vj. Drug Details
Drug Name(s)\\\\\\\\\\\\\\\\tWIGRETTES
FDA Application No.\\\\\\\\\\\\\\\\t(ANDA) 086750
Active Ingredient(s)\\\\\\\\\\\\\\\\tERGOTAMINE TARTRATE
Company\\\\\\\\\\\\\\\\tORGANON USA INC
Original Approval or Tentative Approval Date\\\\\\\\\\\\\\\\tJuly 29, 1982
Drug Name(s)\\\\\\\\\\\\\\\\tWIGRETTES
FDA Application No.\\\\\\\\\\\\\\\\t(ANDA) 086750
Active Ingredient(s)\\\\\\\\\\\\\\\\tERGOTAMINE TARTRATE
Company\\\\\\\\\\\\\\\\tORGANON USA INC
Original Approval or Tentative Approval Date\\\\\\\\\\\\\\\\tJuly 29, 1982
Uses
This combination medication is used to treat or prevent a certain type of headache (vascular headaches such as migraine headaches and cluster headaches). Ergotamine helps narrow widened blood vessels in the head, which reduces the throbbing effects of vascular headaches.
How to use Wigrettes sublingual
Place one tablet under the tongue, allowing it to dissolve as directed by your doctor. Do not chew or swallow the tablet. Do not eat or drink while the tablet is dissolving in your mouth.
Dosage is based on your medical condition and response to therapy. This medication works best if it is taken as the first signs of the headache occur. If you wait until the headache has worsened, the medication may not work as well.
This medication usually should be taken only as needed. It is not meant for long-term daily use. The maximum dose is 3 tablets in any 24-hour period and 5 tablets in any 7-day period.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time (more than a few weeks) or in high doses. In such cases, rebound headaches may occur if you suddenly stop using this medication. This headache may be different from your original headache and may last a few days. Report any such headaches to your doctor right away. Consult your doctor or pharmacist for more details.
Inform your doctor if you notice increased use of this medication, the medication not working as well, a worsening of headaches, an increase in the number of headaches, or use of this medication for more than 2 headache episodes a week. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.
Side Effects
Nausea, vomiting, and dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: slow/fast/irregular heartbeat, tingling/pain/coldness in the fingers/toes, whitish fingers/toes/nails, loss of feeling in the fingers/toes, bluish hands/feet, muscle pain/weakness, severe stomach/abdominal pain, lower back pain, little or no urine.Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, vision changes, confusion, slurred speech.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Precautions
Before taking this medication, tell your doctor or pharmacist if you are allergic to ergotamine; or to other ergot alkaloids (e.g., dihydroergotamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blood circulation disease (e.g., peripheral vascular disease such as arteriosclerosis, thrombophlebitis, Raynaud's disease), uncontrolled high blood pressure, nutrient deficiency (malnutrition), heart/blood vessel disease (e.g., coronary artery disease, stroke, recent heart attack), liver disease, kidney disease, severe infection, severe itching.Before using this medication, tell your doctor or pharmacist your medical history, especially of: smoking/tobacco use, diabetes, high blood pressure (controlled).This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Remember that alcohol may be a cause of headaches.Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems (including chest pain, fast/slow/irregular heartbeat) and decreased blood flow to the brain/hands/feet. Do not use tobacco while taking this medication. If you smoke, talk to your doctor about how to stop smoking.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.