Zolmitriptan 5mg Tablets

Zolmitriptan is a selective agonist for 5-hydroxytryptamine1B (5-HT1B) and 5-hydroxytryptamine1D (5-HT1D) receptors. It is believed to exert its antimigraine effects by causing vasoconstriction of intracranial blood vessels, which are dilated during a migraine attack, and by inhibiting the release of pro-inflammatory neuropeptides (e.g., substance P, calcitonin gene-related peptide) from trigeminal nerve endings.

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Loss of eyesight (which can be long-lasting)
Diarrhea or constipation
Severe stomach pain or bloody diarrhea
Weight loss
Leg cramps
Feeling of heaviness or tightness in the leg muscles
Feeling cold
Burning or aching pain in the feet or toes
Shortness of breath
Abnormal sensations, such as burning, numbness, or tingling
Serotonin syndrome, a potentially life-threatening condition, which may cause:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, or vomiting
+ Severe headache
Heart problems, including:
+ Heart attack
+ Abnormal heartbeat
+ Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
+ Cold sweats
+ Shortness of breath
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
Brain blood vessel problems, including:
+ Stroke
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Changes in eyesight

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following:

Feeling dizzy, sleepy, tired, or weak
Feeling of warmth
Feeling of heaviness or pressure
Dry mouth
Upset stomach or vomiting

If you experience any of these side effects or any others that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, consult your doctor for medical advice.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms.
Certain health conditions, including:
+ High blood pressure
+ Liver disease
A history of specific health problems, such as:
+ Chest pain or pressure
+ Diseased arteries in the legs or arms
+ Heart attack
+ Heart disease
+ Poor blood flow in the heart, brain, bowel, or kidney
+ Stroke or transient ischemic attack (TIA)
+ Certain types of migraines, including hemiplegic or basilar migraines
+ Abnormal heartbeat, such as Wolff-Parkinson-White syndrome
Recent use of certain medications for depression, including isocarboxazid, phenelzine, or tranylcypromine, within the last 14 days. Taking this medication within 14 days of these drugs can cause severe high blood pressure.
Use of other medications for migraine or headache, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or sumatriptan, within the last 24 hours.
Use of ergotamine, methysergide, dihydroergotamine, or similar medications within the last 24 hours.

Special Considerations for Children:

If you are under 18 years of age, inform your doctor. This medication is not approved for use in children younger than 18 years of age.

Interactions with Other Medications and Health Conditions:

This is not an exhaustive list of all potential interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have.
* Before starting, stopping, or changing the dose of any medication, consult with your doctor to ensure it is safe to take this medication with your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid operating a vehicle or engaging in activities that require alertness. This medication is not intended to prevent or reduce the frequency of migraine headaches; it is designed to treat individual migraine episodes. If you experience a headache that is different from your typical migraine, consult your doctor before taking this medication.

Taking a higher dose or using this medication more frequently than prescribed by your doctor may lead to worsening of your headaches. As this class of medication can cause high blood pressure, it is crucial to have your blood pressure monitored as directed by your doctor. If you have risk factors for heart disease, such as high blood pressure, high cholesterol, being overweight, having high blood sugar or diabetes, smoking cigarettes, being a male over 40 years old, having a family history of early heart disease, or being a postmenopausal female, exercise caution and discuss your individual situation with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant women, those planning to become pregnant, or breastfeeding mothers should consult their doctor to discuss the potential benefits and risks of this medication to both themselves and their baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 2 weeks of discontinuing MAOI)
• Ergot-type drugs (e.g., ergotamine, dihydroergotamine) (within 24 hours)
• Other 5-HT1 agonists (e.g., sumatriptan, naratriptan) (within 24 hours)

• Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (increased risk of serotonin syndrome)
• Cimetidine (increases zolmitriptan Cmax and AUC)

• Propranolol (slight increase in zolmitriptan AUC and Cmax, but no dose adjustment needed)
• Oral Contraceptives (no significant interaction)

• Migraine pain intensity and associated symptoms (nausea, photophobia, phonophobia)
• Chest pain, tightness, or pressure (can indicate cardiac ischemia)
• Neck pain or tightness
• Paresthesias (tingling, numbness)
• Dizziness or vertigo
• Fatigue or somnolence
• Signs of serotonin syndrome (agitation, hallucinations, rapid heart beat, fever, overactive reflexes, nausea, vomiting, diarrhea, incoordination)
• Signs of stroke (sudden numbness or weakness, confusion, trouble speaking, vision problems, severe headache)

Zolmitriptan is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Zolmitriptan is excreted into breast milk. The amount is small, and adverse effects on breastfed infants are unlikely. However, caution is advised. Consider waiting 2-3 hours after a dose before breastfeeding to minimize infant exposure.

Not recommended for children under 12 years due to lack of efficacy and safety data. For adolescents 12-17 years, the oral disintegrating tablet formulation is approved, but with a lower maximum daily dose (5 mg/24 hours) compared to adults.

Use with caution in elderly patients (over 65 years) due to a higher likelihood of underlying cardiovascular disease. No specific dose adjustment is generally required based on age alone, but individual assessment of cardiovascular risk is important.

• Zolmitriptan is effective for acute migraine treatment but should not be used for migraine prevention.
• Advise patients to take the medication at the first sign of a migraine attack, but not during the aura phase if it precedes the headache.
• Counsel patients on the importance of not exceeding the maximum daily dose (10 mg in 24 hours) to avoid medication overuse headache.
• Screen patients for cardiovascular risk factors (e.g., hypertension, hyperlipidemia, diabetes, smoking, family history of CAD) before initiating triptan therapy.
• Inform patients about potential triptan-related sensations (e.g., chest pressure, neck tightness, tingling) which are usually mild and transient, but to seek immediate medical attention for severe or persistent symptoms.
• Avoid concomitant use with MAOIs, ergot derivatives, or other triptans due to increased risk of adverse events.

• Other Triptans (e.g., sumatriptan, rizatriptan, eletriptan, frovatriptan, naratriptan, almotriptan)
• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen
• Combination analgesics (e.g., Excedrin Migraine)
• CGRP Receptor Antagonists (gepants like rimegepant, ubrogepant)
• Ditans (e.g., lasmiditan)
• Ergot Alkaloids (e.g., ergotamine, dihydroergotamine)
• Anti-emetics (for associated nausea/vomiting, e.g., metoclopramide, ondansetron)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.