Provera 2.5mg Tablets

Medroxyprogesterone acetate (MPA) is a synthetic progestin. It acts on the estrogen-primed endometrium, converting it from a proliferative to a secretory state. It also inhibits pituitary gonadotropin secretion (LH and FSH), which can prevent ovulation. In hormone therapy, it is used to counteract the estrogen-induced proliferation of the endometrium, thereby reducing the risk of endometrial hyperplasia and carcinoma.

Serious Side Effects: Seek Medical Help Immediately

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 medical attention right away:

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 changes, such as:
+ A lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, including:
+ Itching or discharge
+ Abnormal vaginal bleeding
Mood changes, such as:
+ Depression
+ Other mood changes
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
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in vision
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of pancreatitis, such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Memory problems or loss
Feeling confused

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, contact your doctor or seek medical attention if they bother you or do not go away:

Weight gain or loss
Headache
Dizziness
Drowsiness
Fatigue
Weakness
Nervousness
Excitability
Upset stomach or vomiting
Bloating
Changes in sex interest
Acne
Hair loss
Hair growth
Enlarged breasts
Tender breasts
Vaginal bleeding or spotting
Stomach pain
Trouble sleeping
Changes in menstrual cycle or absence of periods

Hormone Therapy (HT) Specific Side Effects

Stomach cramps
Joint pain
* Leg cramps

Reporting Side Effects

If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. You can also contact your doctor for medical advice about side effects.

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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer or other types of cancer
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen or progesterone
Unexplained vaginal bleeding
If you are breastfeeding or plan to breastfeed
* If you are pregnant or think you may be pregnant. Note: This medication should not be taken during pregnancy.

Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.

Important Warnings and Cautions

Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. Your doctor may instruct you to stop taking this medication before certain surgical procedures. If you need to stop taking this medication, your doctor will advise you on when to resume treatment 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 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 an extended period, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of blood clots.

Monitoring and Precautions

If you have diabetes, closely monitor your blood sugar levels. High triglyceride levels have been associated with this medication, so inform your doctor if you have a history of elevated triglycerides. Regularly undergo blood tests and bone density checks as directed by your doctor. Take calcium and vitamin D supplements as advised by your doctor.

Breast Cancer Risk

There may be an increased risk of breast cancer associated with this medication. Ensure you 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 avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and protective clothing and eyewear to minimize sun exposure.

Special Considerations

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

Hormone Therapy (HT) Considerations

Drugs like this one have been associated with high blood pressure. Regularly check your blood pressure as directed by your doctor. Certain side effects, such as heart attack, stroke, breast cancer, and others, have been reported in people taking estrogen with progestin. The risk of these side effects may vary depending on factors like treatment duration, estrogen use with or without progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.

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

• CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin - may increase MPA plasma concentrations)
• Grapefruit juice (may increase MPA levels)
• Corticosteroids (MPA may decrease corticosteroid clearance)
• Cyclosporine (MPA may inhibit cyclosporine metabolism)
• Anticoagulants (MPA may alter coagulation parameters, requiring monitoring)

• Laboratory tests (may affect thyroid function tests, coagulation tests, glucose tolerance tests)

• Unusual vaginal bleeding or spotting
• Breast lumps or pain
• Severe headache or migraine
• Vision changes (e.g., sudden partial or complete loss of vision, double vision)
• Speech disturbances
• Weakness or numbness in an arm or leg
• Chest pain, shortness of breath, coughing up blood (signs of pulmonary embolism)
• Pain, swelling, or redness in a leg (signs of deep vein thrombosis)
• Yellowing of skin or eyes (jaundice)
• Dark urine, light-colored stools (signs of liver problems)
• Mood changes, depression
• Memory loss or confusion (especially in older women)

Contraindicated in pregnancy. Medroxyprogesterone acetate is classified as Pregnancy Category X. There is evidence of fetal risk based on human experience, and the risks of use in pregnant women clearly outweigh any possible benefits.

Use with caution. Medroxyprogesterone is excreted in breast milk. While generally considered compatible with breastfeeding, observe the infant for any potential adverse effects (e.g., jaundice, breast enlargement). The American Academy of Pediatrics considers progestins compatible with breastfeeding.

Safety and efficacy have not been established in pediatric patients for the indications typically treated with 2.5mg oral tablets (e.g., HRT). Not recommended for use in prepubertal girls. Higher doses are used for specific pediatric conditions like precocious puberty, but not the 2.5mg oral tablet.

Use with caution. Women 65 years of age or older have an increased risk of probable dementia when receiving combined estrogen plus progestin therapy. Increased risk of stroke and DVT has also been observed in this population. Use the lowest effective dose for the shortest duration consistent with treatment goals and risks.

• Medroxyprogesterone 2.5mg is most commonly used as part of continuous combined hormone replacement therapy (HRT) to protect the endometrium from estrogen-induced hyperplasia in postmenopausal women with an intact uterus.
• Always assess for contraindications (e.g., undiagnosed abnormal genital bleeding, breast cancer, active DVT/PE, severe liver disease) before initiating therapy.
• Patients should be advised of the Black Box Warnings regarding cardiovascular events, breast cancer, and probable dementia, especially with long-term use in HRT.
• Regular monitoring, including annual physical exams, breast exams, and mammograms, is crucial.
• Any new or unusual vaginal bleeding should be promptly investigated to rule out endometrial pathology.
• Consider the lowest effective dose for the shortest duration consistent with treatment goals and risks.

• Other progestins (e.g., micronized progesterone, norethindrone)
• Selective Estrogen Receptor Modulators (SERMs) for specific indications (e.g., tamoxifen, raloxifene)
• Non-hormonal therapies for menopausal symptoms (e.g., SSRIs/SNRIs, gabapentin, clonidine)
• For abnormal uterine bleeding: other hormonal therapies (e.g., oral contraceptives, IUDs), surgical options.

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.