Nivaquine Syrup (sanofi-aventis)

1. Name Of The Medicinal Product

Nivaquine Syrup

2. Qualitative And Quantitative Composition

Chloroquine Sulphate BP 68 mg/5 ml.

3. Pharmaceutical Form

Syrup.

4. Clinical Particulars

4.1 Therapeutic Indications

Nivaquine is a 4-aminoquinoline compound which has a high degree of activity against the asexual erythrocytic forms of all species of malaria parasites.

It is indicated for the prevention of malaria.

Route of administration: oral.

4.2 Posology And Method Of Administration

Prevention of malaria

Adults: 6 x 5 ml Nivaquine Syrup (300 mg chloroquine base) to be taken once a week on the same day each week.

Infants and children up to 12 years: 5 mg chloroquine base per kg bodyweight to be taken once a week on the same day each week.

It is advisable to start taking Nivaquine 1 week before entering an endemic area and to continue for 4 weeks after leaving.

4.3 Contraindications

The use of chloroquine is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.

Nivaquine is generally contraindicated in pregnancy. However, clinicians may decide to administer Nivaquine to pregnant women for the prevention or treatment of malaria. Ocular or inner ear damage may occur in infants born of mothers who receive high doses of chloroquine throughout pregnancy.

4.4 Special Warnings And Precautions For Use

Nivaquine should be used with care in patients with a history of epilepsy as it has been reported to provoke seizures. Caution is advised in cases of porphyria (precipitated disease may be especially apparent in patients with a high alcohol intake), hepatic disease (particularly cirrhosis) or renal disease, severe gastrointestinal, neurological and blood disorders and in patients receiving anticoagulant therapy.

Nivaquine should be used with care in patients with psoriasis as the condition may be exacerbated.

Although Nivaquine may have a temporary effect on visual accommodation during short term treatment, irreversible retinal damage may occur with prolonged treatment (see sections 4.7 and 4.8, below). Therefore, patients should be advised to discontinue the medication and seek immediate medical advice if they notice any deterioration in their vision which persists for more than 48 hours. Ophthalmological examination should always be carried out before and regularly (3-6 monthly intervals) during prolonged treatment. Retinal damage is particularly likely to occur if treatment has been given for longer than one year, or if the total dosage has exceeded 1.6 g/kg bodyweight. These precautions also apply to patients receiving chloroquine continuously at weekly intervals as a prophylactic against malarial attack for more than three years.

Bone marrow depression, including aplastic anaemia occurs rarely. Full blood counts should therefore be carried out regularly during extended treatment. Caution is required if drugs known to induce blood disorders are used concurrently.

Resistance of Plasmodium falciparum to chloroquine is well documented. When used as malaria prophylaxis official guidelines and local information on prevalence of resistance to anti-malarial drugs should be taken into consideration.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant administration of chloroquine with magnesium-containing antacids or kaolin may result in reduced absorption of chloroquine. Chloroquine should, therefore, be administered at least two hours apart from antacids or kaolin.

Concomitant use of cimetidine and chloroquine may result in an increased half-life and a decreased clearance of chloroquine.

Chloroquine and mefloquine can lower the convulsive threshold. Co-administration of chloroquine and mefloquine may increase the risk of convulsions. Also, the activity of antiepileptic drugs might be impaired if co-administered with chloroquine.

There have been isolated case reports of an increased plasma ciclosporin level when ciclosporin and chloroquine were co-administered.

Chloroquine may affect the antibody response to rabies vaccine (HDCV).

Caution is advised in patients receiving anticoagulant therapy.

Co-administration of chloroquine and other drugs that have arrhythmogenic potential (e.g. amiodarone) may increase the risk of cardiac arrhythmias.

Concomitant administration of chloroquine and digoxin may increase plasma concentrations of digoxin.

Concomitant use of chloroquine with neostigmine or pyridostigmine has the potential to increase the symptoms of myasthenia gravis and thus diminish the effects of neostigmine and pyridostigmine.

4.6 Pregnancy And Lactation

Nivaquine is generally contraindicated in pregnancy. However, clinicians may decide to administer Nivaquine to pregnant women for the prevention or treatment of malaria. Ocular or inner ear damage may occur in infants born of mothers who receive high doses of chloroquine throughout pregnancy.

Although chloroquine is excreted in breast milk, the amount is insufficient to confer any benefit on the infant. Separate chemoprophylaxis for the infant is required.

When used for rheumatoid disease breast feeding is not recommended.

4.7 Effects On Ability To Drive And Use Machines

Nivaquine has a temporary effect on visual accommodation and patients should be warned that they should not drive or operate machinery if they are affected.

4.8 Undesirable Effects

Cardiovascular

- cardiomyopathy has been reported during long term therapy at high doses,

- cardiac dysrhythmias at high doses can occur,

- hypotension.

Central Nervous System (See Section 4.4)

- seizures,

- convulsions have been reported rarely (these may result from cerebral malaria. Such patients should receive an injections of phenobarbital to prevent seizures, in a dose of 3.5mg/kg in addition to intravenous administration of Nivaquine),

- psychiatric disorders such as anxiety, confusion, hallucinations, delirium.

Eye disorders (See Sections 4.4 and 4.7)

- transient blurred vision and reversible corneal opacity,

- cases of retinopathy as well as cases of irreversible retinal damage have been reported during long term, high dose therapy.

- macular defects of colour vision, optic atrophy, scotomas, field defects, blindness and pigmented deposits, difficult in focusing, diplopia.

Gastro-intestinal

- gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal cramps.

General

- headache.

Haematological (See Section 4.4)

- bone marrow depression, including aplastic anaemia, agranulocytosis, thrombocytopenia, neutropenia occurs rarely.

Hepatic

- changes in liver function, including hepatitis and abnormal liver function tests, have been reported rarely.

Hypersensitivity

- allergic and anaphylactic reactions, urticaria and angiodema have occurred rarely.

Hearing disorders

- ototoxicity such as tinnitus, reduced hearing, nerve deafness.

Muscular

- neuropathy, myopathy.

Skin (See Section 4.4)

- skin eruptions, pruritis, depigmentation, loss of hair, exacerbation of psoriasis, photosensitivity, pigmentation of the nails and mucosae (long term use).

- Rare reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and similar desquamation-type events.

4.9 Overdose

Chloroquine is highly toxic in overdosage; children are particularly susceptible to toxic doses of chloroquine. The chief symptoms of overdose include circulatory collapse due to a potent cardiotoxic effect, respiratory arrest and coma. Symptoms may progress rapidly after initial headache, drowsiness, visual disturbances nausea and vomiting. Death may result from circulatory or respiratory failure or cardiac dysrhythmia.

Gastric lavage should be carried out urgently, first protecting the airways and instituting artificial ventilation where necessary. There is a risk of cardiac arrest following aspiration of gastric contents in more serious cases. Activated charcoal left in the stomach may reduce absorption of any remaining chloroquine from the gut. Circulatory status (with central venous pressure measurement), respiration, plasma electrolytes and blood gases should be monitored, with correction of hypokalaemia and acidosis if indicated. Cardiac arrhythmias should not be treated unless life threatening; drugs with quinidine-like effects should be avoided.

Early administration of the following has been shown to improve survival in cases of serious poisoning:

1) Adrenaline infusion (0.25 micrograms/kg/min initially, with increments of 0.25 micrograms/kg/min until adequate systolic blood pressure (more than 100 mm mercury) is restored; adrenaline reduces the effects of chloroquine on the heart through its inotropic and vasoconstrictor effects.

2) Diazepam infusion (2 mg/kg over 30 minutes as a loading dose, followed by 1-2 mg/kg/day for up to 2-4 days). Diazepam may minimise cardiotoxicity.

Acidification of the urine, haemodialysis, peritoneal dialysis or exchange transfusions have not been shown to be of value in treating chloroquine -poisoning. Chloroquine is excreted very slowly, therefore symptomatic cases merit observation for several days.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antimalarials, Aminoquinolines

ATC code: P01B A01

Chloroquine is used for the prevention of malaria. It has rapid schizonticidal effect and appears to affect cell growth by interfering with DNA; its activity also seems to depend on preferential accumulation in the infected erythrocyte. Chloroquine kills the erythrocytic forms of malaria parasites at all stages of development.

5.2 Pharmacokinetic Properties

Chloroquine is readily absorbed from the gastro-intestinal tract and about 55% in the circulation is bound to plasma proteins. It accumulates in high concentrations in some tissues, such as kidneys, liver, lungs and spleen and is strongly bound in melanin containing cells such as those in the eyes and the skin; it is also bound to double stranded DNA, present in red blood cells containing schizonts. Chloroquine is eliminated very slowly from the body and it may persist in tissues for a long period. Up to 70% of a dose may be excreted unchanged in urine and up to 25% may be excreted also in the urine as the desethyl metabolite. The rate of urinary excretion of chloroquine is increased at low pH values.

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, carcinogenic potential, toxicity to reproduction.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose,

Monosodium glutamate,

Saccharin sodium,

Propylene glycol,

Methyl parahydroxybenzoate,

Propyl parahydroxybenzoate,

Peppermint Oil,

Pineapple flavour,

Caramel,

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Nivaquine should be stored below 25^oC, protected from light.

6.5 Nature And Contents Of Container

Amber glass bottle containing 100 ml. Either with rolled on pilfer proof aluminium cap and PVDC emulsion coated wad, or HDPE/polypropylene child resistant cap with a tamper evident band.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 04425/0329

9. Date Of First Authorisation/Renewal Of The Authorisation

06 March 2003

10. Date Of Revision Of The Text

21 September 2010

Legal category

P

Auralgan

Pronunciation: AN-tee-PYE-reen/BEN-zoe-kane/POL-ee-COHS-an-ol
Generic Name: Antipyrine/Benzocaine/U-Polycosanol
Brand Name: Examples include Auralgan and Treagan

Auralgan is used for:

Relieving pain and inflammation in the ear caused by certain ear conditions. It may be used with antibiotics given by mouth to treat certain ear infections. It may also be used to help remove a buildup of earwax.

Auralgan is an astringent, analgesic, and anesthetic combination. It works by relieving pressure and reducing inflammation, congestion, pain, and discomfort.

Do NOT use Auralgan if:

• you are allergic to any ingredient in Auralgan or to similar medicines


• your eardrum is perforated or you have a discharge from the ear

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

Before using Auralgan:

Some medical conditions may interact with Auralgan. 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

Some MEDICINES MAY INTERACT with Auralgan. However, no specific interactions with Auralgan are known at this time.

Ask your health care provider if Auralgan 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 Auralgan:

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

• Auralgan is for topical use in the ear canal only. Do not get Auralgan in the eyes, nose, or mouth. If you get Auralgan in any of these areas, rinse right away with cool water.


• Before using, hold the ear drop container in your hand for 1 or 2 minutes to avoid dizziness that may result from putting cold drops into the ear. To use ear drops, lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. Moisten a clean cotton plug with Auralgan and gently insert into the ear canal to prevent medicine from leaking out.


• To prevent germs from contaminating the medicine, do not touch the applicator to any surface, including the ear. Do not rinse dropper after use. Keep the container tightly closed.


• If Auralgan is brown or contains particles, do not use it.


• If you miss a dose of Auralgan, use 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 use 2 doses at once.

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

Important safety information:

• Auralgan may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


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

Possible side effects of Auralgan:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Auralgan. 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); irritation not present when you began using Auralgan.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

See also: Auralgan 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 Auralgan:

Store Auralgan at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Protect from freezing. Keep the container tightly closed. Store away from heat, moisture, and light. Keep Auralgan out of the reach of children and away from pets.

General information:

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


• Auralgan 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 Auralgan. 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 Auralgan resources

• Auralgan Side Effects (in more detail)
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• Auralgan Support Group
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• Ear Wax Impaction

Anemagen

Pronunciation: EYE-urn/sux-IN-ic AS-id/VYE-ta-min C/VYE-ta-min B 12/DES-ih-kay-ted STUH-mak SUB-stans
Generic Name: Iron/Succinic Acid/Vitamin C/Vitamin B12/Desiccated Stomach Substance
Brand Name: Examples include Anemagen and Chromagen

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or a doctor at once.

Anemagen is used for:

Treating certain types of anemia that can be helped by increasing the amount of iron in the body (eg, anemia caused by pregnancy, blood loss, low dietary iron, metabolic disease, surgery). It may also be used for other conditions as determined by your doctor.

Anemagen is a combination of vitamins and minerals. It works by replacing iron in the body.

Do NOT use Anemagen if:

• you are allergic to any ingredient in Anemagen


• you have too much iron in your body (eg, hemochromatosis, hemosiderosis)

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

Before using Anemagen:

Some medical conditions may interact with Anemagen. 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 another type of anemia (eg, hemolytic anemia, megaloblastic anemia, pernicious anemia)


• if you have stomach or bowel problems (eg, Crohn disease, inflammation, ulcer), metabolism problems, porphyria, or a blood disease (eg, thalassemia)


• if you have had multiple blood transfusions

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

• Doxycycline, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Anemagen

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

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

• Take Anemagen by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow Anemagen whole. Do not break, crush, or chew before swallowing.


• Take Anemagen with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Anemagen.


• If you also take antacids, bisphosphonates (eg, etidronate), cephalosporins (eg, cefdinir), doxycycline, hydantoins (eg, phenytoin), levodopa, methyldopa, penicillamine, quinolones (eg, ciprofloxacin, levofloxacin), tetracyclines (eg, minocycline), or thyroid hormones (eg, levothyroxine), ask your doctor or pharmacist how to take them with Anemagen.


• If you miss a dose of Anemagen, 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 Anemagen.

Important safety information:

• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not take large doses of vitamins while you take Anemagen unless your doctor tells you to.


• Anemagen may cause your stools to darken. This is normal and not a cause for concern.


• Anemagen may interfere with certain lab tests, such as tests used to check for blood in the stool. Make sure your doctor and lab personnel know you are using Anemagen.


• Lab tests, including blood counts and iron levels, may be performed while you use Anemagen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Anemagen should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Anemagen while you are pregnant. Anemagen is found in breast milk. If you are or will be breast-feeding while you use Anemagen, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Anemagen:

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; darkened or green stools; diarrhea; nausea; stomach upset; vomiting.

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); black, tarry stools; blood or streaks of blood in the stool; severe or persistent vomiting or stomach pain.

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: Anemagen 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 black, tarry stools; chest pain; coma; dizziness; fast heartbeat; fever; increased or decreased urination; increased thirst or hunger; seizures; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or drowsiness; unusually pale skin; weak pulse.

Proper storage of Anemagen:

Store Anemagen at 77 degrees F (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 Anemagen out of the reach of children and away from pets.

General information:

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


• Anemagen 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 Anemagen. 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 Anemagen resources

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

• multivitamin with iron Concise Consumer Information (Cerner Multum)


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• Ferrex 150 Forte Prescribing Information (FDA)


• Ferrex 150 Forte Plus Prescribing Information (FDA)


• Ferrex 28 Prescribing Information (FDA)


• FerroGels Forte Prescribing Information (FDA)


• Hematogen Forte Prescribing Information (FDA)


• Integra F Prescribing Information (FDA)


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• Anemia
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Multivitamins

Generic Name: Multivitamins (MUL-ti-VYE-ta-mins)
Brand Name: Examples include Stress-600 and Thera-Tabs

Multivitamins is used for:

Treating or preventing low levels of vitamins in the body. It may also be used for other conditions as determined by your doctor.

Multivitamins is a vitamin supplement. It works by providing extra vitamins to the body.

Do NOT use Multivitamins if:

• you are allergic to any ingredient in Multivitamins

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

Before using Multivitamins:

Some medical conditions may interact with Multivitamins. 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

Some MEDICINES MAY INTERACT with Multivitamins.

Ask your health care provider if Multivitamins 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 Multivitamins:

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

• Take Multivitamins by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Multivitamins, 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 Multivitamins.

Important safety information:

• Do not take large doses of vitamins while you use Multivitamins unless your doctor tells you to.


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

Possible side effects of Multivitamins:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Multivitamins. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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

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 nausea; vomiting.

Proper storage of Multivitamins:

Store Multivitamins at room temperature. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Multivitamins out of the reach of children and away from pets.

General information:

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


• Multivitamins 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.

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

• Multivitamins Use in Pregnancy & Breastfeeding
• Multivitamins Drug Interactions
• Multivitamins Support Group
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UAD Caine

Generic Name: lidocaine injection (LYE doe kane)

Brand Names: Anestacaine, UAD Caine, Xylocaine HCl, Xylocaine-MPF

What is UAD Caine (lidocaine injection)?

Lidocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Lidocaine injection is used to numb an area of your body to help reduce pain or discomfort caused by invasive medical procedures such as surgery, needle punctures, or insertion of a catheter or breathing tube.

Lidocaine injection is also given in an epidural (spinal block) to reduce the discomfort of contractions during labor.

Lidocaine injection is sometimes used to treat irregular heart rhythms that may signal a possible heart attack.

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

What is the most important information I should know about UAD Caine (lidocaine injection)?

You should not receive this medication if you are allergic to lidocaine or any other type of numbing medicine.

Before you receive lidocaine injection, tell your doctor if you have liver or kidney disease, heart disease, coronary artery disease, circulation problems, or a history of malignant hyperthermia.

To treat irregular heart rhythms, your doctor may prescribe a LidoPen auto-injector. This is a prefilled automatic injection device to be used in an emergency. Keep the device with you at all times.

Your doctor will describe the signs and symptoms to watch for when deciding when it's time to use lidocaine injection at home. Never use the LidoPen auto-injector without first calling your doctor.

With the LidoPen auto-injector you will also receive a CardioBeeper to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper.

Lidocaine can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication

What should I discuss with my healthcare provider before receiving UAD Caine (lidocaine injection)?

You should not receive this medication if you are allergic to lidocaine or any other type of numbing medicine.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use lidocaine injection:

• liver disease;


• kidney disease;


• 
  

  heart disease;

  
  


• 
  

  coronary artery disease, circulation problems; or

  
  


• 
  

  a history of malignant hyperthermia.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether lidocaine injection 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 is lidocaine injection given?

Lidocaine is given as an injection through a needle placed into a vein or directly into the body area to be numbed. Your doctor, nurse, or other healthcare provider will give you this injection.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving lidocaine injection in a hospital setting.

To treat irregular heart rhythms, you may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

The LidoPen auto-injector is a prefilled automatic injection device to be used in an emergency. Keep the device with you at all times. Your doctor will describe the signs and symptoms to watch for when deciding when it's time to use the injection.

Never use the LidoPen auto-injector without first calling your doctor.

Do not use the auto-injector in or near a vein or into your buttocks. Inject the medication only in your upper thigh or upper arm.

With the LidoPen auto-injector you will also receive a CardioBeeper. This device is used to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper so you will be able to quickly use it in an emergency.

Store the LidoPen auto-injector at room temperature away from moisture and extreme hot or cold.

What happens if I miss a dose?

Since lidocaine injection is used only when needed, you are not likely to be on a dosing schedule.

Never use the LidoPen auto-injector without first calling your doctor.

What happens if I overdose?

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

Overdose symptoms may include drowsiness, confusion, nervousness, ringing in your ears, blurred vision, feeling hot or cold, numbness, muscle twitches, uneven heartbeats, seizure (convulsions), slowed breathing, or respiratory failure (breathing stops).

What should I avoid while receiving UAD Caine (lidocaine injection)?

Lidocaine can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication

Avoid eating or chewing within 1 hour after lidocaine injection is used to numb your mouth or throat. You may have trouble swallowing which could lead to choking. You may also accidentally bite the inside of your mouth if you are still numb an hour after treatment with lidocaine injection.

UAD Caine (lidocaine injection) side effects

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

• 
  

  feeling anxious, shaky, dizzy, restless, or depressed;

  
  


• 
  

  drowsiness, vomiting, ringing in your ears, blurred vision;

  
  


• 
  

  confusion, twitching, seizure (convulsions);

  
  


• 
  

  fast heart rate, rapid breathing, feeling hot or cold;

  
  


• 
  

  weak or shallow breathing, slow heart rate, weak pulse; or

  
  


• 
  

  feeling like you might pass out.

  
  

Less serious side effects include:

• 
  

  mild bruising, redness, itching, or swelling where the medication was injected;

  
  


• 
  

  mild dizziness;

  
  


• 
  

  nausea;

  
  


• 
  

  numbness in places where the medicine is accidentally applied.

  
  

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 UAD Caine (lidocaine injection)?

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

More UAD Caine resources

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

• Lidocaine Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)


• lidocaine Intradermal Advanced Consumer (Micromedex) - Includes Dosage Information


• Lidocaine Prescribing Information (FDA)


• Lidocaine Hydrochloride Monograph (AHFS DI)


• Lidocaine Hydrochloride (Local Anesthetic) Monograph (AHFS DI)

Compare UAD Caine with other medications

• Anesthesia
• Arrhythmia
• Ventricular Fibrillation
• Ventricular Tachycardia

Where can I get more information?

• Your doctor or pharmacist can provide more information about lidocaine injection.

See also: UAD Caine side effects (in more detail)

Midamor

Generic Name: amiloride (a MIL o ride)

Brand Names: Midamor

What is Midamor (amiloride)?

Amiloride is a potassium-sparing diuretic (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

Amiloride is used to treat or prevent hypokalemia (low potassium levels in the blood).

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

What is the most important information I should know about Midamor (amiloride)?

Do not use this medication if you have kidney disease, urination problems, or high levels of potassium in your blood. Do not use potassium supplements or other diuretics while you are taking amiloride.

Before using this medication, tell your doctor if you have heart or liver disease, or a breathing disorder.

Avoid drinking alcohol, which can increase some of the side effects of amiloride.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking amiloride.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

What should I discuss with my doctor before taking Midamor (amiloride)?

Do not use this medication if you have:

• kidney disease or are unable to urinate;


• 
  

  high potassium levels (hyperkalemia); or

  
  


• 
  

  if you are taking potassium supplements, or another potassium-sparing diuretic such Moduretic, spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium, Dyazide, Maxzide).

  
  

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before using amiloride, tell your doctor if you have:

• 
  

  diabetes;

  
  


• 
  

  heart disease;

  
  


• 
  

  cirrhosis or other liver disease;

  
  


• 
  

  a breathing disorder; or

  
  


• 
  

  if you are using another diuretic.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether amiloride 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 Midamor (amiloride)?

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

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

Take each dose with a full glass of water. Take amiloride with food.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

Amiloride can interfere with the results of a glucose tolerance test. Stop using this medication for at least 3 days before you have this test. Tell any doctor who treats you that you are using amiloride.

Store this medication at room temperature away from heat, light, and moisture. Do not allow the tablets to freeze.

See also: Midamor dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include dizziness, thirst, feeling light-headed, slow heartbeat, or fainting.

What should I avoid while taking Midamor (amiloride)?

Avoid drinking alcohol, which can increase some of the side effects of amiloride. Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking amiloride.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Midamor (amiloride) 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 any of these serious side effects:

• 
  

  numbness or tingly feeling;

  
  


• 
  

  muscle pain or weakness;

  
  


• 
  

  slow, fast, or uneven heartbeat;

  
  


• 
  

  feeling drowsy, restless, or light-headed;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  dry mouth, increased thirst, tiredness, nausea, vomiting;

  
  


• 
  

  shallow breathing;

  
  


• 
  

  tremors, confusion; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  mild nausea, loss of appetite;

  
  


• 
  

  gas, stomach pain; or

  
  


• 
  

  skin rash.

  
  

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 Midamor (amiloride)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• 
  

  cyclosporine (Neoral, Sandimmune, Gengraf);

  
  


• 
  

  tacrolimus (Prograf);

  
  


• 
  

  lithium;

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others; or

  
  


• 
  

  indomethacin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Motrin, Advil), diclofenac (Voltaren), naproxen (Aleve, Naprosyn), piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others.

  
  

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

More Midamor resources

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

• Midamor Prescribing Information (FDA)


• Midamor MedFacts Consumer Leaflet (Wolters Kluwer)


• Midamor Monograph (AHFS DI)


• Midamor Advanced Consumer (Micromedex) - Includes Dosage Information


• Amiloride Prescribing Information (FDA)

Compare Midamor with other medications

• Ascites
• Edema
• Heart Failure
• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about amiloride.

See also: Midamor side effects (in more detail)

Sorine

Generic Name: sotalol (Oral route)

SOE-ta-lol

Oral route(Tablet)

To minimize the risk of induced arrhythmia, patients initiated or reinitiated on sotalol should be placed for a minimum of three days (on their maintenance dose) in a facility that can provide continuous cardiac resuscitation and ECG monitoring. Creatinine clearance should be calculated prior to dosing. Sotalol marketed under the brand name Betapace(R) is indicated for the treatment of documented life-threatening ventricular arrhythmias. Sotalol marketed under the brand name Betapace AF(R) is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial flutter (AFIB/AFL)) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Betapace(R) and Betapace AF(R) cannot be substituted for each other because of significant differences in labeling (eg, indications, patient package insert, dosing administration, and safety information) .

Commonly used brand name(s)

In the U.S.

• Betapace


• Betapace AF


• Sorine

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

Uses For Sorine

Sotalol is used to control rapid heartbeats and abnormal heart rhythms .

This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and at a regular rhythm .

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

Before Using Sorine

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 sotalol in the pediatric population. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of sotalol in geriatric patients .

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.

• Bepridil


• Cisapride


• Dronedarone


• Grepafloxacin


• Levomethadyl


• Mesoridazine


• Pimozide


• Sparfloxacin


• Terfenadine


• Thioridazine


• Ziprasidone

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.

• Acecainide


• Acetazolamide


• Albuterol


• Amiloride


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Apomorphine


• Aprindine


• Arformoterol


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Azithromycin


• Azosemide


• Bambuterol


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bitolterol


• Bretylium


• Broxaterol


• Bumetanide


• Canrenoate


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Chlorthalidone


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clenbuterol


• Clomipramine


• Clonidine


• Clopamide


• Clozapine


• Colterol


• Crizotinib


• Cyclothiazide


• Dasatinib


• Desipramine


• Dibenzepin


• Diltiazem


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Dronedarone


• Droperidol


• Enflurane


• Epinephrine


• Erythromycin


• Ethacrynic Acid


• Etozolin


• Fenoldopam


• Fenoterol


• Fenquizone


• Fingolimod


• Flecainide


• Fluconazole


• Fluoxetine


• Formoterol


• Foscarnet


• Furosemide


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Hexoprenaline


• Hydrochlorothiazide


• Hydroflumethiazide


• Ibutilide


• Iloperidone


• Imipramine


• Indacaterol


• Indapamide


• Isoetharine


• Isoflurane


• Isradipine


• Itraconazole


• Ketoconazole


• Lapatinib


• Levalbuterol


• Levofloxacin


• Lidocaine


• Lidoflazine


• Lopinavir


• Lorcainide


• Lumefantrine


• Mannitol


• Mefloquine


• Metaproterenol


• Methadone


• Metolazone


• Moricizine


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Pirbuterol


• Piretanide


• Polythiazide


• Posaconazole


• Prilocaine


• Probucol


• Procainamide


• Procaterol


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinethazone


• Quinidine


• Quinine


• Ranolazine


• Reproterol


• Rimiterol


• Risperidone


• Ritodrine


• Salmeterol


• Saquinavir


• Sematilide


• Sertindole


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Spiramycin


• Spironolactone


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tedisamil


• Telavancin


• Telithromycin


• Terbutaline


• Tetrabenazine


• Ticrynafen


• Toremifene


• Torsemide


• Trazodone


• Tretoquinol


• Triamterene


• Trichlormethiazide


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Tulobuterol


• Vandetanib


• Vardenafil


• Vasopressin


• Vemurafenib


• Verapamil


• Voriconazole


• Xipamide


• Zolmitriptan


• Zotepine

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.

• Abarelix


• Acarbose


• Aceclofenac


• Acemetacin


• Acetohexamide


• Alclofenac


• Alfuzosin


• Amlodipine


• Apazone


• Arbutamine


• Benfluorex


• Benoxaprofen


• Bromfenac


• Bufexamac


• Bunazosin


• Carprofen


• Chlorpropamide


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Digoxin


• Dipyrone


• Doxazosin


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Felodipine


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Guar Gum


• Ibuprofen


• Indomethacin


• Indoprofen


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Isoxicam


• Ketoprofen


• Ketorolac


• Lacidipine


• Lercanidipine


• Lornoxicam


• Manidipine


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Metformin


• Methyldopa


• Mibefradil


• Miglitol


• Moxisylyte


• Nabumetone


• Naproxen


• Nicardipine


• Nifedipine


• Niflumic Acid


• Nilvadipine


• Nimesulide


• Nimodipine


• Nisoldipine


• Nitrendipine


• Oxaprozin


• Oxyphenbutazone


• Phenoxybenzamine


• Phentolamine


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Pranidipine


• Prazosin


• Propyphenazone


• Proquazone


• Repaglinide


• St John's Wort


• Sulindac


• Suprofen


• Tamsulosin


• Tenidap


• Tenoxicam


• Terazosin


• Tiaprofenic Acid


• Tolazamide


• Tolbutamide


• Tolmetin


• Trimazosin


• Troglitazone


• Urapidil


• Zomepirac

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:

• Asthma or


• Bradycardia (slow heartbeat) or


• Heart block or


• Heart failure or


• Long QT syndrome (heart rhythm problem)—Should not use in patients with these conditions .

• Diabetes or


• Hyperthyroidism (overactive thyroid) or


• Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

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

• Lung disease (e.g., bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition .

• Sick sinus syndrome (heart rhythm problem)—Use with caution. May make this condition worse .

Proper Use of sotalol

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

For the first three days, you will receive this medicine in a hospital where your heart rhythm can be monitored .

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous .

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 abnormal heart rhythms:
    
    • Adults—At first, 80 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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 Sorine

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

Sotalol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests .

Sorine 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:

More common

• Blurred vision


• chest pain or discomfort


• confusion


• diarrhea


• difficult or labored breathing


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


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


• lightheadedness, dizziness, or fainting


• nausea and vomiting


• shortness of breath


• sweating


• swelling of face, fingers, feet, or lower legs


• tightness in chest


• unusual tiredness or weakness


• wheezing

Less common

• Abdominal pain or swelling


• back pain


• black, tarry stools


• blood in eyes


• blood in urine


• body aches or pain


• bruising or purple areas on skin


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


• change in consciousness


• cold hands and feet


• cough or hoarseness


• coughing up blood


• decreased alertness


• decreased urine output


• difficulty in speaking


• dilated neck veins


• double vision


• ear congestion


• extreme fatigue


• feeling of warmth or heat


• fever or chills


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


• headache


• inability to move arms, legs, or facial muscles


• inability to speak


• irregular breathing


• joint pain or swelling


• loss of voice


• lower back or side pain


• nasal congestion


• nervousness


• noisy breathing


• nosebleeds


• painful, burning, or difficult urination


• pounding in the ears


• runny nose


• slow speech


• sneezing


• sore throat


• troubled breathing


• weight gain

Rare

• Bleeding gums


• fast breathing, sometimes with wheezing


• large amount of fat in the blood


• not able to move


• pinpoint red spots on skin


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


• swollen glands


• unusual bleeding or bruising

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

Symptoms of overdose

• Anxiety


• cold sweats


• coma


• cool, pale skin


• depression


• increased hunger


• nightmares


• no heartbeat


• seizures


• shakiness


• slurred speech

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

More common

• Acid or sour stomach


• belching


• difficulty in sleeping


• heartburn


• indigestion


• lack or loss of strength


• pain in arms or legs


• stomach discomfort or upset

Less common

• Abnormal ejaculation


• bloated


• decreased sexual performance or desire


• disturbed color perception


• double vision


• excess air or gas in stomach or intestines


• full feeling


• halos around lights


• loss of appetite


• loss of vision


• mood changes


• night blindness


• overbright appearance of lights


• passing gas


• skin rash


• tunnel vision


• weight changes

Rare

• Crying


• depersonalization


• difficulty in moving


• dysphoria


• euphoria


• feeling of constant movement of self or surroundings


• hair loss, thinning of hair


• increased sensitivity of skin to sunlight


• itching skin


• lack of coordination


• mental depression


• muscle aching or cramping


• muscle pains or stiffness


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• redness or other discoloration of skin


• sensation of spinning


• severe sunburn

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: Sorine side effects (in more detail)

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Indocin Injection

Generic Name: indomethacin

Dosage Form: injection, powder, lyophilized, for solution
Sterile

Indocin® I.V.

(indomethacin for injection)

Rx only

DESCRIPTION

Sterile INDOCIN® I.V. (indomethacin for injection) for intravenous administration is lyophilized indomethacin for injection. Each vial contains indomethacin for injection equivalent to 1 mg indomethacin as a white to yellow lyophilized powder or plug. Variations in the size of the lyophilized plug and the intensity of color have no relationship to the quality or amount of indomethacin present in the vial.

Indomethacin for injection is designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid, sodium salt, trihydrate. Its molecular weight is 433.82. Its empirical formula is C19H15ClNNaO4•3H2O and its structural formula is:

CLINICAL PHARMACOLOGY

Although the exact mechanism of action through which indomethacin causes closure of a patent ductus arteriosus is not known, it is believed to be through inhibition of prostaglandin synthesis. Indomethacin has been shown to be a potent inhibitor of prostaglandin synthesis, both in vitro and in vivo. In human newborns with certain congenital heart malformations, PGE 1 dilates the ductus arteriosus. In fetal and newborn lambs, E type prostaglandins have also been shown to maintain the patency of the ductus, and as in human newborns, indomethacin causes its constriction.

Studies in healthy young animals and in premature infants with patent ductus arteriosus indicated that, after the first dose of intravenous indomethacin, there was a transient reduction in cerebral blood flow velocity and cerebral blood flow. Similar decreases in mesenteric blood flow and velocity have been observed. The clinical significance of these effects has not been established.

In double-blind, placebo-controlled studies of INDOCIN I.V. in 460 small pre-term infants, weighing 1750 g or less, the neonates treated with placebo had a ductus closure rate after 48 hours of 25 to 30 percent, whereas those treated with INDOCIN I.V. had a 75 to 80 percent closure rate. In one of these studies, a multicenter study, involving 405 pre-term infants, later re-opening of the ductus arteriosus occurred in 26 percent of neonates treated with INDOCIN I.V., however, 70 percent of these closed subsequently without the need for surgery or additional indomethacin.

Pharmacokinetics and Metabolism

The disposition of indomethacin following intravenous administration (0.2 mg/kg) in pre-term neonates with patent ductus arteriosus has not been extensively evaluated. Even though the plasma half-life of indomethacin was variable among premature infants, it was shown to vary inversely with postnatal age and weight. In one study, of 28 neonates who could be evaluated, the plasma half-life in those less than 7 days old averaged 20 hours (range: 3-60 hours, n=18). In neonates older than 7 days, the mean plasma half-life of indomethacin was 12 hours (range: 4-38 hours, n=10). Grouping the neonates by weight, mean plasma half-life in those weighing less than 1000 g was 21 hours (range: 9-60 hours, n=10); in those neonates weighing more than 1000 g, the mean plasma half-life was 15 hours (range: 3-52 hours, n=18).

Following intravenous administration in adults, indomethacin is eliminated via renal excretion, metabolism, and biliary excretion. Indomethacin undergoes appreciable enterohepatic circulation. The mean plasma half-life of indomethacin is 4.5 hours. In the absence of enterohepatic circulation, it is 90 minutes. Indomethacin has been found to cross the blood-brain barrier and the placenta.

In adults, about 99 percent of indomethacin is bound to protein in plasma over the expected range of therapeutic plasma concentrations. The percent bound in neonates has not been studied. In controlled trials in premature infants, however, no evidence of bilirubin displacement has been observed as evidenced by increased incidence of bilirubin encephalopathy (kernicterus).

INDICATIONS AND USAGE

INDOCIN I.V. is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray.

CONTRAINDICATIONS

INDOCIN I.V. is contraindicated in: neonates with proven or suspected infection that is untreated; neonates who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; neonates with thrombocytopenia; neonates with coagulation defects; neonates with or who are suspected of having necrotizing enterocolitis; neonates with significant impairment of renal function; neonates with congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta).

WARNINGS

Gastrointestinal Effects

In the collaborative study, major gastrointestinal bleeding was no more common in those neonates receiving indomethacin than in those neonates on placebo. However, minor gastrointestinal bleeding (i.e., chemical detection of blood in the stool) was more commonly noted in those neonates treated with indomethacin. Severe gastrointestinal effects have been reported in adults with various arthritic disorders treated chronically with oral indomethacin. [For further information, see package insert for Capsules INDOCIN® (Indomethacin).]

Central Nervous System Effects

Prematurity per se, is associated with an increased incidence of spontaneous intraventricular hemorrhage. Because indomethacin may inhibit platelet aggregation, the potential for intraventricular bleeding may be increased. However, in the large multicenter study of INDOCIN I.V. (see CLINICAL PHARMACOLOGY), the incidence of intraventricular hemorrhage in neonates treated with INDOCIN I.V. was not significantly higher than in the control neonates.

Renal Effects

INDOCIN I.V. may cause significant reduction in urine output (50 percent or more) with concomitant elevations of blood urea nitrogen and creatinine, and reductions in glomerular filtration rate and creatinine clearance. These effects in most neonates are transient, disappearing with cessation of therapy with INDOCIN I.V. However, because adequate renal function can depend upon renal prostaglandin synthesis, INDOCIN I.V. may precipitate renal insufficiency, including acute renal failure, especially in neonates with other conditions that may adversely affect renal function (e.g., extracellular volume depletion from any cause, congestive heart failure, sepsis, concomitant use of any nephrotoxic drug, hepatic dysfunction). When significant suppression of urine volume occurs after a dose of INDOCIN I.V., no additional dose should be given until the urine output returns to normal levels.

INDOCIN I.V. in pre-term infants may suppress water excretion to a greater extent than sodium excretion. When this occurs, a significant reduction in serum sodium values (i.e., hyponatremia) may result. Neonates should have serum electrolyte determinations done during therapy with INDOCIN I.V. Renal function and serum electrolytes should be monitored (see PRECAUTIONS, Drug Interactions and DOSAGE AND ADMINISTRATION).

PRECAUTIONS

General

INDOCIN (Indomethacin) may mask the usual signs and symptoms of infection. Therefore, the physician must be continually on the alert for this and should use the drug with extra care in the presence of existing controlled infection.

Severe hepatic reactions have been reported in adults treated chronically with oral indomethacin for arthritic disorders. [For further information, see package insert for Capsules INDOCIN (Indomethacin).] If clinical signs and symptoms consistent with liver disease develop in the neonate, or if systemic manifestations occur, INDOCIN I.V. should be discontinued.

INDOCIN I.V. may inhibit platelet aggregation. In one small study, platelet aggregation was grossly abnormal after indomethacin therapy (given orally to premature infants to close the ductus arteriosus). Platelet aggregation returned to normal by the tenth day. Premature infants should be observed for signs of bleeding.

The drug should be administered carefully to avoid extravascular injection or leakage as the solution may be irritating to tissue.

Drug Interactions

Since renal function may be reduced by INDOCIN I.V., consideration should be given to reduction in dosage of those medications that rely on adequate renal function for their elimination. Because the half-life of digitalis (given frequently to pre-term infants with patent ductus arteriosus and associated cardiac failure) may be prolonged when given concomitantly with indomethacin, the neonate should be observed closely; frequent ECGs and serum digitalis levels may be required to prevent or detect digitalis toxicity early. Furthermore, in one study of premature infants treated with INDOCIN I.V. and also receiving either gentamicin or amikacin, both peak and trough levels of these aminoglycosides were significantly elevated.

Therapy with indomethacin may blunt the natriuretic effect of furosemide. This response has been attributed to inhibition of prostaglandin synthesis by non-steroidal anti-inflammatory drugs. In a study of 19 premature infants with patent ductus arteriosus treated with either INDOCIN I.V. alone or a combination of INDOCIN I.V. and furosemide, results showed that neonates receiving both INDOCIN I.V. and furosemide had significantly higher urinary output, higher levels of sodium and chloride excretion, and higher glomerular filtration rates than did those receiving INDOCIN I.V. alone. In this study, the data suggested that therapy with furosemide helped to maintain renal function in the premature infant when INDOCIN I.V. was added to the treatment of patent ductus arteriosus.

Indomethacin usually does not influence the hypoprothrombinemia produced by anticoagulants. When indomethacin is added to anticoagulants, prothrombin time should be monitored closely. In post marketing experience, bleeding has been reported in patients on concomitant treatment with anticoagulants and INDOCIN I.V. Caution should be exercised when INDOCIN I.V. and anticoagulants are administered concomitantly.

In some patients with compromised renal function, the co-administration of an NSAID and an ACE inhibitor or angiotensin II antagonist may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.

Neonatal Effects

In rats and mice, oral indomethacin 4.0 mg/kg/day given during the last three days of gestation caused a decrease in maternal weight gain and some maternal and fetal deaths. An increased incidence of neuronal necrosis in the diencephalon in the live-born fetuses was observed. At 2.0 mg/kg/day, no increase in neuronal necrosis was observed as compared to the control groups. Administration of 0.5 or 4.0 mg/kg/day during the first three days of life did not cause an increase in neuronal necrosis at either dose level.

Pregnant rats, given 2.0 mg/kg/day and 4.0 mg/kg/day during the last trimester of gestation, delivered offspring whose pulmonary blood vessels were both reduced in number and excessively muscularized. These findings are similar to those observed in the syndrome of persistent pulmonary hypertension of the neonate.

ADVERSE REACTIONS

In a double-blind, placebo-controlled trial of 405 premature infants weighing less than or equal to 1750 g with evidence of large ductal shunting, in those neonates treated with indomethacin (n=206), there was a statistically significantly greater incidence of bleeding problems, including gross or microscopic bleeding into the gastrointestinal tract, oozing from the skin after needle stick, pulmonary hemorrhage, and disseminated intravascular coagulopathy. There was no statistically significant difference between treatment groups with reference to intracranial hemorrhage.

The neonates treated with indomethacin for injection also had a significantly higher incidence of transient oliguria and elevations of serum creatinine (greater than or equal to 1.8 mg/dL) than did the neonates treated with placebo.

The incidences of retrolental fibroplasia (grades III and IV) and pneumothorax in neonates treated with INDOCIN I.V. were no greater than in placebo controls and were statistically significantly lower than in surgically-treated neonates.

The following additional adverse reactions in neonates have been reported from the collaborative study, anecdotal case reports, from other studies using rectal, oral, or intravenous indomethacin for treatment of patent ductus arteriosus or in marketed use. The rates are calculated from a database which contains experience of 849 indomethacin-treated neonates reported in the medical literature, regardless of the route of administration. One year follow-up is available on 175 neonates and shows no long-term sequelae which could be attributed to indomethacin. In controlled clinical studies, only electrolyte imbalance and renal dysfunction (of the reactions listed below) occurred statistically significantly more frequently after INDOCIN I.V. than after placebo. Reactions marked with a single asterisk (*) occurred in 3-9 percent of indomethacin-treated neonates; those marked with a double asterisk (**) occurred in 3-9 percent of both indomethacin- and placebo-treated neonates. Unmarked reactions occurred in less than 3 percent of neonates.

Renal:  renal failure, renal dysfunction in 41 percent of neonates, including one or more of the following: reduced urinary output; reduced urine sodium, chloride, or potassium, urine osmolality, free water clearance, or glomerular filtration rate; elevated serum creatinine or BUN; uremia.

Cardiovascular:  intracranial bleeding**, pulmonary hypertension.

Gastrointestinal:  gastrointestinal bleeding*, vomiting, abdominal distention, transient ileus, gastric perforation, localized perforation(s) of the small and/or large intestine, necrotizing enterocolitis.

Metabolic:  hyponatremia*, elevated serum potassium*, reduction in blood sugar, including hypoglycemia, increased weight gain (fluid retention).

Coagulation:  decreased platelet aggregation (see PRECAUTIONS).

The following adverse reactions have also been reported in neonates treated with indomethacin, however, a causal relationship to therapy with INDOCIN I.V. has not been established:

Cardiovascular:  bradycardia.

Respiratory:  apnea, exacerbation of pre-existing pulmonary infection.

Metabolic:  acidosis/alkalosis.

Hematologic:  disseminated intravascular coagulation, thrombocytopenia.

Ophthalmic:  retrolental fibroplasia.**

A variety of additional adverse experiences have been reported in adults treated with oral indomethacin for moderate to severe rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute painful shoulder and acute gouty arthritis (see package insert for Capsules INDOCIN (indomethacin) for additional information concerning adverse reactions and other cautionary statements). Their relevance to the pre-term infant receiving indomethacin for patent ductus arteriosus is unknown, however, the possibility exists that these experiences may be associated with the use of INDOCIN I.V. in pre-term infants.

To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck Inc. at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

FOR INTRAVENOUS ADMINISTRATION ONLY.

Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as three intravenous doses of INDOCIN I.V. given at 12-24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of INDOCIN I.V., no additional doses should be given until laboratory studies indicate that renal function has returned to normal (see WARNINGS, Renal Effects).

Dosage according to age is as follows:

AGE at 1st dose	DOSAGE (mg/kg)
Less than 48 hours	1st 0.2	2nd 0.1	3rd 0.1
2-7 days	0.2	0.2	0.2
over 7 days	0.2	0.25	0.25

If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of INDOCIN I.V., no further doses are necessary. If the ductus arteriosus re-opens, a second course of 1-3 doses may be given, each dose separated by a 12-24 hour interval as described above.

If the neonate remains unresponsive to therapy with INDOCIN I.V. after 2 courses, surgery may be necessary for closure of the ductus arteriosus. If severe adverse reactions occur, STOP THE DRUG.

Directions For Use

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

The reconstituted solution is clear, slightly yellow and essentially free from visible particles.

The solution should be prepared only with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, all diluents should be preservative-free. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Any unused portion of the solution should be discarded because there is no preservative contained in the vial. A fresh solution should be prepared just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20-30 minutes.

INDOCIN I.V. is not buffered. Further dilution with intravenous infusion solutions is not recommended.

HOW SUPPLIED

Sterile INDOCIN I.V. is a lyophilized white to yellow powder or plug supplied as single dose vials containing indomethacin for injection, equivalent to 1 mg indomethacin.

NDC 67386-511-51.

Storage

Store at 20-25°C (68-77°F). See USP controlled room temperature. Protect from light. Store container in carton until contents have been used.

Manufactured by: Merck & Co., Inc., Whitehouse Station, NJ 08889, U.S.A.

For: Lundbeck Inc., Deerfield, IL 60015, U.S.A.

® Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Revised: January 2010

PRINCIPAL DISPLAY PANEL

NDC 67386-511-51

Sterile Indocin® I.V.

(indomethacin for injection)

1 mg

12 x (3 x 1 mg Single Dose Vials)

Rx only

 

INDOCIN  indomethacin  injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67386-511 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDOMETHACIN SODIUM (INDOMETHACIN) INDOMETHACIN SODIUM 1 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67386-511-51 36 VIAL In 1 PACKAGE contains a VIAL 1 1 VIAL In 1 VIAL This package is contained within the PACKAGE (67386-511-51)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018878	01/30/1985

Labeler - Lundbeck Inc. (018343595)

Establishment
Name	Address	ID/FEI	Operations
Merck Sharp & Dohme Corp.		002387926	manufacture

Revised: 01/2010Lundbeck Inc.

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