ZOLMITRIPTAN

Zolmitriptan Pregnancy Warnings

Embryolethality and fetal abnormalities including malformations and variations has been demonstrated in reproductive toxicity studies in rats and rabbits at clinically relevant exposures. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Zolmitriptan Breastfeeding Warnings

Caution is recommended Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: Infant exposures should be minimized by avoiding breast-feeding for 24 hours after treatment.

Minor side effects (if these symptoms persist or worsen, inform your doctor)

• pain or tightness in the chest or throat, tingling sensations, ,flushing,weakness, dizziness, abdominal discomfort, and sweating.

Severe allergic reactions are rare. Get immediate medical help if you notice the following:

• rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Precautions

• Safety and efficacy of nasal spray have not been established in patients younger than 12 years.

• Safety and efficacy of oral tablets and oral disintegrating tablets have not been established in patients younger than 18 years.

• Should only be used when there is a clear need during pregnancy as it may harm an unborn baby. If you are planning to be pregnant or think you may be pregnant, discuss the risks and benefits of use with your doctor.

• Not recommended for use during pregnancy as it may harm an unborn baby. If you are planning to be pregnant or think you may be pregnant, discuss the risks and benefits of use with your doctor.

Drug Interactions

Taking multiple drugs may affect how medications work and/or cause unwanted side effects. List down all the medications you are taking and inform your physician and pharmacist. Do not take, discontinue, or alter any dose of medications without prior approval of your physician.

• Products that may interact with this medication include:
  • Monoamine oxidase inhibitors, for example, isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and procarbazine (Matulane) Serotonin reuptake inhibitors (SSRIs) fluoxetine (Prozac), paroxetine (Paxil), and sertraline (Zoloft) Ergots, like dihydroergotamine (DHE) and ergotamine tartrate (Cafergot), Cimetidine (Tagamet).

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

Missed Dose: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and as soon as you remember, take a regular dose or if the time of the next dose is near, wait for it before taking another dose and resume your usual schedule. Do not increase the dose to compensate for the missed dose.

Storage

• Room temperature
• Do not expose to light and moisture
• Do not store in the bathroom
• Keep all medications away from pets and children

Brands

Also marketed as

• Zomig [ AstraZeneca ]