Medroxyprogesterone 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 inhibit ovulation. In the context of abnormal uterine bleeding or secondary amenorrhea, it provides exogenous progestin to induce secretory changes in the endometrium and subsequent withdrawal bleeding upon discontinuation, or to stabilize the endometrium.

Serious Side Effects: Seek Medical Attention 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 help 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-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
+ 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

Most people do not experience serious side effects, and some may only have minor side effects. If you notice any of the following symptoms, contact your doctor or seek medical help 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 have questions about side effects or experience any symptoms that concern you, 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, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
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 might 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. Never 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 advise you to stop taking this medication before certain surgical procedures. If you need to stop taking this medication, your doctor will instruct you 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 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.

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
Follow your doctor's instructions for regular blood work and bone density tests. Take calcium and vitamin D supplements as directed 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 lab tests, so inform all your healthcare providers and lab workers that you are taking this medication. 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 when going outside.

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

Hormone Therapy (HT) Specific Warnings
If you are taking this medication as part of hormone therapy, be aware that high blood pressure has been associated with similar medications. Monitor 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 a progestin. Discuss the benefits and risks of using this medication with your doctor, considering factors such as treatment duration, estrogen use with or without a progestin, and other individual factors that may affect your risk of side effects.

• Aminoglutethimide (may significantly decrease MPA plasma concentrations)
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort - may decrease MPA efficacy)

• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir - may increase MPA plasma concentrations)
• Grapefruit juice (may increase MPA levels)
• Warfarin (MPA may alter anticoagulant effects, monitor INR)

• Glucuronidation inhibitors (e.g., ascorbic acid, acetaminophen - theoretical interaction, not clinically significant for MPA)

• Abnormal vaginal bleeding (spotting, breakthrough bleeding)
• Breast tenderness or lumps
• Headaches/migraines
• Mood changes, depression
• Nausea, abdominal discomfort
• Fluid retention, weight gain
• Signs of thromboembolism (e.g., sudden severe headache, vision changes, chest pain, shortness of breath, leg pain/swelling)
• Signs of liver problems (e.g., yellowing skin/eyes, dark urine, severe stomach pain)

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

Medroxyprogesterone is excreted in breast milk. While generally considered compatible with breastfeeding at low doses, caution is advised. Observe the infant for any adverse effects (e.g., jaundice, breast enlargement).

Safety and efficacy in pre-pubertal children have not been established. Use in adolescents for gynecological indications should be carefully considered after menarche and after ruling out other causes for menstrual irregularities.

No specific dose adjustment is generally required based on age alone. However, geriatric patients may be more susceptible to adverse effects, particularly cardiovascular events, especially if used in combination with estrogen. Use with caution and monitor closely.

• Medroxyprogesterone 5mg is typically used for short-term cyclic therapy (e.g., 5-10 days per month) to induce withdrawal bleeding or regulate cycles, not for continuous contraception.
• Ensure a negative pregnancy test before initiating therapy, especially for secondary amenorrhea.
• Advise patients that withdrawal bleeding usually occurs 3-7 days after the last dose.
• Long-term use of progestins, especially at higher doses or in combination with estrogen, carries risks of cardiovascular events and breast cancer; these risks are less pronounced for short-term, low-dose use for menstrual disorders but should still be considered.
• Patients should be advised to report any signs of blood clots (e.g., sudden severe headache, chest pain, leg pain/swelling) immediately.

• Norethindrone acetate (another oral progestin)
• Oral contraceptives (for menstrual regulation, if contraception is also desired)
• Progesterone (micronized oral progesterone)
• Lifestyle modifications (for some cases of amenorrhea/DUB, e.g., weight management, stress reduction)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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 overdose, including the medication taken, the amount, and the time it occurred.