Levofloxacin Drops

Pronunciation: LEE-voe-FLOX-a-sin
Generic Name: Levofloxacin
Brand Name: Iquix

Levofloxacin Drops are used for:

Treating corneal ulcers caused by bacteria sensitive to Levofloxacin Drops. It may also be used for other conditions as determined by your doctor.

Levofloxacin Drops are a fluoroquinolone eye drop. It works by blocking bacteria from reproducing in the eye.

Do NOT use Levofloxacin Drops if:

• you are allergic to any ingredient in Levofloxacin Drops or to any other fluoroquinolone antibiotic (eg, ciprofloxacin, gatifloxacin)

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

Before using Levofloxacin Drops:

Some medical conditions may interact with Levofloxacin Drops. Tell your health care provider 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

Some MEDICINES MAY INTERACT with Levofloxacin Drops. Because little, if any, of Levofloxacin Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Levofloxacin Drops 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 Levofloxacin Drops:

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

• Levofloxacin Drops are only for the eye. Do not get it in your nose or mouth.


• To use Levofloxacin Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• Do not wear contact lenses while you are using Levofloxacin Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.


• Levofloxacin Drops works best if it is used at the same time each day.


• To clear up your infection completely, use Levofloxacin Drops for the full course of treatment. Keep using it even if you feel better in a few days.


• Do not miss any doses of Levofloxacin Drops. If you miss a dose of Levofloxacin Drops, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Levofloxacin Drops.

Important safety information:

• Levofloxacin Drops may cause blurred vision. This effect may be worse if you take it with alcohol or certain medicines. Use Levofloxacin Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Be sure to use Levofloxacin Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Levofloxacin Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• If you notice vision changes, vaginal irritation or itching, or white patches in your mouth, contact your doctor at once.


• Diabetes patients - Levofloxacin Drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Levofloxacin Drops should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Levofloxacin Drops while you are pregnant. Levofloxacin Drops are found in breast milk. If you are or will be breast-feeding while you take Levofloxacin Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Levofloxacin Drops:

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:

Blurred vision; headache; strange taste.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); double vision or other vision changes; eye itching or pain; eye or eyelid swelling.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Levofloxacin Drops:

Store Levofloxacin Drops 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 Levofloxacin Drops out of the reach of children and away from pets.

General information:

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


• Levofloxacin Drops 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 Levofloxacin Drops. 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 Levofloxacin resources

• Levofloxacin Use in Pregnancy & Breastfeeding
• Levofloxacin Support Group
• 0 Reviews for Levofloxacin - Add your own review/rating

Compare Levofloxacin with other medications

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Propranolol Solution

Pronunciation: proe-PRAN-oh-lol
Generic Name: Propranolol
Brand Name: Generic only. No brands available.

Do not suddenly stop taking Propranolol Solution. Sharp chest pain, irregular heartbeat, and, sometimes, heart attack may occur if you suddenly stop Propranolol Solution. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking Propranolol Solution. This should be done even if you only take Propranolol Solution for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Propranolol Solution again.

Propranolol Solution is used for:

Treating high blood pressure or certain types of irregular heartbeat. It is used in patients with angina to decrease angina frequency and increase exercise tolerance. It is used to decrease the risk of heart death in certain patients who have survived a heart attack. It is used to manage certain types of tremors, a heart condition called hypertrophic subaortic stenosis, or certain symptoms of pheochromocytoma (an adrenal gland tumor). It is also used to prevent migraine headaches. It may also be used for other conditions as determined by your doctor.

Propranolol Solution is a beta-blocker. It works by slowing down the heart and decreasing the amount of blood it pumps out. This decreases blood pressure, helps the heart pump more efficiently, and reduces the workload on the heart. Exactly how Propranolol Solution works to treat migraines or tremors is not known.

Do NOT use Propranolol Solution if:

• you are allergic to any ingredient in Propranolol Solution


• you have moderate to severe heart block, sick sinus syndrome, or a very slow heartbeat and you do not have a permanent pacemaker


• you have uncontrolled heart failure or shock caused by serious heart problems


• you have asthma


• the patient is a child with diabetes or heart failure


• you are taking mibefradil

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Propranolol Solution:

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

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


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


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


• if you have a history of other heart problems (eg, angina, congestive heart failure, slow heartbeat)


• if you have a history of liver or kidney problems, blood vessel disease, lung or breathing problems (eg, chronic bronchitis, chronic obstructive pulmonary disease [COPD], emphysema), diabetes, low blood sugar, overactive thyroid, or glaucoma


• if you have Wolff-Parkinson-White syndrome, Down syndrome, Raynaud syndrome, or an adrenal gland tumor (pheochromocytoma)


• if you smoke or drink alcohol


• if you are scheduled to have surgery or receive anesthesia

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

• Mibefradil because the risk of serious heart side effects may be increased


• Diphenhydramine because it may increase the risk of Propranolol Solution's side effects. Before you start any new medicine, including over-the-counter medicines, check the label to see if it contains diphenhydramine. If it does or you are not sure, check with doctor or pharmacist


• Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, heart problems, irregular heartbeat, diabetes, prostate problems, blood thinning, thyroid problems, depression, mental or mood problems, immune system suppression, allergic reactions, asthma or other lung or breathing problems, high cholesterol, seizures, multiple sclerosis [MS]), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Propranolol Solution, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Propranolol Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Propranolol Solution:

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

• Take Propranolol Solution by mouth. Talk to your doctor about how you should take it with regard to food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you are taking an antacid with aluminum in it, take it at least 2 hours after you take Propranolol Solution.


• Take Propranolol Solution on a regular schedule to get the most benefit from it. Taking Propranolol Solution at the same time each day will help you remember to take it.


• Continue to take Propranolol Solution even if you feel well. Do not miss any doses.


• Do not suddenly stop taking Propranolol Solution. You may have an increased risk of side effects. If you need to stop Propranolol Solution, your doctor will gradually lower your dose.


• If you miss a dose of Propranolol Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Propranolol Solution.

Important safety information:

• Propranolol Solution may cause drowsiness, dizziness, light-headedness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Propranolol Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol while you are taking Propranolol Solution; it may increase the risk of Propranolol Solution's side effects.


• Do NOT take more than the recommended dose, change your dose, or stop taking Propranolol Solution without checking with your doctor. When taking Propranolol Solution for high blood pressure, it may take a few days to several weeks to receive the full benefits from Propranolol Solution.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Tell your doctor or dentist that you take Propranolol Solution before you receive any medical or dental care, emergency care, or surgery.


• If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Propranolol Solution.


• Propranolol Solution may lower your blood sugar levels. This is most likely to happen in infants and children or in patients who have diabetes or kidney problems. It may also occur after prolonged physical activity or during fasting. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. If this occurs, eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens.


• Diabetes patients - Propranolol Solution may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Propranolol Solution may interfere with certain lab tests, including glaucoma screening and dobutamine stress echocardiography. Be sure your doctor and lab personnel know you are taking Propranolol Solution.


• Lab tests, including blood pressure and heart function, may be performed while you use Propranolol Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Propranolol Solution with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Propranolol Solution in CHILDREN; they may be more sensitive to its effects, especially low blood sugar levels, certain heart problems, or shortness of breath.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Propranolol Solution while you are pregnant. Propranolol Solution is found in breast milk. If you are or will be breast-feeding while you use Propranolol Solution, check with your doctor. Discuss any possible risks to your baby.

If you stop taking Propranolol Solution suddenly, you may have WITHDRAWAL symptoms. These may include worsening chest pain along with possible heart attack.

Possible side effects of Propranolol Solution:

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

Constipation; diarrhea; dizziness; drowsiness; fatigue; light-headedness; nausea; stomach upset or cramping; trouble sleeping; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fever with aching and sore throat; hallucinations; irregular heartbeat; memory loss; mental or mood changes (eg, depression); numbness or tingling of the hands; red, swollen, blistered, or peeling skin; severe or persistent dizziness or light-headedness; shortness of breath or wheezing; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusually slow heartbeat; very cold or blue fingers or toes; vision changes.

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: Propranolol 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 fainting; severe dizziness or light-headedness; shortness of breath; swelling of the hands, ankles, or feet; trouble breathing; very slow heart rate.

Proper storage of Propranolol Solution:

Store Propranolol Solution between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Propranolol Solution out of the reach of children and away from pets.

General information:

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


• Propranolol Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Propranolol Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Propranolol resources

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

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• Pheochromocytoma
• Tardive Dyskinesia
• Thyrotoxicosis

Paracetamol 120mg / 5ml Oral Suspension

1. Name Of The Medicinal Product

Paracetamol 120mg/5ml Oral Suspension

2. Qualitative And Quantitative Composition

Paracetamol (micronised) 120mg/5ml

3. Pharmaceutical Form

Oral Suspension

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of mild to moderate pain, including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains.

For the reduction of fever and to be used as an adjunctive treatment to relieve symptoms of cold and flu.

4.2 Posology And Method Of Administration

For oral administration only

Recommended doses:

		120 mg/5ml
CHILDREN	3 - 12 months	2.5 - 5ml
	1 - 5 years	5 - 10ml
	6 - 12 years	10 - 20ml

These doses may be repeated every 4 - 6 hours when necessary with a maximum of 4 doses in 24 hours.

Adults and children over 12: 20 - 40ml every 4 - 6 hours to a maximum of 4g daily.

If pyrexia develops after immunisation, a child can be given a dose of Paracetamol followed, if necessary, by a second dose 4 - 6 hours later. The dose of Paracetamol for post immunisation pyrexia in an infant aged 2 - 3 months is 60mg (2.5ml of the 120mg/5ml presentation); an oral syringe can be obtained from any Pharmacy to give the small dose volume required. The parents should be warned that if the pyrexia persists after the second dose medical advice should be sought.

4.3 Contraindications

Hypersensitivity to paracetamol and/or other constituents.

Patients with severe hepatic dysfunction.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not give with any other paracetamol-containing products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed serious liver damage.

Do not exceed the recommended dose.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Excipients in the formulation

This product contains hydroxybenzoates. These may cause allergic reactions (possibly delayed). The product also contains sucrose (3g per 5ml dose) and sorbitol. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The hepatotoxicity of Paracetamol, particularly after overdosage, may be increased by drugs which induce liver microsomal enzymes such as barbiturates, tricyclic antidepressants, and alcohol.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Antivirals: Regular use of Paracetamol possibly reduces metabolism of Zidovudine (increased risk of neutropenia).

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in clinically significant quantities. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causality related to paracetamol.

Cases of acute pancreatitis have been reported. Paracetamol has been widely used and reports of adverse reactions are rare, and are generally associated with overdosage.

Allergic reactions occur occasionally.

Nephrotoxic effects are uncommon and have not been reported in association with therapeutic doses, except after prolonged administration.

4.9 Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

a) Is on long term treatment wih carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b) Regularly consumes ethanol in excess of recommended amounts

Or

c) Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required, the patient should be given intravenous N-acetylcysteine in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and, to a lesser extent, through a peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat regulating centre to produce peripheral vaso-dilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

5.2 Pharmacokinetic Properties

Oral absorption is rapid and almost complete, it may be decreased if Paracetamol is taken following a high carbohydrate meal.

There is no significant protein binding with doses producing plasma concentrations of below 60mcg (µg)/ml, but may reach moderate levels with high or toxic doses.

Approximately 90 - 95% of a dose is metabolised in the liver, primarily by conjugation with glucuronic acid, sulphuric acid and cysteine. An intermediate metabolite, which may accumulate in overdosage after primary metabolic pathways become saturated, is hepatotoxic and possibly nephrotoxic.

Half life is 1 to 4 hours; does not change with renal failure but may be prolonged in acute overdosage, in some forms of hepatic disease, in the elderly, and in the neonate; may be somewhat shortened in children.

Time to peak concentration, 0.5 - 2 hours; peak plasma concentrations, 5 - 20mcg (µg)/ml (with doses up to 650mg); time to peak effect, 1- 3 hours; duration of action, 3- 4 hours.

Elimination is by the renal route, as metabolites, primarily conjugates, 3% of a dose may be excreted unchanged.

Peak concentration of 10 - 15mcg(µg)/ml have been measured in breast milk, 1 - 2 hours following maternal ingestion of a single 650mg dose. Half life in breast milk is 1.35 - 3.5 hours.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Propylene glycol, methyl hydroxybenzoate, propyl hydroxybenzoate, xanthan gum, sorbitol solution 70%, sucrose, mango flavour 545329E and purified water.

6.2 Incompatibilities

None stated

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store below 25°C. Protect from light

6.5 Nature And Contents Of Container

Amber (Type III) glass bottle with capacity of 60ml, 100ml, 125ml, 500ml and 1000ml.

Closure:

1. Aluminium, wadded, roll-on, pilfer proof closure. 2. HDPE, child resistant, tamper evident, EPE wadded closure 3. HDPE, tamper evident, EPE wadded closure.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

8. Marketing Authorisation Number(S)

PL 0427/0077

9. Date Of First Authorisation/Renewal Of The Authorisation

11 January 1995

10. Date Of Revision Of The Text

Oct 2009

Triaminic Flu Cough & Fever

Generic Name: acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine (a SEET a MIN oh fen, KLOR fen EER a meen, DEX troe meth OR fan, SOO doe ee FED rin)

Brand Names: Alka-Seltzer Plus Cough and Cold Liquigel, Children's Tylenol Flu, Comtrex Cold and Flu Maximum Strength Liquid, Comtrex Cold and Flu Maximum Strength Tablet, Robitussin Flu, Robitussin Honey Flu Nighttime, Theraflu (pseudoephedrine) Cold & Cough, Theraflu Flu & Cough, Theraflu Night Cough and Cold and Flu, Theraflu Nightime Maximum Strength, Theraflu Severe Cold & Congestion, Triaminic Cold and Fever, Triaminic Flu, Cough & Fever, Vicks 44 Cold, Flu and Cough, Vicks Formula 44M

What is Triaminic Flu, Cough & Fever (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

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.

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

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

The combination of acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Dextromethorphan will not treat a cough that is caused by smoking.

Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medication?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not use 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. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking this medication?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use a cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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

• 
  

  liver disease, cirrhosis, or a history of alcoholism;

  
  


• 
  

  a blockage in your digestive tract (stomach or intestines);

  
  


• 
  

  diabetes;

  
  


• 
  

  kidney disease;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

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

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  pheochromocytoma (an adrenal gland tumor); or

  
  


• 
  

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

  
  

It is not known whether acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use cold medicine without medical advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Do not use cold medicine without medical advice if you are breast-feeding a baby.

How should I take Triaminic Flu, Cough & Fever (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

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

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

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

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

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

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

What happens if I overdose?

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

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking this medication?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

This medication 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:

• 
  

  fast or pounding heartbeats, severe restless feeling or nervousness;

  
  


• 
  

  mood changes, confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  feeling short of breath;

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  constipation or diarrhea;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  feeling nervous or restless.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Triaminic Flu, Cough & Fever (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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

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

• 
  

  leflunomide (Arava);

  
  


• 
  

  topiramate (Topamax);

  
  


• 
  

  zonisamide (Zonegran);

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  an antidepressant;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  bladder or urinary medications;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  a bronchodilator;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with acetaminophen, chlorpheniramine, dextromethorphan, 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 Triaminic Flu, Cough & Fever resources

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

Compare Triaminic Flu, Cough & Fever with other medications

• Cold Symptoms
• Influenza

Where can I get more information?

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

See also: Triaminic Flu, Cough & Fever side effects (in more detail)

Saxagliptin

Pronunciation: SAX-a-GLIP-tin
Generic Name: Saxagliptin
Brand Name: Onglyza

Saxagliptin is used for:

Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by increasing the amount of insulin released by your body, and by decreasing the amount of sugar made by your body.

Do NOT use Saxagliptin if:

• you are allergic to any ingredient in Saxagliptin


• you have type 1 diabetes


• you have high blood or urine ketone levels associated with diabetes (diabetic ketoacidosis)

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

Before using Saxagliptin:

Some medical conditions may interact with Saxagliptin. 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 history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by another DPP-4 inhibitor (eg, sitagliptin)


• if you have kidney problems or are on dialysis


• if you have an unusual or prolonged infection or a history of diabetic ketoacidosis


• if you have a history of pancreatitis, gallstones, high blood triglyceride levels, or alcohol abuse


• if you are using insulin

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

• Thiazolidinediones (eg, pioglitazone) because the risk of peripheral edema (swelling of the hands and feet) may be increased


• Clarithromycin, itraconazole, ketoconazole, nefazodone, protease inhibitors (eg, atazanavir, boceprevir, ritonavir), or telithromycin because they may increase the risk of Saxagliptin's side effects


• Sulfonylureas (eg, glipizide) because the risk of low blood sugar may be increased by Saxagliptin

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

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

• Saxagliptin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Saxagliptin refilled.


• Take Saxagliptin by mouth with or without food.


• Continue to take Saxagliptin even if you feel well. Do not miss any doses.


• If you miss a dose of Saxagliptin, 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 Saxagliptin.

Important safety information:

• Carry an ID card at all times that says you have diabetes.


• Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Saxagliptin.


• Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Saxagliptin exactly as prescribed, tell your doctor.


• Do NOT take more than the recommended dose without checking with your doctor.


• It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.


• The risk of low blood sugar may be increased when Saxagliptin is used along with certain other medicines for diabetes (eg, sulfonylureas). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• Lab tests, including fasting blood glucose, hemoglobin A_1c, and kidney function, may be performed while you use Saxagliptin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Saxagliptin with caution in the ELDERLY; they may be more sensitive to its effects.


• Saxagliptin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Saxagliptin while you are pregnant. It is not known if Saxagliptin is found in breast milk. If you are or will be breast-feeding while you use Saxagliptin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Saxagliptin:

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:

Headache; symptoms of upper respiratory tract infection (eg, cough, runny or stuffy nose, sneezing, sore throat).

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); flaking, peeling, or swelling of the skin; frequent or painful urination; swelling of the hands, ankles, legs, or feet; symptoms of pancreatitis (eg, severe stomach or back pain with or without nausea or vomiting).

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

See also: Saxagliptin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Saxagliptin:

Store Saxagliptin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Saxagliptin out of the reach of children and away from pets.

General information:

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


• Saxagliptin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Saxagliptin. 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 Saxagliptin resources

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

• Saxagliptin Professional Patient Advice (Wolters Kluwer)


• saxagliptin Advanced Consumer (Micromedex) - Includes Dosage Information


• Onglyza Prescribing Information (FDA)


• Onglyza Consumer Overview

Compare Saxagliptin with other medications

• Diabetes, Type 2

Insulin Aspart Cartridges

Pronunciation: IN-su-lin AS-part
Generic Name: Insulin Aspart
Brand Name: Novolog

Insulin Aspart Cartridges are used for:

Treating diabetes mellitus. Insulin Aspart Cartridges are usually used with a longer-acting insulin or insulin pump therapy.

Insulin Aspart Cartridges are a fast-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.

Do NOT use Insulin Aspart Cartridges if:

• you are allergic to any ingredient in Insulin Aspart Cartridges


• you are having an episode of low blood sugar

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

Before using Insulin Aspart Cartridges:

Some medical conditions may interact with Insulin Aspart Cartridges. 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 drink alcoholic beverages or smoke


• if you have kidney or liver problems; nerve problems; adrenal, pituitary, or thyroid problems; or diabetic ketoacidosis


• if you use 3 or more insulin injections per day


• if you are fasting, are on a low-salt (sodium) diet, have blood electrolyte problems (eg, high blood sodium levels, low blood potassium levels), or you exercise

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

• Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, pramlintide, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased


• Atypical antipsychotics (eg, risperidone), corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Insulin Aspart Cartridges's effectiveness, resulting in high blood sugar

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

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

• An extra patient leaflet is available with Insulin Aspart Cartridges. Talk to your pharmacist if you have questions about this information.


• Use Insulin Aspart Cartridges within 5 to 10 minutes before a meal unless directed otherwise by your doctor.


• If you will be using Insulin Aspart Cartridges at home, a health care provider will teach you how to use it. Be sure you understand how to use Insulin Aspart Cartridges. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• You may use Insulin Aspart Cartridges in an insulin pump if you are directed to do so by your doctor. If you are using an insulin pump, do NOT dilute Insulin Aspart Cartridges or mix it together with any other type of insulin.


• Insulin Aspart Cartridges should be clear and colorless. Do not use Insulin Aspart Cartridges if it contains particles; is cloudy, thickened, or discolored; or if the vial or container is cracked or damaged.


• If you are mixing Insulin Aspart Cartridges with NPH insulin, draw Insulin Aspart Cartridges into the syringe first. Inject the dose immediately after mixing, as directed by your doctor. Do not mix Insulin Aspart Cartridges with any other type of insulin.


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.


• Injection sites within an injection area (abdomen, buttock, thigh, upper arm) must be rotated from one injection to the next. Do not inject medicine into skin that is red, swollen, or itchy.


• Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.


• Insulin Aspart Cartridges begins lowering blood sugar within 10 to 20 minutes after an injection. The peak effect occurs within 1 to 3 hours after a dose. The effect lasts for up to 3 to 5 hours.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you should ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Insulin Aspart Cartridges.

Important safety information:

• Insulin Aspart Cartridges may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you use it with alcohol or certain medicines. Use Insulin Aspart Cartridges with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase the risk of developing high or low blood sugar.


• Do NOT use more than the recommended dose, use Insulin Aspart Cartridges more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor.


• Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.


• Stress or illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you will still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.


• Tell your doctor or dentist that you take Insulin Aspart Cartridges before you receive any medical or dental care, emergency care, or surgery.


• If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.


• Carry an ID card at all times that says you have diabetes.


• An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If not treated, loss of consciousness, coma, or death may occur. If these symptoms occur, tell your doctor right away.


• Check with your doctor if you notice a depression in the skin or skin thickening at the injection site. You may need to change your injection technique.


• Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Insulin Aspart Cartridges. Tell your doctor if you have had a recent change in diet or physical activity.


• Lab tests, including fasting blood glucose levels and hemoglobin A_1c levels, may be performed while you use Insulin Aspart Cartridges. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Insulin Aspart Cartridges with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.


• Insulin Aspart Cartridges should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Insulin Aspart Cartridges while you are pregnant. It is not known if Insulin Aspart Cartridges are found in breast milk. If you are or will be breast-feeding while you use Insulin Aspart Cartridges, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Insulin Aspart Cartridges:

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:

Redness, swelling, itching, or mild pain at the injection site; weight gain.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); burning, numbness, or tingling of the arms, hands, legs, or feet; changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mental or mood changes; muscle pain, weakness, or cramping; seizures; slurred speech; swelling; tremor; trouble concentrating; unusual hunger; unusual sweating; weakness.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center or emergency room immediately. Symptoms may include chills; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Proper storage of Insulin Aspart Cartridges:

VIALS: Store new (unopened) vials in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store used (open) vials either in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature, below 86 degrees F (30 degrees C). Store away from heat and light. If Insulin Aspart Cartridges has been frozen or overheated, throw it away. Do not draw up medicine into a syringe and store for later use. Throw away unrefrigerated or opened vials after 28 days, even if they still contain medicine.

CARTRIDGE SYSTEMS and PREFILLED SYRINGES: Store new (unopened) cartridge systems or prefilled syringes in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Insulin Aspart Cartridges. Store used (open) cartridge systems or prefilled syringes at room temperature, below 86 degrees F (30 degrees C). Do NOT store used (open) cartridges or prefilled syringes in the refrigerator. Store away from heat and light. If Insulin Aspart Cartridges has been frozen or overheated, throw it away. Throw away unrefrigerated or used cartridge systems or prefilled syringes after 28 days, even if they still contain medicine.

Avoid temperatures above 98.6 degrees F (37 degrees C). Do not leave Insulin Aspart Cartridges in a car on a warm or sunny day. Do not use Insulin Aspart Cartridges after the expiration date stamped on the label. Keep Insulin Aspart Cartridges, as well as syringes and needles, out of the reach of children and away from pets. If you are using Insulin Aspart Cartridges in an insulin pump, or if Insulin Aspart Cartridges has been mixed with other medicines or diluted, you may need to store it differently. Ask your doctor, pharmacist, or other health care provider how to store Insulin Aspart Cartridges.

General information:

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


• Insulin Aspart Cartridges 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 Insulin Aspart Cartridges. 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 Insulin Aspart resources

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

Compare Insulin Aspart with other medications

• Diabetes, Type 1
• Diabetes, Type 2

Inspra

Generic Name: eplerenone (Oral route)

e-PLER-en-one

Commonly used brand name(s)

In the U.S.

• Inspra

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Aldosterone Receptor Antagonist

Uses For Inspra

Eplerenone belongs to the general class of medicines called antihypertensives. It is used alone or together with other medicines to treat high blood pressure (hypertension). This medicine is also used to treat congestive heart failure (CHF) after a heart attack.

High blood pressure adds to the work load of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Hypertension may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

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

Before Using Inspra

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 eplerenone in children with hypertension below 4 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of eplerenone in children with heart failure. 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 eplerenone in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving eplerenone.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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.

• Amiloride


• Clarithromycin


• Itraconazole


• Ketoconazole


• Nefazodone


• Nelfinavir


• Potassium


• Ritonavir


• Spironolactone


• Triamterene


• Troleandomycin

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.

• Alacepril


• Arsenic Trioxide


• Benazepril


• Captopril


• Cilazapril


• Delapril


• Enalaprilat


• Enalapril Maleate


• Erythromycin


• Fluconazole


• Fosinopril


• Imidapril


• Lisinopril


• Moexipril


• Pentopril


• Perindopril


• Quinapril


• Ramipril


• Saquinavir


• Spirapril


• Temocapril


• Trandolapril


• Verapamil


• Zofenopril

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.

• Licorice

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:

• Diabetes with microalbuminuria or


• Hyperkalemia (high potassium in the blood) or


• Kidney disease, severe —Should not be used in patients with these conditions.

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

Proper Use of Inspra

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

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 oral dosage form (tablets):
  
  • For congestive heart failure after a heart attack:
    
    • Adults—At first, 25 milligrams (mg) once a day, then your dose may be increased to 50 mg once a day. Your doctor may adjust your dose as needed and tolerated.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For high blood pressure:
    
    • Adults, teenagers, and children above 4 years of age—At first, 50 milligrams (mg) once a day. Your doctor may increase your dose to 50 mg two times a day.
    
    
    • Children up to 4 years of age—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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Inspra

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not take the following medicines if you are using eplerenone:

• Amiloride (e.g., Midamor®) or


• Clarithromycin (e.g., Biaxin®) or


• Itraconazole (e.g., Sporanox®) or


• Ketoconazole (e.g., Nizoral®) or


• Nefazodone (e.g., Serzone®) or


• Nelfinavir (e.g., Viracept®) or


• Ritonavir (e.g., Norvir®) or


• Spironolactone (e.g., Aldactone®) or


• Triamterene (e.g., Dyrenium®) or


• Troleandomycin (e.g., Tao®).

Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes containing potassium.

This medicine may increase the amount of potassium in your blood. Check with your doctor right away if you are having abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeats; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Inspra 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

• Excess of cholesterol in the blood


• excess of triglycerides in the blood

Incidence not known

• Abdominal or stomach pain


• arm, back, or jaw pain


• chest pain or discomfort


• chest tightness or heaviness


• confusion


• difficulty with breathing


• dizziness


• fast or irregular heartbeat


• headache


• irregular heartbeat


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


• nausea


• nervousness


• numbness or tingling in the hands, feet, or lips


• pain or discomfort in the arms, jaw, back, or neck


• rash


• shortness of breath


• sweating


• vomiting


• weakness or heaviness of the legs

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

• Abnormal vaginal bleeding


• breast pain


• chills


• cloudy urine


• cough


• diarrhea


• fever


• general feeling of discomfort or illness


• joint pain


• loss of appetite


• muscle aches and pains


• swelling of the breasts or breast soreness in both females and males


• unusual tiredness or weakness

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: Inspra 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.

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More Inspra resources

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

• Inspra Prescribing Information (FDA)


• Inspra MedFacts Consumer Leaflet (Wolters Kluwer)


• Inspra Concise Consumer Information (Cerner Multum)


• Inspra Monograph (AHFS DI)


• Eplerenone Prescribing Information (FDA)


• Eplerenone Professional Patient Advice (Wolters Kluwer)

Compare Inspra with other medications

• Heart Failure
• High Blood Pressure