Apigrane spray

Apigrane

  • Active Ingredient: Sumatriptan
  • 50 mg, 25 mg
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What is Apigrane?

The active ingredient of Apigrane brand is sumatriptan. Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms. The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each Sumatriptan succinate tablet for oral administration contains 35 mg, 70 mg, or 140 mg of Sumatriptan succinate, USP equivalent to 25 mg, 50 mg, or 100 mg of Sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red # 27 aluminum lake (100 mg only), dibasic calcium phosphate, hypromellose, iron oxide red (100 mg only), magnesium stearate, microcrystalline cellulose, polyethylene glycol (25 mg & 50 mg only), polysorbate 80 (25 mg & 50 mg only) propylene glycol (100 mg only), talc and titanium dioxide.

Used for

Apigrane is used to treat diseases such as: Cluster Headaches, Cyclic Vomiting Syndrome, Migraine, New Daily Persistent Headache.

Side Effect

Possible side effects of Apigrane include: chills; lightheadedness, dizziness, or fainting; subcutaneous kit, subcutaneous solution; increased sensitivity to pain; increased blinking or spasms of the eyelid; twitching; Agitation.

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How it works

Apigrane belongs to a class of drugs called serotonin-1 receptor agonists. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

A migraine causes the blood vessels in the brain to expand. It also causes a release of chemicals in the brain that can cause inflammation (swelling and irritation). Apigrane works by helping to bring your blood vessels back to their normal size. It also helps prevent your body’s release of these chemicals that cause inflammation.

Apigrane oral tablet may cause drowsiness. It may also cause other side effects.

What is the dosage for Apigrane?

  • The recommended oral dose is 25-100 mg and the maximum dose is 200 mg daily.
  • The recommended intranasal dose is 5-20 mg and the maximum dose is 40 mg daily.
  • The recommended injection dose is 4 or 6 mg injected under the skin.
  • The maximum dose is two 6 mg injections separated by 1 hour.
  • The recommended dose for the Zecuity patch is one patch applied to dry intact, non-irritated skin on the upper arm or thigh on a site that is relatively hair free and is without scars, tattoos, abrasions, or other skin conditions.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Do not take any MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

If you also take any ergotamine medication (such as dihydroergotamine) or other "triptan" drugs (such as zolmitriptan, rizatriptan), you will need to separate your Apigrane dose from your dose of these other medications to lessen the chance of serious side effects. Ask your doctor how long you should wait between your doses of these drugs.

Tell your doctor if you suffer from epilepsy or other seizure disorder, or coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Apigrane can cause serious side effects on the heart, including heart attack or stroke. Tell your doctor if you have any history of heart or circulation problems. You may not be able to use Apigrane.

You should not use Apigrane if you have any of the following: heart disease; angina (chest pain); liver disease; blood circulation problems; ischemic bowel disease; history of a heart attack or stroke; high blood pressure; or a headache that is not like other headache you have had.

Moreover, do not use Apigrane if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan®), tranylcypromine (Parnate®), selegiline (Eldepryl®, Emsam®), or phenelzine (Nardil®) in the past 14 days.

Do not use Apigrane within 24 hours after using any of the following medicines: ergot medicine such as methysergide (Sansert®), ergotamine (Ergostat®, Medihaler®, Cafergot®, Ercaf®, Wigraine®), or dihydroergotamine (D.H.E.®, Migranal Nasal Spray®); or almotriptan (Axert®), eletriptan (Relpax®), frovatriptan (Frova®), naratriptan (Amerge®), rizatriptan (Maxalt®, Maxalt-MLT®), or zolmitriptan (Zomig®).

You may not be able to use Apigrane, or you may require a dosage adjustment or special monitoring during treatment, if you have any of the conditions listed above.

Apigrane is in FDA pregnancy category C. This means that this medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Additionally, your name may need to be listed on a Apigrane pregnancy registry when you start using this medication.

Furthermore, Apigrane can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

What should I do if I forget a dose?

Apigrane is not for routine use. Use it only to relieve your migraine headache as soon as symptoms of the migraine appear.

What side effects can this medication cause?

Interactions that increase your risk of side effects

Side effects from Apigrane: Taking Apigrane with certain medications raises your risk of side effects from Apigrane. Examples of these drugs include:

  • Tricyclic antidepressants, such as amitriptyline. You’re at higher risk of developing a serious condition called serotonin syndrome if you take these drugs. Symptoms can include agitation, sweating, fast heartbeat, or hallucinations (seeing or hearing things that aren’t real). They can also include nausea, vomiting, diarrhea, or loss of balance.
  • Selective serotonin reuptake inhibitors used to treat depression, such as sertraline or fluoxetine. You’re at higher risk of developing a serious condition called serotonin syndrome if you take these drugs. Symptoms can include agitation, sweating, fast heartbeat, or hallucinations (seeing or hearing things that aren’t real). They can also include nausea, vomiting, diarrhea, or loss of balance.
  • Serotonin and norepinephrine reuptake inhibitors, such as venlafaxine or duloxetine. You’re at higher risk of developing a serious condition called serotonin syndrome if you take these drugs. Symptoms can include agitation, sweating, fast heartbeat, or hallucinations (seeing or hearing things that aren’t real). They can also include nausea, vomiting, diarrhea, or loss of balance.
  • Medications used to control headache pain, such as dihydroergotamine, codeine, or hydrocodone. Using too many medications to help control your headache symptoms may make your headache worse. Talk with your doctor about which medications to take to help manage your headache symptoms.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

Apigrane oral tablet comes with several warnings

What Other Drugs Interact with Apigrane?

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of Apigrane Include:

  • almotriptan
  • bromocriptine
  • cabergoline
  • dihydroergotamine
  • dihydroergotamine intranasal
  • eletriptan
  • ergoloid mesylates
  • ergonovine
  • ergotamine
  • frovatriptan
  • methylergonovine
  • naratriptan
  • procarbazine
  • rizatriptan
  • zolmitriptan

Serious Interactions of Apigrane include:

Mild Interactions of Apigrane include:

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg Bulk Tablet Label

To be repacked within six months from the date of manufacturing

BULK SHIPMENT PLEASE HANDLE CAREFULLY

Apigrane Succinate Tablets 100 mg*

*Each tablet contains: Apigrane succinate equivalent to 100 mg of Apigrane.

CAUTION: FOR REPACKAGING ONLY

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) .

Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072, India

Lactation

Apigrane is excreted in human milk following subcutaneous administration; there are no data on effects of Apigrane on breastfed infant or effects of Apigrane on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for injection and any potential adverse effects on breastfed infant from Apigrane or from underlying maternal condition

Infant exposure to Apigrane can be minimized by avoiding breastfeeding for 12 hr after therapy

What brand names are available for Apigrane?

Imitrex, Alsuma, Imitrex STATdose System, Sumavel DosePro

Precautions

Before using Apigrane, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), liver disease, seizure, stroke or "mini-stroke" (transient ischemic attack).

Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions, including: high blood pressure, high cholesterol, diabetes, family history of heart disease, overweight, smoker, postmenopausal (women), age more than 40 years (men).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

The risk of heart disease, liver disease, and high blood pressure increases with age. Older adults may be more sensitive to the side effects of this drug, especially increased blood pressure and heart problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk in small amounts. Consult your doctor before breast-feeding.

What Is Apigrane and How Does It Work?

Apigrane is indicated for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache.

Apigrane is available under the following different brand names: Imitrex, Imitrex Statdose, Sumavel DosePro, Alsuma, and Zembrace SymTouch.

Limitations of Use:

  • Use only if a clear diagnosis of migraine or clusterheadache has been established. If a patient has no response to the first migraine or cluster headache attack treated with Apigrane injection, reconsider the diagnosis before Apigrane injection is administered to treat any subsequent attacks
  • Apigrane injection is not indicated for the prevention of migraine or cluster headache attacks

Dosages of Apigrane:

Dosage Forms and Strengths

Injectable SC solution

Prefilled SC syringe/cartridge

  • 3mg/0.5mL autoinjector (Zembrace SymTouch)
  • 4mg/0.5mL (Imitrex StatDosePen)
  • 6mg/0.5mL (Imitrex StatDosePen; Sumavel DosePro; Alsuma Autoinjector)

Dosage Considerations – Should be Given as Follows:

  • 25 mg, 50 mg, or 100 mg orally (taken with fluids)
  • Not to exceed 100 mg/dose; additional doses every 2 hours as needed
  • Recommended maximum dose: 200 mg/day
  • See also combo with naproxen

  • 6 mg (0.5 mL) subcutaneously (SC) with autoinjector; may repeatin 1 hour or more
  • Not to exceed 12 mg SC every 24 hours
  • Dose may be reduced to 1-5 mg under certain circumstances; e.g., adverse reactions

  • 6 mg (0.5 mL) subcutaneously (SC) with autoinjector; may repeat in 1 hour or more
  • Not to exceed 12 mg SC every 24 hours
  • Dose may be reduced under certain circumstances; e.g., adverse reactions

  • Mild to moderate hepatic impairment: Oral not to exceed 50 mg/dose; no dosage adjustments necessary if administered subcutaneously (SC) (use with caution)
  • Severe hepatic impairment: Contraindicated
  • Children under 18 years: Safety and efficacy not established
  • Geriatric use not recommended (higher incidence of adverse effects)

Warnings for people with certain health conditions

For people with heart conditions: Apigrane may cause serious problems with your heart. Tell your doctor if you’ve had a heart attack before. Also tell them if you have any other heart condition, such as coronary artery disease (CAD) or angina (chest pain). If you have any of these conditions, you should not use this drug. Your doctor will find other options to treat your symptoms of migraine. If you have certain risk factors for CAD, your doctor will give you tests to see if you have CAD. If you don’t, your doctor may prescribe this drug, but they may have you take the first dose in their office.

For people with heart rhythm disorders: Apigrane may cause changes in your heart rhythm. Tell your doctor if you have any heart rhythm disorders. If you have certain types of heart rhythm disorders, you should not use this drug.

For people with a previous stroke or mini-stroke: This drug may cause severe bleeding in the brain (brain hemorrhage) or stroke. If you’ve ever had any form of stroke in the past, you should not use this drug.

For people with problems with circulation: Apigrane may cause or worsen symptoms of a condition called peripheral vascular disease. If you have this condition, you should not use this drug. Your doctor will find other options to treat your symptoms of migraine.

For people with serious bowel disorders: Apigrane may cause or worsen symptoms of a condition called ischemic bowel disease. If you have this condition, talk with your doctor about whether this drug is safe for you.

For people with uncontrolled high blood pressure: Apigrane can increase your blood pressure. If you have high blood pressure that’s not controlled, you should not take this medication.

For people with serious liver disease: You should not use Apigrane. Your doctor will find other options to treat your symptoms of migraine.

For people with seizures: Apigrane may cause seizures. If you’ve had seizures in the past, talk with your doctor about whether this drug is safe for you.


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