Orphenadrine-injection

INJECTION: Boxes of 6 (NDC 0089-0540-06 ) 2 mL ampuls, each ampul containing 60 mg of orphenadrine citrate in aqueous solution.

Store at controlled room temperature 15°-30°C (59°-86°F).

September 2007. Manufactured for Graceway Pharmaceuticals, LLC Bristol, TN 37620. By Hospira, Inc. Lake Forest, IL 60045. Effective Date: 10/01/2007. FDA Rev date: 2/11/2008

Orphenadrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol, which can increase some of the side effects of orphenadrine.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, and medicine for seizures, depression or anxiety can add to sleepiness caused by orphenadrine. Tell your doctor if you regularly use any of these medicines, or any other muscle relaxer.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how orphenadrine injection affects you.
• Have your blood work checked if you are on this medicine for a long time. Talk with your doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• This medicine is used with rest, PT (physical therapy), pain drugs, and other therapies.
• If you are 65 or older, use orphenadrine injection with care. You could have more side effects.
• This medicine is not approved for use in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense muscles in man. Orphenadrine citrate also possesses anti-cholinergic actions.

Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (megaesophagus) and myasthenia gravis.

Contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.

INJECTION: Boxes of 10 (NDC 17478-538-02) 2 mL vials, each vial containing 60 mg of orphenadrine citrate in aqueous solution.

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Single dose vial. Discard unused portion.

AKORN

Manufactured by: Akorn, Inc.

Lake Forest, IL 60045

RF00N
Rev. 03/12

Principal Display Panel Text for Container Label:

NDC 17478-538-02

Orphenadrine

Citrate

Injection, USP

60 mg (30 mg/mL)

Rx only 2 mL Sterile

For I.M. or I.V. Use.

Single dose vial.

Principal Display Panel Text for Carton Label:

NDC 17478-538-02

Orphenadrine Citrate Injection, USP

60 mg (30 mg/mL)

For Intravenous or Intramuscular Use

Single-dose Vial

10 Sterile Vials (2 ml each)

Rx only Akorn Logo