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|N3 Gesic Forte

ORPHENADRINE AND 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

‡ In Canada, Aspirin is a brand name. Acetylsalicylic acid is the generic name in Canada. ASA, a synonym for acetylsalicylic acid, is the term that commonly appears on Canadian product labels.

Category

• Analgesic-skeletal muscle relaxant

Description

Orphenadrine and aspirin (or-FEN-a-dreen and AS-pir-in) combination is used to help relax certain muscles in your body and relieve the pain and discomfort caused by strains, sprains, or other injury to your muscles. However, this medicine does not take the place of rest, exercise, or other treatment that your doctor may recommend for your medical problem.

Orphenadrine acts in the central nervous system (CNS) to produce its muscle relaxant effects. Actions in the CNS may also be responsible for some of its side effects. Orphenadrine also has other actions (antimuscarinic) that may be 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"s prescription. 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 will do. This is a decision you and your doctor will make. For orphenadrine and aspirin combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to orphenadrine, caffeine, aspirin or other salicylates including methyl salicylate (oil of wintergreen), or to any of the following medicines:

• 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 other substances, such as foods, preservatives, or dyes.

Pregnancy—

• For aspirin : Studies in humans have not shown that aspirin causes birth defects. However, aspirin has caused birth defects in animal studies.
  Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn"s weight and possible death of the fetus or newborn baby. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects.
  Regular use of aspirin late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn baby. Also, use of aspirin during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn baby. In addition, too much use of aspirin during the last 3 months of pregnancy may increase the length 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 pregnancy unless it has been ordered by your doctor .
• For orphenadrine : Orphenadrine has not been reported to cause birth defects or other problems in humans.

Breast-feeding—This medicine has not been shown to cause problems in nursing babies. However, aspirin passes into the breast milk. Also, caffeine passes into the breast milk in small amounts. It is not known whether orphenadrine passes into the breast milk.

Children—Do not give a medicine containing aspirin to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child"s doctor . This is very important because aspirin may cause a serious illness called Reye"s syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if 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 during treatment.

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

Older adults—Elderly people are especially sensitive to the effects of 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 used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking orphenadrine and aspirin combination, it is especially important that your health 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 together with 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 may be increased

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

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

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

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

Other medical problems—The presence of other medical problems may affect the use of orphenadrine and aspirin combination. Make sure 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 your condition 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 intestinal blockage, or
• Enlarged prostate or
• Fast or irregular heartbeat or
• Glaucoma or
• Myasthenia gravis or
• Urinary tract blockage—Orphenadrine has side effects that may be harmful to people with these conditions

• Gout—Aspirin can make this condition worse and can also lessen the 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 condition worse

• 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 to lessen stomach irritation.

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

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

Dosing—The dose of orphenadrine and aspirin combination medicine will be different for different people. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of the combination medicine. If your dose is different, do not change it unless your doctor 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 containing 50 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 remember within an hour or so of the missed dose, take it right away. But if you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children. Overdose of aspirin is especially dangerous 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 break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If you will be taking this medicine for a long time (for example, more than a few weeks), 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 orphenadrine or aspirin or other salicylates be especially careful, since taking them while taking this medicine may lead to overdose. If you have any questions about this, check with your health care professional.

Too much use of acetaminophen or certain other medicines together with the aspirin in this combination medicine may increase the chance of unwanted effects. 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 you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or any of the following medicines together with this combination medicine for more than a few days, unless your doctor 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 sugar test results if you are regularly taking 6 or more of the regular-strength tablets 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 sugar tests. If you have any questions about this, check with your health care professional especially if your diabetes is not well controlled.

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

The orphenadrine in this combination medicine may add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or 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 some dental anesthetics. Also, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin. Do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine .

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

Dryness of the mouth may occur while you are taking this medicine. For temporary 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 than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you think that you or someone else may have taken an overdose of this medicine, get emergency help at once . Taking an overdose of this medicine may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in 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 medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

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

Revised: 08/11/1994

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