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Monday, 3 September 2012

Propofol

Class: General Anesthetics, Miscellaneous
VA Class: CN203
Chemical Name: 2,6-Bis(1-methylethyl) phenol
Molecular Formula: C₁₂H₁₈O
CAS Number: 2078-54-8
Brands: Diprivan

Microbial Contamination

Propofol injectable emulsion can support microbial growth.¹ (See Potential for Microbial Contamination under Cautions.)

Use strict aseptic technique at all times during handling; failure to use aseptic technique may result in microbial contamination and possible fever, infection/sepsis, other life-threatening illness, and/or death.¹ ² ¹⁰³ ¹¹³ ¹⁹⁴ ¹⁹⁵ ¹⁹⁷ ¹⁹⁸ ¹⁹⁹

Discard unused portions within the required time limits.¹ ² (See Stability and Sterility Considerations under Dosage and Administration.)

Do not use if contamination is suspected.¹ ² ¹⁹⁴

Introduction

Sedative and hypnotic.¹ ²

Uses for Propofol

Induction and Maintenance of Anesthesia

Induction and/or maintenance of anesthesia as the sedative and hypnotic component of balanced anesthesia (benzodiazepines, anticholinergic agents, depolarizing and nondepolarizing skeletal muscle relaxants, opiate analgesics, inhalation and/or regional anesthetic) or total IV anesthesia (balanced anesthesia in which the IV anesthetic completely replaces the inhalation anesthetic) in patients undergoing inpatient or outpatient surgery.¹ ² ⁶ ⁷ ⁸ ⁹ ¹¹⁸ ¹⁹²

Produces adequate general anesthesia in patients undergoing various types of surgery, including neurosurgery (e.g., craniotomy, intracranial aneurysm);¹ ² ⁶ cardiovascular (e.g., CABG);¹ ² ⁶ ⁷ abdominal;⁶ ocular;⁶ ear, nose, and throat (ENT);⁸ orthopedic;⁸ and general surgery.¹ ²

Considered the hypnotic of choice by some clinicians for patients undergoing outpatient surgery.¹¹⁸ Usually is associated with similar or faster early recovery (time to awakening and eye opening) from anesthesia, more rapid recovery of psychomotor performance and time to discharge, and lower incidence of adverse effects (e.g., nausea, vomiting, cough, hiccups) compared with other IV anesthetic agents (e.g., etomidate, methohexital, thiopental) or conventional combinations (e.g., an IV induction agent and an inhalation anesthetic).⁶ ⁷ ⁹ ¹⁰ ¹¹⁸

Monitored Anesthesia Care (MAC)

Initiation and maintenance of MAC sedation (alone or in combination with an opiate analgesic and/or a benzodiazepine) in adults undergoing diagnostic procedures or in conjunction with local or regional anesthesia for surgical procedures.¹ ² ⁶ ⁷ ¹⁵² ¹⁵³ ¹⁵⁴ ¹⁵⁵ ¹⁵⁶ ¹⁵⁷ ¹⁵⁸

Provides sedation, analgesia, anxiolysis, and/or amnesia without assisted respiration or loss of consciousness⁶ ⁷ ¹³¹ when administered prior to and/or during dental,⁶ endoscopic (e.g., gastroscopy, bronchoscopy, colonoscopy),⁶ ⁷ diagnostic,⁷ oral,⁷ or other procedures such as extracorporeal lithotripsy,⁶ ⁷ transvaginal oocyte retrieval,⁶ ⁷ central venous catheter placement,⁷ herniorrhaphy,⁷ and electrical cardioversion.⁶

Used in conjunction with local or regional anesthesia for surgical procedures, including orthopedic (hip or knee arthoplasty),⁶ ³⁰ abdominal,⁶ or urologic⁶ surgery.

Produces less postoperative sedation, drowsiness, confusion, clumsiness, and nausea and a more rapid recovery of psychomotor performance than IV midazolam; however, midazolam has been associated with less pain at the injection site, less frequent oxygen requirements for decreased oxygen saturation, and more effective intraoperative amnesia.⁶ ⁷ ⁹ ²³ ⁴² ⁴³ ¹⁷⁰ ¹⁷¹ Quality of intraoperative sedation and time to discharge appear to be similar.⁶ ⁷ ²³

Sedation in Critical Care Settings

Short-term sedation and control of stress responses in intubated and mechanically ventilated adults in a critical care setting¹ ² ⁵ ³³ ³⁴ ³⁵ ³⁶ ³⁷ ³⁹ ⁴⁰ ⁴¹ ⁴⁷ ⁶⁹ ¹³² ¹³³ ¹³⁵ when used alone or in combination with an opiate analgesic (e.g., morphine, fentanyl, hydromorphone) and/or peridural analgesia with local anesthetics.¹ ² ⁵ ⁸ ³³ ³⁵ ³⁶ ³⁸ ³⁹ ⁴¹ ⁶⁹ ¹³² ¹³³ ¹³⁵ ¹³⁶ ¹⁵⁹ ¹⁶⁰ ¹⁶²

Some experts state that midazolam or diazepam should be used for rapid sedation in acutely agitated patients, while propofol is the preferred sedative when rapid awakening (e.g., for neurologic assessment or extubation) is important.¹³⁶

Seizures

Has been used in patients with refractory status epilepticus†.⁴ ¹⁷ ⁴⁸ ⁴⁹ ¹³⁴ ¹³⁷ ¹⁶⁸ ¹⁶⁹

Nausea and Vomiting

Has been used for the management of postoperative nausea and vomiting†.¹⁷ ⁵⁰

Has been used in combination with conventional antiemetics for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy†.¹⁷ ⁵¹ ⁵²

Pruritus

Has been used effectively for relief of pruritus† associated with use of spinal opiates or with cholestasis.¹⁷ ⁵³ ⁵⁴ ⁵⁵ ⁵⁶

Misuse and Abuse

Abuse and dependence, sometimes resulting in death, have been reported.⁵⁷ ⁶⁵ ⁶⁶ ⁸³ ¹⁰⁹ ²⁰⁰ ²⁰¹ ²⁰² ²⁰³ ²⁰⁴ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ Most reports involved health-care professionals (principally anesthesiology personnel),⁵⁷ ¹⁰⁹ ²⁰¹ ²⁰² ²⁰³ ²⁰⁴ ²⁰⁹ but abuse by lay persons also reported.²⁰⁰ ²⁰⁶ ²⁰⁸ ²⁰⁹

Currently not subject to control under the Federal Controlled Substances Act of 1970; however, some clinicians have suggested such control or some other means of ensuring greater accountability (e.g., restriction of access, drug accounting procedures, routine testing for propofol in drug screenings of at-risk individuals).¹ ⁶⁵ ⁶⁷ ⁸³ ¹⁹⁴ ²⁰⁴ ²⁰⁵ Prevalence of abuse and related deaths appears to be greater at institutions with no established system to control or monitor propofol use.²⁰⁴ ²⁰⁵

Propofol Dosage and Administration

Administration

IV Administration

Administer by IV infusion¹ ² ⁴ ⁶ ⁸ ⁹ ¹⁰ ¹⁰² ¹¹⁸ or IV injection.¹ ² ³ ⁴ ⁶ ⁸ ⁹ ¹⁰ ¹⁰² ¹¹⁸

For IV infusion, use a controlled-infusion device (pump), preferably a volumetric pump.¹ ² In patients undergoing magnetic resonance imaging (MRI), use metered controlled devices when mechanical pumps are not suitable.¹ ²

Use the larger veins of the forearm or antecubital fossa (rather than hand veins) in adults and children to minimize pain at the injection site; may also administer IV lidocaine prior to administration of propofol to minimize pain.¹ ² ¹⁴⁴ (See Local Effects under Cautions.) Administer 1 mL of 1% lidocaine hydrochloride solution 30–120 seconds prior to propofol administration or add lidocaine to propofol immediately prior to administration in quantities not exceeding 20 mg of lidocaine hydrochloride per 200 mg of propofol.¹ ² ⁴ ⁶ ⁸ ⁹ ¹⁴⁴ ¹⁹⁴

Transfer contents of the vial into a sterile, single-use syringe immediately after the vial is opened and after cleaning the rubber stopper with 70% isopropyl alcohol; use a sterile venting spike when withdrawing propofol from vials.¹ ² ⁷

Prepare propofol for single patient use only.¹ ¹⁹⁴ Label syringes with appropriate information, including the date and time the vial was opened.¹ ¹⁹⁴

Shake well just prior to administration.¹ ²

Clinical experience with use of inline filters for administration during general anesthesia, MAC sedation, or sedation in critical care settings is limited.¹ ² An inline membrane filter may be used; however, the mean pore diameter of the filter should be ≥5 mcm unless it has been demonstrated that the filter does not restrict the flow and/or cause breakdown of the emulsion.¹ ² ¹¹ Use filters with caution and only when clinically appropriate.¹ ¹⁹⁴ Monitor continuously for restricted flow and breakdown of the emulsion.¹ ¹⁹⁴

Stability and Sterility Considerations

For solution and drug compatibility, see Compatibility under Stability.

Manufacturers state that propofol should not be admixed with other therapeutic agents prior to administration.¹ ² ¹² Do not administer through the same catheter as blood, serum, or plasma.¹ ²

Observe strict aseptic technique.¹ ² ³ Although commercially available preparations contain ingredients that retard growth of microorganisms (e.g., Diprivan contains edetate disodium 0.005%), the emulsion still may support growth of microorganisms.¹ ³ ¹⁹⁴ Do not use the emulsion if contamination is suspected.¹ ² ¹⁹⁴

General anesthesia or MAC sedation: Start administration promptly and complete within 12 hours after opening the vials or syringes.¹ ² ⁷ ¹⁹⁴ Prepare propofol for use immediately prior to initiation of each individual anesthetic/sedative procedure.¹ Discard any unused portion, reservoirs, dedicated administration tubing, and/or solutions containing propofol at the end of the anesthetic procedure or after 12 hours (whichever occurs sooner).¹ ¹⁹⁴ FDA recommends completing administration from a single vial or syringe within 6 hours of opening when propofol is used for general anesthesia or procedural sedation (see Potential for Microbial Contamination under Cautions).¹⁹⁵ Flush the IV line every 12 hours (one manufacturer recommends flushing with 5% dextrose)¹⁹² and at the end of the procedure to remove residual propofol emulsion.¹ ² ¹⁸¹ ¹⁹⁴

Sedation in critical care settings: Minimize manipulations of IV lines; start administration promptly and complete within 12 hours after inserting spike in vial.¹ ² ⁷ Use a sterile vent spike and sterile tubing.¹ ¹⁹⁴ Discard any unused portion and the IV tubing at the end of the procedure or after 12 hours.¹

Dilution

May administer as a 1% (10 mg/mL) emulsion without dilution.¹ ²

If dilution is necessary, the emulsion should be diluted only with 5% dextrose injection; concentration should be ≥0.2% (2 mg/mL) in order to maintain the emulsion.¹ ² ⁴ Discard if there is evidence of separation of the emulsion.¹ ²

Rate of Administration

Administer slowly to minimize adverse effects (e.g., hypotension, respiratory depression).¹ ² (See Respiratory and Cardiovascular Effects under Cautions.)

For IV injection, administer in incremental doses.¹ ² ³ ⁴ ⁶ ⁸ ⁹ ¹⁰ ¹⁰² ¹¹⁸ (See Dosage.)

Adjust rate of continuous IV infusions according to individual requirements.¹ ² (See Dosage.) In the absence of clinical signs indicating light anesthesia and until a mild response to surgical stimulation develops, titrate infusion rate downward to avoid administration at rates higher than clinically necessary.¹ ²

Allow sufficient time between dosage adjustments for onset of peak response.¹ ² (See Dosage.)

Dosage

Individual response to propofol is variable; therefore, adjust dosage (including infusion rate or amount and frequency of incremental doses) according to individual requirements and response, age, weight, clinical status (e.g., ASA physical status, degree of debilitation), blood lipid profile, underlying pathologic conditions (e.g., shock, intestinal obstruction, malnutrition, anemia, burns, advanced malignancy, ulcerative colitis, uremia, alcoholism), and type and amount of premedication or concomitant medication(s) used.¹ ² ¹¹⁸ Use the smallest effective dosage.¹ ²

Pediatric Patients

Induction and Maintenance of General Anesthesia

IV

Induction of anesthesia in children 3–16 years of age (following no premedication or premedication with oral benzodiazepines or IM opiate agonists): 2.5–3.5 mg/kg over 20–30 seconds in those with ASA physical status of I or II.¹ ² Within this dosage range, younger patients may require higher induction dosages than older patients.¹ ² A lower dosage is recommended for induction of anesthesia in patients with ASA physical status of III or IV.¹ ²

Maintenance of anesthesia in children 2 months to 16 years of age: Initially, 125–300 mcg/kg per minute (7.5–18 mg/kg per hour) administered concomitantly with inhaled 60–70% nitrous oxide and oxygen in those with ASA physical status of I or II.¹ ² Dosage of 200–300 mcg/kg per minute may be required for the first 30 minutes after induction, then decrease dosage to 125–150 mcg/kg per minute (unless clinical signs of light anesthesia develop) by titration, according to the patient’s response.¹ ² Within this dosage range, younger patients may require higher infusion rates than older patients.¹ ²

Adults

Induction and Maintenance of General Anesthesia

General Surgery

Induction of anesthesia (following no premedication or premedication with oral benzodiazepines or IM opiate agonists) in adults <55 years of age with ASA physical status of I or II: 40 mg (2–2.5 mg/kg) every 10 seconds according to the patient’s response until the onset of induction.¹ ²

Maintenance of anesthesia in adults <55 years of age: Initially, 100–200 mcg/kg per minute (6–12 mg/kg per hour) administered concomitantly with inhaled 60–70% nitrous oxide and oxygen.¹ ² Higher IV infusion rates of 150–200 mcg/kg per minute may be required for the first 10–15 minutes after induction, then decrease the infusion rate by 30–50% during the first 30 minutes of maintenance anesthesia.¹ ²

Alternatively, for maintenance of anesthesia in adults <55 years of age: 20–50 mg by intermittent IV injection in combination with inhaled nitrous oxide.¹ ² ¹⁹² Additional IV doses of 25–50 mg may be given, if necessary, as determined by clinical signs (increases in pulse rate, BP, sweating, and/or lacrimation) indicating a stress response to surgical stimulation or emergence from anesthesia.¹ ² ¹⁹⁴

Cardiac Anesthesia

Induction of anesthesia: 20 mg (0.5–1.5 mg/kg) every 10 seconds, administered by slow IV injection until the onset of induction.¹ ² ¹⁹² Dosage of 25 mcg/kg per minute may be used for management of anxiolysis prior to induction.¹ ²

Maintenance of anesthesia: 100–150 mcg/kg per minute as a continuous IV infusion when used as the primary agent and supplemented with a continuous infusion of an opiate agonist (e.g., alfentanil, fentanyl, sufentanil) administered to provide analgesia.¹ ² Higher propofol dosages will reduce opiate analgesic dosage requirements.¹ ²

When an opiate agonist is used as the primary agent for maintenance of anesthesia, administer propofol at a rate of ≥50 mcg/kg per minute; ensure adequate amnesia.¹ ² ¹⁹⁴

Neurosurgery

Induction of anesthesia: 20 mg (1–2 mg/kg) every 10 seconds until the onset of induction.¹ ²

Maintenance of anesthesia: 100–200 mcg/kg per minute (6–12 mg/kg per hour).¹ ²

Monitored Anesthesia Care

IV

Initiation of MAC sedation in adults <55 years of age: Infusion of 100–150 mcg/kg per minute (6–9 mg/kg per hour) for 3–5 minutes; alternatively, injection of 0.5 mg/kg over 3–5 minutes.¹ ² Slow rate of infusion or injection recommended to reduce the risk of apnea and hypotension.¹ ²

Maintenance dosage in adults <55 years of age: Infusion of 25–75 mcg/kg per minute (1.5–4.5 mg/kg per hour) for the first 10–15 minutes, then decrease the infusion rate to 25–50 mcg/kg per minute.¹ ² Adjust dosage according to clinical effect, allowing approximately 2 minutes for onset of peak drug response.¹ ²

Alternatively, for maintenance therapy, administer intermittent IV injections of 10 or 20 mg; however, a variable-rate IV infusion is preferred.¹ ² (See Monitored Anesthesia Care under Cautions.)¹ ²

In neurosurgical patients, reduce maintenance dosage by 20%.¹ ² Rapid IV injection is not recommended in these patients because of an increased risk of adverse cardiorespiratory effects.¹ ²

Sedation in Critical Care Settings

IV

Initially, 5 mcg/kg per minute (0.3 mg/kg per hour) for ≥5 minutes in patients with residual effects from anesthetic or sedative drugs.¹ ² ⁵ Increase the infusion rate slowly in increments of 5–10 mcg/kg per minute (0.3–0.6 mg/kg per hour) over 5–10 minutes until desired sedation is achieved.¹ ² ⁵ Initiate and increase the infusion rate slowly in these patients to minimize the risk of hypotension or acute overdosage.¹ ² ⁵

For maintenance of sedation: 5–50 mcg/kg per minute (0.3–3 mg/kg per hour); higher maintenance infusion rates occasionally required.¹ ² ⁵ Rapid IV (“bolus”) administration of 10- or 20-mg doses may be used to rapidly increase depth of sedation in patients in whom development of hypotension is unlikely.¹ ²

Use the lowest effective dosage in patients with residual effects from anesthetic drugs or in those currently receiving other sedatives or opiates.¹ ² ¹⁸¹ ¹⁹²

Assess level of sedation and CNS function at regular intervals (at least daily during maintenance sedation); adjust infusion rate accordingly to ensure adequate titration of the sedation level.¹ ² ¹³⁶ ¹⁸¹ ¹⁹²

Do not administer Diprivan injectable emulsion as a continuous IV infusion for >5 days without a drug-free interval to allow replacement of estimated or measured urinary zinc losses.¹ ² ¹³⁶ (See Edetate Disodium Content under Cautions.)

Some tolerance to the drug’s sedative effects may occur during long-term (>7 days) therapy; increasing the infusion rate may be necessary.⁵ ⁶⁴ However, such effects also may be associated with changes in drug elimination or an improved health status of the patient.⁶⁴

Seizures†

Refractory Status Epilepticus†

Initially, 1- to 2-mg/kg doses by IV injection over 5 minutes; repeat when seizure activity no longer is adequately controlled.⁴ ¹³⁷ Maintenance infusion of 2–10 mg/kg per hour; adjust the infusion rate until the lowest rate of infusion needed to suppress epileptiform activity is achieved.⁴ ¹³⁷ Gradually decrease the dosage to prevent withdrawal seizures.¹³⁷

Nausea and Vomiting†

Postoperative Nausea and Vomiting†

Doses of 10–15 mg have been used.¹⁷ ⁵⁰

Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy†

Dosage of 1 mg/kg per hour as a continuous IV infusion has been used.¹⁷ ⁵¹ ⁵²

Pruritus†

Pruritus Associated with Use of Spinal Opiates†

Doses of 10 mg administered by direct IV injection have been used; alternatively, IV infusions of 0.5–1 mg/kg per hour have been used.¹⁷ ⁵³ ⁵⁴

Pruritus Associated With Cholestasis†

Doses of 15 mg administered by direct IV injection have been used; alternatively, IV infusions of 1–1.5 mg/kg per hour have been used.¹⁷ ⁵³ ⁵⁴

Special Populations

Geriatric Patients (≥55 Years of Age), Debilitated Patients, and Patients with ASA Physical Status of III or IV

Induction and Maintenance of General Anesthesia

Induction of anesthesia: 20 mg (1–1.5 mg/kg) every 10 seconds according to the individual patient’s condition and response until the onset of induction.¹ ²

Maintenance of anesthesia: 50–100 mcg/kg per minute (3–6 mg/kg per hour) administered concomitantly with inhaled 60–70% nitrous oxide and oxygen.¹ ²

Monitored Anesthesia Care

Initiation of MAC sedation: Dosages similar to those for healthy adults are required.¹ ² ¹⁹²

Maintenance of MAC sedation: Reduce dosage by 20%.¹ ² Rapid IV injection is not recommended because of an increased risk of adverse cardiorespiratory effects.¹ ²

Cautions for Propofol

Contraindications

Known hypersensitivity to propofol or any ingredient in the formulation.¹ ¹⁹⁴

Known hypersensitivity to eggs, egg products, soybeans, or soy products.¹ ¹⁹⁴

Warnings/Precautions

Warnings

Respiratory and Cardiovascular Effects

Can depress respiration;¹ ² ⁵ ⁶ ⁸ ⁹ apnea occurs frequently during induction of anesthesia.¹ ² ⁴ ⁶ ⁸ ⁹ ¹⁰ ¹¹⁸

Cardiovascular depressant¹ ² ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹⁸ with effects greater than or equal to those associated with other IV anesthetic induction agents.⁶ ⁸ ⁹ ¹⁰ ¹¹⁸ The main adverse cardiovascular effect during induction of anesthesia is hypotension, with ≥30% decreases in systolic and diastolic BP.¹ ² ⁴ ⁶ ⁷ ¹¹⁸

Patients with impaired myocardial function, intravascular volume depletion, or abnormally low vascular tone (sepsis) may be more susceptible to hypotension.¹ ²

Management of hypotension may include discontinuance of propofol, increasing the rate of IV fluid administration (except when additional fluid therapy is contraindicated), elevation of the lower extremities, and/or use of vasopressors.¹ ²

Possible bradycardia, asystole, and rarely, cardiac arrest, especially in pediatric patients receiving fentanyl concomitantly.¹ ² (See Specific Drugs under Interactions.) Consider intervention with anticholinergic agents (e.g., atropine, glycopyrrolate) to modify potential increases in vagal tone associated with surgical stimuli or concomitant use of certain drugs (e.g., succinylcholine).¹ ²

Pulmonary edema reported rarely; causal relationship not established.¹ ²

Monitor sedated patients continuously for early signs of hypotension and bradycardia;¹ ² ¹⁹⁴ also monitor for adverse respiratory effects (e.g., apnea, airway obstruction, oxyhemoglobin desaturation), especially in those undergoing MAC sedation.¹ ² ¹⁹⁴

Cardiorespiratory effects are more likely to occur following administration of rapid IV (“bolus”) injections, especially in patients with ASA physical status of III or IV and in geriatric or debilitated patients.¹ ² ¹⁹⁴ (See Special Populations under Dosage and Administration.)

Facilities necessary for intubation, assisted respiration, administration of oxygen, and cardiopulmonary resuscitation should be readily available.¹ ² ⁶ ⁷ ¹³⁰ ¹³¹ ¹⁹²

Supervised Administration

Should be administered for general anesthesia or MAC sedation only by individuals experienced in the use of general anesthesia who are not involved in the conduct of the surgical and/or diagnostic procedure.¹ ² ⁶ ⁷ ¹³⁰ ¹³¹

Should be administered for sedation of intubated, mechanically ventilated patients in critical care settings only by individuals qualified in the management of patients in these settings and trained in cardiovascular resuscitation and airway management.¹ ² ⁷ ¹⁹²

Potential for Microbial Contamination

Potential for microbial contamination of the injection and consequent development of fever, infection, sepsis, other life-threatening illness, or death with improper aseptic technique in handling propofol.¹ ² ¹⁰³ ¹⁹⁴

Although commercially available preparations contain ingredients that retard growth of microorganisms, they are not considered antimicrobially preserved products by USP standards.¹ ¹⁰³ ¹⁹⁴ Contamination of propofol with even very small numbers of microorganisms may result in clinical disease;¹⁹⁷ strict aseptic technique and strict adherence to the manufacturer’s preparation and handling instructions are required.¹ ¹⁰³ ¹¹³ ¹⁹⁴ ¹⁹⁵ ¹⁹⁷ ¹⁹⁸ ¹⁹⁹ (See Stability and Sterility Considerations under Dosage and Administration.)

Do not use the emulsion if contamination is suspected; discard unused portions as recommended by the manufacturers.¹ ² (See Stability and Sterility Considerations under Dosage and Administration.)

Several clusters of patients experiencing chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia reported.¹⁹⁵ Symptoms developed 6–18 hours after propofol administration and lasted up to 3 days.¹⁹⁵ Several patients were hospitalized and one experienced seizures; all patients recovered without apparent sequelae.¹⁹⁵ Evaluate patients who develop these symptoms shortly after receiving propofol for bacterial sepsis and report such cases to the FDA MedWatch program.¹⁹⁵

Specific lots of propofol (Teva) were recalled secondary to the presence of elevated endotoxin levels.¹⁹⁶

Dependence, Tolerance, and Abuse

Dependence and abuse, sometimes resulting in death, have been reported.⁵⁷ ⁸³ ¹⁰⁹ ²⁰⁰ ²⁰¹ ²⁰² ²⁰³ ²⁰⁴ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ Most reported cases have involved health-care professionals (principally anesthesiology personnel),⁵⁷ ⁶⁵ ⁶⁶ ¹⁰⁹ ²⁰¹ ²⁰² ²⁰³ ²⁰⁴ ²⁰⁹ but abuse by lay persons also reported.²⁰⁰ ²⁰⁶ ²⁰⁸ ²⁰⁹

Psychological dependence (e.g., intense craving for the drug, loss of control over amount and frequency of use) reported in cases of propofol abuse.⁵⁷ ²⁰⁰ ²⁰² ²⁰⁶ ²⁰⁷ Withdrawal symptoms (e.g., insomnia, anxiety, difficulty concentrating), suggesting physical dependence, observed rarely.²⁰² Signs of tolerance also observed.¹⁰⁹ ²⁰⁰ ²⁰⁶

Sensitivity Reactions

Sulfite Sensitivity

Some formulations contain sulfites that may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.² ¹⁶³ ¹⁹⁴

Hypersensitivity Reactions

Anaphylactoid and/or anaphylactic reactions (e.g., angioedema, bronchospasm, erythema, hypotension) and flushing, possibly related to propofol, reported in <1% of adults undergoing anesthesia or MAC sedation with the drug; may be fatal or life-threatening.¹ ² ⁴ ⁶ ¹⁹⁴

General Precautions

Local Effects

Pain at the injection site occurs in up to 70% of patients¹⁴⁴ following peripheral IV administration.¹ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ⁸⁹ ¹¹⁸ ¹⁴⁴ Thrombosis or phlebitis reported rarely.¹ ²

Pain, but no evidence of major sequelae, reported following inadvertent intra-arterial injection.¹ ² ⁸ ¹¹⁸ Local pain, swelling, blisters and/or tissue necrosis reported rarely following inadvertent extravasation.¹ ²

To minimize pain at the injection site, use the larger veins of the forearm or antecubital fossa rather than hand veins; may also administer lidocaine prior to IV administration of propofol¹ ² ⁴ ⁶ ⁸ ⁹ ¹⁴⁴ (see IV Administration under Dosage and Administration). Other methods have been used: prior administration of opiates or metoclopramide, prior application of a tourniquet, topical nitroglycerin or a local anesthetic cream, or administration of propofol at low temperatures (4–5°C).⁶

Metabolic Effects

Propofol infusion syndrome reported in patients receiving propofol for sedation in a critical care setting.¹ ¹⁹⁴ ²¹¹ Characterized by severe metabolic acidosis, hyperkalemia, lipidemia, rhabdomyolysis, hepatomegaly, and cardiac, renal, or circulatory failure.¹ ¹⁹⁴ ²¹¹ Occurs most frequently in patients receiving prolonged, high-dose infusions (>5 mg/kg per hour for >48 hours) but has occurred following short-term, high-dose infusions during surgical anesthesia.¹ ¹⁹⁴ ²¹¹

Closely monitor patients for development of unexplained acidosis, rhabdomyolysis, and cardiac or renal failure.²¹¹ Consider alternate means of sedation in the setting of prolonged need for sedation, increasing propofol dosage requirements to maintain a constant level of sedation, or onset of metabolic acidosis during propofol infusion.¹ ¹⁹⁴

Effects on Lipids

Commercial propofol preparations are oil-in-water emulsions; use with caution in patients with disorders of lipid metabolism (e.g., primary hyperlipoproteinemia, diabetic hyperlipemia, pancreatitis).¹ ²

Prolonged administration may result in increased serum lipid concentrations (e.g., hypertriglyceridemia); monitor patients undergoing sedation in a critical care setting who are at risk of developing hyperlipidemia for increases in serum triglyceride concentrations or serum turbidity.¹ ²

Reduce the quantity of concurrently administered lipids (e.g., fat emulsions for parenteral nutrition) in these patients in order to compensate for the amount of lipids contained in the propofol formulation (1 mL of propofol injectable emulsion contains 0.1 g of fat [1.1 kcal]).¹ ²

Edetate Disodium Content

Certain formulations (Diprivan) contain 0.005% of edetate disodium, a heavy metal antagonist that can chelate many divalent and trivalent cations.¹ ¹³⁶

Patients receiving continuous infusions for sedation in critical care settings should not receive formulations containing edetate disodium for >5 days without a drug-free interval to allow replacement of estimated or measured urinary zinc losses.¹

In patients who are predisposed to zinc deficiency

Sunday, 26 August 2012

Pediotic

Generic Name: hydrocortisone, neomycin, and polymyxin B otic (HYE droe KOR ti sone, NEE oh MYE sin, POL ee MIX in B)

Brand Names: Cort-Biotic, Cortatrigen, Cortatrigen Modified, Cortisporin Otic, Cortomycin, Oti-Sone, Pediotic

What is Pediotic (hydrocortisone, neomycin, and polymyxin B otic)?

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Neomycin and polymyxin B are antibiotics that fight bacteria.

The combination of hydrocortisone, neomycin, and polymyxin B otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Hydrocortisone, neomycin, and polymyxin B otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Pediotic (hydrocortisone, neomycin, and polymyxin B otic)?

You should not use this medication if you are allergic to hydrocortisone, neomycin, or polymyxin B, or if you have a ruptured ear drum, or an ear infection caused by chickenpox, or herpes infection (simplex or zoster).

Before using this medication, tell your doctor if you have herpes (simplex or zoster), chickenpox or small pox, any ear infection that causes blistering, asthma or sulfite allergy, or if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing. Stop using this medication and call your doctor at once if you have skin rash, redness, swelling, itching, dryness, scaling, severe burning or stinging, or other irritation in or around the ear. Other serious side effects include new signs of infection, hearing loss, or urinating less than usual or not at all.

What should I discuss with my health care provider before using Pediotic (hydrocortisone, neomycin, and polymyxin B otic)?

You should not use this medication if you are allergic to hydrocortisone, neomycin, or polymyxin B, or if you have:

a ruptured ear drum; or

an ear infection caused by chickenpox, or herpes infection (simplex or zoster).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

herpes (simplex or zoster);

chickenpox or small pox;

any ear infection that causes blistering;

asthma or sulfite allergy; or

if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

FDA pregnancy category C. It is not known whether hydrocortisone, neomycin, and polymyxin B otic ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrocortisone and colistin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication in a child younger than 2 years old.

How should I use Pediotic (hydrocortisone, neomycin, and polymyxin B otic)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Before using this medication, clean and dry your ear canal with sterile cotton.

Shake the ear drops well just before you measure a dose.

This medication is usually given as 4 to 5 drops into the affected ear every 6 to 8 hours. Children may need to use fewer drops. Follow your doctor's instructions about how much medication you should use and how often.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.

As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in the ear and keep it moist by adding more of the medication every 4 to 8 hours. Replace the cotton at least every 24 hours. Follow your doctor's instructions about the use of cotton with this medication.

Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include hearing problems, or urinating less than usual.

What should I avoid while using Pediotic (hydrocortisone, neomycin, and polymyxin B otic)?

Avoid getting this medication in your eyes. If this does happen, rinse with water.

Pediotic (hydrocortisone, neomycin, and polymyxin B otic) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

skin rash, redness, swelling, itching, dryness, scaling, or other irritation in or around the ear;

severe burning, stinging, or other irritation when using the medication;

new signs of infection;

hearing loss; or

urinating less than usual or not at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Pediotic (hydrocortisone, neomycin, and polymyxin B otic)?

It is not likely that other drugs you take orally or inject will have an effect on hydrocortisone, neomycin, and polymyxin B used in the ears. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Pediotic resources

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

Pediotic Prescribing Information (FDA)

Pediotic Advanced Consumer (Micromedex) - Includes Dosage Information

Cortomycin Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Cortomycin Prescribing Information (FDA)

Compare Pediotic with other medications

Otitis Externa
Otitis Media

Where can I get more information?

Your pharmacist can provide more information about hydrocortisone, neomycin, and polymyxin B otic.

See also: Pediotic side effects (in more detail)

Metalyse 8,000 units

Metalyse

8,000 units powder and solvent for solution for injection

Tenecteplase

Read all of this leaflet carefully before you start receiving this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What METALYSE is and what it is used for

2. Before you receive METALYSE

3. How is METALYSE administered

4. Possible side effects

5. How to store METALYSE

6. Further information

What Metalyse Is And What It Is Used For

METALYSE is a powder and solvent for solution for injection. This means that each pack contains:

one vial of 8,000 units METALYSE powder and one pre-filled syringe containing 8 ml water for injections.

Before use, the solvent (water for injections) is added to the powder to form a solution that is given by injection.

METALYSE belongs to a group of medicines called thrombolytic agents. These medicines help to dissolve blood clots. Tenecteplase is a recombinant fibrin-specific plasminogen activator.

METALYSE is used to treat myocardial infarctions (heart attacks) within 6 hours after the onset of symptoms and helps to dissolve the blood clots that have formed in the blood vessels of the heart. This helps to prevent the damage caused by heart attacks and has been shown to save lives.

Before You Receive Metalyse

METALYSE will not be prescribed and given by your doctor

if you have previously had a sudden life-threatening allergic reaction (severe hypersensitivity) to the active ingredient tenecteplase, to gentamicin (a trace residue from the manufacturing process) or any of the other ingredients of METALYSE. If treatment with Metalyse is nevertheless considered to be necessary, facilities for reanimation should be immediately available in case of need;

if you have, or have recently had, an illness that increases your risk of bleeding (haemorrhage), including:
- a bleeding disorder or tendency to bleed (haemorrhage)
- stroke (cerebrovascular event)
- very high, uncontrolled blood pressure
- a head injury
- severe liver disease
- a stomach ulcer (peptic ulcer)
- varicose veins in the gullet (oesophageal varices)
- abnormality of the blood vessels (e.g. an aneurysm)
- certain tumours
- inflammation of the lining around the heart (pericarditis); inflammation or infection of the heart valves (endocarditis);

if you are taking tablets/capsules used to “thin” the blood, such as warfarin or coumarin (anti-coagulants);

if you have an inflamed pancreas (pancreatitis);

if you have recently had major surgery including surgery to your brain or spine;

if you have been given cardiopulmonary resuscitation (chest compressions) for more than 2 minutes duration, in the last two weeks.

Your doctor will take special care with METALYSE

if you have had any allergic reaction other than a sudden life-threatening allergic reaction (severe hypersensitive) to the active substance tenecteplase, to gentamicin (a trace residue from the manufacturing process), or to any of the other ingredients of Metalyse (see section 6: “Further information”);

if you have high blood pressure;

if you have problems with circulation of blood in the brain (cerebrovascular disease);

if you have had gastrointestinal (gut) or genitourinary bleeding within the last ten days (this may cause blood in stools or urine);

if you have a heart valve abnormality (e.g. mitral stenosis) with an abnormal heart rhythm (e.g. atrial fibrillation);

if you have had an intramuscular injection in the last two days;

if you are aged over 75 years;

if you weigh less than 60 kg.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor for advice before you are given METALYSE.

How Is Metalyse Administered

The doctor calculates your dose of METALYSE according to your bodyweight, based on the following scheme:

Bodyweight less than 60kg 6,000 units

Bodyweight 60 to 70kg 7,000 units

Bodyweight 70 to 80kg 8,000 units

Bodyweight 80 to 90kg 9,000 units

Bodyweight above 90kg 10,000 units

Your doctor will give you medication to prevent blood clotting in addition to METALYSE, as soon as possible after your chest pain starts.

METALYSE is given by a single injection into a vein by a doctor who is experienced in the use of this type of drug.

Your doctor will give METALYSE as soon as possible after your chest pain starts as a single dose.

Repetition is not recommended.

Possible Side Effects

Like all medicines, METALYSE can cause side effects, although not everybody gets them.

Evaluation of side effects is based on the following frequencies:

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000

rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the available data

The side effects described below have been experienced by people given METALYSE:

Very Common:

bleeding

Common:

bleeding at the injection or puncture site

nosebleeds

genitourinary bleeding (you may notice blood in your urine)

bruising

gastro-intestinal bleeding (e.g. bleeding from the stomach or bowel)

Uncommon:

irregular heart beat (reperfusion arrhythmias), sometimes leading to cardiac arrest

internal bleeding in the abdomen (retroperitoneal bleeding)

bleeding in the brain (cerebral haemorrhage). Death or permanent disability may occur following bleeding in the brain or other serious bleeding events

bleeding in the eyes (eye haemorrhage)

Rare:

low blood pressure (hypotension)

bleeding in the lungs (pulmonary haemorrhage)

hypersensitivity (anaphylactoid reactions) e.g. rash, hives (urticaria), swelling of the throat

bleeding into the area surrounding the heart (haemopericardium)

blood clot in the lung (pulmonary embolism) and in the vessels of other organ systems (thrombotic embolisation)

Not known :

fat embolism (clots consisting of fat)

nausea

vomiting

body temperature increased (fever)

blood transfusions as consequence of bleedings

As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration:

Very common:

Low blood pressure (hypotension)

Irregular heart beat

Chest pain (angina pectoris)

Common:

Further heart attack (recurrent ischaemia)

Heart failure

Shock due to heart failure

Inflammation of the lining around the heart

Fluid in the lungs (pulmonary oedema)

Uncommon:

Heart arrest

Problem with the heart valve or heart lining (mitral valve incompetence, pericardial effusion)

Blood clot in the veins (venous thrombosis)

Fluid between the heart lining and the heart (cardiac tamponade)

Rupture of the heart muscle (myocardial rupture)

Rare:

Blood clot in the lung (pulmonary embolism)

These cardiovascular events can be life-threatening and may lead to death.

In case of bleeding in the brain events related to the nervous system have been reported e.g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).

Tell your doctor immediately if you think you are experiencing any of these side effects.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Metalyse

Keep out of the reach and sight of children.

Do not store above 30°C.

Keep the container in the outer carton in order to protect from light.

Once METALYSE has been reconstituted it may be stored for 24 hours at 2-8°C and 8 hours at 30°C. However, for microbiological reasons your doctor will normally use the reconstituted solution for injection immediately.

Do not use METALYSE after the expiry date which is stated on the label/carton.

Further Information

What METALYSE contains

The active substance is tenecteplase. One vial contains 8,000 units of tenecteplase. One pre-filled syringe contains 8 ml of water for injections.

The other ingredients are L-arginine, phosphoric acid and polysorbate 20.

The METALYSE solvent is water for injections.

Gentamicin is contained as trace residue from the manufacturing process.

What METALYSE looks like and contents of the pack

The folding box contains one vial with a lyophilised powder, one ready for use syringe with a solvent, one vial adapter and one needle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Birkendorfer Strasse 65

D-88397 Biberach/Riss

Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom

Boehringer Ingelheim Ltd.

Tel:+44 1344 424 600

This leaflet was last approved in 06/2010

Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu

74366-01

Wednesday, 22 August 2012

PerioGard Solution

Pronunciation: klor-HEX-ih-deen
Generic Name: Chlorhexidine
Brand Name: Examples include Peridex and PerioGard

PerioGard Solution is used for:

Treating certain types of gingivitis between dental visits as part of a professional program. It may also be used for other conditions as determined by your doctor.

PerioGard Solution is a topical antimicrobial. It works by reacting with the microbial cell surface, destroying the cell membrane, and killing the cell.

Do NOT use PerioGard Solution if:

you are allergic to any ingredient in PerioGard Solution

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

Before using PerioGard Solution:

Tell your health care provider 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 fillings or other dental work on your front teeth, or if you have periodontitis (another dental disease)

Some MEDICINES MAY INTERACT with PerioGard Solution. However, no specific interactions with PerioGard Solution are known at this time.

Ask your health care provider if PerioGard 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 PerioGard Solution:

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

Use after breakfast and before bedtime unless otherwise instructed by your doctor.

First brush your teeth. Measure the prescribed amount in the cap, which is marked for medicine dosing. Rinse for 30 seconds, then spit out the medicine. Do not swallow PerioGard Solution.

Do not rinse with water or other mouthwashes, brush teeth, or eat immediately after using PerioGard Solution.

If you miss a dose of PerioGard Solution, use 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 use 2 doses at once.

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

Important safety information:

You should have a dental appointment at least every six months while you are using PerioGard Solution.

PerioGard Solution may cause staining of the teeth that can usually be removed with appropriate dental procedures. Discuss any questions or concerns with your doctor.

PerioGard Solution should be used with extreme caution in CHILDREN younger than 18 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 PerioGard Solution while you are pregnant. It is not known if PerioGard Solution is found in breast milk. If you are or will be breast-feeding while you use PerioGard Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of PerioGard 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:

Mild irritation; tartar; taste changes; tooth staining.

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); numbness or tingling in the mouth; sores or irritation of the mouth; swelling not present when you began using PerioGard Solution.

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: PerioGard 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 include nausea or signs of alcohol intoxication.

Proper storage of PerioGard Solution:

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

General information:

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

PerioGard 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 PerioGard 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

More PerioGard resources

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

Compare PerioGard with other medications

Gingivitis
Mucositis
Periodontitis

Monday, 20 August 2012

Alavert

Generic Name: loratadine (lor AT a deen)

Brand Names: Alavert, Alavert Allergy, Claritin, Claritin 24 Hour Allergy, Claritin Hives Relief, Claritin Liqui-Gels, Claritin Reditab, Clear-Atadine, Clear-Atadine Children's, Dimetapp ND, Loratadine Reditab, ohm Allergy Relief, Tavist ND, Wal-itin

What is Alavert (loratadine)?

Loratadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Loratadine is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. It is also used to treat skin hives and itching in people with chronic skin reactions.

Loratadine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Alavert (loratadine)?

You should not take this medication if you are allergic to loratadine or to desloratadine (Clarinex).

Ask a doctor or pharmacist before taking this medicine if you have liver or kidney disease.

Do not give this medication to a child younger than 6 years old without the advice of a doctor.

Loratadine disintegrating tablets (Claritin Reditab) may contain phenylalanine. Talk to your doctor before using this form of loratadine if you have phenylketonuria (PKU).

What should I discuss with my healthcare provider before taking Alavert (loratadine)?

You should not take this medication if you are allergic to loratadine or to desloratadine (Clarinex).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

kidney disease; or

liver disease.

FDA pregnancy category B: This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Loratadine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Loratadine disintegrating tablets (Claritin Reditab, Alavert) may contain phenylalanine. Talk to your doctor before using this form of loratadine if you have phenylketonuria (PKU).

Do not give this medication to a child younger than 6 years old without the advice of a doctor.

How should I take Alavert (loratadine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Loratadine is usually taken once per day. Follow your doctor's instructions.

Do not crush, chew, or break the regular loratadine tablet. Swallow the pill whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To take loratadine orally disintegrating tablet (Claritin RediTab, Alavert):

Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

Using dry hands, remove the tablet and place it on your tongue. It will begin to dissolve right away.

Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Swallow several times as the tablet dissolves. If desired, you may drink water to help swallow the dissolved tablet.

Call your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, drowsiness, and fast or pounding heartbeat.

What should I avoid while taking Alavert (loratadine)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Alavert (loratadine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fast or uneven heart rate;

feeling like you might pass out;

jaundice (yellowing of your skin or eyes); or

seizures (convulsions).

Less serious side effects may include:

headache;

nervousness;

feeling tired or drowsy;

stomach pain, diarrhea;

dry mouth, sore throat hoarseness;

eye redness, blurred vision;

nosebleed; or

skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Alavert (loratadine)?

There may be other drugs that can interact with loratadine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Alavert resources

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

Alavert Prescribing Information (FDA)

Alavert Syrup MedFacts Consumer Leaflet (Wolters Kluwer)

Loratadine Professional Patient Advice (Wolters Kluwer)

Loratadine Monograph (AHFS DI)

Claritin Consumer Overview

Claritin Prescribing Information (FDA)

Claritin 24 Hour Allergy MedFacts Consumer Leaflet (Wolters Kluwer)

Claritin Liqui-Gels MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Alavert with other medications

Hay Fever
Urticaria

Where can I get more information?

Your pharmacist can provide more information about loratadine.

See also: Alavert side effects (in more detail)

Saturday, 18 August 2012

gadobenate Intravenous

gad-oh-BEN-ate dye-MEG-loo-meen

Intravenous route(Solution)

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs (ie, chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)), or acute kidney injury. Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced MRI. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes), perform lab testing to estimate the GFR. For patients with the highest NSF risk, do not exceed recommended dose and allow a sufficient time period for elimination prior to readministration .

Commonly used brand name(s)

In the U.S.

Multihance

Available Dosage Forms:

Solution

Therapeutic Class: Radiological Ionic Contrast Media

Uses For gadobenate

Gadobenate is a magnetic resonance imaging (MRI) contrast agent. Contrast agents are used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of diagnostic procedure. They use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation. Gadobenate is a gadolinium-based contrast agent (GBCA).

Gadobenate is given by injection before MRI to help diagnose problems in the brain, spine, and other parts of your body.

gadobenate is to be used only by or under the direct supervision of a doctor.

Before Using gadobenate

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to gadobenate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadobenate solution in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of gadobenate Multipack™ in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadobenate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving gadobenate.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of gadobenate

A doctor or other trained health professional will give you gadobenate. gadobenate is given through a needle placed in one of your veins just before you have an MRI scan.

Precautions While Using gadobenate

It is very important that your doctor check the progress of you or your child while you are receiving gadobenate and during the MRI scan. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Check with your doctor right away if you or your child have burning or itching of the skin; red or dark patches on the skin; skin swelling, hardening, or tightening; joint stiffness; limited range of motion in the arms and legs; pain that is deep in the hip bone or ribs; or muscle weakness. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).

gadobenate may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have cold, clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.

Tell your doctor right away if you or your child have mild, burning pain; feeling of warmth or coldness; redness or swelling at the injection site.

gadobenate can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Before you have any medical tests, tell the medical doctor in charge that you or your child are using gadobenate. The results of some tests may be affected by gadobenate.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

gadobenate Side Effects

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 or nurse immediately if any of the following side effects occur:

Rare

Abdominal or stomach pain

anxiety

back pain

black, tarry stools

bladder pain

bloody or cloudy urine

blue lips and fingernails

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or discomfort

chills

confusion

convulsions

cough

coughing that sometimes produces a pink frothy sputum

dark urine

decreased urination

deep or fast breathing with dizziness

difficult or labored breathing

difficult, burning, or painful urination

difficult, fast, or noisy breathing, sometimes with wheezing

difficulty with breathing or swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

excessive muscle tone

fainting

fast, slow, or irregular heartbeat

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

hives

inability to move the legs or arms

increased sweating

itching

lightheadedness, dizziness, or fainting

lower back or side pain

muscle stiffness

muscle tension or tightness

nausea

nervousness

numbness of the feet, hands, and around the mouth

pain in the shoulders, arms, jaw, or neck

pain or redness at the injection site

pale skin

pale skin at the injection site

paralysis of one side of the body

pounding heartbeat

pounding in the ears

problems with speech or speaking

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

reddening of the skin, especially around the ears

shakiness in the legs, arms, hands, or feet

shortness of breath

skin rash

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sudden shortness of breath or troubled breathing

sugar in the urine

sweating

swelling in the legs and ankles

swelling of the eyes, face, or inside of the nose

swollen glands

tightness in the chest

tiredness

trembling or shaking of the hands or feet

unusual bleeding or bruising

unusual tiredness or weakness

wheezing

yellow eyes or skin

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:

Less common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

feeling hot

Rare

Acid or sour stomach

bad, unusual, or unpleasant (after) taste

belching

blurred or loss of vision

change in sense of smell

change in taste

continuing ringing or buzzing or other unexplained noise in the ears

decreased awareness or responsiveness

diarrhea

difficulty having a bowel movement (stool)

difficulty with moving

disturbed color perception

double vision

dry mouth

ear pain

feeling unusually cold

halos around lights

hearing loss

heartburn

hives or welts

indigestion

joint pain

lack or loss of strength

loss of bowel control

muscle aches or cramps

muscle spasms

night blindness

overbright appearance of lights

redness of the eye

redness of the skin

severe sleepiness

shivering

stomach discomfort, upset, or pain

stuffy nose

swelling of the eyelid

swollen joints

tunnel vision

vomiting

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.

See also: gadobenate Intravenous side effects (in more detail)

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More gadobenate Intravenous resources

Gadobenate Intravenous Side Effects (in more detail)
Gadobenate Intravenous Use in Pregnancy & Breastfeeding
Gadobenate Intravenous Drug Interactions
Gadobenate Intravenous Support Group
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