Imitrex Information
Imitrex (Sumatriptan) Description
Imitrex (Sumatriptan) Tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine receptor subtype agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:
The empirical formula is CHNOS•CHO, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each Imitrex (Sumatriptan) Tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. Each 100-mg tablet also contains hypromellose, iron oxide, titanium dioxide, and triacetin.
Imitrex (Sumatriptan) Clinical Pharmacology
Sumatriptan is an agonist for a vascular 5-hydroxytryptamine receptor subtype (probably a member of the 5-HT family) having only a weak affinity for 5-HT, 5-HT, and 5-HT receptors and no significant affinity (as measured using standard radioligand binding assays) or pharmacological activity at 5-HT, 5-HTor 5-HT receptor subtypes or at alpha-, alpha-, or beta-adrenergic; dopamine; dopamine; muscarinic; or benzodiazepine receptors.
The vascular 5-HT receptor subtype that sumatriptan activates is present on cranial arteries in both dog and primate, on the human basilar artery, and in the vasculature of human dura mater and mediates vasoconstriction. This action in humans correlates with the relief of migraine headache. In addition to causing vasoconstriction, experimental data from animal studies show that sumatriptan also activates 5-HT receptors on peripheral terminals of the trigeminal nerve innervating cranial blood vessels. Such an action may also contribute to the antimigrainous effect of sumatriptan in humans.
In the anesthetized dog, sumatriptan selectively reduces the carotid arterial blood flow with little or no effect on arterial blood pressure or total peripheral resistance. In the cat, sumatriptan selectively constricts the carotid arteriovenous anastomoses while having little effect on blood flow or resistance in cerebral or extracerebral tissues.
The mean maximum concentration following oral dosing with 25 mg is 18 ng/mL (range: 7 to 47 ng/mL) and 51 ng/mL (range: 28 to 100 ng/mL) following oral dosing with 100 mg of sumatriptan. This compares with a C of 5 and 16 ng/mL following dosing with a 5- and 20-mg intranasal dose, respectively. The mean C following a 6-mg subcutaneous injection is 71 ng/mL (range: 49 to 110 ng/mL). The bioavailability is approximately 15%, primarily due to presystemic metabolism and partly due to incomplete absorption. The C is similar during a migraine attack and during a migraine-free period, but the T is slightly later during the attack, approximately 2.5 hours compared to 2.0 hours. When given as a single dose, sumatriptan displays dose proportionality in its extent of absorption (area under the curve [AUC]) over the dose range of 25 to 200 mg, but the C after 100 mg is approximately 25% less than expected (based on the 25-mg dose).
A food effect study involving administration of Imitrex (Sumatriptan) Tablets 100 mg to healthy volunteers under fasting conditions and with a high-fat meal indicated that the C and AUC were increased by 15% and 12%, respectively, when administered in the fed state.
Plasma protein binding is low (14% to 21%). The effect of sumatriptan on the protein binding of other drugs has not been evaluated, but would be expected to be minor, given the low rate of protein binding. The apparent volume of distribution is 2.4 L/kg.
The elimination half-life of sumatriptan is approximately 2.5 hours. Radiolabeled C-sumatriptan administered orally is largely renally excreted (about 60%) with about 40% found in the feces. Most of the radiolabeled compound excreted in the urine is the major metabolite, indole acetic acid (IAA), which is inactive, or the IAA glucuronide. Only 3% of the dose can be recovered as unchanged sumatriptan.
In vitro studies with human microsomes suggest that sumatriptan is metabolized by monoamine oxidase (MAO), predominantly the A isoenzyme, and inhibitors of that enzyme may alter sumatriptan pharmacokinetics to increase systemic exposure. No significant effect was seen with an MAO-B inhibitor (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions).
max
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 monoamine oxidase inhibitors (MAOI) with subcutaneous sumatriptan. In a study of 14 healthy females, pretreatment with an MAO-A inhibitor decreased the clearance of subcutaneous sumatriptan. Under the conditions of this experiment, the result was a 2-fold increase in the area under the sumatriptan plasma concentration x time curve (AUC), corresponding to a 40% increase in elimination half-life. This interaction was not evident with an MAO-B inhibitor.
A small study 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.
Imitrex (Sumatriptan) Clinical Studies
The efficacy of Imitrex (Sumatriptan) Tablets in the acute treatment of migraine headaches was demonstrated in 3, randomized, double-blind, placebo-controlled studies. Patients enrolled in these 3 studies were predominately female (87%) and Caucasian (97%), with a mean age of 40 years (range, 18 to 65 years). 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 up to 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 postdose. A second dose of Imitrex (Sumatriptan) Tablets or other medication was allowed 4 to 24 hours after the initial treatment for recurrent headache. Acetaminophen was offered to patients in Studies 2 and 3 beginning at 2 hours after initial treatment if the migraine pain had not improved or worsened. Additional medications were allowed 4 to 24 hours after the initial treatment for recurrent headache or as rescue in all 3 studies. The frequency and time to use of these additional treatments were also determined. In all studies, doses of 25, 50, and 100 mg were compared to placebo in the treatment of migraine attacks. In 1 study, doses of 25, 50, and 100 mg were also compared to each other.
In all 3 trials, the percentage of patients achieving headache response 2 and 4 hours after treatment was significantly greater among patients receiving Imitrex (Sumatriptan) Tablets at all doses compared to those who received placebo. In 1 of the 3 studies, there was a statistically significant greater percentage of patients with headache response at 2 and 4 hours in the 50- or 100-mg group when compared to the 25-mg dose groups. There were no statistically significant differences between the 50- and 100-mg dose groups in any study. The results from the 3 controlled clinical trials are summarized in Table 1.
The estimated probability of achieving an initial headache response over the 4 hours following treatment is depicted in Figure 1.
For patients with migraine-associated nausea, photophobia, and/or phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours (Study 1) and at 4 hours (Studies 1, 2, and 3) following administration of Imitrex (Sumatriptan) Tablets compared to placebo.
As early as 2 hours in Studies 2 and 3 or 4 hours in Study 1, through 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.
There is evidence that doses above 50 mg do not provide a greater effect than 50 mg. There was no evidence to suggest that treatment with sumatriptan was associated with an increase in the severity of recurrent headaches. The efficacy of Imitrex (Sumatriptan) Tablets was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the patient; relationship to menses; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There were insufficient data to assess the impact of race on efficacy.
Imitrex (Sumatriptan) Indications And Usage
Imitrex (Sumatriptan) Tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.
Imitrex (Sumatriptan) Tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of Imitrex (Sumatriptan) Tablets have not been established for cluster headache, which is present in an older, predominantly male population.
Imitrex (Sumatriptan) Warnings
Imitrex (Sumatriptan) Tablets should only be used where a clear diagnosis of migraine headache has been established.
Sumatriptan should not be given to patients with documented ischemic or vasospastic coronary artery disease (CAD) (see CONTRAINDICATIONS). It is strongly recommended that sumatriptan not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient’s medical history or electrocardiographic investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, sumatriptan should not be administered (see CONTRAINDICATIONS).
For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of sumatriptan tablets take place in the setting of a physician’s office or similar medically staffed and equipped facility unless the patient has previously received sumatriptan. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following Imitrex (Sumatriptan) Tablets in these patients with risk factors.
It is recommended that patients who are intermittent long-term users of sumatriptan and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use sumatriptan.
The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to sumatriptan.
Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours following the administration of Imitrex (Sumatriptan) (sumatriptan succinate) Injection or Imitrex (Sumatriptan) Tablets. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low.
The fact that sumatriptan can cause coronary vasospasm, that some of these events have occurred in patients with no prior cardiac disease history and with documented absence of CAD, and the close proximity of the events to sumatriptan use support the conclusion that some of these cases were caused by the drug. In many cases, however, where there has been known underlying coronary artery disease, the relationship is uncertain.
Among the more than 1,900 patients with migraine who participated in premarketing controlled clinical trials of subcutaneous sumatriptan, there were 8 patients who sustained clinical events during or shortly after receiving sumatriptan that may have reflected coronary artery vasospasm. Six of these 8 patients had ECG changes consistent with transient ischemia, but without accompanying clinical symptoms or signs. Of these 8 patients, 4 had either findings suggestive of CAD or risk factors predictive of CAD prior to study enrollment.
Among approximately 4,000 patients with migraine who participated in premarketing controlled and uncontrolled clinical trials of sumatriptan nasal spray, 1 patient experienced an asymptomatic subendocardial infarction possibly subsequent to a coronary vasospastic event.
Cardiac events that have been observed to have onset within 1 hour of sumatriptan administration include: coronary artery vasospasm, transient ischemia, myocardial infarction, ventricular tachycardia and ventricular fibrillation, cardiac arrest, and death.
Some of these events occurred in patients who had no findings of CAD and appear to represent consequences of coronary artery vasospasm. However, among domestic reports of serious cardiac events within 1 hour of sumatriptan administration, almost all of the patients had risk factors predictive of CAD and the presence of significant underlying CAD was established in most cases (see CONTRAINDICATIONS).
Imitrex (Sumatriptan) Precautions
Chest discomfort and jaw or neck tightness have been reported following use of Imitrex (Sumatriptan) Tablets and have also been reported infrequently following administration of Imitrex (Sumatriptan) Nasal Spray. Chest, jaw, or neck tightness is relatively common after administration of Imitrex (Sumatriptan) Injection. Only rarely have these symptoms been associated with ischemic ECG changes. However, because sumatriptan may cause coronary artery vasospasm, patients who experience signs or symptoms suggestive of angina following sumatriptan should be evaluated for the presence of CAD or a predisposition to Prinzmetal variant angina before receiving additional doses of sumatriptan, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur. Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud syndrome following sumatriptan should be evaluated for atherosclerosis or predisposition to vasospasm (see WARNINGS).
Imitrex (Sumatriptan) should also be administered with caution to patients with diseases that may alter the absorption, metabolism, or excretion of drugs, such as impaired hepatic or renal function.
There have been rare reports of seizure following administration of sumatriptan. Sumatriptan should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.
Care should be taken to exclude other potentially serious neurologic conditions before treating headache in patients not previously diagnosed with migraine headache or who experience a headache that is atypical for them. There have been rare reports where patients received sumatriptan for severe headaches that were subsequently shown to have been secondary to an evolving neurologic lesion (see WARNINGS).
For a given attack, if a patient does not respond to the first dose of sumatriptan, the diagnosis of migraine should be reconsidered before administration of a second dose.
Overuse of acute migraine treatments has been associated with the exacerbation of headache (medication overuse headache) in susceptible patients. Withdrawal of the treatment may be necessary.
See PATIENT INFORMATION at the end of this labeling for the text of the separate leaflet provided for patients.
Patients should be cautioned about the risk of serotonin syndrome with the use of sumatriptan or other triptans, especially during combined use with SSRIs or SNRIs.
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Pregnancy Category C. In reproductive toxicity studies in rats and rabbits, oral treatment with sumatriptan was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to rabbits, sumatriptan has been shown to be embryolethal. There are no adequate and well-controlled studies in pregnant women. Therefore, Imitrex (Sumatriptan) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In assessing this information, the following findings should be considered.
The intravenous administration of sumatriptan to pregnant rats throughout organogenesis at 12.5 mg/kg/day, the maximum dose tested, did not cause embryolethality. This dose is equivalent to the maximum single recommended human oral dose of 100 mg on a mg/m basis. Additionally, in a study in rats given subcutaneous sumatriptan daily prior to and throughout pregnancy at 60 mg/kg/day, the maximum dose tested, there was no evidence of increased embryo/fetal lethality. This dose is equivalent to approximately 6 times the maximum recommended single human oral dose of 100 mg on a mg/m basis.
A study in which rats were dosed daily with oral sumatriptan prior to and throughout gestation demonstrated embryo/fetal toxicity (decreased body weight, decreased ossification, increased incidence of rib variations) and an increased incidence of a syndrome of malformations (short tail/short body and vertebral disorganization) at 500 mg/kg/day. The highest no-effect dose was 50 mg/kg/day, or approximately 5 times the maximum single recommended human oral dose of 100 mg on a mg/m basis. In a study in rats dosed daily with subcutaneous sumatriptan prior to and throughout pregnancy, at a dose of 60 mg/kg/day, the maximum dose tested, there was no evidence of teratogenicity. This dose is equivalent to approximately 6 times the maximum recommended single human oral dose of 100 mg on a mg/m basis.
2
Oral treatment of pregnant rats with sumatriptan from gestational day 17 through postnatal day 21 demonstrated a decrease in pup survival measured at postnatal days 2, 4, and 20 at the dose of 1,000 mg/kg/day. The highest no-effect dose for this finding was 100 mg/kg/day, approximately 10 times the maximum single recommended human oral dose of 100 mg on a mg/m basis. In a similar study in rats by the subcutaneous route there was no increase in pup death at 81 mg/kg/day, the highest dose tested, which is equivalent to 8 times the maximum single recommended human oral dose of 100 mg on a mg/m basis.
Safety and effectiveness of Imitrex (Sumatriptan) Tablets in pediatric patients under 18 years of age have not been established; therefore, Imitrex (Sumatriptan) Tablets are not recommended for use in patients under 18 years of age.
Two controlled clinical trials evaluating sumatriptan nasal spray (5 to 20 mg) in pediatric patients aged 12 to 17 years enrolled a total of 1,248 adolescent migraineurs who treated a single attack. The studies did not establish the efficacy of sumatriptan nasal spray compared to placebo in the treatment of migraine in adolescents. Adverse events observed in these clinical trials were similar in nature to those reported in clinical trials in adults.
Five controlled clinical trials (2 single attack studies, 3 multiple attack studies) evaluating oral sumatriptan (25 to 100 mg) in pediatric patients aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. These studies did not establish the efficacy of oral sumatriptan compared to placebo in the treatment of migraine in adolescents. Adverse events observed in these clinical trials were similar in nature to those reported in clinical trials in adults. The frequency of all adverse events in these patients appeared to be both dose- and age-dependent, with younger patients reporting events more commonly than older adolescents.
Postmarketing experience documents that serious adverse events have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal sumatriptan. These reports include events similar in nature to those reported rarely in adults, including stroke, visual loss, and death. A myocardial infarction has been reported in a 14-year-old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration. Since clinical data to determine the frequency of serious adverse events in pediatric patients who might receive injectable, oral, or intranasal sumatriptan are not presently available, the use of sumatriptan in patients aged younger than 18 years is not recommended.
Imitrex (Sumatriptan) Adverse Reactions
Significant hypertensive episodes, including hypertensive crises, have been reported on rare occasions in patients with or without a history of hypertension (see WARNINGS).
Imitrex (Sumatriptan) Drug Abuse And Dependence
One clinical study with Imitrex (Sumatriptan) 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.
Imitrex (Sumatriptan) 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 Imitrex (Sumatriptan) 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.
Imitrex (Sumatriptan) Dosage And Administration
In controlled clinical trials, single doses of 25, 50, or 100 mg of Imitrex (Sumatriptan) 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 Imitrex (Sumatriptan) 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 Imitrex (Sumatriptan) Injection, additional single Imitrex (Sumatriptan) 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).
Imitrex (Sumatriptan) How Supplied
Imitrex (Sumatriptan) Tablets, 25, 50, and 100 mg of sumatriptan (base) as the succinate.
Imitrex (Sumatriptan) Tablets, 25 mg are white, triangular-shaped, film-coated tablets debossed with “I” on one side and“25” on the other in blister packs of 9 tablets (NDC 0173-0735-00).
Imitrex (Sumatriptan) Tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with “Imitrex (Sumatriptan) 50” on one side and a chevron shape (^) on the other in blister packs of 9 tablets (NDC 0173-0736-01).
Imitrex (Sumatriptan) Tablets, 100 mg, are pink, triangular-shaped, film-coated tablets debossed with “Imitrex (Sumatriptan) 100” on one side and a chevron shape (^) on the other in blister packs of 9 tablets (NDC 0173-0737-01).
Imitrex (Sumatriptan) Patient Information
The following wording is contained in a separate leaflet provided for patients.
Read this leaflet carefully before you start to take Imitrex (Sumatriptan) Tablets. Keep the leaflet for reference because it gives you a summary of important information about Imitrex (Sumatriptan) 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 Imitrex (Sumatriptan) Tablets. Ask your healthcare provider for more information or advice.
Imitrex (Sumatriptan) Tablets are a kind of medicine called a triptan. You should take it only if you have a prescription.
Imitrex (Sumatriptan) Tablets are used to relieve your migraine. They are used to prevent attacks or reduce the number of attacks you have. Use Imitrex (Sumatriptan) Tablets only to treat an actual migraine attack.
The decision to use Imitrex (Sumatriptan) Tablets is one that you and your healthcare provider should make together, based on your personal needs and health.
Imitrex (Sumatriptan) and PAXIL are registered trademarks of GlaxoSmithKline. The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2010, GlaxoSmithKline. All rights reserved.
February 2010
IMT:2PIL
Imitrex (Sumatriptan) Principal Display Panel
NDC 0173-0735-00
Imitrex (Sumatriptan)
(SUMATRIPTAN SUCCINATE)
TABLETS
25 mg
9 Tablets
R only
Each tablet contains sumatriptan succinate equivalent to 25 mg of sumatriptan.
Do not use if package is torn or broken or if you receive fewer tablets than your doctor prescribed.
See prescribing information for dosage information.
Store between 36 and 86F (2 and 30C).
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Canada
©2006, GlaxoSmithKline
10000000035879 Rev. 11/06
Imitrex (Sumatriptan) Principal Display Panel
NDC 0173-0736-01
Imitrex (Sumatriptan)
(SUMATRIPTAN SUCCINATE)
TABLETS
50 mg
9 Tablets
R only
Each tablet contains sumatriptan succinate equivalent to 50 mg of sumatriptan.
Do not use if package is torn or broken or if you receive fewer tablets than your doctor prescribed.
See prescribing information for dosage information.
Store between 36 and 86F (2 and 30C).
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Canada
©2006, GlaxoSmithKline
10000000035878 Rev. 11/06
Imitrex (Sumatriptan) Prinicpal Display Panel
NDC 0173-0737-01
Imitrex (Sumatriptan)
(SUMATRIPTAN SUCCINATE)
TABLETS
100 mg
9 Tablets
R only
Each tablet contains sumatriptan succinate equivalent to 100 mg of sumatriptan.
Do not use if package is torn or broken or if you receive fewer tablets than your doctor prescribed.
See prescribing information for dosage information.
Store between 36 and 86F (2 and 30C).
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Canada
©2006, GlaxoSmithKline
10000000035877 Rev. 12/06
