DESCRIPTION SECTION

11 DESCRIPTION

Zolmitriptan tablets, USP contain zolmitriptan, which is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure:


The molecular formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to off-white powder that is readily soluble in water.

Zolmitriptan tablets, USP are available as 2.5 mg (yellow and functionally- score) and 5 mg (pink, not scored) film-coated tablets for oral administration. The film-coated tablets contain anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 2.5 mg tablets contain yellow iron oxide and the 5 mg tablets contain red iron oxide.

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INDICATIONS & USAGE SECTION

Highlight: Zolmitriptan tablets are a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use:

• Use only after a clear diagnosis of migraine has been established (1)
• Not indicated for the prophylactic therapy of migraine (1)
• Not indicated for the treatment of cluster headache (1)

1 INDICATIONS AND USAGE

Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use

• Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks.
• Zolmitriptan tablets are not indicated for the prevention of migraine attacks.
• Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache.

DOSAGE & ADMINISTRATION SECTION

Highlight: * Recommended starting dose: 1.25 mg or 2.5 mg (2.1)

• Maximum single dose: 5 mg (2.1)
• May repeat dose after 2 hours if needed; not to exceed 10 mg in any 24­-hour period (2.1)
• Moderate or Severe Hepatic Impairment: 1.25 mg recommended (2.3, 8.6)

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended starting dose of zolmitriptan tablets is 1.25 mg or 2.5 mg. The 1.25 mg dose can be achieved by manually breaking the functionally-scored 2.5 mg tablet in half. The maximum recommended single dose of zolmitriptan tablets is 5 mg.

In controlled clinical trials, a greater proportion of patients had headache response following a 2.5 mg or 5 mg dose than following a 1 mg dose. There was little added benefit from the 5 mg dose compared to the 2.5 mg dose, but adverse reactions were more frequent with the 5 mg dose.

If the migraine has not resolved by 2 hours after taking zolmitriptan tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 10 mg in any 24-hour period.

The safety of zolmitriptan tablets in the treatment of an average of more than three migraines in a 30-day period has not been established.

2.3 Dosing in Patients with Hepatic Impairment

The recommended dose of zolmitriptan tablets in patients with moderate to severe hepatic impairment is 1.25 mg (one-half of one 2.5 mg zolmitriptan tablet) because of increased zolmitriptan blood levels in these patients and elevation of blood pressure in some of these patients. Limit the total daily dose in patients with severe hepatic impairment to no more than 5 mg per day.

2.4 Dosing in Patients taking Cimetidine

If zolmitriptan tablets are co-administered with cimetidine, limit the maximum single dose of zolmitriptan tablets to 2.5 mg, not to exceed 5 mg in any 24-hour period [see Drug Interactions (7.5), Clinical Pharmacology (12.3)].

DOSAGE FORMS & STRENGTHS SECTION

Highlight: * Tablets: 2.5 mg functionally-scored (3)

• Tablets: 5 mg (not scored) (3)

3 DOSAGE FORMS AND STRENGTHS

2.5 mg Tablets: Yellow colored, round, biconvex, film-coated tablets debossed with ‘C’ and ‘C’ on either side of the score line on one side and ‘37’ on the other side (functionally-scored).

5 mg Tablets: Pink colored, round, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘51’ on the other side (not scored).

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CONTRAINDICATIONS SECTION

Highlight: * History of coronary artery disease (CAD) or coronary vasospasm (4)

• Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4)
• History of stroke, transient ischemic attack, or hemiplegic or basilar migraine (4)
• Peripheral vascular disease (4)
• Ischemic bowel disease (4)
• Uncontrolled hypertension (4)
• Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan), or an ergotamine-containing medication (4)
• Monoamine oxidase (MAO)-A inhibitor used in past 2 weeks (4)
• Known hypersensitivity to zolmitriptan tablets (4)

4 CONTRAINDICATIONS

Zolmitriptan tablets are contraindicated in patients with:

• Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or coronary artery vasospasm including Prinzmetal’s angina [see Warnings and Precautions (5.1)].
• Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2)].
• History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4)].
• Peripheral vascular disease (PVD) [see Warnings and Precautions (5.5)].
• Ischemic bowel disease [see Warnings and Precautions (5.5)].
• Uncontrolled hypertension [see Warnings and Precautions (5.8)].
• Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions (7.1, 7.3)].
• Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent use of a MAO-A inhibitor (that is within 2 weeks) [see Drug Interactions (7.2), Clinical Pharmacology (12.3)].
• Known hypersensitivity to zolmitriptan tablets (angioedema and anaphylaxis seen) [see Adverse Reactions (6.2)].

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SPL PATIENT PACKAGE INSERT SECTION

Patient Information

Zolmitriptan Tablets, USP
****(zole" mi trip' tan)

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Please read this information before you start taking zolmitriptan tablets and each time you renew your prescription just in case anything has changed. Remember, this summary does not take the place of discussions with your doctor. You and your doctor should discuss zolmitriptan tablets when you start taking your medication and at regular checkups.

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** What are zolmitriptan tablets?**

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Zolmitriptan tablets are a prescription medication used to treat migraine headaches in adults. Zolmitriptan tablets are not for other types of headaches. The safety and efficacy of zolmitriptan tablets in patients under 18 have not been established.

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** What is a Migraine Headache?**

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Migraine is an intense, throbbing headache. You may have pain on one or both sides of your head. You may have nausea and vomiting, and be sensitive to light and noise. The pain and symptoms of a migraine headache can be worse than a common headache. Some women get migraines around the time of their menstrual period. Some people have visual symptoms before the headache, such as flashing lights or wavy lines, called an aura.****

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** How does zolmitriptan tablets work?**

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Treatment with zolmitriptan tablets reduces swelling of blood vessels surrounding the brain. This swelling is associated with the headache pain of a migraine attack. Zolmitriptan tablets block the release of substances from nerve endings that cause more pain and other symptoms like nausea, and sensitivity to light and sound. It is thought that these actions contribute to relief of your symptoms by zolmitriptan tablets.

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** Who should not take zolmitriptan tablets?**

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** Do not take zolmitriptan tablets if you:**

• Have heart disease or a history of heart disease
• Have uncontrolled high blood pressure
• Have hemiplegic or basilar migraine (if you are not sure about this, ask your doctor)
• Have or had a stroke or problems with your blood circulation
• Have serious liver problems
• Have taken any of the following medicines in the last 24 hours: other “triptans” like almotriptan (AXERT®), eletriptan (RELPAX®), frovatriptan (FROVA®), naratriptan (AMERGE®), rizatriptan (MAXALT®), sumatriptan (IMITREX®), sumatriptan/naproxen (TREXIMET); ergotamines like BELLERGAL-S®, CAFERGOT®, ERGOMAR®, WIGRAINE®; dihydroergotamine like D.H.E. 45® or MIGRANAL®; or methysergide (SANSERT®). These medications have side effects similar to zolmitriptan tablets.
• Have taken monoamine oxidase (MAO) inhibitors such as phenelzine sulfate (NARDIL®) or tranylcypromine sulfate (PARNATE®) for depression or other conditions within the last 2 weeks.
• Are allergic to zolmitriptan tablets or any of its ingredients. The active ingredient is zolmitriptan. The inactive ingredients are listed at the end of this leaflet.

Tell your doctor about all the medicines you take or plan to take, including prescription and non-prescription medicines, supplements, and herbal remedies.

Tell your doctor if you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types of drugs for depression or other disorders. Common SSRIs are CELEXA® (citalopram HBr), LEXAPRO® (escitalopram oxalate), PAXIL® (paroxetine), PROZAC® (fluoxetine), SYMBYAX® (olanzapine/fluoxetine), ZOLOFT® (sertraline), SARAFEM® (fluoxetine) and LUVOX® (fluvoxamine). Common SNRIs are CYMBALTA® (duloxetine) and EFFEXOR® (venlafaxine). Your doctor will decide if you can take zolmitriptan tablets with your other medicines.

Tell your doctor if you know that you have any of the following: risk factors for heart disease like high cholesterol, diabetes, smoking, obesity (overweight), menopause, or a family history of heart disease or stroke.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if zolmitriptan tablets will harm your unborn baby.

Tell your doctor if you are breast feeding or plan to breast feed. It is not known if zolmitriptan passes into your breast milk. Talk to your doctor about the best way to feed your baby while using zolmitriptan tablets.

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** How should I take zolmitriptan tablets?**

• Take zolmitriptan tablets exactly as your doctor tells you to take them. Your doctor will tell you how much zolmitriptan to take and when to take it.
• Safely throw away any unused tablets or pieces of tablets that have been removed from the blister packaging.
• If your headache comes back after your first dose, you may take a second dose any time after 2 hours of taking the first dose. For any attack where the first dose did not work, do not take a second dose without talking with your doctor. Do not take more than a total of 10 mg of zolmitriptan (tablets or spray combined) in any 24 hour period. If you take too much medicine, contact your doctor, hospital emergency department, or poison control center right away.

What are the possible side effects of zolmitriptan tablets?

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Zolmitriptan tablets are generally well tolerated. As with any medicine, people taking zolmitriptan tablets may have side effects. The side effects are usually mild and do not last long.

The most common side effects of zolmitriptan tablets are:

• pain, pressure or tightness in the neck, throat or jaw
• dizziness
• tingling or other abnormal sensations
• tiredness
• drowsiness
• feeling warm or cold
• nausea
• feeling of tightness or heaviness in other areas of the body
• dry mouth

In very rare cases, patients taking triptans may experience serious side effects, such as heart attacks, high blood pressure, stroke, or serious allergic reactions. Extremely rarely, patients have died.Call your doctor right away if you have any of the following problems after taking zolmitriptan tablets:

• severe tightness, pain, pressure or heaviness in your chest, throat, neck, or jaw
• shortness of breath or wheezing
• sudden or severe stomach pain
• hives; tongue, mouth, or throat swelling
• problems seeing
• unusual weakness or numbness

Some people may have a reaction called serotonin syndrome, which can be life- threatening, when they use zolmitriptan tablets. In particular, this reaction may occur when they use zolmitriptan tablets together with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (hallucinations, agitation, coma), fast heartbeat, changes in blood pressure, high body temperature or sweating, tight muscles, trouble walking, nausea, vomiting, and diarrhea. Call your doctor immediately if you have any of these symptoms after taking zolmitriptan tablets.

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** This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you.**

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** What to do in case of an overdose?**

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Call your doctor or poison control center or go to the nearest hospital emergency room.

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** General advice about zolmitriptan tablets**

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Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use zolmitriptan tablets for a condition for which it was not prescribed. Do not give zolmitriptan tablets to other people, even if they have the same symptoms as you. People may be harmed if they take medicines that have not been prescribed for them.

This leaflet summarizes the most important information about zolmitriptan tablets. If you would like more information about zolmitriptan tablets, talk to your doctor. You can ask your doctor or pharmacist for information on zolmitriptan tablets that is written for healthcare professionals. You can also call Rising Pharma Holdings, Inc. at 1(844) 874-7464.

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** What are the ingredients in zolmitriptan tablets?**

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Active ingredient: zolmitriptan

Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 2.5 mg tablets contain yellow iron oxide and the 5 mg tablets contain red iron oxide.

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** Store zolmitriptan tablets at** 20° to 25°C (68° to 77°F) and away from children. Protect from light and moisture. Discard when expired.

The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited**.** The makers of these brands are not affiliated with and do not endorse Aurobindo Pharma Limited or its products.

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Made in India

Code: TS/DRUGS/22/2009

Issued: 04/2021

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