AMERGE Film-coated tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

GlaxoSmithKline LLC

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

AMERGE is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response ...

2. Dosage and Administration

2.1 Dosing Information 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 ...

3. Dosage Forms and Strengths

1-mg white tablets, D-shaped, film-coated, and debossed with GX CE3. 2.5-mg green tablets, D-shaped, film-coated, and debossed with GX CE5.

4. Contraindications

AMERGE is contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including ...

5. Warnings and Precautions

5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetals Angina AMERGE is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, ...

6. Adverse Reactions

The following adverse reactions are discussed in more detail in other sections of the prescribing information: Myocardial ischemia, myocardial infarction, and Prinzmetals angina [see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

7. Drug Interactions

7.1 Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications ...

8.1. Pregnancy

Risk Summary There are no adequate data on the developmental risk associated with use of AMERGE in pregnant women. Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant ...

8.2. Lactation

Risk Summary There are no data on the presence of naratriptan in human milk, the effects of naratriptan on the breastfed infant, or the effects of naratriptan on milk production. Naratriptan is present ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Therefore, AMERGE is not recommended for use in patients younger than 18 years of age. One controlled clinical trial evaluated ...

8.5. Geriatric Use

Clinical trials of AMERGE did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. Other reported clinical experience has not ...

8.6. Renal Impairment

The use of AMERGE is contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug. In patients with mild to moderate renal impairment, ...

8.7. Hepatic Impairment

The use of AMERGE is contraindicated in patients with severe hepatic impairment (Child-Pugh Grade C) because of decreased clearance. In patients with mild or moderate hepatic impairment (Child-Pugh Grade ...

10. Overdosage

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 ...

11. Description

AMERGE contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide ...

12.1. Mechanism of Action

Naratriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Migraines are likely due to local cranial vasodilatation and/or to the release of sensory neuropeptides (including substance ...

12.2. Pharmacodynamics

In the anesthetized dog, naratriptan has been shown to reduce the carotid arterial blood flow with little or no effect on arterial blood pressure or total peripheral resistance. While the effect on blood ...

12.3. Pharmacokinetics

Absorption Naratriptan is well absorbed, with about 70% oral bioavailability. Following administration of a 2.5-mg tablet, the peak concentrations are obtained in 2 to 3 hours. After administration of ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In carcinogenicity studies, mice and rats were given naratriptan by oral gavage for 104 weeks. There was no evidence of an increase in tumors related to naratriptan administration in mice ...

14. Clinical Studies

The efficacy of AMERGE in the acute treatment of migraine headaches was evaluated in 3 randomized, double-blind, placebo-controlled trials in adult patients (Trials 1, 2, 3). These trials enrolled adult ...

16.1. How Supplied

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 ...

16.2. Storage and Handling

Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Myocardial Ischemia and/or Infarction, Prinzmetals Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular ...