Zolmitriptan

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Legal Issues

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

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.

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History

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Other Information

Zolmitriptan tablets are selective 5-hydroxytryptamine 1B/1D (5HT1B/1D) receptor agonists. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5yl]methyl]-2-oxazolidinone and has the following chemical structure:

The molecular formula is C16H21N3O2 representing molecular weight of 287.36. Zolmitriptan is a white to off-white powder that is freely soluble in methanol and dimethylsulfoxide, insoluble in water.

Zolmitriptan tablets are available as 2.5 mg (yellow) and 5 mg (pink) film coated tablets for oral administration. The film coated tablets contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, polysorbate, titanium dioxide, yellow iron oxide, and red iron oxide.

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Zolmitriptan Manufacturers

Camber Pharmaceuticals Inc

Zolmitriptan | Camber Pharmaceuticals Inc

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)].

No Recall
Bluepoint Laboratories

Zolmitriptan | Bluepoint Laboratories

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.
2.4Dosing 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)].

No Recall
Mylan Pharmaceuticals Inc.

Zolmitriptan | Mylan Pharmaceuticals Inc.

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 coadministered 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)].

No Recall
Apotex Corp

Zolmitriptan | Apotex Corp

2.1 Dosing Information
The recommended starting dose of zolmitriptan 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 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, 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 in the treatment of an average of more than three migraines in a 30-day period has not been established.
2.2 Administration of Zolmitriptan Orally Disintegrating Tablets
Instruct patients not to break zolmitriptan orally disintegrating tablets because they are not functionally-scored. Administration with liquid is not necessary.

Orally disintegrating tablets are packaged in a blister pack. Instruct patients not to remove the tablet from the blister until just prior to dosing. Subsequently, instruct patients to peel the blister pack open, and to place the orally disintegrating tablet on the tongue, where it will dissolve and it will be swallowed with the saliva.
2.3 Dosing in Patients with Hepatic Impairment
The recommended dose of zolmitriptan 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.

The use of zolmitriptan orally disintegrating tablets is not recommended in patients with moderate or severe hepatic impairment because these orally disintegrating tablets should not be broken in half [see Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
2.4 Dosing in Patients taking Cimetidine
If zolmitriptan is co-administered with cimetidine, limit the maximum single dose of zolmitriptan to 2.5 mg, not to exceed 5 mg in any 24-hour period [see Drug Interactions (7.5), Clinical Pharmacology (12.3)].

No Recall
Cadila Healthcare Limited

Zolmitriptan | Cadila Healthcare Limited

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, 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 in the treatment of an average of more than three migraines in a 30 day period has not been established.
2.2 Administration of Zolmitriptan Orally Disintegrating Tablets
Instruct patients not to break zolmitriptan orally disintegrating tablets because they are not functionally-scored.

Administration with liquid is not necessary.

Orally disintegrating tablets are packaged in a blister pack. Instruct patients not to remove the tablet from the blister until just prior to dosing. Subsequently, instruct patients to peel the blister pack open, and to place the orally disintegrating tablet on the tongue, where it will dissolve and it will be swallowed with the saliva.
2.3 Dosing in Patients with Hepatic Impairment
The recommended dose of zolmitriptan 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.

The use of zolmitriptan orally disintegrating tablets is not recommended in patients with moderate or severe hepatic impairment because these orally disintegrating tablets should not be broken in half [see Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
2.4 Dosing in Patients taking Cimetidine
If zolmitriptan is coadministered with cimetidine, limit the maximum single dose of zolmitriptan to 2.5 mg, not to exceed 5 mg in any 24 hour period [see Drug Interactions (7.5), Clinical Pharmacology (12.3)].

No Recall
Zydus Pharmaceuticals (Usa) Inc.

Zolmitriptan | Zydus Pharmaceuticals (usa) Inc.

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, 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 in the treatment of an average of more than three migraines in a 30 day period has not been established.
2.2 Administration of Zolmitriptan Orally Disintegrating Tablets
Instruct patients not to break zolmitriptan orally disintegrating tablets because they are not functionally-scored.

Administration with liquid is not necessary.

Orally disintegrating tablets are packaged in a blister pack. Instruct patients not to remove the tablet from the blister until just prior to dosing. Subsequently, instruct patients to peel the blister pack open, and to place the orally disintegrating tablet on the tongue, where it will dissolve and it will be swallowed with the saliva.
2.3 Dosing in Patients with Hepatic Impairment
The recommended dose of zolmitriptan 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.

The use of zolmitriptan orally disintegrating tablets is not recommended in patients with moderate or severe hepatic impairment because these orally disintegrating tablets should not be broken in half [see Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
2.4 Dosing in Patients taking Cimetidine
If zolmitriptan is coadministered with cimetidine, limit the maximum single dose of zolmitriptan to 2.5 mg, not to exceed 5 mg in any 24 hour period [see Drug Interactions (7.5), Clinical Pharmacology (12.3)].

No Recall
Glenmark Generics Inc.,usa

Zolmitriptan | Glenmark Generics Inc.,usa

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.
2.4Dosing 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)].

No Recall
Global Pharmaceuticals, Division Of Impax Laboratories Inc.

Zolmitriptan | Global Pharmaceuticals, Division Of Impax Laboratories Inc.

2.1 Dosing Information
The recommended starting dose of zolmitriptan tablets and zolmitriptan orally disintegrating 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 or zolmitriptan orally disintegrating 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 zolmitriptan orally disintegrating 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 and zolmitriptan orally disintegrating tablets in the treatment of an average of more than three migraines in a 30‑day period has not been established.
2.2 Administration of Zolmitriptan Orally Disintegrating Tablets
Instruct patients not to break zolmitriptan orally disintegrating tablets because they are not functionally-scored. Administration with liquid is not necessary.

Orally disintegrating tablets are packaged in a blister pack. Instruct patients not to remove the tablet from the blister until just prior to dosing. Subsequently, instruct patients to peel the blister pack open, and to place the orally disintegrating tablet on the tongue, where it will dissolve and it will be swallowed with the saliva.
2.3 Dosing in Patients with Hepatic Impairment
The recommended dose of zolmitriptan tablets and zolmitriptan orally disintegrating 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.

The use of zolmitriptan orally disintegrating tablets is not recommended in patients with moderate or severe hepatic impairment because these orally disintegrating tablets should not be broken in half [see Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
2.4 Dosing in Patients taking Cimetidine
If zolmitriptan tablets or zolmitriptan orally disintegrating tablets is co‑administered with cimetidine, limit the maximum single dose of zolmitriptan tablets or zolmitriptan orally disintegrating tablets to 2.5 mg, not to exceed 5 mg in any 24‑hour period [see Drug Interactions (7.5), Clinical Pharmacology (12.3)].

No Recall
Macleods Pharmaceuticals Limited

Zolmitriptan | Macleods Pharmaceuticals Limited

2.1 Dosing Information
The recommended starting dose of zolmitriptan tablets are 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 tablet 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, 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 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 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)].

No Recall