A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. To make sure sumatriptan is safe for you, tell your doctor if you have: It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Sumatriptan can pass into breast milk and may harm a nursing baby. Do not breast-feed within 12 hours after using sumatriptan.
If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby. Sumatriptan is not approved for use by anyone younger than 18 years old. How should I use sumatriptan? Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Use sumatriptan as soon as you notice headache symptoms. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Take one sumatriptan tablet whole with a full glass of water.
Do not split the tablet. After taking a tablet: If your headache does not completely go away, or goes away and comes back, take a second tablet 2 hours after the first. Do not take more than mg of sumatriptan oral tablets in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets. After using the nasal spray: Following administration, sumatriptan can be associated with transient symptoms including chest pain and tightness, which may be intense and involve the throat see section 4.
Where such symptoms are thought to indicate ischaemic heart disease, no further doses of sumatriptan should be given, and an appropriate evaluation should be carried out. There have been rare post-marketing reports describing patients with serotonin syndrome including altered mental status, autonomic instability and neuromuscular abnormalities following the use of a selective serotonin reuptake inhibitor SSRI and sumatriptan.
Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors SNRIs. Sumatriptan should be administered with caution to patients with conditions that may affect significantly the absorption, metabolism or excretion of the drug, e.
Sumatriptan should be used with caution in patients with a history of seizures or other risk factors which lower the seizure threshold, as seizures have been reported in association with sumatriptan see section 4. Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of sumatriptan.
Reactions may range from cutaneous hypersensitivity to anaphylaxis. Evidence of cross sensitivity is limited, however, caution should be exercised before using sumatriptan in these patients. Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John's Wort Hypericum perforatum.
Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued.
The diagnosis of medication overuse headache MOH should be suspected in patients who have frequent or daily headaches despite or because of the regular use of headache medications. The recommended dose of sumatriptan should not be exceeded.
Sumatriptan should not be given to patients with risk factors for ischaemic heart disease, including those patients who are heavy smokers or users of nicotine substitution therapies, without prior cardiovascular evaluation see section 4. Special consideration should be give to postmenopausal women and males over 40 with these risk factors. These evaluations however, may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease.
The increased risk of coronary vasospasms is a theoretical possibility and concomitant administration is contraindicated see section 4. This will also depends on the doses and types of products used.
The effects may be additive. Undesirable effects can occur more frequently in cases of concomitant use of triptans and herbal preparations containing St. The elimination half-life of Sumatriptan is approximately 2. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of Sumatriptan.
Sumatriptan succinate is chemically designated as 3-[2- dimethylamino ethyl]-N-methyl-indolemethanesulfonamide succinate 1: Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each Sumatriptan succinate tablet for oral administration contains 35 mg, 70 mg, or mg of Sumatriptan succinate, USP equivalent to 25 mg, 50 mg, or mg of Sumatriptan, respectively.
Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see Warnings and Precautions 5.
Pharmacokinetics Absorption and Bioavailability: The Cmax is similar during a migraine attack and during a migraine-free period, but the Tmax is slightly later during the attack, approximately 2. The effect of Sumatriptan on the protein binding of other drugs has not been evaluated. The apparent volume of distribution is 2.
In vitro studies with human microsomes suggest that Sumatriptan is metabolized by MAO, predominantly the A isoenzyme. Most of a radiolabeled dose of Sumatriptan excreted in the urine is the major metabolite indole acetic acid IAA or the IAA glucuronide, both of which are inactive. Most of the radiolabeled compound excreted in the urine is the major metabolite, indole acetic acid IAA , which is inactive, or the IAA glucuronide.
The pharmacokinetics of Sumatriptan in the elderly mean age: The effect of renal impairment on the pharmacokinetics of Sumatriptan has not been examined. The liver plays an important role in the presystemic clearance of orally administered Sumatriptan. Accordingly, the bioavailability of Sumatriptan following oral administration may be markedly increased in patients with liver disease. The pharmacokinetics of Sumatriptan in patients with severe hepatic impairment has not been studied.
The use of Sumatriptan succinate tablets in this population is contraindicated [see Contraindications 4 and Use in Specific Populations 8. In a trial comparing females to males, no pharmacokinetic differences were observed between genders for AUC, Cmax, Tmax, and half-life. Oral Sumatriptan has not been evaluated for race differences.
Due to gut and hepatic metabolic first-pass effects, the increase of systemic exposure after coadministration of an MAO-A inhibitor with oral Sumatriptan is greater than after coadministration of the MAO inhibitors with subcutaneous Sumatriptan. A small trial evaluating the effect of pretreatment with an MAO-A inhibitor on the bioavailability from a 25 mg oral Sumatriptan tablet resulted in an approximately 7-fold increase in systemic exposure.
Alcohol consumed 30 minutes prior to Sumatriptan ingestion had no effect on the pharmacokinetics of Sumatriptan. There was no evidence in either species of an increase in tumors related to Sumatriptan administration. It is not clear whether this finding was due to an effect on males or females or both. Dogs receiving oral Sumatriptan developed corneal opacities and defects in the corneal epithelium.
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