Ranexa

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Ranexa Recall

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Side Effects & Adverse Reactions

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Legal Issues

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Ranexa is indicated for the treatment of chronic angina.

Ranexa may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.

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History

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Other Information

Ranexa (ranolazine) is available as a film-coated, non-scored, extended-release tablet for oral administration.

Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula:

Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water.

Ranexa tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, methacrylic acid copolymer (Type C), microcrystalline cellulose, polyethylene glycol, sodium hydroxide, and titanium dioxide. Additional inactive ingredients for the 500 mg tablet include polysorbate 80 and FD&C Yellow No. 6 Lake; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, and Iron Oxide Yellow.

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Ranexa Manufacturers

Gilead Sciences, Inc.

Ranexa | Gilead Sciences, Inc.

2.1 Dosing Information
Initiate Ranexa dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take Ranexa with or without meals. Swallow Ranexa tablets whole; do not crush, break, or chew.

The maximum recommended daily dose of Ranexa is 1000 mg twice daily.

If a dose of Ranexa is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
2.2 Dose Modification
Dose adjustments may be needed when Ranexa is taken in combination with certain other drugs [see Drug Interactions (7.1)]. Limit the maximum dose of Ranexa to 500 mg twice daily in patients on diltiazem, verapamil, and other moderate CYP3A inhibitors. Down-titrate Ranexa based on clinical response in patients concomitantly treated with P-gp inhibitors, such as cyclosporine.

No Recall
Cardinal Health

Ranexa | Cardinal Health

2.1 Dosing Information
Initiate Ranexa dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take Ranexa with or without meals. Swallow Ranexa tablets whole; do not crush, break, or chew.

The maximum recommended daily dose of Ranexa is 1000 mg twice daily.

If a dose of Ranexa is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
2.2 Dose Modification
Dose adjustments may be needed when Ranexa is taken in combination with certain other drugs [see Drug Interactions (7.1)]. Limit the maximum dose of Ranexa to 500 mg twice daily in patients on diltiazem, verapamil, and other moderate CYP3A inhibitors. Down-titrate Ranexa based on clinical response in patients concomitantly treated with P-gp inhibitors, such as cyclosporine.

No Recall
Gilead Sciences, Inc.

Ranexa | Gilead Sciences, Inc.

2.1 Dosing Information
Initiate RANEXA dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take RANEXA with or without meals. Swallow RANEXA tablets whole; do not crush, break, or chew.

The maximum recommended daily dose of RANEXA is 1000 mg twice daily.

If a dose of RANEXA is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
2.2 Dose Modification
Dose adjustments may be needed when RANEXA is taken in combination with certain other drugs [see Drug Interactions (7.1)] . Limit the maximum dose of RANEXA to 500 mg twice daily in patients on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin. Use of RANEXA with strong CYP3A inhibitors is contraindicated [see Contraindications (4), Drug Interactions (7.1)]. Use of P-gp inhibitors, such as cyclosporine, may increase exposure to RANEXA. Titrate RANEXA based on clinical response [see Drug Interactions (7.1)].

No Recall
Carilion Materials Management

Ranexa | Carilion Materials Management

2.1 Dosing Information
Initiate RANEXA dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take RANEXA with or without meals. Swallow RANEXA tablets whole; do not crush, break, or chew.

The maximum recommended daily dose of RANEXA is 1000 mg twice daily.

If a dose of RANEXA is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
2.2 Dose Modification
Dose adjustments may be needed when RANEXA is taken in combination with certain other drugs . Limit the maximum dose of RANEXA to 500 mg twice daily in patients on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin. Use of RANEXA with strong CYP3A inhibitors is contraindicated Use of P-gp inhibitors, such as cyclosporine, may increase exposure to RANEXA. Titrate RANEXA based on clinical response [see ] Drug Interactions (7.1)[see , ]. Contraindications (4)Drug Interactions (7.1)[see ]. Drug Interactions (7.1)

No Recall
Cardinal Health

Ranexa | Cardinal Health

2.1 Dosing Information
Initiate Ranexa dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take Ranexa with or without meals. Swallow Ranexa tablets whole; do not crush, break, or chew.

The maximum recommended daily dose of Ranexa is 1000 mg twice daily.

If a dose of Ranexa is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
2.2 Dose Modification
Dose adjustments may be needed when Ranexa is taken in combination with certain other drugs [see Drug Interactions (7.1)]. Limit the maximum dose of Ranexa to 500 mg twice daily in patients on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin. Use of Ranexa with strong CYP3A inhibitors is contraindicated [see Contraindications (4), Drug Interactions (7.1)].

Use of P-gp inhibitors, such as cyclosporine, may increase exposure to Ranexa. Titrate Ranexa based on clinical response [see Drug Interactions (7.1)].

No Recall