Medroxyprogesterone 150mg/ml Vial

Medroxyprogesterone acetate (MPA) is a synthetic progestin. When administered at contraceptive doses, it acts primarily by inhibiting gonadotropin secretion, thereby preventing follicular maturation and ovulation. It also causes thickening of cervical mucus, which inhibits sperm penetration, and thinning of the endometrium, which reduces the likelihood of implantation.

Serious Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek 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
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Breast-related symptoms, including:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, such as:
+ Itching or discharge
+ Abnormal vaginal bleeding
Depression or other mood changes
Seizures
Fluid retention, which may cause swelling, weight gain, or 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

Most people taking this medication do not experience severe side effects. However, some may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor 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

This list is not exhaustive, and you may experience other side effects not mentioned here. 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.

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

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
A history of certain health conditions, such as:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer or other cancers
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that may be influenced by 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

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

Additional Important Information:
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.

Important Warnings and Precautions

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

Risk of Blood Clots

This medication may increase the risk of blood clots, which can be life-threatening. Blood clots can occur in the form of a 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 developing blood clots.

Managing Other Health Conditions

If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this medication. High triglyceride levels have been reported in patients taking this drug, so inform your doctor if you have a history of elevated triglyceride levels.

Regular Health Check-Ups

Your doctor will recommend regular blood tests and bone density checks to monitor your health while taking this medication. It is also essential to take calcium and vitamin D supplements as advised by your doctor.

Breast Cancer Risk

There may be a higher risk of breast cancer associated with this medication. To minimize this risk, it is vital to have regular breast exams, gynecology check-ups, and perform breast self-exams as instructed by your doctor.

Lab Tests and Skin Effects

This medication may affect certain laboratory 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, so it is essential to avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and protective clothing and eyewear to minimize your risk of skin damage.

Special Precautions

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are trying to conceive, it may take some time after your last dose of this medication to become pregnant. Discuss this with your doctor.

Pregnancy and Contraception

If you are able to become pregnant, a pregnancy test will be performed to confirm that 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 (pregnancy outside the uterus).

Sexual Health

This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use latex or polyurethane condoms to minimize the risk of transmission. If you have questions or concerns, discuss them with your doctor.

Interactions with Other Medications

Certain medications or herbal products may interact with this drug, reducing its effectiveness. Ensure that your doctor and pharmacist are aware of all the medications you are taking.

• Aminoglutethimide (may significantly decrease MPA levels)
• CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, St. John's Wort - may decrease MPA efficacy)

• Bosentan (may decrease MPA levels)
• Griseofulvin (may decrease MPA levels)
• Ritonavir (may decrease MPA levels)
• Warfarin (potential for altered anticoagulant effect, monitor INR)

• Irregular bleeding or spotting
• Weight gain
• Headaches
• Mood changes (depression)
• Breast tenderness
• Abdominal pain
• Signs of thromboembolic events (e.g., severe leg pain, chest pain, shortness of breath, sudden vision changes)
• Signs of allergic reaction (rash, itching, swelling)

Contraindicated in pregnancy. If pregnancy occurs during use, the drug should be discontinued. There is no evidence of teratogenicity, but exposure during pregnancy is not recommended.

Small amounts of medroxyprogesterone acetate are excreted in breast milk. Generally considered compatible with breastfeeding, but caution is advised, especially in the immediate postpartum period. No adverse effects on infant growth or development have been consistently reported.

Not indicated for use before menarche. For adolescents, the potential for bone mineral density loss should be carefully weighed against the benefits of contraception, especially if used for more than 2 years. Alternative methods should be considered.

Not typically used for contraception in geriatric populations. For palliative cancer treatment, dose adjustments are generally not required based on age alone, but overall health status, comorbidities, and hepatic function should be considered.

• Depo-Provera is a highly effective, long-acting reversible contraceptive (LARC) that does not require daily compliance.
• A significant side effect is bone mineral density (BMD) loss, especially with prolonged use (>2 years). Patients should be counseled on calcium and vitamin D intake and weight-bearing exercise.
• Irregular bleeding, spotting, or amenorrhea are common side effects, particularly in the first year of use.
• Weight gain is a frequently reported side effect.
• Return to fertility can be delayed after discontinuation, typically 6-12 months, but can be longer.
• Ensure pregnancy is ruled out before each injection if the previous injection was delayed beyond 13 weeks.
• Not protective against STIs.

• Other hormonal contraceptives (e.g., oral contraceptive pills, contraceptive patch, vaginal ring, hormonal IUDs, etonogestrel implant)
• Non-hormonal contraceptives (e.g., copper IUD, condoms, diaphragm)
• For endometriosis: GnRH agonists/antagonists, oral contraceptives, NSAIDs, surgery.
• For cancer: Chemotherapy, radiation, other hormonal therapies.

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 happened.