Equagesic

• Caraco Pharm. Labs., Ltd.

• Mikart, Inc.

• Quality Care Pharmaceuticals

• Women First Healthcare, Inc.

In the U.S.

• Equagesic
• Micrainin

Available Dosage Forms:

• Tablet

Therapeutic Class: Salicylate, Aspirin Combination

Pharmacologic Class: NSAID

Chemical Class: Carbamate

If you will be taking this medicine regularly for a long time:

• Your doctor should check your progress at regular visits.
• Check with your doctor at least every 4 months to make sure you need to continue taking this medicine.

If you will be taking this medicine in large doses or for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain aspirin or other salicylates (including bismuth subsalicylate [e.g., Pepto-Bismol]), be especially careful. Taking or using any of these medicines while taking this combination medicine containing aspirin may lead to overdose. If you have any questions about this, check with your health care professional.

This medicine will 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; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine, especially if you are taking the medicine in high doses or for a long time. Check with your doctor if you have any questions about this.

Too much use of this medicine together with certain other medicines may increase the chance of stomach problems. Therefore, do not regularly take this medicine together with any of the following medicines, unless directed to do so by your medical doctor or dentist:

• Acetaminophen (e.g., Tylenol)
• 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)
• Naproxen (e.g., Naprosyn)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)

If you are taking a laxative containing cellulose, do not take it within 2 hours of taking this medicine. Taking these medicines close together may make this medicine less effective by preventing the aspirin (contained in this combination medicine) from being absorbed by your body.

For diabetic patients:

• False urine sugar test results may occur if you take 8 or more 325-mg (5-grain) doses of aspirin (contained in this combination medicine) every day for several days in a row. Smaller doses or occasional use of aspirin usually will not affect urine sugar tests. If you have any questions about this, check with your doctor, especially if your diabetes is not well controlled.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests, such as the metyrapone test and the phentolamine test, may be affected by this medicine.

If you plan to have surgery, including dental surgery, do not take aspirin (contained in this combination medicine) for 5 days before the surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or other CNS depressants with it may lead to unconsciousness and possibly death. Some signs of an overdose are continuing ringing or buzzing in ears; any hearing loss; severe confusion, drowsiness, or weakness; shortness of breath or slow or troubled breathing; staggering; and slow heartbeat.

This medicine may cause some people to become dizzy, lightheaded, drowsy, 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.

Meprobamate (contained in this combination medicine) may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

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.

Check with your doctor immediately if any of the following side effects occur:

• Wheezing, shortness of breath, troubled breathing, or tightness in chest

• Any loss of hearing
• bloody urine
• confusion (severe)
• convulsions (seizures)
• diarrhea (severe or continuing)
• dizziness or lightheadedness (continuing)
• drowsiness (severe)
• fast or deep breathing
• hallucinations (seeing, hearing, or feeling things that are not there)
• headache (severe or continuing)
• increased sweating
• nausea or vomiting (continuing)
• nervousness or excitement (severe)
• ringing or buzzing in ears (continuing)
• slow heartbeat
• slurred speech
• staggering
• stomach pain (severe or continuing)
• unexplained fever
• unusual or uncontrolled flapping movements of the hands, especially in elderly patients
• unusual thirst
• vision problems
• weakness (severe)

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

Check with your doctor as soon as possible if any of the following side effects occur:

• Bloody or black, tarry stools
• confusion
• skin rash, hives, or itching
• sore throat and fever
• unusual bleeding or bruising
• unusual excitement
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Drowsiness
• heartburn or indigestion
• nausea with or without vomiting
• stomach pain (mild)

• Blurred vision or change in near or distant vision
• dizziness or lightheadedness
• headache

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Clumsiness or unsteadiness
• confusion
• convulsions (seizures)
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased dreaming
• muscle twitching
• nausea or vomiting
• nervousness or restlessness
• nightmares
• trembling
• trouble in sleeping

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to ease pain.
• It is used to treat anxiety.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017

Each tablet of Equagesic, for oral administration, contains 200 mg meprobamate and 325 mg aspirin. Chemically, meprobamate is 2-methyl-2-propyl-1,3- propanediol dicarbamate. Its molecular formula is C9H18N2O4 with a molecular weight of 218.25.

Chemically, aspirin is benzoic acid 2-(acetyloxy)-. Its molecular formula is C9H8O4 with a molecular weight of 180.16. It occurs as an odorless white, needle like crystalline or powdery substance. When exposed to moisture, aspirin hydrolyzes into salicylic and acetic acids, and gives off a vinegary odor. It is highly lipid soluble and slightly soluble in water. The structural formulas of meprobamate and aspirin are:

MEPROBAMATE

ASPIRIN

The inactive ingredients present are D&C Yellow 10, FD&C Red 3, FD&C Yellow 6, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and starch.

Usage in Pregnancy and Lactation

An increased risk of congenital malformations associated with the use of minor tranquilizers (meprobamate, chlordiazepoxide, and diazepam) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided.

Because of the known effect of non-steroidal anti-inflammatory drugs (NSAIDs) on the fetal cardiovascular system (closure of the ductus arteriosus), use during the third trimester of pregnancy should be avoided. Salicylate products have also been associated with alterations in maternal and neonatal hemostasis mechanisms, decreased birth weight, and perinatal mortality. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. Meprobamate passes the placental barrier. It is present both in umbilical-cord blood at or near maternal plasma levels and in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. When use of meprobamate is contemplated in breast-feeding patients, the drug’s higher concentrations in breast milk as compared to maternal plasma levels should be considered.

Equagesic is contraindicated in patients with acute intermittent porphyria and in patients with allergic or idiosyncratic reactions to aspirin, meprobamate, or related compounds, such as carbromal, carisoprodol, mebutamate, nonsteroidal anti-inflammatory drug products, salicylates, or tybamate. Equagesic is also contraindicated in patients with the syndrome of asthma, rhinitis, and nasal polyps. The aspirin component of Equagesic may cause severe angioedema, bronchospasm (asthma), or urticaria. Reye’s syndrome: Aspirin should not be used in children or teenagers for viral infections, with or without fever, because of the risk of Reye’s syndrome with concomitant use of aspirin in certain viral illnesses.

Body as a Whole

Fever, hypothermia, thirst.

Allergic or Idiosyncratic

Severe hypersensitivity reactions, including anaphylaxis, angioneurotic edema, anuria, asthma, bronchospasm, bullous dermatitis, chills, erythema multiforme, exfoliative erythroderma, laryngeal edema, oliguria, proctitis, purpura, Stevens-Johnson syndrome, stomatitis, and urticaria. Milder reactions are characterized by an itchy, erythematous maculopapular, or urticarial rash which may be generalized or confined to the groin. Other reactions have included acute nonthrombocytopenic purpura, adenopathy, cross-sensitivity between meprobamate/ mebutamate and meprobamate/carbromal, ecchymoses, eosinophilia, fixed-drug eruption with cross-reaction to carisoprodol, leukopenia, peripheral edema, and petechiae.

Cardiovascular

Various forms of arrhythmia, hypotension, palpitation, syncope, tachycardia, and transient ECG changes.

Central Nervous System

Agitation, ataxia, cerebral edema, coma, confusion, dizziness, drowsiness, dysphoria, euphoria, fast EEG activity, headache, impairment of visual accommodation, lethargy, overstimulation, paradoxical excitement, paresthesias, sedation, slurred speech, subdural or intracranial hemorrhage, seizures, vertigo, and weakness.

Fluid and Electrolyte

Dehydration, hyperkalemia, metabolic acidosis, and respiratory alkalosis.

Gastrointestinal

Abdominal pain, constipation, diarrhea, dyspepsia, epigastric discomfort, gastric distress, gastrointestinal bleeding, heartburn, hepatitis, nausea, pancreatitis, Reye’s syndrome, transient elevations of hepatic enzymes, ulceration and perforation, and vomiting.

Hematologic (see also “Allergic or Idiosyncratic”)

 Agranulocytosis and aplastic anemia have been reported, although no causal relationship has been established, coagulopathy, disseminated intravascular coagulation, exacerbation of porphyric symptoms, hemolytic anemia, iron deficiency anemia, occult blood loss, prolongation of the prothrombin time, thrombocytopenia, and thrombocytopenic purpura.

Musculoskeletal

Rhabdomyolysis

Metabolism

Hyperglycemia and hypoglycemia

Reproductive

Prolonged pregnancy and labor, stillbirths, lower birth weight infants, and antepartum and postpartum bleeding.

Respiratory

Acute airway obstruction, hyperpnea, pulmonary edema, and tachypnea.

Special Senses

Hearing loss and tinnitus.

Urogenital

Interstitial nephritis, papillary necrosis, proteinuria, and renal insufficiency and failure.