Overall, the frequency of adverse events reported in the studies of cluster headache were generally lower. In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented.
Because the reports include events observed in open and uncontrolled studies, the role of IMITREX Injection in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug.
Cardiovascular: Infrequent were hypertension, hypotension, bradycardia, tachycardia, palpitations, pulsating sensations, various transient ECG changes nonspecific ST or T wave changes, prolongation of PR or QTc intervals, sinus arrhythmia, nonsustained ventricular premature beats, isolated junctional ectopic beats, atrial ectopic beats, delayed activation of the right ventricle , and syncope. Rare were pallor, arrhythmia, abnormal pulse, vasodilatation, and Raynaud syndrome.
Endocrine and Metabolic: Infrequent was thirst. Rare were polydipsia and dehydration. Eye: Frequent was vision alterations. Infrequent was irritation of the eye. Gastrointestinal: Frequent were abdominal discomfort and dysphagia. Infrequent were gastroesophageal reflux and diarrhea. Musculoskeletal: Frequent were muscle cramps. Infrequent were various joint disturbances pain, stiffness, swelling, ache. Rare were muscle stiffness, need to flex calf muscles, backache, muscle tiredness, and swelling of the extremities.
Neurological: Frequent was anxiety. Infrequent were mental confusion, euphoria, agitation, relaxation, chills, sensation of lightness, tremor, shivering, disturbances of taste, prickling sensations, paresthesia, stinging sensations, facial pain, photophobia, and lacrimation.
Respiratory: Infrequent was dyspnea. Rare were influenza, diseases of the lower respiratory tract, and hiccoughs. Skin: Infrequent were erythema, pruritus, and skin rashes and eruptions.
Rare was skin tenderness. Urogenital: Rare were dysuria, frequency, dysmenorrhea, and renal calculus. Rare was fever. Because the reports include events observed in open and uncontrolled studies, the role of IMITREX in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.
Breasts: Breast swelling, cysts, disorder of breasts, lumps, masses of breasts, nipple discharge, primary malignant breast neoplasm, and tenderness. Cardiovascular: Abdominal aortic aneurysm, angina, atherosclerosis, cerebral ischemia, cerebrovascular lesion, heart block, peripheral cyanosis, phlebitis, thrombosis, and transient myocardial ischemia.
Endocrine and Metabolic: Elevated thyrotropin stimulating hormone TSH levels; endocrine cysts, lumps, and masses; fluid disturbances; galactorrhea; hyperglycemia; hypoglycemia; hypothyroidism; weight gain; and weight loss.
Eye: Accommodation disorders, blindness and low vision, conjunctivitis, disorders of sclera, external ocular muscle disorders, eye edema and swelling, eye hemorrhage, eye itching, eye pain, keratitis, mydriasis, and visual disturbances. Mouth and Teeth: Disorder of mouth and tongue e. Musculoskeletal: Acquired musculoskeletal deformity, arthralgia and articular rheumatitis, arthritis, intervertebral disc disorder, muscle atrophy, muscle tightness and rigidity, musculoskeletal inflammation, and tetany.
Respiratory: Asthma, breathing disorders, bronchitis, cough, and lower respiratory tract infection. Urogenital: Abnormal menstrual cycle, abortion, bladder inflammation, endometriosis, hematuria, increased urination, inflammation of fallopian tubes, intermenstrual bleeding, menstruation symptoms, micturition disorders, urethritis, and urinary infections. Miscellaneous: Contusions, difficulty in walking, edema, hematoma, hypersensitivity, fever, fluid retention, lymphadenopathy, overdose, speech disturbance, swelling of extremities, swelling of face, and voice disturbances.
The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of IMITREX Injection in their causation cannot be reliably determined.
It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration. Blood: Hemolytic anemia, pancytopenia, thrombocytopenia. Eye: Ischemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis, loss of vision. Neurological: Central nervous system vasculitis, cerebrovascular accident, dysphasia, serotonin syndrome, subarachnoid hemorrhage.
Respiratory: Bronchospasm in patients with and without a history of asthma. Following subcutaneous administration of sumatriptan, pain, redness, stinging, induration, swelling, contusion, subcutaneous bleeding, and, on rare occasions, lipoatrophy depression in the skin or lipohypertrophy enlargement or thickening of tissue have been reported.
No gross overdoses in clinical practice have been reported. Overdoses would be expected from animal data dogs at 0. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
If side effects are dose limiting, then lower doses may be used see Table 1. The maximum recommended dose that may be given in 24 hours is two 6-mg injections separated by at least 1 hour. Controlled clinical trials have failed to show that clear benefit is associated with the administration of a second 6-mg dose in patients who have failed to respond to a first injection.
An autoinjection device is available for use with the 4- and 6-mg prefilled syringe cartridges to facilitate self-administration in patients using the 4- or 6-mg dose.
In patients receiving doses other than 4 or 6 mg, only the 6-mg single-dose vial dosage form should be used. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
IMITREX Injection contains sumatriptan base as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:. This product's prescribing information may have been updated. Please refer to ww. Additional barcode label applied by: Physicians Total Care, Inc.
Tulsa, Oklahoma If you have any questions, ask your healthcare provider. The grey and blue Carrying Case is used for storing the unloaded Pen and the Cartridge Pack when they are not being used.
The Cartridge Pack holds 2 individually sealed Syringe Cartridges. The Cartridge Pack for the 4-mg strength of this medicine is yellow, and the Cartridge Pack for the 6-mg strength is blue as shown. Refill Cartridge Packs are available. The grey and blue Pen is used to automatically inject 1 dose of medicine from a Syringe Cartridge.
Do not touch the Blue Button until you have pressed the Pen against your skin to give a dose. If you press it at any other time, you might lose a dose. The Safety Catch keeps the Pen from accidentally firing until you are ready. The Pen will only work when you slide the grey part of the barrel down to the blue part. Always check to make sure that the white Priming Rod is not sticking out from the end of the Pen as shown in Figure 2 before you load a new Syringe Cartridge.
If it is sticking out, you will lose that dose. Do not load the Pen until you are ready to give yourself an injection. Do not use if either seal is broken or missing when you first open the Carrying Case.
Tear off one of the tamper-evident seals see Figure 1. Throw away the seal. Open the lid over the Syringe Cartridge. Check to make sure the white Priming Rod is not sticking out from the lower end of the Pen see Figure 2 inset.
If it is sticking out, put the Pen back into the Carrying Case and press down firmly until you feel it click. Then take the Pen out of the Carrying Case. Put the Pen in the Cartridge Pack. Turn it to the right clockwise until it will not turn any more about half a turn see Figure 3. Hold the loaded Pen by the ridges and pull it straight out see Figure 4. You may need to pull hard on the Pen, but this is normal. Do not press the Blue Button yet.
The Pen is now ready to use. Do not put the loaded Pen back into the Carrying Case because that will damage the needle. Before injecting your medicine, choose an area with a fatty tissue layer see Figure 5a or Figure 5b.
Ask your healthcare provider if you have a question about where to inject. Clean the skin around this area. Without pushing the Blue Button, press the loaded Pen firmly against the skin so that the grey barrel slides down toward the blue section that holds the Syringe Cartridge see Figure 4.
This releases the Safety Catch that keeps the Pen from firing by mistake until you are ready. Push the Blue Button. Hold the Pen still for at least 5 seconds. If the Pen is taken away from the skin too soon, not all the medicine will come out.
After 5 seconds, carefully take the Pen away from your skin. The needle will be showing see Figure 6. Do not touch the needle. Right after you take a dose with the Pen, you need to return the used Syringe Cartridge to the Cartridge Pack. Push the Pen down into the empty side of the Cartridge Pack as far as it will go see Figure 7. Turn the Pen to the left counterclockwise about half a turn until it is released from the Syringe Cartridge see Figure 8.
Because the Pen has now been used, the white Priming Rod will stick out from the lower end of the Pen. Close the Cartridge Pack lid over the used Syringe Cartridge.
When the used Syringe Cartridges are inserted correctly, the Cartridge Pack is a disposable, protective case to help you avoid needle sticks and use the syringes correctly. Put the Pen back into the Carrying Case and press it down firmly until you feel it click. Close the Carrying Case lid.
It is available for administration by four different routes: oral, subcutaneous, intranasal, and rectal. To summarise evidence from four Cochrane intervention reviews on the efficacy and tolerability of sumatriptan in the treatment of acute migraine attacks in adults by four routes of administration oral, subcutaneous, intranasal, and rectal compared with both placebo and active comparators. The included reviews were written by the authors of this overview; no additional searching was carried out.
All included reviews were conducted according to a standard protocol and reported a standard set of outcomes. From each individual review we extracted results for pain relief at different levels, and adverse events. No additional statistical comparison was undertaken as part of the overview. We focused on the most important findings for doses and routes licensed in North America or Europe oral 25 mg, 50 mg, mg; subcutaneous 4 mg, 6 mg; intranasal 5 mg, 10 mg, 20 mg; rectal 25 mg.
Included reviews provided data for 18 different dose and route of administration combinations in 52, participants. Data for the primary outcomes sought were generally well reported, and involved adequate numbers of participants to give confidence in the results, except for the rectal route of administration, where numbers were low. Subcutaneous administration provided more rapid pain relief than the other routes. Taking medication early, when pain was mild, was more effective than waiting until the pain was moderate or severe.
Always return the empty cartridge and needle to their container before discarding them. Do not throw away the autoinjector unit, because refills are available. This medicine comes with a patient information leaflet. Read and follow the instructions carefully.
Ask your doctor if you have any questions. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine.
Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
Keep from freezing. Throw away used syringes or autoinjectors in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
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