Trelstar Depot

Generic Name: triptorelin (TRIP toe REL in)

Brand Names: Trelstar Depot, Trelstar Depot Mixject, Trelstar LA, Trelstar LA Mixject

What is Trelstar Depot (triptorelin)?

Triptorelin is a man-made form of a hormone that regulates many processes in the body. Triptorelin overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily.

Triptorelin is used to treat the symptoms of prostate cancer. Triptorelin treats only the symptoms of prostate cancer and does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.

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

What is the most important information I should know about Trelstar Depot (triptorelin)?

You should not use this medication if you are allergic to triptorelin or similar drugs such as leuprolide (Lupron, Viadur, Eligard) or goserelin (Zoladex).

Before using triptorelin, tell your doctor if you have any type of cancer that has spread to your spine, a bladder obstruction or problems with urination, diabetes, heart disease, high blood pressure, high cholesterol, a history of stroke or heart attack, or if you smoke.

After your injection, your prostate cancer symptoms may get worse for a short time because triptorelin raises your testosterone levels. These side effects should get better within 3 or 4 weeks. Call your doctor if your symptoms do not improve, or if they get worse while using triptorelin. Some of the side effects of triptorelin are symptoms of prostate cancer that may occur because the medicine raises your testosterone levels. Call your doctor at once if you have pain or burning when you urinate, blood in your urine, bone pain, numbness, tingling, muscle weakness, or loss of movement in any part of your body. Although triptorelin is not for use by women, this medication can cause birth defects and should not be used by a woman who is pregnant or who may become pregnant.

What should I discuss with my healthcare provider before using Trelstar Depot (triptorelin)?

You should not use this medication if you are allergic to triptorelin or similar drugs such as leuprolide (Lupron, Viadur, Eligard) or goserelin (Zoladex).

If you have any of these other conditions, you may need a triptorelin dose adjustment or special tests:

• 
  

  any type of cancer that has spread to your spine;

  
  


• 
  

  a bladder obstruction or problems with urination;

  
  


• 
  

  diabetes, heart disease, high blood pressure, recent weight gain, high cholesterol (especially in men);

  
  


• 
  

  heart disease, high blood pressure, high cholesterol;

  
  


• 
  

  a history of heart attack or stroke; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category X. Although triptorelin is not for use by women, this medication can harm an unborn baby or cause birth defects. Triptorelin should not be used by a woman who is pregnant or who may become pregnant. It is not known whether triptorelin passes into breast milk or if it could harm a nursing baby. Although triptorelin is not for use by women, this medication should not be used while breast-feeding a baby.

How should I use Trelstar Depot (triptorelin)?

Triptorelin is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

This medication comes with a vial (bottle) of powder medicine and a prefilled syringe of sterile water. The powder must be mixed with the sterile water before using the medicine. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not save the mixture for later use. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Triptorelin is usually given once every 4, 12, or 24 weeks. Your dose schedule will depend on the strength of triptorelin you are using. Follow your doctor's dosing instructions very carefully.

After your injection, your prostate cancer symptoms may get worse for a short time because triptorelin raises your testosterone levels. These side effects should get better within 3 or 4 weeks. Call your doctor if your symptoms do not improve, or if they get worse while using triptorelin.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store vials and prefilled syringes at room temperature away from moisture, heat, and light. Do not freeze.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of triptorelin.

What happens if I overdose?

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

What should I avoid while using Trelstar Depot (triptorelin)?

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

Trelstar Depot (triptorelin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect. Some of these side effects are symptoms of prostate cancer that may occur because the medicine raises your testosterone levels:

• 
  

  painful or difficult urination, burning when you urinate, blood in the urine;

  
  


• 
  

  bone pain;

  
  


• 
  

  numbness, tingling, or muscle weakness (especially in your legs and feet);

  
  


• 
  

  loss of movement in any part of your body;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech; or

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

  
  

Less serious side effects may include:

• 
  

  hot flashes;

  
  


• 
  

  back pain, pain or swelling in your legs;

  
  


• 
  

  headache, dizziness, tired feeling;

  
  


• 
  

  decreased interest in sex, impotence, trouble having an orgasm;

  
  


• 
  

  nausea, vomiting, diarrhea, upset stomach;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  breast pain or swelling; or

  
  


• 
  

  pain where the medicine was injected.

  
  

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 Trelstar Depot (triptorelin)?

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

More Trelstar Depot resources

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

• Trelstar Depot Prescribing Information (FDA)


• Trelstar Depot MedFacts Consumer Leaflet (Wolters Kluwer)


• Trelstar Depot Advanced Consumer (Micromedex) - Includes Dosage Information


• Trelstar LA Prescribing Information (FDA)


• Triptorelin Pamoate Monograph (AHFS DI)

Compare Trelstar Depot with other medications

• Prostate Cancer

Where can I get more information?

• Your doctor or pharmacist can provide more information about triptorelin.

See also: Trelstar Depot side effects (in more detail)

Terramycin with Polymyxin B

oxytetracycline hydrochloride and polymyxin B sulfate

Dosage Form: Ophthalmic Ointment

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Terramycin® and other antibacterial drugs, Terramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Terramycin with Polymyxin B Description

Each gram of sterile ointment contains oxytetracycline HCl equivalent to 5 mg oxytetracycline, 10,000 units of polymyxin B sulfate, white petrolatum, and liquid petrolatum.

ACTIONS

Terramycin is a widely used antibiotic with clinically proved activity against gram-positive and gram-negative bacteria, rickettsiae, spirochetes, large viruses, and certain protozoa.

Polymyxin B Sulfate, one of a group of related antibiotics derived from Bacillus polymyxa, is rapidly bactericidal. This action is exclusively against gram-negative organisms. It is particularly effective against Pseudomonas aeruginosa (B. pyocyaneus), and Koch-Weeks bacillus, frequently found in local infections of the eye.

There is thus made available a particularly effective antimicrobial combination of the broad-spectrum antibiotic Terramycin as well as polymyxin B sulfate against primarily causative or secondarily infecting organisms.

INDICATIONS

The sterile preparation, Terramycin with Polymyxin B Sulfate Ophthalmic Ointment, is indicated for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Terramycin with Polymyxin B Sulfate-susceptible organisms.

It may be administered topically alone, or as an adjunct to systemic therapy.

It is effective in infections caused by susceptible strains of staphylococci, streptococci, pneumococci, Hemophilus influenzae, Pseudomonas aeruginosa, Koch-Weeks bacillus, and Proteus.

To reduce the development of drug-resistant bacteria and maintain effectiveness of Terramycin and other antibacterial drugs, Terramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications

This drug is contraindicated in individuals who have shown hypersensitivity to any of its components.

Precautions

As with all antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate specific therapy should be instituted.

Prescribing Terramycin in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information For Patients

Patients should be counseled that antibacterial drugs including Terramycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Terramycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Terramycin or other antibacterial drugs in the future.

Adverse Reactions

Terramycin with Polymyxin B Sulfate Ophthalmic Ointment is well tolerated by the epithelial membranes and other tissues of the eye. Allergic or inflammatory reactions due to individual hypersensitivity are rare.

Terramycin with Polymyxin B Dosage and Administration

Approximately ½ inch of the ointment is squeezed from the tube onto the lower lid of the affected eye two to four times daily.

The patient should be instructed to avoid contamination of the tip of the tube when applying the ointment.

How is Terramycin with Polymyxin B Supplied

Terramycin with Polymyxin B Sulfate Ophthalmic Ointment is supplied in 1/8 oz (3.5 g) tubes (NDC 0049-0801-08).

Rx only

LAB-0193-3.0

TERRAMYCIN  oxytetracycline hydrochloride and polymyxin b sulfate  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-0801 Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Oxytetracycline Hydrochloride (Oxytetracycline) Active 5 MILLIGRAM  In 1 GRAM Polymyxin B Sulfate (Polymyxin) Active 10000 UNITS  In 1 GRAM white petrolatum Inactive   liquid petrolatum Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0049-0801-08 3.5 g (GRAM) In 1 TUBE None

Revised: 04/2006Roerig

More Terramycin with Polymyxin B resources

• Terramycin with Polymyxin B Side Effects (in more detail)
• Terramycin with Polymyxin B Dosage
• Terramycin with Polymyxin B Use in Pregnancy & Breastfeeding
• 0 Reviews for Terramycin with Polymyxin B - Add your own review/rating

Compare Terramycin with Polymyxin B with other medications

• Conjunctivitis, Bacterial
• Eye Dryness/Redness

Konsyl Powder

Pronunciation: SILL-i-um
Generic Name: Psyllium
Brand Name: Examples include Konsyl and Metamucil Smooth Texture

Konsyl Powder is used for:

Treating occasional constipation and restoring regularity. It may also be used for other conditions as determined by your doctor.

Konsyl Powder is a fiber laxative. It works by absorbing water and swelling in the intestines. This helps the stool form the bulk necessary to be easily passed.

Do NOT use Konsyl Powder if:

• you are allergic to any ingredient in Konsyl Powder


• you have appendicitis, difficulty swallowing, severe constipation, intestinal blockage, or undiagnosed rectal bleeding

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

Before using Konsyl Powder:

Some medical conditions may interact with Konsyl Powder. 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 sudden change in bowel habits persisting for more than 2 weeks


• if you have stomach or intestinal pain, nausea, or vomiting

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

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

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

• Konsyl Powder may be taken with or without food.


• Empty the contents of 1 packet (unless directed by your doctor to use a different dose) into an empty glass. Mix Konsyl Powder with a full glass (at least 8 oz or 240 mL) of water or other liquid. Stir briskly and drink immediately. If the mixture thickens, add more liquid and stir.


• Do not take other oral medicines within 2 hours before or 2 hours after taking Konsyl Powder.


• If you miss a dose of Konsyl Powder, 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 Konsyl Powder.

Important safety information:

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


• Do not take additional laxatives or stool softeners with Konsyl Powder unless directed by your doctor.


• Do not use Konsyl Powder if you experience stomach pain, nausea, vomiting, or rectal bleeding, except under the direction of your doctor.


• If you notice a sudden change in bowel habits that lasts for 2 weeks or more, do not continue using Konsyl Powder. Instead, check with your doctor.


• Taking this product without enough liquid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty swallowing. If you experience chest pain, vomiting, or difficulty swallowing or breathing after taking this product, seek immediate medical attention.


• Do not use Konsyl Powder in CHILDREN younger than 12 years of age without first checking with your doctor.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Konsyl Powder, discuss with your doctor the benefits and risks of using Konsyl Powder during pregnancy. It is unknown if Konsyl Powder is excreted in breast milk. If you are or will be breast-feeding while you are using Konsyl Powder, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Konsyl Powder:

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:

Abdominal fullness; minor bloating.

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); chest pain; difficulty swallowing; trouble breathing; vomiting.

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: Konsyl 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.

Proper storage of Konsyl Powder:

Store Konsyl Powder 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 Konsyl Powder out of the reach of children and away from pets.

General information:

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


• Konsyl Powder 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 Konsyl Powder. 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 Konsyl resources

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

Compare Konsyl with other medications

• Constipation
• Dietary Fiber Supplementation
• Irritable Bowel Syndrome

Sildenafil Citrate

Class: Phosphodiesterase Inhibitors
VA Class: GU900
Chemical Name: 2 - Hydroxy - 1,2,3 - propanetricarboxylate - 1 - [[3 - (6,7 - dihydro - 1 - methyl - 7 - oxo - 3 - propyl - 1H - pyrazolo[4,3 - d - pyrimidin - 5 - yl) - 4 - ethoxyphenyl]sulfonyl] - 4 - methyl - piperazine
Molecular Formula: C₂₂H₃₀N₆O₄S•C₆H₈O₇
CAS Number: 171599-83-0
Brands: Revatio, Viagra

Special Alerts:

[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors sildenafil (Viagra), tadalafil (Levitra), vardenafil (Cialis) for the treatment of erectile dysfunction, and sildenafil (Revatio) for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for sildenafil (Viagra), tadalafil, and vardenafil were revised. FDA is working with the manufacturer to revise the labeling for sildenafil (Revatio). For more information visit the FDA website at: , , , , , and .

Introduction

Vasodilating agent; a selective phosphodiesterase (PDE) type 5 inhibitor.^{1 2 4 5 7 8 10 24 27 33 41 56 57 67 91 131 184 203}

Uses for Sildenafil Citrate

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Erectile Dysfunction

To facilitate attainment of a sexually functional erection in males with erectile dysfunction (ED, impotence).^{1 4 6 7 8 9 10 25 33 34 67 81 102 104 105 107 108 112 118 119 126 127 128 129 130 131 132 133 134 135 140 142 143 144 189}

Most experts currently recommend that selective PDE type 5 inhibitors be offered as first-line therapy for erectile dysfunction unless contraindicated.¹⁸⁹ Insufficient evidence to support the superiority of one selective PDE type 5 inhibitor over another.¹⁸⁹

Pulmonary Arterial Hypertension

Symptomatic treatment (e.g., to improve exercise capacity) of pulmonary arterial hypertension (PAH; WHO group I pulmonary hypertension).^{203 204 205 206 207 208 209 210 211 213}

Precise role (alone and combined with other therapies) remains to be fully elucidated.^{204 206 207 208 209 210 211 213} Whether long-term sildenafil therapy has a beneficial effect on mortality remains to be established;^{205 208 213} some preliminary data suggest a survival benefit.²⁰⁹

Sildenafil Citrate Dosage and Administration

General

Erectile Dysfunction

• 
  

  Carefully individualize dosage according to the patient’s tolerance and erectile response.^{1 33 67 77 81}

  
  


• 
  

  Sexual stimulation is required for response to therapy.¹

  
  

Administration

Oral Administration

Erectile Dysfunction

Administer orally ^{1 33 208} no more than once daily.^{1 67 81 93 94 102 107 114 130 131}

Administer about 1 hour (range: 4 hours to 30 minutes) before sexual activity.^{1 60 91 127 132}

Administration with a high-fat meal may delay the onset of action.^{1 114 115 117 131}

PAH

Administer orally 3 times daily (approximately 4–6 hours apart) without regard to meals.^{203 208}

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as sildenafil citrate; dosage expressed in terms of sildenafil.^{1 203}

Adults

Erectile Dysfunction

Oral

Initially, 50 mg.^{1 28 33 81 91 93 94 102 105 118 130 132 149 161} Depending on effectiveness and tolerance, increase dosage to a maximum of 100 mg or decrease to 25 mg.^{1 28 33 91 93 94 105 149 161}

PAH

Oral

20 mg 3 times daily.²⁰³ Efficacy of lower dosages not established.²⁰³

Prescribing Limits

Adults

Erectile Dysfunction

Oral

Maximum 100 mg daily.^{1 60 91 114 131}

PAH

Oral

Dosages up to 80 mg 3 times daily have been studied but have not been more effective than recommended dosage of 20 mg 3 times daily.^{203 207 208 209}

Special Populations

Hepatic Impairment

Erectile Dysfunction

Oral

Reduce initial dose to 25 mg.^{1 28 31 67}

PAH

Oral

No dosage adjustments necessary for mild to moderate hepatic impairment (Child-Pugh class A and B).²⁰³ Not studied in severe hepatic impairment (Child-Pugh class C).²⁰³

Renal Impairment

Erectile Dysfunction

Oral

If Cl_cr is <30 mL/minute, reduce initial dose to 25 mg.^{1 28 67 80 131}

PAH

Oral

No dosage adjustment needed, even in severe impairment (Cl_cr <30 mL/minute).²⁰³

Geriatric Patients

Erectile Dysfunction

Oral

Reduce initial dose to 25 mg in men ≥65 years of age.^{1 31 67}

PAH

Oral

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.²⁰³

Cautions for Sildenafil Citrate

Contraindications

• 
  

  Known hypersensitivity to sildenafil or any ingredient in the formulation.^{1 203}

  
  


• 
  

  Concomitant use of organic nitrates or nitrites.^{1 29 57 67 148 154 203} (See Specific Drugs under Interactions.)

  
  


• 
  

  Should not be used for treatment of erectile dysfunction in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.^{1 67 154 189}

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Cardiovascular Effects

Serious, potentially fatal cardiovascular effects reported rarely.^{1 2 4 6 7 9 10 33 56 61 67 91 93 94 102 107 114 127 130 132 208}

Use with caution in the treatment of erectile dysfunction in patients with a recent (within 6 months) MI, stroke, or life-threatening arrhythmia;^{1 31 101 127 144 154 155 159} in patients with resting hypotension (BP <90/50 mm Hg) or hypertension (BP >170/110 mm Hg);^{1 31 101 127 144 154 155 159} or in patients with cardiac failure or CAD causing unstable angina.^{1 31 101 127 144 154 155 159} Assess cardiovascular and cerebrovascular status (including use of organic nitrates and nitrites) prior to initiating therapy.^{1 28 30 31 53 64 65 67 91 93 121 154 189}

Safety and efficacy for the treatment of PAH not established in patients with a recent (within 6 months) MI, stroke, or life-threatening arrhythmia; in patients with hypertension (BP >170/110 mm Hg) or with CAD causing unstable angina; or in those currently receiving bosentan (see Specific Drugs under Interactions).²⁰³ Caution advised.²⁰³

Possible symptomatic hypotension may occur in patients receiving concomitant^{1 31 67} α-adrenergic blocking agents; hypotension may be severe or fatal in patients receiving an organic nitrate or nitrite concomitantly.^{1 28 29 31 53 57 61 67 69 148} (See Specific Drugs under Interactions.)

Consider whether patients with underlying cardiovascular disease (e.g., severe left ventricular outflow obstruction, autonomic dysfunction, resting hypotension [BP <90/50 mm Hg], fluid depletion) could be adversely affected by sildenafil’s vasodilatory activity,²⁰³ especially in combination with sexual activity.^{1 67 154}

Use not recommended in patients with pulmonary veno-occlusive disease.²⁰³ Clinical data on use in this population are not available, and pulmonary vasodilators may worsen cardiovascular status of such patients.²⁰³ If pulmonary edema occurs during sildenafil therapy, consider the possibility of pulmonary veno-occlusive disease.²⁰³

Ocular Effects

Possible visual disturbances (e.g., blue/green vision, changes in light sensitivity), particularly at high doses.^{1 33 56 57 67 77 86 87 88 91 95 203 208} Possible persistent and/or serious retinal changes in older patients or with long-term use.^{32 87 88 95 106}

Nonarteritic anterior ischemic optic neuropathy (NAION) reported rarely in patients receiving PDE type 5 inhibitors for the treatment of erectile dysfunction.^{1 182 183 190 191 192 194 195 196 197 198 199 202 203} Potential increased risk of NAION in the second eye in patients who already have had NAION in one eye.^{1 182 183 196 202 203}

Use with caution in patients with retinitis pigmentosa.^{1 31 32 60 155 203} Periodically monitor retinal function in patients with ocular manifestations suggestive of retinal effects and in those at risk.^{88 115}

Priapism

Possible prolonged erections (>4 hours in duration) and priapism (painful erection >6 hours).^{1 31 139 146 147}

May result in penile tissue damage and permanent loss of potency if priapism is not treated immediately.^{1 31} Use with caution in patients with conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).^{1 33 114 115 159 203}

Interactions with Potent CYP3A4 Inhibitors

Concomitant use with potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir) substantially increases serum sildenafil concentrations.^{1 203} Depending on the particular use of sildenafil (e.g., erectile dysfunction, PAH) and the specific CYP3A4 inhibitor, concomitant use may not be recommended or precautions (e.g., dosage adjustments) may be required.^{1 203} (See Specific Drugs under Interactions.)

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Assessment of Patients with Erectile Dysfunction

Thorough medical history and physical examination recommended to diagnose erectile dysfunction, determine potential underlying causes, exclude potentially reversible or treatable causes, and identify appropriate treatment.^{1 12 28 30 31 36 57 58 65 66 70 78 82 83 94 114 115 119 144 145 160 161}

Review of patient’s current drug regimens recommended to detect possible drug-induced erectile dysfunction.^{12 28 70 81 118 119 144 152 161}

Hypotensive Effects

Possible hypotensive reaction in patients receiving concomitant antihypertensive therapy, in patients with CHF and a borderline low blood volume and low BP status, and in patients with left-ventricular outflow obstruction.^{28 31 67} (See Specific Drugs under Interactions.) Monitor BP during initiation of therapy in these patients.^{28 67 159}

Bleeding Disorders

Use with caution in patients with bleeding disorders or active peptic ulcers.^{1 27 33 67 131}

Incidence of epistaxis in sildenafil-treated patients is higher in those with PAH secondary to connective tissue disease (13%) than in those with primary pulmonary hypertension (3%).²⁰³

GU Precautions

Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie’s disease).^{1 33 114 115 159 203}

Concomitant Therapies for Erectile Dysfunction

Safety and efficacy not established for use in combination with other treatments for erectile dysfunction; combined therapy is not recommended.^{1 155}

Specific Populations

Pregnancy

Category B.^{1 203}

Lactation

Not known whether sildenafil is distributed into milk.²⁰³ Use with caution in nursing women.²⁰³

Pediatric Use

Safety and efficacy not established in patients <18 years of age;^{115 203} however, has been used effectively in a limited number of children† for symptomatic treatment of PAH.^{158 205 206}

Geriatric Use

Pooled clinical trial data indicate that efficacy in men ≥65 years of age with erectile dysfunction is similar to that in younger men.^{131 157} Decreased clearance and increased plasma concentrations may increase incidence of adverse effects in geriatric patients with erectile dysfunction.^{1 60 139} (See Geriatric Patients under Dosage and Administration.)

Insufficient data from clinical trials to determine whether geriatric patients with PAH respond differently than younger adults, but other clinical experience has not identified overall differences in response relative to younger patients.²⁰³

Select dosage carefully due to greater frequency of decreased renal, hepatic, and/or cardiac function and of concomitant disease or drug therapy observed in geriatric patients.²⁰³

Hepatic Impairment

Decreased clearance.^{1 31 60 67 69 203} (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Decreased clearance in patients with severe renal impairment.^{1 60 67 80 203} (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Erectile dysfunction: Headache,^{1 4 6 7 9 10 31 33 56 91 93 104 105 107 130 132 208} flushing,^{1 4 7 9 33 56 67 93 105 107 130 132} dyspepsia/heartburn.^{1 7 10 31 33 67 91 93 102 107 132}

PAH: Headache,^{203 208 211} dyspepsia,^{203 208} flushing,^{203 208} epistaxis,²⁰³ insomnia,^{203 208} exacerbated dyspnea,²⁰³ diarrhea,^{203 208} myalgia,²⁰³ erythema,^{203 208} pyrexia.²⁰³

Interactions for Sildenafil Citrate

Metabolized principally by CYP3A4 and to some extent by CYP2C9; weakly inhibits CYP1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 in vitro.^{1 26 59 67 91 203}

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4 and CYP2C9: Potential pharmacokinetic interaction (increased plasma sildenafil concentrations).^{1 26 59 67 91 203 212}

Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma sildenafil concentrations).^{1 26 59 67 91 203 212}

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP1A2, 2C9, 2C19, 2D6, 2E1, and 3A4:^{1 26 67} Potential pharmacokinetic interaction (increased substrate concentrations).²⁰³

Specific Drugs

Drug	Interaction	Comments
α-Adrenergic blockers	Possible potentiation of systemic vasodilation189 203 and occurrence of symptomatic hypotension1 203	Do not administer doses >25 mg within 4 hours before or after α-adrenergic blocker1 Use with caution in PAH203
Alcohol	No additive hypotensive effects reported1 203	Consider possibility that heavy alcohol ingestion could add to stress of sexual activity and risk of cardiac ischemia during coitus67 115 and that alcohol consumption also may contribute to erectile dysfunction12 28 58 70 82 114 115 119
Amlodipine	Possible additive hypotensive effects1 29 114 154 203
Antacids	Oral bioavailability of sildenafil unaffected by single doses of aluminum and magnesium hydroxides-containing antacid1 114 203
Antidepressants (e.g., SSRIs, tricyclic antidepressants)	Pharmacokinetic interaction unlikely1
Antifungal agents (itraconazole, ketoconazole)	Possible increased AUC of sildenafil1 114 203	Consider lower initial sildenafil dose (25 mg) for treatment of erectile dysfunction1 67 Concomitant use not recommended in PAH203
Antihypertensive and hypotensive agents	Potential additive hypotensive effects1 29 67 203	Monitor during initial therapy, especially in patients receiving multiple agents and those with CHF28 67 159 or renal impairment28 67 80
Antiretroviral agents (HIV protease inhibitors)	Decreased clearance, increased plasma concentrations of sildenafil, and increased risk of sildenafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)26 59 67 84 114 136 137 139 166 167 168 169 170 171 172 173 174 175 200 201 203	Caution advised;84 166 167 168 169 170 171 172 173 174 175 closely monitor for adverse effects59 84 166 167 168 171 170 174 175 200 Amprenavir, atazanavir, fosamprenavir, indinavir, lopinavir in fixed combination with ritonavir, nelfinavir, ritonavir, saquinavir, tipranavir in combination with low-dose ritonavir: reduce initial sildenafil dose for treatment of erectile dysfunction to 25 mg and do not exceed a single 25-mg dose every 48 hours59 166 167 168 169 170 171 172 173 174 175 200 Concomitant ritonavir and sildenafil not recommended in PAH203 Concomitant saquinavir and sildenafil in PAH: No dosage adjustments necessary203
Antiretroviral agents (nonnucleoside reverse transcriptase inhibitors [NNRTIs])	Delavirdine: Possible increased sildenafil concentrations and risk of sildenafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)29 169 Efavirenz, nevirapine: Possible decreased plasma sildenafil concentrations and/or altered plasma NNRTI concentrations203	Delavirdine: Reduce initial sildenafil dose for treatment of erectile dysfunction to 25 mg and do not exceed a single 25-mg dose every 48 hours; monitor for adverse effects29 169 Efavirenz, nevirapine: Possible dosage adjustments of either sildenafil or the NNRTI203
Antipsychotics	Pharmacokinetic interaction unlikely1 60 118
Aspirin	No increase in bleeding time reported1 60 65 67 114 203
Atorvastatin	Pharmacokinetic interaction unlikely203
Barbiturates	Possible decreased plasma sildenafil concentrations and/or altered plasma barbiturate concentrations203	Possible dosage adjustment of either sildenafil or the barbiturate203
Bosentan	Decreased plasma sildenafil concentrations203 212 Increased plasma bosentan concentrations203	Possible dosage adjustment of either agent203
Carbamazepine	Possible decreased plasma sildenafil concentrations and/or altered plasma carbamazepine concentrations 203	Possible dosage adjustment of either agent 203
Cimetidine	Increased plasma sildenafil concentrations1 67 203	Consider lower initial sildenafil dose (25 mg) for treatment of erectile dysfunction67
Contraceptives, oral	Pharmacokinetic interaction unlikely203
Erythromycin	Increased AUC of sildenafil1 69 114 203	Consider lower initial sildenafil dose (25 mg) for treatment of erectile dysfunction1 67 Dosage adjustment not necessary in PAH203
Heparin	Increased bleeding time reported in animals1 203	Current evidence does not preclude concomitant heparin67 114 115
Inhaled nitrites (e.g., amyl or butyl nitrite)	Possible sudden and marked BP reduction; potentially serious or even fatal26 67 92 Possible beneficial augmented cardiovascular effects in PAH204 210 211	Concomitant use contraindicated1 29 57 67 148 154 (see Cautions)
Nitrates and nitrites (e.g., nitroglycerin, isosorbide dinitrate)	Potentiation of vasodilatory effects (e.g., decrease in SBP of >25 mm Hg) of organic nitrates and nitrites; potentially life-threatening hypotension and/or hemodynamic compromise can result1 28 29 31 33 53 57 61 67 69 91 127 131 148	Concomitant use contraindicated1 29 57 67 148 154 203 (see Cautions) Some clinicians suggest that nitrates and nitrites may be given >24 hours after sildenafil, but the point at which these drugs can be given safely after sildenafil is unclear;1 29 31 67 154 avoid concomitant use unless benefits outweigh risks67 114
Phenytoin	Possible decreased plasma sildenafil concentrations and/or altered plasma phenytoin concentrations203	Possible dosage adjustment of either agent203
Phosphodiesterase (PDE) inhibitors (e.g., dipyridamole, theophylline)	Potential pharmacodynamic interaction (increased inotropic effects in cardiac muscle, vascular smooth muscle relaxation, and platelet-aggregation inhibition)67	Risk of cardiotoxic, hypotensive, or hemorrhagic event after concomitant use of specific or nonspecific PDE inhibitor (e.g., dipyridamole, theophylline) not known but appears unlikely67
Rifamycins (rifabutin, rifampin)	Possible decreased plasma sildenafil concentrations1 69 203 (theoretically less likely with rifabutin than rifampin103 ) and/or altered plasma rifabutin or rifampin concentrations203	Possible dosage adjustment of either sildenafil or the rifamycin203
Sodium nitroprusside	Potentiation of vasodilatory effects (e.g., decrease in SBP of >25 mm Hg) of organic nitrates and nitrites; potentially life-threatening hypotension and/or hemodynamic compromise can result1 28 29 31 33 53 57 61 67 69 91 127 131 148 Also may potentiate the inhibitory effect of nitric oxide and sodium nitroprusside (a nitric oxide donor) on platelet aggregation1 57 67 203	Concomitant use contraindicated1 29 57 67 148 154 (see Cautions) Some clinicians suggest that nitrates and nitrites may be given >24 hours after sildenafil, but the point at which these drugs can be given safely after sildenafil is unclear;1 29 31 67 154 avoid concomitant use unless benefits outweigh risks67 114
Tolbutamide	Pharmacokinetic interaction unlikely67 114 203
Warfarin	Pharmacokinetic interaction unlikely67 114 Increased bleeding (epistaxis) observed with concomitant use in patients with PAH203

Sildenafil Citrate Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration;^{1 4 56 67 91 116 117 203} however, only about 40% of a dose reaches systemic circulation unchanged.^{1 4 56 67 91 114 116 131 203}

Peak plasma concentration usually attained within 30–120 minutes.^{1 4 91 117 127 1}

Sodium Chloride Solution

Pronunciation: SO-dee-uhm KLOR-ide
Generic Name: Sodium Chloride
Brand Name: Generic only. No brands available.

Sodium Chloride Solution is used for:

Replacing fluids and sodium chloride when you are not able to drink enough liquids or when additional fluids are needed. It may be used as a way to give injectable medicines, to flush intravenous (IV lines), and for other conditions as determined by your doctor.

Sodium Chloride Solution is an electrolyte solution (sterile IV solution). It works by supplementing the body with fluid and sodium chloride.

Do NOT use Sodium Chloride Solution if:

• you are allergic to any ingredient in Sodium Chloride Solution

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

Before using Sodium Chloride Solution:

Some medical conditions may interact with Sodium Chloride 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 congestive heart failure or other heart problems, kidney or liver problems, swelling with or without sodium retention, high blood volume, high blood potassium or sodium levels, a damaged urinary tract, or circulation problems

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

• Corticosteroids (eg, prednisone) or corticotropin because the risk of side effects of Sodium Chloride Solution may be increased

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

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

• Sodium Chloride Solution is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Sodium Chloride Solution at home, carefully follow the injection procedures taught to you by your health care provider.


• If Sodium Chloride Solution contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Sodium Chloride 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 Sodium Chloride Solution.

Important safety information:

• LAB TESTS, including blood electrolyte levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Sodium Chloride Solution with caution in the ELDERLY because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Sodium Chloride Solution, discuss with your doctor the benefits and risks of using Sodium Chloride Solution during pregnancy. It is unknown if Sodium Chloride Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Sodium Chloride Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Sodium Chloride 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:

Fever; increased urination; vein irritation.

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); confusion; muscle twitching; pain, redness, or swelling at the injection site; seizures; weakness.

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.

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.

Proper storage of Sodium Chloride Solution:

Sodium Chloride Solution is usually handled and stored by a health care provider. If you are using Sodium Chloride Solution at home, store Sodium Chloride Solution as directed by your pharmacist or health care provider. Keep Sodium Chloride Solution out of the reach of children and away from pets.

General information:

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


• Sodium Chloride 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 Sodium Chloride 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 Sodium Chloride resources

• Sodium Chloride Drug Interactions
• Sodium Chloride Support Group
• 0 Reviews for Sodium Chloride - Add your own review/rating

Compare Sodium Chloride with other medications

• Postural Orthostatic Tachycardia Syndrome

Tarabine PFS

Generic Name: cytarabine (sye TAR a been)

Brand Names: Cytosar-U, Tarabine PFS

What is Tarabine PFS (cytarabine)?

Cytarabine is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Cytarabine is used to treat certain types of leukemia (blood cancers). Cytarabine is also used to treat leukemia associated with meningitis.

Cytarabine will not treat an active meningitis infection that has already developed in the body.

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

What is the most important information I should know about Tarabine PFS (cytarabine)?

Cytarabine can cause serious side effects on your brain or central nervous system that may not be reversible. Cytarabine is usually given together with a steroid medication to help lessen these side effects. Talk with your doctor about the risks and benefits of using this medication. Do not use cytarabine if you are pregnant. It could harm the unborn baby.

Before you receive cytarabine, tell your doctor if you have a seizure disorder or a history of head injury or brain tumor.

Cytarabine can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection. Do not receive a "live" vaccine while you are being treated with cytarabine. The live vaccine may not work as well during this time, and may not fully protect you from disease.

What should I discuss with my healthcare provider before receiving Tarabine PFS (cytarabine)?

Cytarabine can cause serious side effects on your brain or central nervous system that may not be reversible. Cytarabine is usually given together with a steroid medication to help lessen these side effects. Talk with your doctor about the risks and benefits of using this medication. You should not receive this medication if you are allergic to cytarabine.

To make sure you can safely receive cytarabine, tell your doctor if you have any of these other conditions:

• 
  

  epilepsy or other seizure disorder; or

  
  


• 
  

  a history of head injury or brain tumor.

  
  

FDA pregnancy category D. Do not receive cytarabine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether cytarabine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving cytarabine.

How is cytarabine given?

Cytarabine is given as an injection through a needle placed into a vein, under the skin, or into the space around the spinal cord. You will receive this injection in a clinic or hospital setting.

Cytarabine is usually given once every 2 to 4 weeks. Follow your doctor's dosing instructions very carefully.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when cytarabine is injected.

After receiving an injection in the space around your spinal cord, you will need to lie flat for at least 1 hour. You will be watched closely during this time to make sure you do not have serious side effects.

Cytarabine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your cytarabine injection.

What happens if I overdose?

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while receiving Tarabine PFS (cytarabine)?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while receiving cytarabine. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Tarabine PFS (cytarabine) side effects

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

• 
  

  fever with nausea, vomiting, and headache;

  
  


• 
  

  problems with your vision or hearing;

  
  


• 
  

  loss of movement in any part of your body;

  
  


• 
  

  loss of bowel or bladder control;

  
  


• 
  

  fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  
  


• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  
  


• 
  

  confusion, unusual thoughts or behavior;

  
  


• 
  

  trouble standing or walking,

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  pain or burning when you urinate;

  
  


• 
  

  feeling like you might pass out; or

  
  


• 
  

  feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

  
  

Less serious side effects may include:

• 
  

  drowsiness, dizziness, weakness, memory problems;

  
  


• 
  

  constipation, diarrhea, mild nausea;

  
  


• 
  

  back pain, pain in your arms or legs;

  
  


• 
  

  headache; or

  
  


• 
  

  trouble sleeping (insomnia).

  
  

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 Tarabine PFS (cytarabine)?

Tell your doctor if you take digoxin (Lanoxin).

This list is not complete and other drugs may interact with cytarabine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Tarabine PFS resources

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

• Cytarabine Prescribing Information (FDA)


• Cytarabine Professional Patient Advice (Wolters Kluwer)


• Cytarabine Monograph (AHFS DI)


• cytarabine Advanced Consumer (Micromedex) - Includes Dosage Information


• Cytarabine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Tarabine PFS with other medications

• Acute Myeloid Leukemia
• Acute Nonlymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Leukemia
• Meningeal Leukemia
• Non-Hodgkin's Lymphoma

Where can I get more information?

• Your pharmacist can provide more information about cytarabine.

See also: Tarabine PFS side effects (in more detail)

Theophylline and guaifenesin

thee-OF-i-lin, gwye-FEN-e-sin

Available Dosage Forms:

• Elixir


• Tablet


• Syrup


• Capsule, Liquid Filled


• Liquid


• Capsule

Therapeutic Class: Bronchodilator, Xanthine Combination

Chemical Class: Methylxanthine

Uses For theophylline and guaifenesin

Theophylline and guaifenesin combination is used to treat or prevent the symptoms of asthma or to treat chronic bronchitis and emphysema. theophylline and guaifenesin relieves cough, wheezing, shortness of breath, and troubled breathing. It works by opening up the bronchial tubes (air passages) of the lungs and increasing the flow of air through them.

theophylline and guaifenesin is available only with your doctor's prescription.

Before Using theophylline and guaifenesin

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 theophylline and guaifenesin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to theophylline and guaifenesin 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

The side effects of theophylline are more likely to occur in newborn infants, who are usually more sensitive to the effects of theophylline and guaifenesin.

Although there is no specific information about the use of guaifenesin in children, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Patients older than 60 years of age are likely to require a lower dose than younger adults. If the amount of theophylline is too high, side effects are more likely to occur. Your doctor may want to take blood samples to determine whether a dose change is needed.

Although there is no specific information about the use of guaifenesin in the elderly, it is not expected to cause different side effects or problems in older people than it does in younger adults.

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

Guaifenesin

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.

Theophylline

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. When you are taking theophylline and guaifenesin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using theophylline and guaifenesin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion


• Cimetidine


• Ciprofloxacin


• Deferasirox


• Desogestrel


• Dienogest


• Drospirenone


• Enoxacin


• Erythromycin


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etintidine


• Etonogestrel


• Fluvoxamine


• Halothane


• Idrocilamide


• Imipenem


• Levofloxacin


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Mexiletine


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Pefloxacin


• Peginterferon Alfa-2a


• Rofecoxib


• Thiabendazole


• Troleandomycin


• Vemurafenib


• Zileuton

Using theophylline and guaifenesin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenosine


• Adinazolam


• Alprazolam


• Aminoglutethimide


• Amiodarone


• Azithromycin


• Bromazepam


• Brotizolam


• Cannabis


• Carbamazepine


• Chlordiazepoxide


• Clobazam


• Clonazepam


• Clorazepate


• Diazepam


• Disulfiram


• Estazolam


• Febuxostat


• Flunitrazepam


• Flurazepam


• Fosphenytoin


• Halazepam


• Interferon Alfa-2a


• Ipriflavone


• Isoproterenol


• Ketazolam


• Lorazepam


• Lormetazepam


• Medazepam


• Methotrexate


• Midazolam


• Nilutamide


• Nitrazepam


• Oxazepam


• Pancuronium


• Pentoxifylline


• Phenobarbital


• Phenytoin


• Piperine


• Prazepam


• Propafenone


• Quazepam


• Rifampin


• Rifapentine


• Riluzole


• Ritonavir


• Secobarbital


• St John's Wort


• Tacrine


• Tacrolimus


• Telithromycin


• Temazepam


• Ticlopidine


• Triazolam


• Viloxazine


• Zafirlukast

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using theophylline and guaifenesin with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use theophylline and guaifenesin, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine


• food

Other Medical Problems

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

• Convulsions (seizures)—Theophylline may make this condition worse

• Heart failure or


• Liver disease or


• Underactive thyroid—The effects of theophylline may be increased

Proper Use of theophylline and guaifenesin

theophylline and guaifenesin works best when taken with a glass of water on an empty stomach (either 30 minutes to 1 hour before meals or 2 hours after meals) since that way it will get into the blood sooner. However, in some cases your doctor may want you to take theophylline and guaifenesin with meals or right after meals to lessen stomach upset. If you have any questions about how you should be taking theophylline and guaifenesin, check with your doctor.

Take theophylline and guaifenesin only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of serious side effects.

In order for theophylline and guaifenesin to help your medical problem, it must be taken every day in regularly spaced doses as ordered by your doctor . This is necessary to keep a constant amount of theophylline and guaifenesin in the blood. To help keep the amount constant, do not miss any doses.

Make certain your health care professional knows if you are on any special diet, such as a high-protein, low-carbohydrate or low-protein, high-carbohydrate diet.

Dosing

The dose of theophylline and guaifenesin 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 theophylline and guaifenesin. 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.

After you begin taking theophylline and guaifenesin combination, it is very important that your doctor check your blood level of theophylline at regular intervals to find out if your dose of theophylline and guaifenesin combination needs to be changed. Do not change your dose of theophylline and guaifenesin combination unless your doctor tells you to do so.

Missed Dose

If you miss a dose of theophylline and guaifenesin, take 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. Do not double doses.

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 theophylline and guaifenesin

Your doctor should check your progress at regular visits, especially for the first few weeks after you begin taking theophylline and guaifenesin. A blood test may be taken to help your doctor decide whether the dose of theophylline and guaifenesin should be changed.

The theophylline in theophylline and guaifenesin may add to the central nervous system stimulant effects of caffeine-containing foods or beverages such as chocolate, cocoa, tea, coffee, and cola drinks. Avoid eating or drinking large amounts of these foods or beverages while taking theophylline and guaifenesin . If you have any questions about this, check with your doctor.

A change in your usual behavior or physical well-being may affect the way theophylline and guaifenesin works in your body. Check with your doctor if you:

• have a fever of 102 °F or higher for at least 24 hours or higher than 100 °F for longer than 24 hours.


• start or stop smoking.


• start or stop taking another medicine.


• change your diet for a long time.

Before you have myocardial perfusion studies (a medical test that shows how well blood is flowing to your heart), tell the medical doctor in charge that you are taking theophylline and guaifenesin. The results of the test may be affected by theophylline and guaifenesin.

theophylline and guaifenesin 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:

Less common or rare

• Heartburn and/or vomiting

Symptoms of toxicity

• Abdominal pain, continuing or severe


• confusion or change in behavior


• convulsions (seizures)


• dark or bloody vomit


• diarrhea


• dizziness or lightheadedness


• fast and/or irregular heartbeat, continuing


• nervousness or restlessness, continuing


• trembling, continuing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Fast heartbeat


• headache


• increased urination


• nausea


• nervousness


• trembling


• trouble in sleeping

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: theophylline and guaifenesin side effects (in more detail)

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More theophylline and guaifenesin resources

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

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