Sumatriptan Succinate (Page 5 of 6)

DRUG ABUSE AND DEPENDENCE

One clinical study with sumatriptan succinate injection enrolling 12 patients with a history of substance abuse failed to induce subjective behavior and/or physiologic response ordinarily associated with drugs that have an established potential for abuse.

OVERDOSAGE

Patients (N = 670) have received single oral doses of 140 to 300 mg without significant adverse effects. Volunteers (N = 174) have received single oral doses of 140 to 400 mg without serious adverse events.

Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation. The elimination half-life of sumatriptan is approximately 2.5 hours (see CLINICAL PHARMACOLOGY), and therefore monitoring of patients after overdose with sumatriptan succinate tablets should continue for at least 12 hours or while symptoms or signs persist.

It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.

DOSAGE AND ADMINISTRATION

In controlled clinical trials, single doses of 25, 50, or 100 mg of sumatriptan succinate tablets were effective for the acute treatment of migraine in adults. There is evidence that doses of 50 and 100 mg may provide a greater effect than 25 mg (see CLINICAL TRIALS). There is also evidence that doses of 100 mg do not provide a greater effect than 50 mg. Individuals may vary in response to doses of sumatriptan succinate tablets. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of a higher dose with the potential for a greater risk of adverse events.

If the headache returns or the patient has a partial response to the initial dose, the dose may be repeated after 2 hours, not to exceed a total daily dose of 200 mg. If a headache returns following an initial treatment with sumatriptan succinate injection, additional single sumatriptan succinate tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

Because of the potential of MAO-A inhibitors to cause unpredictable elevations in the bioavailability of oral sumatriptan, their combined use is contraindicated (see CONTRAINDICATIONS).

Hepatic disease/functional impairment may also cause unpredictable elevations in the bioavailability of orally administered sumatriptan. Consequently, if treatment is deemed advisable in the presence of liver disease, the maximum single dose should in general not exceed 50 mg (see CLINICAL PHARMACOLOGY for the basis of this recommendation).

HOW SUPPLIED

Sumatriptan succinate tablets, 25, 50, and 100 mg of sumatriptan (base) as the succinate.

Sumatriptan succinate tablets, 25 mg are white, triangular-shaped, film-coated tablets debossed with “S” on one side and “I” on the other

Bottles of 30 (Child Resistant Cap)………………………..… . NDC 62756-520-83

Bottles of 100 (Child Resistant Cap) ……………………….… NDC 62756-520-88

Bottles of 100 (Non Child Resistant Cap) …………….………..NDC 62756-520-08

Bottles of 1000 (Non Child Resistant Cap)………..…..……… NDC 62756-520-18

Unit dose blister pack of 9 (1×9) tablets……………….……… NDC 62756-520-69

Unit dose blister pack of 9 (3×3) tablets……………….……… NDC 62756-520-93

Sumatriptan succinate tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with “S” on one side and “50” on the other

Bottles of 30 (Child Resistant Cap)………………….…….…. NDC 62756-521-83

Bottles of 100 (Child Resistant Cap) …………….……..…..…NDC 62756-521-88

Bottles of 100 (Non Child Resistant Cap) …………….……….NDC 62756-521-08

Bottles of 1000 (Non Child Resistant Cap) ………..…..…….. NDC 62756-521-18

Unit dose blister pack of 9 (1×9) tablets ……………….…….. NDC 62756-521-69

Unit dose blister pack of 9 (3×3) tablets……………..….…….NDC 62756-521-93

Sumatriptan succinate tablets, 100 mg are pink, triangular-shaped, film-coated tablets debossed with “S” on one side and “100” on the other.

Bottles of 30 (Child Resistant Cap) …………………..……..NDC 62756-522-83

Bottles of 100 (Child Resistant Cap) ………………..………NDC 62756-522-88

Bottles of 100 (Non Child Resistant Cap)…………..…..….. NDC 62756-522-08

Bottles of 1000 (Non Child Resistant Cap) ………..…..……NDC 62756-522-18

Unit dose blister pack of 9 (1×9) tablets…………………………..NDC 62756-522-69

Unit dose blister pack of 9 (3×3) tablets…………………………….NDC 62756-522-93

Store at 20° — 25°C (68° — 77°F); excursions permitted to 15° — 30°C (59° — 86°F) (See USP controlled Room Temperature.)

ANIMAL TOXICOLOGY

Corneal Opacities: Dogs receiving oral sumatriptan developed corneal opacities and defects in the corneal epithelium. Corneal opacities were seen at the lowest dosage tested, 2 mg/kg/day, and were present after 1 month of treatment. Defects in the corneal epithelium were noted in a 60-week study. Earlier examinations for these toxicities were not conducted and no-effect doses were not established; however, the relative exposure at the lowest dose tested was approximately 5 times the human exposure after a 100 mg oral dose. There is evidence of alterations in corneal appearance on the first day of intranasal dosing to dogs. Changes were noted at the lowest dose tested, which was approximately one half the maximum single human oral dose of 100 mg on a mg/m2 basis.

PATIENT INFORMATION

The following wording is contained in a separate leaflet provided for patients.

Information for the Patient

Sumatriptan Succinate Tablets

Read this leaflet carefully before you start to take sumatriptan succinate tablets. Keep the leaflet for reference because it gives you a summary of important information about sumatriptan succinate tablets.

Read the leaflet that comes with each refill of your prescription because there may be new information.

This leaflet does not have all the information about sumatriptan succinate tablets. Ask your healthcare provider for more information or advice.

What are sumatriptan succinate tablets ?

Sumatriptan succinate tablets are a kind of medicine called a triptan. You should take it only if you have a prescription.

Sumatriptan succinate tablets are used to relieve your migraine. They are not used to prevent attacks or reduce the number of attacks you have. Use sumatriptan succinate tablets only to treat an actual migraine attack.

The decision to use sumatriptan succinate tablets is one that you and your healthcare provider should make together, based on your personal needs and health.

Talk with your healthcare provider before taking sumatriptan succinate tablets

1. Risk factors for heart disease to tell your healthcare provider:

Tell your healthcare provider if you have risk factors for heart disease such as:

  • high blood pressure
  • high cholesterol
  • being overweight
  • diabetes
  • smoking
  • strong family history of heart disease
  • you are postmenopausal
  • you are a male over 40 years of age

If you do have risk factors for heart disease, your healthcare provider should check you for heart disease to see if sumatriptan succinate tablets are right for you.

Although most of the people who have taken sumatriptan succinate tablets have not had any serious side effects, some have had serious heart problems. Deaths have been reported, but these were rare considering the extensive worldwide use of sumatriptan succinate tablets. Usually, serious problems happened in people with known heart disease. It was not clear whether sumatriptan succinate tablets had anything to do with these deaths.

2. Important questions to ask yourself before you take sumatriptan succinate tablets:

If the answer to any of the following questions is YES or if you do not know the answer, then please talk with your healthcare provider before you take sumatriptan succinate tablets.

  • Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you not using adequate contraception? Are you breastfeeding?
  • Do you have any chest pain, heart disease, shortness of breath, or irregular heartbeats? Have you had a heart attack?
  • Do you have risk factors for heart disease (see list above)?
  • Have you had a stroke, a mini-stroke (also called a transient ischemic attack or TIA), or Raynaud syndrome?
  • Do you have high blood pressure?
  • Have you ever had to stop taking this or any other medicine because of an allergy or other problems?
  • Are you taking any other migraine medicines, including other triptans? Are you taking any medicines containing ergotamine, dihydroergotamine, or methysergide?
  • Are you taking any medicine for depression or other health problems such as a monoamine oxidase inhibitor, selective serotonin reuptake inhibitor (SSRI), or serotonin norepinephrine reuptake inhibitor (SNRI)? Common SSRIs are citalopram HBr (CELEXA®*), escitalopram oxalate (LEXAPRO®*), paroxetine (PAXIL®*), fluoxetine (PROZAC®* /SARAFEM®*), olanzapine/fluoxetine (SYMBYAX®*), sertraline (ZOLOFT®*), and fluvoxamine. Common SNRIs are duloxetine (CYMBALTA®*) and venlafaxine (EFFEXOR®*).
  • Have you had, or do you have, any disease of the liver or kidney?
  • Have you had, or do you have, epilepsy or seizures?
  • Is this headache different from your usual migraine attacks?

Remember, if you answered YES to any of the above questions, then talk with your healthcare provider about it.

Important points about sumatriptan succinate tablets

1. The use of sumatriptan succinate tablets during pregnancy:

Do not take sumatriptan succinate tablets if you are pregnant, think you might be pregnant, are trying to become pregnant, or are not using adequate contraception unless you have talked with your healthcare provider about this.

2. How to take sumatriptan succinate tablets:

For adults, the usual dose is a single tablet swallowed whole with water or other liquids. Do not split tablets. If your symptoms of migraine come back or if you have a partial response to the first dose, you can take a second tablet 2 hours after the first tablet, but not sooner.

For any attack where you have no response to the first tablet, do not take a second tablet without first talking to your healthcare provider. Do not take more than a total of 200 mg of sumatriptan succinate tablets in any 24-hour period. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

3. What to do if you take an overdose:

If you have taken more medicine than has been prescribed for you, contact either your healthcare provider, hospital emergency department, or nearest poison control center right away.

4. How to store your medicine:

Keep your medicine in a safe place where children cannot reach it. It may be harmful to children.

Do not take tablets out of the packaging until you are ready to take them. Do not store the tablets in any other container.

Store your medicine away from heat and light. Store at 20° – 25° C (68° – 77° F); excursions permitted to 15° – 30° C (59° – 86° F).

The expiration date of your medicine is printed on the packaging. If your medicine has expired, throw it away.

If your healthcare provider decides to stop your treatment, do not keep any leftover medicine unless your healthcare provider tells you to.

Some possible side effects of sumatriptan succinate tablets

  • Some patients feel pain or tightness in the chest or throat when using sumatriptan succinate tablets. If this happens to you, tell your healthcare provider before taking any more sumatriptan succinate tablets. If the chest pain, tightness, or pressure is severe or does not go away, call your healthcare provider right away.
  • Call your healthcare provider right away if you have sudden and/or severe abdominal pain after you take sumatriptan succinate tablets.
  • Some people may have a reaction called serotonin syndrome when they take certain kinds of medicines for depression called SSRIs or SNRIs while they are taking sumatriptan succinate tablets. Symptoms may include confusion, hallucinations, fast heartbeat, feeling faint, fever, sweating, muscle spasm, difficulty walking, and/or diarrhea. Call your healthcare provider right away if you have any of these symptoms after taking sumatriptan succinate tablets.
  • Shortness of breath; wheeziness; heart throbbing; swelling of eyelids, face, or lips; or a skin rash, skin lumps, or hives happens rarely. If it happens to you, then tell your healthcare provider right away. Do not take any more sumatriptan succinate tablets unless your healthcare provider tells you to.
  • Some people may feel tingling, heat, flushing (redness of face lasting a short time), heaviness, or pressure after taking sumatriptan succinate tablets. A few people may feel drowsy, dizzy, tired, or sick. If you have any of these symptoms, tell your healthcare provider at your next visit.
  • If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your healthcare provider right away.

*The following are registered trademarks of their respective manufacturers: PROZAC® /Eli Lilly and Company; ZOLOFT® /Pfizer Pharmaceuticals; PAXIL® /Glaxosmithkline; CELEXA® /Forest Labs; LEXAPRO® /Forest Labs; SARAFEM® /Warner Chilcott/Lilly; SYMBYAX® /Lilly; CYMBALTA® /Eli Lilly and Company; EFFEXOR® /Wyeth Pharmaceuticals Inc.

Manufactured by:
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri-Kurla Road,
Andheri (East), Mumbai – 400 059
India.

Distributed by:
Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive
Detroit, MI 48202
ISS. 01/2009 PJPI0090

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