Medroxyprogesterone 150mg/ml Pf Syr

Manufacturer SUN Active Ingredient Medroxyprogesterone Injection (Intramuscular)(me DROKS ee proe JES te rone) Pronunciation me DROKS ee proe JES te rone
WARNING: Using this drug for birth control or endometriosis pain may cause bone loss. Bone loss is greater the longer the drug is used and may not go back to normal. It is not known what the effects will be on bones when used in teenagers and young adults. Do not use this drug for longer than 2 years unless other options will not work or cannot be used. @ COMMON USES: It is used to prevent pregnancy.It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Contraceptive, Progestin
đŸ§Ŧ
Pharmacologic Class
Progestin
🤰
Pregnancy Category
Contraindicated for contraceptive use (formerly Category X)
✅
FDA Approved
Oct 1992
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Medroxyprogesterone injection is a type of birth control given as a shot every three months. It works by preventing your body from releasing an egg (ovulation), thickening the fluid in your cervix to block sperm, and thinning the lining of your uterus to prevent pregnancy. It's a very effective method of contraception.
📋

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered via an intramuscular injection.

Storing and Disposing of Your Medication

In most cases, this medication will be administered in a hospital or doctor's office. However, if you need to store it at home, be sure to follow the storage instructions provided by your doctor.

Missing a Dose

If you miss a dose, contact your doctor immediately to determine the best course of action.
💡

Lifestyle & Tips

  • This injection does not protect against sexually transmitted infections (STIs), including HIV/AIDS. Always use condoms to prevent STIs.
  • Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
  • Report any unusual or severe side effects immediately.
  • Maintain a healthy diet and engage in weight-bearing exercise to help support bone health, especially if using for a long time.
  • Do not smoke, as smoking increases the risk of serious cardiovascular side effects, especially with hormonal contraceptives.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 150 mg intramuscularly (IM) every 3 months (13 weeks)
Dose Range: 150 - 150 mg

Condition-Specific Dosing:

Contraception: 150 mg IM every 3 months (13 weeks). The injection should be given within the first 5 days of a normal menstrual period, or within 5 days postpartum if not breastfeeding, or at 6 weeks postpartum if breastfeeding.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: 150 mg IM every 3 months (13 weeks), same as adult dosing for post-menarcheal adolescents.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment needed.
Moderate: No specific dose adjustment needed.
Severe: No specific dose adjustment needed.
Dialysis: Not applicable, as medroxyprogesterone is highly protein bound and extensively metabolized.

Hepatic Impairment:

Mild: No specific dose adjustment needed.
Moderate: Use with caution; monitor for signs of fluid retention or worsening liver function.
Severe: Use with caution; medroxyprogesterone is extensively metabolized by the liver. Contraindicated in severe liver disease.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Medroxyprogesterone acetate (MPA) is a synthetic progestin. Its primary mechanism of action as a contraceptive is the inhibition of gonadotropin secretion (follicle-stimulating hormone [FSH] and luteinizing hormone [LH]), which prevents follicular maturation and ovulation. It also causes thickening of the cervical mucus, making it more difficult for sperm to penetrate, and induces endometrial atrophy, making the endometrium unsuitable for implantation.
📊

Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IM injection (100% of administered dose is available systemically from the depot).
Tmax: Approximately 3 weeks (range 3-20 days) after IM injection.
FoodEffect: Not applicable for IM injection.

Distribution:

Vd: Approximately 20 Âą 3 L (after IV administration)
ProteinBinding: Approximately 90% (primarily to albumin, not to sex hormone-binding globulin [SHBG]).
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 50 days (range 40-50 days) after a single IM dose.
Clearance: Approximately 0.07 L/min (after IV administration).
ExcretionRoute: Primarily via urine and feces as glucuronide and sulfate conjugates.
Unchanged: <1% of the dose is excreted unchanged in urine.
âąī¸

Pharmacodynamics

OnsetOfAction: Contraceptive effect begins immediately if injected within the first 5 days of a menstrual cycle. Otherwise, backup contraception is needed for 7 days.
PeakEffect: Peak plasma concentrations reached around 3 weeks post-injection, maintaining contraceptive levels for 3 months.
DurationOfAction: Contraceptive effect lasts for at least 13 weeks (3 months).

Safety & Warnings

âš ī¸

BLACK BOX WARNING

Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. Depo-Provera Contraceptive Injection should be used as a long-term birth control method (for more than 2 years) only if other birth control methods are inadequate.
âš ī¸

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 or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Eye problems, including:
+ Changes in vision or loss of vision
+ Bulging eyes
+ Changes in how contact lenses feel
Breast-related symptoms, such as:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, including:
+ Itching or discharge
+ Abnormal vaginal bleeding
Mood changes, such as depression
Seizures
Fluid retention, which may cause:
+ Swelling
+ Weight gain
+ Trouble breathing
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:

Weight gain or loss
Headache
Dizziness, drowsiness, tiredness, or weakness
Nervousness or excitability
Upset stomach or vomiting
Bloating
Changes in sex interest
Acne
Hair loss or growth
Enlarged or tender breasts
Vaginal bleeding or spotting
Stomach pain
Trouble sleeping
Changes in menstrual cycle or absence of periods
* Irritation at the injection site

Reporting Side Effects

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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe pain in your leg (calf or thigh)
  • Sudden severe chest pain or shortness of breath
  • Sudden severe headache or migraine
  • Sudden vision changes (e.g., partial or complete loss of vision, double vision)
  • Yellowing of the skin or eyes (jaundice)
  • Severe abdominal pain
  • Lump in your breast
  • Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
📋

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 before starting this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced.
A history of certain health problems, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer or other cancers
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen or progesterone
Unexplained vaginal bleeding
Pregnancy or potential pregnancy, as this medication should not be taken during pregnancy
* Breast-feeding or plans to breast-feed

Additional Considerations for Children:
If your child has not yet started menstruating, discuss this with your doctor before giving them this medication.

Interactions with Other Medications and Health Problems:
This is not an exhaustive list of all potential interactions. It is crucial to inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
âš ī¸

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 drug 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.

Blood Clot Risk
This medication may increase the risk of blood clots, which can be life-threatening. Blood clots can occur in the form of heart attack, stroke, or clots in the leg, lung, or eye. If you have a history of blood clots, inform your doctor. Additionally, if you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of blood clots.

Diabetes and Triglyceride Monitoring
If you have diabetes, closely monitor your blood sugar levels. This medication may also cause high triglyceride levels. Inform your doctor if you have a history of high triglyceride levels.

Regular Health Checks
Regularly check your blood work and bone density as advised by your doctor. Take calcium and vitamin D supplements as directed by your doctor.

Breast Cancer Risk
There may be a higher risk of breast cancer associated with this medication. Ensure you have regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.

Lab Tests and Skin Effects
This medication may affect certain lab tests, so inform all your healthcare providers and lab workers that you are taking this drug. Additionally, this medication may cause dark skin patches on your face. Avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear.

Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Fertility
If you plan to become pregnant, it may take some time after your last dose of this medication to conceive. Discuss this with your doctor. If you are able to become pregnant, a pregnancy test will be conducted to confirm you are not pregnant before starting this medication. If you become pregnant or experience severe stomach pain while taking this medication, contact your doctor immediately. This medication may increase the risk of ectopic pregnancy.

Sexual Health
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use latex or polyurethane condoms during sex, and consult your doctor if you have questions.

Interactions with Other Medications
Certain medications or herbal products may interact with this medication, reducing its effectiveness. Ensure your doctor and pharmacist are aware of all your medications.
🆘

Overdose Information

Overdose Symptoms:

  • Overdose is unlikely with a single IM injection.
  • Symptoms of excessive progestin exposure might include nausea, vomiting, breast tenderness, dizziness, or fatigue, but these are generally mild and self-limiting.

What to Do:

There is no specific antidote. Management is supportive. In case of suspected overdose or severe symptoms, seek immediate medical attention or call a poison control center (1-800-222-1222).

Drug Interactions

🔴

Major Interactions

  • Aminoglutethimide: May significantly decrease medroxyprogesterone plasma concentrations, potentially reducing contraceptive efficacy. Consider alternative contraception.
🟡

Moderate Interactions

  • CYP3A4 Inducers (e.g., Carbamazepine, Phenytoin, Rifampin, St. John's Wort): May decrease medroxyprogesterone plasma concentrations, potentially reducing contraceptive efficacy. Clinical significance for IM depot is generally considered low due to the sustained release, but monitoring for breakthrough bleeding or considering alternative contraception may be prudent with long-term concomitant use.
  • Ritonavir and other HIV protease inhibitors: May alter progestin levels, though specific data for medroxyprogesterone IM is limited. Monitor for efficacy or side effects.
đŸŸĸ

Minor Interactions

  • Bosentan: May decrease progestin levels.
  • Griseofulvin: May decrease progestin levels.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Pregnancy test

Rationale: To ensure the patient is not pregnant before initiating contraception.

Timing: Before first injection.

Physical examination (including blood pressure, breast exam, pelvic exam)

Rationale: To assess overall health and identify any contraindications or risk factors.

Timing: Before first injection.

Medical history review (especially for thromboembolic disorders, liver disease, breast cancer, unexplained vaginal bleeding)

Rationale: To identify contraindications or conditions requiring caution.

Timing: Before first injection.

📊

Routine Monitoring

Blood pressure

Frequency: Annually or as clinically indicated.

Target: Normal limits for age and health status.

Action Threshold: Significant increase or development of hypertension.

Weight

Frequency: Every 3-6 months or as clinically indicated.

Target: Maintain healthy weight; monitor for significant changes.

Action Threshold: Significant or rapid weight gain.

Bone Mineral Density (BMD)

Frequency: Consider baseline and follow-up DEXA scans for long-term users (e.g., >2 years) or those with other risk factors for osteoporosis.

Target: Maintain healthy BMD.

Action Threshold: Significant BMD loss (e.g., Z-score < -2.0 for adolescents, T-score < -2.5 for adults).

Review of menstrual bleeding patterns

Frequency: At each follow-up visit (every 3 months).

Target: Expected changes include amenorrhea or irregular bleeding.

Action Threshold: Excessive or prolonged bleeding, or new onset of severe pain.

đŸ‘ī¸

Symptom Monitoring

  • Signs of thromboembolic events (e.g., severe leg pain, chest pain, shortness of breath, sudden severe headache, vision changes)
  • Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • Severe abdominal pain
  • Persistent or severe mood changes, including depression
  • Unexplained vaginal bleeding (especially if heavy or prolonged)
  • Lumps in the breast
  • Jaundice (yellowing of skin or eyes)

Special Patient Groups

🤰

Pregnancy

Medroxyprogesterone injection is contraindicated for use during pregnancy as a contraceptive. If pregnancy occurs during use, the injection should be discontinued. There is no evidence of adverse effects on the fetus from inadvertent exposure during early pregnancy.

Trimester-Specific Risks:

First Trimester: Contraindicated for contraceptive use. No evidence of teratogenicity from inadvertent exposure.
Second Trimester: Contraindicated for contraceptive use.
Third Trimester: Contraindicated for contraceptive use.
🤱

Lactation

Medroxyprogesterone is excreted in breast milk in small amounts. It is generally considered compatible with breastfeeding, particularly after the immediate postpartum period (e.g., 6 weeks postpartum) once lactation is well-established. No adverse effects on infant growth or development have been consistently reported.

Infant Risk: Low risk. Monitor breastfed infants for any unusual effects, though unlikely.
đŸ‘ļ

Pediatric Use

Approved for use in post-menarcheal adolescents. The bone mineral density (BMD) loss associated with long-term use is a particular concern in this age group, as adolescence is a critical period for bone accretion. Use for more than 2 years should be carefully considered.

👴

Geriatric Use

Not indicated for contraception in postmenopausal women. For other indications (e.g., hormone therapy), dose adjustments may be considered based on individual patient factors and comorbidities, but generally no specific geriatric dosing guidelines for this formulation.

Clinical Information

💎

Clinical Pearls

  • Medroxyprogesterone IM injection is a highly effective, long-acting reversible contraceptive (LARC) method.
  • Patients must return for injections every 3 months (13 weeks) to maintain contraceptive efficacy. Missing an injection can lead to pregnancy.
  • Irregular bleeding, spotting, or amenorrhea are common side effects, especially during the first year of use. This is generally not harmful.
  • Weight gain is a commonly reported side effect, though the exact mechanism and extent vary among individuals.
  • The black box warning regarding bone mineral density loss is important. Discuss this risk with patients, especially adolescents and those with other risk factors for osteoporosis. Consider alternative methods for long-term contraception (>2 years) if other methods are suitable.
  • Fertility typically returns within 6-12 months after discontinuing the injection, but can vary.
🔄

Alternative Therapies

  • Combined oral contraceptives (pills)
  • Progestin-only pills (mini-pills)
  • Contraceptive patch
  • Vaginal ring
  • Contraceptive implant (e.g., Etonogestrel implant)
  • Intrauterine devices (IUDs - hormonal and non-hormonal)
  • Barrier methods (e.g., condoms, diaphragm)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
  • Emergency contraception
💰

Cost & Coverage

Average Cost: Varies, typically $75-$150 per 150mg/ml prefilled syringe
Generic Available: Yes
Insurance Coverage: Often covered by most insurance plans, typically Tier 1 or Tier 2 for generic. May be covered at 100% under ACA preventive care mandates.
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.