Sumatriptan Succ-Naproxen Sod (sumatriptan succinate/naproxen sodium)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Administer orally, with or without food. Tablets should not be split, crushed, or chewed.

*Recommended dosage in pediatric patients 12 to 17 years of age: 1 tablet containing 10 mg sumatriptan and 60 mg naproxen sodium.

*The maximum recommended dosage in a 24-hour period is 1 tablet containing 85 of sumatriptan and 500 mg of naproxen sodium.

*The safety of treating an average of more than 2 migraine headaches in pediatric patients in a 30-day period has not been established. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

*See Full Prescribing Information for additional instructions on dosage and administration.

*Recommended dosage in adults: 1 tablet containing 85 mg of sumatriptan and 500 mg of naproxen sodium. The fixed-combination 85/500 mg tablet contains a dose of sumatriptan higher than the lowest effective dose. The choice of the dose of sumatriptan, and of the use of the fixed-combination preparation should be made on an individual basis, weighing the possible benefit of a higher dose of sumatriptan with the potential for a greater risk of adverse reactions.

*The maximum recommended dosage in a 24-hour period is 2 tablets containing 85 mg of sumatriptan and 500 mg of naproxen sodium, taken at least 2 hours apart.

*The safety of treating an average of more than 5 migraine headaches in adults in a 30-day period has not been established. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*History of coronary artery disease or coronary vasospasm.

*In the setting of CABG surgery.

*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-HT1 agonist (e.g., another triptan) or of ergotamine-containing medication.

*Concurrent or recent (past 2 weeks) use of monoamine oxidase (MAO)-A inhibitor.

*History of asthma, urticaria, other allergic type reactions, rhinitis, or nasal polyps syndrome after taking aspirin or other NSAIA/analgesic drugs.

*Known hypersensitivity to sumatriptan, naproxen, or any components of the fixed-combination preparation (angioedema and anaphylaxis seen).

*Severe hepatic impairment.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >=2%) in adults: Dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth.

The most common adverse reactions (incidence >=2%) in pediatric patients: Hot flush (i.e., hot flashes), muscle tightness.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and effectiveness of sumatriptan/naproxen sodium in pediatric patients under 12 years of age have not been established.

The safety and efficacy of sumatriptan/naproxen sodium for the acute treatment of migraine in pediatric patients 12 to 17 years of age was established in a double-blind, placebo-controlled trial.

Use of NSAIAs, including sumatriptan/naproxen sodium, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of sumatriptan/naproxen sodium use between about 20 and 30 weeks of gestation, and avoid sumatriptan/naproxen sodium use at about 30 weeks of gestation and later in pregnancy.

Use of NSAIAs, including sumatriptan/naproxen sodium, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Use of NSAIAs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.

Data from observational studies regarding other potential embryofetal risks of NSAIA use in women in the first or second trimesters of pregnancy are inconclusive.

Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population). In animal studies, administration of sumatriptan and naproxen, alone or in combination, during pregnancy resulted in developmental toxicity (increased incidences of fetal malformations, embryofetal and pup mortality, decreased embryofetal growth) at clinically relevant doses. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as naproxen sodium resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses.

All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine.

Several studies have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

Avoid use of NSAIAs in women at about 30 weeks gestation and later in pregnancy, because NSAIAs, including sumatriptan/naproxen sodium, can cause premature closure of the fetal ductus arteriosus.

If an NSAIA is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If sumatriptan/naproxen sodium treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue the fixed-combination therapy and follow up according to clinical practice.

There are no studies on the effects of naproxen tablets during labor or delivery. In animal studies, NSAIAs, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. Sumatriptan is excreted in human milk following subcutaneous administration. There is no information regarding sumatriptan concentrations in milk from lactating women following administration of sumatriptan tablets.

There are no data on the effects of naproxen or sumatriptan on the breastfed infant or the effects of naproxen or sumatriptan on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sumatriptan/naproxen sodium and any potential adverse effects on the breastfed infant from the drugs or from the underlying maternal condition.

Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with sumatriptan tablets.

Elderly patients, compared to younger patients, are at greater risk for NSAIA-associated serious cardiovascular, GI, and/or renal adverse reactions. Sumatriptan/naproxen sodium is not recommended for use in elderly patients who have decreased renal function, higher risk for unrecognized CAD, and increases in blood pressure that may be more pronounced in the elderly.

A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan/naproxen sodium.