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AMERGE
Overview
What is AMERGE?
AMERGE contains naratriptan hydrochloride, a selective 5-HT receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:
The empirical formula is CHNOS•HCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water.
Each AMERGE tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium; hypromellose; lactose; magnesium stearate; microcrystalline cellulose; triacetin; and titanium dioxide, iron oxide yellow (2.5-mg tablet only), and indigo carmine aluminum lake (FD&C Blue No. 2) (2.5-mg tablet only) for coloring.
What does AMERGE look like?
What are the available doses of AMERGE?
Tablets: 1 mg and 2.5 mg (, )
What should I talk to my health care provider before I take AMERGE?
Pregnancy: Based on animal data, may cause fetal harm. ()
How should I use AMERGE?
AMERGE is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
The recommended dose of AMERGE is 1 mg or 2.5 mg.
If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period.
The safety of treating an average of more than 4 migraine attacks in a 30‑day period has not been established.
What interacts with AMERGE?
Sorry No Records found
What are the warnings of AMERGE?
Sorry No Records found
What are the precautions of AMERGE?
Sorry No Records found
What are the side effects of AMERGE?
Sorry No records found
What should I look out for while using AMERGE?
AMERGE is contraindicated in patients with:
What might happen if I take too much AMERGE?
Adverse reactions observed after overdoses of up to 25 mg included increases in blood pressure resulting in lightheadedness, neck tension, tiredness, and loss of coordination. Also, ischemic ECG changes likely due to coronary artery vasospasm have been reported.
The elimination half-life of naratriptan is about 6 hours ; therefore monitoring of patients after overdose with AMERGE should continue for at least 24 hours or while symptoms or signs persist. There is no specific antidote to naratriptan. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of naratriptan.
How should I store and handle AMERGE?
Store in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or expose to temperatures above 30°C (86°F). Discard if frozen. If refrigeration is unavailable, ZINBRYTA may be stored protected from light up to 30°C (86°F) for a period up to 30 days. Do not place ZINBRYTA back into the refrigerator after allowing it to warm to room temperature. Discard after 30 days without refrigeration. Store in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or expose to temperatures above 30°C (86°F). Discard if frozen. If refrigeration is unavailable, ZINBRYTA may be stored protected from light up to 30°C (86°F) for a period up to 30 days. Do not place ZINBRYTA back into the refrigerator after allowing it to warm to room temperature. Discard after 30 days without refrigeration. AMERGE tablets containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt. AMERGE tablets, 1 mg, are white, D-shaped, film-coated tablets debossed with “GX CE3” on one side in blister packs of 9 tablets (NDC 0173-0561-00).AMERGE tablets, 2.5 mg, are green, D-shaped, film-coated tablets debossed with “GX CE5” on one side in blister packs of 9 tablets (NDC 0173-0562-00).Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].AMERGE tablets containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt. AMERGE tablets, 1 mg, are white, D-shaped, film-coated tablets debossed with “GX CE3” on one side in blister packs of 9 tablets (NDC 0173-0561-00).AMERGE tablets, 2.5 mg, are green, D-shaped, film-coated tablets debossed with “GX CE5” on one side in blister packs of 9 tablets (NDC 0173-0562-00).Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].AMERGE tablets containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt. AMERGE tablets, 1 mg, are white, D-shaped, film-coated tablets debossed with “GX CE3” on one side in blister packs of 9 tablets (NDC 0173-0561-00).AMERGE tablets, 2.5 mg, are green, D-shaped, film-coated tablets debossed with “GX CE5” on one side in blister packs of 9 tablets (NDC 0173-0562-00).Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].AMERGE tablets containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt. AMERGE tablets, 1 mg, are white, D-shaped, film-coated tablets debossed with “GX CE3” on one side in blister packs of 9 tablets (NDC 0173-0561-00).AMERGE tablets, 2.5 mg, are green, D-shaped, film-coated tablets debossed with “GX CE5” on one side in blister packs of 9 tablets (NDC 0173-0562-00).Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Naratriptan binds with high affinity to human cloned 5-HT receptors. Migraines are likely due to local cranial vasodilatation and/or to the release of sensory neuropeptides (including substance P and calcitonin gene-related peptide) through nerve endings in the trigeminal system. The therapeutic activity of AMERGE for the treatment of migraine headache is thought to be due to the agonist effects at the 5-HT receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
Non-Clinical Toxicology
AMERGE is contraindicated in patients with:Specific drug interaction studies have not been conducted. Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; therefore, it may impair intestinal absorption of doxercalciferol. Magnesium-containing antacids and doxercalciferol should not be used concomitantly because such use may lead to the development of hypermagnesemia (see ). The use of mineral oil or other substances that may affect absorption of fat may influence the absorption and availability of doxercalciferol. Although not examined specifically, enzyme inducers (such as glutethimide and phenobarbital) may affect the 25-hydroxylation of doxercalciferol and may necessitate dosage adjustments. Cytochrome P450 inhibitors (such as ketoconazole and erythromycin) may inhibit the 25-hydroxylation of doxercalciferol. Hence, formation of the active doxercalciferol moiety may be hindered.
AMERGE is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of AMERGE. Some of these reactions occurred in patients without known CAD. AMERGE may cause coronary artery vasospasm (Prinzmetal’s angina) even in patients without a history of CAD.
Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving AMERGE. If there is evidence of CAD or coronary artery vasospasm, AMERGE is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of AMERGE in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of AMERGE. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of AMERGE.
The following adverse reactions are discussed in more detail in other sections of the prescribing information:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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