Verapamil (Verapamil Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Verapamil hydrochloride extended-release capsules are indicated for the management of essential hypertension.

DOSAGE AND ADMINISTRATION

Essential Hypertension

The dose of verapamil hydrochloride extended-release should be individualized by titration. The usual daily dose of extended-release verapamil hydrochloride in clinical trials has been 240 mg given by mouth once daily in the morning. However, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., elderly, small people, etc.). Upward titration should be based on therapeutic efficacy and safety evaluated approximately 24 hours after dosing. The antihypertensive effects of verapamil hydrochloride extended-release are evident within the first week of therapy.

If adequate response is not obtained with 120 mg of verapamil hydrochloride extended-release, the dose may be titrated upward in the following manner:

1. 180 mg in the morning,
2. 240 mg in the morning,
3. 360 mg in the morning,
4. 480 mg in the morning.

Verapamil extended-release capsules are for once a day administration. When switching from immediate-release verapamil to verapamil hydrochloride extended-release capsules, the same total daily dose of verapamil hydrochloride extended-release capsules can be used.

As with immediate-release verapamil, dosages of verapamil hydrochloride extended-release capsules should be individualized and titration may be needed in some patients.

Sprinkling the Capsule Contents on Food

Verapamil Hydrochloride Extended-release Bead Filled Capsules may also be administered by carefully opening the capsule and sprinkling the beads on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the beads. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any bead/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a verapamil hydrochloride extended-release capsule is not recommended.

HOW SUPPLIED

Verapamil Hydrochloride Extended-release Capsules, are available in 120 mg, 180 mg and 240 mg capsules.

The 120 mg capsule is a bluish green opaque cap/white opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is radially printed with MYLAN over 6320 in black ink on both the cap and the body. They are available as follows:

NDC 0378-6320-93
bottles of 30 capsules

NDC 0378-6320-01
bottles of 100 capsules

NDC 0378-6320-05
bottles of 500 capsules

The 180 mg capsule is a bluish green opaque cap/light green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is radially printed with MYLAN over 6380 in black ink on both the cap and the body. They are available as follows:

NDC 0378-6380-93
bottles of 30 capsules

NDC 0378-6380-01
bottles of 100 capsules

NDC 0378-6380-05
bottles of 500 capsules

The 240 mg capsule is a bluish green opaque cap/bluish green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is radially printed with MYLAN over 6440 in black ink on both the cap and the body. They are available as follows:

NDC 0378-6440-93
bottles of 30 capsules

NDC 0378-6440-01
bottles of 100 capsules

NDC 0378-6440-05
bottles of 500 capsules

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Brief digressions above 25°C while not detrimental, should be avoided.

Avoid excessive heat.

Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REVISED FEBRUARY 2009
CVERER:R8