Thursday, October 27, 2016

Dexamethasone injection



Generic Name: dexamethasone (injection) (DEX a METH a sone)

Brand Names: Cortastat, Cortastat 10, Cortastat LA, De-Sone LA, Dexacen-4, Dexasone, Dexasone LA, Solurex, Solurex LA


What is dexamethasone?

Dexamethasone is in a class of drugs called steroids. Dexamethasone prevents the release of substances in the body that cause inflammation.


Dexamethasone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, breathing disorders, inflammatory eye conditions, blood cell disorders, leukemia, or endocrine disorders.


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


What is the most important information I should know about dexamethasone?


You should not use this medication if you are allergic to dexamethasone or sulfites, or if you have a fungal infection anywhere in your body.

Before using dexamethasone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.


Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.


Avoid activities that place too much stress on your joints. Dexamethasone can decrease pain and swelling, and you may be tempted to increase your activity if you are feeling better. Any joint damage may go unnoticed while you are being treated with dexamethasone.


Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.


Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.


Do not receive a "live" vaccine while you are being treated with dexamethasone. Vaccines may not work as well while you are using a steroid. Ask your doctor when you can safely receive a live vaccine after your dexamethasone treatment ends.


What should I discuss with my healthcare provider before using dexamethasone?


You should not use this medication if you are allergic to dexamethasone or sulfites, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before using this medication, tell your doctor about any illness or infection you have had within the past several weeks.


Other medical conditions you should tell your doctor about before using dexamethasone include:



  • asthma;




  • liver disease (such as cirrhosis);




  • kidney disease;




  • a thyroid disorder;




  • a history of malaria;




  • osteoporosis;




  • a muscle disorder such as myasthenia gravis;




  • glaucoma or cataracts;




  • herpes simplex infection of the eyes;




  • stomach ulcers, ulcerative colitis, or diverticulitis;




  • depression or mental illness;




  • congestive heart failure;




  • high blood pressure; or




  • if you have recently had a heart attack.



If you have any of these conditions, you may need a dose adjustment or special tests to safely use dexamethasone.


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

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.


How is dexamethasone injection given?


Dexamethasone is given as an injection into a muscle or through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.


Your doctor may occasionally change your dose to make sure you get the best results from this medication.


Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.


This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using dexamethasone.


Dexamethasone injection is usually given for only a few days. After your treatment ends, you may have withdrawal symptoms such as fever, weakness, and joint or muscle pain. Talk to your doctor about how to treat or avoid any withdrawal symptoms.

What happens if I miss a dose?


Since dexamethasone injection is given as needed by a healthcare professional, it is not likely that you will miss a dose.


What happens if I overdose?


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

A single large dose of dexamethasone is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.


What should I avoid after receiving dexamethasone?


Avoid activities that place too much stress on your joints. Dexamethasone can decrease pain and swelling, and you may be tempted to increase your activity if you are feeling better. Any joint damage may go unnoticed while you are being treated with dexamethasone.


Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.


Do not receive a "live" vaccine while you are being treated with dexamethasone. Vaccines may not work as well while you are using a steroid. Ask your doctor when you can safely receive a live vaccine after your dexamethasone treatment ends.


Dexamethasone side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your doctor at once if you have any of these serious side effects:

  • problems with your vision;




  • swelling, rapid weight gain, feeling short of breath;




  • severe depression, unusual thoughts or behavior, seizure (convulsions);




  • bloody or tarry stools, coughing up blood;




  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);




  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).



Less serious side effects may include:



  • sleep problems (insomnia), mood changes;




  • acne, dry skin, thinning skin, bruising or discoloration;




  • slow wound healing;




  • increased sweating;




  • headache, dizziness, spinning sensation;




  • nausea, stomach pain, bloating; or




  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


Dexamethasone Dosing Information


Usual Adult Dose for Acute Mountain Sickness:

Oral, IV and IM (injections as sodium phosphate):
0.75 to 9 mg per day in divided doses every 6 to 12 hours
IM (as acetate):
8 to 16 mg, may repeat in 1 to 3 weeks
Intralesional (as acetate):
0.8 to 1.6 mg
Intraarticular and soft tissue as acetate):
4 to 16 mg, may repeat in 1 to 3 weeks
Intraarticular, intralesional, or soft tissue (as sodium phosphate):
0.4 to 6 mg per day

Usual Adult Dose for Asthma -- Acute:

Oral, IV and IM (injections as sodium phosphate):
0.75 to 9 mg per day in divided doses every 6 to 12 hours
IM (as acetate):
8 to 16 mg, may repeat in 1 to 3 weeks
Intralesional (as acetate):
0.8 to 1.6 mg
Intraarticular and soft tissue as acetate):
4 to 16 mg, may repeat in 1 to 3 weeks
Intraarticular, intralesional, or soft tissue (as sodium phosphate):
0.4 to 6 mg per day

Usual Adult Dose for Croup:

Oral, IV and IM (injections as sodium phosphate):
0.75 to 9 mg per day in divided doses every 6 to 12 hours
IM (as acetate):
8 to 16 mg, may repeat in 1 to 3 weeks
Intralesional (as acetate):
0.8 to 1.6 mg
Intraarticular and soft tissue as acetate):
4 to 16 mg, may repeat in 1 to 3 weeks
Intraarticular, intralesional, or soft tissue (as sodium phosphate):
0.4 to 6 mg per day

Usual Adult Dose for Anti-inflammatory:

Oral, IV and IM (injections as sodium phosphate):
0.75 to 9 mg per day in divided doses every 6 to 12 hours
IM (as acetate):
8 to 16 mg, may repeat in 1 to 3 weeks
Intralesional (as acetate):
0.8 to 1.6 mg
Intraarticular and soft tissue as acetate):
4 to 16 mg, may repeat in 1 to 3 weeks
Intraarticular, intralesional, or soft tissue (as sodium phosphate):
0.4 to 6 mg per day

Usual Adult Dose for Cerebral Edema:

Initial 10 mg IV once, followed by 4 mg IM every 6 hours until symptoms of cerebral edema subside. Dosage may be reduced after 2 to 4 days, and discontinued slowly over a period of 5 to 7 days.

Usual Adult Dose for Cushing's Syndrome:

Suppression test or diagnosis for Cushing's syndrome:
1 mg orally at 11 p.m. Blood plasma cortisol measurement at 8 a.m. the next morning.
or
0.5 mg by mouth every 6 hours for 48 hours (with 24 hour urine collection for 17 hydroxycorticosteroid excretion).

Differentiation of Cushing's syndrome due to ACTH excess from Cushing's due to other causes: Oral: Dexamethasone 2 mg every 6 hours for 48 hours (with 24 hour urine collection for 17 hydroxycorticosteroid excretion).

Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced:

Prophylaxis:
10 mg to 20 mg orally or IV, 15 to 30 minutes before treatment on each treatment day
For continuous infusion of chemotherapy:
10 mg orally or IV every 12 hours on each treatment day.
For mildly emetogenic therapy: 4 mg oral, IV or IM every 4 to 6 hours.
Delayed nausea and vomiting:
8 mg orally every 12 hours for 2 days; then 4 mg every 12 hours for 2 days.
or
20 mg orally 1 hour before chemotherapy; then 10 mg orally 12 hours after chemotherapy; then 8 mg orally every 12 hours for 4 doses; then 4 mg orally every 12 hours for 4 doses.

Usual Adult Dose for Shock:

Addisonian crisis/shock:
4 to 10 mg IV as single dose, repeat if necessary.

Unresponsive shock:
1 to 6 mg/kg IV as a single dose or up to 40 mg initially followed by repeat doses every 2 to 6 hours while shock persists.

Usual Adult Dose for Multiple Myeloma:

Multiple myeloma: Oral, IV: 40 mg/day, days 1 to 4, 9 to 12, and 17 to 20, repeated every 4 weeks (alone or as part of a regimen).

Usual Adult Dose for Multiple Sclerosis:

Multiple sclerosis (acute exacerbation): Oral: 30 mg/day for 1 week, followed by 4 to 12 mg/day for 1 month.

Usual Adult Dose for Adrenal Insufficiency:

Physiological replacement: Oral, IM, IV (should be given as sodium phosphate): 0.03 to 0.15 mg/kg/day or 0.6 to 0.75 mg/m2/day in divided doses every 6 to 12 hours.

Usual Pediatric Dose for Cerebral Edema:

Initial loading dose: 1 to 2 mg/kg once orally, IV or IM.
Maintenance: 1 to 1.5 mg /kg/day, give in divided doses every 4 to 6 hours for 5 days then taper for 5 days, then discontinue. Maximum dose: 16 mg/day.

Usual Pediatric Dose for Meningitis -- Meningococcal:

(Not approved by FDA):

Meningitis (H. influenzae type b): Infants and Children 6 weeks or older: IV: 0.15 mg/kg/dose every 6 hours for the first 2 to 4 days of antibiotic treatment; start dexamethasone 10 to 20 minutes before or with the first dose of antibiotic. If antibiotics have already been administered, dexamethasone use has not been shown to improve patient outcome and is not recommended. Note: For pneumococcal meningitis, data has not shown clear benefit from dexamethasone administration; risk and benefits should be considered prior to use.

Usual Pediatric Dose for Meningitis -- Haemophilus influenzae:

(Not approved by FDA):

Meningitis (H. influenzae type b): Infants and Children 6 weeks or older: IV: 0.15 mg/kg/dose every 6 hours for the first 2 to 4 days of antibiotic treatment; start dexamethasone 10 to 20 minutes before or with the first dose of antibiotic. If antibiotics have already been administered, dexamethasone use has not been shown to improve patient outcome and is not recommended. Note: For pneumococcal meningitis, data has not shown clear benefit from dexamethasone administration; risk and benefits should be considered prior to use.

Usual Pediatric Dose for Meningitis -- Pneumococcal:

(Not approved by FDA):

Meningitis (H. influenzae type b): Infants and Children 6 weeks or older: IV: 0.15 mg/kg/dose every 6 hours for the first 2 to 4 days of antibiotic treatment; start dexamethasone 10 to 20 minutes before or with the first dose of antibiotic. If antibiotics have already been administered, dexamethasone use has not been shown to improve patient outcome and is not recommended. Note: For pneumococcal meningitis, data has not shown clear benefit from dexamethasone administration; risk and benefits should be considered prior to use.

Usual Pediatric Dose for Meningitis - Listeriosis:

(Not approved by FDA):

Meningitis (H. influenzae type b): Infants and Children 6 weeks or older: IV: 0.15 mg/kg/dose every 6 hours for the first 2 to 4 days of antibiotic treatment; start dexamethasone 10 to 20 minutes before or with the first dose of antibiotic. If antibiotics have already been administered, dexamethasone use has not been shown to improve patient outcome and is not recommended. Note: For pneumococcal meningitis, data has not shown clear benefit from dexamethasone administration; risk and benefits should be considered prior to use.

Usual Pediatric Dose for Anti-inflammatory:

0.08 to 0.3 mg/kg/day or 2.5 to 5 mg/m2/day in divided doses every 6 to 12 hours.

Usual Pediatric Dose for Nausea/Vomiting -- Chemotherapy Induced:

(Not approved by FDA):

Prior to chemotherapy:
10 mg/meter squared IV for first dose (maximum 20 mg) then 5 mg/meter squared/dose every 6 hours as needed.

Usual Pediatric Dose for Asthma -- Acute:

Asthma exacerbation: Oral, IM, IV: 0.6 mg/kg once (maximum dose: 16 mg)

Usual Pediatric Dose for Croup:

(Not approved by FDA):

Croup (laryngotracheobronchitis): Oral, IM, IV: 0.6 mg/kg once (maximum: 20 mg). A single dose of 0.15 mg/kg has also been shown effective.

Usual Pediatric Dose for Adrenal Insufficiency:

Physiological replacement: Oral, IM, IV (should be given as sodium phosphate): 0.03 to 0.15 mg/kg/day or 0.6 to 0.75 mg/m2/day in divided doses every 6 to 12 hours.

Usual Pediatric Dose for Acute Mountain Sickness:

(Not approved by FDA):
Acute mountain sickness (AMS)/high altitude cerebral edema (HACE); treatment: Oral, IM, IV: 0.15 mg/kg/dose every 6 hours; consider using for high altitude pulmonary edema because of associated HACE with this condition.

Usual Pediatric Dose for Bronchopulmonary Dysplasia:

(Not approved by FDA):
Bronchopulmonary dysplasia, facilitation of ventilator wean: postnatal age =7 days: Oral, IV: Initial: 0.15 mg/kg/day given in divided doses every 12 hours for 3 days, then tapered every 3 days over 7 days; total dexamethasone dose: 0.89 mg/kg given over 10 days; others have used 0.2 mg/kg/day given once daily and tapered every 3 days over 7 days (total dexamethasone dose: 1 mg/kg) ( or tapered over 14 days (total dexamethasone dose: 1.9 mg/kg). Note: High doses (0.5 mg/kg/day) do not confer additional benefit over lower doses, are associated with higher incidence of adverse effects (including adverse neurodevelopmental outcomes), and are not recommended for use. However, a meta-analysis reported total cumulative doses greater than 4 mg/kg reduced the relative risk for the combined outcome, mortality, or bronchopulmonary dysplasia; further studies are needed.


What other drugs will affect dexamethasone?


There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:



  • aspirin (taken on a daily basis or at high doses);




  • a diuretic (water pill);




  • a blood thinner such as warfarin (Coumadin);




  • diet pills, or cough and cold medications;




  • indomethacin (Indocin); or




  • seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).



This list is not complete and there may be other drugs that can interact with dexamethasone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More dexamethasone resources


  • Dexamethasone Dosage
  • Dexamethasone Use in Pregnancy & Breastfeeding
  • Drug Images
  • Dexamethasone Drug Interactions
  • Dexamethasone Support Group
  • 12 Reviews for Dexamethasone - Add your own review/rating


Compare dexamethasone with other medications


  • Addison's Disease
  • Adrenal Insufficiency
  • Adrenocortical Insufficiency
  • Adrenogenital Syndrome
  • Ankylosing Spondylitis
  • Aphthous Ulcer
  • Aspiration Pneumonia
  • Asthma
  • Asthma, acute
  • Atopic Dermatitis
  • Bronchopulmonary Dysplasia
  • Bursitis
  • Cerebral Edema
  • Chorioretinitis
  • Croup
  • Cushing's Syndrome
  • Dermatitis Herpetiformis
  • Eczema
  • Epicondylitis, Tennis Elbow
  • Erythroblastopenia
  • Evan's Syndrome
  • Gouty Arthritis
  • Hay Fever
  • Hemolytic Anemia
  • Hypercalcemia of Malignancy
  • Idiopathic Thrombocytopenic Purpura
  • Inflammatory Bowel Disease
  • Inflammatory Conditions
  • Iridocyclitis
  • Iritis
  • Juvenile Rheumatoid Arthritis
  • Keratitis
  • Leukemia
  • Loeffler's Syndrome
  • Lymphoma
  • Meningitis, Haemophilus influenzae
  • Meningitis, Listeriosis
  • Meningitis, Meningococcal
  • Meningitis, Pneumococcal
  • Mountain Sickness / Altitude Sickness
  • Multiple Myeloma
  • Multiple Sclerosis
  • Mycosis Fungoides
  • Nausea/Vomiting, Chemotherapy Induced
  • Neurosarcoidosis
  • Pemphigus
  • Psoriatic Arthritis
  • Pulmonary Tuberculosis
  • Rheumatoid Arthritis
  • Sarcoidosis
  • Seborrheic Dermatitis
  • Shock
  • Synovitis
  • Systemic Lupus Erythematosus
  • Thrombocytopenia
  • Toxic Epidermal Necrolysis
  • Tuberculous Meningitis
  • Ulcerative Colitis
  • Uveitis, Posterior


Where can I get more information?


  • Your pharmacist can provide more information about dexamethasone.



Blephamide





Dosage Form: ophthalmic ointment
Blephamide®

(sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10% / 0.2%

sterile



Blephamide Description


Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) is a sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid which have the following chemical structures:




Chemical Names:


Sulfacetamide sodium: N-sulfanilylacetamide monosodium salt monohydrate. Prednisolone acetate: 11β, 17, 21-trihydroxpregna-1, 4-diene-3, 20-dione, 21-acetate.



Contains: Actives: sulfacetamide sodium 10%, prednisolone acetate 0.2%; Preservative: phenylmercuric acetate 0.0008%; Inactives: mineral oil, petrolatum (and) lanolin alcohol, and white petrolatum.



Blephamide - Clinical Pharmacology


Corticosteriods suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antibacterial drug may be used when this inhibition is considered to be clinically significant in a particular case.


When a decision to administer both a corticosteroid and an antibacterial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.


The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.



Microbiology: Sulfacetamide exerts a bacteriostatic effect against susceptible bacteria by restricting the synthesis of folic acid required for growth through competition with p-aminobenzoic acid.


Some strains of these bacteria may be resistant to sulfacetamide or resistant strains may emerge in vivo.


The anti-infective component in Blephamide® ointment is included to provide action against specific organisms susceptible to it. Sulfacetamide sodium is active in vitro against susceptible strains of the following microorganisms: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group). Haemophilus influenzae, Klebsiella species, and Enterobacter species. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens (see INDICATIONS AND USAGE).



Indications and Usage for Blephamide


Blephamide® ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.


Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.


The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.


The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.


The product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens.


A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.



Contraindications


Blephamide® ophthalmic ointment is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.


This product is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides and to other corticosteroids. See WARNINGS. (Hypersensitivity to the antimicrobial component occurs at a higher rate than for other components.)



Warnings


NOT FOR INJECTION INTO THE EYE.


Prolonged use of corticosteroids may result in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.


Acute anterior uveitis may occur in susceptible individuals, primarily Blacks.


Prolonged use of Blephamide® ophthalmic ointment may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.


If the product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.


A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.


The use of steroids after cataract surgery may delay healing and increase the incidence of filtering blebs.


The use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.


Topical steroids are not effective in mustard gas keratitis and Sjögren's keratoconjunctivitis.


Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Sensitization may recur when asulfonamide is readministered, irrespective of the route of administration.


If signs of hypersensitivity or other serious reaction occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids has been demonstrated (see ADVERSE REACTIONS).



Precautions



General:


The initial prescription and renewal of the medication order beyond 8 g of ointment should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.


The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Use with caution in patients with severe dry eye. Fungal cultures should be taken when appropriate.


The p-aminobenzoic acid present in purulent exudates competes with sulfonamides and can reduce their effectiveness.


Ophthalmic ointments may retard corneal healing.



Information for Patients:


If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician (see WARNINGS).


This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the tube tip to eyelids or to any other surface. The use of this tube by more than one person may spread infection. Keep tube tightly closed when not in use. Keep out of the reach of children.



Laboratory Tests:


Eyelid cultures and tests to determine the susceptibility of organisms to sulfacetamide may be indicated if signs and symptoms persist or recur in spite of the recommended course of treatment with Blephamide® ophthalmic ointment.



Drug Interactions:


Blephamide® ophthalmic ointment is incompatible with silver preparations. Local anesthetics related to p-aminobenzoic acid may antagonize the action of the sulfonamides.



Carcinogenesis, Mutagenesis, Impairment of Fertility:


Prednisolone has been reported to be noncarcinogenic. Long-term animal studies for carcinogenic potential have not been performed with sulfacetamide.


One author detected chromosomal nondisjunction in the yeast Saccharomyces cerevisiae following application of sulfacetamide sodium. The significance of this finding to topical ophthalmic use of sulfacetamide sodium in the human is unknown.


Mutagenic studies with prednisolone have been negative. Studies on reproduction and fertility have not been performed with sulfacetamide. A long-term chronic toxicity study in dogs showed that high oral doses of prednisolone prevented estrus. A decrease in fertility was seen in male and female rats that were mated following oral dosing with another glucocorticosteroid.



Pregnancy:


Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with sulfacetamide sodium. Prednisolone has been shown to be teratogenic in rabbits, hamsters, and mice. In mice, prednisolone has been shown to be teratogenic when given in doses 1 to 10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women dosed with corticosteroids.


Kernicterus may be precipitated in infants by sulfonamides being given systemically during the third trimester of pregnancy. It is not known whether sulfacetamide sodium can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.


Blephamide® ophthalmic ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.



Nursing Mothers:


It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.


Systemically administrated sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for serious adverse reactions in nursing infants from sulfacetamide sodium and prednisolone acetate ophthalmic ointments, a decision should be made whether to discontinue nursing or to discontinue the medication.



Pediatric Use:


Safety and effectiveness in children below the age of six have not been established.



Adverse Reactions


Adverse reactions have occurred with corticosteroid/antibacterial combination drugs which can be attributed to the corticosteroid component, the antibacterial component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.


Reactions occurring most often from the presence of the antibacterial ingredient are allergic sensitizations. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see WARNINGS).


Sulfacetamide sodium may cause local irritation.


The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.


Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical corticosteroids.


Corticosteroid-containing preparations can also cause acute anterior uveitis or perforation of the globe. Mydriaisis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.


Secondary Infection: The development of secondary infection has occurred after use of combinations containing corticosteroids and antibacterials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroid. The possibility of fungal invasion must be considered in any persistant corneal ulceration where corticosteroid treatment has been used.


Secondary bacterial ocular infection following suppression of host responses also occurs.



Blephamide Dosage and Administration


A small amount, approximately 1/2 inch ribbon of ointment, should be applied in the conjunctival sac three or four times daily and once or twice at night.


Not more than 8 g should be prescribed initially.


The dosing of Blephamide® ophthalmic ointment may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application.


If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).



How is Blephamide Supplied


Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% is supplied sterile in ointment tubes of the following size:


3.5 g - NDC 0023-0313-04


Note: Store between 15°-25°C (59°-77°F).


Rx only.


Revised September 2004


© 2004 Allergan, Inc.

Irvine, California 92612, U.S.A.

® Marks owned by Allergan, Inc.


6284X


71412US11P



NDC 0023-0313-04 Rx Only


Blephamide®


(sulfacetamide sodium and prednisolone

acetate ophthalmic ointment, USP) 10%/0.2%


3.5g Sterile




ALLERGAN


NDC 0023-0313-04


3.5 g


Blephamide®


(sulfacetamide

sodium and

prednisolone

acetate

ophthalmic

ointment, USP)


10 % / 0.2 %


sterile


Rx only










Blephamide 
sulfacetamide sodium and prednisolone acetate  ointment










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0023-0313
Route of AdministrationOPHTHALMICDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sulfacetamide sodium (sulfacetamide)sulfacetamide sodium100 mg  in 1 g
prednisolone acetate (prednisolone)prednisolone acetate2 mg  in 1 g












Inactive Ingredients
Ingredient NameStrength
phenylmercuric acetate 
mineral oil 
petrolatum 
lanolin alcohols 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10023-0313-041 TUBE In 1 CARTONcontains a TUBE
13.5 g In 1 TUBEThis package is contained within the CARTON (0023-0313-04)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08774801/01/1987


Labeler - Allergan, Inc. (144796497)









Establishment
NameAddressID/FEIOperations
Allergan, Inc.362898611MANUFACTURE
Revised: 01/2012Allergan, Inc.

Wednesday, October 26, 2016

Dolorex


Pronunciation: aH-seet-ah-MIN-oh-fen/SAL-ih-sill-ah-mide/fen-ill-tole-OX-a-meen
Generic Name: Acetaminophen/Salicylamide/Phenyltoloxamine
Brand Name: Examples include Dolorex and Duraxin


Dolorex is used for:

Treating mild to moderate aches and pains associated with headache, muscle and joint soreness, backache, menstrual cramps, colds and flu, sinusitis, toothache, and minor pain from arthritis, and to reduce fever. It may also be used to treat other conditions as determined by your doctor.


Dolorex is an analgesic, antihistamine, and antipyretic combination. It works by blocking substances in the body that cause fever, pain, and inflammation. It also blocks histamine, which causes sneezing and itchy, watery eyes.


Do NOT use Dolorex if:


  • you are allergic to any ingredient in Dolorex

  • you have lung problems (asthma, emphysema, chronic obstructive pulmonary disease [COPD]), difficulty urinating due to an enlarged prostate, glaucoma, kidney or liver problems, or blood clotting problems

  • you are taking medicine for blood clotting or sodium oxybate (GHB)

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



Before using Dolorex:


Some medical conditions may interact with Dolorex. 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 bleeding problems, blood vessel problems in the brain, blockage of the stomach, chickenpox, flu, rheumatoid arthritis, Kawasaki syndrome, prostate problems, blockage of the urinary tract, or difficulty urinating

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


  • Isoniazid or sodium oxybate because the risk of side effects may be increased

  • Blood thinners (eg, warfarin) because the risk of side effects, including the risk of bruising or bleeding, may be increased

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


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


  • Take Dolorex with food and a large glass of water or milk to reduce stomach irritation.

  • If you miss a dose of Dolorex and you are using it regularly, 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 Dolorex.



Important safety information:


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

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

  • Avoid taking medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Dolorex. Dolorex will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

  • Do not exceed the recommended dosage or take Dolorex for longer than prescribed without checking with your doctor.

  • If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Dolorex or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Dolorex may increase your risk for liver damage.

  • If you are taking Dolorex for pain or fever and your symptoms do not improve within 10 days or if they become worse, check with your doctor.

  • Before you have any medical or dental treatments or surgery, tell the doctor or dentist that you are taking Dolorex.

  • Do not give Dolorex to a child or teenager who has chickenpox, the flu, or another viral infection. Use of Dolorex for treating the symptoms of a viral infection may cause a serious illness called Reye syndrome.

  • Dolorex is not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been established.

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


Possible side effects of Dolorex:


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:



Drowsiness; dry mouth, nose, or throat; heartburn; nausea; thickening of mucus in the nose and throat; upset stomach.



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); bloody or black stools; confusion; dark urine or pale stools; decreased urination; diarrhea; difficulty swallowing; dizziness; hearing loss; hoarseness; persistent sore throat or other signs of infection; ringing in the ears; severe stomach pain; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.



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: Dolorex 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 abnormal behavior; dark urine; excessive sweating; extreme tiredness; fast or deep breathing; loss of consciousness; ringing in the ears; stomach pain; vomiting.


Proper storage of Dolorex:

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


General information:


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

  • Dolorex 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 Dolorex. 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 Dolorex resources


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


  • Be-Flex Plus Prescribing Information (FDA)



Compare Dolorex with other medications


  • Pain


Besifloxacin Ophthalmic


be-si-FLOX-a-sin


Commonly used brand name(s)

In the U.S.


  • Besivance

Available Dosage Forms:


  • Suspension

Therapeutic Class: Antibiotic


Chemical Class: Fluoroquinolone


Uses For besifloxacin


Besifloxacin ophthalmic (eye) preparation is used to treat infections of the eye, such as bacterial conjunctivitis. Besifloxacin belongs to a group of medicines called fluoroquinolone antibiotics. It works by killing bacteria that cause conjunctivitis.


besifloxacin is available only with your doctor's prescription.


Before Using besifloxacin


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 besifloxacin, the following should be considered:


Allergies


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


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of besifloxacin in children. However, safety and efficacy have not been established in children younger than 1 year of age.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of besifloxacin in the elderly.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


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


Interactions with Medicines


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


Interactions with Food/Tobacco/Alcohol


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


Proper Use of besifloxacin


Your doctor will tell you how much of besifloxacin to use and how often. Do not use more medicine or use it more often than your doctor tells you to. besifloxacin is not for long-term use.


To use the eye drops:


  • First, wash your hands. Then turn the closed bottle upside down and shake it one time before putting the medicine in your eye. Remove the cap with the bottle still being held upside down.

  • Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, 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 eye. Do not blink. Keep the eye closed for 1 or 2 minutes to allow the medicine to cover the eye.

  • If you think you did not get the drop of medicine into your eye properly, repeat the directions with another drop.

  • 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.

To help clear up your eye infection completely, keep using besifloxacin for the full time of treatment, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.


Dosing


The dose of besifloxacin 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 besifloxacin. 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 dosage form (eye drops):
    • For bacterial conjunctivitis:
      • Adults and children 1 year of age and older—Put one drop in the affected eye three times a day, with each dose at least four to twelve hours apart.

      • Infants younger than 1 year of age—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of besifloxacin, 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.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using besifloxacin


If your eye infection does not improve, or if it becomes worse, check with your doctor.


Stop using besifloxacin and check with your doctor right away if you have a rash, itching, or red or swollen skin around the eye or eyelid. These may be symptoms of an allergic reaction.


Do not wear contact lenses while you are using besifloxacin to avoid further eye irritation.


besifloxacin 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 immediately if any of the following side effects occur:


Less common
  • Blurred vision

  • eye pain

  • itching of the eye

  • red, sore eyes

  • swelling of the eye or eyelid

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
  • Headache

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: besifloxacin Ophthalmic side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More besifloxacin Ophthalmic resources


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


  • Besivance Prescribing Information (FDA)

  • Besivance Monograph (AHFS DI)

  • Besivance Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Besivance Consumer Overview



Compare besifloxacin Ophthalmic with other medications


  • Conjunctivitis, Bacterial
  • Ophthalmic Surgery


Tuesday, October 25, 2016

Dextromethorphan, diphenhydramine, and phenylephrine


Generic Name: dextromethorphan, diphenhydramine, and phenylephrine (DEX troe me THOR fan, DYE fen HYE dra meen, and FEN il EFF rin)

Brand names: Dytan-DM, Triaminic Day Time Night Time Cold & Cough, Duratuss AC 12, D-Tann DM, Triaminic Day Time Night Time Cold & Cough


What is dextromethorphan, diphenhydramine, and phenylephrine?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.


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


Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of diphenhydramine, dextromethorphan, and phenylephrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.


This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Diphenhydramine, dextromethorphan, and phenylephrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about dextromethorphan, diphenhydramine, and phenylephrine?


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use cough or cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my healthcare provider before taking dextromethorphan, diphenhydramine, and phenylephrine?


Do not use cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use cough or cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

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



  • a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;




  • diabetes;




  • liver or kidney disease;




  • epilepsy or other seizure disorder;




  • cough with mucus, or cough caused by emphysema or chronic bronchitis;




  • enlarged prostate or urination problems;




  • low blood pressure;




  • pheochromocytoma (an adrenal gland tumor); or




  • if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).




FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Do not use cough or cold medicine without medical advice if you are pregnant. This medicine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use cough or cold medicine without medical advice if you are breast-feeding a baby.

How should I take dextromethorphan, diphenhydramine, and phenylephrine?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.


Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?


Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


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

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


What should I avoid while taking dextromethorphan, diphenhydramine, and phenylephrine?


This medicine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of this medication. Ask a doctor or pharmacist before using any other cold, allergy, cough, or sleep medicine. Antihistamines, cough suppressants, and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, cough suppressant, or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Avoid becoming overheated or dehydrated during exercise and in hot weather. This medication can decrease sweating and you may be more prone to heat stroke.

Dextromethorphan, diphenhydramine, and phenylephrine 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. Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • fast, slow, or uneven heart rate;




  • severe headache, mood changes, hallucinations;




  • severe dizziness or anxiety, feeling like you might pass out;




  • tremor, seizure (convulsions);




  • easy bruising or bleeding, unusual weakness;




  • fever;




  • urinating less than usual or not at all;




  • feeling short of breath; or




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, uneven heartbeats, seizure).



Less serious side effects may include:



  • mild headache;




  • mild dizziness, drowsiness;




  • dry mouth, nose, or throat;




  • nausea, diarrhea, constipation, upset stomach;




  • feeling nervous, restless, or irritable;




  • blurred vision; or




  • sleep problems (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.


Dextromethorphan, diphenhydramine, and phenylephrine Dosing Information


Usual Adult Dose for Allergic Rhinitis:

Dextromethorphan/diphenhydrAMINE/PE 15 mg-12.5 mg-15 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 75 mg-25 mg-7.5 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours.

Usual Adult Dose for Cold Symptoms:

Dextromethorphan/diphenhydrAMINE/PE 15 mg-12.5 mg-15 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 75 mg-25 mg-7.5 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours.

Usual Adult Dose for Cough and Nasal Congestion:

Dextromethorphan/diphenhydrAMINE/PE 15 mg-12.5 mg-15 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 75 mg-25 mg-7.5 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours.

Usual Adult Dose for Sinusitis:

Dextromethorphan/diphenhydrAMINE/PE 15 mg-12.5 mg-15 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 75 mg-25 mg-7.5 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours.

Usual Pediatric Dose for Allergic Rhinitis:

Dextromethorphan/diphenhydrAMINE/PE 15 mg-12.5 mg-15 mg/5 mL oral suspension, extended release:
2 to 5 years: 2.5 mL orally every 12 hours.
6 to 11 years: 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 75 mg-25 mg-7.5 mg/5 mL oral suspension, extended release
2 to 5 years: 1.25 to 2.5 mL orally every 12 hours.
6 to 11 years: 2.5 to 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

Usual Pediatric Dose for Cold Symptoms:

Dextromethorphan/diphenhydrAMINE/PE 15 mg-12.5 mg-15 mg/5 mL oral suspension, extended release:
2 to 5 years: 2.5 mL orally every 12 hours.
6 to 11 years: 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 75 mg-25 mg-7.5 mg/5 mL oral suspension, extended release
2 to 5 years: 1.25 to 2.5 mL orally every 12 hours.
6 to 11 years: 2.5 to 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

Usual Pediatric Dose for Cough and Nasal Congestion:

Dextromethorphan/diphenhydrAMINE/PE 15 mg-12.5 mg-15 mg/5 mL oral suspension, extended release:
2 to 5 years: 2.5 mL orally every 12 hours.
6 to 11 years: 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 75 mg-25 mg-7.5 mg/5 mL oral suspension, extended release
2 to 5 years: 1.25 to 2.5 mL orally every 12 hours.
6 to 11 years: 2.5 to 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

Usual Pediatric Dose for Sinusitis:

Dextromethorphan/diphenhydrAMINE/PE 15 mg-12.5 mg-15 mg/5 mL oral suspension, extended release:
2 to 5 years: 2.5 mL orally every 12 hours.
6 to 11 years: 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 75 mg-25 mg-7.5 mg/5 mL oral suspension, extended release
2 to 5 years: 1.25 to 2.5 mL orally every 12 hours.
6 to 11 years: 2.5 to 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.


What other drugs will affect dextromethorphan, diphenhydramine, and phenylephrine?


Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by diphenhydramine or dextromethorphan.


Ask a doctor or pharmacist if it is safe for you to take this medication if you are also using any of the following drugs:



  • atropine (Atreza, Sal-Tropine);




  • benztropine (Cogentin);




  • diphenhydramine (Benadryl) applied to the skin;




  • topiramate (Topamax);




  • zonisamide (Zonegran);




  • an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), and others;




  • anti-nausea medications such as belladonna (Donnatal), dimenhydrinate (Dramamine), droperidol (Inapsine), methscopolamine (Pamine), or scopolamine (Transderm Scop);




  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), or Urogesic Blue;




  • bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);




  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or




  • ulcer medicine such as glycopyrrolate (Robinul) or mepenzolate (Cantil).



This list is not complete and other drugs may interact with diphenhydramine, dextromethorphan, and phenylephrine. 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 dextromethorphan, diphenhydramine, and phenylephrine resources


  • Dextromethorphan, diphenhydramine, and phenylephrine Use in Pregnancy & Breastfeeding
  • Dextromethorphan, diphenhydramine, and phenylephrine Drug Interactions
  • Dextromethorphan, diphenhydramine, and phenylephrine Support Group
  • 0 Reviews for Dextromethorphan, diphenhydramine, and phenylephrine - Add your own review/rating


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  • Cold Symptoms
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Where can I get more information?


  • Your pharmacist can provide more information about diphenhydramine, dextromethorphan, and phenylephrine.



Doxorubicin Intravenous


dox-oh-ROO-bi-sin


Intravenous route(Solution;Powder for Solution)

Severe local tissue necrosis will occur if there is extravasation during administration; do not administer by the intramuscular or subcutaneous route. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure (CHF) may occur either during therapy or months to years after termination of therapy. The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 400 mg/m(2). Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) have been reported in patients treated with anthracyclines. Pediatric patients are also at risk for developing secondary AML. Reduce dosage in patients with impaired hepatic function. Severe myelosuppression may occur with therapy .



Commonly used brand name(s)

In the U.S.


  • Adriamycin

Available Dosage Forms:


  • Powder for Solution

  • Solution

Therapeutic Class: Antineoplastic Agent


Chemical Class: Anthracycline


Uses For doxorubicin


Doxorubicin belongs to the general group of medicines known as antineoplastics. It is used to treat some kinds of cancers of the blood; lymph system; bladder; breast; stomach; lung; ovaries; thyroid; nerves; kidneys; bones; and soft tissues, including muscles and tendons. It may also be used to treat other kinds of cancer, as determined by your doctor.


Doxorubicin seems to interfere with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by doxorubicin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.


Before you begin treatment with doxorubicin, you and your doctor should talk about the good doxorubicin will do as well as the risks of using it.


Doxorubicin is to be administered only by or under the supervision of your doctor.


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 these uses are not included in product labeling, doxorubicin is used in certain patients with the following medical conditions:


  • Autoimmune deficiency syndrome (AIDS)–associated Kaposi's sarcoma (a type of cancer of the skin and mucous membranes that is more common in patients with AIDS)

  • Cancer of the adrenal cortex (the outside layer of the adrenal gland)

  • Cancer of the cervix

  • Cancer of the endometrium

  • Cancer of the esophagus

  • Cancers of the head and neck

  • Cancer of the liver

  • Cancer of the pancreas

  • Cancer of the prostate

  • Cancer of the thymus (a small organ found under the breast bone)

  • Carcinoid tumors

  • Chronic lymphocytic leukemia (a type of cancer of the blood and lymph system)

  • Ewing's sarcoma (a type of cancer found in the bone)

  • Gestational trophoblastic tumors (tumors in the uterus or womb)

  • Hepatoblastoma (a certain type of liver cancer that occurs in children)

  • Multiple myeloma (a certain type of cancer of the blood)

  • Non–small cell lung cancer (a certain type of lung cancer usually associated with prior smoking, passive smoking, or radon exposure)

  • Retinoblastoma (a type of eye cancer found primarily in children)

  • Tumors in the ovaries

Before Using doxorubicin


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 doxorubicin, the following should be considered:


Allergies


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


Heart problems are more likely to occur in children younger than 2 years of age, who are usually more sensitive to the effects of doxorubicin.


Geriatric


Heart problems are more likely to occur in the elderly, who are usually more sensitive to the effects of doxorubicin. The elderly may also be more likely to have blood problems.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using doxorubicin.


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 receiving doxorubicin, 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 doxorubicin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Rotavirus Vaccine, Live

Using doxorubicin 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.


  • Adenovirus Vaccine Type 4, Live

  • Adenovirus Vaccine Type 7, Live

  • Bacillus of Calmette and Guerin Vaccine, Live

  • Cisplatin

  • Clozapine

  • Docetaxel

  • Glucosamine

  • Influenza Virus Vaccine, Live

  • Measles Virus Vaccine, Live

  • Mumps Virus Vaccine, Live

  • Paclitaxel

  • Rotavirus Vaccine, Live

  • Rubella Virus Vaccine, Live

  • Smallpox Vaccine

  • Stavudine

  • Trastuzumab

  • Typhoid Vaccine

  • Valspodar

  • Varicella Virus Vaccine

  • Warfarin

  • Yellow Fever Vaccine

  • Zidovudine

Using doxorubicin 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.


  • Cyclosporine

  • Eltrombopag

  • Phenytoin

  • Sorafenib

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 doxorubicin. Make sure you tell your doctor if you have any other medical problems, especially:


  • Chickenpox (including recent exposure) or

  • Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

  • Gout or

  • Kidney stones—Doxorubicin may increase levels of uric acid in the body, which can cause gout or kidney stones

  • Heart disease—Risk of heart problems caused by doxorubicin may be increased

  • Liver disease—Effects of doxorubicin may be increased because of its slower removal from the body

Proper Use of doxorubicin


Doxorubicin is sometimes given together with certain other medicines. If you are receiving a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.


While you are using doxorubicin, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.


Doxorubicin often causes nausea and vomiting. However, it is very important that you continue to receive the medication, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.


Dosing


The dose of doxorubicin 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 doxorubicin. 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.


Precautions While Using doxorubicin


It is very important that your doctor check your progress at regular visits to make sure that doxorubicin is working properly and to check for unwanted effects.


While you are being treated with doxorubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Doxorubicin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine, since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.


Doxorubicin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:


  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.

  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

  • Avoid contact sports or other situations where bruising or injury could occur.

If doxorubicin accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.


doxorubicin 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 immediately if any of the following side effects occur:


Less common
  • Fast or irregular heartbeat

  • pain at place of injection

  • shortness of breath

  • swelling of feet and lower legs

Rare
  • Black, tarry stools

  • blood in urine

  • pinpoint red spots on skin

  • unusual bleeding or bruising

  • wheezing

Check with your doctor as soon as possible if any of the following side effects occur:


More common
  • Sores in mouth and on lips

Less common
  • Cough or hoarseness accompanied by fever or chills

  • darkening or redness of skin (if you recently had radiation treatment)

  • fever or chills

  • joint pain

  • lower back or side pain accompanied by fever or chills

  • painful or difficult urination accompanied by fever or chills

  • red streaks along injected vein

  • stomach pain

Rare
  • Skin rash or itching

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:


More common
  • Nausea and vomiting

Less common
  • Darkening of soles, palms, or nails

  • diarrhea

Doxorubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is to be expected and only lasts for 1 or 2 days after each dose is given.


doxorubicin often causes a temporary and total loss of hair. After treatment with doxorubicin has ended, normal hair growth should return.


After you stop using doxorubicin, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:


  • Fast or irregular heartbeat

  • shortness of breath

  • swelling of feet and lower legs

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.



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  • Doxorubicin Intravenous Support Group
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