Methylergonovine oral and injection

You should not use methylergonovine during your pregnancy. This medication is to be used only after delivery of your baby.

Do not breast-feed within 12 hours after taking methylergonovine. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

You should not use methylergonovine if you are allergic to it, or if you have:

• high blood pressure;

• toxemia of pregnancy; or

• if your baby has not yet been born.

To make sure methylergonovine is safe for you, tell your doctor if you have:

• liver or kidney disease; or

• risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease).

You should not use methylergonovine during your pregnancy. This medicine is to be used only after delivery of your baby.

Do not breast-feed within 12 hours after taking methylergonovine. Methylergonovine may pass into breast milk in small amounts and could affect a nursing baby. In some cases, you will need to use this medication for up to 1 week after your baby is born. You may need to use a breast pump to establish and maintain your milk flow until your methylergonovine treatment is finished. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include vomiting, stomach pain, throbbing headache, numbness or tingling in your fingers or toes, cold feeling, weak or shallow breathing, or seizure (convulsions).

Applies to methylergonovine: oral tablet

Other dosage forms:

• injection solution

Along with its needed effects, methylergonovine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking methylergonovine:

• Abdominal pain
• headache
• increased blood pressure

• 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

• 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 of methylergonovine may occur that usually do not need 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 tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

Applies to methylergonovine: injectable solution, oral tablet

Cardiovascular

Cardiovascular side effects have included palpitations, hypertension, hypotension, acute myocardial infarction, transient chest pains, arterial spasm (coronary and peripheral), bradycardia, and tachycardia. Postmarketing reports have included ventricular fibrillation, ventricular tachycardia, angina pectoris and atrioventricular block.[Ref]

Hematologic

Hematologic side effects have included thrombophlebitis.[Ref]

Metabolic

Metabolic side effects have included water intoxication.[Ref]

Nervous system

Nervous system side effects have included tinnitus, hallucinations and dizziness. Postmarketing reports have included cerebrovascular accident and paraesthesia.[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea, foul taste, nausea and vomiting.[Ref]

Dermatologic

Dermatologic side effects have included diaphoresis and rash.[Ref]

Genitourinary

Genitourinary side effects have included hematuria.[Ref]

Respiratory

Respiratory side effects have included dyspnea and nasal congestion.[Ref]

Some side effects of methylergonovine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.