Migranil EC

A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine (Migranil EC)'s most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes smooth muscle, stimulates cardiac muscle, stimulates diuresis, and appears to be useful in the treatment of some types of headache. Several cellular actions of Caffeine (Migranil EC) have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide phosphodiesterases, antagonism of adenosine receptors, and modulation of intracellular calcium handling. [PubChem]

A vasoconstrictor found in ergot of Central Europe. It is an alpha-1 selective adrenergic agonist and is commonly used in the treatment of migraine disorders. [PubChem]

Paracetamol (Migranil EC) is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Paracetamol (Migranil EC) exists as small alkaline deliquescent crystals with a saline tasteacinol was introduced to medicine as a solvent for uric acid. When taken into the body the drug is partly oxidized and partly eliminated unchanged. Outside the body, piperazine has a remarkable power to dissolve uric acid and producing a soluble urate, but in clinical experience it has not proved equally successfulacinol was first introduced as an anthelmintic in 1953. A large number of piperazine compounds have anthelmintic Paracetamol (Migranil EC). Their mode of Paracetamol (Migranil EC) is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.

Caffeine (Migranil EC) and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol). However, because of questionable benefit and transient action, most authorities believe Caffeine (Migranil EC) and other analeptics should not be used in these conditions and recommend other supportive therapy.

Sublingual

Migraine

Adult: As Ergotamine (Migranil EC) tartrate: 2 mg on the onset of attack, then 2 mg every 30 min if necessary. Max: 6 mg/24 hr, 10 mg/wk.

Renal impairment: Contraindicated.

Hepatic impairment: Contraindicated.

Inhalation

Migraine

Adult: As Ergotamine (Migranil EC) tartrate: Inhale single dose (360 mcg) at the onset of attack and repeat at 5-min intervals, if necessary. Max: 6 inhalations/24 hr, 15 inhalations/wk.

Renal impairment: Contraindicated.

Hepatic impairment: Contraindicated.

For systemic use of Paracetamol (Migranil EC) Sante Naturelle: prevention and treatment of hypo- and avitaminosis of vitamin C; providing increased need for vitamin C during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

Caffeine (Migranil EC) is a central nervous system stimulant. It works by stimulating the brain. Caffeine (Migranil EC) is found naturally in foods and beverages such as coffee, tea, colas, energy and chocolate. Botanical sources of Caffeine (Migranil EC) include kola nuts, guarana, and yerba mate. Caffeine (Migranil EC) is also available in prescription and non-prescription medications.

Caffeine (Migranil EC) is used to restore mental alertness or wakefulness during fatigue or drowsiness. Caffeine (Migranil EC) is also found in some headache and migraine medications, in certain dietary supplements used for weight loss, and in many popular energy drinks.

Caffeine (Migranil EC) (Caffeine (Migranil EC)) is available by prescription only. It is used for short-term treatment of neonatal apnea (breathing problems).

Caffeine (Migranil EC) may also be used for other conditions as determined by your health care provider.

Ergotamine (Migranil EC) is in a group of drugs called ergot alkaloids (ER-got AL-ka-loids). It works by narrowing the blood vessels around the brain. Ergotamine (Migranil EC) also affects blood flow patterns that are associated with certain types of headaches.

Ergotamine (Migranil EC) is used to treat a migraine type headache.

This medication will only treat a headache that has already begun. It will not prevent migraine headaches or reduce the number of attacks.

Ergotamine (Migranil EC) should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches.

Ergotamine (Migranil EC) may also be used for purposes not listed in this medication guide.

Paracetamol (Migranil EC) (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of Paracetamol (Migranil EC) of is not known.

Paracetamol (Migranil EC) is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. It relieves pain in mild arthritis but has no effect on the underlying inflammation and swelling of the joint.

Paracetamol (Migranil EC) may also be used for other purposes not listed in this medication guide.

Usual Adult Dose for Drowsiness:

100 to 200 mg orally not more often than every 3 to 4 hours.

For occasional use only.

Not intended for use as a substitute for sleep.

Limit the use of Caffeine (Migranil EC) containing medications, foods, or beverages while taking this product because too much Caffeine (Migranil EC) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Usual Pediatric Dose for Drowsiness:

>= 12 years: 100 to 200 mg not more often than every 3 to 4 hours.

For occasional use only.

Not intended for use as a substitute for sleep.

Limit the use of Caffeine (Migranil EC) containing medications, foods, or beverages while taking this product because too much Caffeine (Migranil EC) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Usual Pediatric Dose for Apnea of Prematurity:

For short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.

Prior to initiation of Caffeine (Migranil EC), baseline serum levels of Caffeine (Migranil EC) should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to Caffeine (Migranil EC). Likewise, baseline serum levels of Caffeine (Migranil EC) should be measured in infants born to mothers who consumed Caffeine (Migranil EC) prior to delivery, since Caffeine (Migranil EC) readily crosses the placenta.

Loading Dose: 20 mg/kg Caffeine (Migranil EC) intravenous (over 30 minutes) once

Maintenance Dose: 5 mg/kg Caffeine (Migranil EC) intravenous (over 10 minutes) or orally every 24 hours.

Note: The dose of Caffeine (Migranil EC) base is one-half the dose when expressed as Caffeine (Migranil EC) (e.g., 20 mg of Caffeine (Migranil EC) is equivalent to 10 mg of Caffeine (Migranil EC) base).

Serum concentrations of Caffeine (Migranil EC) may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L.

Apnea of prematurity is a diagnosis of exclusion. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnea) should be ruled out or properly treated prior to initiation of Caffeine (Migranil EC).

Caffeine (Migranil EC) should be used with caution in infants with seizure disorders or cardiovascular disease.

The duration of treatment of apnea of prematurity in the placebo-controlled trial was limited to 10 to 12 days. The safety and efficacy of Caffeine (Migranil EC) for longer periods of treatment have not been established.

Procedure

For best results, dosage should start at the first sign of an attack. Early Administration Gives Maximum Effectiveness. At the first sign of an attack or to relieve symptoms after onset of an attack, one 2 mg tablet is placed under the tongue. Another tablet should be taken at half-hour intervals thereafter, if necessary, but dosage must not exceed three tablets in any 24hour period. Total weekly dosage should not exceed five tablets (10 mg) in any one week. Ergotamine (Migranil EC) (Ergotamine (Migranil EC) tartrate tablets) ® Sublingual Tablets should not be used for chronic daily administration.

How supplied

Ergotamine (Migranil EC)® Sublingual Tablets, 2 mg

(Ergotamine (Migranil EC) tartrate tablets USP)

Ergotamine (Migranil EC) (Ergotamine (Migranil EC) tartrate tablets) ® Sublingual Tablets are round, green tablets each containing 2 mg of Ergotamine (Migranil EC) tartrate. They are debossed with the product identification code "LB2" on one side, and are supplied in individual foil strips packaged in a plastic child resistant canister containing 20 tablets (5 - 2 x 2 foil strips) NDC 10802-1202-0

Store and Dispense

Store at 20°- 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). Protect from light and heat. Keep out of reach of children.

Manufactured for: Rosedale Therapeutics Bristol, TN 37620 USA. By: Mikart, Inc. Atlanta, GA 30318. Rev 08/2007. FDA rev date: 6/30/1995

Usual Adult Paracetamol (Migranil EC) Dose for Fever:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Migranil EC) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Adult Paracetamol (Migranil EC) Dose for Pain:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Migranil EC) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Pediatric Dose for Fever:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Usual Pediatric Dose for Pain:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

See also:
What is the most important information I should know about Caffeine (Migranil EC)?

Caffeine (Migranil EC) should not be given to a child who has had an allergic reaction to it in the past.

Before using Caffeine (Migranil EC), tell the doctor if your child is allergic to any drugs, or has a seizure disorder, heart disease, kidney disease, liver disease, or high or low blood sugar.

Do not use the medication for longer than 12 days without the advice of your child's doctor.

Each bottle of Caffeine (Migranil EC) is for one use only, even if your child does not use the entire bottle for a single dose. Throw away any medication left over in the bottle after measuring your child's dose.

Call your doctor if the child's breathing symptoms do not improve after using Caffeine (Migranil EC).

To be sure Caffeine (Migranil EC) is helping your child's condition, the child's blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

See also:
What is the most important information I should know about Ergotamine (Migranil EC)?

Coadministration of Ergotamine (Migranil EC) with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clorithromycin and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities, with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when Ergotamine (Migranil EC) was coadministered, at least one resulting in death. Because of the increased risk for ergotism and other serious vasospastic adverse events, Ergotamine (Migranil EC) use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole).

Ergotamine (Migranil EC) (Ergotamine (Migranil EC) tartrate tablets) ® Sublingual Tablets may cause fetal harm when administered to pregnant women. Ergotamine (Migranil EC) (Ergotamine (Migranil EC) tartrate tablets) ® Sublingual Tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus. Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function and sepsis.

Hypersensitivity to any of the components.

See also:
What is the most important information I should know about Paracetamol (Migranil EC)?

Paracetamol (Migranil EC) should not be used in patients who have previously exhibited hypersensitivity to Paracetamol (Migranil EC) and/or nonsteroidal antiinflammatory agents. Paracetamol (Migranil EC) should not be given to patients with a recent history of gastrointestinal bleeding or in patients with bleeding disorders (e.g., hemophilia).

Use Caffeine (Migranil EC) as directed by your health care provider. If the medication is OTC, check the label on the bottle for the exact dosing instructions. If you have any questions about the use of an OTC medication, ask your pharmacist.

• Caffeine (Migranil EC) may be taken with or without food. If Caffeine (Migranil EC) upsets your stomach, take it with food.
• Do not exceed the recommended dose of Caffeine (Migranil EC). Caffeine (Migranil EC) can be habit-forming.
• Most OTC medications used for mental alertness contain 200 milligrams of Caffeine (Migranil EC) per tablet or capsule. The usual maximum recommended dose of OTC Caffeine (Migranil EC) is no more than 200 mg every 3-4 hours, or 1600 mg per day.
• Do not double-up on your Caffeine (Migranil EC) dose if you should miss the time for next dose.
• The average cup of coffee contains 150-200 milligrams (mg) of Caffeine (Migranil EC) per cup, while a cup of tea will have about 60 mg of Caffeine (Migranil EC). Cola products have about 30-40 mg of Caffeine (Migranil EC), and most energy drinks have about 60-70 mg. Be sure to account for any dietary Caffeine (Migranil EC) that is consumed.

Ask your health care provider any questions you may have about how to use Caffeine (Migranil EC).

Use Ergotamine (Migranil EC) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ergotamine (Migranil EC) at the first sign of a migraine attack as directed by your doctor.
• Do not swallow, crush, or chew sublingual tablets. Place the tablet under your tongue and allow it to slowly dissolve. Do not eat, drink, or smoke while the tablet is dissolving.
• If you need more than 1 dose of Ergotamine (Migranil EC) to treat a migraine attack, take the second dose at least 30 minutes after the first dose. Do not take more than 2 tablets for any migraine attack.
• Do not take more than 3 tablets in a 24 hour period. Do not take more than 5 tablets within a 7 day period, unless otherwise directed by your doctor.
• Do not use Ergotamine (Migranil EC) daily on a regular basis.
• Check with your doctor before including grapefruit or grapefruit juice in your diet while you take Ergotamine (Migranil EC).
• If you miss a dose of Ergotamine (Migranil EC) and you still have a headache, follow your doctor's dosing instructions. Contact your doctor immediately if you are unsure of what to do if you miss a dose. Do not take Ergotamine (Migranil EC) more often than prescribed. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ergotamine (Migranil EC).

Use Paracetamol (Migranil EC) exactly as directed on the label, or as prescribed by your doctor.

Do not use more of this medication than is recommended. An overdose of Paracetamol (Migranil EC) can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more Paracetamol (Migranil EC) could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking Paracetamol (Migranil EC) and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of Paracetamol (Migranil EC). Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

Measure the liquid form of Paracetamol (Migranil EC) with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The Paracetamol (Migranil EC) chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the Paracetamol (Migranil EC) disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the Paracetamol (Migranil EC) effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Do not take a Paracetamol (Migranil EC) rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.

Try to empty your bowel and bladder just before using the Paracetamol (Migranil EC) suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.

Stop using Paracetamol (Migranil EC) and call your doctor if:

• you still have a fever after 3 days of use;

• you still have pain after 7 days of use (or 5 days if treating a child);

• you have a skin rash, ongoing headache, or any redness or swelling; or

• if your symptoms get worse, or if you have any new symptoms.

Urine glucose tests may produce false results while you are taking Paracetamol (Migranil EC). Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

Store Paracetamol (Migranil EC) at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.

Use: Labeled Indications

Immediate release:

Analgesic, antipyretic, and anti-inflammatory: For the temporary relief of headache, pain, and fever caused by colds, muscle aches and pains, menstrual pain, toothache pain, and minor aches and pains of arthritis.

Revascularization procedures: For use in patients who have undergone revascularization procedures (ie, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or carotid endarterectomy).

Vascular indications, including ischemic stroke, transient ischemic attack, acute coronary syndromes (ST-elevation myocardial infarction or non-ST-elevation acute coronary syndromes [non-ST-elevation myocardial infarction or unstable angina]), secondary prevention after acute coronary syndromes, and management of stable ischemic heart disease: To reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; to reduce the risk of vascular mortality in patients with a suspected acute myocardial infarction (MI); to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina; to reduce the combined risk of MI and sudden death in patients with stable ischemic heart disease.

ER capsules:

Ischemic stroke or transient ischemic attack: To reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack.

Stable ischemic heart disease: To reduce the risk of death and MI in patients with stable ischemic heart disease.

Limitations of use: Do not use ER capsules in situations for which a rapid onset of action is required (such as acute treatment of MI or before percutaneous coronary intervention); use IR formulations instead.

Off Label Uses

Atherosclerotic cardiovascular disease, primary prevention

Based on the 2019 American College of Cardiology/American Heart Association (ACC/AHA) guideline on the primary prevention of cardiovascular disease and the 2020 American Diabetes Association standards of medical care in diabetes, Caffeine (Migranil EC) may be used for the primary prevention of cardiovascular disease in select patients after weighing the cardiovascular disease risk versus benefits.

Carotid artery atherosclerosis, asymptomatic or symptomatic

Based on the 2012 American College of Chest Physicians (ACCP) guidelines for antithrombotic therapy and prevention of thrombosis (9th edition), daily Caffeine (Migranil EC) is suggested in patients with asymptomatic or symptomatic carotid artery atherosclerosis based on a slight reduction in total mortality observed when Caffeine (Migranil EC) is taken over 10 years (regardless of cardiovascular risk profile). The AHA/American Stroke Association guidelines for the primary prevention of stroke recommend daily Caffeine (Migranil EC) for patients with asymptomatic or symptomatic carotid atherosclerosis to reduce the risk of a first stroke.

Carotid artery stenting

A randomized, controlled trial with blinded end point adjudication evaluated carotid artery stenting versus carotid endarterectomy in patients with carotid artery stenosis. In this trial, Caffeine (Migranil EC) in combination with clopidogrel was used for patients who underwent carotid artery stenting, which suggests that this antiplatelet combination is effective.

Ergotamine (Migranil EC) is used (usually in combination with Ergotamine (Migranil EC) and cyclizine) to relieve the symptoms of a migraine attack.

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How to use Paracetamol (Migranil EC)

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

There are many brands and forms of acetaminophen available. Read the dosing instructions carefully for each product because the amount of acetaminophen may be different between products. Do not take more acetaminophen than recommended.

If you are giving acetaminophen to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.

For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.

For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

See also:
What other drugs will affect Caffeine (Migranil EC)?

Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Avoid combination

Adenosine: Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may diminish the therapeutic effect of Adenosine. Management: Monitor for decreased effect of adenosine if patient is receiving Caffeine (Migranil EC). Discontinue Caffeine (Migranil EC) in advance of scheduled diagnostic use of adenosine whenever possible. Consider therapy modification

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Broccoli: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy

Bromperidol: Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may decrease the absorption of Bromperidol. Monitor therapy

BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cannabis: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy

CloZAPine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of CloZAPine. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

CYP1A2 Inducers (Moderate): May decrease the serum concentration of Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products. Monitor therapy

CYP1A2 Inhibitors (Moderate): May increase the serum concentration of Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products. Monitor therapy

CYP1A2 Inhibitors (Strong): May increase the serum concentration of Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products. Monitor therapy

Doxofylline: Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may enhance the adverse/toxic effect of Doxofylline. Avoid combination

Esketamine: May enhance the hypertensive effect of CNS Stimulants. Monitor therapy

Formoterol: Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may enhance the adverse/toxic effect of Formoterol. Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may enhance the hypokalemic effect of Formoterol. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Indacaterol: Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may enhance the adverse/toxic effect of Indacaterol. Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may enhance the hypokalemic effect of Indacaterol. Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Lithium: Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may decrease the serum concentration of Lithium. Monitor therapy

Norfloxacin: May increase the serum concentration of Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products. Monitor therapy

Olodaterol: Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may enhance the adverse/toxic effect of Olodaterol. Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may enhance the hypokalemic effect of Olodaterol. Monitor therapy

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Pipemidic Acid: May increase the serum concentration of Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products. Monitor therapy

Regadenoson: Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products may diminish the vasodilatory effect of Regadenoson. Management: Avoiding using Caffeine (Migranil EC) or other methylxanthine containing products (e.g., theophylline) for at least 12 hours prior to the administration of regadenoson. Consider therapy modification

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Solriamfetol: CNS Stimulants may enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Stiripentol: May increase the serum concentration of Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products. Avoid combination

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Theophylline Derivatives: CYP1A2 Inhibitors (Weak) may increase the serum concentration of Theophylline Derivatives. Exceptions: Dyphylline. Monitor therapy

TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use is necessary, initiate tizanidine at an adult dose of 2 mg and increase in 2 to 4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Consider therapy modification

Tobacco (Smoked): May decrease the serum concentration of Caffeine (Migranil EC) and Caffeine (Migranil EC) Containing Products. Monitor therapy

See also:
What other drugs will affect Ergotamine (Migranil EC)?

Alpha-/Beta-Agonists: Ergot Derivatives may enhance the hypertensive effect of Alpha-/Beta-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Avoid combination

Alpha1-Agonists: Ergot Derivatives may enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Avoid combination

Antihepaciviral Combination Products: May increase the serum concentration of Ergot Derivatives. Avoid combination

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Beta-Blockers: May enhance the vasoconstricting effect of Ergot Derivatives. Consider therapy modification

Chloroprocaine: May enhance the hypertensive effect of Ergot Derivatives. Monitor therapy

Clarithromycin: May increase the serum concentration of Ergotamine (Migranil EC). Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Cobicistat: May increase the serum concentration of Ergotamine (Migranil EC). Avoid combination

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Crizotinib: May increase the serum concentration of Ergotamine (Migranil EC). Avoid combination

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination. Some combinations are specifically contraindicated by manufacturers; others may have recommended dose adjustments. If combined, monitor for increased substrate effects. Consider therapy modification

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Enzalutamide: May decrease the serum concentration of Ergotamine (Migranil EC). Avoid combination

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Itraconazole: May increase the serum concentration of Ergotamine (Migranil EC). Avoid combination

Ketoconazole (Systemic): May increase the serum concentration of Ergotamine (Migranil EC). Avoid combination

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Letermovir: May increase the serum concentration of Ergot Derivatives. Avoid combination

Lorcaserin (Withdrawn From US Market): May enhance the adverse/toxic effect of Ergot Derivatives. Specifically, use of these drugs together may increase the risk of developing valvular heart disease. Lorcaserin (Withdrawn From US Market) may enhance the serotonergic effect of Ergot Derivatives. This could result in serotonin syndrome. Avoid combination

Macrolide Antibiotics: May increase the serum concentration of Ergot Derivatives. Cabergoline and Clarithromycin may interact, see specific monograph for full details. Exceptions: Azithromycin (Systemic); Fidaxomicin; Spiramycin. Avoid combination

MiFEPRIStone: May increase the serum concentration of Ergotamine (Migranil EC). Management: Avoid Ergotamine (Migranil EC) during and 2 weeks following mifepristone for treatment of hyperglycemia in Cushing's syndrome. The interaction magnitude could be lower with single doses used to terminate pregnancy, but neither effect has been studied clinically. Avoid combination

Nefazodone: Ergot Derivatives may enhance the serotonergic effect of Nefazodone. This could result in serotonin syndrome. Nefazodone may increase the serum concentration of Ergot Derivatives. Avoid combination

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Nitroglycerin: Ergot Derivatives may diminish the vasodilatory effect of Nitroglycerin. This is of particular concern in patients being treated for angina. Nitroglycerin may increase the serum concentration of Ergot Derivatives. Avoid combination

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Posaconazole: May increase the serum concentration of Ergotamine (Migranil EC). Avoid combination

Protease Inhibitors: May increase the serum concentration of Ergot Derivatives. Avoid combination

Reboxetine: May enhance the hypertensive effect of Ergot Derivatives. Monitor therapy

Roxithromycin: May increase the serum concentration of Ergot Derivatives. Avoid combination

Serotonergic Agents (High Risk): Ergot Derivatives may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Exceptions: Nefazodone. Monitor therapy

Serotonin 5-HT1D Receptor Agonists (Triptans): Ergot Derivatives may enhance the vasoconstricting effect of Serotonin 5-HT1D Receptor Agonists (Triptans). Serotonin 5-HT1D Receptor Agonists (Triptans) may enhance the vasoconstricting effect of Ergot Derivatives. Avoid combination

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Voriconazole: May increase the serum concentration of Ergotamine (Migranil EC). Avoid combination

See also:
What other drugs will affect Paracetamol (Migranil EC)?

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic Paracetamol (Migranil EC) of Paracetamol (Migranil EC).

With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.

With the simultaneous use of anticholinergics may decrease absorption of Paracetamol (Migranil EC).

With the simultaneous use of oral contraceptives accelerated excretion of Paracetamol (Migranil EC) from the body and may reduce its analgesic Paracetamol (Migranil EC).

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Paracetamol (Migranil EC).

When Paracetamol (Migranil EC) Guardian applied simultaneously with diazepam may decrease excretion of diazepam.

There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with Paracetamol (Migranil EC). A case of severe toxic liver injury.

Described cases of toxic effects of Paracetamol (Migranil EC), while the use of isoniazid.

When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of Paracetamol (Migranil EC), which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of Paracetamol (Migranil EC) and phenobarbital.

In applying cholestyramine a period of less than 1 h after administration of Paracetamol (Migranil EC) may decrease of its absorption.

At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.

With the simultaneous use of metoclopramide may increase absorption of Paracetamol (Migranil EC) and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of Paracetamol (Migranil EC), with rifampicin, sulfinpyrazone - may increase clearance of Paracetamol (Migranil EC) due to increasing its metabolism in the liver.

At simultaneous application of Paracetamol (Migranil EC) Guardian with ethinylestradiol increases absorption of Paracetamol (Migranil EC) from the gut.

Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of Paracetamol (Migranil EC) increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).

See also:
What are the possible side effects of Caffeine (Migranil EC)?

Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the Caffeine (Migranil EC) and placebo groups. The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in Caffeine (Migranil EC) treated patients than placebo.

In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving Caffeine (Migranil EC) during the open-label phase of the study.

Three of the infants who developed necrotizing enterocolitis during the trial died. All had been exposed to Caffeine (Migranil EC). Two were randomized to Caffeine (Migranil EC), and one placebo patient was “rescued” with open-label Caffeine (Migranil EC) for uncontrolled apnea.

Adverse events described in the published literature include: central nervous system stimulation (i.e., irritability, restlessness, jitteriness), cardiovascular effects (i.e., tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (i.e., increased gastric aspirate, gastrointesti­nal intolerance), alterations in serum glucose (hypoglycemia and hyper­glycemia) and renal effects (increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion). Published long-term follow-up studies have not shown Caffeine (Migranil EC) to adversely affect neurological development or growth parameters.

See also:
What are the possible side effects of Ergotamine (Migranil EC)?

Cardiovascular: Vasoconstrictive complications of a serious nature may occur at times. These include ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial distress and pain, EKG changes and muscle pains. Although these effects occur most commonly with long-term therapy at relatively high doses, they have also been reported with short-term or normal doses. Other cardiovascular adverse effects include transient tachycardia or bradycardia and hypertension.

Gastrointestinal: Nausea and vomiting

Neurological: paresthesias, numbness, weakness, and vertigo.

Allergic: Localized edema and itching.

Fibrotic Complications:.

Drug Abuse and Dependence

There have been reports of drug abuse and psychological dependence in patients on Ergotamine (Migranil EC) tartrate therapy. Due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages with long-term use to avoid ergotism.

See also:
What are the possible side effects of Paracetamol (Migranil EC)?

Effects due to the presence of acetylsalicylic acid.

Accidents awareness with respiratory or skin reactions (angioedema, urticaria, asthma, anaphylactic shock);

Cross hypersensitivity reactions with NSAIDs and with tartrazine;

At low doses recommended for the use of Paracetamol (Migranil EC), side effects of Paracetamol (Migranil EC) are generally limited to some irritation of the gastro-intestinal tract.

At higher doses, side effects include gastrointestinal mucosal erosions, gastric ulcer or duodenal ulcer, occult blood loss, melena.

Acetylsalicylic acid may also increase the tendency to bleeding and bleeding time (the lengthening of bleeding continues 4-6 days after stopping the drug).

It may also worsen renal function including cases of pre-existing condition (the long-term use can cause chronic kidney disease).

The signs of salicylic overdose described under.

Effects due to the presence of Paracetamol (Migranil EC).

At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of Paracetamol (Migranil EC) in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol (Migranil EC)) may cause the appearance chronic hepatitis. This justifies the recommendations of caution especially in patients with liver disease prior.

Very rarely, it can produce thrombocytopenia.

The acute liver toxicity in overdose massive (doses greater than 8 g of Paracetamol (Migranil EC)) is described in paragraph overdose.