Naloxone 400 micrograms / ml solution for injection (hameln)

Read all of this leaflet carefully before this medicine is administered to you.

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



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



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



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

Naloxone 400 micrograms/ml solution for injection

- naloxone hydrochloride -

In this leaflet:

• 1. What Naloxone 400 micrograms/ml solution for injection is and what it is used for



• 2. Before Naloxone 400 micrograms/ml solution for injection is administered to you



• 3. How Naloxone 400 micrograms/ml solution for injection is administered



• 4. Possible side effects



• 5. How to store Naloxone 400 micrograms/ml solution for injection



• 6. Further information

What Naloxone 400 Micrograms/Ml Solution For Injection Is And What It Is Used For

Naloxone 400 micrograms/ml solution for injection is a drug used to counter the effects of opioid overdose, for example morphine overdose.

Naloxone 400 micrograms/ml solution for injection is used for reversal of unwanted effects of opioids for countering life-threatening depression of the central nervous system and respiratory system (breathing difficulties).

Naloxone 400 micrograms/ml solution for injection is also used to diagnose an acute opioid overdose or intoxication.

If a woman has been given analgesic drugs during labour, a newborn child can be treated with Naloxone 400 micrograms/ml solution for injection for reversal of unwanted effects of opioids, e.g. if he/she suffers from breathing problems or depression of the central nervous system.

Before Naloxone 400 Micrograms/Ml Solution For Injection Is Administered To You

Naloxone 400 micrograms/ml solution for injection must not be administered

• If you are allergic (hypersensitive) to naloxone hydrochloride or to any of the ingredients of this medicinal product.

Take special care with Naloxone 400 micrograms/ml solution for injection and tell your doctor

• If you are physically dependent on opioids (for example morphine) or have received high doses of these drugs (you may get strong withdrawal symptoms after receiving Naloxone 400 micrograms/ml solution for injection because of a rapid reversal of the opioid effect; these symptoms may be high blood pressure, palpitations, severe difficulties in breathing or cardiac arrest).



• If you have any heart or circulation problems (because side effects like high or low blood pressure, palpitations or severe difficulties in breathing may appear more likely).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

• If you are taking painkilling medication like buprenorphine. The painkilling effect may even become stronger while you are treated with Naloxone 400 micrograms/ml solution for injection. However, the reversal of unwanted effects, like respiratory depression caused by buprenorphine is limited.



• If you are taking sedatives, as Naloxone 400 micrograms/ml solution for injection may possibly have a less rapid effect.



• If you are taking any medication that may affect your heart or circulation (e.g. antihypertensive drugs e.g. clonidine), even those not prescribed.

Using Naloxone 400 micrograms/ml solution for injection with food and drink

Please inform your doctor if you drank alcohol. In patients with multi-intoxication (with opioids and sedatives or alcohol) Naloxone 400 micrograms/ml solution for injection may have a less rapid effect.

Pregnancy and breast-feeding

There is no sufficient information available regarding the use of Naloxone 400 micrograms/ml solution for injection in pregnant women. During pregnancy, your doctor will assess the benefit of Naloxone 400 micrograms/ml solution for injection against possible risks to the embryo or to the foetus.

It is not known whether Naloxone 400 micrograms/ml solution for injection passes into breast milk and it has not been established whether infants who are breast-fed are affected by Naloxone 400 micrograms/ml solution for injection. Therefore, breast-feeding should be avoided for 24 hours after treatment. Ask your doctor for advice before taking any medicine.

Driving and using machines

After receiving Naloxone 400 micrograms/ml solution for injection for the reversal of the effects of opioids you must not drive a vehicle, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours as the effects of opioids may possibly recur.

Important information about some of the ingredients of Naloxone 400 micrograms/ml solution for injection

This medicinal product contains 3.8 mmol (88.5 mg) sodium per maximum daily dose. Please tell your doctor, if you are on a low sodium diet, he/she will take it into account.

How Naloxone 400 Micrograms/Ml Solution For Injection Is Administered

The usual doses given to you are

Reversal of the unwanted effects of opioids

Adults: 0.1-0.2 mg, if necessary additional injections of 0.1 mg may be given

Children: 0.01-0.02 mg per kg body weight, if necessary additional injections of the same dose may be given

Diagnosis of opioid overdose or intoxication

Adults: 0.4-2 mg, if necessary the injections can be repeated at intervals of 2-3 minutes. The maximum dose of 10 mg should not be exceeded.

Children: 0.01 mg per kg body weight, if necessary an additional injection of 0.1 mg per kg may be given

Reversal of the unwanted effects of opioids in neonates whose mothers have received opioids

0.01 mg per kg body weight, if necessary additional injections may be given:

For reversal of the unwanted effects of opioids (in adults, children and also in neonates) patients are monitored to ensure that the desired effect of Naloxone 400 micrograms/ml solution for injection occurs. Additional doses may be given every 1-2 hours if necessary.

In elderly patients with heart or circulation problems or in those receiving medicines that can produce heart or circulation disorders (e.g. cocaine, methamphetamine, tricyclic antidepressants, calcium channel blockers, beta-blockers, digoxin) Naloxone 400 micrograms/ml solution for injection will be used with caution since serious side effects such as fast heart beats (ventricular tachycardia and fibrillation) have occurred.

If you have the impression that the effect of Naloxone 400 micrograms/ml solution for injection is too strong or too weak, talk to your doctor.

Method of administration

Naloxone 400 micrograms/ml solution for injection will be given to you always by intravenous or intramuscular injection (into a vein or into a muscle) or, after dilution, as an intravenous infusion (over a longer period). Naloxone 400 micrograms/ml solution for injection will be given by your anaesthetist or an experienced physician.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Naloxone 400 micrograms/ml solution for injection can cause side effects, although not everybody gets them.

The frequency of side effects is classified into the following categories:

Very common: in more than 1 in 10 patients

Common: in more than 1 in 100 patients, but less than 1 in 10 patients

Uncommon: in more than 1 in 1,000 patients, but less than 1 in 100 patients

Rare: in more than 1 in 10,000 patients, but less than 1 in 1,000 patients

Very rare: in less than 1 in 10,000 patients, including isolated reports

It may be difficult to know what side effects Naloxone 400 micrograms/ml solution for injection has, because it is always given after other drugs have also been used.

Immune system disorders

Very rare: Allergic reactions (nettle rash, nasal catarrh or a cold, difficulty breathing, Quincke's oedema (facial swelling)), allergic shock.

Nervous system disorders

Common: Dizziness, headache.

Uncommon: Involuntary trembling or quivering (tremour), sweating.

Rare: Seizures, tension.

Cardiac disorders

Common: Fast heart beat.

Uncommon: Changes in the way your heart beats, slow heart rate.

Very rare: Fibrillation, cardiac arrest.

Vascular disorders

Common: Increased or decreased blood pressure (you may have a headache or feel faint).

Respiratory disorders

Very rare: Fluid on the lungs (pulmonary oedema).

Gastrointestinal disorders

Very common: Nausea.

Common: Vomiting.

Uncommon: Diarrhoea, dry mouth.

Skin and subcutaneous tissue disorders

Very rare: Discolouration and lesions of the skin (erythema multiforme).

General disorders and administration site conditions

Common: If too large a dose is given after an operation, you may become excited and feel pain (because the painkilling effects of the medicines you were given will have been counteracted as well as the effects on your breathing).

Uncommon: Over breathing (hyperventilation), irritation of the blood vessel wall has been reported after i.v. administration; local irritation and inflammation have been reported after i.m. administration.

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Naloxone 400 Micrograms/Ml Solution For Injection

Keep out of the reach and sight of children.

Naloxone 400 micrograms/ml solution for injection must not be administered after the expiry date, which is stated on the ampoule label and the carton. The expiry date refers to the last day of that month.

Keep the ampoules in the outer carton in order to protect from light.

Store below 25°C.

Store diluted solutions below 25°C.

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

Further Information

What Naloxone 400 micrograms/ml solution for injection contains

The active substance is naloxone hydrochloride.

Each 1 ml ampoule contains 0.4 mg naloxone hydrochloride (as naloxone hydrochloride dihydrate).

The other ingredients are sodium chloride, hydrochloric acid diluted (for pH adjustment) and water for injections.

What Naloxone 400 micrograms/ml solution for injection looks like and contents of the pack

Naloxone 400 micrograms/ml solution for injection is a clear and colourless solution in colourless glass ampoules containing 1 ml solution for injection.

Pack sizes: 5 and 10 ampoules

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

hameln pharma plus gmbh

Langes Feld 13

31789 Hameln

Germany

Manufacturer

hameln pharmaceuticals gmbh

Langes Feld 13

31789 Hameln

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Finland: Naloxon Hameln 0,4 mg/ml injektioneste, liuos

Germany: Naloxon-hameln 0,4 mg/ml Injektionslösung

Norway: Naloxon Hameln 0,4 mg/ml injeksjonsvæske, oppløsning

Sweden: Naloxon Hameln 0,4 mg/ml injektionsvätska, lösning

The Netherlands: Naloxon HCl-hameln 0,4 mg/ml, oplossing voor injectie

United Kingdom: Naloxone 400 micrograms/ml solution for injection

This leaflet was last approved in 11/2007

Nitrocot

Generic Name: nitroglycerin (Oral route, Sublingual route)

nye-troe-GLIS-er-in

Commonly used brand name(s)

In the U.S.

• Nitrocot


• Nitrolingual


• NitroMist


• Nitroquick


• Nitrostat


• Nitrotab


• Nitro-Time

In Canada

• Gen-Nitro


• Nitrolingual Pumpspray

Available Dosage Forms:

• Spray


• Tablet, Extended Release


• Tablet


• Capsule, Extended Release

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Uses For Nitrocot

Nitroglycerin is used to prevent angina (chest pain) caused by coronary artery disease. This medicine is also used to relieve an angina attack that is already occurring.

Nitroglycerin belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, or just before exercise or a stressful event, this helps prevent angina attacks from occurring.

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

Before Using Nitrocot

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 have not been performed on the relationship of age to the effects of nitroglycerin in the pediatric population. 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 nitroglycerin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Sildenafil


• Tadalafil


• Vardenafil

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.

• Alteplase, Recombinant

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.

• Acetylcysteine


• Aspirin


• Dihydroergotamine


• Pancuronium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Anemia, severe or


• Head injury, severe with increased pressure in the head or


• Heart attack, acute (already occurring)—Should not be used in patients with these conditions.

• Congestive heart failure or


• Heart attack, recent or


• Hypertrophic cardiomyopathy (a heart disease) or


• Hypotension (low blood pressure) or


• Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse.

Proper Use of nitroglycerin

This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to Nitrocot. 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.

Nitroglycerin is available as two types of products that are used for different reasons. The extended-release capsules are used every day on a specific schedule to prevent angina attacks. The oral spray and sublingual tablets work quickly to stop an angina attack that has already started or they can be used to prevent angina if you plan to exercise or expect a stressful event.

When you begin to feel an attack of angina starting (chest pains, tightness or squeezing in the chest), sit down. Then place a sublingual tablet in your mouth or under your tongue. If you use the oral spray, you should spray it on or under the tongue. You may become dizzy, lightheaded, or faint soon after using a tablet or spray, so it is safer to sit rather than stand while the medicine is working. If you become dizzy or faint while sitting, take several deep breaths and bend forward with your head between your knees. Remain calm and you should feel better in a few minutes.

Nitroglycerin sublingual tablets should not be chewed, crushed, or swallowed. They work much faster when absorbed through the lining of the mouth. Place the tablet under the tongue or between the cheek and gum, and let it dissolve. Do not eat, drink, smoke, or use chewing tobacco while a tablet is dissolving.

Nitroglycerin sublingual tablets usually give relief in 1 to 5 minutes. However, if the pain is not relieved, you may use a second tablet 5 minutes after you take the first tablet. If the pain continues for another 5 minutes, a third tablet may be used. If you still have chest pain after a total of 3 tablets, contact your doctor or go to a hospital emergency room right away. Do not drive yourself and call 911 if necessary.

You may administer 1 or 2 sprays of Nitroglycerin oral spray at the onset of chest pain. If the pain continues after 5 minutes, a third spray may be used. You must wait 5 minutes after the first 1 or 2 sprays before using a third spray. If you still have chest pain after a total of 3 sprays, contact your doctor or go to a hospital emergency room right away. Do not drive yourself and call 911 if necessary. Do not use more than 3 sprays in a 15-minute period.

Swallow the extended-release capsule whole. Do not split, crush, or chew it.

You should take the extended-release capsule first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not take it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

To use the oral spray:

• Remove the plastic cap.


• Do not shake the container.


• If this is a new bottle or container, prime the pump before use by releasing a test spray. This must be done 5 or 10 times into the air away from your face and other people.


• If this is an old bottle and you have not used it for more than 6 weeks, you must prime it again with 1 or 2 test sprays.


• Hold the container upright with your forefinger on top of the grooved button. Open your mouth and bring the container as close to it as possible.


• Press the button firmly with the forefinger to release the spray 1 or 2 times onto or under the tongue. Do not inhale or breathe in the spray.


• Release the button and close your mouth, but do not swallow right away. Do not spit out the spray or rinse your mouth for at least 5 to 10 minutes.


• If you need a third spray, you must wait 5 minutes after the second spray. Use exactly the same steps you used for the first spray. No more than 3 sprays should be given within 15 minutes.


• Replace the cover after using the medicine.


• Always place the spray bottle in an upright position if not in use. Also, check the fluid level of Nitromist® container regularly. If the fluid reaches the top or middle of the hole on the side of container, this is an indicator that you must get a refill.


• Do not use the spray near heat, an open flame, or while smoking.

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 angina prevention or treatment:
  
  • For oral dosage form (extended-release capsules):
    
    • Adults—2.5 to 6.5 milligrams (mg) three to four times a day. Your doctor may increase your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For sublingual dosage form (spray):
    
    • Adults—One or two sprays on or under the tongue at the first sign of an chest pain. Sprays may be repeated every 5 minutes as needed. You must wait 5 minutes before administering a third spray if 2 sprays are used initially. Do not use more than 3 sprays in 15 minutes. To prevent angina from exercise or stress, use 1 or 2 sprays 5 to 10 minutes before the activity.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For sublingual dosage form (tablets):
    
    • Adults—One tablet placed under the tongue or between the cheek and gum at the first sign of an angina attack. One tablet may be used every 5 minutes as needed, for up to 15 minutes. Do not take more than 3 tablets in 15 minutes. To prevent angina from exercise or stress, use 1 tablet 5 to 10 minutes before the activity.
    
    
    • Children—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 extended-release capsules in a closed container at room temperature, away from heat, moisture, and direct light.

Sublingual tablets should be kept in the original glass bottle. Screw the cap on tightly after each use and store the bottle at room temperature, away from heat, moisture, and direct light.

Store the oral spray at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not forcefully open the container or throw it into a fire, even if it is empty.

Precautions While Using Nitrocot

If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you have an angina attack, you must go to the hospital right away.

This medicine may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.

Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

Do not stop using this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Blurred vision or dryness of the mouth may occur while using this medicine. Check with your doctor if this concerns you.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have cracks in the skin; feeling of warmth; loss of heat from the body; rash; red, swollen skin; redness of the face, neck, arms and occasionally, upper chest; or scaly skin while you are using 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.

Nitrocot 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

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• difficult or labored breathing


• feeling faint, dizzy, or lightheadedness


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• headache


• rapid weight gain


• shortness of breath


• sweating


• tightness in the chest


• tingling of the hands or feet


• unusual weight gain or loss


• wheezing

Rare

• Bluish-colored lips, fingernails, or palms


• dark urine


• fever


• pale skin


• rapid heart rate


• sore throat


• unusual bleeding or bruising


• unusual tiredness or weakness

Incidence not known

• Arm, back, or jaw pain


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• confusion


• cough


• cracks in the skin


• difficulty with swallowing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fainting


• fast, irregular, pounding, or racing heartbeat or pulse


• feeling of constant movement of self or surroundings


• feeling of warmth


• hives


• increased sweating


• itching


• loss of heat from the body


• nausea or vomiting


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


• rash


• red, swollen skin


• redness of the face, neck, arms, and occasionally, upper chest


• scaly skin


• sensation of spinning


• skin rash


• weakness

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

Symptoms of overdose

• Blurred or loss of vision


• bulging soft spot on the head of an infant


• change in consciousness


• change in the ability to see colors, especially blue or yellow


• cold, clammy skin


• disturbed color perception


• double vision


• flushed skin


• halos around lights


• headache, severe and throbbing


• increased sweating


• loss of appetite


• loss of consciousness


• night blindness


• overbright appearance of lights


• paralysis


• slow or irregular heartbeat


• tunnel vision

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

• Abdominal or stomach pain


• body aches or pain


• congestion


• hoarseness


• lack or loss of strength


• runny nose


• sneezing


• stuffy nose


• tender, swollen glands in the neck


• voice changes

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: Nitrocot 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 Nitrocot resources

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

• Nitroglycerin Professional Patient Advice (Wolters Kluwer)


• Nitroglycerin Monograph (AHFS DI)


• Nitroglycerin MedFacts Consumer Leaflet (Wolters Kluwer)


• Minitran Prescribing Information (FDA)


• Minitran Patch MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitro-Bid Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitro-Bid Prescribing Information (FDA)


• Nitro-Dur Prescribing Information (FDA)


• Nitro-Time Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitro-Time Prescribing Information (FDA)


• NitroMist Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)


• NitroMist Consumer Overview


• NitroMist Prescribing Information (FDA)


• NitroQuick MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitrogard MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitrolingual Prescribing Information (FDA)


• Nitrostat Prescribing Information (FDA)


• Rectiv Consumer Overview

Compare Nitrocot with other medications

• Angina
• Angina Pectoris Prophylaxis
• Heart Attack
• Heart Failure
• High Blood Pressure

Altabax

Generic Name: Retapamulin
Class: Antibacterials
Chemical Name: (3aS,4R,5S,6S,8R,9R,9aR,10R) - 6 - ethenyldecahydro - 5 - hydroxy - 4,6,9,10 - tetramethyl - 1 - oxo - 3a,9 - propano - 3aH - cyclopentacycloocten - 8 - yl - [[(3exo) - 8 - methyl - 8 - azabicyclo[3.2.1]oct - 3 - yl]thio] acetic acid ester
Molecular Formula: C₃₀H₄₇NO₄S
CAS Number: 224452-66-8

Introduction

Antibacterial; pleuromutilin antibiotic.^{1 2 3 4 5 6 7}

Uses for Altabax

Impetigo

Treatment of impetigo caused by Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] isolates only) or Streptococcus pyogenes (group A β-hemolytic streptococci).¹

May be used when impetigo covers no more than 100 cm² in total area in adults or no more than 2% of total body surface area in pediatric patients ≥9 months of age.¹

Altabax Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a 1% ointment.¹

Do not apply to the eye or mucous membranes.¹

Do not administer orally, intranasally, or intravaginally.¹

Apply a thin layer of ointment to affected area.¹

Treated area may be covered with a sterile bandage or gauze dressing, if desired.¹ An occlusive covering may protect the treated area and prevent accidental transfer of ointment to eyes or other areas and may prevent infants and young children from accidentally touching or licking the lesion site.¹

Wash hands after applying the ointment.¹

Dosage

Pediatric Patients

Skin Infections

Impetigo

Topical

Children ≥9 months of age: Apply thin layer of 1% ointment to affected area twice daily for 5 days (up to 2% of total body surface area).¹

Adults

Skin Infections

Impetigo

Topical

Apply thin layer of 1% ointment to affected area twice daily for 5 days (up to 100 cm² total body surface area).¹

Prescribing Limits

Pediatric Patients

Skin Infections

Impetigo

Topical

Maximum treatment area is 2% of total body surface area.¹

Adults

Skin Infections

Impetigo

Topical

Maximum treatment area is 100 cm².¹

Cautions for Altabax

Contraindications

Manufacturer states no known contraindications.¹

Warnings/Precautions

Warnings

Administration Precautions

For external use only.¹ Use only for topical application to skin; not evaluated for topical use on mucosal surfaces.¹ Not intended for oral, intranasal, ophthalmic, or intravaginal use.¹

Sensitivity Reactions

Local irritation (i.e., application site irritation/pruritus, application site pain, eczema, erythema, contact dermatitis, pruritus) reported following topical application.¹

If sensitization or severe local irritation occurs, discontinue the drug, wipe off ointment, and institute appropriate alternative therapy for the infection.¹

General Precautions

Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria.¹

If superinfection occurs, discontinue the drug and institute appropriate therapy.¹

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of retapamulin and other anti-infectives, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether topical retapamulin is distributed into milk.¹ Caution advised.¹

Pediatric Use

Safety and efficacy not established in children <9 months of age.¹

Geriatric Use

Safety and efficacy in geriatric patients ≥65 years of age similar to younger adults.¹

Common Adverse Effects

Application site irritation.^{1 7 9}

Interactions for Altabax

Metabolized by CYP3A4.¹

Possible effects of concurrent topical application of retapamulin and other topical products to the same skin area not studied to date.¹

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Because retapamulin has low systemic exposure following topical application to skin, retapamulin dosage adjustments are unnecessary when administered concomitantly with CYP3A4 inhibitors (e.g., ketoconazole).¹

Based on in vitro CYP inhibition studies and low systemic exposure following topical application to skin, retapamulin is unlikely to affect metabolism of other CYP substrates.¹

Specific Drugs

Drug	Interaction	Comments
Ketoconazole	Increased retapamulin AUC and peak plasma concentrations reported with concomitant oral ketoconazole and topical retapamulin1	Dosage adjustments not necessary1

Altabax Pharmacokinetics

Absorption

Bioavailability

Systemic exposure is low following topical application to intact or abraded skin.¹

Plasma Concentrations

Following once-daily topical application of 1% ointment to 800 cm² of occluded intact skin in adults, median peak plasma concentration was 3.5 ng/mL on day 7 (range 1.2– 7.8 ng/mL);¹ plasma concentrations generally were undetectable on day 1 (lower limit of detection was 0.5 ng/mL).¹

Following once-daily topical application of 1% ointment to 200 cm² of occluded abraded skin in adults, median peak plasma concentration was 11.7 ng/mL on day 1 (range 5.6–22.1 ng/mL) and 9 ng/mL on day 7 (range 6.7–12.8 ng/mL).¹

Following twice-daily topical application of 1% ointment in adults and pediatric patients 2–17 years of age, 11% had measurable plasma concentrations (median concentration 0.8 ng/mL);¹ maximum plasma concentrations in adult or pediatric patients were 10.7 ng/mL or 18.5 ng/mL, respectively.¹

Distribution

Extent

Not known whether distributed into milk following topical application.¹

Plasma Protein Binding

Approximately 94%.¹

Elimination

Metabolism

In vitro studies with human hepatocytes indicate the main routes of metabolism are monooxygenation and dioxygenation;¹ in vitro studies with human liver microsomes indicate the main routes of metabolism are monooxygenation and N-demethylation to numerous metabolites.¹

Metabolized by CYP3A4.¹

Elimination Route

Not investigated due to low systemic exposure after topical application.¹

Stability

Storage

Topical

Ointment

25°C (may be exposed to 15–30°C).¹

Actions and SpectrumActions

• 
  

  Semisynthetic pleuromutilin antibiotic.^{1 2 3 4 5 6}

  
  


• 
  

  Usually bacteriostatic;^{1 2} may be bactericidal at high concentrations (MBC is 1000 times higher than the MIC).¹

  
  


• 
  

  Selectively inhibits bacterial protein synthesis by binding to a distinct site on the 50s subunit of the bacterial ribosome, inhibiting peptidyl transfer, blocking P-site interactions, and preventing normal formation of active 50S ribosomal subunits.^{1 2 3 4 6 8 9}

  
  


• 
  

  Active in vitro and in vivo against oxacillin-susceptible (methicillin-susceptible) Staphylococcus aureus and Streptococcus pyogenes (group A β-hemolytic streptococci).^{1 2 5}

  
  


• 
  

  Although oxacillin-resistant (methicillin-resistant) S. aureus may be susceptible to retapamulin in vitro,^{1 2 5 6} this does not correlate with clinical efficacy in patients with oxacillin-resistant S. aureus infections.^{1 9} Treatment failure may be related to virulence factors.¹

  
  


• 
  

  Active in vitro against some strains of S. aureus resistant to mupirocin and/or erythromycin.^{2 6}

  
  


• 
  

  S. aureus with decreased susceptibility to retapamulin has been produced in vitro.¹

  
  


• 
  

  Target-specific cross-resistance with other classes of anti-infectives has not been demonstrated.^{1 4}

  
  

Advice to Patients

• 
  

  Importance of applying to affected skin as directed and avoiding use in the eyes and nose, on the mouth or lips, or inside the female genital tract; do not swallow.¹

  
  


• 
  

  Importance of completing full course of treatment, even if symptoms improve.¹

  
  


• 
  

  Importance of notifying clinician if symptoms do not improve within 3–4 days after starting therapy.¹

  
  


• 
  

  Importance of discontinuing use and contacting clinician if application site worsens in irritation, redness, itching, burning, swelling, blistering, or oozing.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Retapamulin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Ointment	1%	Altabax	GlaxoSmithKline

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Altabax 1% Ointment (GLAXO SMITH KLINE): 10/$74.56 or 30/$208.31

Altabax 1% Ointment (GLAXO SMITH KLINE): 15/$100.99 or 45/$285.98

Altabax 1% Ointment (GLAXO SMITH KLINE): 5/$49.33 or 15/$127.17

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

References

1. GlaxoSmithKline. ALTABAX (retapamulin) ointment prescribing information. Research Triangle Park, NC; 2007 April.

2. Rittenhouse S, Biswas S, Broskey J et al. Selection of retapamulin, a novel pleuromutilin for topical use. Antimicrob Agents Chemother. 2006; 50:3882-5. [PubMed 17065625]

3. Davidovich C, Bashan A, Auerbach-Nevo T et al. Induced-fit tightens pleuromutilins binding to ribosomes and remote interactions enable their selectivity. Proc Natl Acad Sci USA. 2007; 104:4291-6. [PubMed 17360517]

4. Yan K, Madden L, Choudhry AE et al. Biochemical characterization of the interactions of the novel pleuromutilin derivative retapamulin with bacterial ribosomes. Antimicrob Agents Chemother. 2006; 50:3875-81. [PubMed 16940066]

5. Pankuch GA, Gengrong L, Hoellman DB et al. Activity of retapamulin against Streptococcus pyogenes and Staphylococcus aureus evaluated by agar dilution, microdilution, E-test, and disk diffusion methodologies. Antimicrob Agents Chemother. 2006; 50:1727-30. [PubMed 16641442]

6. Jones RN, Fritsche TR, Sader HS et al. Activity of retapamulin (SB-275833), a novel pleuromutilin, against selected resistant gram-positive cocci. Antimicrob Agents Chemother. 2006; 50:2583-86. [PubMed 16801451]

7. Oranje A, van der Wouden J, Erasmus MC et al. Retapamulin ointment for the treatment of impetigo in adults and children: results of a phase III, placebo-controlled, double-blind trial. J Am Acad Dermatol. 2007; 56(Supp2):P16. Abstract.

8. Hunt E. Pleuromutilin antibiotics. Drugs Future. 2000; 25:1163-8.

9. GlaxoSmithKline, Philadelphia, PA: Personal communication.

More Altabax resources

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

• Altabax Prescribing Information (FDA)


• Altabax Advanced Consumer (Micromedex) - Includes Dosage Information


• Altabax Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Altabax Consumer Overview

Compare Altabax with other medications

• Acne
• Impetigo

Nevanac

nepafenac

Dosage Form: ophthalmic suspension
FULL PRESCRIBING INFORMATION

Indications and Usage for Nevanac

Nevanac® ophthalmic suspension is indicated for the treatment of pain and inflammation associated with cataract surgery.

Nevanac Dosage and Administration

Recommended Dosing

One drop of Nevanac® should be applied to the affected eye three-times-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period.

Use with Other Topical Ophthalmic Medications

Nevanac® may be administered in conjunction with other topical ophthalmic medications such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics.

If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

Dosage Forms and Strengths

Sterile ophthalmic suspension: 0.1%

3 mL in a 4 mL bottle

Contraindications

Nevanac® is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAID.

Warnings and Precautions

Increased Bleeding Time

With some nonsteroidal anti-inflammatory drugs including Nevanac®, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

It is recommended that Nevanac® ophthalmic suspension be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

Delayed Healing

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) including Nevanac®, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Corneal Effects

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs including Nevanac® and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post surgery may increase patient risk and severity of corneal adverse events.

Contact Lens Wear

Nevanac® should not be administered while using contact lenses.

Adverse Reactions

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Ocular Adverse Reactions

The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These events occurred in approximately 5 to 10% of patients.

Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment.

Some of these events may be the consequence of the cataract surgical procedure.

Non-Ocular Adverse Reactions

Non-ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects.

Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. At this dose, the animal plasma exposure to nepafenac and amfenac was approximately 260 and 2400 times human plasma exposure at the recommended human topical ophthalmic dose for rats and 80 and 680 times human plasma exposure for rabbits, respectively. In rats, maternally toxic doses =10 mg/kg were associated with dystocia, increased postimplantation loss, reduced fetal weights and growth, and reduced fetal survival.

Nepafenac has been shown to cross the placental barrier in rats. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Nevanac® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Non-teratogenic Effects.

Because of the known effects of prostaglandin biosynthesis inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of Nevanac® during late pregnancy should be avoided.

Nursing Mothers

Nevanac® is excreted in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nevanac® ophthalmic suspension is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Nevanac® in pediatric patients below the age of 10 years have not been established.

Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Nevanac Description

Nevanac® (nepafenac ophthalmic suspension) 0.1% is a sterile, topical, nonsteroidal anti-inflammatory (NSAID) prodrug for ophthalmic use. Each mL of Nevanac® suspension contains 1 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-benzoylbenzeneacetamide with an empirical formula of C15H14N2O2. The structural formula of nepafenac is:

Nepafenac is a yellow crystalline powder. The molecular weight of nepafenac is 254.28. Nevanac® ophthalmic suspension is supplied as a sterile, aqueous 0.1% suspension with a pH approximately of 7.4.

The osmolality of Nevanac®ophthalmic suspension is approximately 305 mOsmol/kg.

Each mL of Nevanac® contains: Active: nepafenac 0.1% Inactives: mannitol, carbomer 974P, sodium chloride, tyloxapol, edentate disodium, benzalkonium chloride 0.005% (preservative), sodium hydroxide and/or hydrochloric acid to adjust pH and purified water, USP.

Nevanac - Clinical Pharmacology

Mechanism of Action

After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.

Pharmacokinetics

Low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours post dose, respectively, following bilateral topical ocular three-times-daily dosing of nepafenac ophthalmic suspension, 0.1%. The mean steady-state Cmax for nepafenac and for amfenac were 0.310 ± 0.104 ng/ml and 0.422 ± 0.121 ng/ml, respectively, following ocular administration.

Nepafenac at concentrations up to 300 ng/mL did not inhibit the in vitro metabolism of 6 specific marker substrates of cytochrome P450 (CYP) isozymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4). Therefore, drug-drug interactions involving CYP mediated metabolism of concomitantly administered drugs are unlikely. Drug-drug interactions mediated by protein binding are also unlikely.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Nepafenac has not been evaluated in long-term carcinogenicity studies. Increased chromosomal aberrations were observed in Chinese hamster ovary cells exposed in vitro to nepafenac suspension. Nepafenac was not mutagenic in the Ames assay or in the mouse lymphoma forward mutation assay. Oral doses up to 5,000 mg/kg did not result in an increase in the formation of micronucleated polychromatic erythrocytes in vivo in the mouse micronucleus assay in the bone marrow of mice.

Nepafenac did not impair fertility when administered orally to male and female rats at 3 mg/kg (approximately 90 and 380 times the plasma exposure to the parent drug, nepafenac, and the active metabolite, amfenac, respectively, at the recommended human topical ophthalmic dose).

Clinical Studies

In two double-masked, randomized clinical trials in which patients were dosed three-times-daily beginning one day prior to cataract surgery, continued on the day of surgery and for the first two weeks of the postoperative period, Nevanac® ophthalmic suspension demonstrated clinical efficacy, compared to its vehicle in treating postoperative inflammation.

Patients treated with Nevanac® ophthalmic suspension were less likely to have ocular pain and measurable signs of inflammation (cells and flare) in the early postoperative period through the end of treatment than those treated with its vehicle.

For ocular pain in both studies a significantly higher percentage of patients (approximately 80%) in the nepafenac group reported no ocular pain on the day following cataract surgery (Day 1) compared to those in the vehicle group (approximately 50%).

Results from clinical studies indicated that Nevanac® has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

How Supplied/Storage and Handling

Nevanac® (nepafenac ophthalmic suspension) is supplied in a natural, oval, low density polyethylene DROP-TAINER® dispenser with a natural low density polyethylene dispensing plug and gray polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

3 mL in 4 mL bottle NDC 0065-0002-03

Storage: Store at 2 - 25°C (36 - 77°F).

Patient Counseling Information

Slow or Delayed Healing

Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

Avoiding Contamination of the Product

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

Contact Lens Wear

Nevanac® should not be administered while wearing contact lens.

Intercurrent Ocular Conditions

Patients should be advised that if they develop an intercurrent ocular condition (e.g., trauma, or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use of the multi-dose container.

Concomitant Topical Ocular Therapy

If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

Shake Well Before Use

Patients should be advised to shake the bottle well.

U.S. Patent No; 5,475,034 and 7,834,059.

    

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

©2007, 2008, 2011 Novartis AG

    

9006966-0711

PRINCIPAL DISPLAY PANEL

NDC 0065 - 0002 - 03                STERILE

Nevanac®

(nepafenac ophthalmic

suspension) 0.1%

3 mL

Alcon®

Nevanac  nepafenac  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0002 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEPAFENAC (NEPAFENAC) NEPAFENAC 1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   MANNITOL   CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)   SODIUM CHLORIDE   TYLOXAPOL   EDETATE DISODIUM   SODIUM HYDROXIDE   HYDROCHLORIC ACID   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0065-0002-03 3 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021862	09/06/2005

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 10/2011Alcon Laboratories, Inc.

More Nevanac resources

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

• Nevanac Monograph (AHFS DI)


• Nevanac Advanced Consumer (Micromedex) - Includes Dosage Information


• Nevanac MedFacts Consumer Leaflet (Wolters Kluwer)


• Nevanac Consumer Overview

Compare Nevanac with other medications

• Postoperative Increased Intraocular Pressure
• Postoperative Ocular Inflammation

Nostril

Generic Name: phenylephrine (Nasal route)

fen-il-EF-rin

Commonly used brand name(s)

In the U.S.

• Neo-Synephrine


• Nostril


• Pretz-D


• Rhinall


• Tur-Bi-Cal


• Vicks Sinex

Available Dosage Forms:

• Solution


• Gel/Jelly


• Spray

Therapeutic Class: Decongestant

Pharmacologic Class: Sympathomimetic

Chemical Class: Alkylarylamine

Uses For Nostril

Phenylephrine is used for the temporary relief of congestion or stuffiness in the nose caused by hay fever or other allergies, colds, or sinus trouble. It may also be used in ear infections to relieve congestion.

This medicine may also be used for other conditions as determined by your doctor.

This medicine is available without a prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Nostril

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

Children may be especially sensitive to the effects of nasal phenylephrine. This may increase the chance of side effects during treatment.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of nasal phenylephrine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rasagiline


• Selegiline

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.

• Amitriptyline


• Amoxapine


• Clomipramine


• Desipramine


• Dothiepin


• Doxepin


• Imipramine


• Lofepramine


• Nortriptyline


• Opipramol


• Protriptyline


• Trimipramine

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:

• Type 2 diabetes mellitus or


• Heart or blood vessel disease or


• High blood pressure or


• Overactive thyroid—Nasal phenylephrine may make the condition worse

Proper Use of phenylephrine

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

To use the nose drops:

• Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.


• Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.


• To avoid spreading the infection, do not use the container for more than one person.

To use the nose spray:

• Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. For best results, spray once or twice into each nostril and wait 3 to 5 minutes to allow the medicine to work. Then, blow your nose gently and thoroughly. Repeat until the complete dose is used.


• Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.


• To avoid spreading the infection, do not use the container for more than one person.

To use the nose jelly:

• Blow your nose gently. Wash your hands before applying the medicine. With your finger, place a small amount of jelly (about the size of a pea) up each nostril. Sniff it well back into the nose.


• Wipe the tip of the tube with a clean, damp tissue and replace the cap right after use.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without first checking with your doctor. To do so may make your runny or stuffy nose worse and may also increase the chance of side effects.

Dosing

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

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

• For stuffy nose:
  
  • For nose jelly dosage form:
    
    • Adults—Use a small amount in the nose every three or four hours as needed.
    
    
    • Children—Use is not recommended.
    
    
  
  
  • For nose drops dosage form:
    
    • Adults and children 12 years of age and older—Use two or three drops of a 0.25 to 0.5% solution in the nose every four hours as needed.
    
    
    • Children 6 to 12 years of age—Use two or three drops of a 0.25% solution in the nose every four hours as needed.
    
    
    • Children 4 to 6 years of age—Use two or three drops of a 0.125 or 0.16% solution in the nose every four hours as needed.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  
  • For nose spray dosage form:
    
    • Adults and children 12 years of age and older—Use two or three sprays of a 0.25 to 0.5% solution in the nose every four hours as needed.
    
    
    • Children 6 to 12 years of age—Use two or three sprays of a 0.25% solution in the nose every four hours as needed.
    
    
    • Children 4 to 6 years of age—Use and dose must be determined by your doctor.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  

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

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.

Nostril Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Symptoms of too much medicine being absorbed into the body

Note: The above side effects are more likely to occur in children because there is a greater chance that too much of this medicine may be absorbed into the body.

• Fast, irregular, or pounding heartbeat


• headache or dizziness


• increased sweating


• nervousness


• paleness


• trembling


• trouble in sleeping

• Increase in runny or stuffy nose

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:

• Burning, dryness, or stinging of inside of nose

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.

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 Nostril resources

• Nostril Use in Pregnancy & Breastfeeding
• Nostril Drug Interactions
• Nostril Support Group
• 4 Reviews for Nostril - Add your own review/rating

Compare Nostril with other medications

• Nasal Congestion

Cholelithiasis w/ Acute Cholecystitis and Obstruction Medications

There are currently no drugs listed for "Cholelithiasis w/ Acute Cholecystitis and Obstruction".

Learn more about Cholelithiasis w/ Acute Cholecystitis and Obstruction

Micromedex Care Notes:

• Cholelithiasis

Medical Encyclopedia:

• Acute cholecystitis
• Gallbladder disease

Drug List:

Novolin N Innolet

Generic Name: insulin isophane (IN soo lin EYE soe fane)

Brand Names: HumuLIN N, HumuLIN N Pen, NovoLIN N, NovoLIN N Innolet, NovoLIN N PenFill, Relion NovoLIN N

What is Novolin N Innolet (insulin isophane)?

Insulin isophane is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin isophane is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin isophane is used to treat diabetes.

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

What is the most important information I should know about Novolin N Innolet (insulin isophane)?

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin isophane is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

What should I discuss with my healthcare provider before using Novolin N Innolet (insulin isophane)?

Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin isophane, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Insulin isophane is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin isophane passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Novolin N Innolet (insulin isophane)?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Insulin isophane is given as an injection (shot) under your skin. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your insulin isophane dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials, cartridges, injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label. Unopened vials may also be stored at room temperature for up to 28 days, away from heat and bright light. Throw away any insulin not used within 28 days. Storing after your first use: Keep the "in-use" vials, cartridges, or prefilled syringes at room temperature and use prior to the expiration date. Keep the in-use injection pen at room temperature and use it within 14 days. Do not refrigerate.

Do not freeze insulin isophane, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Since insulin isophane is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin isophane, be sure to eat a meal or snack within 30 to 60 minutes. Do not use extra insulin isophane to make up a missed dose.

It is important to keep insulin isophane on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using Novolin N Innolet (insulin isophane)?

Do not change the brand of insulin isophane or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin isophane.

Novolin N Innolet (insulin isophane) side effects

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin isophane. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin isophane.

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.

What other drugs will affect Novolin N Innolet (insulin isophane)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

• 
  

  albuterol (Proventil, Ventolin);

  
  


• 
  

  clonidine (Catapres);

  
  


• 
  

  reserpine;

  
  


• 
  

  guanethidine (Ismelin); or

  
  


• 
  

  beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.

  
  

There are many other medicines that can increase or decrease the effects of insulin isophane on lowering your blood sugar. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Novolin N Innolet resources

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

• Insulin Isophane InnoLets MedFacts Consumer Leaflet (Wolters Kluwer)


• Humulin N Prescribing Information (FDA)


• Humulin N Consumer Overview


• Humulin N Pens MedFacts Consumer Leaflet (Wolters Kluwer)


• Novolin N Prescribing Information (FDA)

Compare Novolin N Innolet with other medications

• Diabetes, Type 1
• Diabetes, Type 2
• Gestational Diabetes

Where can I get more information?

• Your pharmacist can provide more information about insulin isophane.

See also: Novolin N Innolet side effects (in more detail)