Nasop

Generic Name: phenylephrine (FEN il EFF rin)

Brand Names: Ah-Chew D, Dimetapp Cold Drops, Lusonal, Nasop, Nasop12, PediaCare Children's Decongestant, Phenyl-T, Sudafed PE, Sudafed PE Children's Nasal Decongestant, Sudafed PE Quick Dissolve, Sudogest PE, Triaminic Thin Strips Cold

What is Nasop (phenylephrine)?

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

Phenylephrine is used to treat nasal congestion and sinus pressure caused by allergies, the common cold, or the flu. Phenylephrine may be used to treat congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

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

What is the most important information I should know about Nasop (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 are allergic to phenylephrine.

Do not use phenylephrine if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take phenylephrine before these other drugs have cleared from your body.

Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have heart disease, heart rhythm disorder, high blood pressure, circulation problems, diabetes, glaucoma, a thyroid disorder, kidney disease, an enlarged prostate or urination problems, anxiety, sleep problems, bipolar disorder or other mental illness.

Phenylephrine may interact with heart or blood pressure medications, antidepressants, diabetes medications, migraine headache medications, and other decongestants.

Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

What should I discuss with my healthcare provider before taking Nasop (phenylephrine)?

You should not use this medication if you are allergic to phenylephrine.

Do not use phenylephrine if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take phenylephrine before these other drugs have cleared from your body.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have:

• 
  

  heart disease, heart rhythm disorder;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  circulation problems (such as Raynaud's syndrome);

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  a thyroid disorder;

  
  


• kidney disease;


• 
  

  an enlarged prostate or urination problems;

  
  


• 
  

  sleep problems, anxiety; or

  
  


• 
  

  mental illness such as bipolar disorder.

  
  

FDA pregnancy category C. Is not known whether this medication will harm an unborn baby. Before you take phenylephrine, tell doctor if you are pregnant. Phenylephrine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Disintegrating and liquid forms of cold medicine may contain sugar or artificial sweeteners (phenylalanine). This would be important to know if you have diabetes or phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about sugar or phenylalanine.

How should I use Nasop (phenylephrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. 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. You may take phenylephrine with food if it upsets your stomach. Take the phenylephrine tablet with a full glass of water.

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

The chewable phenylephrine tablet must be chewed thoroughly before you swallow it.

To use the phenylephrine disintegrating strip, place one strip on your tongue and allow it to dissolve without chewing.

To use the disintegrating tablet, make sure your hands are dry and peel back the foil from the blister package. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Phenylephrine is usually taken every 4 hours. Follow the directions on the medicine label. Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store phenylephrine at room temperature away from moisture and heat. Keep the disintegrating tablets or strips in their package until you are ready to take one.

Throw away any unused phenylephrine after the expiration date on the label has passed. Do not flush this medication down a toilet. Ask your pharmacist about the safest way to dispose of unused medicines.

What happens if I miss a dose?

Cold medicine is usually taken only as needed, so you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include feeling restless or nervous, severe dizziness, sweating, vomiting, hallucinations, fast or uneven heart rate, fainting, seizure (convulsions), and weak or shallow breathing.

What should I avoid while using Nasop (phenylephrine)?

Do not use any other over-the-counter cold, allergy, or cough medication without first asking your doctor or pharmacist. Phenylephrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much phenylephrine. Read the label of any other medicine you are using to see if it contains phenylephrine or another decongestant.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Avoid smoking. It can add to the effects of phenylephrine in decreasing blood flow, which can lead to uncomfortable symptoms. Avoid drinking alcohol while you are taking phenylephrine.

Nasop (phenylephrine) side effects

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

• 
  

  severe dizziness, restless feeling, nervousness, or insomnia;

  
  


• 
  

  unusual thoughts or behavior;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  tremors or shaking;

  
  


• 
  

  numbness, tingling, or cold feeling in your hands or feet; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  headache, dizziness;

  
  


• 
  

  feeling excited or restless (especially in children);

  
  


• 
  

  upset stomach; or

  
  


• 
  

  mild sleep problems.

  
  

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 Nasop (phenylephrine)?

Tell your doctor about all other medications you use, especially:

• 
  

  other decongestants, including nasal sprays;

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  medicine to treat diabetes;

  
  


• 
  

  medicines to treat high blood pressure such as reserpine, methyldopa (Aldomet), and others;

  
  


• 
  

  migraine headache medicine such as ergotamine (Ergomar), naratriptan (Amerge), sumatriptan (Imitrex) or zolmitriptan (Zomig);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), and others; or

  
  


• 
  

  a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others.

  
  

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

More Nasop resources

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

• Nasop Dissolving Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• AH-Chew D Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Lusonal Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Neo-Synephrine Nasal Advanced Consumer (Micromedex) - Includes Dosage Information


• Neo-Synephrine MedFacts Consumer Leaflet (Wolters Kluwer)


• Phenylephrine Hydrochloride Monograph (AHFS DI)


• Sudafed PE Consumer Overview


• Sudafed PE MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Nasop with other medications

• Hypotension
• Nasal Congestion
• Shock
• Supraventricular Tachycardia

Where can I get more information?

• Your pharmacist can provide more information about phenylephrine.

See also: Nasop side effects (in more detail)

Nascobal

Generic Name: Vitamin B12
Class: Vitamin B Complex
VA Class: VT100
Chemical Name: 5,6-dimethyl-benzimidazolyl cyanocobamide,
CAS Number: 68-19-9

Introduction

A cobalt-containing, B complex vitamin.^a Cyanocobalamin and hydroxocobalamin are synthetic forms of vitamin B₁₂.^a

Hydroxocobalamin: Antidote for cyanide poisoning.¹⁰⁴

Uses for Nascobal

Vitamin B₁₂ Deficiency

Treatment of pernicious anemia and other vitamin B₁₂ deficiency states.^{a 102 105}

Parenteral cyanocobalamin or hydroxocobalamin: Treatment of vitamin B₁₂ deficiency due to inadequate intrinsic factor (IF) secretion; impaired intestinal absorption; or dietary deficiency associated with a vegetarian diet.^{a 102 105}

Cyanocobalamin is considered the parenteral vitamin B₁₂ preparation of choice; hydroxocobalamin may be preferred for initial treatment.^a

Cyanocobalamin nasal spray: Used to maintain hematologic status in adults with pernicious anemia with no nervous system involvement who have responded to parenteral vitamin B ₁₂ therapy.¹⁰³ Also used as a supplement for vitamin B₁₂ deficiency due to dietary deficiency, impaired absorption, inadequate secretion of IF, or certain other conditions.¹⁰³

Dietary Requirements

Adequate intake needed to prevent vitamin B₁₂ deficiency and neurologic complications associated with vitamin B₁₂ deficiency.¹⁰¹

Adequate intake of vitamin B₁₂ usually can be accomplished through consumption of foodstuffs; however, about 10–30% of geriatric individuals are unable to absorb naturally occurring vitamin B₁₂ and should consume vitamin B₁₂-fortified food or supplements.¹⁰¹ Inadequate intake can occur in vegetarians and their breast-fed infants.^a Mixed foods whose main ingredient is meat, fish, or poultry; milk; and fortified ready-to-eat cereals are the main sources of vitamin B₁₂ in the diet of US adults and children.¹⁰¹

Recommended Dietary Allowance (RDA) in adults based on amount needed to maintain hematologic status and normal serum vitamin B₁₂ concentrations.¹⁰¹

Adequate intake (AI) established for infants ≤6 months of age based on observed mean vitamin B₁₂ intake of infants fed principally human milk; AI for infants 7–12 months of age based on AI for younger infants and data in adults.¹⁰¹

RDA for children 1–18 years of age based on data in adults.¹⁰¹

Metabolic Disorders

Parenteral cyanocobalamin: Management of hereditary deficiency of transcobalamin II.^a

Schilling Test

Parenteral cyanocobalamin and hydroxocobalamin: Used in conjunction with cyanocobalamin Co 57 in Schilling test to study vitamin B₁₂ absorption. ^a

Cyanide Poisoning

Hydroxocobalamin (Cyanokit): Treatment of known or suspected cyanide poisoning.^{104 107 108 109} Used in conjunction with airway and cardiovascular support and management of seizure activity.¹⁰⁴

Nascobal Dosage and Administration

Administration

Cyanocobalamin is administered orally, intranasally, or by IM or deep sub-Q injection.^{a 102 103}

Hydroxocobalamin is administered by IM injection or IV infusion.^{104 105}

Oral Administration

Oral therapy is inferior to parenteral therapy. ^a May be used for treatment of dietary vitamin B₁₂ deficiency in patients with normal GI absorption.^a

Parenteral Administration

Cyanocobalamin: Administer by IM or deep sub-Q injection.¹⁰² If administered sub-Q, avoid injection into the dermis or upper subcutaneous tissue.^a Avoid administering IV; vitamin is rapidly excreted in urine when administered IV.¹⁰²

Hydroxocobalamin: Administer by IM injection (vitamin deficiency)¹⁰⁵ or by IV infusion (cyanide poisoning).¹⁰⁴ Avoid administering IV for vitamin deficiency.¹⁰⁵

For drug compatibility information, see Compatibility under Stability.

IV Administration for Cyanide Poisoning

Hydroxocobalamin: (Cyanokit); Administer by IV infusion.¹⁰⁴

May require a dedicated IV line.¹⁰⁴ Administration through the same IV line as blood products not recommended.¹⁰⁴

Reconstitution

Reconstitute vial containing 2.5 g of hydroxocobalamin with 100 mL of 0.9% sodium chloride injection; invert or rock vial for at least 30 seconds.¹⁰⁴ Do not shake vial.¹⁰⁴ Lactated Ringer's injection or 5% dextrose injection can be used if 0.9% sodium chloride injection is not available.¹⁰⁴ Reconstituted solution contains 25 mg/mL.¹⁰⁴

Rate of Administration

Initial 5-g dose: 15 minutes.¹⁰⁴

Second 5-g dose: 15 minutes (for patients in extremis) to 2 hours; rate depends on patient condition.¹⁰⁴

Intranasal Administration

Administer intranasally using a metered-dose pump.¹⁰³ Administer 1 hour before or 1 hour after ingestion of hot foods or liquids.¹⁰³

Prior to intranasal administration, clear nasal passages.¹¹⁰ Insert the nasal adapter 1 cm into one nostril, point the tip of the adapter toward the back of the nose, hold the other nostril closed, and tilt head slightly forward, pump the drug into nostril, sniff gently during and immediately after dosing, return head to upright position, remove pump unit from nose.^{110 a}

Efficacy has not been established in patients with nasal congestion, allergic rhinitis, or upper respiratory tract infection; defer use until these symptoms have subsided.¹⁰³

Prime the pump before each use.¹⁰³

Dosage

Vitamin B ₁₂ deficiency: Duration of therapy depends on cause; long-term therapy not needed when other therapeutic measures correct the underlying cause of the deficiency.^a

Cyanocobalamin metered-dose pump delivers 500 mcg of the drug (0.1 mL) per actuation.¹⁰³

Pediatric Patients

Vitamin B ₁₂ Deficiency

IM

Hydroxocobalamin: Initially, single doses of 100 mcg to total dose of 1–5 mg given over ≥2 weeks.¹⁰⁵

Hydroxocobalamin: Maintenance, 30–50 mcg every 4 weeks.¹⁰⁵

Dietary and Replacement Requirements

Oral

Infants born to vegan mothers: Supplement with AI from birth because these infants' vitamin B₁₂ stores are low and their mother’s milk may supply very small amounts of the vitamin.¹⁰¹

Infants ≤6 months of age: Recommended AI is 0.4 mcg (0.06 mcg/kg) daily.¹⁰¹

Infants 7–12 months of age: Recommended AI is 0.5 mcg (0.06 mcg/kg) daily.¹⁰¹

Children 1–3 years of age: RDA is 0.9 mcg daily.¹⁰¹

Children 4–8 years of age: RDA is 1.2 mcg daily.¹⁰¹

Children 9–13 years of age: RDA is 1.8 mcg daily.¹⁰¹

Children 14-18 years of age: RDA is 2.4 mcg daily.¹⁰¹

The RDAs will not meet the needs of individuals with malabsorption syndrome.¹⁰¹

Cyanide Poisoning†

IV

Hydroxocobalamin: 70 mg/kg has been used.^{104 107}

Adults

Vitamin B ₁₂ Deficiency

IM or Sub-Q

Cyanocobalamin: Initially, 100 mcg daily for 6–7 days.¹⁰² If clinical manifestations improve and reticulocyte response observed, administer 100 mcg every other day for 7 doses and then 100 mcg every 3–4 days for 2–3 weeks.¹⁰²

Cyanocobalamin: Maintenance, 100 mcg every month.¹⁰²

IM

Hydroxocobalamin: Initially, 30 mcg daily for 5–10 days.¹⁰⁵

Hydroxocobalamin: Maintenance, 100–200 mcg every month.¹⁰⁵

Intranasal

Maintenance, 500 mcg (one actuation) once weekly.¹⁰³ Increase dose in patients who experience a decline in serum vitamin B₁₂ concentrations after 1 month of therapy.¹⁰³

Dietary and Replacement Requirements

Oral

Men and women ≥19 years of age: RDA is 2.4 mcg daily.¹⁰¹

Adults ≥51 years of age should obtain most of their vitamin B₁₂ from fortified food or a vitamin B₁₂ supplement.¹⁰¹

The RDAs will not meet the needs of individuals with malabsorption syndrome.¹⁰¹

Cyanide Poisoning

IV

Hydroxocobalamin: Initially, 5 g (two 2.5-g vials).¹⁰⁴ A second 5-g dose may be administered, based on the severity of the poisoning and clinical response.¹⁰⁴

Schilling Test

IM or Sub-Q

Cyanocobalamin: Flushing dose is 1000 mcg.¹⁰²

IM

Hydroxocobalamin: Flushing dose is 1000 mcg. ¹⁰⁵

Special Populations

Pregnant Women

RDA for pregnant women is 2.6 mcg daily.¹⁰¹

Lactating Women

RDA for lactating women is 2.8 mcg daily.¹⁰¹

Requirements increased in lactating women to ensure adequate concentration of the vitamin in milk.¹⁰¹

Cautions for Nascobal

Contraindications

• 
  

  Known hypersensitivity to vitamin B₁₂, cobalt, or any ingredient in the formulation.^{102 103 105}

  
  


• 
  

  No contraindications when used for treatment of cyanide poisoning.¹⁰⁴

  
  

Warnings/Precautions

Warnings

Hypokalemia

Fatal hypokalemia reported in intensively treated patients with megaloblastic anemia.^{a 102 103 105} Monitor serum potassium concentrations during early vitamin B₁₂ therapy and administer potassium if necessary.^{105 a}

Polycythemia Vera

Vitamin B₁₂ deficiency may suppress signs of polycythemia vera; treatment may unmask this condition.^a

Ocular Effects

Avoid use in patients with early Leber’s disease (hereditary optic nerve atrophy); rapid and severe optic nerve atrophy reported.^{102 103}

Sensitivity Reactions

Sensitivity Reactions

Anaphylaxis reported with parenteral preparations.^{102 103}

Hydroxocobalamin (Cyanokit): Rash, mainly acneiform, reported in 20 or 44% of individuals receiving a 5- or 10-g dose, respectively.¹⁰⁴

Skin Test

Administer an intradermal test dose prior to administration of vitamin B₁₂ for vitamin deficiency in patients who may be sensitive to cobalamins.^a

General Precautions

Laboratory Monitoring

Obtain hematocrit, reticulocyte count, vitamin B₁₂, folate, and iron levels prior to treatment for vitamin B₁₂ deficiency.^{102 103} Monitor hematologic parameters as necessary during therapy.^{102 103}

Aluminum

Some cyanocobalamin injection preparations contain aluminum, which may be toxic.¹⁰² Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.¹⁰² Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.¹⁰²

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum >4–5 mcg/kg daily accumulate aluminum at levels associated with CNS and bone toxicity.¹⁰² Tissue loading may occur at even lower rates of administration.¹⁰²

Benzyl Alcohol in Neonates

Cyanocobalamin injection may contain benzyl alcohol as a preservative; benzyl alcohol has been associated with toxicity in neonates.^{102 111 112 113 114 115 116} (See Pediatric Precautions.)

Blood Pressure

Transient elevations in BP reported in individuals receiving IV hydroxocobalamin.¹⁰⁴

Undiagnosed Anemia

Use extreme caution if folic acid is administered to patients with undiagnosed anemia; may obscure the diagnosis of pernicious anemia by alleviating hematologic manifestations of the disease while allowing neurologic complications to progress.^a

Renal Effects

Oxalate crystals observed in the urine of healthy individuals and cyanide poisoning victims following administration of hydroxocobalamin.¹⁰⁴

Specific Populations

Pregnancy

Category C.^{102 103 104 105}

Lactation

Distributed into human milk.^{102 103}

Hydroxocobalamin (Cyanokit): Caution advised; no data available to determine when breast-feeding may be restarted following administration of IV hydroxocobalamin.¹⁰⁴

Pediatric Use

Hydroxocobalamin (Cyanokit): Safety and efficacy not established.¹⁰⁴

Cyanocobalamin: Benzyl alcohol has been associated with toxicity (“gasping syndrome”) in neonates; each mL of cyanocobalamin injection (e.g., preparation manufacturered by Abraxis) contains 15 mg of benzyl alcohol.^{102 111 112 113 114 115 116}

Geriatric Use

Hydroxocobalamin (Cyanokit): No substantial differences in safety and efficacy relative to younger adults.¹⁰⁴ Dosage adjustment not needed.¹⁰⁴

Hepatic Impairment

Hydroxocobalamin (Cyanokit): Safety and efficacy not studied in patients with hepatic impairment.¹⁰⁴

Renal Impairment

Hydroxocobalamin (Cyanokit): Safety and efficacy not studied in patients with renal impairment.¹⁰⁴ Hydroxocobalamin and cyanocobalamin excreted unchanged in urine.¹⁰⁴

Common Adverse Effects

Usually nontoxic even in large doses; mild transient diarrhea, peripheral vascular thrombosis, itching, transitory exanthema, urticaria, body swelling reported in patients receiving parenteral preparations.^a

Interactions for Nascobal

Colchicine, aminosalicylic acid and its salts, and excessive alcohol intake lasting >2 weeks may reduce absorption of vitamin B₁₂ from the GI tract.^{102 103}

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
Ascorbic acid	May destroy substantial amounts of dietary vitamin B12a	Consider this if large doses of ascorbic acid are ingested within 1 hour of administration of oral vitamin B12a
Chloramphenicol	May antagonize the hematopoietic response to vitamin B12 in vitamin-deficient patientsa	Monitor; consider alternate anti-infectives a
Cyanide antidotes	Safety of concomitant use of hydroxocobalamin with other cyanide antidotes not established104	Caution104 (See Parenteral under Stability and IV Administration under Dosage and Administration)
Laboratory parameters determined by colorimetric methods	Hydroxocobalamin (Cyanokit): Deep red color in blood and/or urine may interfere with certain laboratory tests (e.g., clinical chemistry, hematology, coagulation, urine parameters)104	Consult the product labeling for specific information
Methotrexate	Invalidates diagnostic microbiologic blood assays for vitamin B12102 103
Prednisone	Increased absorption of vitamin B12 and secretion of IF reported in a few patients with pernicious anemiaa	Does not occur in patients with partial or total gastrectomy; clinical importance unknowna
Pyrimethamine	Invalidates diagnostic microbiologic blood assays for vitamin B12102 103
Test for intrinsic factor (IF) antibodies	Prior administration of cyanocobalamin may result in false-positive test resultsa

Nascobal Pharmacokinetics

Absorption

Bioavailability

Irregularly absorbed from the distal small intestine following oral administration. ^a Requires gastric IF for active absorption from the GI tract.^a

Following parenteral (IM or sub-Q) administration, hydroxocobalamin is absorbed more slowly than cyanocobalamin.^a

Following administration of cyanocobalamin nasal spray, bioavailability is about 6.1% compared with IM administration.¹⁰³

Distribution

Extent

Distributed into liver, bone marrow, and other tissues.^{103 a}

Crosses the placenta and is distributed into milk.^a

Elimination

Elimination Route

50–98% may be excreted in urine.¹⁰²

Stability

Storage

Oral

Tablets

Cool dry place. ¹⁰⁶

Parenteral

Solution for Injection

20–25°C; protect from light.¹⁰²

Powder for Injection

25°C (may be exposed to 15–30°C).¹⁰⁴ May be stored for short periods at temperatures that occur with usual transport (15 days 5–40°C), transport in the desert (4 days 5–60°C), and freeze/defrost cycles (15 days in a range from -20 to 40°C).¹⁰⁴

Store reconstituted solution at ≤40°C; discard 6 hours after reconstitution.¹⁰⁴

Nasal Spray

Upright at 15–30°C; protect from light. ¹⁰³ Keep covered in carton until needed.¹⁰³ Protect from freezing.¹⁰³

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Hydroxocobalamin (Cyanokit): Incompatible with ascorbic acid, diazepam, dobutamine, dopamine, fentanyl, nitroglycerin, pentobarbital, propofol, sodium nitrite, sodium thiosulfate, thiopental.¹⁰⁴

Cyanocobalamin injection: Reported to be incompatible with chlorpromazine hydrochloride, phytonadione, prochlorperazine edisylate, warfarin sodium, ascorbic acid, dextrose, heavy metals, oxidizing or reducing agents, and alkaline or strongly acidic solutions.^a

Cyanocobalamin: Solution Compatibility^HID

Compatible
Dextran 6% in dextrose 5%
Dextran 6% in sodium chloride 0.9%
Dextrose-Ringer's injection combinations
Dextrose-Ringer’s injection, lactated, combinations
Dextrose-saline combinations
Dextrose 2½, 5, or 10% in water
Fructose 10% in sodium chloride 0.9%
Fructose 10% in water
Invert sugar 5 and 10% in sodium chloride 0.9%
Invert sugar 5 and 10% in water
Ionosol products
Ringer's injection
Ringer's injection, lactated
Sodium chloride 0.45 or 0.9%
Sodium lactate (1/6) M

Cyanocobalamin: Drug Compatibility

Admixture CompatibilityHID

Compatible
Ascorbic acid injection
Chloramphenicol sodium phosphate
Metaraminol bitartrate
Vitamin B complex with C

Y-Site CompatibilityHID

Compatible
Heparin sodium
Hydrocortisone sodium succinate
Potassium chloride
Vitamin B complex with C

ActionsActions

• 
  

  An exogenous source of vitamin B₁₂ is required for nucleoprotein and myelin synthesis, cell reproduction, normal growth, and the maintenance of normal erythropoiesis.^a

  
  


• 
  

  In cyanide poisoning, hydroxocobalamin binds to the cyanide ion to form cyanocobalamin which is excreted in the urine.¹⁰⁴

  
  

Advice to Patients

• 
  

  Advise patients with pernicious anemia that they must receive maintenance dosages of cyanocobalamin or hydroxocobalamin for the remainder of their lives to prevent irreversible neurologic damage.^a

  
  


• 
  

  Advise patient of necessity of follow-up tests to confirm adequacy of therapy.¹⁰³

  
  


• 
  

  Advise individuals who follow a vegetarian diet that contains no animal products to take oral vitamin B₁₂ regularly.^{102 103}

  
  


• 
  

  Importance of informing patients using intranasal cyanocobalamin to administer the dose at least 1 hour before or after ingestion of hot foods or liquids.¹⁰³

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{102 103}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{102 103} Importance of vitamin B₁₂ supplements in pregnant and lactating women who follow a vegetarian diet.^{102 103} Advise women given hydroxocobalamin for cyanide poisoning to discuss timing of resumption of breast-feeding with their clinician.¹⁰⁴

  
  


• 
  

  Advise patients given hydroxocobalamin for cyanide poisoning that skin redness may last up to 2 weeks and urine coloration may last up to 5 weeks.¹⁰⁴ Importance of avoiding direct sun exposure while skin is discolored.¹⁰⁴

  
  


• 
  

  Importance of informing patients of other important precautionary information.^a (See Cautions.)

  
  

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cyanocobalamin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	25 mcg*
		50 mcg*
		100 mcg*
		250 mcg*
		500 mcg*
		1000 mcg*
Parenteral	Injection	100 mcg/mL*
		1000 mcg/mL*
Nasal	Spray	500 mcg/metered spray	Nascobal (with benzalkonium chloride)	QOL Medical

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Hydroxocobalamin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection	1000 mcg/mL*
	For Injection	2.5 g	Cyanokit	Dey

Vitamin B₁₂ is also commercially available in combination with other vitamins and minerals.^a

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 05/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cyanocobalamin 1000MCG/ML Solution (AMERICAN REGENT): 10/$13.99 or 20/$18.98

Cyanocobalamin 1000MCG/ML Solution (AMERICAN REGENT): 25/$35.99 or 75/$89.97

Cyanocobalamin 1000MCG/ML Solution (AMERICAN REGENT): 30/$19.99 or 90/$45.98

Nascobal 500MCG/0.1ML Solution (PAR): 2/$295.98 or 6/$875.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 01, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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

100. National Research Council Food and Nutrition Board Subcommittee on the Tenth Edition of the RDAs. Recommended dietary allowances. 10th ed. Washington, DC: National Academy Press; 1989:158-65.

101. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for thiamin, riboflavin, niacin, vitamin B₆, folate, vitamin B₁₂, pantothenic acid, biotin, and choline. Washington, DC: National Academy Press; 1998. (Prepublication copy uncorrected proofs.)

102. Abraxis Pharmaceuticals. Cyanocobalamin injection prescribing information. Schaumburg, IL; 2005 Jun.

103. QOL Medical Company. Nascobal (cyanocobalamin nasal spray) prescribing information. Kirkland, WA; 2006 Aug.

104. Dey. Cyanokit (hydroxocobalamin for injection) prescribing information. Napa, CA; 2006 Dec. (

105. Watson Laboratories. Hydroxocobalamin injection prescribing information. Corona, CA; 2006 Feb.

106. Nature's bounty vitamin B₁₂ 1000 mcg tablets package information. From (). Accessed 31 May 2007.

107. Geller RJ, Barthold C, Saiers JA, Hall AH. Pediatric cyanide poisoning: causes, manifestations, management, and unmet needs. Pediatrics. 2006; 118:2146-58. [PubMed 17079589]

108. Borron SW, Baud FJ, Mégarbane B, Bismuth C. Hydroxocobalamin for severe acute cyanide poisoning by ingestion or inhalation. Am J Emerg Med. 2007; 25:551-8. [PubMed 17543660]

109. Borron SW, Baud FJ, Barriot P et al. Prospective study of hydroxocobalamin for acute cyanide poisoning in smoke inhalation. Ann Emerg Med. 2007; 49:794-801. [PubMed 17481777]

110. QOL Medical Company. Nascobal (cyanocobalamin nasal spray) patient information. Kirkland, WA; 2006.

111. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356-8. [IDIS 175725] [PubMed 6889041]

112. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12:10-11. [PubMed 7188569]

113. Anon. Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982; 31:290-91. [IDIS 150868] [PubMed 6810084]

114. Gershanik J. Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. [IDIS 160823] [PubMed 7133084]

115. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288-92. [PubMed 6440575]

116. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344-6. [IDIS 181207] [PubMed 6695984]

a. AHFS drug information 2007. McEvoy GK, ed. Vitamin B₁₂. Bethesda, MD: American Society of Health-System Pharmacists, 2007; 3628-31.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:444-7.

Novo-Clavamoxin 125

Generic Name: amoxicillin and clavulanate (Oral route)

a-mox-i-SIL-in, KLAV-ue-la-nate poe-TAS-ee-um

Commonly used brand name(s)

In the U.S.

• Amoclan


• Augmentin


• Augmentin ES-600


• Augmentin XR

In Canada

• Alti-Amoxi Clav


• Apo-Amoxi Clav


• Novo-Clavamoxin 125


• Novo-Clavamoxin 250


• Ratio-Amoxi Clav 250f

Available Dosage Forms:

• Tablet


• Tablet, Extended Release


• Powder for Suspension


• Tablet, Chewable

Therapeutic Class: Antibiotic

Pharmacologic Class: Penicillin, Aminopenicillin

Uses For Novo-Clavamoxin 125

Amoxicillin and clavulanate combination is used to treat bacterial infections in many different parts of the body.

Amoxicillin and clavulanate combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Novo-Clavamoxin 125

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin and clavulanate chewable tablets and oral suspension in children.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin and clavulanate tablets in children weighing 40 kilograms (kg) or more. However, safety and efficacy have not been established in children weighing less than 40 kg.

Appropriate studies have not been performed on the relationship of age to the effects of amoxicillin and clavulanate extended-release tablets in teenagers and children younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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 this medicine, 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 this medicine 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.

• Methotrexate


• Venlafaxine

Using this medicine 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.

• Acenocoumarol


• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Khat


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Probenecid


• Warfarin

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Diarrhea or


• Liver disease—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Kidney disease, severe—The extended-release tablets should not be used in patients with this condition.

• Liver disease, history of with amoxicillin and clavulanate combination or


• Mononucleosis ("mono")—Should not be used in patients with these conditions.

• Phenylketonuria (PKU)—The chewable tablet and oral suspension contain phenylalanine, which can make this condition worse.

Proper Use of amoxicillin and clavulanate

This section provides information on the proper use of a number of products that contain amoxicillin and clavulanate. It may not be specific to Novo-Clavamoxin 125. Please read with care.

Take this medicine exactly as directed by your doctor. 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.

You may take this medicine with or without meals. However, it is best to take this medicine at the start of a meal or snack to avoid an upset stomach.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

If you are using the chewable tablets, chew the tablet completely before swallowing.

There are certain flavors that can be mixed with the oral suspension to make it taste better. If you or your child do not like the taste of this medicine, ask your pharmacist about these flavorings.

Keep the oral suspension refrigerated. Shake it well before measuring the dose. Use a dosing spoon or medicine dropper to measure the dose. The average household teaspoon may not hold the right amount of liquid. Rinse the dosing spoon or dropper with water after each use.

Do not change brands or dosage forms of amoxicillin and clavulanate combination without first checking with your doctor. Different products may not work the same way. If you refill your medicine and it looks different, ask your pharmacist about the change.

Dosing

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

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

• For bacterial infections:
  
  • For oral dosage form (chewable tablets, suspension):
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours.
    
    
    • Children and infants above 3 months of age and weighing less than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 milligrams (mg) per kilogram (kg) of body weight per day (mg/kg/day), divided and given every 8 hours, or 25 to 90 mg/kg/day, divided and given every 12 hours.
    
    
    • Infants younger than 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 30 milligrams (mg) per kilogram (kg) of body weight per day, divided and given every 12 hours.
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—2000 milligrams (mg) every 12 hours.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours.
    
    
    • Children weighing less than 40 kilograms (kg)—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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

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.

Store the chewable tablets, regular tablets, and extended-release tablets at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the oral suspension in the refrigerator. Throw away any unused portion after 10 days. Keep from freezing.

Precautions While Using Novo-Clavamoxin 125

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

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Amoxicillin and clavulanate combination may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

In some young patients, tooth discoloration may occur while using this medicine. The teeth may appear to have brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.

Amoxicillin and clavulanate combination may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (e.g., condoms, a diaphragm, or a contraceptive foam or jelly) while using this medicine.

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

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

Novo-Clavamoxin 125 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

• Hives or welts


• itching


• itching of the vagina or genital area


• pain during sexual intercourse


• redness of the skin


• skin rash


• thick, white vaginal discharge with no odor or with a mild odor

Rare

• Bloody or cloudy urine


• fever


• greatly decreased frequency of urination or amount of urine


• seizures


• swelling of the feet or lower legs

Incidence not known

• Abdominal or stomach cramps or tenderness


• back, leg, or stomach pains


• black, hairy tongue


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the stools


• bloody nose


• chest pain


• chills


• clay-colored stools


• cough or hoarseness


• cracks in the skin


• dark urine


• diarrhea


• diarrhea, watery and severe, which may also be bloody


• difficulty with breathing


• difficulty with moving


• difficulty with swallowing


• dizziness


• fast heartbeat


• fever with or without chills


• general body swelling


• general feeling of tiredness or weakness


• headache


• heavier menstrual periods


• increased thirst


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• loss of appetite


• loss of heat from the body


• lower back or side pain


• muscle stiffness


• nausea or vomiting


• pain


• pain, swelling, or redness in the joints


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


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


• rash


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• scaly skin


• shortness of breath


• sore throat


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


• swollen glands


• tightness in the chest


• troubled breathing with exertion


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight loss


• upper right abdominal pain


• vomiting of blood


• wheezing


• white patches in the mouth or throat or on the tongue


• white patches with diaper rash


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach pain


• bloody or cloudy urine


• diarrhea


• fever


• greatly decreased frequency of urination or amount of urine


• pain or burning while urinating


• skin rash


• sleepiness


• swelling of the feet or lower legs


• vomiting

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:

Rare

• Anxiety


• dry mouth


• hyperventilation


• irregular heartbeats


• irritability


• nervousness


• restlessness


• shaking


• sleeplessness


• tooth discoloration


• trouble sitting still


• trouble with sleeping


• unable to sleep

Incidence not known

• Burning feeling in the chest or stomach


• indigestion


• redness, swelling, or soreness of the tongue


• stomach upset


• swelling or inflammation of the mouth

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: Novo-Clavamoxin25 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 Novo-Clavamoxin 125 resources

• Novo-Clavamoxin 125 Side Effects (in more detail)
• Novo-Clavamoxin 125 Use in Pregnancy & Breastfeeding
• Drug Images
• Novo-Clavamoxin 125 Drug Interactions
• Novo-Clavamoxin 125 Support Group
• 69 Reviews for Novo-Clavamoxin25 - Add your own review/rating

Compare Novo-Clavamoxin 125 with other medications

• Aspiration Pneumonia
• Bacterial Infection
• Bronchitis
• Febrile Neutropenia
• Kidney Infections
• Melioidosis
• Otitis Media
• Pneumonia
• Sinusitis
• Skin and Structure Infection
• Skin Infection
• Small Bowel Bacterial Overgrowth
• Strep Throat
• Upper Respiratory Tract Infection
• Urinary Tract Infection

Emla Topical

Generic Name: lidocaine and prilocaine (Topical application route)

LYE-doe-kane, PRIL-oh-kane

Commonly used brand name(s)

In the U.S.

• Emla

Available Dosage Forms:

• Cream


• Film


• Kit

Therapeutic Class: Anesthetic Combination

Chemical Class: Amino Amide

Uses For Emla

Lidocaine and prilocaine topical cream is used on the skin or in the genital area to cause numbness or loss of feeling before certain medical procedures. It is used to prevent pain caused by an injection, the drawing of blood from a vein, or minor surgeries such as removing warts. This medicine contains a mixture of two topical local anesthetics (numbing medicines). It deadens the nerve endings in the skin.

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

Before Using Emla

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine and prilocaine topical cream in children. However, because of this medicine's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency, history of or


• Heart disease or


• Heart rhythm problems or


• Infection at or near the place of application or


• Large sores, broken skin, or severe injury at the area of application—May cause side effects to become worse.

• Methemoglobinemia (blood disorder), history of—Should not use in patients with this condition.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Emla

A nurse or other trained health care professional will apply this medicine to you or your child before a medical procedure in a hospital or clinic.

You may be taught how to apply this medicine to yourself or your child at home before the medical procedure. Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if too much is used, because more of it is absorbed through the skin.

Do not apply this medicine to open wounds, burns, or broken or inflamed skin, unless directed otherwise by your doctor.

Be careful not to get any of this medicine in the eyes, because it can cause severe eye irritation. If any of the medicine does get into your eye, do not rub or wipe the eye, even if it hurts. Wash the eye with water and call your doctor right away.

Be careful not to get any of this medicine in the ears, because it can cause serious hearing problems. If any of the medicine does get into your ear, wash the ear with water and call your doctor right away.

Be careful not to get any of this medicine in the mouth. Serious unwanted effects may occur if the medicine is swallowed.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use:

• Wash your hands with soap and water before and after applying the medicine.


• Apply a thick layer of medicine to the area where numbness is needed. Do not spread the medicine on the skin.


• Cover the medicine with a special bandage called an occlusive dressing. This will keep the medicine in place. Your doctor will give you the bandage or tell you what to use.


• Seal the edges of the bandage to keep the medicine from leaking. Do not lift the bandage or disturb it. Keeping the medicine tightly covered helps it work properly.


• For babies or young children, a second covering may be used to prevent them from touching the medicine.


• Carefully watch your baby or child while the medicine is in place. Do not let them loosen or remove the bandage, touch the medicine, or put it in the mouth, eyes, nose, or ears.


• Keep the bandage in place until you or your child arrive at the hospital or clinic.


• Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.

Dosing

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

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

• For topical dosage form (cream):
  
  • For preventing pain caused by medical procedures:
    
    • Adults and teenagers—Apply 1 to 2.5 grams in a thick layer to the skin area. The size of the area to be covered and the length of time the medicine is kept in place will depend on the procedure. Cover the area with a bandage. The medicine may need to stay on the skin for up to 2 hours. Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The cream is applied in a thick layer to the skin area. The size of the area to be covered and the length of time the medicine is kept in place will depend on the procedure. Cover the area with a bandage. Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.
    
    
  
  

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 Emla

It is very important that your doctor check you or your child closely for any problems or unwanted effects that may be caused by this medicine.

Do not use this medicine on a baby younger than 3 months of age unless your child's doctor tells you to. Young babies may have more unwanted effects if too much is used and absorbed through the skin. If you use this medicine on a baby younger than 3 months of age, blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of the hands, face, or mouth after you receive the medicine.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. Remove the cream and call your doctor right away if you or your child develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing.

Using too much of this medicine or using it on a large area of your skin can cause serious unwanted effects. Remove the cream and contact your doctor right away if you or your child have any of these symptoms: lightheadedness, dizziness, vision problems, an irregular or slow heartbeat, difficulty with breathing, or convulsions.

During the time that the skin feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you or your child have normal feeling in the area. Do not scratch or rub the area, and do not allow very hot or very cold objects to touch it.

Emla 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:

Rare

• Cough


• difficulty with swallowing


• large, hive-like swellings on the eyelids, face, lips, or tongue


• severe dizziness or feeling faint


• shortness of breath


• skin rash, itching, or hives


• stuffy nose


• tightness in the chest


• troubled breathing


• wheezing

Incidence not known

• Blisters on skin at application site


• blue or blue-purple color of lips, fingernails, mouth, or skin


• blurred or double vision


• convulsions


• dark urine


• dizziness or drowsiness


• fainting


• feeling hot, cold, or numb


• headache


• irregular or fast heartbeat


• muscle twitching or trembling


• nausea or vomiting


• ringing or buzzing in the ears


• shortness of breath or troubled breathing


• unusual excitement, nervousness, or restlessness


• unusual tiredness or weakness

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

More common

• Burning, swelling, itching, or skin rash at application site


• white or red skin at the application site

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: Emla Topical 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 Emla Topical resources

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

Compare Emla Topical with other medications

• Anesthesia

Prelieve PMS

Pronunciation: Not applicable.
Generic Name: Chaste Tree
Brand Name: Examples include Prelieve PMS and Vitex Extract

Prelieve PMS is used for:

Irregularities of the menstrual cycle, premenstrual syndrome (PMS), and breast pain. It may also have other uses. Check with your pharmacist for details regarding the particular brand you use.

Prelieve PMS is an herbal product. It is thought to work by regulating hormone production through the pituitary gland in the brain.

Do NOT use Prelieve PMS if:

• you are allergic to any ingredient in Prelieve PMS


• you are pregnant

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

Before using Prelieve PMS:

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

• if you are 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

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

• Dopamine agonists (eg, bromocriptine, levodopa) because side effects may be increased by Prelieve PMS

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

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

• Dosing depends on the use and the source of the product.


• Use as directed on the package, unless instructed otherwise by your doctor.


• It may take several days to months for this product to work.


• If you miss taking a dose of Prelieve PMS for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use Prelieve PMS.

Important safety information:

• Prelieve PMS may reduce the effectiveness of birth control pills. Use an additional form of contraception (eg, condoms) while you are taking this product.


• If you will be taking this product for irregularities of the menstrual cycle or for breast pain and swelling, consult your doctor first. It is important to receive an accurate diagnosis of your symptoms before taking this product.


• This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: Do not take this product if you are pregnant. If you are or will be breast-feeding while you are using this product, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Prelieve PMS:

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:

Acne; cramping; diarrhea; hair loss; headache; increased menstrual flow; stomach pain; tiredness.

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).

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: Prelieve PMS 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 Prelieve PMS:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Prelieve PMS out of the reach of children and away from pets.

General information:

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


• Prelieve PMS 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 Prelieve PMS. 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 Prelieve PMS resources

• Prelieve PMS Side Effects (in more detail)
• Prelieve PMS Support Group
• 0 Reviews · Be the first to review/rate this drug

Exactacain Topical Anesthetic Spray

benzocaine, butamben, tetracaine hydrochloride

Dosage Form: aerosol, spray


Exactacain Topical Anesthetic Spray

Use As Directed

Not for ophthalmic use.

Active Ingredients:

Benzocaine .......................14.0% w/w

Butamben ...........................2.0% w/w

Tetracaine Hydrochloride ....2.0% w/w

(Percentages refer to concentrate and exclude propellant) 

Contains:


Benzalkonium Chloride, Cetyldimethylethylammonium bromide, Dipropylene Glycol, Flavoring (Cherry), Saccharin. Also Contains: Propellant HFA-134a 1,1,1,2-tetrafluoroethane).

Action:

The onset of Exactacain produced anesthesia is rapid (approximately 30 seconds) and the duration of anesthesia is typically 30-60 minutes, when used as directed. This effect is due to the rapid onset, but short duration of action of Benzocaine coupled with the slow onset, but extended duration of Tetracaine HCI and bridged by the intermediate action of Butamben.

It is believed that all of these agents act by reversibly blocking nerve conduction. Speed and duration of action is determined by the ability of the agent to be absorbed by the mucous membrane and nerve sheath and then to diffuse out, and ultimately be metabolized (primarily by plasma cholinesterases) to inert metabolites which are excreted in the urine.

Indications:

Exactacain is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Exactacain is indicated for use to control pain or gagging. Exactacain is indicated for use to control pain and for use for surgical and endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures when feasible.

Dosage and Administration:

Apply 3 metered sprays of Exactacain for normal anesthesia. Dosing in excess of 6 metered sprays is contraindicated. Tissue need not be dried prior to application of Exactacain. Exactacain should be applied directly to the site where pain control is required.

Adverse Reactions:

Hypersensitivity Reactions: Unpredictable adverse reactions (ie, hypersensitivity, including anaphylaxis) are extremely rare.

Localized allergic reactions may occur after prolonged or repeated use of any aminobenzoate anesthetic. The most common adverse reaction caused by local anesthetics is contact dermatitis characterized by erythema and pruritus that may progress to vesiculation and oozing. This occurs most commonly in patients following prolonged self-medication, which is contraindicated. If rash, urticaria, edema, or other manifestations of allergy develop during use, the drug should be discontinued. To minimize the possibility of a serious allergic reaction, Exactacain preparation should not be applied for prolonged periods except under continual supervision. Dehydration of the epithelium or an escharotic effect may also result from prolonged contact.

Precaution:

On rare occasions, methemoglobinemia has been reported in connection with the use of products containing Benzocaine and related compounds. Care should be used not to exceed 6 metered sprays. If a patient becomes cyanotic, treat appropriately to counteract (such as with methylene blue, if medically indicated).

Use in Pregnancy:

Safe use of Exactacain has not been established with respect to possible adverse effects upon fetal development. Therefore, Exactacain should not be used during early pregnancy, unless in the judgment of a physician, the potential benefits outweigh the unknown hazards. Routine precaution for the use of any topical anesthetic should be observed when Exactacain is used.

Use in pediatric and geriatric populations:

Appropriate pediatric and geriatric dosage has not been established for this product. Dosage should be reduced in the debilitated elderly, acutely ill, very young patients or others with conditions resulting in a greater risk from methemoglobinemia.

Contraindications:

Exactacain is not suitable and should never be used for injection. Do not use on the eyes. To avoid excessive systemic absorption, Exactacain should not be applied to large areas of denuded or inflamed tissue. Exactacain should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. Tolerance may vary with the status of the patient. Dosage should be reduced in the debilitated elderly, acutely ill, very young patients or others with conditions resulting in a greater risk from methemoglobinemia.

Individual dosage of tetracaine hydrochloride in excess of 6 metered sprays is contraindicated. Exactacain should not be used under dentures or cotton rolls, as retention of the active ingredients under a denture or cotton roll could possibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using Exactacain.

Disposable Applicators for Exactacain Spray:

• The 5” Exactacain disposable, single-use applicators are designed for accessibility and
  
  application of Exactacain, at the required site of pain control


• A disposable applicator is inserted firmly into the spray nozzle on the can of Exactacain


• The disposable applicator should be discarded after each patient use and a new disposable applicator inserted prior to the next use of the product

How Supplied:

Exactacain is available in a 60 g can (including propellant) NDC 16781-113-60, packaged with 100 disposable applicators. Additional disposable applicators are available (order number 16781-113-00).

Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. DO NOT spray in eyes.

Store at controlled room temperature, 20°C-25°C (68°F-77°F). The canister should be at room temperature before use.

Marketed by: 

Cumberland, RI 02864

(888) 713-8154

www.onsettx.com

Reorder No:

Exactacain Spray 16781-113-60

Additional Disposable Applicators:

16781-113-00

P/N 2601 Rev. 0

Revision Date: 9/08

Exactacain is a trademark of Onset Therapeutics

Patent pending.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – Box with 60 g Can and Disposable Applicators

NDC 16781-113-60

Rx ONLY

ExactacainTM

(benzocaine 14%, butamben 2%, tetracaine hydrochloride 2%) spray

Topical Anesthetic

Contents:

One 60 gram can of Exactacain Spray

100 disposable applicators

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – Can, 60 Grams

NDC 16781-113-60

Rx ONLY

Exactacain®

(benzocaine 14%, butamben 2%, tetracaine hydrochloride 2%) spray

Topical Anesthetic

60 GRAMS

EXACTACAIN  TOPICAL ANESTHETIC benzocaine,butamben,tetracaine hydrochloride  aerosol, spray

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16781-113 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (BENZOCAINE) BENZOCAINE 14 g  in 100 g BUTAMBEN (BUTAMBEN) BUTAMBEN 2 g  in 100 g TETRACAINE HYDROCHLORIDE (TETRACAINE) TETRACAINE HYDROCHLORIDE 2 g  in 100 g

Inactive Ingredients Ingredient Name Strength DIPROPYLENE GLYCOL   BENZALKONIUM CHLORIDE   SACCHARIN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 16781-113-60 1 CAN In 1 BOX contains a CAN 1 60 g In 1 CAN This package is contained within the BOX (16781-113-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/23/2005	10/31/2012

Labeler - Onset Dermatologics LLC (793223707)

Registrant - Onset Dermatologics LLC (964275155)

Establishment
Name	Address	ID/FEI	Operations
Onset Dermatologics LLC		793223707	Manufacture

Revised: 11/2011Onset Dermatologics LLC

More Exactacain Topical Anesthetic Spray resources

• Exactacain Topical Anesthetic Spray Side Effects (in more detail)
• Exactacain Topical Anesthetic Spray Use in Pregnancy & Breastfeeding
• Exactacain Topical Anesthetic Spray Support Group
• 0 Reviews · Be the first to review/rate this drug