Methylergonovine (Oral)

Methylergonovine is used to prevent and control bleeding from the uterus that can happen after childbirth. It is part of a group of medicines called ergot alkaloids. This medicine works by acting directly on the smooth muscles of the uterus and helps prevent bleeding after giving birth.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Using this medicine while you are pregnant can harm your unborn baby. This medicine may cause contraction of the uterus and cause you to give birth early.

This medicine may increase your chance of having a heart attack. This is more likely to happen if you have diabetes, high cholesterol, or if you smoke or are overweight. Call your doctor right away if you have chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, or sweating while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how age affects the effects of methylergonovine in children. Safety and effectiveness have not been established.

Geriatric

Although appropriate studies on how age affects the effects of methylergonovine have not been conducted in older adults, no specific problems for elderly patients have been documented so far. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and adjustments in the dose for those receiving methylergonovine.

Breast Feeding

Studies indicate that this medication may change milk production or composition. If an alternative to this medication is not prescribed, you should watch the infant for side effects and ensure adequate milk intake.

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Almotriptan
• Amprenavir
• Atazanavir
• Boceprevir
• Cobicistat
• Darunavir
• Delavirdine
• Eletriptan
• Fosamprenavir
• Frovatriptan
• Indinavir
• Itraconazole
• Ketoconazole
• Letermovir
• Lopinavir
• Naratriptan
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Posaconazole
• Ritonavir
• Rizatriptan
• Saquinavir
• Sumatriptan
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole
• Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Dobutamine
• Dopamine
• Ephedrine
• Epinephrine
• Fluconazole
• Fluvoxamine
• Lenacapavir
• Norepinephrine
• Phenylephrine
• Propatyl Nitrate
• Vasopressin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken during or around meals or with certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or provide special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

Having other medical issues may impact the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Coronary artery disease or
• Diabetes or
• Hypercholesterolemia (high cholesterol in the blood)—May increase the risk of more serious side effects.

• Hypertension (high blood pressure) or
• Toxemia (high blood pressure during pregnancy)—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

• Obliterative vascular disease (blood vessel disease) or
• Sepsis (severe infection in the blood)—Use with caution. May worsen these conditions.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if you experience any of the following side effects:

More common

• Abdominal pain
• headache
• increased blood pressure

Rare

• Blood in the urine
• change in skin color
• chest pain or discomfort
• difficult or labored breathing
• difficulty with swallowing
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• hives
• lightheadedness, dizziness, or fainting
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• slow or fast heartbeat
• skin rash
• sweating
• vomiting

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• inability to speak
• seizures
• severe or sudden headache
• slurred speech
• temporary blindness
• weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to provide ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Rare

• Continuous ringing or buzzing or other unexplained noise in the ears
• cramps in the legs
• diarrhea
• foul taste
• increased sweating
• nausea
• stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your health care professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Methergine

Available Dosage Forms:

• Tablet

Therapeutic Class: Uterine Stimulant

Chemical Class: Ergot Alkaloid

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For prevention of bleeding after childbirth: Adults—0.2 milligram (mg) three or four times a day, for up to 1 week. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.