FROVA Tablet (2018)
Βιβλιογραφική αναφορά
Συγγραφείς
Endo Pharmaceuticals, Inc.
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1. Indications and Usage
FROVA is indicated for the acute treatment of migraine with or without aura in adults. <u>Limitations of Use:</u> Use only if a clear diagnosis of migraine has been established. If a patient has no response ...
2. Dosage and Administration
Dosing Information The recommended dose is a single tablet of FROVA (frovatriptan 2.5 mg) taken orally with fluids. If the migraine recurs after initial relief, a second tablet may be taken, providing ...
3. Dosage Forms and Strengths
<u>2.5 mg Tablets:</u> Round, white, film-coated tablets debossed with 2.5 on one side and E on the other side.
4. Contraindications
FROVA is contraindicated in patients with: Ischemic coronary artery disease (CAD) (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia), or coronary artery vasospasm, ...
5. Warnings and Precautions
5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetals Angina FROVA is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, ...
6. Adverse Reactions
The following serious adverse reactions are described elsewhere in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetals Angina <em>[see Warnings and Precautions (5.1)] ...
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 to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions were identified during post approval use of FROVA. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably ...
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 the use of FROVA in pregnant women. In animal studies, frovatriptan produced developmental toxicity (embryofetal lethality, ...
8.2. Lactation
Risk Summary There are no data on the presence of frovatriptan in human milk, the effects of frovatriptan on the breastfed infant, or the effects of frovatriptan on milk production. In rats, oral dosing ...
8.4. Pediatric Use
The safety and effectiveness in pediatric patients have not been established. Therefore, FROVA is not recommended for use in patients under 18 years of age. There are no additional adverse reactions identified ...
8.5. Geriatric Use
Mean blood concentrations of frovatriptan in elderly patients were 1.5 to 2 times higher than those seen in younger adults <em>[see Clinical Pharmacology (12.3)]</em>. No dosage adjustment is necessary. ...
8.6. Hepatic Impairment
No dosage adjustment is necessary when FROVA is given to patients with mild to moderate hepatic impairment. There is no clinical or pharmacokinetic experience with FROVA in patients with severe hepatic ...
10. Overdosage
The elimination half-life of frovatriptan is 26 hours <em>[see Clinical Pharmacology (12.3)]</em>. Therefore, monitoring of patients after overdose with frovatriptan should continue for at least 48 hours ...
11. Description
FROVA (frovatriptan succinate) tablets contain frovatriptan succinate, a selective 5-hydroxy-tryptamine<sub>1</sub> (5-HT<sub>1B/1D</sub>) receptor subtype agonist (triptan), as the active ingredient. ...
12.1. Mechanism of Action
Frovatriptan binds with high affinity to 5-HT<sub>1B/1D</sub> receptors. The therapeutic activity of FROVA is thought to be due to the agonist effects at the 5-HT<sub>1B/1D</sub> receptors on intracranial ...
12.3. Pharmacokinetics
The pharmacokinetics of frovatriptan are similar in migraine patients and healthy subjects. Absorption Mean maximum blood concentrations (C<sub>max</sub>) in patients are achieved approximately 2 to 4 ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis The carcinogenic potential of orally administered frovatriptan was evaluated in an 84-week study in mice (4, 13, and 40 mg/kg/day), a 104-week study in rats (8.5, 27, and 85 mg/kg/day), ...
14. Clinical Studies
The efficacy of FROVA in the acute treatment of migraine headaches was demonstrated in four randomized, double-blind, placebo-controlled, short-term outpatient trials. In these trials, patients received ...
16.1. How Supplied
FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate salt, are available as round, white, film-coated tablets debossed with 2.5 on one side and E on the other side. The tablets are ...
16.2. Storage and Handling
Store FROVA tablets at controlled room temperature, 25ºC (77ºF) excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture.
17. Patient Counseling Information
Advise the patient to read the FDA approved patient labeling (Patient Information). Myocardial Ischemia and/or Infarction, Prinzmetals Angina, Other Vasospastic Reactions, and Cerebrovascular Events Inform ...