Labetalol Hydrochloride

Class: beta-Adrenergic Blocking Agents
VA Class: CV100
Chemical Name: 2-Hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride
Molecular Formula: C₁₉H₂₄N₂O₃•HCl
CAS Number: 32780-64-6
Brands: Normodyne, Trandate

Introduction

Selective α- and nonselective β-adrenergic blocking agent.^{1 2 3 4 5 6 7 8 9 19 21 22 23 32 336}

Uses for Labetalol Hydrochloride

Hypertension

Management of hypertension, alone or in combination with other classes of antihypertensive agents.^{2 4 13 253 293}

One of several preferred initial therapies in hypertensive patients with heart failure, post-MI, high coronary disease risk, or diabetes mellitus.³²⁶

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.³²⁶

Effective in controlling BP in pregnant women with moderate to severe hypertension,^{64 68 185 285 297} severe pregnancy-induced hypertension,^{64 68 95 185 244 285 297 298} or hypertension with superimposed pregnancy-induced hypertension.^{64 68 185 285} Has reduced proteinuria and prevented eclampsia in hypertensive pregnant women with proteinuria.^{64 65 68 185}

Severe Hypertension and Hypertensive Crisis

Used parenterally for immediate BP reduction in severe hypertension or in hypertensive crises when considered an emergency;^{1 3 7 8 13 14 15 16 51 52 53 73 79 93 94 152 197 198 209 210 235 236 240 293 331 336} generally suitable for most hypertensive emergencies except when acute cardiac failure is present.^{239 331}

Has been used for rapid reduction of BP in pediatric patients 1–17 years of age† with hypertensive urgencies or emergencies.†³³³

Pheochromocytoma

Has been used alone in patients with pheochromocytoma to control hypertension and symptoms resulting from excessive β-receptor stimulation.^{51 85 181 182 183 184} However, some clinicians caution against use unless pretreatment with α-adrenergic blocking agents (e.g., IV phentolamine) has occurred.⁷ May be more effective when tumors predominantly secrete epinephrine rather than norepinephrine, and with sustained rather than paroxysmal hypertension.⁸⁵ (See Pheochromocytoma under Cautions.)

Preeclampsia

As an alternative to IV hydralazine, administered IV for controlling BP in pregnant women with preeclampsia† when delivery is imminent.³³¹

Controlled Hypotension during Anesthesia

Treatment to produce controlled hypotension during anesthesia† to reduce bleeding resulting from surgical procedures.^{7 183 190 191 192 193 194 195}

Angina

Management of chronic stable angina pectoris†.^{7 17 18 127}

Tetanus

Management of sympathetic overactivity syndrome associated with severe tetanus†.^{196 200 201 202}

Labetalol Hydrochloride Dosage and Administration

General

Hypertension

• 
  

  Monitor BP during initial titration or subsequent upward dosage adjustment; large or abrupt reductions in BP generally should be avoided. With continued oral dosing, BP can be measured approximately 12 hours after a dose to determine if further dosage titration is necessary.^{2 4} (See Absorption under Pharmacokinetics.)

  
  


• 
  

  Adjust oral dosage according to standing BP.^{2 4 293} Adjust gradually (e.g., every 2–4 weeks)²⁰³ over a period of 4–12 weeks^{9 75 76 203} to minimize or avoid adverse effects (e.g., nausea, dizziness) and improve patient tolerance.²⁰³

  
  


• 
  

  If long-term therapy is discontinued, gradually reduce dosage over a period of 1–2 weeks.^{2 4 293} (See Abrupt Withdrawal of Therapy under Cautions.)

  
  


• 
  

  When transferring from other hypotensive agents, start with usual initial labetalol dosage, and gradually decrease dosage of the existing regimen.^{2 4}

  
  

Severe Hypertension and Hypertensive Crisis

• 
  

  Adjust dosage according to the severity of hypertension and the patient’s supine BP response and tolerance.^{1 3 293}

  
  


• 
  

  Initial goal of IV therapy is to reduce mean arterial BP by no more than 25% within minutes to 1 hour, followed by further reduction if stable toward 160/100 to 110 mm Hg within the next 2–6 hours, avoiding excessive declines in pressure that could precipitate renal, cerebral, or coronary insufficiency.²⁹³ If this BP is well tolerated and the patient is clinically stable, further gradual reductions toward normal can be implemented in the next 24–48 hours.³³¹

  
  


• 
  

  Patients with aortic dissection should have systolic pressure reduced to <100 mm Hg if tolerated.³³¹

  
  

Preeclampsia

• 
  

  Administer antihypertensives before labor induction for persistent DBPs ≥105–110 mm Hg, aiming for levels of 95–105 mm Hg.³³¹

  
  


• 
  

  Monitor BP closely.³³¹

  
  

Administration

Administer orally,^{2 4 7 8 19 23 47 49} by direct IV injection, or by continuous IV infusion.^{1 3 7 19 23 51 52 53 73 79 93 94 210}

Oral Administration

Usually administered in 2 divided doses daily.^{2 4} If adverse effects (e.g., nausea, dizziness) occur and are intolerable (particularly with dosages ≥1.2 g daily), administration in 3 divided doses daily may improve patient tolerance and/or facilitate dosage titration.^{2 4}

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by slow, direct IV injection or by slow, continuous IV infusion.^{1 3 7 19 23 51 52 53 73 79 93 94 210}

Labetalol injection is intended for use in hospitalized patients.¹

Patients must be kept in a supine position during and for 3 hours after IV administration since symptomatic orthostatic hypotension is likely to occur if patients are tilted upward or allowed to assume an upright position.^{1 3} (See Hypotension under Cautions.)

Dilution

For IV infusion, dilute labetalol injection to an appropriate concentration in a compatible IV infusion solution (e.g., add 200 mg of the drug to 160 mL of 5% dextrose injection to provide a solution containing 1 mg/mL).^{1 3}

Rate of Administration

Administer repeat doses by slow, direct IV injection over a 2-minute period at intervals of 10 minutes.^{1 3 53 73 79 94 277 293 297 298}

Administer diluted solutions by slow, continuous IV infusion^{1 3 51 73 210 277 293 297} with a controlled-infusion device to facilitate a desired rate of infusion.^{1 3}

Dosage

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

Pediatric Patients

Hypertension†

Oral

Initially, 1–3 mg/kg daily given in 2 divided doses.³³³ Increase dosage as necessary up to a maximum of 10–12 mg/kg or 1.2 g daily given in 2 divided doses.³³³

Severe Hypertension and Hypertensive Crisis†

IV Injection

Children 1–17 years of age: 0.2–1 mg/kg up to maximum of 40 mg per dose by direct IV injection.³³³

IV Infusion

Alternatively, 0.25–3 mg/kg per hour by continuous IV infusion.³³³

Adults

Hypertension

Monotherapy

Oral

Initially, 100 mg twice daily.^{2 4 277 293}

Adjust dosage in increments of 100 mg twice daily every 2 or 3 days until optimum BP response is achieved.^{2 4}

For maintenance, manufacturer recommends a usual dosage of 200–400 mg twice daily.^{2 4 277 293 326 331} Manufacturer states that some adults with severe hypertension may require up to 1.2 g–2.4 g administered in 2 or 3 divided doses daily.^{2 4 a}

JNC 7 recommends a usual range of 100–400 mg twice daily.³²⁶ JNC recommends adding another drug, if needed, rather than continuing to increase dosage.³²⁶

Combination Therapy

Oral

Initially, 100 mg twice daily, in combination with a diuretic.^{2 4 277 293}

Adjustment of labetalol dosage may be necessary when diuretic is initiated in a patient already receiving labetalol; optimum maintenance dosage is usually lower.^{2 4}

Severe Hypertension and Hypertensive Crisis

IV Injection

Initially, 20–80 mg by slow, direct IV injection.^{1 3 7 19 53 79 94 274 277 293 336}

Higher initial doses (e.g., 1–2 mg/kg) have been administered,^{51 55 235} but the 20-mg dose is recommended to minimize adverse effects and the risks associated with too rapid reduction in BP.^{23 53 79}

May give additional doses, usually 40–80 mg^{1 3 7 53 79 94} (range: 20–80 mg),^{19 73 79 274 277 293 336} at 10-minute intervals until the desired supine BP is achieved or up to a total cumulative dose of 300 mg.^{1 3 7 19 53 73 79 94 274 297 298 336}

IV Infusion

Alternatively, initial rate of 0.5–2 mg/minute by continuous IV infusion; adjust rate according to the BP response.^{1 3 7 19 52 73 210 274 277 293 297}

The usual effective, cumulative dose is 50–200 mg; up to 300 mg may be required.^{1 3}

Progressive, incremental IV infusion regimen† (i.e., infusing 20, 40, 80, and 160 mg/hour for 1 hour at each dose level, or until the desired BP is achieved) has been used, and may result in more gradual BP reduction, minimizing adverse effects compared with repeated IV injections of the drug.^{21 51 197} Controlled comparisons of various IV administration methods are not available.

Oral (following IV dosage)

Discontinue IV therapy and initiate oral labetalol therapy when the DBP begins to increase.^{1 3}

Initially 200 mg, followed in 6–12 hours by an additional dose of 200 or 400 mg, depending on the BP response.^{1 3}

If necessary, oral dosage may be increased in usual increments at 1-day intervals while the patient is hospitalized.^{1 3}

Follow the usual oral dosage recommendations for subsequent outpatient dosage titration or maintenance dosing.^{1 3}

Preeclampsia

IV

Initially, 20 mg by slow, direct IV injection, followed by 40 mg IV 10 minutes later and then 80-mg doses at 10-minute intervals for 2 additional doses.³³¹

Prescribing Limits

Pediatric Patients

Hypertension

Oral

Maximum 10–12 mg/kg or 1.2 g daily.³³³

Severe Hypertension and Hypertensive Crisis†

IV Injection

Children 1–17 years of age: Maximum 40 mg per dose.³³³

Adults

Hypertension

Oral

Maximum titration increment of 200 mg twice daily.^a

Severe Hypertension and Hypertensive Crisis

IV

Maximum cumulative dose of 300 mg.^{1 3 7 19 53 73 79 94 274 297 298}

Preeclampsia

IV

Maximum cumulative dose of 220 mg.³³¹

Special Populations

Hepatic Impairment

Dosage reduction may be necessary, but specific data are currently not available.^{7 39}

Renal Impairment

No dosage adjustment required in patients with mild to moderate renal impairment.^{60 146 147 239} In patients with severe renal impairment (i.e., Cl_cr <10 mL/minute) undergoing dialysis, once-daily dosing may be adequate.²⁴¹

Geriatric Patients

Oral

Adjustment in initial dosage not required.^a Maintenance dosage requirements are lower in most geriatric patients; 100–200 mg twice daily usually required.^{4 a 4}

Cautions for Labetalol Hydrochloride

Contraindications

• 
  

  Obstructive airway disease (e.g., bronchial asthma).^{1 2 3 4 311}

  
  


• 
  

  Overt cardiac failure.^{1 2 3 4 311}

  
  


• 
  

  Heart block greater than first degree.^{1 2 3 4 311}

  
  


• 
  

  Cardiogenic shock.^{1 2 3 4 311}

  
  


• 
  

  Severe bradycardia.^{1 2 3 4 311}

  
  


• 
  

  Other conditions associated with severe and prolonged hypotension.^{1 3 4 247}

  
  


• 
  

  Known hypersensitivity to labetalol or any ingredient in the formulation.^{1 3 4 247}

  
  

Warnings/Precautions

Warnings

Hepatic Effects

Rarely, jaundice, hepatitis, severe hepatocellular injury, and elevated liver function test results have occurred; usually reversible following discontinuance,^{1 2 3 4 247 248} however, hepatic necrosis and death have been reported.^{1 2 3 4 247 248 254 255 275 276}

Discontinue immediately if jaundice or laboratory evidence of hepatic injury occurs.^{1 2 3 4 247 248}

Perform liver function tests at the first signs or symptoms of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness, flu-like syndrome).^{1 2 3 4 247 248}

Cardiac Failure

Possible precipitation of CHF.^{1 2 3 4 7} Use contraindicated in patients with overt CHF;^{1 2 3 4} may use cautiously in patients with well-compensated heart failure (e.g., those controlled with cardiac glycosides and/or diuretics).^{1 2 3 4} Use with caution in patients with inadequate cardiac function.^{1 2 3 4 7}

Adequate treatment (e.g., with a cardiac glycoside and/or diuretic) and close observation recommended if signs and symptoms of impending cardiac failure occur; if cardiac failure continues, discontinue therapy, gradually if possible.^{1 2 3 4}

Abrupt Withdrawal of Therapy

Abrupt withdrawal may exacerbate angina symptoms or precipitate MI in patients with CAD.^{1 2 3 4} Avoid abrupt discontinuance.^{2 4} Gradually decrease dosage over a period of 1–2 weeks, particularly in patients with ischemic heart disease and monitor patients carefully.^{1 2 3 4} If exacerbation of angina occurs or acute coronary insufficiency develops, reinstitute therapy promptly, at least temporarily, and initiate appropriate measures for the management of unstable angina pectoris.^{1 2 3 4}

Labetalol may be less likely than pure β-adrenergic blocking agents to produce adverse cardiovascular withdrawal reactions (e.g., angina, rebound hypertension) following abrupt withdrawal;^{9 74 75 76 77 78 164} angina pectoris has not been reported to date following discontinuance of labetalol.^{1 2 3 4}

Bronchospastic Disease

Possible inhibition of bronchodilation produced by endogenous catecholamines; use generally not recommended in patients with bronchospastic disease.^{2 4}

May use oral labetalol with caution in patients with nonallergic bronchospasm (e.g., chronic bronchitis, emphysema) who do not respond to or cannot tolerate other hypotensive agents;^{2 4} use smallest effective dose to minimize inhibition of endogenous or exogenous β-adrenergic agonist activity.^{2 4}

Do not use IV labetalol in patients with nonallergic bronchospasm at the usual therapeutic doses; has not been studied adequately.^{1 3}

Pheochromocytoma

Use with caution in patients with pheochromocytoma;^{1 2 3 4 186 187} oral labetalol may induce paradoxical hypertensive crisis.^{7 186 187 203} Use not recommended unless pretreatment with α-adrenergic blocking agents (e.g., IV phentolamine) has occurred.⁷

Employ appropriate methods for determining urinary catecholamines if used in known or suspected pheochromocytoma.^{1 2 3 4} (See Specific Drugs and Laboratory Tests under Interactions.)

Diabetes and Hypoglycemia

Possible decreased signs and symptoms of hypoglycemia (e.g., tachycardia, BP changes),^{1 2 3 4} impaired glucose tolerance, delayed rate of recovery of blood glucose concentration following drug-induced hypoglycemia, altered hemodynamic response to hypoglycemia (possibly resulting in exaggerated hypertensive response), and impaired peripheral circulation.^{211 212}

Use with caution in patients with diabetes mellitus;^{1 2 3 4} dosage adjustment of the hypoglycemic agent may be necessary.^{1 2 3 4}

Major Surgery

Severe, protracted hypotension and difficulty in restarting or maintaining a heart beat have occurred during surgery in some patients receiving β-adrenergic blocking agents;^{1 2 3 4} however, withdrawal of β-adrenergic blocking agent prior to major surgery is controversial.^{1 2 3 4}

Effect of labetalol’s α-adrenergic activity in patients undergoing major surgery has not been evaluated,^{1 2 3 4} but several deaths have been reported with the use of the injection during surgery, including when used to control bleeding.^{1 3}

Synergistic hypotensive response occurs with concomitant use of IV labetalol and halothane anesthesia.^{1 2 3 4 183 190 191 192 193 194 195} (See Specific Drugs and Laboratory Tests under Interactions.)

Severely Elevated BP

Use caution when reducing severely elevated BP.^{1 3}

Use IV labetalol in hospitalized patients,^{1 3} and achieve the desired reduction over longest period of time compatible with the patient’s clinical status.^{1 3}

Avoid rapid or excessive reductions in SBP or DBP.^{1 3}

Serious adverse effects (e.g., cerebral infarction, optic nerve infarction, angina, and ischemic changes in the ECG)^{51 79 197} have been reported when severely elevated BP was reduced over several hours to up to 1 or 2 days with other hypotensive agents.³¹¹

General Precautions

Hypotension

Orthostatic hypotension associated with loss of consciousness reported occasionally following IV administration^{51 54 55 132} and rarely following oral administration.^{2 4} Symptomatic orthostatic hypotension is likely to occur if supine patients are tilted upward or allowed to assume the upright position within 3 hours following IV administration.^{1 3}

If hypotension occurs, place the patient in Trendelenburg’s position, administer IV fluids, and/or temporarily discontinue administration of the drug.^{51 79 94 197}

Patients should remain supine during and for up to 3 hours after IV administration.^{1 3} Establish patient’s ability to tolerate an upright position before any ambulation (e.g., use of toilet facilities) is permitted; advise patient on how to proceed gradually to become ambulatory and observe at the time of initial ambulation.^{1 3}

Laboratory Tests

Monitor laboratory parameters at regular intervals in patients receiving long-term oral therapy.^{2 4}

Routine laboratory tests are usually not required before or after IV administration.^{1 3}

In patients with concomitant illnesses (e.g., impaired renal function), perform appropriate tests to monitor these conditions.^{1 2 3 4}

Possible Prescribing and Dispensing Errors

Ensure accuracy of prescription; similarity in spelling of labetalol hydrochloride and Lamictal (lamotrigine, an anticonvulsant agent) has resulted in dispensing errors.^{319 320} Errors may be associated with serious adverse events (e.g., status epilepticus, serious lamotrigine rash) in patients receiving the wrong drug.^{319 320}

History of Anaphylactic Reactions

Possible increased reactivity to a variety of allergens;¹ patients may be less responsive to usual doses of epinephrine used to treat anaphylactic reactions.^{1 3 4}

Other Precautions

Shares the toxic potentials of β-adrenergic and postsynaptic α₁-adrenergic blocking agents;^{1 2 3 4 7 8 9} observe the usual precautions of these agents.^{1 2 3 4 7}

Specific Populations

Pregnancy

Category C.^{1 2 3 4 247 248 a} (See Hypertension and also see Preeclampsia under Uses.)

Lactation

Distributed into milk.^{1 2 3 4 6 7 64 68 69} Caution if used in nursing women.^{1 2 3 4}

Pediatric Use

Safety and efficacy not fully established;^{1 2 3 4 247 248} however, some experts have recommended dosages for hypertension based on current limited clinical experience.³³³

Geriatric Use

Orthostatic symptoms (e.g., orthostatic hypotension, dizziness, lightheadedness) are more likely in geriatric individuals than in younger adults; caution geriatric patients about the possibility of such symptoms.⁴

A lower maintenance dosage may be required because of reduced elimination in geriatric patients.⁴ (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution; metabolism of the drug may be decreased.^{1 2 3 4 7 39 247 248} (See Special Populations under Pharmacokinetics.)

Renal Impairment

Elimination half-life may be increased in patients with severe renal impairment undergoing dialysis; once-daily dosing may be possible in these patients.²⁴¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Symptomatic orthostatic hypotension,^{1 2 3 4 7 8 9 19 23 46 51 54 55 79 81 83 88 91 94 96 100 108 122 129 132 158 159 247 248} dizziness^{1 2 3 4 8 23 74 75 76 79 80 81 82 88 90 158 159} or lightheadedness,^{23 51 53 85} fatigue,^{1 2 3 4 23 75 76 78 87 159} nausea,^{1 2 3 4 7 8 19 23 51 53 74 75 76 78 79 80 81 82 83 87 90 93 94 158 159 247 248} dyspepsia.^{1 2 3 4 7 8 23 74 75 76 79 82 83 93 94 158 159 247 248}

Interactions for Labetalol Hydrochloride

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
β-adrenergic agonists	Labetalol may antagonize bronchodilating effects1 2 3 4	Greater than usual dosages of β-adrenergic agonist bronchodilators may be required1 2 3 4
Calcium-channel blocking agents (e.g., verapamil, diltiazem)	Possible additive therapeutic256 257 258 259 260 261 262 263 264 265 267 268 269 270 271 272 273 and adverse effects257 261 264 266 267 268 271 272 273	Use concomitantly with caution1 3 4 247 258 259 260 261 264 266 268 271 272 273 290 291
Cimetidine	Absolute bioavailability of oral labetalol substantially increased, possibly via enhanced absorption or decreased first-pass hepatic metabolism 1 2 3 4 180 229	Carefully adjust labetalol dosage for optimal BP control with concomitant use1 2 3 4 229
Diuretics	Increased hypotensive effect 2 4 7 8 9 13 15 19 72 76 77 78 80 81 82 83 85 87 90 91 96 97 99 231 234	Usually used to therapeutic advantage; careful dosage adjustments recommended

Ephedrine/Guaifenesin

Pronunciation: eh-FED-rin/gwye-FEN-ah-sin
Generic Name: Ephedrine/Guaifenesin
Brand Name: Primatene Asthma

Ephedrine/Guaifenesin is used for:

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

Ephedrine/Guaifenesin is a decongestant and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Ephedrine/Guaifenesin if:

• you are allergic to any ingredient in Ephedrine/Guaifenesin


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


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (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 Ephedrine/Guaifenesin:

Some medical conditions may interact with Ephedrine/Guaifenesin. 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 a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate or other prostate problems, seizures, or an overactive thyroid


• if you have chronic cough

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Ephedrine/Guaifenesin may be increased


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


• Bromocriptine because the risk of side effects may be increased by Ephedrine/Guaifenesin


• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Ephedrine/Guaifenesin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ephedrine/Guaifenesin 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 Ephedrine/Guaifenesin:

Use Ephedrine/Guaifenesin 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.

• Ephedrine/Guaifenesin may be taken with or without food.


• Take Ephedrine/Guaifenesin with a full glass of water unless otherwise directed by your doctor.


• If you miss a dose of Ephedrine/Guaifenesin, 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 Ephedrine/Guaifenesin.

Important safety information:

• Ephedrine/Guaifenesin may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ephedrine/Guaifenesin. Using Ephedrine/Guaifenesin alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take appetite suppressants while you are taking Ephedrine/Guaifenesin without checking with your doctor.


• Ephedrine/Guaifenesin contains ephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains ephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Ephedrine/Guaifenesin for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Ephedrine/Guaifenesin may interfere with certain lab test results. Make sure that all of your doctors and laboratory personnel know that you are taking Ephedrine/Guaifenesin.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ephedrine/Guaifenesin.


• Use Ephedrine/Guaifenesin with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Ephedrine/Guaifenesin in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Ephedrine/Guaifenesin, discuss with your doctor the benefits and risks of using Ephedrine/Guaifenesin during pregnancy. It is unknown if Ephedrine/Guaifenesin is excreted in breast milk. Do not breast-feed while taking Ephedrine/Guaifenesin.

Possible side effects of Ephedrine/Guaifenesin:

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:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

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: Ephedrine/Guaifenesin 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; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Ephedrine/Guaifenesin:

Store Ephedrine/Guaifenesin 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 Ephedrine/Guaifenesin out of the reach of children and away from pets.

General information:

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


• Ephedrine/Guaifenesin 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 Ephedrine/Guaifenesin. 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 Ephedrine/Guaifenesin resources

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

Compare Ephedrine/Guaifenesin with other medications

• Cold Symptoms

Vantas 50mg Implant

Vantas 50 mg implant

histrelin acetate

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

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


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


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


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

In this leaflet:

• 1. What Vantas is and what it is used for


• 2. Before you use Vantas


• 3. How to use Vantas


• 4. Possible side effects


• 5. How to store Vantas


• 6. Further information

What Vantas Is And What It Is Used For

• Vantas is a medicine delivery system which is surgically placed (or implanted) under the skin and contains an active substance called histrelin.



• It is used for the treatment of advanced prostate cancer because it may help to relieve your prostate cancer symptoms.



• Each Vantas implant contains 50 milligrams of histrelin acetate. After insertion under your skin, it releases 41 micrograms of histrelin (equivalent to 50 micrograms of histrelin acetate) per day into your body, over a period of 12 months.



• Histrelin blocks your body from making and secreting hormones so that testosterone levels are reduced or cannot be detected in your blood.

Before You Use Vantas

Do not use Vantas:

• If you are allergic (hypersensitive) to the active substance, histrelin acetate, to other medicines called GnRH (Gonadotropin Releasing Hormone) agonists or to any of the other ingredients. (See section 6 for a list of other ingredients.)



• If you are a woman. Vantas has not been studied in women and is not for use in women.



• If you are a child (under 18). Vantas has not been studied in children and is not for use in children.

If you think any of these apply to you, talk to your doctor before having the implant. Then follow the advice given to you.

Take special care with Vantas

It is possible that your symptoms may get worse or new symptoms occur, during the first week of treatment (See Section 4 - Side Effects). If this happens, phone your doctor immediately.

Taking Vantas with other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, or are thinking of taking any other medicines, including medicines obtained without a prescription. It is not known whether Vantas and other medicines can affect one another.

Pregnancy and breast-feeding

Vantas has not been studied in pregnant or breast-feeding women as it is not for use in women.

Driving and using machines

Immediately after receiving the implant, extra care should be taken when driving, because of the cut and stitches which you have just had.

There have been no studies completed on the effects of Vantas on driving.

Important information about some of the ingredients of Vantas

The container of this medicinal product contains latex rubber. May cause severe allergic reactions.

How To Use Vantas

• Only Vantas implantation device can be used for insertion of the implant.


• The implant is placed under the skin of the inside of your upper arm by your doctor.


• Your doctor will numb your arm, make a small cut (incision) and place the implant under the skin.


• The cut will be closed with stitches and special surgical tape and then covered with a bandage.

During the first week:

• Keep the bandage in place for at least one day.


• Do not remove the surgical steri-strips. Steri-strips look like thread and your doctor used them to close the cut which he made in your skin in order to put the implant in. They will drop off by themselves.


• Avoid heavy lifting and exercising of the treated arm for 7 days after the insertion of the implant.


• For 24 hours after the insertion of the implant, keep the treated arm clean and dry. Do not bathe or swim for 24 hours.

During the first year:

• Remember to see your doctor for routine checks, which are offered to make sure that the implant is still in place and is still working.



• The implant could work its way out of your body through the cut where it was originally put in. This does not happen often. You may actually notice it coming out, or, rarely, it may come out without you noticing it. If you think it has come out, phone your doctor.



• Your doctor will do blood tests to confirm that you are responding to the treatment, for example by having your prostate specific antigen (PSA) or testosterone levels checked.



• After 12 months, the implant must be removed.



• The implant may be difficult to feel under your skin. If it cannot be felt under your skin at the time when it is to be removed, your doctor may order a special test, such as ultrasound or a CT scan, in order to locate it.



• After removal, your doctor may then insert a new implant to continue your treatment.

If you use more Vantas than you should

There have been no reported cases of overdose. The implant is given to you under strict medical supervision.

If you stop using Vantas

If you wish to stop taking this medicine, please talk to your doctor.

If you have any further questions about the use of this product, please ask your doctor.

Possible Side Effects

Like all medicines Vantas can cause side effects, though not everybody gets them.

This medicine can cause an increase in testosterone during the first week after insertion. Your symptoms may get worse for a few weeks. You may get new symptoms.

Contact your doctor immediately if you:

• get new, or worse, bone pain;


• feel weak;


• get feelings of weakness in your legs;


• have blood in your urine;


• have problems urinating or cannot urinate.

You may get some pain, bruising and redness at the place where the implant is inserted, at the time it is being inserted or removed and for a while afterwards. These reactions usually go away within two weeks, without any treatment.

If your incision is not healing but looks and feels as if it is getting worse (bleeding, redness, soreness), contact your doctor.

If you notice any of the following side effects, contact your doctor:

Very common side effects (more than 1 in every 10 patients treated) are:

• hot flushes (reddening of the face and/or neck).

Common side effects (less than 1 in every 10 patients treated) are:

• the kidneys not working as well as they should , frequent urinating, difficulties in passing any urine;


• shortness of breath after exercising;


• depression, problems getting to sleep , less interest in sex;


• dizziness, headache;


• blushing;


• testicles becoming smaller, enlargement of breasts, impotence;


• skin reactions where the implant was inserted, such as pain, tenderness, redness;


• other reactions to the implantation procedure, such as weakness and tiredness;


• some temporary damage to the liver cells;


• pain in the joints, pain in the arms and legs;


• constipation;


• weight gain, raised blood sugar level;


• growth of excess hair.

Uncommon side effect (less than 1 in every 100 patients treated) are:

• anaemia, abdominal discomfort,


• nausea;


• fluid retention, food cravings, high calcium levels, high cholesterol, increased appetite;


• irritability;


• shaking;


• weight loss;


• irregular heart beating and/or a premature beat of the heart (palpitations);


• abnormal bleeding;


• bruising, night sweats, itching, excessive sweating;


• back pain, muscle spasms, muscle infiltration, neck pain;


• painful and difficult urination, blood in urine, kidney stone, kidney failure;


• breast pain, breast tenderness, genital itching, sexual dysfunction;


• feelings of cold, tiredness, feeling unwell, peripheral oedema, pain, swelling;


• stent blockage;


• detectable as a result of various blood tests, including: higher liver enzymes (elevated aspartate-aminotransferase), elevated blood lactate dehydrogenase, elevated blood testosterone, abnormality in kidney function tests (lowered creatinine clearance), elevated acid phosphatase in the prostate.

Rare side effects (less than 1 in every 1,000 patients treated) are:

• skin infection;


• inflammation.

Vantas can also cause a loss in bone mineral density. This can lead to frailty of the bones (osteoporosis).

If you notice any side effects not mentioned in this leaflet, please contact your doctor.

How To Store Vantas

• Keep out of the reach and sight of children.



• Do not use Vantas after the expiry date, which is stated on the carton and on the vial. The expiry date refers to the last day of the month.



• Store implant in a refrigerator (2 °C - 8 °C). Do not freeze.



• Store implant in the original package in order to protect from light.



• Store implantation device at room temperature (20 °C - 25 °C), and keep out of direct sunlight

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.

Further Information

What Vantas contains:

• The active substance is 50 mg of histrelin acetate.


• The other ingredients are in the medicine core pellet. This contains the ingredient stearic acid (E570). There are four drug core pellets inserted into an acrylic co-polymer shell. This acrylic co-polymer shell consists of 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate and trimethylolpropane trimethacrylate. All of these are plastics which have been used previously in implants.

What Vantas looks like and contents of the pack

Vantas is an implant and is supplied in a carton containing an amber plastic pouch, which in turn carries the vial containing the Vantas implant.

The implantation device is contained in a polyethylene sachet, which is placed in a carton.

The glass vial containing the implant has a Teflon-coated stopper and an aluminium seal. The implant is immersed in 2 ml of 1.8% sterile sodium chloride solution and looks like a thin tube.

A Package Insert, with insertion and removal instructions for your doctor, together with this Package Leaflet is provided with the product.

Marketing Authorisation Holder and Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

This leaflet was last approved in: 11-May -2009

Irapen

Irapen may be available in the countries listed below.

Ingredient matches for Irapen

Ampicillin

Ampicillin is reported as an ingredient of Irapen in the following countries:

• Oman

International Drug Name Search

Pyrethrins with Piperonyl Butoxide

Class: Scabicides and Pediculicides
ATC Class: P03BA
VA Class: AP300
CAS Number: 8003-34-7
Brands: A200, Licide, Pronto, RID

Introduction

Pediculicide; fixed-combination preparation containing pyrethrins (a pediculicide) and piperonyl butoxide (has little or no insecticidal activity but potentiates that of pyrethrins).^a

Uses for Pyrethrins with Piperonyl Butoxide

Pediculosis

Topical treatment of pediculosis capitis (head lice infestation).^{103 104 107 112 117 120 121 122 123}

An alternative rather than a preferred treatment for pediculosis capitis.^{107 108} Permethrin 1% generally considered the treatment of choice, and malathion 0.5% is recommended when permethrin resistance is suspected.^{103 107 108 113 114 116 117 125}

Base selection of a pediculicide on efficacy (including both pediculicidal and ovicidal activity), safety, cost, availability, ease of application, age of patient, presence of other scalp infections, patient preference, severity of the infestation, potential for transmission, number of recurrences, and the pattern of resistance in the geographic region.¹¹³

Topical treatment of pediculosis pubis (pubic lice infestation).^{101 104 112 115 120 121 122 123} Considered a pediculicide of choice by CDC and others for treatment of pediculosis pubis, including in HIV-infected patients.^{101 104 112 115}

Topical treatment of pediculosis corporis (body lice infestation).^{103 120 121 122 123 124 125} In some cases, body louse infestations may be treated by improved hygiene and by decontaminating clothes and bedding by washing at temperatures that kill lice.^{103 125} If the infestation is severe, a pediculicide should also be used (e.g., topical permethrin, topical pyrethrins with piperonyl butoxide, topical malathion, oral ivermectin).^{124 125}

One of several options recommended for treatment of pediculosis corporis in the adjunctive treatment of epidemic (louse-borne) typhus.¹⁰³ The causative agent of epidemic typhus (Rickettsia prowazekii) is transmitted person-to-person by Pediculus humanus corporis and thorough delousing (especially among exposed contacts of individuals with typhus) is recommended in epidemic situations.¹⁰³

Scabies

Not effective for treatment of scabies (mite infestation).^a

Pyrethrins with Piperonyl Butoxide Dosage and Administration

General

Measures to Avoid Reinfestation and Transmission

• 
  

  To avoid reinfestation or transmission of pediculosis or scabies, most experts recommend that clothing and bed linen that may have been contaminated by the infested individual during the 2 days prior to treatment should be decontaminated (machine-washed in hot water and dried in a hot dryer, dry-cleaned, or treated with an appropriate pesticide) or removed from body contact for ≥72 hours.^{103 104 106 113}

  
  


• 
  

  Although it may not be necessary, items that cannot be laundered or dry-cleaned should be removed from contact and sealed in a plastic bag for 10–14 days.^{103 106 116}

  
  


• 
  

  Combs and brushes used by the infected patient may be disinfected by soaking in hot water (temperature >54°C) for 5–10 minutes;^{103 106} alternatively, they can be soaked in alcohol or a pediculicide for 1 hour.^{106 112}

  
  


• 
  

  Furniture and floors of rooms inhabited by patients infested with lice should be thoroughly vacuumed.^{103 106 116} Fumigation of living areas is not necessary and is not recommended.^{103 106 114 116}

  
  


• 
  

  In the treatment of pediculosis capitis (head lice infestation), a fine-toothed comb often is recommended to remove any remaining nits (eggs) or nit shells.^{103 106 112 113 116 117 118} Some experts do not consider nit removal necessary since only live lice can be transmitted, but recommend it for aesthetic reasons and to decrease diagnostic confusion and unnecessary retreatment.^{103 116 117 118} Others strongly recommend removal of nits (especially those within 1 cm of the scalp) since no pediculicide is 100% ovicidal and potentially viable nits may remain on the hair after pediculicide treatment.^{103 116 117 118} Although many schools will not allow children with nits to attend, AAP and other experts consider these no-nit policies excessive.^{103 114 116}

  
  

Administration

Topical Administration

Apply topically, usually as a shampoo containing 0.33% pyrethrins and 4% piperonyl butoxide.^{120 121 122 123}

For external use only.^{120 121 122 123} Do not administer orally and do not apply to mucous membranes (e.g., inside the nose, mouth, or vagina).^{120 121 122 123}

Do not apply to eyebrows or eyelashes and avoid contact with eyes.^{120 121 122 123} Eyes should be closed tightly and covered with a soft towel or washcloth while the shampoo is applied to scalp hair or washed off.^{120 121 122 123}

Shake containers of pyrethrins with piperonyl butoxide before using.^{120 123}

Dosage

Pediatric Patients

Pediculosis

Pediculosis Capitis (Head Lice Infestation) or Pediculosis Corporis (Body Lice Infestation)

Topical

Apply to dry scalp hair or other affected areas in an amount sufficient to thoroughly wet the area.^{120 121 122 123} If treating head lice, first apply behind ears and to back of neck.^{120 121} After 10 minutes, add warm water to form a good lather, wash, and thoroughly rinse with water until all lather is gone.^{120 121 122 123} Dry the hair with a clean towel and comb with a fine tooth comb to remove any remaining nits.^{120 121 122 123}

One treatment may be successful, but treatment should be repeated after 7–10 days to kill any newly hatched lice.^{103 107 113 116 117 121 122 123} Do no use more than twice in 24 hours.¹²³

Adults

Pediculosis

Pediculosis Capitis (Head Lice Infestation) or Pediculosis Corporis (Body Lice Infestation)

Topical

Apply to dry scalp hair or other affected areas in an amount sufficient to thoroughly wet the area.^{120 121 122 123} If treating head lice, first apply behind ears and to back of neck.^{120 121} After 10 minutes, add warm water to form a good lather, wash, and thoroughly rinse with water until all lather is gone.^{120 121 122 123} Dry the hair with a clean towel and comb with a fine tooth comb to remove any remaining nits.^{120 121 122 123}

One treatment may be successful, but treatment should be repeated after 7–10 days to kill any newly hatched lice.^{103 107 113 116 117 121 122 123} Do not use more than twice in 24 hours.¹²³

Pediculosis Pubis (Pubic Lice Infestation)

Topical

Apply to the pubic area.¹⁰⁴ After 10 minutes, rinse off with water.¹⁰⁴

CDC recommends reevaluating the patient 1 week after treatment if symptoms persist;¹⁰⁴ retreatment may be necessary if lice or eggs are found.¹⁰⁴ Some clinicians recommend routine retreatment 7–10 days after initial treatment.¹⁰³ If retreatment is necessary, CDC recommends use of an alternative regimen.¹⁰⁴

Cautions for Pyrethrins with Piperonyl Butoxide

Contraindications

• 
  

  Known hypersensitivity or intolerance to any ingredient in the formulation.

  
  

Warnings/Precautions

Sensitivity Reactions

Asthmatic Episodes

May cause breathing difficulty or an asthmatic episode in susceptible individuals.^{120 121 122}

Use with caution in individuals allergic to ragweed.^{120 121 122 123}

Discontinue use and contact a clinician if breathing difficulties occur.^{120 121}

Contact Dermatitis

Pyrethrins may be contact allergens; sensitization characterized by dermatitis may be due to impurities from the pyrethrum flowers.^a

Commercially available preparations of pyrethrins are refined, and only mild skin sensitization has been reported.^a

General Precautions

Administration Precautions

Avoid contact with the eyes since ocular irritation may occur.^{120 121 122 123} Do not use for treatment of pediculosis of the eyebrows or eyelashes.^{120 121 122 123}

If accidental contact with the eyes occurs, the affected eye(s) should be flushed thoroughly with water.^{120 121 122 123} If eye irritation occurs, discontinue use and contact a clinician.^{120 121 122}

Avoid contact with mucous membranes (e.g., inside the nose, mouth, or vagina) since irritation may occur.^{120 121 122 123}

Dermatologic Reactions

Local irritation or erythema may occur.^{120 121 a}

If skin irritation or infection occurs, discontinue use and contact a clinician.^{120 121 122 123}

Do not use on acutely inflamed skin or raw, weeping surfaces.^a

Specific Populations

Pregnancy

CDC considers pyrethrins with piperonyl butoxide a pediculicide of choice when treatment is considered necessary in a pregnant woman.¹⁰⁴

Pregnant women should consult a clinician before self-medicating with pyrethrins with piperonyl butoxide ^{120 121 122}

Lactation

Not known whether distributed into milk. CDC considers pyrethrins with piperonyl butoxide a pediculicide of choice when treatment is considered necessary in a lactating woman.¹⁰⁴

Lactating women should consult a clinician before self-medicating with pyrethrins with piperonyl butoxide.^{120 121 122}

Pediatric Use

Should not be used in children <2 years of age unless directed by a clinician.^{120 121}

Keep out of reach of children.^{120 121 122}

Common Adverse Effects

Local irritation (erythema, pruritus, urticaria, edema, eczema).^{120 121 a 123}

Pyrethrins with Piperonyl Butoxide Pharmacokinetics

Absorption

Bioavailability

Pyrethrins is absorbed through intact skin when applied topically.^a Piperonyl butoxide is poorly absorbed through intact skin when applied topically.^a

Distribution

Extent

Information regarding systemic distribution of pyrethrins and piperonyl butoxide following topical application not available.^a

Elimination

Elimination Route

Information regarding elimination of pyrethrins and piperonyl butoxide following topical application not available.^a

Stability

Storage

Topical

Shampoo

Well-closed containers at <40°C, preferably between 15–30°C.^a

Actions and SpectrumActions

• 
  

  Pyrethrins (also known as pyrethrum extract) contains the purified derivatives of pyrethrum flowers (Chrysanthemum cinerariaefolium) and is a complex of substances that includes the alcohols and esters of pyrethrolone and cinerolone, the alcohol of chrysanthemic acid, and the ester of pyrethric acid.^a Piperonyl butoxide is a synthetic piperic acid derivative.^a

  
  


• 
  

  Following absorption through the chitinous exoskeleton of arthropods, pyrethrins stimulates the nervous system and blocks nerve impulse transmissions, resulting in paralysis and death.^a

  
  


• 
  

  Piperonyl butoxide has little or no insecticidal activity, but potentiates that of pyrethrins by inhibiting the hydrolytic enzymes responsible for metabolism of pyrethrins in arthropods.^a

  
  


• 
  

  Pyrethrins is active against Pediculus humanus var. capitis (head louse), P. humanus var. corporis (body louse), and Phthirus pubis (pubic or crab louse), and may have some activity against their nits (eggs).^a Pyrethrins also is toxic to houseflies, fleas, chiggers, and mosquitoes.^a

  
  


• 
  

  Therapeutic failure and resistance to pyrethrins has been reported in P. humanus.^{107 116} The prevalence of resistance in the US is unclear.^{103 116}

  
  


• 
  

  Treatment failures do not necessarily mean resistance is present since failures can also be related to misdiagnosis, noncompliance with the treatment regimen, and reinfestation.^{108 116}

  
  

Advice to Patients

• 
  

  Importance of using only as directed.^{120 121 122 123}

  
  


• 
  

  Advise patients regarding personal protective measures to avoid reinfestation or transmission of lice.^{103 104 106 113}

  
  


• 
  

  Importance of not using on eyebrows or eyelashes and avoiding contact with the eyes since ocular irritation may occur.^{120 121 122 123} If accidental contact with the eyes occurs, the affected eye(s) should be flushed thoroughly with water.^{120 121 122 123}

  
  


• 
  

  Importance of avoiding contact with mucous membranes (e.g., inside the nose, mouth, vagina).^{120 121 122 123}

  
  


• 
  

  Advise patients to discontinue treatment and consult their clinician if skin or scalp irritation or infection is present or develops, if eyebrows or eyelashes are infested with lice, or if eye irritation occurs.^{120 121 122 123}

  
  


• 
  

  Advise patients using pyrethrins with piperonyl butoxide that breathing problems or asthmatic episodes may occur in susceptible individuals.^{120 121} If breathing difficulties occur, discontinue treatment and consult a clinician.^{120 121}

  
  


• 
  

  Importance of immediately consulting clinician and/or poison control center if pyrethrins with piperonyl butoxide is accidentally ingested.^{120 121}

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{120 121 122}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{120 121 122}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{120 121 122} (See Cautions.)

  
  

Preparations

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

Pyrethrins with Piperonyl Butoxide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Shampoo	Pyrethrins 0.33% with Piperonyl Butoxide 4%	A200 Lice Killing Shampoo (with benzyl alcohol and isopropyl alcohol)	Hogil
			A200 Lice Treatment Kit (with benzyl alcohol and isopropyl alcohol; with comb and lice control spray)	Del
			Licide (with benzyl alcohol 2.4% and petroleum distillate 1.2%)	Reese
			Pronto Plus Lice Killing Mousse Shampoo Plus Vitamin E (with benzyl alcohol and isopropyl alcohol)	Del
			Pronto Plus Lice Killing Shampoo (with benzyl alcohol and isopropyl alcohol)	Del
			RID Maximum Strength Lice Killing Shampoo (with isopropyl alcohol)	Bayer

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 September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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

101. Brown S, Becher J, Brady W. Treatment of ectoparasitic infections: review of the English-language literature, 1982-1992. Clin Infect Dis. 1995; 20:S104-9. [IDIS 345865] [PubMed 7540875]

103. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.

104. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2006. MMWR Recomm Rep. 2006; 55(RR-11):1-94.

105. Wilson DC, Leyva WH, King LE. Arthropod bites and stings. In: Fitzpatrick TB, Eisen AZ, Wolff K et al, eds. Dermatology in general medicine. 4th ed. New York: McGraw Hill Inc. 1993:2810-26.

106. Centers for Disease Control and Prevention. Treating head lice. From the CDC website () Accessed 2003 Aug 5.

107. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Aug 2004. From the Medical Letter web site ()

108. Anon. Drugs for head lice. Med Lett Drugs Ther. 1997; 39:6-7. [PubMed 9008683]

109. Reviewers’ comments (personal observations) on permethrin 84:04.12.

110. Lindane Shampoo, USP, 1% prescribing information. From the FDA web site (). Accessed 2003 Apr 4.

111. Mathieu ME, Wilson BB. Scabies. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s principles and practices of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000:2974-6.

112. Meinking TL, Entzel P, Villar ME et al. Comparative efficacy of treatments for pediculosis capitis infections. Arch Dermatol. 2001; 137:287-92. [IDIS 461253] [PubMed 11255326]

113. Jones KN, English JC. Review of common therapeutic options in the United States for the treatment of pediculosis capitis. Clin Infect Dis. 2003; 36:1355-61. [IDIS 511964] [PubMed 12766828]

114. Roberts RJ. Head lice. N Engl J Med. 2002; 346:1645-50. [IDIS 481320] [PubMed 12023998]

115. Wendel K, Rompalo A. Scabies and Pediculosis pubis: an update of treatment regimens and general review. Clin Infect Dis. 2002; 35(Suppl 2):S146-51.

116. American Academy of Pediatrics. Head lice. Pediatrics. 2002; 110:638-43. [IDIS 486240] [PubMed 12205271]

117. Burkhart CG, Burkhart CN, Burkhart KM. An assessment of topical and oral prescription and over-the-counter treatments for head lice. J Am Acad Dermatol. 1998; 38:979-82. [IDIS 405854] [PubMed 9632008]

118. Burkhart CN, Burkhart CG, Pchalek I et al. The adherent cylindrical nit structure and its chemical denaturation in vitro: an assessment with therapeutic implications for head lice. Arch Pediatr Adolescent Med. 1998; 152:711- 2.

119. Reviewers’ comments (personal observations) on Permethrin 84:04.12.

120. Del Pharmaceuticals. Pronto maximum strength lice killing shampoo (pyrethrins with piperonyl butoxide) product information. Farmington, NY; 2002.

121. Bayer Healthcare. Rid (pyrethrins with piperonyl butoxide) product information. Morristown, NJ.

122. Hogli Pharmaceutical Corp. A200 lice killing shampoo (pyrethrins with piperonyl butoxide) product information.

123. Del Pharmaceuticals. Pronto plus lice killing mousse shampoo kit (pyrethrins with piperonyl butoxide) product information. Farmington, NY; 2007.

124. Centers for Disease Control and Prevention. Body lice infestation. From the CDC website () Accessed 2007 Jun 14.

125. Flinders DC, De Schweinitz P. Pediculosis and scabies. Am Fam Physician. 2004; 69:341-50. [IDIS 510826] [PubMed 14765774]

a. AHFS Drug Information 2006. McEvoy GK, ed. Pyrethrins with piperonyl butoxide. American Society of Health-System Pharmacists; 2006:3509-10.

More Pyrethrins with Piperonyl Butoxide resources

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