ORPHENADRINEAND ASPIRIN (Systemic)

Some commonly used brand names are:

In the U.S.?

• Norgesic
• Norgesic Forte
• Norphadrine
• Norphadrine Forte
• N3 Gesic
• N3 Gesic Forte
• Orphenagesic
• Orphenagesic Forte

In Canada?

?
• Norgesic
• Norgesic Forte

Category

• Analgesic-skeletal muscle relaxant

Description

Orphenadrine and aspirin (or-FEN-a-dreen and AS-pir-in) combination is used to helprelax certain muscles in your body and relieve the pain and discomfort causedby strains, sprains, or other injury to your muscles. However, this medicinedoes not take the place of rest, exercise, or other treatment that your doctormay recommend for your medical problem.

Orphenadrine acts in the central nervous system (CNS) to produce its musclerelaxant effects. Actions in the CNS may also be responsible for some of itsside effects. Orphenadrine also has other actions (antimuscarinic) that maybe responsible for some of its side effects.

This combination medicine also contains caffeine (kaf-EEN).

In the U.S., this combination medicine is available only with your doctor'sprescription. In Canada, it is available without a prescription.

These medicines are available in the following dosage forms:

Oral
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For orphenadrine andaspirin combination, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to orphenadrine, caffeine, aspirin or other salicylatesincluding methyl salicylate (oil of wintergreen), or to any of the followingmedicines:

• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen, oral (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Nabumetone (e.g., Relafen)
• Naproxen (e.g., Naprosyn)
• Oxaprozin (e.g., Daypro)
• Oxyphenbutazone (e.g., Tandearil)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Suprofen (e.g., Suprol)
• Tenoxicam (e.g., Mobiflex)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)
• Zomepirac (e.g., Zomax)

Also tell your health care professional if you are allergic to any othersubstances, such as foods, preservatives, or dyes.

Pregnancy?

• For aspirin: Studies in humans have notshown that aspirin causes birth defects. However, aspirin has caused birthdefects in animal studies.
  Some reports have suggested that too much use of aspirin late in pregnancymay cause a decrease in the newborn's weight and possible death of the fetusor newborn baby. However, the mothers in these reports had been taking muchlarger amounts of aspirin than are usually recommended. Studies of motherstaking aspirin in the doses that are usually recommended did not show theseunwanted effects.
  Regular use of aspirin late in pregnancy may cause unwanted effects onthe heart or blood flow in the fetus or in the newborn baby. Also, use ofaspirin during the last 2 weeks of pregnancy may cause bleeding problems inthe fetus before or during delivery or in the newborn baby. In addition, toomuch use of aspirin during the last 3 months of pregnancy may increase thelength of pregnancy, prolong labor, cause other problems during delivery,or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancyunless it has been ordered by your doctor.
• For orphenadrine: Orphenadrine has notbeen reported to cause birth defects or other problems in humans.

Breast-feeding?This medicine has not been shown to cause problemsin nursing babies. However, aspirin passes into the breast milk. Also, caffeinepasses into the breast milk in small amounts. It is not known whether orphenadrinepasses into the breast milk.

Children?Do not give a medicine containingaspirin to a child or a teenager with a fever or other symptoms of a virusinfection, especially flu or chickenpox, without first discussing its usewith your child's doctor. This is very important because aspirin maycause a serious illness called Reye's syndrome in children with fever causedby a virus infection, especially flu or chickenpox. Children who do not havea virus infection may also be more sensitive to the effects of aspirin, especiallyif they have a fever or have lost large amounts of body fluid because of vomiting,diarrhea, or sweating. This may increase the chance of side effects duringtreatment.

There is no specific information about the use of orphenadrine in children.

Older adults?Elderly people are especially sensitive to the effectsof aspirin. This may increase the chance of side effects during treatment.

There is no specific information about the use of orphenadrine in the elderly.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingorphenadrine and aspirin combination, it is especially important that yourhealth care professional know if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Carbenicillin by injection (e.g., Geopen) or
• Cefamandole (e.g., Mandol) or
• Cefoperazone (e.g., Cefobid) or
• Cefotetan (e.g., Cefotan) or
• Dipyridamole (e.g., Persantine) or
• Divalproex (e.g., Depakote) or
• Heparin or
• Medicine for inflammation or pain, except narcotics, or
• Moxalactam (e.g., Moxam) or
• Pentoxifylline (e.g., Trental) or
• Plicamycin (e.g., Mithracin) or
• Ticarcillin (e.g., Ticar) or
• Valproic acid (e.g., Depakene)?Taking these medicines togetherwith aspirin may increase the chance of bleeding

• Anticholinergics (medicine for abdominal or stomach spasms or cramps)or
• Central nervous system (CNS) depressants or
• Methotrexate (e.g., Mexate) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine[e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane],doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g.,Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])or
• Vancomycin (e.g., Vancocin)?The chance of side effects maybe increased

• Antidiabetics, oral (diabetes medicine you take by mouth)?Aspirinmay increase the effects of the antidiabetic medicine; a change in dose maybe needed if aspirin is taken regularly

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)?Aspirin can keep these medicinesfrom working properly for treating gout; also, taking aspirin together withsulfinpyrazone may increase the chance of bleeding

• Urinary alkalizers (medicine that makes the urine less acid, suchas acetazolamide [e.g., Diamox], dichlorphenamide [e.g., Daranide], methazolamide[e.g., Neptazane], potassium or sodium citrate and/or citric acid)?Thesemedicines may make aspirin less effective by causing it to be removed fromthe body more quickly

• Zidovudine (e.g., AZT; Retrovir)?Aspirin may increase the bloodlevels of zidovudine, which increases the chance of serious side effects

Other medical problems?The presence of other medicalproblems may affect the use of orphenadrine and aspirin combination. Makesure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Overactive thyroid or
• Stomach ulcer or other stomach problems?Aspirin may make yourcondition worse

• Asthma, allergies, and nasal polyps, history of or
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Kidney disease or
• Liver disease?The chance of side effects may be increased

• Disease of the digestive tract, especially esophagus disease or intestinalblockage, or
• Enlarged prostate or
• Fast or irregular heartbeat or
• Glaucoma or
• Myasthenia gravis or
• Urinary tract blockage?Orphenadrine has side effects that maybe harmful to people with these conditions

• Gout?Aspirin can make this condition worse and can also lessenthe effects of some medicines used to treat gout

• Heart disease?The chance of some side effects may be increased.Also, the caffeine present in this combination medicine can make your conditionworse

• Hemophilia or other bleeding problems or
• Vitamin K deficiency?Aspirin may increase the chance of bleeding

Proper Use of This Medicine

Take this medicine with food or a full glass (8 ounces) of water tolessen stomach irritation.

Do not take this medicine if it has a strong vinegar-likeodor. This odor means the aspirin in it is breaking down. If you haveany questions about this, check with your health care professional.

Do not take more of this medicine than your doctorordered to lessen the chance of side effects or overdose.

Dosing?The dose of orphenadrine and aspirin combinationmedicine will be different for different people. Followyour doctor's orders or the directions on the label. The followinginformation includes only the average doses of the combination medicine. If your dose is different, do not change it unless yourdoctor tells you to do so.

• For oral dosage forms (tablets):
  • For muscle pain and stiffness:
    • Adults and teenagers?One or two tablets containing 25 milligrams(mg) of orphenadrine and 385 mg of aspirin, or one-half or one tablet containing50 mg of orphenadrine and 770 mg of aspirin, three or four times a day.
    • Children?Dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine and rememberwithin an hour or so of the missed dose, take it right away. But if you donot remember until later, skip the missed dose and go back to your regulardosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children. Overdose of aspirin is especiallydangerous in young children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink,or in other damp places. Heat or moisture may cause the medicine to breakdown.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If youwill be taking this medicine for a long time (for example, more than a fewweeks), your doctor should check your progress at regular visits.

Check the labels of all nonprescription (over-the-counter[OTC]) and prescription medicines you now take. If any contain orphenadrineor aspirin or other salicylates be especially careful, since taking them whiletaking this medicine may lead to overdose. If you have any questions aboutthis, check with your health care professional.

Too much use of acetaminophen or certain other medicines together withthe aspirin in this combination medicine may increase the chance of unwantedeffects. The risk depends on how much of each medicine you take every day,and on how long you take the medicines together. If your doctor directs youto take these medicines together on a regular basis, follow his or her directionscarefully. However, do not take acetaminophen or any of the following medicinestogether with this combination medicine for more than a few days, unless yourdoctor has directed you to do so and is following your progress:

• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen, oral (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Nabumetone (e.g., Relafen)
• Naproxen (e.g., Naprosyn)
• Oxaprozin (e.g., Daypro)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Tenoxicam (e.g., Mobiflex)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)

For diabetic patients:

• The aspirin in this combination medicine may cause false urine sugartest results if you are regularly taking 6 or more of the regular-strengthtablets or 3 or more of the double-strength tablets of this medicine a day.Smaller doses or occasional use of aspirin usually will not affect urine sugartests. If you have any questions about this, check with your health care professionalespecially if your diabetes is not well controlled.

Do not take this medicine for 5 days before any surgery, including dentalsurgery, unless otherwise directed by your medical doctor or dentist. Takingaspirin during this time may cause bleeding problems.

The orphenadrine in this combination medicine may add to the effects ofalcohol and other CNS depressants (medicines that slow down the nervous system,possibly causing drowsiness). Some examples of CNS depressants are antihistaminesor medicine for hay fever, other allergies, or colds; sedatives, tranquilizers,or sleeping medicine; prescription pain medicine or narcotics; barbiturates;medicine for seizures; other muscle relaxants; or anesthetics, including somedental anesthetics. Also, stomach problems may be more likely to occur ifyou drink alcoholic beverages while you are taking aspirin. Do not drink alcoholic beverages, and check with your doctor before takingany of the medicines listed above, while you are using this medicine.

This medicine may cause some people to have blurred vision or to becomedrowsy, dizzy, lightheaded, faint, or less alert than they are normally. Make sure you know how you react to this medicine before youdrive, use machines, or do anything else that could be dangerous if you aredizzy or are not alert.

Dryness of the mouth may occur while you are taking this medicine. Fortemporary relief, use sugarless candy or gum, melt bits of ice in your mouth,or use a saliva substitute. However, if dry mouth continues for more than2 weeks, check with your dentist. Continuing dryness of the mouth may increasethe chance of dental disease, including tooth decay, gum disease, and fungusinfections.

If you think that you or someone else may have takenan overdose of this medicine, get emergency help at once. Taking anoverdose of this medicine may cause unconsciousness or death. Signs of overdoseinclude convulsions (seizures), hearing loss, confusion, ringing or buzzingin the ears, severe drowsiness or tiredness, severe excitement or nervousness,and fast or deep breathing.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Get emergency help immediatelyif any of the following symptoms of overdose occur:

Any loss of hearing; bloody urine; confusion; convulsions (seizures); diarrhea; dizziness or lightheadedness(severe); drowsiness (severe); excitement or nervousness (severe); fast or deepbreathing; hallucinations (seeing, hearing, or feelingthings that are not there); headache (severe or continuing); increased sweating; nauseaor vomiting (severe or continuing); ringing or buzzingin the ears (continuing); uncontrollable flappingmovements of the hands, especially in elderly patients; unexplained fever; unusual thirst; vision problems

Symptoms of overdose in children

Changes in behavior; drowsiness or tiredness(severe); fast or deep breathing

Also, check with your doctoras soon as possible if any of the following side effects occur:

Less common or rare

Abdominal or stomach pain, cramping, or burning (severe); bloody or black, tarry stools; decreasedurination; eye pain; fainting; fast or pounding heartbeat; shortness of breath, troubled breathing, tightness in chest, or wheezing; skin rash, hives, itching, or redness; sores, ulcers, or white spots on lips or in mouth; swollen and/or painful glands; unusual bleeding orbruising; unusual tiredness or weakness; vomiting of blood or material that looks like coffee grounds

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

More common

Abdominal or stomach cramps, pain, or discomfort (mild to moderate); dryness of mouth; heartburnor indigestion; nausea or vomiting (mild)

Less common

Blurred or double vision or other vision problems; confusion; constipation; difficult urination; dizziness or lightheadedness; drowsiness; excitement,nervousness, or restlessness; headache; muscle weakness; trembling; unusually large pupils of eyes

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.