Norflex

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.

Before taking orphenadrine, tell your doctor if you are taking any of the following medicines:

• atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
• bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);
• glycopyrrolate (Robinul);
• mepenzolate (Cantil);
• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with orphenadrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Do not take this medication if you are allergic to orphenadrine, or if you have problems with urination, an enlarged prostate, glaucoma, a blockage in your stomach or intestines, trouble swallowing, or myasthenia gravis.

Do not crush, chew, or break the extended-release tablet. Swallow the pill whole. Breaking or crushing the pill may cause too much of the drug to be released at one time.

Orphenadrine may be habit-forming and should be used only by the person it was prescribed for. Orphenadrine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

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.

Do not take this medication if you are allergic to orphenadrine, or if you have:

• problems with urination;
• enlarged prostate;
• glaucoma;
• a blockage in your stomach or intestines;
• trouble swallowing; or
• myasthenia gravis.

Before taking orphenadrine, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease;
• a heart rhythm disorder; or
• coronary artery disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take orphenadrine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether orphenadrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Orphenadrine may be habit-forming. Never share orphenadrine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Orphenadrine is usually taken 2 times per day, once in the morning and once in the evening. Follow your doctor's dosing instructions.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Orphenadrine is only part of a complete program of treatment that may also include rest, physical therapy, or other pain relief measures.

Store orphenadrine at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Keep track of the amount of medicine used from each new bottle. Orphenadrine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Taking orphenadrine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with orphenadrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Skeletal muscle relaxant; tertiary amine antimuscarinic.a b c k

• Potential to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.a b k

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.a b k

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b k

• Importance of informing patients of other important precautionary information.a b k (See Cautions.)

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2-methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.

Norflex Injection contains 60 mg of orphenadrine citrate in aqueous solution in each ampul. Norflex Injection also contains: sodium bisulfite NF, 2.0 mg; sodium chloride USP, 5.8 mg; sodium hydroxide, to adjust pH; and water for injection USP, q.s. to 2 mL.

Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

Adverse reactions of orphenadrine are mainly due to the mild anti-cholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of mental confusion. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported. No causal relationship has been established.

Rare instances of anaphylactic reaction have been reported associated with the intramuscular injection of Norflex Injection.

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

Orphenadrine is toxic when overdosed and typically induces anticholinergic effects. In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2-3 grams for adults; however, the range of toxicity is variable and unpredictable. Treatment for orphenadrine overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring, and appropriate supportive treatment of any emergent anticholinergic effects.