Sunday, October 7, 2012

Narcan



Generic Name: Naloxone Hydrochloride
Class: Opiate Antagonists
VA Class: CN102
CAS Number: 357-08-4


REMS:


FDA approved a REMS for naloxone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of naloxone and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page () or the ASHP REMS Resource Center ().



Introduction

Essentially a pure opiate antagonist.113


Uses for Narcan


Opiate-induced Depression and Acute Opiate Overdosage


Treatment of opiate-induced depression, including respiratory depression, caused by natural and synthetic opiates such as anileridine, codeine, diphenoxylate, fentanyl, heroin, hydromorphone, levorphanol, meperidine, methadone, morphine, oxymorphone, concentrated opium alkaloids hydrochlorides, and propoxyphene.113 116


Useful for the treatment of opiate-induced depression, including respiratory depression, caused by certain opiate partial agonists including butorphanol, nalbuphine, pentazocine, and cyclazocine.113


Useful for the treatment of mild or moderate as well as severe opiate-induced respiratory depression.b


Administration should be accompanied by other resuscitative measures such as administration of oxygen, mechanical ventilation, or artificial respiration.b


Duration of respiratory depression following opiate agonist overdosage may be longer than the duration of naloxone action and other more immediate supportive and symptomatic treatment also should be initiated.d


Use in patients physically dependent on opiate agonists may precipitate an acute withdrawal syndrome that cannot be readily suppressed while the action of the antagonist (naloxone) persists.d


If opiate abstinence syndrome is precipitated by naloxone, symptoms will be apparent within a few minutes and maximal within 30 minutes after administration; effects usually will be more severe than those following withdrawal of the opiate agonist.d


Some value in the management of buprenorphine overdosage but should not be relied on for treatment of respiratory depression.c Reversal of agonist effects develops slowly.113


Not effective in the management of acute toxicity caused by levopropoxyphene.b


Diagnosis of Opiate Overdosage


Aid in the diagnosis of suspected acute opiate overdosage (e.g., in the absence of confirmatory history and/or definitive diagnostic clinical findings).113 e


Diagnosis of Chronic Opiate Abuse (Naloxone Challenge Test)


Has been used as an aid in the diagnosis of chronic opiate abuse, but preferable to use chemical methods to detect the presence of opiates in urine, since naloxone may precipitate severe withdrawal symptoms in patients physically dependent on opiates.b


Screening test (the naloxone challenge test) prior to induction of naltrexone therapy for opiate cessation in patients formerly dependent on opiates who have completed detoxification.b Such screening can avoid precipitating opiate withdrawal following administration of naltrexone.d


Alcohol- or Clonidine-induced Coma


Has been used in intoxicated patients to reverse alcohol-induced coma and to reverse clonidine-induced coma and respiratory depression.b


Detoxification and Maintenance Treatment of Opiate Dependence


A combination of methadone hydrochloride and naloxone hydrochloride in a ratio of 20:1 has been administered orally in the detoxification or maintenance treatment of opiate dependence in conjunction with appropriate social and medical services.b


May prevent opiate euphoria and thus decrease the desire for opiates.b


Has been used for rapid or ultrarapid detoxification in the management of opiate withdrawal in opiate-dependent individuals, both in inpatient and outpatient settings.112


Rapid opiate detoxification involves the administration of opiate antagonists such as naloxone and/or naltrexone to shorten the time period of detoxification.112


Ultrarapid detoxification is similar, but involves the administration of opiate antagonists (i.e., naloxone, naltrexone) while the patient is sedated or under general anesthesia.112


Risk of adverse respiratory and cardiovascular effects associated with this procedure must be considered as well as the costs of general anesthesia and hospitalization.112


Minimization of Pentazocine or Buprenorphine Abuse Potential


Used orally in fixed combination with pentazocine hydrochloride or buprenorphine hydrochloride to minimize abuse potential of pentazocine or buprenorphine; antagonistic effect of naloxone will predominate if the combinations are administered parenterally and/or if usual oral doses are exceeded.114 115


Narcan Dosage and Administration


Administration


Administer by IV, sub-Q, or IM injection, or by IV infusion.113 116


IV administration is recommended for emergency situations.113 116


Because absorption may be erratic or delayed, AAP does not endorse sub-Q or IM injection in children or neonates with opiate intoxication.113


When IV access cannot be established in emergency situations, consider administration via an endotracheal tube in adult and pediatric patients (this route not recommended in neonates).100 101 102 104 105 106 107 108 109 110 111 116 Also consider intraosseous injection in pediatric patients.116


IV Administration


For drug compatibility information, see Compatibility under Stability.


Continuous IV infusions may be most appropriate in patients who require higher doses, continue to experience recurrent respiratory or CNS depression after effective therapy with repeated doses, and/or in whom the effects of long-acting opiates are being antagonized.b


Dilution

Continuous IV infusion: 2 mg of naloxone hydrochloride may be diluted in 500 mL of 0.9% sodium chloride or 5% dextrose injection to produce a solution containing 0.004 mg/mL (4 mcg/mL).113


Rate of Administration

Titrate in accordance with patient’s response.113


Dosage


Available as naloxone hydrochloride; dosage expressed in terms of the salt.113


Pediatric Patients


Postoperative Opiate Depression

IV

Initial dosage: Usually, 0.005–0.01 mg, given at 2- to 3-minute intervals until desired response (i.e., adequate ventilation and alertness without substantial pain or discomfort) is obtained.113


Additional doses may be necessary at 1- to 2-hour intervals depending on response and dosage and duration of action of the opiate administered.113 (See Excessive Dosage in Surgery under Cautions.)


Opiate Overdosage

Diagnosis

IV

Children: Initially, 0.01 mg/kg; if this dose does not produce the expected response, may give a subsequent 0.1-mg/kg dose.113


Treatment

Duration of opiate action often exceeds that of naloxone; opiate depressant effects may return as the effects of naloxone diminish, and additional naloxone doses (or a continuous IV infusion) may be required.113 116


Closely observe the patient for a day or longer regardless of degree of apparent improvement.b


IV

Children: Initially, 0.01 mg/kg; if this dose does not produce the desired degree of response, may give a subsequent 0.1-mg/kg dose.113 f


Alternatively, children <5 years of age or weight ≤20 kg: 0.1 mg/kg; repeat as necessary.116 b


Alternatively, children ≥5 years of age or weight >20 kg: 2 mg; repeat as necessary.116 b


Continuous IV infusion dosage regimens have not been well established, and the rate of administration must be titrated according to the patient’s response.b


Experience with continuous IV infusions in children is limited, but children may require higher infusion rates on a mg/kg basis than adults.b


Infusion rates in children usually have ranged from 0.024–0.16 mg/kg per hour; alternatively, a pediatric infusion rate of 0.4 mg/hour has been suggested.b


Intraosseous or Endotracheal

Use lower doses to reverse respiratory depression from therapeutic opiate use.116


Adults


Postoperative Opiate Depression

IV

Initial dosage: Usually, 0.1–0.2 mg, given at 2- to 3-minute intervals until desired response (i.e., adequate ventilation and alertness without substantial pain or discomfort) is obtained; additional doses may be necessary at 1- to 2-hour intervals depending on response and dosage and duration of action of the opiate administered.113


Alternatively, 0.005 mg/kg, repeated after 15 minutes if necessary.b


Continuous IV infusion: 0.0037 mg/kg per hour.b


Opiate Overdosage

Diagnosis

IV

Initial dosage: Usually, 0.4–2 mg IV, administered at 2- to 3-minute intervals if necessary; if no response is observed after a total of 10 mg of the drug has been administered, the depressive condition may be caused by a drug or disease process not responsive to naloxone.113


Treatment

Duration of opiate action often exceeds that of naloxone; opiate depressant effects may return as the effects of naloxone diminish, and additional naloxone doses (or a continuous IV infusion) may be required.113 116


Closely observe the patient for a day or longer regardless of the degree of apparent improvement.b


IV

Initial dosage: Usually, 0.4–2 mg IV, administered at 2- to 3-minute intervals if necessary; if no response is observed after a total of 10 mg of the drug has been administered, the depressive condition may be caused by a drug or disease process not responsive to naloxone.113 116


Continuous IV infusion dosage regimens of naloxone have not been well established, and the rate of administration must be titrated according to the patient’s response.b


IV infusion: IV loading dose of 0.4 mg, followed by a continuous IV infusion at an initial rate of 0.4 mg/hour; alternatively, other clinicians have recommended that an IV loading dose of 0.005 mg/kg be given, followed by continuous infusion of 0.0025 mg/kg per hour.b


IV infusion: Alternatively, IV loading dose of 0.005 mg/kg, followed by continuous IV infusion of 0.0025 mg/kg per hour.b


For patients with chronic opiate addiction, use lower dose and titrate slowly to minimize adverse cardiovascular effects and withdrawal symptoms.116


IM or Sub-Q

0.4–0.8 mg; repeated as necessary.116


Diagnosis of Chronic Opiate Abuse (Naloxone Challenge Test)

Performed prior to induction of naltrexone therapy in patients formerly physically dependent on opiates who have completed detoxification and in those suspected of having been dependent on opiates.


Do not perform the naloxone challenge test in patients who are exhibiting manifestations of opiate withdrawal, those whose urine shows evidence of opiates, or those in whom there is a high degree of suspicion that opiates are still being used, since naloxone may precipitate potentially severe opiate withdrawal.


If manifestations of opiate withdrawal are evident following naloxone challenge test, naltrexone therapy should not be attempted.


During the appropriate period in the naloxone challenge test, the patient should be closely monitored for the appearance of manifestations of opiate withdrawal and vital signs should be monitored.


If manifestations of opiate withdrawal are evident following the naloxone challenge test, do not initiate naltrexone therapy due to potential risk of precipitating more severe and prolonged withdrawal with naltrexone; naloxone challenge test may be repeated in 24 hours in these patients.


If evidence of withdrawal is absent, naltrexone therapy may be initiated.


Some clinicians caution that even minor and/or transient GI symptoms following naloxone challenge be considered evidence of withdrawal since patients with such symptoms will often develop severe and disturbing GI symptoms if naltrexone therapy is then initiated.


IV

Use a sterile syringe containing 0.8 mg of naloxone hydrochloride.


Initially, a 0.2-mg IV dose and, while the needle remains in the vein, observe the patient for 30 seconds for evidence of opiate withdrawal.


Alternatively, an initial 0.2-mg IV dose, then observe patient for 15 minutes for evidence of withdrawal.


Manifestations of withdrawal include, but are not limited to, nasal stuffiness, rhinorrhea, lacrimation, yawning, sweating, tremor, abdominal cramps, vomiting, piloerection, myalgia, and skin crawling.


If no evidence of withdrawal, inject the remaining 0.6-mg IV dose and observe the patient for an additional 20 minutes for evidence of withdrawal.


Some clinicians recommend that a total IV dose of 2 mg be used in the test since withdrawal has been precipitated by the first oral dose of naltrexone despite a negative naloxone challenge test using lower doses and a false-negative test rarely occurs with the 2-mg naloxone hydrochloride dose.


Sub-Q

Inject the entire 0.8-mg dose and observe the patient for 20 minutes for evidence of opiate withdrawal.


If evidence of opiate withdrawal is present, naltrexone therapy should be delayed and the naloxone challenge test repeated in 24 hours with the 0.8-mg dose and every 24 hours until results are negative.


If it is uncertain whether the patient is opiate free or is undergoing opiate withdrawal following an initial test, the naloxone challenge test should be repeated at that time with a 1.6-mg dose.


To repeat the naloxone challenge test in these patients, a 1.6-mg dose of naloxone hydrochloride should be injected IV and the patient observed for evidence of opiate withdrawal; if evidence of opiate withdrawal is absent, naltrexone therapy may be initiated.


Diagnosis of Opiate Dependence

IM, then IV

Initial single dose of 0.16 mg IM; if no withdrawal manifestations are evident after 20–30 minutes, a second dose of 0.24 mg is given IV.b


Negative test results assumed if no withdrawal manifestations are apparent within 30 minutes after the second dose.b


Withdrawal manifestations induced by naloxone begin to diminish 20–40 minutes after injection and are essentially gone within 1.5 hours.b


Prescribing Limits


Adults


Known or Suspected Opiate Overdosage

IV, IM or Sub-Q

If no response is observed after a total of 10 mg is been administered, the depressive condition may be caused by a drug or disease process not responsive to naloxone.113


Special Populations


Hepatic Impairment


No specific dosage recommendations.b


Renal Impairment


No specific dosage recommendations.b


Geriatric Patients


No specific dosage recommendations; in general, dose selection should be cautious, usually initiating at the lower end or the normal range.113


Cautions for Narcan


Contraindications



  • Known hypersensitivity to naloxone or any ingredient in the formulation.113



Warnings/Precautions


Warnings


Additional Resuscitative Measures

When used in the management of acute opiate overdosage, other resuscitative measures (e.g., maintenance of an adequate airway, artificial respiration, cardiac massage, vasopressor agents) should be readily available and used when necessary.113


Excessive Dosage in Surgery

Avoid excessive dosage following the use of opiates during surgery because naloxone may result in excitement, agitation, an increase in BP, and clinically important reversal of analgesia; a reversal of opiate effects achieved too rapidly may induce nausea, vomiting, sweating, tremor, tachycardia, increased BP, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest, which may result in death.113


Physical Opiate Dependence

Caution in patients known or suspected to be physically dependent on opiates (including neonates born to women who are opiate dependent) because severe withdrawal manifestations may be precipitated.113


General Precautions


Cardiovascular Disease

Caution in patients with preexisting cardiovascular disease or in those receiving potentially cardiotoxic drugs, since serious adverse cardiovascular effects (e.g., ventricular tachycardia and fibrillation, pulmonary edema, cardiac arrest) resulting in death, coma, and encephalopathy have occurred in postoperative patients following administration of naloxone.113 (See Common Adverse Effects under Cautions.)


Repeat Administration

Carefully monitor patients who have responded to naloxone since the duration of action of some opiates may exceed that of naloxone; monitor pediatric patients for at least 24 hours.113 Give repeated doses of naloxone to these patients when necessary.113


Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.


Specific Populations


Pregnancy

Category C;113 considered category B by some experts.g


Lactation

Not known whether naloxone is distributed into milk.113 g Caution advised if used in nursing women.113


Pediatric Use

Safety and efficacy in management of hypotension associated with septic shock not established in pediatric patients.113 In a study of 2 neonates with septic shock, treatment with naloxone produced positive pressor response; however, one patient subsequently died after intractable seizures.113


Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.113 Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.113


Hepatic Impairment

Safety and efficacy not established; use with caution.113


Renal Impairment

Safety and efficacy not established; use with caution.113


Common Adverse Effects


Nausea and vomiting rarely postoperatively with parenteral dose exceeding that usually recommended; a causal relationship has not been established.b


Analgesia reversal, excitement, agitation, and increased BP may occur with excessive postoperative doses.113


Postoperative use: Hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest; sequelae include death, coma, and encephalopathy.113


Opiate overdosage: Tremor and hyperventilation associated with an abrupt return to consciousness.b


Opiate dependence: Abrupt dependence reversal may precipitate acute withdrawal.113


Adverse cardiovascular effects have occurred most frequently in postoperative patients with preexisting cardiovascular disease or in those receiving other drugs that produce similar adverse cardiovascular effects. (See Cardiovascular Disease under Cautions.)


Interactions for Narcan


Specific Drugs












Drug



Interaction



Comments



Cardiotoxic drugs



Serious adverse cardiovascular effects (e.g., ventricular tachycardia and fibrillation, pulmonary edema, cardiac arrest) resulting in death, coma, and encephalopathy reported in postoperative patients113



Use concomitantly with caution113



Methohexital



Methohexital appears to block the acute onset of withdrawal symptoms induced by naloxone in opiate addicts113


Narcan Pharmacokinetics


Absorption


Bioavailability


Rapidly inactivated following oral administration.b


Although effective orally, doses much larger than those required for parenteral administration are required for complete antagonism.b


Onset


IV: Within 1–2 minutes.b


Sub-Q or IM: Within 2–5 minutes.b


Duration


Depends on the dose and route of administration and is more prolonged following IM than IV administration.113


Distribution


Extent


Parenteral: Rapidly distributed into body tissues and fluids.113


Readily (within 2 minutes) crosses the placenta.113 g


Unknown whether distributed into milk.113 g


Plasma Protein Binding


Weakly bound to plasma proteins (mainly albumin).113


Elimination


Metabolism


Rapidly metabolized in the liver, principally by conjugation with glucuronic acid.113


Major metabolite is naloxone-3-glucuronide.113


Also undergoes N-dealkylation and reduction of the 6-keto group followed by conjugation.b


Elimination Route


Oral or IV dose: 25–40% excreted as metabolites in urine in 6 hours, about 50% in 24 hours, and 60–70% in 72 hours.113


Half-life


Adults: 30–81 minutes.113


Neonates: About 3 hours.113


Stability


Storage


Parenteral


Injection

25°C (may be exposed to 15–30°C); protect from light.113


Stable at pH 2.5–5.b


Use diluted solutions (e.g., 4 mcg/mL in 5% dextrose or 0.9% sodium chloride injection) within 24 hours; discard unused portions after 24 hours.113


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Parenteral


Do not mix with preparations containing bisulfite, metabisulfite, long-chain or high molecular weight anions, or any solution having an alkaline pH.113


Drug Compatibility




Admixture CompatibilityHID

Compatible



Verapamil HCl










Y-Site CompatibilityHID

Compatible



Fenoldopam mesylate



Linezolid



Propofol



Incompatible



Amphotericin B cholesteryl sulfate complex



Lansoprazole


Actions



  • Essentially a pure opiate antagonist.113




  • In usual doses in patients who have not recently received opiates, naloxone exerts little or no pharmacologic effect.113




  • In patients who have received large doses of morphine or other analgesic drugs with morphine-like effects, naloxone antagonizes most of the effects of the opiate.113




  • Increase in respiratory rate and minute volume, decrease toward normal in arterial PCO2, and return to normal in blood pressure if depressed.b




  • Because the duration of action of naloxone is generally shorter than that of the opiate, the effects of the opiate may return as the effects of naloxone dissipate.113




  • Antagonizes opiate-induced sedation or sleep.b




  • Does not produce tolerance or physical or psychological dependence.113




  • It is thought to act as a competitive antagonist at mc, κ, and σ opiate receptors in the CNS; it is thought that the drug has the highest affinity for the μ receptor.113



Advice to Patients



  • Inform family about use and administration of drug.PDH




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.




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




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



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name























Naloxone Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



Injection



0.4 mg/mL*



Naloxone Hydrochloride Injection



Narcan



Endo



1 mg/mL



Naloxone Hydrochloride Injection


















Pentazocine and Naloxone Hydrochlorides

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets



Pentazocine Hydrochloride 50 mg (of pentazocine) and Naloxone Hydrochloride 0.5 mg (of naloxone)



Pentazocine and Naloxone Hydrochlorides Tablets (C-IV)



Talwin Nx Caplets (C-IV; scored)



Sanofi-Aventis


















Naloxone Hydrochloride Dihydrate Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Sublingual



Tablets



0.5 mg (of naloxone) with Buprenorphine Hydrochloride 2 mg (of buprenorphine)



Suboxone (C-III)



Reckitt Benckiser



2 mg (of naloxone) with Buprenorphine Hydrochloride 8 mg (of buprenorphine)



Suboxone (C-III)



Reckitt Benckiser


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Pentazocine-Naloxone HCl 50-0.5MG Tablets (WATSON LABS): 30/$42.99 or 90/$112.97


Talwin NX 50-0.5MG Tablets (SANOFI-AVENTIS U.S.): 30/$55.99 or 90/$155.97



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References


Only references cited for selected revisions after 1984 are available electronically.



100. Brown DH, Kasuya A, Leiken JB. Endotracheal administration in the critical care setting. J Emerg Med. 1987; 5:407-14. [PubMed 3312392]



101. Ward JT Jr. Endotracheal drug therapy. Am J Emerg Med. 1983; 1:71-2. [PubMed 6393996]



102. Tandberg D. Endotracheal naloxone. Am J Emerg Med. 1983; 1:366-7. [PubMed 6680644]



103. Tandberg D, Abercrombie D. Treatment of heroin overdose with endotracheal naloxone. Ann Emerg Med. 1982; 11:443-5. [PubMed 7103164]



104. Greenberg MI. The use of endotracheal medication in cardiac emergencies. Resuscitation. 1984; 12:155-65. [PubMed 6096940]



105. Hahnel J, Lindner KH, Ahnefeld FW. Endobroncial administration of emergency drugs. Resuscitation. 1989; 17:261-72. [PubMed 2548271]



106. Greenberg MI, Roberts JR, Baskin SI. Endotracheal naloxone reversal of morphine-induced respiratory depression in rabbits. Ann Emerg Med. 1980; 9:289-92. [PubMed 7386953]



107. Raehl CL. Endotracheal drug therapy in cardiopulmonary resuscitation. Clin Pharm. 1986; 5:572-9. [IDIS 217499] [PubMed 3527527]



108. American Academy of Pediatrics Committee on Drugs. Emergency drug doses for infants and children. Pediatrics. 1988; 81:462-5. [PubMed 3422026]



109. American Academy of Pediatrics Committee on Drugs. Emergency drug doses for infants and children and naloxone use in newborns: clarification. Pediatrics. 1989; 83:803. [IDIS 254337] [PubMed 2717301]



110. American Academy of Pediatrics Committee on Drugs. Naloxone dosage and route of administration for infants and children: addendum to emergency drug doses for infants and children. Pediatrics. 1990; 86:484-5. [IDIS 273346] [PubMed 2388800]



111. Emergency Cardiac Care Committee and Subcommittees, American Heart Association. Guidelines for cardiopulmonary resuscitation and emergency cardiac care. JAMA. 1992; 268:2171-302. [PubMed 1404767]



112. O’Connor PG, Kosten TR. Rapid and ultrarapid opioid detoxification techniques. JAMA. 1998; 279:229-34.



113. Endo Pharmaceuticals. Narcan (naloxone hydrochloride injection, USP) prescribing information. Chadds Ford, PA; 2003 Jul.



114. Reckitt Benckiser Pharmaceuticals, Inc. Suboxone (buprenorphine hydrochloride and naloxone hydrochloride dihydrate) sublingual tablets and Subutex (buprenorphine hydrochloride) sublingual tablets prescribing information. Richmond, VA. Accessed 2005 Nov 7.



115. Sanofi-Synthelabo Inc. Talwin NX (pentazocine and naloxone hydrochlorides) prescribing information. New York, NY; 2003 May.



116. The American Heart Association. Guidelines 2005 for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2005; 112(Suppl I): IV1-211.



117. Eigel B. (American Heart Association, Dallas, TX): Personal communication; 2006 Dec 18.



118. field JM, Hazinski MF, Gilmore D, eds. Handbook of emergency cardiovascular care for healthcare providers. Dallas, TX: American Heart Associaiton; 2005:95.



b. AHFS drug information 2004. McEvoy GK, ed. Naloxone. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2093-5.



c. AHFS drug information 2004. McEvoy GK, ed. Buprenorphine. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2067-74.



d. AHFS drug information 2004. McEvoy GK, ed. Opiate agonists general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2030-35.



e. Goldfrank LR, Flomenbaum NE, Lewin NA, et al. Goldfrank’s toxicologic emergencies. 7th ed. New York: McGraw-Hill; 2002: 909.



f. Behrman RE, Kliegman RM, Jenson HB. Nelson textbook of pediatrics. 17th ed. Elsevier Publishing: 2470.



g. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2002: 969.



PDH. Schilling McCann JA, Publisher. Pharmacists drug handbook. 2nd ed. Philadelphia, PA: Lippincott Williams and Wilkins and American Society of Health-System Pharmacists; 2003.



HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1201-3.



More Narcan resources


  • Narcan Side Effects (in more detail)
  • Narcan Use in Pregnancy & Breastfeeding
  • Narcan Drug Interactions
  • Narcan Support Group
  • 0 Reviews for Narcan - Add your own review/rating


  • Narcan Prescribing Information (FDA)

  • Narcan Concise Consumer Information (Cerner Multum)

  • Narcan MedFacts Consumer Leaflet (Wolters Kluwer)

  • Naloxone Prescribing Information (FDA)



Compare Narcan with other medications


  • Opioid Overdose

Friday, September 28, 2012

Zarontin Solution


Pronunciation: ETH-oh-SUX-i-mide
Generic Name: Ethosuximide
Brand Name: Zarontin


Zarontin Solution is used for:

Controlling absence epilepsy (previously known as petit mal seizures). It may also be used for other conditions as determined by your doctor.


Zarontin Solution is an anticonvulsant. It acts in the brain to reduce the number of absence seizures.


Do NOT use Zarontin Solution if:


  • you are allergic to any ingredient in Zarontin Solution or similar medicines

Contact your doctor or health care provider right away if any of these apply to you.



Before using Zarontin Solution:


Some medical conditions may interact with Zarontin Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have liver or kidney disease, lupus, or a blood disorder (eg, porphyria)

  • if you have a history of mood or mental problems, including suicidal thoughts or attempts

Some MEDICINES MAY INTERACT with Zarontin Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Zarontin Solution

  • Valproic acid because it may affect the amount of Zarontin Solution in your blood

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zarontin Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Zarontin Solution:


Use Zarontin Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.


  • Zarontin Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zarontin Solution refilled.

  • Take Zarontin Solution by mouth with or without food.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • Taking Zarontin Solution at the same time each day will help you remember to take it. Take Zarontin Solution on a regular schedule to get the most benefit from it.

  • Continue to take Zarontin Solution even if you feel well. Do not miss any doses.

  • If you miss a dose of Zarontin Solution, take it as soon as possible. If it is almost time for you next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zarontin Solution.



Important safety information:


  • Zarontin Solution may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zarontin Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Zarontin Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Increasing or decreasing the dose as well as adding or stopping other medicines should be done slowly. Rapidly stopping Zarontin Solution may suddenly make absence seizures worse.

  • Zarontin Solution may cause swelling and tenderness of your gums. Brush and floss your teeth on a regular schedule and have regular dental checkups.

  • Patients who take Zarontin Solution may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Zarontin Solution closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

  • Lab tests, including complete blood cell counts, liver function, and kidney function tests, may be performed while you use Zarontin Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Zarontin Solution should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zarontin Solution while you are pregnant. Zarontin Solution is found in breast milk. If you are or will be breast-feeding while you use Zarontin Solution, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Zarontin Solution:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Diarrhea; dizziness; drowsiness; headache; loss of appetite; nausea; stomach pain; stomach upset; vomiting; weight loss.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); increased number of seizures; lupus symptoms (eg, butterfly-shaped rash on the face, joint pain or swelling); new or worsening mood or mental changes (eg, depression); nightmares; red, swollen, blistered, or peeling skin; signs of infection (eg, fever, sore throat); suicidal thoughts or attempts; trouble concentrating; trouble sleeping; unusual bruising, bleeding, or fatigue.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Zarontin side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include central nervous system depression (eg, coma with slow, shallow breathing); nausea; vomiting.


Proper storage of Zarontin Solution:

Store Zarontin Solution below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not freeze. Keep Zarontin Solution out of the reach of children and away from pets.


General information:


  • If you have any questions about Zarontin Solution, please talk with your doctor, pharmacist, or other health care provider.

  • Zarontin Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zarontin Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Zarontin resources


  • Zarontin Side Effects (in more detail)
  • Zarontin Dosage
  • Zarontin Use in Pregnancy & Breastfeeding
  • Drug Images
  • Zarontin Drug Interactions
  • Zarontin Support Group
  • 4 Reviews for Zarontin - Add your own review/rating


Compare Zarontin with other medications


  • Seizures

Thursday, September 27, 2012

pirbuterol inhaler


Generic Name: pirbuterol inhaler (peer BYOO ter ole)

Brand Names: Maxair, Maxair Autohaler


What is pirbuterol inhalation?

Pirbuterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.


Pirbuterol inhalation is used to treat conditions such as asthma, bronchitis, and emphysema.


Pirbuterol inhalation may also be used for conditions other than those listed in this medication guide.


What is the most important information I should know about pirbuterol inhalation?


It is very important that you use your pirbuterol inhaler properly, so that the medicine gets into your lungs. Your doctor may want you to use a spacer with your inhaler. Talk to your doctor about proper inhaler use.


Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.


Who should not use pirbuterol inhalation?


Before using this medication, tell your doctor if you have



  • heart disease or high blood pressure,




  • epilepsy or another seizure disorder,




  • diabetes,




  • an overactive thyroid (hyperthyroidism), or




  • any type of liver or kidney disease.



You may require a lower dose or special monitoring during therapy with pirbuterol if you have any of the conditions listed above.


Pirbuterol is in the FDA pregnancy category C. This means that it is not known whether pirbuterol inhalation will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is not known whether pirbuterol passes into breast milk. Do not use pirbuterol inhalation without first talking to your doctor if you are breast-feeding a baby. Pirbuterol inhalation is not approved for use by children younger than 12 years of age.

How should I use pirbuterol inhalation?


Take pirbuterol inhalation exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse or doctor to explain them to you.


Shake the inhaler several times and uncap the mouthpiece. Breathe out fully and place your lips around the mouthpiece. Take a deep, slow breath as you push down on the canister. Hold your breath for several seconds, then exhale slowly.

The Autohaler releases the correct amount of drug. The force of your inhalation will trigger the release. You do not have to press down on a canister. Follow the instructions that accompany your inhaler.


If you take more than one dose at a time, wait for at least 1 full minute, then repeat the procedure.


Rinse your mouth after each use of the inhaler.


If you also use a steroid inhaler, use your pirbuterol inhaler first to open up your airways, then use the steroid inhaler as directed.


It is very important that you use your pirbuterol inhaler properly, so that the medicine gets into your lungs. Your doctor may want you to use a spacer with your inhaler. Talk to your doctor about proper inhaler use.


Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.


Keep your inhaler clean and dry. Keep the mouthpiece capped to avoid getting dirt inside it. Clean your inhaler once a day by removing the canister and mouthpiece and immersing it in warm water or alcohol. Allow the parts to dry, then reassemble the inhaler.


Carry your inhaler with you at all times in case of emergencies. Get a refill before you run out of medicine and before going on vacation.


What happens if I miss a dose?


Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a pirbuterol overdose include angina or chest pain, irregular heartbeats or a fluttering heart, seizures, tremor, weakness, headache, nausea, and vomiting.


What should I avoid while using pirbuterol inhalation?


Avoid situations that may trigger an asthma attack such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet fur.


Pirbuterol inhalation side effects


Stop using pirbuterol and seek emergency medical attention if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or




  • chest pain or irregular heartbeats.



Other, less serious side effects may be more likely to occur. Continue to use pirbuterol inhalation and talk to your doctor if you experience



  • headache, dizziness, lightheadedness, or insomnia;




  • tremor or nervousness;




  • sweating;




  • nausea, vomiting, or diarrhea; or




  • dry mouth.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


Pirbuterol inhaler Dosing Information


Usual Adult Dose for Asthma -- Acute:

2 puffs (0.4 mg) orally repeated every 4 to 6 hours. One puff (0.2 mg) repeated every 4 to 6 hours may be sufficient for some patients. A total daily dose of 12 inhalations should not be exceeded.

Usual Adult Dose for Asthma -- Maintenance:

2 puffs (0.4 mg) orally repeated every 4 to 6 hours. One puff (0.2 mg) repeated every 4 to 6 hours may be sufficient for some patients. A total daily dose of 12 inhalations should not be exceeded.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Acute:

2 puffs (0.4 mg) orally repeated every 4 to 6 hours. One puff (0.2 mg) repeated every 4 to 6 hours may be sufficient for some patients. A total daily dose of 12 inhalations should not be exceeded.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

2 puffs (0.4 mg) orally repeated every 4 to 6 hours. One puff (0.2 mg) repeated every 4 to 6 hours may be sufficient for some patients. A total daily dose of 12 inhalations should not be exceeded.

Usual Pediatric Dose for Asthma -- Acute:

>=12 years:

2 puffs (0.4 mg) orally repeated every 4 to 6 hours. One puff (0.2 mg) repeated every 4 to 6 hours may be sufficient for some patients. A total daily dose of 12 inhalations should not be exceeded.

Usual Pediatric Dose for Asthma -- Maintenance:

>=12 years:

2 puffs (0.4 mg) orally repeated every 4 to 6 hours. One puff (0.2 mg) repeated every 4 to 6 hours may be sufficient for some patients. A total daily dose of 12 inhalations should not be exceeded.

Usual Pediatric Dose for Chronic Obstructive Pulmonary Disease -- Acute:

>=12 years:

2 puffs (0.4 mg) orally repeated every 4 to 6 hours. One puff (0.2 mg) repeated every 4 to 6 hours may be sufficient for some patients. A total daily dose of 12 inhalations should not be exceeded.

Usual Pediatric Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

>=12 years:

2 puffs (0.4 mg) orally repeated every 4 to 6 hours. One puff (0.2 mg) repeated every 4 to 6 hours may be sufficient for some patients. A total daily dose of 12 inhalations should not be exceeded.


What other drugs will affect pirbuterol?


Before using this medication, tell your doctor if you are taking any of the following medicines:


  • a beta-blocker (used to treat high blood pressure and other heart conditions) such as atenolol (Tenormin), metoprolol (Lopressor), or propranolol (Inderal). These medicines may greatly decrease the effects of pirbuterol and lead to an asthma attack.

  • other commonly used beta-blockers, including acebutolol (Sectral), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), labetalol (Normodyne, Trandate), nadolol (Corgard), and pindolol (Visken).

  • a tricyclic antidepressant such as amitriptyline (Elavil), doxepin (Sinequan), or nortriptyline (Pamelor). Very high blood pressure and other effects harmful to the heart may occur if these medicines are taken with pirbuterol.

  • other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), and protriptyline (Vivactil).

  • a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate). Very high blood pressure and other effects harmful to the heart may also occur if these medicines are taken with pirbuterol.


  • another inhaled bronchodilator such as albuterol (Ventolin, Proventil), bitolterol (Tornalate), isoetharine (Bronkometer, Bronkosol), isoproterenol (Isuprel, Medihaler-Iso), metaproterenol (Alupent, Metaprel), salmeterol (Servent), or terbutaline (Brethaire, Brethine, Bricanyl). Using other inhaled medicines to open up your lungs will increase the risk of damage to your heart when you are taking pirbuterol.




  • caffeine, diet pills, or decongestants. These may also increase heart-related side effects.



Drugs other than those listed here may also interact with pirbuterol inhalation, or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.



More pirbuterol inhaler resources


  • Pirbuterol inhaler Side Effects (in more detail)
  • Pirbuterol inhaler Dosage
  • Pirbuterol inhaler Use in Pregnancy & Breastfeeding
  • Pirbuterol inhaler Drug Interactions
  • Pirbuterol inhaler Support Group
  • 5 Reviews for Pirbuterol inhaler - Add your own review/rating


Compare pirbuterol inhaler with other medications


  • Asthma, acute
  • Asthma, Maintenance
  • COPD, Acute
  • COPD, Maintenance


Where can I get more information?


  • Your pharmacist has additional information about pirbuterol written for health professionals that you may read.

See also: pirbuterol inhaler side effects (in more detail)


Wednesday, September 26, 2012

Codeine/Guaifenesin/Pseudoephedrine Liquid


Pronunciation: KOE-deen/gwye-FEN-e-sin/SOO-doe-e-FED-rin
Generic Name: Codeine/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Mytussin DAC and Robitussin DAC


Codeine/Guaifenesin/Pseudoephedrine Liquid is used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.


Codeine/Guaifenesin/Pseudoephedrine Liquid is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant loosens mucus and lung secretions in the chest and makes coughs more productive.


Do NOT use Codeine/Guaifenesin/Pseudoephedrine Liquid if:


  • you are allergic to any ingredient in Codeine/Guaifenesin/Pseudoephedrine Liquid or any other codeine- or morphine-related medicine (eg, oxycodone)

  • you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)

  • you are having an asthma attack

  • you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.



Before using Codeine/Guaifenesin/Pseudoephedrine Liquid:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, hydrocodone, dihydrocodeine, oxycodone)

  • if you have a history of glaucoma; an enlarged prostate gland or other prostate problems; heart problems; diabetes; high blood pressure; blood vessel problems; stroke; liver or kidney problems; blockage of the stomach, bowel, or bladder; adrenal gland problems; or thyroid problems

  • if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery

  • if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if you have a cough that occurs with large amounts of mucus

  • if you have a fever, severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)

  • if you have very poor health or a history of alcohol abuse, other substance abuse, or suicidal thoughts or actions

  • if you are taking medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Codeine/Guaifenesin/Pseudoephedrine Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Codeine/Guaifenesin/Pseudoephedrine Liquid's side effects

  • Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Codeine/Guaifenesin/Pseudoephedrine Liquid's effectiveness

  • Bromocriptine or sodium oxybate (GHB) because the risk of their side effects may be increased by Codeine/Guaifenesin/Pseudoephedrine Liquid

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Codeine/Guaifenesin/Pseudoephedrine Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Codeine/Guaifenesin/Pseudoephedrine Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Codeine/Guaifenesin/Pseudoephedrine Liquid:


  • Take Codeine/Guaifenesin/Pseudoephedrine Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Drink plenty of water while taking Codeine/Guaifenesin/Pseudoephedrine Liquid.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Codeine/Guaifenesin/Pseudoephedrine Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Codeine/Guaifenesin/Pseudoephedrine Liquid.



Important safety information:


  • Codeine/Guaifenesin/Pseudoephedrine Liquid may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Codeine/Guaifenesin/Pseudoephedrine Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Codeine/Guaifenesin/Pseudoephedrine Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Codeine/Guaifenesin/Pseudoephedrine Liquid may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Do not take diet or appetite control medicines while you are taking Codeine/Guaifenesin/Pseudoephedrine Liquid without checking with your doctor.

  • Codeine/Guaifenesin/Pseudoephedrine Liquid has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • If your symptoms do not get better within 5 days, if they get worse, or if they go away and then come back, check with your doctor.

  • If your symptoms occur along with fever, rash, or persistent headache, contact your doctor.

  • Do not use Codeine/Guaifenesin/Pseudoephedrine Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

  • Codeine/Guaifenesin/Pseudoephedrine Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Codeine/Guaifenesin/Pseudoephedrine Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Codeine/Guaifenesin/Pseudoephedrine Liquid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Codeine/Guaifenesin/Pseudoephedrine Liquid.

  • Tell your doctor or dentist that you take Codeine/Guaifenesin/Pseudoephedrine Liquid before you receive any medical or dental care, emergency care, or surgery.

  • Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

  • Use Codeine/Guaifenesin/Pseudoephedrine Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating.

  • Caution is advised when using Codeine/Guaifenesin/Pseudoephedrine Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.

  • Codeine/Guaifenesin/Pseudoephedrine Liquid should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Codeine/Guaifenesin/Pseudoephedrine Liquid while you are pregnant. Codeine/Guaifenesin/Pseudoephedrine Liquid is found in breast milk. Do not breast-feed while taking Codeine/Guaifenesin/Pseudoephedrine Liquid.


Possible side effects of Codeine/Guaifenesin/Pseudoephedrine Liquid:


All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Codeine/Guaifenesin/Pseudoephedrine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow or rapid breathing; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Codeine/Guaifenesin/Pseudoephedrine Liquid:

Store Codeine/Guaifenesin/Pseudoephedrine Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Codeine/Guaifenesin/Pseudoephedrine Liquid out of the reach of children and away from pets.


General information:


  • If you have any questions about Codeine/Guaifenesin/Pseudoephedrine Liquid, please talk with your doctor, pharmacist, or other health care provider.

  • Codeine/Guaifenesin/Pseudoephedrine Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Codeine/Guaifenesin/Pseudoephedrine Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Codeine/Guaifenesin/Pseudoephedrine resources


  • Codeine/Guaifenesin/Pseudoephedrine Side Effects (in more detail)
  • Codeine/Guaifenesin/Pseudoephedrine Use in Pregnancy & Breastfeeding
  • Codeine/Guaifenesin/Pseudoephedrine Drug Interactions
  • Codeine/Guaifenesin/Pseudoephedrine Support Group
  • 1 Review for Codeine/Guaifenesin/Pseudoephedrine - Add your own review/rating


Compare Codeine/Guaifenesin/Pseudoephedrine with other medications


  • Cold Symptoms

Tuesday, September 25, 2012

Aspergillosis, Meningitis Medications


There are currently no drugs listed for "Aspergillosis, Meningitis".

Learn more about Aspergillosis, Meningitis





Drug List:

Friday, September 21, 2012

Fluoxetine Capsules 20 mg





1. Name Of The Medicinal Product



Fluoxetine Capsules 20 mg.


2. Qualitative And Quantitative Composition



Each capsule contains fluoxetine 20 mg as fluoxetine hydrochloride.



3. Pharmaceutical Form



Capsule.



Hard gelatin capsule, size 3.



Capsule cap is light green opaque. Capsule body is light green opaque.



Capsule contains an almost white powder. Capsule is marked “F20”.



4. Clinical Particulars



4.1 Therapeutic Indications



For the treatment of symptoms of depressive illness, with or without anxiety symptoms, especially when sedation is not required; obsessive-compulsive disorder, and for the symptoms of bulimia nervosa in adults.



4.2 Posology And Method Of Administration



Fluoxetine may be administered as a single or divided dose, during or between meals.



Adults and the elderly:



Depression: The recommended dose is 20mg daily.



Obsessive-compulsive disorder: The recommended initial dose is 20mg daily, thereafter up to 60mg daily may be prescribed after several weeks if a positive response is not obtained with the initial dose.



Bulimia nervosa: The recommended dose is 60mg daily.



Unwanted effects may be more evident at higher doses.



Patients with renal or hepatic dysfunction:



A lower dose, or alternate day dosing, is recommended for patients with hepatic dysfunction or mild to moderate renal failure (i.e. with a glomerular filtrate rate of between 10ml and 50ml per minute). Fluoxetine is contra-indicated in patients with severe renal failure as accumulation may occur in this group during chronic treatment.



Children:



Fluoxetine Capsules 20mg are not recommended for children.



Steady state plasma levels of fluoxetine are only achieved after continued dosing for several weeks. When the patient stops taking fluoxetine the drug will also persist in the body for several weeks.



Method of administration: oral.



Withdrawal symptoms seen on discontinuation of SSRI



Abrupt discontinuation should be avoided. When stopping treatment with fluoxetine the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 Special warnings and precautions for use and 4.8 Undesirable effects). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.



4.3 Contraindications



Fluoxetine is contra-indicated in the following circumstances:



- hypersensitivity to fluoxetine or any of the other ingredients,



- in breast-feeding mothers,



- in unstable or uncontrolled epilepsy,



- in severe renal failure (i.e. GFR <10ml/minute), or



- if the patient has been taking monoamine oxidase inhibitors (MAOIs) within the past 2 weeks due to the “serotonin syndrome", see section 4.5. Interactions.



4.4 Special Warnings And Precautions For Use



Suicide/suicidal thoughts or clinical worsening



Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide



Other psychiatric conditions for which fluoxetine is prescribed can also be associated with an increased risk of suicide



Patients with a history of suicide



Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.



If a rash or other allergic reaction such as urticaria or angioneurotic oedema occurs, fluoxetine should be discontinued, unless an alternative cause can be identified.



Fluoxetine must be discontinued in patients who start having seizures. Fluoxetine should be avoided in patients suffering with unstable epilepsy. Patients with controlled epilepsy should be carefully monitored as prolonged seizures have been reported in this group.



A lower dose, e.g. alternate day dosing, is recommended in patients with significant hepatic impairment or mild to moderate renal failure (GFR 10-50ml/minute) as fluoxetine is extensively metabolised hepatically and excreted renally.



Caution is advised in patients with acute cardiac disease as clinical experience is limited.



Fluoxetine may cause weight loss which may not be desirable in underweight patients who are depressed, although only rarely has fluoxetine been discontinued in patients with depression or bulimia due to this.



Fluoxetine may alter blood glucose control in patients with diabetes. Hypoglycaemia has occurred during treatment with fluoxetine. Hyperglycaemia has developed after discontinuation of fluoxetine. Diabetic patients taking insulin with or without other hypoglycaemic therapy may need to have their dosages of insulin and/or hypoglycaemic drugs adjusted.



Psychosis and mood shift towards manic phase have been reported which may require discontinuation of treatment.



Abrupt discontinuation of treatment should be avoided. Withdrawal reactions have been reported in association with selective serotonin reuptake inhibitors (SSRIs) including fluoxetine, common symptoms include headache, dizziness, paraesthesia, anxiety and nausea. The majority of symptoms experienced on withdrawal of SSRIs are non-serious and self limiting.



There is little clinical experience of concurrent administration of SSRI's and electroconvulsive therapy (ECT), therefore caution is advised.



There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura with SSRI's. Caution is advised in patients taking SSRI's, particularly in concomitant use with drugs known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, aspirin and NSAID's) as well as in patients with a history of bleeding disorders.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



The long elimination time needs to be borne in mind when considering drug interactions.



Fluoxetine binds to plasma protein and concurrent administration may alter plasma concentrations of other plasma protein-bound drugs, or vice versa. In tests, no drug interaction of clinical significance was observed between fluoxetine and chlorothiazide, ethanol, tolbutamide or secobarbital.



Monoamine oxidase inhibitors: at least 14 days should elapse between discontinuation of monoamine oxidase inhibitors (MAOIs) and initiation of treatment with Fluoxetine Capsules. Conversely, at least 5 weeks should elapse between discontinuation of fluoxetine and initiation of therapy with an MAOI. NB this period should be longer if fluoxetine has been prescribed chronically or at higher doses. The serotonin syndrome, i.e. serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation, progressing to delirium and coma) have been reported with concomitant use of MAOIs and fluoxetine or when fluoxetine had been recently discontinued and an MAOI started. Some patients developed features resembling neuroleptic malignant syndrome in which case cyproheptadine or dantrolene may be beneficial.



CNS active drugs such as lithium should be administered with caution with fluoxetine. Reports have been made of both increased and decreased lithium levels and also of lithium toxicity. Levels of lithium should be monitored.



As fluoxetine is metabolised by the hepatic cytochrome CY3PA and P450IID6 isoenzymes, co-administration of other drugs similarly metabolised may lead to drug interactions. Drugs such as flecainide, encainide, vinblastine, carbamazepine and tricyclic antidepressants which have a narrow therapeutic index should be started at a low dose when taken at the same time as fluoxetine or within 5 weeks of stopping fluoxetine. More than 2-fold increases in previously stable plasma levels of tricyclic antidepressants have been seen when fluoxetine has been concomitantly administered.



Restlessness, agitation and gastro-intestinal symptoms have been reported in a small number of patients receiving fluoxetine at the same time as tryptophan.



Patients, previously stable on phenytoin, have developed raised plasma levels of phenytoin and clinical phenytoin toxicity following the start of concomitant fluoxetine therapy.



No drug interaction between fluoxetine and warfarin has been observed in formal testing. However, possible interactions have been rarely reported.



Fluoxetine does not seem to potentiate the effects of alcohol.



Dynamic interactions between fluoxetine and the herbal remedy, St. John's wort (Hypericum perforatum) can occur, resulting in an increase in undesirable effects.



4.6 Pregnancy And Lactation



The safety of fluoxetine has not been established during pregnancy, and therefore its use is not recommended. Fluoxetine is contra-indicated in breast-feeding mothers as breast milk has been found to contain fluoxetine and norfluoxetine.



4.7 Effects On Ability To Drive And Use Machines



Fluoxetine does not seem to affect psychomotor performance. However, if patients find that their concentration is impaired, or they feel tired or dizzy, they should not drive or operate machines.



4.8 Undesirable Effects



General: Asthenia, fever, loss of appetite, weight loss, or hair loss (usually reversible). Rare reports of hyponatraemia (including serum sodium below 110 mmol/litre) have been made which appeared to be reversible on discontinuation of fluoxetine; some cases may have been due to inappropriate ADH secretion. Most reports of hyponatraemia were associated with elderly patients, or patients taking diuretics or who were otherwise volume depleted.



Allergic reactions: see Skin and appendages.



Digestive system: dry mouth, dyspepsia, nausea, vomiting, or diarrhoea.



Hepatic system: abnormal liver function tests have been rarely reported.



Nervous system: the following effects have been reported: headache, nervousness, fatigue, drowsiness, insomnia, anxiety, tremor, dizziness, seizures, hypomania or mania, dyskinesia, movement disorders in patients with risk factors (including drugs associated with movement disorders), worsening of pre-existing movement disorders, or neuroleptic malignant syndrome-like events.



Reproductive system: decreased libido or sexual dysfunction (delayed or inhibited orgasm) may occur.



Respiratory system: pharyngitis or dyspnoea. Rare reports of pulmonary events with dyspnoea as the only preceding symptom (including various inflammatory processes and/or fibrosis) have been made.



Skin and appendages: a small percentage of patients developed rash and/or urticaria. Serious systemic reactions, possibly related to vasculitis, have developed in patients with rash, and rarely death has been reported. Hyperhidrosis, arthralgia, myalgia, serum sickness and anaphylactoid reactions have also been reported. If a rash or other allergic reaction occurs such as urticaria or angioneurotic oedema, fluoxetine should be discontinued, unless an alternative cause can be identified.



The following have been reported in association with fluoxetine but no causal relationship has been established: abnormal bleeding, anaemia (aplastic and immune-related haemolytic), cerebrovascular accident, confusion, ecchymoses, eosinophilic pneumonia, gastrointestinal haemorrhage, hyperprolactinaemia, pancreatitis, pancytopenia, purpura, thrombocytopenia, vaginal bleeding after drug withdrawal and violent behaviour.



Cases of suicidal ideation and suicidal behaviours have been reported during fluoxetine therapy or early after treatment discontinuation (see section 4.4).



4.9 Overdose



The fatal dose is not known. The effects will be potentiated by alcohol taken at the same time. Toxicity is also potentiated by tricyclic antidepressants and MAOIs.



Symptoms



Nausea, vomiting, agitation, tremor, nystagmus and drowsiness may occur. Convulsions have been reported in a small percentage of cases and may not occur until up to ten hours after ingestion. Sinus tachycardia is common. Less frequently bradycardia, hypertension and junctional rhythm may occur.



Rarely features of the "serotonin syndrome" may occur. This includes alteration of mental status, neuromuscular hyperactivity and autonomic instability. There may be hyperpyrexia and elevation of serum creatine kinase. Rhabdomyolysis is rare.



Management



Consider oral activated charcoal if more than 500 mg has been ingested by an adult or if more than 5 mg/kg has been ingested by a child within one hour. Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC Code: N06A B03.



Fluoxetine is a specific serotonin (5-hydroxytryptamine, 5-HT) reuptake inhibitor.



5.2 Pharmacokinetic Properties



Fluoxetine is readily absorbed from the gastro-intestinal tract with peak plasma levels approximately 6-8 hours after oral administration, although steady state plasma concentrations do not occur until after several weeks. Fluoxetine is widely distributed throughout the body and is extensively bound to plasma proteins.



The drug is largely metabolised hepatically to its primary metabolite, norfluoxetine. Fluoxetine has an elimination half-life of about 1-6 days depending on type of administration (acute 1-3 days, chronic 4-6 days). Norfluoxetine's elimination half-life is approximately 4-16 days after multiple doses. This is of clinical significance as after the patient has stopped taking fluoxetine, the active substance and its metabolites may remain in the body for weeks. Excretion is mainly via the kidneys.



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber which are additional to that already included in the other sections of the Summary of Product Characteristics.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Pregelatinised maize starch, anhydrous colloidal silica, magnesium stearate, talc, quinoline yellow (E104), indigo carmine (E132), titanium dioxide (E171) and gelatin.



6.2 Incompatibilities



None known.



6.3 Shelf Life



Blister packs: 24 months. HDPE bottles: 36 months.



6.4 Special Precautions For Storage



Blister pack: Do not store above 25°C. Store in the original package.



HDPE bottle: No special storage recommendations.



6.5 Nature And Contents Of Container



i) Aluminium/PVC blister strips packed in an outer carton, or



ii) A high density polyethylene bottle with low density polyethylene snap-on cap.



Pack sizes: 28 and 30.



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



Sandoz Limited



Woolmer Way



Bordon



Hampshire



GU35 9QE



United Kingdom



8. Marketing Authorisation Number(S)



PL 04416/0330



9. Date Of First Authorisation/Renewal Of The Authorisation



05/03/2009



10. Date Of Revision Of The Text



27/07/2009