IMITREX Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

GlaxoSmithKline LLC

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1. Indications and Usage

IMITREX injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: Use only if a clear diagnosis ...

2. Dosage and Administration

2.1 Dosing Information The maximum single recommended adult dose of IMITREX injection for the acute treatment of migraine or cluster headache is 6 mg injected subcutaneously. For the treatment of migraine, ...

3. Dosage Forms and Strengths

Injection: 4-mg and 6-mg single-dose prefilled syringe cartridges for use with the IMITREX STATdose Pen. Each 0.5 mL injection contains 5.6 mg or 8.4 mg of sumatriptan succinate equivalent to 4 or 6 mg ...

4. Contraindications

IMITREX injection is contraindicated in patients with: Ischemic coronary artery disease (CAD) (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 The use of IMITREX injection is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious ...

6. Adverse Reactions

The following serious adverse reactions are described below and elsewhere in the labeling: Myocardial ischemia, myocardial infarction, and Prinzmetals angina [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 with rates in the clinical trials of ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of IMITREX tablets, IMITREX nasal spray, and IMITREX injection. Because these reactions are reported voluntarily from a population ...

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 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 ...

8.2. Lactation

Risk Summary Sumatriptan is excreted in human milk following subcutaneous administration (see Data). There are no data on the effects of sumatriptan on the breastfed infant or the effects of sumatriptan ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established. IMITREX injection is not recommended for use in patients younger than 18 years of age. Two controlled clinical trials evaluated ...

8.5. Geriatric Use

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

10. Overdosage

Coronary vasospasm was observed after intravenous administration of IMITREX injection [see Contraindications (4)]. Overdoses would be expected from animal data (dogs at 0.1 g/kg, rats at 2 g/kg) ...

11. Description

IMITREX injection contains sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide ...

12.1. Mechanism of Action

Sumatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine and cluster headaches ...

12.2. Pharmacodynamics

Blood Pressure Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see Warnings and Precautions (5.8)] ...

12.3. Pharmacokinetics

Absorption The bioavailability of sumatriptan via subcutaneous site injection to 18 healthy male subjects was 97% ± 16% of that obtained following intravenous injection. After a single 6-mg subcutaneous ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In carcinogenicity studies in mouse and rat, sumatriptan was administered orally for 78 weeks and 104 weeks, respectively, at doses up to 160 mg/kg/day (the high dose in rat was reduced ...

13.2. Animal Toxicology and/or Pharmacology

Corneal Opacities Dogs receiving oral sumatriptan developed corneal opacities and defects in the corneal epithelium. Corneal opacities were seen at the lowest dose tested, 2 mg/kg/day, and were present ...

14. Clinical Studies

14.1 Migraine In controlled clinical trials enrolling more than 1,000 patients during migraine attacks who were experiencing moderate or severe pain and 1 or more of the symptoms enumerated in Table 3, ...

16.1. How Supplied

IMITREX injection contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: Prefilled Syringe and/or Autoinjector ...

16.2. Storage and Handling

Store between 2° and 30°C (36° and 86°F). Protect from light.

17. Patient Counseling Information

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