Therapeutic class: OPIATE AGONISTS  

Common Dosages by Indication:

Tension-Type Headache

take 1 capsule by oral route every 4 hours as needed not to exceed 6 capsules per 24hrs take 2 capsules by oral route every 4 hours as needed not to exceed 6 capsules per 24hrs take 1 - 2 capsules by oral route every 4 hours as needed not to exceed 6 capsules per 24hrs

All Labeled Uses: Tension-Type Headache

Contraindicated Drug Combination:
Clearly contraindicated in all cases and should not be dispensed or administered to the same patient:
SALICYLATES/INFLUENZA VIRUS VACCINE LIVE - Adverse reaction with both drugs
SEDATIVE HYPNOTICS/SODIUM OXYBATE - Adverse reaction of the latter drug
ANTICOAGULANTS/MIFEPRISTONE - Adverse reaction of the former drug
XANTHINE DERIVATIVES/DIPYRIDAMOLE INJECTABLE - Decreased effect of the latter drug
NSAID;ASPIRIN/KETOROLAC - Adverse reaction with both drugs
OPIOID ANALGESICS/NALTREXONE - Decreased effect of the former drug

Severe Interaction:
Action is required to reduce the risk of severe adverse interaction.
THEOPHYLLINE DERIVATIVES/CIMETIDINE - Increased effect of the former drug
ANTICONVULSANTS/CONTRACEPTIVES - Decreased effect of the latter drug
SELECTED NARCOTICS/MAOI'S - Adverse reaction with both drugs
SELECTED NARCOTICS/RASAGILINE; SELEGILINE - Adverse reaction with both drugs
CARBAMAZEPINE; PHENYTOIN; BARBITURATES/TOLVAPTAN - 
SALICYLATES/VARICELLA VIRUS VACCINE LIVE - 
SELECTED NSAIDS; ASPIRIN/PEMETREXED - Increased effect of the latter drug
THEOPHYLLINE DERIVATIVES/ADENOSINE; REGADENOSON - 
BARBITURATES/METHOXYFLURANE - 
BARBITURATES/CYCLOSPORINE - Decreased effect of the latter drug
SALICYLATES/HEPARIN - Increased effect of the latter drug
SALICYLATES/METHOTREXATE - Increased effect of the latter drug
BARBITURATES/ANTICOAGULANTS - Decreased effect of the latter drug
SALICYLATES/ANTICOAGULANTS - Increased effect of the latter drug

Moderate Interaction:
Assess the risk to the patient and take action as needed.
XANTHINE DERIVATIVES/SELECTED MACROLIDE ANTIBIOTICS - Increased effect of the former drug
SALICYLATES/CORTICOSTEROIDS - Decreased effect of the former drug
BARBITURATES/CORTICOSTEROIDS - Decreased effect of the latter drug
BARBITURATES/QUINIDINE - Decreased effect of the latter drug
THEOPHYLLINE DERIVATIVES/LITHIUM - Decreased effect of the latter drug
NARCOTIC ANALGESICS/CIMETIDINE - Increased effect of the former drug
BARBITURATES/ESTROGENS - Decreased effect of the latter drug
CODEINE/QUINIDINE - Decreased effect of the former drug
SELECTED XANTHINE DERIVATIVES/FLUVOXAMINE - Increased effect of the former drug
OPIOIDS/NALBUPHINE - Mixed effects of the former drug
BARBITURATES/PHENOTHIAZINES - Additive side effects from both drugs
ANTICOAGULANTS; ANTIPLATELETS; THROMBOLYTICS/DROTRECOGIN - Adverse reaction with both drugs
ASPIRIN; INDOMETHACIN/TILUDRONATE DISODIUM - Mixed effects of the latter drug
ASPIRIN/ACE INHIBITORS - Decreased effect of the latter drug
NSAIDS; ASPIRIN/SSRI'S; SNRI'S - Adverse reaction with both drugs
PLATELET AGGREGATION INHIBITORS/LEPIRUDIN - Additive side effects from both drugs
BARBITURATES/FELODIPINE - Decreased effect of the latter drug
BARBITURATES/METRONIDAZOLE - Decreased effect of the latter drug
SALICYLATES/VALPROIC ACID - Increased effect of the latter drug
BARBITURATES/THEOPHYLLINES - Decreased effect of the latter drug
ASPIRIN/TICLOPIDINE - Increased effect of the latter drug
SALICYLATES/CARBONIC ANHYDRASE INHIB - Adverse reaction with both drugs
BARBITURATES/VALPROIC ACID - Increased effect of the former drug
SALICYLATES/ANTIDIABETICS, ORAL - Increased effect of the latter drug
SALICYLATES/URICOSURICS - Decreased effect of the latter drug
BARBITURATES; CARBAMAZEPINE/DOXYCYCLINE - Decreased effect of the latter drug
BARBITURATES/SELECTED BETA-BLOCKERS - Decreased effect of the latter drug

Pediatric
Absolute Contraindication: REYE SYNDROME RISK W/ VIRAL ILLNESS, FEVER. RARE USE IN KAWASAKI DISEASE.
Relative Contraindication: SAFETY AND EFFECTIVENESS NOT ESTABLISHED AGE < 12 YEARS.
Warning: CAUTION IN SEIZURE DISORD & CV DISEASE/PREM NEONATE WITH RENAL,HEPATIC IMPAIR
Relative Contraindication: POTENTIAL INCREASED SENSITIVITY TO EFFECTS AND ADVERSE EFFECTS.
Warning: ADVERSE CNS EFFECTS USUALLY MORE SEVERE IN CHILDREN.

Lactation
Precaution: HIGH DOSES MAY CAUSE HYPERACTIVITY AND WAKEFULNESS IN INFANT.
Precaution: POSSIBILITY OF CENTRAL NERVOUS SYSTEM DEPRESSION IN NURSING INFANT.
Precaution: AAP COMPAT;FDA WARNS IN FAST CYP2D6 METABOLIZERS;MONITOR INFANT FOR APNEA
Absolute Contraindication: ONE REPORT OF METABOLIC ACIDOSIS;RISK OF REYE'S SYND W/VIRAL ILLNESS/FEVER

Pregnancy
FDB Only When Necessary: REPORTS OF MISCARRIAGE,POOR FETAL GROWTH POSSIBLY ASSOC W/HIGH DOSES OF CAFFEINE
FDB Contraindicated or Not Recommended: TERATOGENIC; CONSULT MD-ORAL VIT K MAY LOWER NEONATE RISK FROM VIT K DEFICIENCY
Only When Necessary: RISK OF NEONATAL WITHDRAWAL W/CHRONIC USE, RESP DEPRESS W/HIGH DOSES NEAR TERM
Not Recommended: NOT RECOMMENDED ESPECIALLY IN 3RD TRIMESTER OR NEAR TERM

Geriatric
Contraindication: (BEERS02)SEDATING/MAY EXACERBATE DEPRESSION
Precaution: (SOM)(BEERS02)INCREASED RISK FOR GI BLEED/ULCER; USE LOWER DOSES.
Precaution: (SOM)RISKS:HYPOTENSION/RESP.DEPRESS/URINARY RET./CONFUSION/CONSTIP.

Most Frequent:
Abdominal Pain with Cramps, Dizziness, Gastric Hypersecretory Conditions, Gastrointestinal Irritation, Heartburn, Nausea, Vomiting

Less Frequent:
Anxiety, Atelectasis, Blurred Vision, Bradycardia, Constipation, Depression, Diplopia, Excitement, Fainting, False Sense of Well-Being, General Weakness, Headache Disorder, Hypotension, Impaired Cognition, Insomnia, Irritability, Laryngeal Edema, Laryngismus, Lethargy, Malaise, Nervousness, Nightmares, Oliguria, Pulse Changes, Respiratory Depression, Tachyarrhythmia, Tremors, Ureteral Spasm, Vertigo, Visual Changes, Xerostomia

Rare:
Abnormal Hepatic Function Tests, Agranulocytosis, Allergic Dermatitis, Allergic Reactions, Anaphylaxis, Anemia, Angioedema, Anorexia, Ataxia, Biliary Spasm, Bronchospastic Pulmonary Disease, Diarrhea, Drowsy, Drug Dependence, Drug-Induced Hepatitis, Dyspepsia, Dyspnea, Erythema, Exfoliative Dermatitis, Gastritis, Gastrointestinal Hemorrhage, Gastrointestinal Perforation, Gastrointestinal Ulcer, Hallucinations, Hematoma, Hemolytic Anemia, Interstitial Nephritis, Intracranial Bleeding, Involuntary Muscle Movement, Leukopenia, Megaloblastic Anemia, Memory Impairment, Muscle Rigidity, Osteopenia, Pruritus of Skin, Purpura, Rectal Bleeding, Rickets, Seizure Disorder, Skin Rash, Sleep Automatism, Stevens-Johnson Syndrome, Throat Constriction, Thrombocytopenic Disorder, Tinnitus, Tonic Clonic Seizure, Urticaria, Wheezing

Most Significant
Acute Asthma Attack, Alcoholism, Chronic Gastrointestinal Ulcer with Hemorrhage, Chronic Obstructive Pulmonary Disease, Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies, Hemophilia, Lactating Mother, Nasal Polyps with Asthma, Porphyria, Pregnancy, Pseudomembranous Enterocolitis, Recovery Phase Following Myocardial Infarct, Respiratory Depression, Respiratory Insufficiency, Reye's Syndrome, Severe Pain, Severe Thrombocytopenia, Sleep Apnea, Toxin-Mediated Diarrhea, Von Willebrand's Disease

Significant
Bradycardia, Chronic Disease of Respiratory System, Chronic Pain, Chronic Peptic Ulcer, CNS Depression, Conduction Disorder of the Heart, Depression, Duodenitis, Erosive Gastritis, Head Injury, Hepatic Coma, Hepatic Encephalopathy, Hyperammonemia, Hypoprothrombinemia, Inflammatory Bowel Disease, Insomnia, Intracranial Hypertension, Intracranial Lesion, Myocardial Ischemia, Necrotizing Enterocolitis, Pain, Peptic Ulcer, Severe Renal Disease, Substance Abuse, Suicidal Ideation, Thrombotic Thrombocytopenic Purpura

Possibly Significant
Acute Abdominal Pain, Agoraphobia, Anemia, Benign Prostatic Hypertrophy, Biliary Spasm, Disease of Liver, Drug Dependence, Epilepsy, Gallbladder Disease, Gastrointestinal Tract Surgery, Gout, Hyperkinesis, Hypertension, Hypotension, Hypothyroidism, Mood Changes, Neutropenic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Primary Adrenocortical Insufficiency, Procedure on Urinary System, Renal Disease, Renal Disease with Moderate to Severe Function Impairment, Seizure Disorder, Severe Hepatic Disease, Sleep Automatism, Thrombocytopenic Disorder, Ultrarapid Metabolizer due to Cytochrome p450 CYP2D6 Variant, Urethral Stricture, Vitamin K Deficiency