Airacof Solution

Pronunciation: KOE-deen/DYE-fen-HYE-dra-meen/FEN-il-EF-rin
Generic Name: Codeine/Diphenhydramine/Phenylephrine
Brand Name: Examples include Airacof and Endal CD

Airacof Solution is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough caused by colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Airacof Solution is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Airacof Solution if:

• you are allergic to any ingredient in Airacof Solution


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, stomach ulcer, narrow-angle glaucoma, or difficulty urinating, or you are having an asthma attack


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

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

Before using Airacof Solution:

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

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


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


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


• if you have a recent head injury, severe drowsiness, brain tumor or lesion, or increased pressure in the brain


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems (eg, heart disease); fast, slow, or irregular heartbeat; high or low blood pressure; liver problems; low blood volume; diabetes; blood vessel problems; stroke; glaucoma or increased pressure in the eye; a blockage of your stomach, bladder, or intestines; recent stomach or bowel surgery or other stomach or bowel problems (eg, constipation, diarrhea caused by antibiotic use, inflammation, ulcers); trouble urinating; an enlarged prostate or other prostate problems; seizures; mental or mood problems (eg, depression); pancreas problems (eg, pancreatitis); or an overactive thyroid


• if you have a history of asthma, sleep apnea, or other breathing problems (eg, slow or irregular breathing), chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior; or if you are in poor health or are very overweight

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

• Anticholinergics (eg, scopolamine) because a serious bowel problem (paralytic ileus) may occur


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


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone , HIV protease inhibitors (eg, ritonavir), MAOIs (eg, phenelzine), muscle relaxants (eg, cyclobenzaprine), opioid analgesics (eg, hydrocodone), phenothiazines (eg, chlorpromazine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Airacof Solution's side effects


• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Airacof Solution's effectiveness


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Airacof Solution


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Airacof Solution

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

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

• Take Airacof Solution by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Airacof Solution with a full glass of water (8 oz/240 mL).


• Drink plenty of water while taking Airacof Solution.


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


• If you miss a dose of Airacof Solution, 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 Airacof Solution.

Important safety information:

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


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


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


• Do not take diet or appetite control medicines while you take Airacof Solution without checking with your doctor.


• Airacof Solution has codeine, phenylephrine, and diphenhydramine in it. Before you start any new medicine, check the label to see if it has codeine, phenylephrine, or diphenhydramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


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


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


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


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


• Airacof Solution may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Airacof Solution for a few days before the tests.


• Tell your doctor or dentist that you take Airacof Solution before you receive any medical or dental care, emergency care, or surgery.


• Use Airacof Solution with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Airacof Solution in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Airacof Solution should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Airacof Solution can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Airacof Solution while you are pregnant. It is not known if Airacof Solution is found in breast milk. Do not breast-feed while taking Airacof Solution.

Some people who use Airacof Solution for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Airacof Solution suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, irregular heartbeat, irritability, restlessness, trouble sleeping, and unusual sweating.

Possible side effects of Airacof 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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes (eg, irritability); persistent trouble sleeping; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; vision changes or blurred vision.

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: Airacof 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; cold and clammy skin; coma; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Airacof Solution:

Store Airacof Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Airacof Solution out of the reach of children and away from pets.

General information:

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


• Airacof 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 Airacof Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Airacof resources

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

Compare Airacof with other medications

• Cough and Nasal Congestion

Akineton

biperiden hydrochloride

Dosage Form: Tablets

Akineton Description

Each Akineton tablet for oral administration contains 2 mg biperiden hydrochloride. Other ingredients may include corn syrup, lactose, magnesium stearate, potato starch and talc. Akineton is an anticholinergic agent. Biperiden is α-5-Norbornen-2-yl-α-phenyl-1-piperidinepropanol. It is a white, crystalline, odorless powder, slightly soluble in water and alcohol. It is stable in air at normal temperatures. Biperiden may be represented by the following structural formula:

Akineton - Clinical Pharmacology

Akineton is a weak peripheral anticholinergic agent. It has, therefore, some antisecretory, antispasmodic and mydriatic effects. In addition, Akineton possesses nicotinolytic activity. Parkinsonism is thought to result from an imbalance between the excitatory (cholinergic) and inhibitory (dopaminergic) systems in the corpus striatum. The mechanism of action of centrally active anticholinergic drugs such as Akineton is considered to relate to competitive antagonism of acetylcholine at cholinergic receptors in the corpus striatum, which then restores the balance.

The parenteral form of Akineton is an effective and reliable agent for the treatment of acute episodes of extrapyramidal disturbances sometimes seen during treatment with neuroleptic agents. Akathisia, akinesia, dyskinetic tremors, rigor, oculogyric crisis, spasmodic torticollis, and profuse sweating are markedly reduced or eliminated. With parenteral Akineton, these drug-induced disturbances are rapidly brought under control. Subsequently, this can usually be maintained with oral doses which may be given with tranquilizer therapy in psychotic and other conditions requiring an uninterrupted therapeutic program.

Pharmacokinetics and Metabolism

Only limited pharmacokinetic studies of biperiden in humans are available. The serum concentration at 1 to 1.5 hours following a single, 4 mg oral dose was 4-5 ng/mL. Plasma levels (0.1-0.2 ng/mL) could be determined up to 48 hours after dosing. Six hours after an oral dose of 250 mg/kg in rats, 87% of the drug had been absorbed. The metabolism of Akineton is also incompletely understood, but does involve hydroxylation. In normal volunteers a single 10 mg intravenous dose of biperiden seemed to cause a transient rise in plasma cortisol and prolactin. No change in GH, LH, FSH, or TSH levels were seen. Biperiden lactate (10 mg/mL) was not irritating to the tissue of rabbits when injected intramuscularly (1.0 mL) into the sacrospinalis muscles and intradermally (0.25 mL) and subcutaneously (0.5 mL) into the shaved abdominal skin.

Indications and Usage for Akineton

• As an adjunct in the therapy of all forms of parkinsonism (idiopathic, postencephalitic, arteriosclerotic)


• Control of extrapyramidal disorders secondary to neuroleptic drug therapy (e.g., phenothiazines)

Contraindications

1) Hypersensitivity to biperiden 2) Narrow angle glaucoma 3) Bowel obstruction 4) Megacolon

Warnings

Isolated instances of mental confusion, euphoria, agitation and disturbed behavior have been reported in susceptible patients. Also, the central anticholinergic syndrome can occur as an adverse reaction to properly prescribed anticholinergic medication, although it is more frequently due to overdosage. It may also result from concomitant administration of an anticholinergic agent and a drug that has secondary anticholinergic actions (see PRECAUTIONS - Drug Interactions and OVERDOSAGE sections). Caution should be observed in patients with manifest glaucoma, though no prohibitive rise in intraocular pressure has been noted following either oral or parenteral administration. Patients with prostatism, epilepsy or cardiac arrhythmia should be given this drug with caution.

Occasionally, drowsiness may occur, and patients who drive a car or operate any other potentially dangerous machinery should be warned of this possibility. As with other drugs action on the central nervous system, the consumption of alcohol should be avoided during Akineton therapy.

Precautions

Drug Interactions

The central anticholinergic syndrome can occur when anticholinergic agents such as Akineton are administered concomitantly with drugs that have secondary anticholinergic actions, e.g., certain narcotic analgesics such as meperidine, the phenothiazines and other antipsychotics, tricyclic antidepressants, certain antiarrhythmics such as the quinidine salts, and antihistamines. See OVERDOSAGE section for signs and symptoms of the central anticholinergic syndrome, and for treatment.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Akineton. It is also not known whether Akineton can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Akineton should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Akineton is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

Adverse Reactions

Atropine-like side effects such as dry mouth; blurred vision; drowsiness; euphoria or disorientation; urinary retention; postural hypotension; constipation; agitation; disturbed behavior may been seen. A case of generalized choreic movements has been reported in a Parkinson's disease patient when biperiden was added to carbidopa/levodopa. A reduction in rapid eye movement (REM) sleep, characterized by increased REM latency and decreased percentage of REM sleep, has been reported. There usually are no significant changes in blood pressure or heart rate in patients who have been given the parenteral form of Akineton. Mild transient postural hypotension and bradycardia may occur. These side effects can be minimized or avoided by slow intravenous administration. No local tissue reactions have been reported following intramuscular injection. If gastric irritation occurs following oral administration, it can be avoided by administering the drug during or after meals.

The central anticholinergic syndrome can occur as an adverse reaction to properly prescribed anticholinergic medication. See OVERDOSAGE section for signs and symptoms of the central anticholinergic syndrome, and for treatment.

Overdosage

Signs and Symptoms

Overdosage with Akineton produces typical central symptoms of atropine intoxication (the central anticholinergic syndrome). Correct diagnosis depends upon recognition of the peripheral signs of parasympathetic blockade including dilated and sluggish pupils; warm, dry skin; facial flushing;decreased secretions of the mouth, pharynx, nose, and bronchi; foul-smelling breath; elevated temperature, tachycardia, cardiac arrhythmias, decreased bowel sounds, and urinary retention. Neuropsychiatric signs such as delirium, disorientation, anxiety, hallucinations, illusions, confusion, incoherence, agitation, hyperactivity, ataxia, loss of memory, paranoia, combativeness, and seizures may be present. The condition can progress to stupor, coma, paralysis, and cardiac and respiratory arrest and death.

Treatment

Treatment of acute overdose revolves around symptomatic and supportive therapy. If Akineton was administered orally, gastric lavage or other measures to limit absorption should be instituted. A small dose of diazepam or a short acting barbiturate may be administered if CNS excitation is observed. Phenothiazines are contraindicated because the toxicity may be intensified due to their antimuscarinic action, causing coma. Respiratory support, artificial respiration or vasopressor agents may be necessary. Hyperpyrexia must be reversed, fluid volume replaced and acid-base balance maintained. Urinary catheterization may be necessary.

Routine use of physostigmine for overdose is controversial. Delirium, hallucinations, coma, and supraventricular tachycardia (not ventricular tachycardias or conduction defects) seem to respond. If indicated, 1 mg (half this amount for the children or elderly) may be given intramuscularly or by slow intravenous infusion. If there is no response within 20 minutes, and additional 1 mg dose may be given; this may be repeated until a total of 4 mg has been administered, a reversal of the toxic effects occur or excessive cholinergic signs are seen. Frequent monitoring of clinical signs should be done. Since physostigmine is rapidly destroyed, additional injections may be required every one or two hours to maintain control. The relapse intervals tend to lengthen as the toxic anticholinergic agent is metabolized, so the patient should be carefully observed for 8 to 12 hours following the last relapse.

Toxicity in Animals

The LD50 of biperiden in the white mouse is 545 mg/kg orally, 195 mg/kg subcutaneously, and 56 mg/kg intravenously. The acute oral toxicity (LD50) in rats is 750 mg/kg. The intraperitoneal toxicity (LD50) of biperiden lactate in rats was 270 mg/kg and the intravenous toxicity (LD50) in dogs was 222 mg/kg. In dogs under general anesthesia, respiratory arrest occurred at 33 mg/kg (intravenous) and circulatory standstill at 45 mg/kg (intravenous). The oral LD50in dogs is 340 mg/kg. Chronic toxicity studies in both rat and dog have been reported.

Akineton Dosage and Administration

Drug-induced Extrapyramidal Symptoms

Oral: One tablet one to three times daily.

Parkinson's Disease: Oral: The usual beginning dose is one tablet three or four times daily. The dosage should be individualized with the dose titrated upward to a maximum of 8 tablets (16 mg) per 24 hours.

How is Akineton Supplied

Akineton (biperiden hydrochloride) Tablets, 2 mg each, white, embossed on one face with a triangle, bisected on the reverse and imprinted with the number "11."

Bottles of 100 – NDC # 49884-693-01

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in USP.

Akineton is a registered trademark of Knoll AG.

Manufactured for:

PAR PHARMACEUTICAL, INC.

Spring Valley , New York  10977

Manufactured by:

Abbott Laboratories

North Chicago, IL 60064, U.S.A.

Akineton  biperiden hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49884-693 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength biperiden hydrochloride (biperiden) Active 2 MILLIGRAM  In 1 TABLET lactose Inactive   magnesium stearate Inactive   corn syrup Inactive   potato starch Inactive   talc Inactive

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code 11 Contains          Coating false Symbol true

Packaging # NDC Package Description Multilevel Packaging 1 49884-693-01 100 TABLET In 1 BOTTLE None

Revised: 06/2006Abbott Laboratories

More Akineton resources

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

Compare Akineton with other medications

• Extrapyramidal Reaction
• Parkinson's Disease

Agenerase

Generic Name: Amprenavir
Class: HIV Protease Inhibitors
VA Class: AM800
Chemical Name: [3S - [3R*(1R*,2S*)]] - [3 - [[(4 - Aminophenyl)sulfonyl] - (2 - methylpropyl)amino] - 2 - hydroxy - 1 - (phenylmethyl)propyl] tetrahydro-3-furanyl carbamate
Molecular Formula: C₂₅H₃₅N₃O₆S
CAS Number: 161814-49-9

• 
  

  Because of potential risk of toxicity from the large amount of propylene glycol contained in amprenavir oral solution, the oral solution is contraindicated in infants and children <4 years of age, pregnant women, patients with hepatic or renal failure, and those receiving metronidazole or disulfiram and should be used with caution in others.^{1 46} (See Contraindications and see Propylene Glycol-associated Toxicity under Cautions.)

  
  


• 
  

  Amprenavir oral solution should only be used when amprenavir capsules or other HIV protease inhibitors (PIs) cannot be used.⁴⁶

  
  

Introduction

Antiretroviral; HIV protease inhibitor (PI).^{1 46}

Uses for Agenerase

Treatment of HIV Infection

In August 2007, the manufacturer of amprenavir announced that sales of the drug would be discontinued as of October 2007.⁷¹ This action was taken because demand for amprenavir had declined substantially and because of the availability of other treatment options (e.g., fosamprenavir oral suspension for the treatment of HIV-1 infection in children).⁷¹ Patients receiving amprenavir should be evaluated for alternative treatment (e.g., an alternative PI or a different antiretroviral regimen).⁷¹

Treatment of HIV-1 infection in conjunction with other antiretrovirals.^{1 14 15 16 46}

When selecting a PI-based regimen for initial therapy in adults, fosamprenavir (with or without low-dose ritonavir) recommended instead of amprenavir (lower pill burden, once-daily regimen possible, better GI tolerance).¹⁴

If selecting amprenavir for use in multiple-drug regimens, consider that amprenavir is less effective than indinavir in PI-naive patients, that mild to moderate adverse GI effects have led to discontinuance of amprenavir during the first 12 weeks of therapy, and that data are limited regarding response to amprenavir in PI-experienced patients.^{1 46}

Agenerase Dosage and Administration

Administration

Oral Administration

Administer orally.¹ May be given without regard to meals, but avoid high-fat meals since absorption of the drug may be decreased.^{1 14 46}

The liquid-filled capsules and oral solution are not bioequivalent and are not interchangeable on a mg-per-mg basis.^{1 46}

Oral solution should be used only when amprenavir capsules or other PIs cannot be used; switch patients from the oral solution as soon as they are able to take capsules.^{1 46}

Dosage

Must be given in conjunction with other antiretrovirals.^{1 46} If used with ritonavir capsules, dosage adjustment recommended and additional drug interactions must be considered (see Specific Drugs under Interactions.).^{1 46}

Pediatric Patients

Treatment of HIV Infection

Oral

Pediatric Dosage for Treatment of HIV

Age and Weight (kg)	Dosage for Liquid-filled Capsules	Dosage for Oral Solution
4–12 years of age weighing <50 kg	20 mg/kg twice daily or 15 mg/kg 3 times daily (maximum 2.4 g daily)1 15	22.5 mg/kg (1.5 mL/kg) twice daily or 17 mg/kg (1.1 mL/kg) 3 times daily (maximum 2.8 g daily)15 46
13–16 years of age weighing <50 kg	20 mg/kg twice daily or 15 mg/kg 3 times daily (maximum 2.4 g daily)1 15	22.5 mg/kg (1.5 mL/kg) twice daily or 17 mg/kg (1.1 mL/kg) 3 times daily (maximum 2.8 g daily) 15 46
13–16 years of age weighing ≥50 kg	1.2 g twice daily1	1.4 g twice daily14 46
>16 years of age	1.2 g twice daily1	1.4 g twice daily46

Adults

Treatment of HIV Infection

Oral

Liquid-filled Capsules: 1.2 g twice daily.^{1 14}

If used in conjunction with low-dose ritonavir, manufacturer recommends amprenavir 1.2 g once daily with ritonavir 200 mg once daily or amprenavir 600 mg twice daily with ritonavir 100 mg twice daily.¹

Oral Solution: 1.4 g twice daily.^{14 46}

Special Populations

Hepatic Impairment

Dosage recommendations not available for children with hepatic impairment since the drug has not been evaluated in these patients.^{1 46}

Dosage adjustments necessary in adults with hepatic impairment based on Child-Pugh scores; oral solution contraindicated in those with hepatic failure.^{1 46 49}

Liquid-filled Capsules: 450 mg twice daily in adults with Child-Pugh scores 5–8 and 300 mg twice daily in those with Child-Pugh scores 9–12.^{1 49}

Oral Solution: 513 mg (34 mL) twice daily in adults with Child-Pugh scores 5–8 and 342 mg (23 mL) twice daily in those with Child-Pugh scores 9–12.⁴⁶

Renal Impairment

Dosage adjustments not needed.¹

Use oral solution with caution in patients with renal impairment;⁴⁶ oral solution contraindicated in those with renal failure.⁴⁶

Geriatric Patients

Cautious dosage selection; pharmacokinetics have not been studied in this age group.^{1 46}

Cautions for Agenerase

Contraindications

• 
  

  Known hypersensitivity to amprenavir or any ingredient in the formulation.^{1 46}

  
  


• 
  

  Use of oral solution in infants and children <4 years of age, pregnant women, patients with hepatic or renal failure, and patients receiving disulfiram or metronidazole due to the potential risk of propylene glycol-associated toxicity.^{1 46} (See Specific Drugs under Interactions.)

  
  


• 
  

  Concomitant use with drugs highly dependent on CYP3A4 for metabolism and for which elevated plasma concentrations are associated with serious and/or life-threatening events (e.g., cisapride, ergot derivatives, pimozide, midazolam, triazolam).^{1 46} (See Specific Drugs under Interactions.)

  
  


• 
  

  Concomitant use of ritonavir-boosted amprenavir with flecainide or propafenone.^{1 46} (See Specific Drugs under Interactions.)

  
  

Warnings/Precautions

Warnings

Interactions

Concomitant use with certain drugs is not recommended (e.g., rifampin, lovastatin, simvastatin, St. John’s wort, fluticasone) or requires particular caution (e.g., sildenafil, tadalafil, vardenafil).¹ (See Specific Drugs under Interactions.)

Propylene Glycol-Associated Toxicity

Possible toxicity from the large amount of propylene glycol in the oral solution;⁴⁶ only limited information available regarding chronic exposure to large amounts of propylene glycol.⁴⁶

Infants and children <4 years of age, women, and certain ethnic populations (Asians, Native Alaskans, Native Americans) may be at increased risk.⁴⁶ (See Contraindications under Cautions.)

Use oral solution only when amprenavir liquid-filled capsules and other PIs cannot be used.⁴⁶ Switch to amprenavir capsules as soon as patient is able to take capsules.^{1 46}

If oral solution is used, monitor for propylene glycol-associated adverse events (e.g., seizures, stupor, tachycardia, hyperosmolality, lactic acidosis, renal toxicity, hemolysis).⁴⁶

Concomitant use of amprenavir oral solution and ritonavir oral solution not recommended because the large amount of propylene glycol in the amprenavir preparation and alcohol in the ritonavir preparation may compete for the same metabolic elimination pathway.⁴⁶

If accidental overdosage of the oral solution occurs, consider the large amount of propylene glycol in the preparation.^{1 46} Monitor for toxicity and manage acid-base abnormalities;^{1 46} propylene glycol can be removed by hemodialysis.⁴⁶

Hyperglycemic and Diabetogenic Effects

Hyperglycemia, new-onset diabetes mellitus, or exacerbation of preexisting diabetes mellitus reported with use of PIs; diabetic ketoacidosis has occurred.^{1 36 46}

Monitor blood glucose and initiate or adjust dosage of insulin or oral hypoglycemic agents as needed.^{1 46}

Dermatologic Reactions

Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, have occurred.^{1 46}

Discontinue if severe or life-threatening rash or moderate rash accompanied by systemic symptoms occurs.^{1 46}

Sensitivity Reactions

Sulfonamide Hypersensitivity

Because amprenavir is a sulfonamide derivative, use with caution in patients with known sulfonamide allergy.^{1 46}

General Precautions

HIV Resistance

Possibility of HIV resistant to amprenavir and possible cross-resistance to other PIs.^{1 46} Effect of amprenavir therapy on subsequent therapy with other PIs unknown.^{1 46}

Hemophilia A and B

Spontaneous bleeding reported with PIs;^{1 37 41 46} causal relationship not established.^{1 46}

Use with caution in patients with a history of hemophilia type A or B.^{1 37 46} Increased hemostatic (e.g., antihemophilic factor) therapy may be needed.^{1 46}

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]); this may necessitate further evaluation and treatment.¹

Adipogenic Effects

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and general cushingoid appearance.^{1 27 46}

Lipid Effects

Increases in total serum cholesterol and triglyceride concentrations have occurred with amprenavir with or without ritonavir.^{1 46}

Determine serum triglycerides and cholesterol concentrations prior to and periodically during therapy; manage lipid disorders as clinically appropriate.^{1 46} (See HMG-CoA Reductase Inhibitors under Interactions.)

Vitamin E Content

Each 50-mg amprenavir capsule contains 36 units and each mL of the oral solution contains 46 units of vitamin E.^{41 46} Vitamin E content of usual dosages of these formulations exceeds recommended daily intake.^{1 46}

Supplemental vitamin E should not be taken during amprenavir therapy.^{1 46}

The high vitamin E content of the capsules and oral solution may exacerbate vitamin K deficiency caused by anticoagulant therapy or malabsorption.^{1 46}

Effects of long-term, high-dose vitamin E not well characterized and not specifically studied in HIV-infected individuals.^{1 46}

Specific Populations

Pregnancy

Category C.¹

Antiretroviral Pregnancy Registry at 800-258-4263.¹

The oral solution contraindicated during pregnancy because of potential risk to the fetus from the high propylene glycol content.^{1 46 58} Some experts state safety and pharmacokinetic data insufficient to recommend amprenavir liquid-filled capsules in pregnant women.⁵⁸

Lactation

Distributed into milk in rats;^{1 46} not known whether distributed into human milk.^{1 46}

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.^{1 46}

Pediatric Use

Safety and efficacy not established in children <4 years of age.^{1 15 46}

The oral solution contraindicated in infants and children <4 years of age because of potential risk of toxicity from the high propylene glycol content.^{1 46}

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.^{1 46}

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.^{1 46}

Hepatic Impairment

Clearance may be decreased;^{1 46} dosage adjustments necessary.^{1 46 49} (See Hepatic Impairment under Dosage and Administration.)

Use with caution; assess hepatic function prior to and periodically during therapy.^{1 46}

Oral solution contraindicated in those with hepatic failure because of increased risk of propylene glycol-associated adverse events.^{1 46}

Renal Impairment

Effects on amprenavir pharmacokinetics not studied.^{1 46}

Because of increased risk of propylene glycol-associated adverse events, oral solution should be used with caution in those with renal impairment and is contraindicated in those with renal failure.⁴⁶

Common Adverse Effects

Nausea, vomiting, diarrhea, abdominal pain/discomfort, taste disorder, rash, paresthesia (oral/perioral).^{1 27 46}

Interactions for Agenerase

Amprenavir is metabolized by CYP3A4 and also is an inhibitor of CYP3A4.^{1 46}

Does not inhibit CYP2D6, 1A2, 2C9, 2C19, or P2E1.^{1 46}

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors or substrates of CYP3A4 with possible alteration in metabolism of amprenavir and/or the other drug.^{1 4 46}

Specific Drugs

Drug	Interaction	Comments
Abacavir	Possible increased amprenavir plasma concentrations and AUC;1 46 no effect on abacavir pharmacokinetics1 46 In vitro evidence of synergistic antiretroviral effects1 46	No dosage adjustments recommended41
Alcohol	Increased risk of propylene glycol-associated adverse effects in those receiving oral solution46	Alcoholic beverages should not be consumed while receiving amprenavir oral solution46
Antacids	Possible decreased amprenavir concentrations1 46	Take amprenavir at least 1 hour before or after antacids1 46
Antiarrhythmic agents (amiodarone, systemic lidocaine, quinidine)	Possible increased antiarrhythmic agent concentrations;1 46 potential for serious and/or life-threatening effects (e.g., cardiac arrhythmias) with certain agents1 46	Use concomitantly with caution; antiarrhythmic concentration monitoring recommended1 46
Anticoagulants, oral	Warfarin concentrations affected1 46 High vitamin E content of amprenavir preparations may exacerbate blood coagulation defect of vitamin K deficiency caused by anticoagulants1	Monitor INR1 46
Anticonvulsants (carbamazepine, phenobarbital, phenytoin)	Possible decreased amprenavir concentrations;1 46 possible decreased effectiveness of the antiretroviral1 46	Use concomitantly with caution1 46
Antidepressants, tricyclics	Possible increased concentrations of tricyclic antidepressants (amitriptyline, imipramine) and potential for serious and/or life-threatening effects1 46	Monitor tricyclic antidepressant concentrations1 46
Antifungals, azoles (itraconazole, ketoconazole, voriconazole)	Itraconazole or ketoconazole: Possible increased antifungal concentrations;1 46 possible effect on amprenavir pharmacokinetics1 46 Voriconazole: Possible inhibition of amprenavir metabolism and/or voriconazole metabolism68	Itraconazole or ketoconazole: Monitor for adverse effects of the antifungal;1 46 reduction in antifungal dosage may be needed in those receiving itraconazole or ketoconazole dosages >400 mg daily1 46 Voriconazole: Monitor for toxicities related to voriconazole and/or the PI68
Antimycobacterials, rifamycins (rifabutin, rifampin, rifapentine)	Rifabutin: Decreased amprenavir concentrations; increased concentrations of rifabutin and rifabutin metabolite1 50 46 Rifampin: Decreased amprenavir concentrations;1 46 possible loss of virologic response and possible resistance to the antiretroviral1 46	Rifabutin: Reduce rifabutin dosage to ≥50% of usually recommended dosage; monitor for neutropenia by performing weekly CBC as clinically indicated1 46 Rifampin: Concomitant use contraindicated1 45 46 63 Rifapentine: Concomitant use not recommended14
Benzodiazepines	Possible increased concentrations of midazolam or triazolam; potential for serious and/or life-threatening effects (e.g., prolonged or increased sedation or respiratory depression)1 46 Possible increased concentrations of alprazolam, clorazepate, diazepam, flurazepam1 46	Concomitant use with midazolam or triazolam contraindicated1 46 Clinical importance of interaction with other benzodiazepines unknown; a decrease in benzodiazepine dosage may be needed1 46
Calcium-channel blocking agents (diltiazem, felodipine, nifedipine, nicardipine, nimodipine, verapamil, amlodipine, nisoldipine, isradipine)	Possible increased concentrations of calcium-channel blocking agent1 46	Use concomitantly with caution; clinical monitoring recommended1 46
Cisapride	Possible increased cisapride concentrations; potential for serious and/or life-threatening effects (e.g., cardiac arrhythmias)1 46	Concomitant use contraindicated1 14 46
Clarithromycin	Increased amprenavir concentrations and AUC;1 24 46 possible decreased clarithromycin concentrations and decreased 14-hydroxyclarithromycin concentrations and AUC24	No dosage adjustments recommended1 24 41
Corticosteroids (dexamethasone, fluticasone)	Fluticasone nasal spray/oral inhalation: Increased fluticasone concentrations with amprenavir (with or without low-dose ritonavir) resulting in decreased cortisol concentrations1 46 Dexamethasone: Possible decreased amprenavir concentrations; possible loss of virologic response1 46	Fluticasone nasal spray/oral inhalation: Consider alternative in patients receiving amprenavir (without ritonavir), especially when long-term corticosteroid therapy is anticipated; concomitant use with ritonavir-boosted amprenavir not recommended unless potential benefits outweigh risk of systemic corticosteroid adverse effects1 46 Dexamethasone: Use with caution1 46
Darunavir		Concomitant use of ritonavir-boosted darunavir and amprenavir not recommended pending further accumulation of data70
Delavirdine	Possible increased amprenavir concentrations and AUC1 46 Possible decreased delavirdine concentrations and AUC;1 46 possible loss of virologic response and possible resistance to delavirdine1 46	Should not be used concomitantly1 46
Didanosine	Possible decreased amprenavir concentrations with buffered didanosine preparations1 46 In vitro evidence of synergistic antiretroviral effects1 46	Administer amprenavir at least 1 hour before or after buffered didanosine (pediatric oral solution admixed with antacid)1 46
Disulfiram	Potential risk of toxicity if used concomitantly with amprenavir oral solution because of the large amount of propylene glycol in the solution1 46	Concomitant use of disulfiram and amprenavir oral solution contraindicated1 46
Efavirenz	Possible decreased amprenavir concentrations and AUC;1 43 46 possible increased efavirenz AUC43	Appropriate dosages for concomitant use with respect to safety and efficacy not established1 46
Emtricitabine	In vitro evidence of additive or synergistic antiretroviral effectsb
Ergot alkaloids (dihydroergotamine, ergonovine, ergotamine, methylergonovine)	Possible increased concentrations of ergot alkaloids and potential for serious and/or life-threatening effects such as ergot toxicity (peripheral vasospasm and ischemia of the extremities and other tissues)1 46	Concomitant use contraindicated1 14 46 If treatment of uterine atony and excessive postpartum bleeding is indicated in a woman receiving amprenavir, use methylergonovine maleate (Methergine) only if alternative treatments cannot be used and if potential benefits outweigh risks; use methylergonovine at lowest dosage and shortest duration possible58
Estrogens/Progestins	Hormonal contraceptives: Possible decreased amprenavir concentrations with ethinyl estradiol and norethindrone;1 46 possible loss of virologic response and possible resistance to the antiretroviral1 46	Hormonal contraceptives: Use alternative nonhormonal contraceptives1 46
Fosamprenavir	Possible increased toxicity14	Do not use concomitantly; fosamprenavir is a prodrug of amprenavir14
HMG-CoA reductase inhibitors	Possible decreased clearance and increased concentrations of some HMG-CoA reductase inhibitors with potential for increased risk of myopathy (including rhabdomyolysis)1 46	Concomitant use with lovastatin or simvastatin not recommended;1 46 caution if used with other HMG-CoA reductase inhibitors1 46 If used with atorvastatin, use lowest possible initial atorvastatin dosage with careful monitoring1 46 Consider using HMG-COA reductase inhibitors with low potential for interaction (e.g., pravastatin, fluvastatin, rosuvastatin)1 46 59 60 69
Immunosuppressive agents (cyclosporine, sirolimus, tacrolimus)	Potential for increased concentrations of cyclosporine, sirolimus, or tacrolimus1 46	Monitor concentrations of the immunosuppressive agent1 46
Indinavir	Increased plasma concentrations and AUC of amprenavir; decreased plasma concentrations and AUC of indinavir1 46 In vitro evidence of additive antiretroviral effects1 46	Appropriate dosages for concomitant use with respect to safety and efficacy not established1 46
Lamivudine	No evidence of pharmacokinetic interaction1 46	No dosage adjustments recommended41
Lopinavir	Pharmacokinetic interaction may affect both drugs1 46 62	Once-daily lopinavir regimen not recommended with amprenavir62 For treatment-naive adults, manufacturer of lopinavir recommends 400 mg of lopinavir and 100 mg of ritonavir (2 tablets) twice daily; consider a dosage increase to 600 mg of lopinavir and 150 mg of ritonavir (3 tablets) twice daily for treatment-experienced adults when reduced susceptibility to lopinavir is suspected62 Manufacturer of lopinavir recommends that adults receive 533 mg of lopinavir and 133 mg of ritonavir (6.7 mL of the oral solution) twice daily62 For pediatric patients 6 months to 12 years of age, manufacturer of lopinavir recommends that those weighing 7 to <15 kg receive a dosage of 13 mg/kg of lopinavir and 3.25 mg/kg of ritonavir twice daily and those weighing 15–45 kg receive 11 mg/kg of lopinavir and 2.75 mg/kg of ritonavir twice daily; those weighing >45 kg should receive 533 mg of lopinavir and 133 mg of ritonavir (6.7 mL oral solution) twice daily or 400 mg of lopinavir and 100 mg of ritonavir (2 tablets) twice daily62 Pediatric patients ≥12 years of age may receive recommended adult dosage62
Methadone	Decreased amprenavir concentrations and AUC; possible decreased effectiveness of the antiretroviral1 46 Decreased methadone concentrations1 46	Consider alternative antiretroviral agents1 46 If used with amprenavir, monitor and consider possible need to increase methadone dosage1 46
Metronidazole	Potential risk of toxicity if used concomitantly with amprenavir oral solution because of the large amount of propylene glycol in the solution 46	Concomitant use contraindicated46
Nelfinavir	Increased plasma concentrations and AUC of amprenavir1 46 In vitro evidence of additive antiretroviral effects1 46	Appropriate dosages for concomitant use with respect to safety and efficacy not established1 46
Nevirapine	Possible decreased amprenavir concentrations1 46	Appropriate dosages for concomitant use with respect to safety and efficacy not established1 46
Pimozide	Possible increased pimozide concentrations;1 46 potential for serious and/or life-threatening effects (e.g., cardiac arrhythmias)1 46	Concomitant use contraindicated1 14 46
Ritonavir	Increased amprenavir plasma concentrations and AUC;1 46 concomitant low-dose ritonavir used to therapeutic advantage (ritonavir-boosted amprenavir1 Potential for the large amount of propylene glycol in amprenavir oral solution and alcohol in ritonavir oral solution to compete for the same metabolic elimination pathway46 In vitro evidence of additive antiretroviral effects1 46	Reduce amprenavir dosage when used concomitantly with ritonavir; if amprenavir capsules used in adults, use amprenavir 1.2 g once daily with ritonavir 200 mg once daily or amprenavir 600 mg twice daily with ritonavir 100 mg twice daily1 46 Appropriate pediatric dosage of amprenavir capsules used concomitantly with ritonavir not established1 Concomitant use of amprenavir oral solution and ritonavir oral solution not recommended46 If ritonavir and amprenavir used concomitantly, concomitant use of flecainide or propafenone contraindicated1 46
St. John’s wort (Hypericum perforatum)	Possible decreased amprenavir concentrations;1 46 54 55 possible loss of virologic response and possible resistance to the antiretroviral1 46 54 55	Concomitant use not recommended1 14 46 54 55
Saquinavir	Decreased amprenavir concentrations1 46 In vitro evidence of synergistic antiretroviral effects1 46	Appropriate dosages for concomitant use with respect to safety and efficacy not established1 46
Sildenafil	Increased sildenafil concentrations; increased risk of sildenafil-associated adverse effects1 46	Use caution and reduced sildenafil dosage (do not exceed 25 mg every 48 hours); monitor closely for adverse effects (e.g., hypotension, syncope, visual changes, prolonged erection)1 46
Tadalafil	Increased tadalafil concentrations; increased risk of tadalafil-associated adverse effects66	Use initial tadalafil dosage of 5 mg and do not exceed a single dose of 10 mg in 72 hours66
Tenofovir	In vitro evidence of additive or synergistic antiretroviral effectsc
Tipranavir	Possible decreased amprenavir concentrations with ritonavir-boosted tipranavir67	Concomitant use not recommended67
Trazodone	Possible increased trazodone concentrations1 46	Use with caution; consider decreased trazodone dosage1 46
Vardenafil	Possible increased vardenafil concentrations and possible increase in vardenafil-associated adverse effects65	Use initial vardenafil dosage of 2.5 mg and do not exceed a single dose of 2.5 mg in 24 hours65
Vitamin E	Possible excessive vitamin E dosage because of high vitamin E content of amprenavir preparations1 46 High vitamin E doses may exacerbate blood coagulation defect of vitamin K deficiency caused by anticoagulant therapy or malabsorption1	Supplemental vitamin E not recommended1 46
Zidovudine	Possible increased amprenavir AUC;1 46 possible increased zidovudine concentrations and AUC1 46 In vitro evidence of synergistic antiretroviral effects1 46	No dosage adjustments recommended41

Agenerase Pharmacokinetics

Absorption

Bioavailability

Absolute oral bioavailability has not been established.^{1 46}

Amprenavir not appreciably absorbed from GI tract when given alone;^{40 41} amprenavir formulated with vitamin E rapidly absorbed following oral administration.^{1 48}

Peak amprenavir plasma concentrations attained 1–2 hours after oral administration of capsules or oral solution formulated with vitamin E.^{1 48 46}

Amprenavir liquid-filled capsules and oral solution not bioequivalent; oral solution about 14% less bioavailable compared with capsules.^{1 46}

Food

Oral bioavailability of amprenavir may be decreased if administered with a high-fat meal.^{1 46}

Distribution

Extent

Animal studies indicate distribution into various tissues.²

CSF concentrations <1% of plasma concentrations.⁴¹

Amprenavir crosses the placenta and is distributed into milk in animals.⁴¹ Not known whether drug crosses human placenta or is distributed into human milk.¹⁴

Plasma Protein Binding

90% bound to plasma or serum proteins, principally to α₁-acid glycoprotein.^{1 23 46}

Elimination

Metabolism

Metabolized in liver principally by CYP3A4.^{1 4 46}

Elimination Route

About 14% of an oral dose excreted in urine and 75% eliminated in feces.^{1 41 46} Only minimal amounts eliminated unchanged in urine or feces.^{1 46}

Half-life

7.1–10.6 hours in HIV-infected adults with normal renal and hepatic function.^{1 2 41 46 48}

Special Populations

Peak plasma concentrations and AUC may be increased in patients with hepatic impairment.^{1 46 49}

Pharmacokinetics not studied to date in patients with renal impairment; decreased clearance not expected.^{1 46}

Stability

Storage

Oral

Liquid-filled Capsules

25°C.¹

Solution

25°C.⁴⁶

Actions and SpectrumActions

• 
  

  Pharmacologically related to, but structurally different from, other PIs (e.g., atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir) and other currently available antiretrovirals.^{11 21}

  
  


• 
  

  Active against HIV-1 and, to a lesser extent, HIV-2.^{1 7 11 46}

  
  


• 
  

  Inhibits replication of HIV-1 and HIV-2 by interfering with HIV protease.^{1 7 11 46}

  
  


• 
  

  HIV-1 with reduced susceptibility to amprenavir have been selected in vitro and have emerged during therapy with the drug.^{1 2 5 6 7 8 19 20 46}

  
  


• 
  

  Varying degrees of cross-resistance occur among PIs; only limited data available to date regarding cross-resistance between amprenavir and other PIs.¹

AK-Dex ophthalmic

Generic Name: dexamethasone (ophthalmic) (DEX a METH a sone off THAL mik)

Brand Names: AK-Dex, Ocu-Dex

What is AK-Dex (dexamethasone (ophthalmic))?

Dexamethasone ophthalmic is in a class of drugs called corticosteroids. It inhibits processes in the body that cause inflammation. Therefore, the swelling and pain of inflammatory conditions is decreased.

Dexamethasone ophthalmic is used to treat eye inflammation caused by infections, injury, surgery, or other conditions.

Dexamethasone ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about AK-Dex (dexamethasone (ophthalmic))?

Do not stop using this medication suddenly if you have been using it for several weeks or more. Before stopping, you may need to reduce the dose over several days to prevent side effects.

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

Who should not use AK-Dex (dexamethasone (ophthalmic))?

Do not use dexamethasone ophthalmic if you have a bacterial, viral, or fungal infection in your eye without also receiving proper anti-infective treatment. Dexamethasone ophthalmic is in the FDA pregnancy category C. This means that it is not known whether dexamethasone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether dexamethasone ophthalmic passes into breast milk. Do not use dexamethasone ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use AK-Dex (dexamethasone (ophthalmic))?

Use dexamethasone ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops or ointment.

To apply the eyedrops:

• 
  

  Shake the bottle gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out the prescribed number of drops and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using drops in both eyes, repeat the process in the other eye.

  
  

To apply the ointment:

• 
  

  Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.

  
  

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store dexamethasone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

What happens if I miss a dose?

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

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, call an emergency room or poison control center near you. If the drops or ointment have been ingested, call an emergency center for advice.

What should I avoid while using AK-Dex (dexamethasone (ophthalmic))?

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Dexamethasone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with dexamethasone ophthalmic.

AK-Dex (dexamethasone (ophthalmic)) side effects

Serious side effects are not expected with this medication. Rarely, an increase in the pressure inside of the eye, formation of cataracts, or a perforation of the cornea has been reported. Talk to your doctor about any possible side effects.

More commonly, some burning, stinging, irritation, itching, redness, blurred vision, or sensitivity to light may occur.

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 AK-Dex (dexamethasone (ophthalmic))?

Do not use other eyedrops or eye medications during treatment with dexamethasone ophthalmic without first talking to your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.

Drugs other than those listed here may also interact with dexamethasone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More AK-Dex resources

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

Compare AK-Dex with other medications

• Acute Otitis Externa
• Conjunctivitis
• Cyclitis
• Iritis
• Keratitis
• Macular Edema
• Uveitis

Where can I get more information?

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

See also: AK-Dex side effects (in more detail)

AK-Pentolate Ophthalmic

Generic Name: cyclopentolate (Ophthalmic route)

sye-kloe-PEN-toe-late

Commonly used brand name(s)

In the U.S.

• AK-Pentolate


• Cyclogyl


• Cylate


• Ocu-Pentolate

In Canada

• Minims Cyclopentolate 0.5%


• Minims Cyclopentolate 1%

Available Dosage Forms:

• Solution

Therapeutic Class: Mydriatic-Cycloplegic

Pharmacologic Class: Antimuscarinic

Uses For AK-Pentolate

Cyclopentolate is used to dilate (enlarge) the pupil. It is used before eye examinations (such as cycloplegic refraction or ophthalmoscopy).

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, cyclopentolate is used in certain patients with the following medical conditions:

• Posterior synechiae


• Uveitis

Before Using AK-Pentolate

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of cyclopentolate. This may increase the chance of side effects during treatment.

Geriatric

Elderly people are especially sensitive to the effects of cyclopentolate. This may increase the chance of side effects during treatment.

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain damage (in children) or


• Down's syndrome (mongolism) (in children and adults) or


• Glaucoma or


• Spastic paralysis (in children)—Cyclopentolate may make the condition worse

Proper Use of cyclopentolate

This section provides information on the proper use of a number of products that contain cyclopentolate. It may not be specific to AK-Pentolate. Please read with care.

To use:

• First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes, to allow the medicine to be absorbed. This is especially important in infants.


• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them. If you are using the eye drops for an infant or child, be sure to wash the infant's or child's hands also, and do not let any of the medicine get in the infant's or child's mouth.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic solution (eye drops) dosage form:
  
  • For eye examinations:
    
    • Adults—One drop 40 to 50 minutes before the exam. Dose may be repeated in five to ten minutes.
    
    
    • Children—One drop 40 to 50 minutes before the exam. After five to ten minutes, another drop may be used.
    
    
    • Babies—One drop of 0.5% solution.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using AK-Pentolate

After you apply this medicine to your eyes:

• Your pupils will become unusually large and you will have blurring of vision, especially for close objects. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.


• Your eyes will become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor.

If these side effects continue for longer than 36 hours after you have stopped using this medicine, check with your doctor.

AK-Pentolate 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 as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body

• Clumsiness or unsteadiness


• confusion


• constipation, full feeling, passing gas, or stomach cramps or pain


• fast or irregular heartbeat


• convulsions (seizures)


• fever


• flushing or redness of face


• hallucinations (seeing, hearing, or feeling things that are not there)


• passing urine less often


• skin rash


• slurred speech


• swollen stomach (in infants)


• thirst or dryness of mouth


• unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness, especially in children


• unusual drowsiness, tiredness, or weakness

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:

• Blurred vision


• burning of eye


• eye irritation not present before therapy


• increased sensitivity of eyes to light

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: AK-Pentolate Ophthalmic side effects (in more detail)

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More AK-Pentolate Ophthalmic resources

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

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