Zolmitriptan (Page 2 of 7)

5.5 Other Vasospasm Reactions

5-HT1 agonists, including zolmitriptan, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before receiving additional zolmitriptan doses [see Contraindications (4) ].

Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established.

5.6 Medication Overuse Headache

Overuse of acute migraine drugs (e.g. ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

5.7 Serotonin Syndrome

Serotonin syndrome may occur with triptans, including zolmitriptan, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions (7.5)]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually rapidly occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue zolmitriptan if serotonin syndrome is suspected [see Drug Interactions (7.4) ].

5.8 Increase in Blood Pressure

Significant elevations in systemic blood pressure have been reported in patients treated with 5-HT1 agonists including patients without a history of hypertension; very rarely, these increases in blood pressure have been associated with serious adverse reactions. In healthy subjects treated with 5 mg of zolmitriptan, an increase of 1 and 5 mm Hg in the systolic and diastolic blood pressure, respectively, was seen. In a study of patients with moderate to severe liver impairment, 7 of 27 patients experienced 20 to 80 mm Hg elevations in systolic and/or diastolic blood pressure after a dose of 10 mg of zolmitriptan. As with all triptans, blood pressure should be monitored in zolmitriptan-treated patients. Zolmitriptan is contraindicated in patients with uncontrolled hypertension [see Contraindications (4) ].

6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in other sections of the prescribing information:

Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina [see Warnings and Precautions (5.1) ].
Arrhythmias [see Warnings and Precautions (5.2) ].
Chest and or Throat, Neck and Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3) ].
Cerebrovascular Events [see Warnings and Precautions (5.4) ].
Other Vasospasm Reactions [see Warnings and Precautions (5.5) ].
Medication Overuse Headache [see Warnings and Precautions (5.6) ].
Serotonin Syndrome [see Warnings and Precautions (5.7) ].
Increase in Blood Pressure [see Warnings and Precautions (5.8) ].

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In a long-term, open-label study where patients were allowed to treat multiple migraine attacks for up to 1 year, 8% (167 out of 2,058) withdrew from the trial because of adverse reaction.

The most common adverse reactions (≥ 5% and > placebo) in these trials were neck/throat/jaw pain, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth.

Table 1 lists the adverse reactions that occurred in ≥2% of the 2,074 patients in any one of the zolmitriptan 1 mg, 2.5 mg, or 5 mg dose groups in the controlled clinical trials of zolmitriptan in patients with migraines (Studies 1, 2, 3, 4, and 5) [see Clinical Studies (14) ]. Only adverse reactions that were at least 2% more frequent in a zolmitriptan group compared to the placebo group are included.

Several of the adverse reactions appear dose related, notably paresthesia, sensation of heaviness or tightness in chest, neck, jaw, and throat, dizziness, somnolence and possibly asthenia and nausea.

Table 1: Adverse Reaction Incidence in Five Pooled Placebo-Controlled Migraine Clinical Trials1

Placebo

(n=401)

Zolmitriptan Tablets 1 mg

(n=163)

Zolmitriptan Tablets 2.5 mg

(n=498)

Zolmitriptan Tablets

5 mg

(n=1012)

ATYPICAL SENSATIONS

6%

12%

12%

18%

Paresthesia (all types)

2%

5%

7%

9%

Warm/cold sensation

4%

6%

5%

7%

PAIN AND PRESSURE SENSATIONS

7%

13%

14%

22%

Chest-pain/tightness/pressure and/or heaviness

1%

2%

3%

4%

Neck/throat/jaw-pain/tightness/pressure

3%

4%

7%

10%

Heaviness other than chest or neck

1%

1%

2%

5%

Other-pressure/tightness/heaviness

0

2%

2%

2%

DIGESTIVE

8%

11%

16%

14%

Dry mouth

2%

5%

3%

3%

Dyspepsia

1%

3%

2%

1%

Dysphagia

0%

0%

0%

2%

Nausea

4%

4%

9%

6%

NEUROLOGICAL

10%

11%

17%

21%

Dizziness

4%

6%

8%

10%

Somnolence

3%

5%

6%

8%

Vertigo

0%

0%

0%

2%

OTHER

Asthenia

3%

5%

3%

9%

Sweating

1%

0%

2%

3%

1 Only adverse reactions that were at least 2% more frequent in a zolmitriptan group compared to the placebo group are included.

There were no differences in the incidence of adverse reactions in controlled clinical trials in the following subgroups: gender, weight, age, use of prophylactic medications, or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

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