Methergine 0.2mg/ml Inj, 1ml

Methylergonovine is an ergot alkaloid that acts as a direct stimulant on uterine and vascular smooth muscle. It increases the force and frequency of uterine contractions and significantly increases uterine tone, thereby decreasing uterine bleeding. It also causes generalized vasoconstriction.

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 high or low blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Blurred eyesight
Seizures

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 or any other symptoms that bother you or do not go away, contact your doctor:

Headache
Stomach pain
* Upset stomach or vomiting

Reporting Side Effects
This list is not exhaustive, and you may experience other 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.

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

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have high blood pressure or have experienced high blood pressure during pregnancy (preeclampsia).
If you are taking any medications, including prescription and over-the-counter (OTC) drugs, natural products, or vitamins, that may interact with this medication. Certain medications used to treat HIV, infections, depression, and other conditions should not be taken with this drug. Your doctor or pharmacist can advise you on potential interactions.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
* If you are breastfeeding. You should not breastfeed for at least 12 hours after receiving this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have risk factors for heart disease, such as high blood pressure, high cholesterol, being overweight, having high blood sugar or diabetes, smoking cigarettes, being a male over 40 years old, having a family history of early heart disease, or being a female who has gone through menopause, exercise caution and discuss your individual situation with your doctor.

Monitoring your blood pressure is crucial while taking this drug, so be sure to have it checked as frequently as your doctor recommends. Additionally, if you regularly consume grapefruit juice or eat grapefruit, consult with your doctor to discuss any potential interactions.

• Potent CYP3A4 inhibitors (e.g., azole antifungals like ketoconazole, itraconazole; macrolide antibiotics like erythromycin, clarithromycin; protease inhibitors like ritonavir, nelfinavir)
• Other vasoconstrictors (e.g., triptans, other ergot alkaloids, dopamine, dobutamine, ephedrine, epinephrine, norepinephrine)

• Other uterotonics (e.g., oxytocin, carboprost, misoprostol) - increased risk of uterine hypertonus and rupture
• Beta-blockers - increased vasoconstriction and risk of hypertension
• Bromocriptine - increased risk of hypertension and seizures

• Moderate CYP3A4 inhibitors (e.g., cimetidine, fluconazole)
• Vasoconstrictive anesthetics (e.g., halothane, cyclopropane) - may increase risk of hypertension

• Not available

• Headache (especially severe or throbbing)
• Nausea
• Vomiting
• Abdominal pain (cramping)
• Chest pain or tightness
• Dizziness
• Palpitations
• Numbness or tingling in extremities
• Cold or pale extremities
• Visual disturbances

Methylergonovine is contraindicated during pregnancy (before delivery) due to its potent uterotonic effects, which can cause uterine hypertonus, fetal hypoxia, and fetal death. Its primary use is postpartum to prevent or treat uterine atony and hemorrhage.

Methylergonovine is excreted into breast milk. There is a potential for adverse effects in the breastfed infant, including ergotism (e.g., vomiting, diarrhea, weak pulse, unstable blood pressure, convulsions) and decreased milk supply. It is generally recommended to temporarily discontinue breastfeeding for at least 12 hours after the last dose of methylergonovine to minimize infant exposure.

Safety and efficacy have not been established in pediatric patients. Not indicated for use in this population.

Clinical studies of methylergonovine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Use with caution due to potential for increased sensitivity to vasoconstrictive effects.

• IV administration of methylergonovine should be performed slowly over at least 60 seconds to minimize the risk of sudden, severe hypertension, cerebrovascular accident, and myocardial infarction.
• Closely monitor blood pressure, especially in patients with pre-eclampsia, eclampsia, or pre-existing hypertension, as methylergonovine can cause significant increases in blood pressure.
• Methylergonovine is not indicated for the induction of labor or for threatened spontaneous abortion.
• It is often used as a second-line uterotonic agent if oxytocin alone is insufficient to control postpartum hemorrhage.
• Patients should be advised to report any symptoms of ergotism (e.g., numbness, tingling, coldness in extremities, headache, nausea, vomiting) immediately.

• Oxytocin (Pitocin)
• Carboprost tromethamine (Hemabate)
• Misoprostol (Cytotec)
• Tranexamic acid (TXA)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. 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, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred, as this will aid in receiving appropriate treatment.