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Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Naproxen and Sumatriptan Tablets 500 mg/85 mg, reconsider the diagnosis of migraine before Naproxen and Sumatriptan Tablets 500 mg/85 mg is administered to treat any subsequent attacks.
Naproxen and Sumatriptan Tablets 500 mg/85 mg is not indicated for the prevention of migraine attacks.
Safety and effectiveness of Naproxen and Sumatriptan Tablets 500 mg/85 mg have not been established for cluster headache.
Adults
The recommended dosage for adults is 1 tablet of Naproxen and Sumatriptan Tablets 500 mg/85 mg. Naproxen and Sumatriptan Tablets 500 mg/85 mg contains a dose of sumatriptan higher than the lowest effective dose.
The choice of the dose of sumatriptan, and of the use of a fixed combination such as in Naproxen and Sumatriptan Tablets 500 mg/85 mg 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, 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.
The following serious adverse reactions are described below:
Cardiovascular Thrombotic Events
GI Bleeding, Ulceration and Perforation
Arrhythmias
Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure
Cerebrovascular Events
Other Vasospasm Reactions
Hepatotoxicity
Hypertension
Heart Failure and Edema
Medication Overuse Headache
Serotonin Syndrome
Renal Toxicity and Hyperkalemia
Anaphylactic Reactions
Serious Skin Reactions
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Hematological Toxicity
Exacerbation Asthma Related to Aspirin Sensitivity
Cardiovascular Thrombotic Events
The use of Naproxen and Sumatriptan Tablets 500 mg/85 mg is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD) and in the setting of coronary artery bypass graft (CABG) surgery due to increased risk of serious cardiovascular events with sumatriptan and NSAIDS.
Cardiovascular Events with Sumatriptan: There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. Naproxen and Sumatriptan Tablets 500 mg/85 mg may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.
Cardiovascular Thrombotic Events with Nonsteroidal Anti-inflammatory Drugs: Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal.
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs, including naproxen, a component of Naproxen and Sumatriptan Tablets 500 mg/85 mg, cause serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal.
Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure
Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan and are usually non-cardiac in origin. The use of Naproxen and Sumatriptan Tablets 500 mg/85 mg is contraindicated in patients with CAD and those with Prinzmetal’s variant angina.
Hypertension
Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including sumatriptan, a component of Naproxen and Sumatriptan Tablets 500 mg/85 mg. NSAIDs, including naproxen, a component of Naproxen and Sumatriptan Tablets 500 mg/85 mg, can also lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events.
Store below 30°C. Protect from light and moisture.
Keep the medicine out of reach of children.
10 × 1 × 10 Alu/PVC Blister.
S-MEPROX tablets are available in an Alu/PVC blister of 10 tablets. Such 1 blister in a monocarton and Such 10 monocartons in a unit carton with pack insert.
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A pharma CMO is a special kind of an organization, offering contract manufacturing services to pharmaceutical companies for various kinds of drug formulations.
Reduce overall costs and time to market :
Contract manufacturers already have the needed infrastructure and technical staff, so working with a CMO or CDMO can decrease the cost of manufacturing your pharmaceutical products.
Scalability and flexible production capacity :
You can produce what you need when you need it without worrying about excess capacity. Additionally, CMOs understand the importance of quality and compliance, so you don't have to sacrifice safety for scalability.
Save on upgrading and maintaining equipment :
If you have your manufacturing facility, you’ll have to pay to upgrade your equipment as technology advances—which can get expensive. A CMO/CDMO’s only function is to make and distribute products, so part of their core business responsibility is to update their equipment whenever needed and perform maintenance.
Ease supply chain issues :
During the pandemic, there were several instances of supply chain issues, including medicine shortages. CMOs are generally better equipped than startups to handle a supply chain crisis.
Bandwidth to focus on core competencies
When your company resources aren’t directly allocated to manufacturing and distribution, you have more time to focus on other tasks, like marketing your new drug, researching, or working on drug discovery.
We have 7+ manufacturing sites with a minimum of WHO GMP certification and other country-specific approvals like NAFDAC approved, PPK Kenya Approved, TFDA Tanzania Approved, EU-GMP Approved.
We have below manufacturing capacity:
For Tablet, Capsule, and soft gel: up to 1 million units per shift
For Syrup: up to 0.05 Million per shift
For Ampoule and Vial: up to 0.1 million units per shift
For Ointment and Cream: up to 0.1 million units per shift
For Suppository: 0.1 Million units per shift
Contact us directly to receive full information on the product, the formulation, the science behind it, stability data, and more. Our Business Development Manager is a click away.
Conical Pharmaceuticals is a professionally managed and dynamic organization with decades of experience in the pharmaceutical field. With a desire of providing opportunities for a better life, we work very hard to bring quality drugs to our customers. We have instilled a level of trust and confidence amongst our clients by supplying the best quality products.
