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Zolmitriptan (Zolmitriptan)

Trade Name : Zolmitriptan

Ajanta Pharma Limited

TABLET

Strength 2.5 mg/1

ZOLMITRIPTAN Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Zolmitriptan (Zolmitriptan) which is also known as Zolmitriptan and Manufactured by Ajanta Pharma Limited. It is available in strength of 2.5 mg/1 per ml. Read more

Zolmitriptan (Zolmitriptan) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
  • Limitations of Use:
  • Zolmitriptan is a serotonin (5-HT) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ()
  • Limitations of Use:
  • Use only after a clear diagnosis of migraine has been established ()
  • Not indicated for the prophylactic therapy of migraine ()
  • Not indicated for the treatment of cluster headache ()
  • No data
  • Recommended starting dose: 1.25 mg or 2.5 mg ()
  • Maximum single dose: 5 mg ()
  • May repeat dose after 2 hours if needed; not to exceed 10 mg in any 24-hour period ()
  • Moderate or Severe Hepatic Impairment: 1.25 mg recommended (, )
  • 2.5 mg Tablets:
  • 5 mg Tablets:
  • Tablets: 2.5 mg functionally-scored ()
  • Tablets: 5 mg (not scored) ()
  • Zolmitriptan tablets are contraindicated in patients with:
  • History of coronary artery disease (CAD) or coronary vasospasm ()
  • Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ()
  • History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ()
  • Peripheral vascular disease ()
  • Ischemic bowel disease ()
  • Uncontrolled hypertension ()
  • Recent (within 24 hours) use of another 5-HT agonist (e.g., another triptan), or an ergotamine-containing medication ()
  • Monamine oxidase (MAO)-A inhibitor used in past 2 weeks ()
  • Known hypersensitivity to zolmitriptan ()
  • No data
  • Myocardial Ischemia/Infarction, and Prinzmetal's n- Angina:
  • Arrhythmias:
  • Chest/Throat/Neck/Jaw Pain, Tightness, and Pressure:
  • Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke:
  • Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions:
  • Medication Overuse Headache:
  • Serotonin Syndrome:
  • The following adverse reactions are described elsewhere in other sections of the prescribing information:
  • Most common adverse reactions (u22655% and > placebo) were neck/throat/jaw pain/tightness/pressure, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth ()
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ()
  • There is no experience with acute overdose of zolmitriptan tablets. Clinical study subjects who received single 50 mg oral doses of zolmitriptan tablets commonly experienced sedation.
  • There is no specific antidote to zolmitriptan tablets. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.
  • The elimination half-life of zolmitriptan tablets is 3 hoursn n ; therefore, monitor patients after overdose with zolmitriptan tablets for at least 15 hours or until symptoms or signs resolve. It is unknown what effect hemodialysis or peritoneal dialysis has on the plasma concentrations of zolmitriptan.
  • Zolmitriptan tablets, USP contain zolmitriptan USP, which is a selective 5-hydroxytryptamine (5-HT) 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:
  • Theu00a0molecular formula is CHNO, representing a molecular weight of 287.36. Zolmitriptan is a white to cream powder that is slightly soluble in water.
  • Zolmitriptan tablets, USPu00a0are available as 2.5 mg (pink) and 5 mg (yellow) film-coated tablets for oral administration. The film-coated tablets contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, ferric oxide yellow (2.5 mg and 5 mg tablet), ferric oxide red (2.5 mg tablet).n Zolmitriptan tablets meets USP Dissolution Test 2.
  • No data
  • Carcinogenesis
  • Zolmitriptan was administered to mice and rats at doses up to 400 mg/kg/day. Mice were dosed for 85 weeks (males) and 92 weeks (females); rats were dosed for 101 weeks (males) and 86 weeks (females). There was no evidence of drug-induced tumors in mice at plasma exposures (AUC) up to approximately 700 times that in humans at the maximum recommended human dose (MRHD) of 10 mg/day. In rats, there was an increase in the incidence of thyroid follicular cell hyperplasia and thyroid follicular cell adenomas in male rats receiving 400 mg/kg/day. No increase in tumors was observed in rats at 100 mg/kg/day, a dose associated with a plasma AUC approximately 700 times that in humans at the MRHD.
  • Mutagenesis
  • Zolmitriptan
  • in vitro
  • in vitro
  • in vitro
  • in vivo
  • Impairment of Fertility
  • Studies of male and female rats administered zolmitriptan prior to and during mating and up to implantation showed no impairment of fertility at oral doses up to 400 mg/kg/day. The plasma exposure (AUC) at this dose was approximately 3000 times that in humans at the MRHD.
  • Zolmitriptan tablets
  • The
  • Patients enrolled in these 5 studies were predominantly female (82%) and Caucasian (97%) with a mean age of 40 years (range 12-65). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed at 1, 2, and, in most studies, 4 hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours post-dose. A second dose of zolmitriptan tablets or other medication was allowed 2 to 24 hours after the initial treatment for persistent and recurrent headache. The frequency and time to use of these additional treatments were also recorded. In all studies, the effect of zolmitriptan tablets was compared to placebo in the treatment of a single migraine attack.
  • In all five studies, the percentage of patients achieving headache response 2 hours after treatment was significantly greater among patients who received zolmitriptan tablets u00a0at all doses (except for the 1 mg dose in the smallest study) compared to those who received placebo. In Studies 1 and 3, there was a statistically significant greater percentage of patients with headache response at 2 hours in the higher dose groups (2.5 and/or 5 mg) compared to the 1 mg dose group. There were no statistically significant differences between the 2.5 and 5 mg dose groups (or of doses up to 20 mg) for the primary end point of headache response at 2 hours in any study. The results of these controlled clinical studies are summarized in Table 2.
  • The estimated probability of achieving an initial headache response by 4 hours following treatment in pooled Studies 2, 3, and 5 is depicted in Figure 1.
  • Figure 1: Estimated Probability of Achieving Initial Headache Response (Reduction in Headache Severity from Moderate or Severe Pain to Mild or No Headache) Within 4 Hours of Treatment in Pooled Studies 2, 3, and 5*
  • u00a0n
  • *In this Kaplan-Meier plot, the averages displayed are based on pooled data from 3 placebo controlled outpatient trials. Patients not achieving headache response or taking additional treatment prior to 4 hours were censored at 4 hours.
  • For patients with migraine associated photophobia, phonophobia, and nausea at baseline, there was a decreased incidence of these symptoms following administration of zolmitriptan tablets as compared with placebo.
  • Two to 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.
  • Figure 2: The Estimated Probability of Patients Takingu00a0a Second Dose or Other Medication for Migraines over the 24 Hours Following the Initial Dose of Study Treatment in Pooled Studies 2, 3, and 5*
  • Arrayn- Array
  • *In this Kaplan-Meier plot, patients not using additional treatments were censored at 24 hours. The plot includes both patients who had headache response at 2 hours and those who had no response to the initial dose. The studies did not allow taking additional doses of study medication within 2 hours post-dose.
  • The efficacy of zolmitriptan tablets was unaffected by presence of aura; duration of headache prior to treatment; relationship to menses; gender, age, or weight of the patient; pre-treatment nausea or concomitant use of common migraine prophylactic drugs.
  • 2.5 mg Tablets
  • 5 mg Tablets
  • Store zolmitriptan tablets atu00a020-25u00b0C (68-77u00b0F) [see USP Controlled Room Temperature]. Protect from light and moisture.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Myocardial Ischemia and/or Infarction, Prinzmetalu2019s Angina, Other Vasospastic Reactions, and Cerebrovascular Events
  • Inform patients that zolmitriptan tablets may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular reactions can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms. Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions n n n n n n n n .
  • Medication Overuse Headache
  • Inform patients that use of drugs to treat acute migraines for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) n n .
  • Serotonin Syndrome
  • Inform patients about the risk of serotonin syndrome with the use of zolmitriptan tablets or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) n n .
  • Pregnancy
  • Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant.
  • Lactation
  • Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed n n
  • Patient Informationn n- Zolmitriptan (zoleu2019u2019 mi tripu2019 tan) Tablets, USP
  • 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.
  • What are zolmitriptan tablets?
  • 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.
  • What is a Migraine Headache?
  • 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.
  • How does zolmitriptan tablets work?
  • 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 blocks 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.
  • Who should not take zolmitriptan tablets?
  • Do not take zolmitriptan tablets if you:
  • 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.
  • How should I take zolmitriptan tablets?
  • What are the possible side effects of zolmitriptan tablets?
  • 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:
  • 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. n
  • 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.
  • This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you. You can also contact FDA to report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch
  • What to do in case of an overdose?
  • Call your doctor or poison control center or go to the nearest hospital emergency room.
  • General advice about zolmitriptan tablets
  • 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.
  • What are the ingredients in zolmitriptan tablets?
  • Zolmitriptan tablets
  • Active ingredient: zolmitriptan
  • Inactive ingredients:
  • lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, ferric oxide yellow (2.5 mg and 5 mg tablet), ferric oxide red (2.5 mg tablet).
  • Store zolmitriptan tablets at 20-25u00b0C (68-77u00b0F) [see USP Controlled Room Temperature] and away from children. Protect from light and moisture. Discard when expired.
  • Brands mentioned are trademarks of their respective owners and are not trademarks of the Ajanta Pharma Limited. The makers of these brands are not affiliated with Ajanta Pharma Limited or its products.
  • Marketed by:n Bridgewater, NJ 08807. Made in India.
  • Revised: 01/2019
  • .u00a0
  • No data

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