chlorpheniramine, hydrocodone, and pseudoephedrine

Generic Name: chlorpheniramine, hydrocodone, and pseudoephedrine (KLOR fe NEER a meen, HYE droe KOE done, SOO doe ee FED rin)

Brand names: Cordron-HC, Cordron-HC NR, Detuss, Hydrocof-HC, Hydron PCS, Hyphed, JayCof-HC, Notuss-Forte, P-V-Tussin Syrup, Q-V Tussin, Welltuss HC, Zutripro, ...show all 24 brand names.Notuss, M-End (obsolete), Hexatussin, Tussin-V, Tussend, Histinex PV, A-G Tussin, KG-Tussin, Hydrotuss HC, Pediatex HC, Atuss HD, Atuss HS

What is chlorpheniramine, hydrocodone, and pseudoephedrine?

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

Hydrocodone is a narcotic cough medicine.

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

The combination of chlorpheniramine, hydrocodone, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, and cough caused by the common cold or flu.

Chlorpheniramine, hydrocodone, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about chlorpheniramine, hydrocodone, and pseudoephedrine?

Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and pseudoephedrine before the MAO inhibitor has cleared from your body. Chlorpheniramine, hydrocodone, and pseudoephedrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and pseudoephedrine. Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and pseudoephedrine. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

What should I discuss with my healthcare provider before taking chlorpheniramine, hydrocodone, and pseudoephedrine?

Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and pseudoephedrine before the MAO inhibitor has cleared from your body. You should not use chlorpheniramine, hydrocodone, and pseudoephedrine if you are allergic to it.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  asthma, COPD, sleep apnea, or other breathing disorder;

  
  


• liver or kidney disease;


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  glaucoma;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  enlarged prostate, urination problems;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether chlorpheniramine, hydrocodone, and pseudoephedrine will harm an unborn baby. Hydrocodone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using chlorpheniramine, hydrocodone, and pseudoephedrine. It is not known whether chlorpheniramine, hydrocodone, and pseudoephedrine 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 take chlorpheniramine, hydrocodone, and pseudoephedrine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take this medication with or without food.

Measure liquid medicine 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.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

See also: Chlorpheniramine, hydrocodone, and pseudoephedrine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone can be fatal.

Overdose symptoms may include extreme drowsiness, feeling restless or nervous, vomiting, stomach pain, warmth or tingly feeling, seizure (convulsions), pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking chlorpheniramine, hydrocodone, and pseudoephedrine?

Chlorpheniramine, hydrocodone, and pseudoephedrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and pseudoephedrine.

Chlorpheniramine, hydrocodone, and pseudoephedrine 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 this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, seizure); or

  
  


• 
  

  upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, upset stomach, constipation;

  
  


• 
  

  dry mouth;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  warmth, tingling, or redness under your skin; or

  
  


• 
  

  skin rash or itching.

  
  

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.

Chlorpheniramine, hydrocodone, and pseudoephedrine Dosing Information

Usual Adult Dose for Cough and Nasal Congestion:

Chlorpheniramine/hydrocodone/pseudoephedrine 2 mg-5 mg-30 mg oral capsule:
1 to 2 capsules orally every 8 hours.

Chlorpheniramine/hydrocodone/pseudoephedrine 2.5 mg-1.67 mg-17.5 mg/5 mL oral liquid:
10 mL orally every 4 to 6 hours not to exceed 40 mL daily.

Chlorpheniramine/hydrocodone/pseudoephedrine 2.5 mg-1.67 mg-20 mg/5 mL oral liquid:
10 mL orally every 4 to 6 hours.

Chlorpheniramine/hydrocodone/pseudoephedrine 4 mg-5 mg-30 mg/5 mL oral suspension, extended release:
5 to 10 mL orally every 12 hours.

Chlorpheniramine/hydrocodone/pseudoephedrine 4 mg-5 mg-40 mg/5 mL oral syrup:
5 mL orally 3 to 4 times daily not to exceed 4 doses per day.

Chlorpheniramine/hydrocodone/pseudoephedrine 4 mg-5 mg-60 mg/5 mL oral liquid:
5 mL orally every 4 to 6 hours not to exceed 4 doses per day.

Usual Pediatric Dose for Cough and Nasal Congestion:

Chlorpheniramine/hydrocodone/pseudoephedrine 2 mg-5 mg-30 mg oral capsule:
6 to 11 years: 1 capsule orally every 8 hours.
12 years or older: 1 to 2 capsules orally every 8 hours.

Chlorpheniramine/hydrocodone/pseudoephedrine 2.5 mg-1.67 mg-17.5 mg/5 mL oral liquid:
2 to 5 years: 2.5 mL orally every 4 to 6 hours not to exceed 10 mL daily.
6 to 11 years: 5 mL orally every 4 to 6 hours not to exceed 20 mL daily.
12 years or older: 10 mL orally every 4 to 6 hours not to exceed 40 mL daily.

Chlorpheniramine/hydrocodone/pseudoephedrine 2.5 mg-1.67 mg-20 mg/5 mL oral liquid:
2 to 5 years: 2.5 mL orally every 4 to 6 hours.
6 to 11 years: 5 mL orally every 4 to 6 hours.
12 years or older: 10 mL orally every 4 to 6 hours.

Chlorpheniramine/hydrocodone/pseudoephedrine 4 mg-5 mg-30 mg/5 mL oral suspension, extended release:
2 to 5 years: 2.5 mL orally every 12 hours.
6 to 11 years: 2.5 to 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

Chlorpheniramine/hydrocodone/pseudoephedrine 4 mg-5 mg-40 mg/5 mL oral syrup:
6 to 11 years: 2.5 mL orally 3 to 4 times daily not to exceed 4 doses per day.
12 years or older: 5 mL orally 3 to 4 times daily not to exceed 4 doses per day.

What other drugs will affect chlorpheniramine, hydrocodone, and pseudoephedrine?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and pseudoephedrine.

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

• 
  

  blood pressure medication;

  
  


• 
  

  cimetidine (Tagamet);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  an antidepressant;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

  medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril).

  
  

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

More chlorpheniramine, hydrocodone, and pseudoephedrine resources

• Chlorpheniramine, hydrocodone, and pseudoephedrine Side Effects (in more detail)
• Chlorpheniramine, hydrocodone, and pseudoephedrine Dosage
• Chlorpheniramine, hydrocodone, and pseudoephedrine Use in Pregnancy & Breastfeeding
• Chlorpheniramine, hydrocodone, and pseudoephedrine Drug Interactions
• Chlorpheniramine, hydrocodone, and pseudoephedrine Support Group
• 4 Reviews for Chlorpheniramine, hydrocodone, and pseudoephedrine - Add your own review/rating

Compare chlorpheniramine, hydrocodone, and pseudoephedrine with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine, hydrocodone, and pseudoephedrine.

See also: chlorpheniramine, hydrocodone, and pseudoephedrine side effects (in more detail)

Pediatex-CT Chewable Tablets

Pronunciation: dye-fen-HYE-dra-meen/fen-ill-EF-rin
Generic Name: Diphenhydramine/Phenylephrine
Brand Name: Examples include D-Tann and Pediatex-CT

Pediatex-CT Chewable Tablets are used for:

Temporarily relieving symptoms of hay fever, allergies, or the common cold, including nasal congestion, runny nose, sneezing, itching of the nose and throat, and itchy/watery eyes. It may also be used for other conditions as determined by your doctor.

Pediatex-CT Chewable Tablets are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use Pediatex-CT Chewable Tablets if:

• you are allergic to any ingredient in Pediatex-CT Chewable Tablets


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days


• you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

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

Before using Pediatex-CT Chewable Tablets:

Some medical conditions may interact with Pediatex-CT Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have a fast, slow, or irregular heartbeat


• if you have a history of glaucoma; high blood pressure; diabetes; heart problems; ulcers; stroke; asthma; an overactive thyroid; seizures; a blockage of the stomach, bowel, or bladder; trouble breathing when you sleep; trouble sleeping; lung problems (eg, emphysema); the blood disease porphyria; or an enlarged prostate or other prostate problems; adrenal gland problems; blood vessel problems; or if you have difficulty urinating

Some MEDICINES MAY INTERACT with Pediatex-CT Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially if any of the following apply to you:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), indomethacin, furazolidone, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because side effects such as severe headache, high blood pressure, or high fever may occur


• Bromocriptine or sodium oxybate (GHB) because the risk of side effects or toxic effects may be increased by Pediatex-CT Chewable Tablets


• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pediatex-CT Chewable Tablets.


• Digoxin or droxidopa because side effects such as irregular heartbeat or heart attack may occur


• Urinary alkalinizers (eg, sodium bicarbonate) because the side effects of Pediatex-CT Chewable Tablets may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pediatex-CT Chewable Tablets 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 Pediatex-CT Chewable Tablets:

Use Pediatex-CT Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pediatex-CT Chewable Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Chew thoroughly before swallowing.


• If you miss a dose of Pediatex-CT Chewable Tablets and are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pediatex-CT Chewable Tablets.

Important safety information:

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


• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Pediatex-CT Chewable Tablets. Pediatex-CT Chewable Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Contact your health care provider if symptoms last for more than 7 days or are accompanied by a fever.


• Diabetes patients - Pediatex-CT Chewable Tablets may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.


• Pediatex-CT Chewable Tablets contains phenylephrine and diphenhydramine. Before you begin taking any new prescription or nonprescription medicine, including medicine used on the skin, read the ingredients to see if it also contains phenylephrine or diphenhydramine. If it does, or if you are uncertain if it does, contact your doctor or pharmacist.


• If you are scheduled for allergy skin testing, do not take Pediatex-CT Chewable Tablets for several days before the test because it may decrease your response to the skin tests.


• Do not take diet or appetite control medicines while you are taking Pediatex-CT Chewable Tablets without checking with your doctor.


• Do not exceed the recommended dose or take Pediatex-CT Chewable Tablets for longer than prescribed without checking with your doctor.


• If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Pediatex-CT Chewable Tablets.


• Use Pediatex-CT Chewable Tablets with caution in the ELDERLY because they may be more sensitive to its effects.


• Pediatex-CT Chewable Tablets are not recommended for use in NEWBORNS. Safety and effectiveness have not been confirmed.


• Different products may have different dosing instructions for CHILDREN on the package labeling. Follow the dosing instructions provided on the package labeling or by your doctor. If you are unsure of what dose to give a child, check with your doctor.


• Caution is advised when using Pediatex-CT Chewable Tablets in CHILDREN because they may be more sensitive to its effects, especially excitability.


• PREGNANCY AND BREAST-FEEDING: If you become pregnant while taking Pediatex-CT Chewable Tablets, discuss with your doctor the benefits and risks of using Pediatex-CT Chewable Tablets during pregnancy. If you are or will be breast-feeding while you are using Pediatex-CT Chewable Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pediatex-CT Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability (especially in children); headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; chest pain; decreased coordination; difficulty urinating; fast or irregular heartbeat; fever; hallucinations; seizure; severe dizziness and drowsiness; severe nervousness, anxiety, or restlessness; tremors; unusual weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pediatex-CT side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish-colored skin; difficulty breathing; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; mental or mood changes; seizures; severe drowsiness or dizziness; severe excitability; severe nausea or vomiting; sweating; tremors.

Proper storage of Pediatex-CT Chewable Tablets:

Store Pediatex-CT Chewable Tablets at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pediatex-CT Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Pediatex-CT Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Pediatex-CT Chewable Tablets are 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 Pediatex-CT Chewable Tablets. 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 Pediatex-CT resources

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

Compare Pediatex-CT with other medications

• Cold Symptoms
• Hay Fever
• Sinusitis

Omeprazole 40mg Powder for Solution for Injection and Solvent for Omeprazole 40mg Powder for Solution for Injection

1. Name Of The Medicinal Product

Omeprazole 40mg Powder for Solution for Injection and Solvent for Omeprazole 40mg Powder for Solution for Injection

2. Qualitative And Quantitative Composition

Each vial of powder for injection contains omeprazole sodium, equivalent to 40 mg omeprazole.

Each ampoule contains 10 ml of solvent for injection.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Powder and solvent for solution for injection.

The powder for solution for injection is a white to almost white powder.

The solvent for solution for injection is clear solution.

The reconstituted solution has a pH of about 8.6

The reconstituted solution, diluted 1:1 with water, has an osmolarity of about 1.128 Osmol/kg

4. Clinical Particulars

4.1 Therapeutic Indications

As alternative treatment of the oral formulation where fast and pronounced acidity inhibition is required for:

Duodenal ulcer

Benign gastric ulcer

Reflux oesophagitis

Zollinger-Ellison syndrome

4.2 Posology And Method Of Administration

Dosage

Omeprazole 40 mg as once daily intravenous application is only recommended in those incidental cases where oral therapy is inappropriate and pronounced acidity inhibition is essential. The mean reduction of acid production in the stomach during 24 hours is circa 90%. With Zollinger-Ellison patients the recommended initial dosage is 60 mg omeprazole per day. For a 60 mg dose an additional half (5 ml) of the reconstituted solution should be given as an intravenous injection. Any unused solution should be discarded. Higher dosages can be necessary and the dosage should be individually adjusted. With a total dosage of more than 60 mg per day the administration of the daily dosage should be spread out over the day. A one week treatment is usually sufficient.

Reduced renal or hepatic function

The dosage does not need to be adjusted for renal function. In patients with hepatic function disorders the biological availability can be enhanced and the plasma half-life of omeprazole can increase. In these patients a daily dosage of 10-20 mg can be sufficient.

Children

There is limited experience of use in children. Therefore Omeprazole injection is not recommended in children.

The elderly

Omeprazole can be administered to the elderly without adjustment of the dosage.

Method of administration

Preparation

For instructions on reconstitution of the product before administration, see section 6.6

Administration

Omeprazole injection solution may only be administered as an intravenous injection. The solution must not be added to an infusion solution. After preparation the injection must be administered slowly with a maximum speed of 2 ml/minute (over a period of at least 5 minutes, or 2.5 minutes when half of the reconstituted solution is given). After reconstitution, the preparation should be used within 4 hours and any unused portion should be discarded.

4.3 Contraindications

Omeprazole is contraindicated in patients with hypersensitivity to omeprazole or to any of the excipients.

Omeprazole like other proton pump inhibitors should not be administered with atazanavir (see section 4.5).

4.4 Special Warnings And Precautions For Use

In patients with peptic ulcer disease Helicobacter pylori-status should be determined if relevant. In patients who are shown to be Helicobacter pylori-positive, the elimination of the bacterium by eradication therapy should be aimed wherever possible.

In the presence of any alarm symptoms (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia haematemesis or melaena) and when gastric ulcer is suspected, the possibility of malignancy must be excluded before treatment with omeprazole is instituted, as treatment may alleviate symptoms and delay diagnosis.

The diagnosis of reflux oesophagitis should be confirmed endoscopically.

Decreased gastric acidity, due to any means – including proton-pump inhibitors – increases gastric counts of bacteria normally present in the gastro-intestinal tract. Treatment with acid-reducing medicinal products leads to a slightly increased risk of gastrointestinal infections, such as Salmonella and Campylobacter.

In patients with severe impaired hepatic function, liver enzyme values should be checked periodically during treatment with omeprazole.

During combination treatment caution should also be exercised in patients with severe renal and hepatic dysfunction (for dose restriction see section 4.2).

Blindness and deafness have been reported in the use of the injection form of omeprazole; therefore, in severely ill patients the monitoring of visual and auditory senses is recommended.

This medicinal product is essentially 'sodium- free'. The total amount of sodium (Na⁺) in the reconstituted solution is less than 1 mmol (23 mg) per 40 mg dose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

As omeprazole is metabolised in the liver through cytochrome P450 isoforms (mainly CYP 2C19, S-mephenytoin hydroxylase) and inhibits enzymes of the CYP2C subfamily (CYP 2C19 and CYP 2C9) it can delay the elimination of other active substances metabolised by these enzymes. This has been observed for diazepam (and also of other benzodiazepines as triazolam or flurazepam), phenytoin and warfarin.

In patients under continueous treatment with phenytoin, the concomitant treatment with 20 mg daily of omeprazole orally did not modify the phenytoin plasma concentration. In the same way, the concomitant treatment with 20 mg daily of omeprazole orally did not cause a modification in the coagulation time in patients under continueous treatment with warfarin. Periodic monitoring of patients receiving warfarin or phenytoin is recommended and a reduction of warfarin or phenytoin dose may be necessary.

Other active substances that could be affected are hexabarbital, citalopram, imipramine, clomipramine etc.

Omeprazole may inhibit the hepatic metabolism of disulfiram. After concomitant oral use, some possibly related cases of muscular rigidity have been reported.

There are contradictionary data on the interaction of orally administered omeprazole with ciclosporin. Therefore, the plasma levels of ciclosporin should be monitored in those patients treated with omeprazole, because an increase in ciclosporin levels is possible.

Plasma concentrations of omeprazole and clarithromycin are increased during concomitant oral administration. Although, there is no interaction with metronidazole or amoxicillin, these antimicrobial agents are used concomitantly with omeprazole in order to eradicate Helicobacter pylori.

Due to the decreased intragastric acidity, the absorption of ketoconazole or itraconazole may be reduced during omeprazole treatment as it is with other acid secretion inhibitors and antacids.

Simultaneous treatment with omeprazole and digoxin in healthy subjects lead to a 10 % increase in the bioavailability of digoxin as a consequence of the increased gastric pH.

Co-administration of omeprazole (40 mg once daily) with atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 75% decrease in AUC, Cmax, and Cmin). Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. Proton pump inhibitors including omeprazole should not be co-administered with atazanavir (see section 4.3).

Omeprazole may reduce the oral absorption of vitamin B12. This should be taken into account in those patients with low basal levels who undergo a long-term treatment with omeprazole.

Because of potential clinically significant interaction St. John's wort should not be used concomitantly with omeprazole.

There is no evidence of an interaction with caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, phenacetin, estradiol, amoxicillin, budesonide, diclofenac, metronidazole, naproxen, piroxicam, or antacids when omeprazole is given orally.

4.6 Pregnancy And Lactation

There is limited experience on the use of omeprazole in pregnant women. Experience to date indicates no increased risk of congenital malformations or other adverse effects of omeprazole on pregnancy or the unborn child. Animal studies do not indicate direct or indirect harmful effects with respect to reproduction.

Omeprazole Injection should only be prescribed during pregnancy when strictly indicated.

Omeprazole is excreted in breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Omeprazole Injection should be made taken into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.

4.7 Effects On Ability To Drive And Use Machines

No studies on the ability to drive and use machines have been performed. However, apart from side effects affecting the CNS or visual abilities (see 4.8.), no effects on the ability to drive are expected from the intake of omeprazole.

4.8 Undesirable Effects

Omeprazole is well tolerated, in general, undesirable effects are mild and reversible. In clinical trials performed and post-authorisation follow up, the following undesirable effects have been notified, although in most cases a casual relationship could not be established between such reactions and omeprazole treatment. In order to classify them the following frequencies definition have been followed:

- very common (

- common (

- uncommon (

- rare (

- very rare (

Blood and the lymphatic system disorders	Rare: leucopenia, thrombocytopenia, agranulocytosis and pancytopenia. Very rare: changes in blood count
Immune system disorders	Uncommon: urticaria. Rare: hypersensitivity reactions e.g. fever, angioedema, bronchospasm and anaphylatic shock, allergic vasculitis.
Nervous system disorders	Common: somnolence, sleep disturbances (insomnia), vertigo, headaches and drowsiness. These complaints usually improve during continued therapy. Uncommon: paresthesia. Rare: light headedness. Reversible mental confusion, agitation, aggression, depression and hallucinations in predominantly severely ill or elderly patients.
Eye disorders	Uncommon: visual disturbances (blurred vision, loss of visual acuity or reduced field of vision). These conditions usually resolve on cessation of therapy.
Ear and labyrinth disorders	Uncommon: auditory dysfunction (e.g. tinnitus). These conditions usually resolve on cessation of therapy.
Gastrointestinal disorders	Common: diarrhoea, constipation, flatulence (possibly with abdominal pain), nausea and vomiting. In the majority of these cases the symptoms improve if the therapy is continued. Uncommon: taste disturbances. This condition usually resolves on cessation of therapy. Rare: brownish-black discoloration of the tongue during concomitant administration of clarithromycin and benign glandular cysts: both were reversible after cessation of treatment, dryness of the mouth, stomatitis, candidiasis or pancreatitis.
Hepato-biliary disorders	Uncommon: increrase of liver enzyme values (which resolve after discontinuation of therapy). Rare: hepatitis with or without jaundice, hepatic failure and encephalopathy in patients with pre-existing severe liver disease.
Skin and subcutaneous tissue disorders:	Uncommon: pruritus, skin eruptions, alopecia, erythema multiforme or photosensitivity and increased tendency to sweat. Rare: Stevens-Johnson-syndrome or toxic epidermal necrolysis
Musculoskeletal, connective tissue and bone disorders	Rare: muscle weakness, myalgia and joint pain.
Renal and urinary disorders	Rare: nephritis (interstitial nephritis)
Other adverse effects:	Uncommon: malaise, peripheral oedema (which resolved on cessation of therapy) Rare: hyponatremia, gynaecomastia.

In sporadic cases irreversible visual disorders have been reported with very seriously ill patients who were treated with intravenous injections of omeprazole and then, in particular, with high dosages. A causal link has however not been established.

4.9 Overdose

There is limited information available on the effects of overdosage of omeprazole in humans. Intravenous single doses up to 80 mg and daily intravenous doses up to 200 mg or 520 mg in 3 days have been tolerated without undesirable effects.

In cases of overdose, slight tachycardia, somnolence and headache are the most occurring effects. Treatment if necessary is symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), proton pump inhibitors

ATC-code: A02B C01

Omeprazole, a substituted benzimidazole, is a gastric proton pump inhibitor, i.e. omeprazole directly and dose-dependently inhibits the enzyme H⁺,K⁺-ATPase, which is responsible for the gastric acid secretion in the gastric parietal cells. Due to this selective intracellular mode of action and the low affinity for other membrane-bound receptors (such as the histamine H₂, muscarine M₁ or gastrinergic receptors), omeprazole has been assigned to a separate class of acid-inhibiting agents, which block the final step of acid production.

As a consequence of its mode of action, omeprazole leads to an inhibition of both basal and stimulable acid secretion, irrespective of the stimulus type.

Thus, omeprazole increases the pH-value and reduces the volume of gastric acid secretion.

As a weak base the prodrug omeprazole accumulates in the acid environment of the parietal cells and will only become effective as an inhibitor of the H⁺, K⁺-ATPase after being protonised and rearranged.

In an acid environment at a pH of less than 4 the protonised omeprazole is converted to omeprazole sulphenamide, the active substance proper.

Compared to the plasma half-life of the omeprazole base, omeprazole sulphenamide remains in the cell for a longer period of time. Thus the duration of the inhibition of acid secretion is substantially longer than the period in which omeprazole-base is present in plasma. The degree of inhibition of acid secretion is directly correlated to the area under the plasma concentration-time curve (AUC) but not to the plasma concentration at any given time. A sufficiently low pH-value is only found in the gastic parietal cells; this explains the high specificity of omeprazole. It is the omeprazole sulphenamide that binds to the enzyme and inhibits its activity.

If the enzyme-system is inhibited, the pH-value increases and less omeprazole accumulates or is converted in the gastric parietal cells. Consequently, the accumulation of omeprazole is regulated by a kind of feedback-mechanism.

Intravenous administration of omeprazole affords a quick and effecting inhibition of gastric acid production. With duodenal ulcer patients the mean reduction of basal and stimulated acid production during 24 hours is circa 90%.

A single intravenous injection of 40 mg has, over a period of 24 hours, almost the same effect on acid production as an oral dose of 80 mg.

5.2 Pharmacokinetic Properties

Distribution

The distribution volume of omeprazole in the body is relatively small (0.3 l/kg of body weight) and corresponds to that of the extracellular fluid. Approximately 95% is protein bound.

Metabolism and excretion

Omeprazole is entirely metabolised, mainly in the liver by CYP 2C19. The plasma half-life is about 40 minutes, and the total plasma clearance is 0.3 to 0.6 l/min. A small percentage of het patients lack a functional CYP2C19 enzyme and have reduced elimination rate of omeprazole. In these cases, the terminal elimination half-life can be approximately 3 times as long as the normal value, and the area under the plasma concentration-time curve (AUC) of orally administered omeprazole can increase by up to 10 times. The sulphone, sulphide and hydroxy-omeprazole are found in plasma. These metabolites have no significant effect on acid secretion.

About 20% of administered dose is excreted in faeces and the remaining 80% is excreted in urine as metabolites. The two major urinary metabolites are hydroxy-omeprazole and the corresponding carboxylic acid.

Special patient populations

In patients with renal impairment the systematic availability of omeprazole was very similar to that in healthy subjects.

In patients with chronic hepatic disease the clearance of omeprazole is reduced, and the plasma half-life can increase up to approximately 3 hours. The systemic bioavailability can then be enhanced in these patients.

The bioavailability of omeprazole is slightly elevated in the elderly, and the elimination rate is slightly diminished. But the individual values are nearly equal to that of young healthy subjects, and there is no indication that the tolerance in elderly patients treated with normal doses of omeprazole is reduced.

After intravenous administration of 40 mg omeprazole for 5 days, the absolute measured bioavailability increased by about 50 %; this can be explained by decreased hepatic clearance due to saturation of the CYP2C19 enzyme.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction.

Gastric ECL-cell hyperplasia and carcinoids have been observed in life-long studies in rats treated with omeprazole or subjected to partial fundectomy. These changes are the result of sustained hypergastrinaemia secondary to acid inhibition.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Powder for solution for injection:

sodium hydroxide

Solvent for solution for injection:

Macrogol 400

citric acid monohydrate

water for injections.

6.2 Incompatibilities

Omeprazole powder for solution for injection must not be mixed with other medicinal products, except the solvent for injection mentioned in section 6.6. The reconstituted product must not be mixed with other medicinal products.

6.3 Shelf Life

Powder for solution for injection: 2 years

Solvent for solution for injection: 3 years

Reconstituted solution: 4 hours when stored below 25˚C

6.4 Special Precautions For Storage

Powder and solvent for solution for injection: Do not store above 25°C. Store in the original package in order to protect from light

For storage conditions of the reconstituted medicinal product, see section 6.3

Chemical and physical in-use stability has been demonstrated for 4 hours at 25 °C. From a microbiological point of view, the product should be used immediately.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and aseptic conditions.

6.5 Nature And Contents Of Container

Powder for solution for injection:

10 ml colourless glass vial Type I with a rubber stopper, and an aluminium cramping cap with propylene cap

Solvent for solution for injection:

10 ml colourless glass ampoule Type I

Pack sizes: 1, 5 or 10

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

One vial with powder for solution for injection should be mixed with one ampoule containing 10 ml of the solvent for solution for injection. A clear solution should be obtained. Omeprazole powder for injection should only be dissolved with the solvent for injection provided. No other solvents for intravenous injection should be used.

Do not use if any particles are present in the reconstituted solution.

The reconstituted solution is for single use only.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Sandoz Ltd

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR.

United Kingdom

8. Marketing Authorisation Number(S)

PL 04416/0694

9. Date Of First Authorisation/Renewal Of The Authorisation

30/01/2008

10. Date Of Revision Of The Text

11/2010

Oraldene Icemint

1. Name Of The Medicinal Product

ORALDENE ICEMINT

2. Qualitative And Quantitative Composition

ORALDENE ICEMINT contains 0.1% w/v hexetidine.

3. Pharmaceutical Form

Mouthwash.

A clear blue green mouthwash.

4. Clinical Particulars

4.1 Therapeutic Indications

ORALDENE ICEMINT is indicated for use in minor mouth infections including thrush, as an aid in the prevention and treatment of gingivitis, and in the management of sore throat and recurrent aphthous ulcers. ORALDENE ICEMINT is also of value in the alleviation of halitosis and pre- and post- dental surgery.

4.2 Posology And Method Of Administration

Adults and children 12 years and over

Topical administration to the buccal cavity.

Rinse the mouth, or gargle with at least 15 ml of undiluted solution, two or three times a day.

ORALDENE ICEMINT should not be swallowed in large quantities.

Children aged 6 to 11 years

As recommended for adults.

Children under 6 years

Not recommended.

The Elderly

As recommended for adults.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions are known.

4.6 Pregnancy And Lactation

No formal studies have been conducted in man. However, on the basis of animal studies and, in theory, the negligible systemic absorption it is considered highly unlikely that the use of ORALDENE ICEMINT during pregnancy will present a risk to the foetus.

It is not known whether hexetidine is excreted in human breast milk, however, in view of the negligible amount of hexetidine which could be predicted to be systemically absorbed, it is unlikely that concentrations of hexetidine in the milk will present any risk to the neonate/infant.

4.7 Effects On Ability To Drive And Use Machines

ORALDENE ICEMINT is unlikely to affect ability to drive or operate machinery.

4.8 Undesirable Effects

ORALDENE ICEMINT is generally very well-tolerated with a low potential for causing irritation, or sensitisation reactions. Prolonged use of ORALDENE ICEMINT is also well-tolerated.

Patch testing with of hexetidine containing ointment was negative for irritation or sensitisation potential.

In a few individuals mild irritation (described as sore mouth, burning or itching), of the tongue and/or buccal tissues has been reported. Other side effects which are reported very rarely include transient anaesthesia and taste impairment.

4.9 Overdose

Signs and Symptoms of Overdose

There are no reports of alcohol intoxication from overdose with ORALDENE ICEMINT.

Hexetidine, at the strength present in ORALDENE ICEMINT, is non-toxic.

Acute alcoholic intoxication is extremely unlikely, however, it is theoretically possible that, if a massive dose were swallowed by a small child, alcoholic intoxication may occur due to the ethanol content.

There is no evidence to suggest that repeated, excessive administration of hexetidine would lead to hypersensitivity-type reactions.

Treatment of Overdose

Treatment of overdose is symptomatic, but rarely required. In the event of accidental ingestion of the contents of a bottle by a child, a doctor should be consulted immediately. Gastric lavage should be considered within two hours of ingestion and management should relate to treatment of alcoholic intoxication.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Hexetidine is a broad spectrum antimicrobial. It is active both in vivo and in vitro, against gram positive and negative bacterium, as well as yeasts (Candida albicans) and fungi.

5.2 Pharmacokinetic Properties

Specific pharmacodynamic studies have not been carried out on ORALDENE ICEMINT in man.

The oral retention of hexetidine to mucous membranes and dental plaque has been observed. In studies using radiolabelled hexetidine it has been shown that retention on buccal tissues can extend to between 8 and 10 hours after a single oral rinse and in some cases hexetidine has been detected on oral tissues up to 65 hours post-treatment.

No absorption studies following the topical application of ORALDENE ICEMINT have been performed in man.

Pharmacokinetics in renal/hepatic impairment

There have been no specific studies of ORALDENE ICEMINT or hexetidine in renal/hepatic impairment.

Pharmacokinetics in elderly

There have been no specific studies of ORALDENE ICEMINT or hexetidine in the elderly.

5.3 Preclinical Safety Data

Pre-clinical safety data does not add anything of further significance to the presciber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polysorbate 60

Citric acid

Saccharin sodium

Ethanol 96%

Quinoline Yellow (70%) E104

Patent Blue V (85%) E131

Mint flavour

Purified water

6.2 Incompatibilities

None.

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Do not store above 25°C. Keep the container in the outer carton.

6.5 Nature And Contents Of Container

ORALDENE ICEMINT is presented in a clear (Type 3) 200 ml glass bottles, with white aluminium ROPP cap fitted with PET wad or an HDPE plastic cap fitted with a polyterephthalate ethylene faced aluminium/expanded polyethylene laminated wad

Or

a 400ml PET bottle with aluminium ROPP cap fitted with PET wad or an HDPE plastic cap fitted with a polyterephthalate ethylene faced aluminium/expanded polyethylene laminated wad.

6.6 Special Precautions For Disposal And Other Handling

Shake well before use.

Administrative Data

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0107

9. Date Of First Authorisation/Renewal Of The Authorisation

26/09/2006

10. Date Of Revision Of The Text

14 January 2010

Sodium Chloride Injection 3% 5%

3% and 5% Sodium Chloride

Injections USP, (Hypertonic)

These are concentrated sodium chloride solutions. Infuse slowly with constant observation of patient to avoid pulmonary edema.

Sodium Chloride Injection 3% 5% Description

Each 100 mL of 3% Sodium Chloride Injection USP contains:

Sodium Chloride USP 3 g; Water for Injection USP qs

pH: 5.8 (4.5–7.0)     Calculated Osmolarity: 1030 mOsmol/liter

pH may be adjusted with Hydrochloric Acid NF

Concentration of Electrolytes (mEq/liter): Sodium 513     Chloride 513

Each 100 mL of 5% Sodium Chloride Injection USP contains:

Sodium Chloride USP 5 g; Water for Injection USP qs

pH: 5.8 (4.5–7.0)     Calculated Osmolarity: 1710 mOsmol/liter

pH may be adjusted with Hydrochloric Acid NF

Concentration of Electrolytes (mEq/liter): Sodium 856     Chloride 856

3% and 5% Sodium Chloride Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents.

The formula of the active ingredient is:

Ingredient	Molecular Formula	Molecular Weight
Sodium Chloride USP	NaCl	58.44

The EXCEL® Container is Latex-free, PVC-free, and DEHP-free.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Addition of medication should be accomplished using complete aseptic technique.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

Sodium Chloride Injection 3% 5% - Clinical Pharmacology

3% and 5% Sodium Chloride Injections USP provide electrolytes and are a source of water for hydration. They are capable of inducing diuresis depending on the clinical condition of the patient.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Indications and Usage for Sodium Chloride Injection 3% 5%

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration.

3% and 5% Sodium Chloride Injections USP are of particular value in severe salt depletion when rapid electrolyte restoration is of paramount importance. The low salt syndrome may occur in the presence of heart failure, renal impairment, during surgery, and postoperatively. In these conditions, chloride loss frequently exceeds sodium loss.

These hypertonic sodium chloride solutions are also indicated for the following clinical conditions.

•  Hyponatremia and hypochloremia due to electrolyte and fluid loss replaced with sodium-free fluids.


•  Drastic dilution of extracellular body fluid following excessive water intake sometimes resulting from multiple enemas or perfusion of irrigating fluids into open venous sinuses during transurethral prostatic resections.


•  Emergency treatment of severe salt depletion due to excess sweating, vomiting, diarrhea and other conditions.

Contraindications

3% and 5% Sodium Chloride Injections USP are contraindicated in the presence of elevated, normal, or only slightly decreased plasma electrolyte concentrations, or when additives of sodium and chloride could be clinically detrimental.

Warnings

Caution: These are concentrated hypertonic sodium chloride solutions. Infuse very slowly with constant observation of the patient to avoid pulmonary edema.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.

Precautions

General

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

These solutions should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

Additional essential electrolytes, minerals and vitamins should be supplied as needed.

Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

Excessive infusion of hypertonic sodium chloride solutions may supply more sodium and chloride than normally found in serum and can exceed normal tolerance, resulting in hypernatremia. Infusion of excess chloride ions may cause a loss of bicarbonate, resulting in an acidifying effect.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

Do not use plastic container in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with 3% and 5% Sodium Chloride Injections USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with 3% and 5% Sodium Chloride Injections USP. It is also not known whether 3% and 5% Sodium Chloride Injections USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 3% and 5% Sodium Chloride Injections USP should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 3% and 5% Sodium Chloride Injections USP are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of sodium chloride injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a well-placed small bore needle is recommended. (See DOSAGE AND ADMINISTRATION.)

The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Overdosage

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.

Sodium Chloride Injection 3% 5% Dosage and Administration

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Maximum intravenous dosage should be 100 mL given over a period of one hour. Before additional amounts are given, the serum electrolyte concentrations, including chloride and bicarbonate, should be determined to evaluate the need for more sodium chloride.

Intravenous administration of these solutions should not exceed 100 mL/hour or 400 mL/24 hours.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How is Sodium Chloride Injection 3% 5% Supplied

3% and 5% Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL® Containers packaged 24 per case.

NDC	Cat. No.	Size
3% Sodium Chloride Injection USP (Canada DIN 01924184)
0264-7805-10	L8051	500 mL
5% Sodium Chloride Injection USP (Canada DIN 01928007)
0264-7806-10	L8061	500 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Rx only

Revised: September 2010

EXCEL is a registered trademark of B. Braun Medical Inc.

Directions for Use of EXCEL® Container

Caution: Do not use plastic container in series connection.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

NOTE: Before use, perform the following checks:

•  Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.


•  Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.


•  Use only if solution is clear and container and seals are intact.

Preparation for Administration

1. Remove plastic protector from sterile set port at bottom of container.


2. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Some additives may be incompatible.

To Add Medication Before Solution Administration

1. Prepare medication site.


2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.


3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

To Add Medication During Solution Administration

1. Close clamp on the set.


2. Prepare medication site.


3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.


4. Remove container from IV pole and/or turn to an upright position.


5. Evacuate both ports by tapping and squeezing them while container is in the upright position.


6. Mix solution and medication thoroughly.


7. Return container to in use position and continue administration.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4

Y36-002-760   LD-237-1

PRINCIPAL DISPLAY PANEL - 500 mL

3% Sodium Chloride Injection USP

REF L8051

NDC 0264-7805-10

DIN 01924184


500 mL

EXCEL® CONTAINER


Hypertonic

Y94-003-092  LD-259-1

Each 100 mL contains:

Sodium Chloride USP 3 g; Water for Injection USP qs


pH may be adjusted with HCI NF

pH: 5.8 (4.5-7.0)     Calc. Osmolarity: 1030 mOsmol/liter


Electrolytes (mEq/liter):     Na+  513         CI–  513


Sterile, nonpyrogenic. Single dose container.


CAUTION: This is a concentrated sodium chloride solution.

                   Infuse slowly with constant observation of patient

                   to avoid pulmonary edema.


Do not use in series connection. For intravenous use only.

Use only if solution is clear and container and seals are intact.


WARNINGS: Some additives may be incompatible. Consult with

pharmacist. When introducing additives, use aseptic techniques.

Mix thoroughly. Do not store.


Recommended Storage: Room temperature (25°C). Avoid

excessive heat. Protect from freezing. See Package Insert.

Rx only


EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA 


In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4


Y94-003-058

LD-133-2


Do not remove overwrap until ready for use. After removing the overwrap,

check for minute leaks by squeezing container firmly. If leaks are found,

discard solution as sterility may be impaired.

EXP

LOT

PRINCIPAL DISPLAY PANEL - 500 mL

5% Sodium Chloride Injection USP


REF L8061

NDC 0264-7806-10

DIN 01928007

HK 22618


500 mL

EXCEL® CONTAINER


Hypertonic

Y94-003-092  LD-259-1


Each 100 mL contains:

Sodium Chloride USP 5 g; Water for Injection USP qs


pH may be adjusted with HCI NF

pH: 5.8 (4.5-7.0)     Calc. Osmolarity: 1710 mOsmol/liter


Electrolytes (mEq/liter):     Na+  856         CI–  856


Sterile, nonpyrogenic. Single dose container.


CAUTION: This is a concentrated sodium chloride solution. Infuse

                  slowly with constant observation of patient to avoid

                  pulmonary edema.


Do not use in series connection. For intravenous use only.

Use only if solution is clear and container and seals are intact.


WARNINGS: Some additives may be incompatible. Consult with

pharmacist. When introducing additives, use aseptic techniques. Mix

thoroughly. Do not store.


Recommended Storage: Room temperature (25°C). Avoid excessive

heat. Protect from freezing. See Package Insert.

Rx only


EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA


In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4 


Y94-003-059

LD-132-2


Do not remove overwrap until ready for use. After removing the overwrap,

check for minute leaks by squeezing container firmly. If leaks are found,

discard solution as sterility may be impaired.

EXP

LOT

SODIUM CHLORIDE  sodium chloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0264-7805 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 3 g  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0264-7805-10 24 CONTAINER In 1 CASE contains a CONTAINER 1 500 mL In 1 CONTAINER This package is contained within the CASE (0264-7805-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA019635	03/19/1988

SODIUM CHLORIDE  sodium chloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0264-7806 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 5 g  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0264-7806-10 24 CONTAINER In 1 CASE contains a CONTAINER 1 500 mL In 1 CONTAINER This package is contained within the CASE (0264-7806-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA019635	03/09/1988

Labeler - B. Braun Medical Inc. (002397347)

Establishment
Name	Address	ID/FEI	Operations
B. Braun Medical Inc.		037425308	MANUFACTURE

Revised: 06/2011B. Braun Medical Inc.

More Sodium Chloride Injection 3% 5% resources

• Sodium Chloride Injection 3% 5% Drug Interactions
• Sodium Chloride Injection 3% 5% Support Group
• 0 Reviews for Sodium Chloride Injection 3% - Add your own review/rating

Compare Sodium Chloride Injection 3% 5% with other medications

• Postural Orthostatic Tachycardia Syndrome