trel
WARNING: Smoking cigarettes while using this drug raises the chance of severe heart and blood-related side effects. This chance is raised with age (mainly older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age. @ COMMON USES: It is used to prevent pregnancy. If you have been given this drug for some other reason, talk with your doctor for more information.
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Drug Class
Contraceptive
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Pharmacologic Class
Estrogen and progestin combination
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Pregnancy Category
Category X
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FDA Approved
Oct 2001
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This vaginal ring is a type of birth control that you insert into your vagina. It releases two hormones, estrogen and progestin, which work together to prevent pregnancy by stopping your body from releasing an egg, thickening the mucus in your cervix to block sperm, and changing the lining of your uterus. You wear it for three weeks, then take it out for one week, and then insert a new one.
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How to Use This Medicine

Using Your Vaginal Ring: A Step-by-Step Guide

To use this medication correctly, follow your doctor's instructions and read all the information provided. Here's how to use your vaginal ring:

1. Insertion: Wash your hands, remove the ring from its pouch, and keep the pouch for later disposal. Ensure your hands are dry before handling the ring. Fold the ring in half and press the sides together between your thumb and index finger. Gently insert the folded ring into your vagina. Perfect placement is not necessary for the ring to work, and it will not cause discomfort.
2. Wearing the Ring: Leave the ring in place for 3 weeks.
3. Removal and Replacement: Remove the ring at the start of the 4th week. To do this, hook your index finger around the rim or hold the rim between your index finger and middle finger, and gently pull it out. Dispose of the used ring in the pouch provided. Do not flush it down the toilet. Insert a new ring 7 days later, at the same time of day you removed the previous one.

Important Reminders:

After starting this medication, you may need to use a non-hormonal birth control method, such as condoms, for a short period to prevent pregnancy. Follow your doctor's instructions.
If you miss two periods in a row, take a pregnancy test before starting a new cycle.
If you have not used the ring correctly and miss one monthly period, take a pregnancy test.

What to Do If You Miss a Dose or the Ring is Displaced:

If the ring has been in place for up to 1 extra week, it will still be effective. Remove the ring and insert a new one 7 days later.
If the ring has been in place for more than 4 weeks, its effectiveness may be reduced. Consult your doctor to rule out pregnancy and use an additional birth control method, such as condoms, until you know you are not pregnant. If you are not pregnant, insert a new ring and continue using the extra birth control method for 7 days.
If the ring is out of the vagina for less than 3 hours, rinse it with cool to lukewarm water and reinsert it as soon as possible.
If the ring is out of the vagina for more than 3 hours during weeks 1 and 2, rinse it with cool to lukewarm water and reinsert it as soon as possible. Use an additional birth control method, such as condoms, for 7 days after reinsertion.
If the ring is out of the vagina for more than 3 hours during week 3, discard the ring and consult the package insert or your doctor for guidance on when to insert a new ring. Use an additional birth control method, such as condoms, for 7 days after inserting the new ring.
If the ring is out of the vagina for more than 1 week or you are unsure how long it has been out, take a pregnancy test before inserting a new ring. Use an additional birth control method, such as condoms, for 7 days after inserting the new ring.

Storage and Disposal:

Store unused rings at room temperature.
Check with your pharmacist for the expiration date and storage duration.
Do not use expired medication.
* Protect the medication from heat and light.
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Lifestyle & Tips

  • Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots.
  • The ring can be removed for up to 3 hours without losing contraceptive effectiveness. If it's out longer, use back-up contraception.
  • The ring does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms for STI protection.
  • Store the ring at room temperature, away from direct sunlight and moisture. Do not store in the refrigerator or freezer.
  • If you experience persistent or severe side effects, contact your healthcare provider.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Insert one vaginal ring into the vagina and leave it in place for 3 consecutive weeks. Remove the ring for a 1-week ring-free interval. A new ring is inserted after the 1-week ring-free interval.

Condition-Specific Dosing:

initiation: Insert on the first day of menstruation or on the first Sunday after menstruation begins. Back-up contraception may be needed for the first 7 days if not started on day 1.
missed_dose: If the ring is out for less than 3 hours, reinsert it. If out for more than 3 hours (or if ring-free interval is extended beyond 7 days), reinsert and use back-up contraception for 7 days. If this occurs in the third week, consider skipping the ring-free interval.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal adolescents.
Prepubertal: Not indicated
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific data, but unlikely to require adjustment as renal excretion is not primary route for active hormones.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Contraindicated due to impaired steroid metabolism.
Severe: Contraindicated due to impaired steroid metabolism.

Pharmacology

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Mechanism of Action

The primary mechanism of action is the inhibition of ovulation due to the suppression of gonadotropins (FSH and LH). The combination of ethinyl estradiol and etonogestrel also induces changes in the cervical mucus, making it less permeable to sperm, and alters the endometrium, making it less receptive to implantation.
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Pharmacokinetics

Absorption:

Bioavailability: Etonogestrel: Approximately 100% (vaginal). Ethinyl Estradiol: Approximately 100% (vaginal).
Tmax: Etonogestrel: Approximately 1 week after insertion. Ethinyl Estradiol: Approximately 3 days after insertion.
FoodEffect: Not applicable (vaginal administration).

Distribution:

Vd: Etonogestrel: Approximately 2.3 L/kg. Ethinyl Estradiol: Approximately 8.6 L/kg.
ProteinBinding: Etonogestrel: Approximately 95-98% (to albumin and sex hormone-binding globulin [SHBG]). Ethinyl Estradiol: Approximately 98% (to albumin and SHBG).
CnssPenetration: Limited (not primary site of action for contraception).

Elimination:

HalfLife: Etonogestrel: Approximately 29 hours. Ethinyl Estradiol: Approximately 45 hours.
Clearance: Etonogestrel: Approximately 7.5 L/hr. Ethinyl Estradiol: Approximately 35 L/hr.
ExcretionRoute: Etonogestrel: Primarily urine and feces (as metabolites). Ethinyl Estradiol: Primarily urine and feces (as metabolites).
Unchanged: Less than 1% of both hormones are excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Effective after 7 consecutive days of use. Full contraceptive efficacy typically achieved after the first 7 days of continuous use.
PeakEffect: Continuous release provides relatively stable hormone levels over the 3-week period.
DurationOfAction: 3 weeks of continuous contraceptive protection per ring.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, hormonal contraceptives, including Etonogestrel/Ethinyl Estradiol Vaginal Ring, are contraindicated in women who are over 35 years of age and smoke.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellowing of the skin or eyes.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellowing of the skin or eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing.
Toxic shock syndrome (TSS): a rare but potentially life-threatening condition. Seek medical help immediately if you experience diarrhea, dizziness, fainting, fever, muscle pain, stomach upset, vomiting, or a sunburn-like rash.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Vaginal irritation
Weight gain
Headache
Stomach upset or vomiting
Breast tenderness
Stomach pain
Acne
Decreased interest in sex
Changes in menstrual periods, including spotting or bleeding between cycles

This list is not exhaustive. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • ACHES: Abdominal pain (severe), Chest pain (severe), Headaches (severe), Eye problems (blurred vision, loss of vision), Severe leg pain (with or without swelling/redness). These are signs of serious complications like blood clots, stroke, or heart attack.
  • Jaundice (yellowing of skin or eyes)
  • New or worsening high blood pressure
  • Depressed mood or mood changes
  • Lumps in the breast
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
Unexplained vaginal bleeding
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir)
Any health conditions or use of medications, including herbal products, that may interfere with the effectiveness of hormone-based birth control. Your doctor or pharmacist can help you determine if you need to use a non-hormone form of birth control, such as condoms.
A history of jaundice (yellowing of the skin and eyes) during pregnancy or with estrogen use, such as hormonal birth control
Pregnancy or potential pregnancy. Do not take this medication if you are pregnant.

Additionally, it is crucial to inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins

This will help ensure that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this medication before certain surgical procedures. If you need to stop taking this medication, your doctor will provide guidance on when to resume taking it after your surgery or procedure.

Contraceptive Methods

Do not use a diaphragm, cervical cap, or female condom as a contraceptive method while using this vaginal ring.

Diabetes and Blood Sugar Monitoring

If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar levels as directed by your doctor.

Regular Health Check-Ups

Regularly check your blood pressure, as this medication may increase the risk of high blood pressure. Additionally, have your blood work checked as recommended by your doctor.

Blood Clots, Stroke, and Heart Attack

This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor, especially if you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness.

Breast Health

It is crucial to have regular breast exams and gynecology check-ups. Perform breast self-exams as directed by your doctor.

Grapefruit Juice and Medication Interactions

If you consume grapefruit juice or eat grapefruit regularly, consult your doctor, as it may interact with this medication.

Lab Tests and Medication Disclosure

Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.

Skin and Sun Protection

This medication may cause dark skin patches on your face. Avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and protective clothing and eyewear to minimize sun exposure.

Cholesterol and Triglyceride Levels

This medication may increase cholesterol and triglyceride levels. Discuss this risk with your doctor.

Sexually Transmitted Diseases

This medication does not protect against sexually transmitted diseases, such as HIV or hepatitis. Use a latex or polyurethane condom during sexual activity to reduce the risk of transmission.

Vaginal Ring Placement and Removal

Regularly check that the vaginal ring is in place, as directed by your doctor or according to the package insert. If you are unable to find the ring or remove it, contact your doctor immediately.

Vaginal Injury and Ring Breakage

If the vaginal ring breaks, discard it and use a new one. If you experience unusual vaginal pain or bleeding, contact your doctor immediately.

Cancer Risks

Some studies suggest that hormone-based birth control, like this medication, may increase the risk of cervical cancer and breast cancer. However, other studies have not confirmed this association. Discuss any concerns with your doctor.

Pediatric Use and Pregnancy

This medication is not intended for use in children who have not had their first menstrual period. If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.

Breastfeeding

If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Vaginal bleeding (especially in young girls)

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Remove the ring. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (increased ALT levels)
  • Glecaprevir/Pibrentasvir (increased ALT levels)
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Major Interactions

  • Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, Topiramate, Oxcarbazepine, St. John's Wort) - decreased contraceptive efficacy and increased breakthrough bleeding.
  • Certain HIV protease inhibitors (e.g., Ritonavir, Nelfinavir) - variable effects on hormone levels, potential for decreased efficacy.
  • Certain non-nucleoside reverse transcriptase inhibitors (e.g., Nevirapine, Efavirenz) - potential for decreased efficacy.
  • Lamotrigine (decreased lamotrigine levels, potential for seizure control loss).
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Moderate Interactions

  • Moderate CYP3A4 inducers (e.g., Bosentan, Griseofulvin) - potential for decreased efficacy.
  • CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Voriconazole, Grapefruit juice) - potential for increased hormone levels and adverse effects.
  • Atorvastatin, Rosuvastatin (increased AUC of ethinyl estradiol).
  • Thyroid hormones (may require increased thyroid hormone dose due to increased binding protein levels).
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Minor Interactions

  • Acetaminophen (increased ethinyl estradiol levels).
  • Ascorbic acid (increased ethinyl estradiol levels).
  • Cyclosporine (increased cyclosporine levels).
  • Theophylline (increased theophylline levels).

Monitoring

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Baseline Monitoring

Complete medical history and physical examination (including blood pressure, breast exam, and pelvic exam)

Rationale: To identify contraindications, risk factors for adverse events (e.g., VTE, cardiovascular disease), and establish baseline health status.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood pressure

Frequency: Annually, or more frequently if clinically indicated.

Target: <140/90 mmHg (or patient-specific target)

Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may necessitate discontinuation or change in contraceptive method.

Weight and BMI

Frequency: Annually

Target: Healthy range

Action Threshold: Significant weight gain or obesity increases VTE risk.

Signs and symptoms of VTE, stroke, MI, liver disease

Frequency: Ongoing patient education and symptom monitoring.

Target: Absence of symptoms

Action Threshold: Prompt medical evaluation for new or worsening symptoms (e.g., severe leg pain/swelling, sudden chest pain, shortness of breath, severe headache, vision changes, jaundice).

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Symptom Monitoring

  • Severe abdominal pain (possible liver tumor, pancreatitis)
  • Chest pain, shortness of breath, coughing blood (possible pulmonary embolism)
  • Severe headache, sudden vision changes, speech disturbance, weakness/numbness in an arm or leg (possible stroke)
  • Leg pain, swelling, warmth, redness (possible deep vein thrombosis)
  • Yellowing of skin or eyes (jaundice), dark urine, light-colored stools (possible liver problems)
  • Breast lumps
  • Unusual vaginal bleeding or spotting (especially if persistent or heavy)

Special Patient Groups

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Pregnancy

Contraindicated during pregnancy. Discontinue immediately if pregnancy is confirmed. There is no evidence of teratogenicity from inadvertent exposure to combined hormonal contraceptives during early pregnancy.

Trimester-Specific Risks:

First Trimester: No increased risk of birth defects identified from inadvertent exposure.
Second Trimester: Not applicable, should be discontinued.
Third Trimester: Not applicable, should be discontinued.
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Lactation

Not recommended during lactation. Estrogens can reduce the quantity and quality of breast milk and may be excreted in breast milk. Small amounts of etonogestrel and ethinyl estradiol are excreted into breast milk. Consider non-hormonal methods or progestin-only methods if contraception is needed during breastfeeding.

Infant Risk: Potential for adverse effects on the infant (e.g., jaundice, breast enlargement) and reduction in milk supply. Long-term effects on breastfed infants have not been established.
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Pediatric Use

Safety and efficacy are established for post-menarcheal adolescents. Not indicated for use in pre-menarcheal females.

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Geriatric Use

Not indicated for use in postmenopausal women. Contraception is not needed in this population.

Clinical Information

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Clinical Pearls

  • Ensure patients understand the 3-week in, 1-week out schedule and the importance of timely ring insertion/removal.
  • Counsel patients on the 'ACHES' warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain) and to seek immediate medical attention if experienced.
  • Emphasize that the ring does not protect against STIs.
  • Advise patients to use a back-up contraceptive method (e.g., condoms) for the first 7 days of the first cycle, or if the ring is out for more than 3 hours, or if the ring-free interval is extended.
  • Inform patients that breakthrough bleeding or spotting may occur, especially during the first few cycles, and usually resolves with continued use.
  • The ring can be used during intercourse and does not typically interfere with it. If it causes discomfort, it can be temporarily removed for up to 3 hours.
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Alternative Therapies

  • Progestin-only pills (mini-pill)
  • Progestin-only injectable (Depo-Provera)
  • Progestin-only implant (Nexplanon)
  • Intrauterine devices (IUDs - hormonal or copper)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
  • Natural family planning methods
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Cost & Coverage

Average Cost: $150 - $250 per ring (1-month supply)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often covered under preventative care with no co-pay for many plans due to ACA)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure timely and effective treatment.