Astramorph PF Solution

Pronunciation: MORE-feen
Generic Name: Morphine
Brand Name: Examples include Astramorph PF and Duramorph

Astramorph PF Solution is used for:

Treating pain. It may also be used for other conditions as determined by your doctor.

Astramorph PF Solution is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, breathing and circulatory systems) at higher doses.

Do NOT use Astramorph PF Solution if:

• you are allergic to any ingredient in Astramorph PF Solution


• you are taking cimetidine, a phenothiazine (eg, chlorpromazine), sodium oxybate (GHB), or a tricyclic antidepressant (eg, amitriptyline), or you drink alcohol


• you have known or suspected paralysis of the intestines or antibiotic-associated colitis


• you have diarrhea due to poisoning


• you have an upper airway (breathing) obstruction or low blood volume, or you are having an asthma attack


• you will be having general anesthesia

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

Before using Astramorph PF Solution:

Some medical conditions may interact with Astramorph PF 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 asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems, or you have a history of drug abuse or dependence


• if you have increased pressure in the head, a recent head injury, or lesions in the head


• if you have heart, liver, or thyroid disease; curvature of the spine; seizures; or a history of suicidal thoughts or behaviors


• if you have a stomach blockage or inflammatory bowel disease, or you recently had stomach tract surgery

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

• Fluoxetine, naltrexone, rifampin, or risperidone because they may decrease the effectiveness of Astramorph PF Solution


• Barbiturate anesthetics (eg, thiopental), cimetidine, ethanol, ketorolac, phenothiazines (eg, chlorpromazine), sodium oxybate ( GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects (eg, disorientation, respiratory depression, seizures) may occur


• Barbiturate anesthetics (eg, thiopental) or sodium oxybate (GHB) because the risk of their side effects may be increased by Astramorph PF Solution


• Mexiletine or trovafloxacin because their effectiveness may be decreased by Astramorph PF Solution

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

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

• Astramorph PF Solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Astramorph PF Solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Astramorph PF Solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Astramorph PF Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• If you also take trovafloxacin, do not take it within 4 hours before or after taking Astramorph PF Solution. Check with your doctor if you have questions.


• 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.


• If you miss a dose of Astramorph PF Solution and you are using it regularly, 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 Astramorph PF Solution.

Important safety information:

• Astramorph PF Solution may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Astramorph PF Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Astramorph PF Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• The risk of Astramorph PF Solution becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


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


• Do not take Astramorph PF Solution if you have had a severe allergic reaction to morphine or hydromorphone (eg, MS Contin, Roxanol, Dilaudid). If you have a question about whether you are allergic to Astramorph PF Solution or if a certain medicine contains morphine or hydromorphone, contact your doctor or pharmacist.


• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.


• Lab tests, including liver function, kidney function, lung function, and complete blood cell counts, may be performed while you use Astramorph PF 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 Astramorph PF Solution with caution in the ELDERLY; they may be more sensitive to its effects.


• Astramorph PF Solution should not be used 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 Astramorph PF Solution while you are pregnant. Astramorph PF Solution is found in breast milk. Do not breast-feed while taking Astramorph PF Solution.

When used for long periods of time or at high doses, Astramorph PF Solution may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Astramorph PF Solution stops working well. Do not take more than prescribed.

Some people who use Astramorph PF Solution for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Astramorph PF Solution suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Astramorph PF 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:

Agitation; anxiety; changes in vision; confusion; constipation; decreased sex drive; dizziness; drowsiness; dry mouth; exaggerated sense of well-being; fear; frequent urination; headache; incoordination; lack of energy; lightheadedness; loss of appetite; mental clouding; mood swings; nausea; pinpoint pupils; restless mood; sleeplessness; sweating; 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); decreased sexual ability; delirium; difficulty urinating; disorientation; fainting; fast or slow heartbeat; flushing of the face; hallucinations; itching; menstrual changes; mental or mood changes; pounding in the chest; seizures; slowed breathing; tremor; 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: Astramorph PF 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 cold and clammy skin; convulsions; deep sleep; dizziness; drowsiness; lightheadedness; loss of consciousness; slowed breathing; slowed heartbeat.

Proper storage of Astramorph PF Solution:

Store Astramorph PF Solution between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep out of reach of children and away from pets.

General information:

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


• Astramorph PF 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 Astramorph PF 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 Astramorph PF resources

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

Compare Astramorph PF with other medications

• Pain

Auraphene-B otic

Generic Name: carbamide peroxide (otic) (KAR ba mide per OX ide OH tik)

Brand Names: Auraphene-B, Auro Ear Drops, Debrox, Ear Wax, Ear Wax Removal, Mollifene, Murine Ear Drops

What is carbamide peroxide?

Carbamide peroxide otic (for the ears) is used to soften and loosen ear wax, making it easier to remove.

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

What is the most important information I should know about carbamide peroxide?

You should not use this medication if you are allergic to carbamide peroxide, or if you have a ruptured ear drum. Do not use carbamide peroxide if you have any signs of ear infection or injury, such as pain or other irritation, or drainage, discharge, or bleeding from the ear. Do not use this medication in a child younger than 12 years old without the advice of a doctor.

You may hear a bubbling sound inside your ear after using carbamide peroxide ear drops. This is caused by the foaming action of carbamide peroxide, which helps break up the wax inside your ear.

Do not use carbamide peroxide for longer than 4 days in a row. Call your doctor if your ear symptoms do not improve after treatment, or if they get worse. Stop using carbamide peroxide and call your doctor at once if you have a serious side effect such as dizziness, ear pain or other irritation, decreased hearing for a prolonged period of time, or discharge or bleeding from the ear.

What should I discuss with my health care provider before using carbamide peroxide?

You should not use this medication if you are allergic to carbamide peroxide, or if you have any signs of ear infection or injury such as:

• 
  

  ear pain, itching, or other irritation;

  
  


• 
  

  drainage or discharge from the ear; or

  
  


• 
  

  bleeding from the ear.

  
  

FDA pregnancy category C. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Do not use this medication in a child younger than 12 years old without the advice of a doctor.

How should I use carbamide peroxide?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The usual dose of this medication for children is 1 to 5 drops per ear twice daily. The usual dose for adults is 5 to 10 drops per ear twice daily. Follow your doctor's instructions. Carbamide peroxide may be used for up to 4 days, unless your doctor has told you otherwise.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. Hold the dropper upside down over your ear canal and drop the correct number of ear drops into the ear.

You may hear a bubbling sound inside your ear after putting in the drops. This is caused by the foaming action of carbamide peroxide, which helps break up the wax inside your ear.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes. You may use a small piece of cotton ball to plug the ear and keep the medicine from draining out. Follow your doctor's instructions about the use of cotton.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

Wipe the tip of the medicine bottle with a clean tissue. Do not wash the dropper tip.

Carbamide peroxide may be packaged with a bulb syringe that is used to flush out your ear with water.

When filling the bulb syringe, use only warm water that is body temperature (no warmer than 98 degrees F). Do not use hot or cold water.

Hold your head sideways with your ear over a sink or bowl.

Gently pull your ear lobe back and downward to open up the ear canal. Place the tip of the bulb syringe at the opening of your ear canal. Do not insert the tip into your ear.

Squeeze the bulb syringe gently to release the water into your ear. Do not squirt the water with any force into your ear, or you could damage your ear drum.

Remove the syringe and allow the water to drain from your ear into the sink or bowl.

Do not use carbamide peroxide for longer than 4 days in a row. Call your doctor if your ear symptoms do not improve after treatment, or if they get worse.

Clean the bulb syringe by filling it with plain water and emptying it several times. Do not use soap or other cleaning chemicals. Allow the syringe to air dry.

Store the medication and the bulb syringe at room temperature away from moisture, heat, and direct light.

What happens if I miss a dose?

Since carbamide peroxide is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use 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.

An overdose of carbamide peroxide is not likely to cause life-threatening symptoms.

What should I avoid while using carbamide peroxide?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using this medication.

Carbamide peroxide 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 carbamide peroxide and call your doctor at once if you have a serious side effect such as:

• 
  

  dizziness;

  
  


• 
  

  ear pain, itching, or other irritation;

  
  


• 
  

  discharge or bleeding from the ear; or

  
  


• 
  

  decreased hearing for a prolonged period of time.

  
  

Less serious side effects may include:

• 
  

  temporary decrease in hearing after using the ear drops;

  
  


• 
  

  mild feeling of fullness in the ear; or

  
  


• 
  

  mild itching inside the ear.

  
  

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 carbamide peroxide?

It is not likely that other drugs you take orally or inject will have an effect on carbamide peroxided otic. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Auraphene-B resources

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

Compare Auraphene-B with other medications

• Ear Wax Impaction

Where can I get more information?

• Your pharmacist can provide more information about carbamide peroxide.

See also: Auraphene-B side effects (in more detail)

Boots Pain Relief Paracetamol Suspension 3 Months Plus

1. Name Of The Medicinal Product

Galpamol

Junior Paracetamol Suspension

Boots Pain Relief Paracetamol Suspension 3 Months Plus

Galpamol for Children Paracetamol 120mg/5ml Oral Suspension

Infant's & Children's Paracetamol Suspension

Boots Paracetamol Sachets 3 Months Plus 120 mg/5 ml Oral Suspension

2. Qualitative And Quantitative Composition

Paracetamol 120 mg / 5 ml

3. Pharmaceutical Form

Oral Suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of mild to moderate pain including teething pain, and for pyrexia.

4.2 Posology And Method Of Administration

For oral administration. It is important to shake the bottle for at least 10 seconds before use.

For children aged 3 months to 12 years:

Child's Age	How Much	How often (in 24 hours)
3 – 6 months	One 2.5 mL spoonful (small end)	4 times
6 – 24 months	One 5 mL spoonful (large end)	4 times
2 – 4 years	One 5.0 mL spoonful (large end) and one 2.5 mL spoonful (small end)	4 times
4 – 8 years	Two 5 mL spoonfuls (large end)	4 times
8 – 10 years	Three 5 mL spoonfuls (large end)	4 times
10 - 12 years	Four 5 mL spoonfuls (large end)	4 times
• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

For infants aged less than 3 months:

Age	Dose
For post-vaccination fever for babies aged between 2 – 3 months	One 2.5 mL spoonful (small end) If necessary, after 4-6 hours, give a second 2.5 mL dose
• Do not give to babies less than 2 months of age • Do not give more than 2 doses • Leave at least 4 hours between doses • If further doses are needed, talk to your doctor or pharmacist

4.3 Contraindications

Contra-indicated in patients with a known hypersensitivity to paracetamol or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Paracetamol should be used with care in patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Patients should be advised not to take other paracetamol containing products concurrently.

Paracetamol should be used with care in patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Patients should be advised not to take other paracetamol containing products concurrently.

The label should contain the following statements:

• Contains paracetamol.

• Do not give this medicine with any other paracetamol-containing product.

• For oral use only.

• Never give more medicine than shown in the table.

• Do not overfill the spoon.

• Always use the spoon supplied with the pack.

• Do not give to babies less than 2 months of age

• For infants 2-3 months no more than 2 doses should be given.

• Do not give more than 4 doses in any 24 hour period.

• Leave at least 4 hours between doses.

• Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist. .

• As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.

• Do not store above 25°C. Store in the original package.

• Keep out of the reach and sight of children.

• Immediate medical advice should be sought in the event of an overdose, even if the child seems well (label).

• Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage (leaflet).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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

The anti-coagulant 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.

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 a clinically significant amount. Available published data do not contra-indicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

Undesirable effects with paracetamol are rare, however, hypersensitivity including skin rashes may occur. There have been a few reports of blood dyscrasias including thrombocytopenia, and agranulocytosis but these were not necessarily causally related to paracetamol.

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 with carbamazepine, phenobarbitone, 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 deplete 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 24 h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol has analgesic and antipyretic actions probably due to the inhibition of prostaglandin biosynthesis.

5.2 Pharmacokinetic Properties

Paracetamol is readily absorbed from the gastro-intestinal tract and peak plasma concentrations usually occur 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and largely excreted in the urine as sulphate and glucuronide conjugates. Less than 5% is excreted unchanged. The elimination half life varies from about 1 to 4 hours.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol

Dispersible Cellulose

Sodium Methylparaben

Sodium Propylparaben

Citric Acid Anhydrous

Saccharin Sodium

Strawberry Flavour D3694 (containing Propylene Glycol)

Acesulphame K

Carmine Extract P4011 (containing Carmine, Glycerine, Potassium Hydroxide)

Hydrogenated Glucose Syrup

Xanthan Gum

Purified Water

6.2 Incompatibilities

None

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Store at or below 25°C. Do not refrigerate. Protect from light.

6.5 Nature And Contents Of Container

Amber glass or PET bottles with polyethylene child resistant screw closures containing 70 or 100 ml.

5ml unit dose foil laminate sachets sold individually or packed into cartons containing 4, 5, 8, 10, 12, 15, 16 or 20 sachets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Galpharm Healthcare Limited

Hugh House

Upper Cliffe Road

Dodworth Business Park

Dodworth

South Yorkshire

S75 3SP

8. Marketing Authorisation Number(S)

PL 16028/0118

9. Date Of First Authorisation/Renewal Of The Authorisation

8/10/2011

10. Date Of Revision Of The Text

8/10/2011

CIS-PYRO

Dosage Form: injection

CIS-PYRO Description

CIS-PYRO Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Pyrophosphate Injection for diagnostic use by intravenous injection.

Each 10 mL vial contains 12.0 mg of sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted to 5.3-5.7 with hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present. Sealed under nitrogen.

The chemical names are: (1) Diphosphoric acid, Ditin (2+) salt; (2) Ditin (2+) pyrophosphate (4‾). The structural formula is:

When a solution of sterile, non-pyrogenic, oxidant-free isotonic Sodium Pertechnetate Tc99m Injection U.S.P. is added to the vial, Technetium Tc99m Pyrophosphate Injection is formed for intravenous administration.

When a solution of sterile, non-pyrogenic, isotonic saline is added to the vial, it forms a blood pool imaging agent when Sodium Pertechnetate Tc 99m Injection is injected intravenously 30 minutes after the intravenous administration of the non-radioactive reconstituted CIS-PYRO. The precise structure of Technetium Tc 99m Pyrophosphate Injection is not known at this time.

Physical Characteristics

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.¹ The principal photon that is useful for detection and imaging studies is listed in Table 1.

Table 1. Principal Radiation Emission Data

Radiation	Mean Percent Per DIsintegration	Mean Energy (keV)
Gamma-2	89.07	140.5

 ¹Kocher DC: Radioactive decay data tables. DOE/TIC-11026: 108, 1981

External Radiation

The specific gamma ray constant for Tc 99m is 0.78 R/hr-millicurie at 1 cm. The first half-value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

Table 2. Radiation Attenuation by Lead Shielding

Shield Thickness (Pb) cm	Coefficient of Attenuation
0.017	0.5
0.08	10-1
0.16	10-2
0.25	10-3
0.33	10-4

To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.

Table 3. Physical Decay Chart: Tc 99m, half-life 6.02 hourss

Hours	Fraction Remaining	Hours	Fraction Remaining
0*	1.000	7	0.447
1	0.891	8	0.398
2	0.794	9	0.355
3	0.708	10	0.316
4	0.631	11	0.282
5	0.562	12	0.251
6	0.501

*Calibration time

CLINICAL PHARMACOLOGY

When injected intravenously, Technetium Tc 99m Pyrophosphate Injection has a specific affinity for areas of osteogenesis. It is also concentrated in the injured myocardium, primarily in areas of irreversibly damaged myocardial cells.

One to two hours after intravenous injection of Technetium Tc 99m Pyrophosphate Injection, an estimated 40 to 50 percent of the injected dose has been taken up by the skeleton, and approximately 0.01 to 0.02 percent per gram of acutely infarcted myocardium. Within a period of one hour, 10 to 11 percent remains in the vascular system, declining to approximately 2 to 3 percent twenty-four hours post injection. The average urinary excretion was observed to be about 40 percent of the administered dose after 24 hours.

The non-radioactive reconstituted CIS-PYRO also has an affinity for red blood cells. When administered 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76 percent of the injected activity remains in the blood pool providing excellent images of the cardiac chambers.

Indications and Usage for CIS-PYRO

Technetium Tc 99m Pyrophosphate Injection is a bone imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction.

CIS-PYRO is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. When reconstituted with sterile non-pyrogenic isotonic saline and administered intravenously 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76% of the injected radioactivity remains in the blood pool.

Contraindications

None known.

Warnings

As an adjunct in the diagnosis of confirmed myocardial infarction (ECG and serum enzymes positive), the incidence of false negative images has been found to be 6 percent. False negative images can also occur if made prior to 24 hours in the evolutionary phase of the infarct or after 6 days in the resolution phase. In a limited study involving 22 patients in whom the ECG was positive and serum enzymes questionable or negative, but in whom the final diagnosis of acute myocardial infarction was made, the incidence of false negative images was 23 percent. The incidence of false positive images has been found to be 7 to 9 percent. False positive images have also been reported following coronary by-pass graft surgery, in unstable angina pectoris, old myocardial infarcts and in cardiac contusions.

Preliminary reports indicate impairment of brain scans using Sodium Pertechnetate Tc99m Injection which have been preceded by a bone scan using an agent containing stannous ions. The impairment may result in false positive or false negative brain scans. It is recommended, where feasible, that brain scans precede bone imaging procedures. Alternately, a brain imaging agent such as Technetium Tc 99m Pentetate Injection may be employed.

Precautions

General

The lyophilized contents of the CIS-PYRO reaction vial are to be administered to the patient only as an intravenous solution (see Procedures for Reconstitution). Any Sodium Pertechnetate Tc 99m solution which contains an oxidizing agent is not suitable for use with CIS-PYRO. When reconstituted with Sodium Pertechnetate Tc 99m Injection, CIS-PYRO must be used within 6 hours. CIS-PYRO may also be reconstituted with sterile, non-pyrogenic isotonic saline containing no preservatives and injected intravenously prior to the administration of Sodium Pertechnetate Tc 99m Injection.

CIS-PYRO contains no preservatives.

Vials are sealed under nitrogen: air or oxygen is harmful to the contents of the vials and the vials should not be vented.

The components of the CIS-PYRO are supplied sterile and non-pyrogenic. Aseptic procedures normally employed in making additions and withdrawals for sterile, non-pyrogenic containers should be used during addition of the Sodium Pertechnetate Tc 99m Injection and the withdrawal of doses for patient administration.

Shielding should be utilized when preparing Technetium Tc 99m Pyrophosphate Injection.

Technetium Tc 99m Pyrophosphate Injection as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients and clinical personnel consistent with proper patient management.

The solution should not be used if cloudy, discolored, or found to contain particulate matter.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

No special handling is required for the non-radioactive drug product.

Bone Imaging

Both prior to and following Technetium Tc 99m Pyrophosphate Injection administration, if not contraindicated for the patient’s cardiac condition, patients should be encouraged to drink fluids. Patients should void as often as possible after the Technetium Tc 99m Pyrophosphate Injection to minimize background interference and unnecessary radiation exposure from accumulation in the bladder.

Cardiac Imaging

Patient’s cardiac condition should be stable before beginning the cardiac imaging procedure.

Interference from chest wall lesions such as breast tumors and healing rib fractures can be minimized by employing the three recommended projections. (See DOSAGE AND ADMINISTRATION). False-positive and false-negative myocardial scans may occur; therefore, the diagnosis of acute myocardial infarction depends on the overall assessment of laboratory and clinical findings.

Blood Pool Imaging

The non-radioactive reconstituted agent should be injected by direct venipuncture. Heparinized catheter systems should be avoided, as interference with red blood cell tagging will result. Cardiac pool imaging should be initiated 15 to 30 minutes after the administration of Sodium Pertechnetate Tc 99m Injection.

The imaging of gastrointestinal bleeding is dependent on such factors as the region of imaging, rate and volume of the bleed, efficacy of the labeling of the red blood cells and timeliness of imaging. Due to these factors, images should be taken sequentially over a period of time until a positive image is obtained or clinical conditions warrant the discontinuance of the procedure. The period of time for collecting the images may range up to 36 hours.

Technetium Tc 99m Pyrophosphate Injection and the non-radioactive reconstituted CIS-PYRO should be formulated within six (6) hours prior to clinical use.

Carcinogenesis, mutagenesis, impairment of fertility

No long-term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Pyrophosphate Injection affects fertility in males or females. Mutagenesis studies have not been conducted.

Pregnancy Category C

Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Pyrophosphate Injection. It is also not known whether Technetium Tc 99m Pyrophosphate Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m Pyrophosphate Injection should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, to a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing mothers

Technetium Tc 99m Pyrophosphate Injection is excreted in human milk during lactation, therefore, formula feeding should be substituted for breast feeding.

Pediatric use

Safety and effectiveness in pediatric patients have not been established.

Geriatric use

Clinical studies of CIS-PYRO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

Adverse Reactions

Some hypersensitivity reactions have been associated with pyrophosphate use.

CIS-PYRO Dosage and Administration

After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Pyrophosphate Injection in the average ADULT patient (70 kg) is:

Bone Imaging -185-555 megabecquerels (5-15 mCi)

Cardiac Imaging - 370-555 megabecquerels (10-15 mCi)

The suggested dose range of the non-radioactive reconstituted CIS-PYRO in the average ADULT patient (70 kg) is:

Blood Imaging - Administer not less that one-third nor more than the total contents of one vial.

[555-740 megabecquerels (15-20mCi) of Pertechnetate Tc 99m Injection].

Bone and Cardiac Imaging

Technetium Tc 99m Pyrophosphate Injection is injected intravenously over a 10 to 20 second period. For optimal results, bone imaging should be done 1 to 6 hours following administration. Cardiac imaging should be done 30 to 90 minutes following administration. The acute myocardial infarct can be visualized from 24 hours to 6 days following onset of symptoms, with maximum localization at 48 to 72 hours. Cardiac imaging should be done with a gamma scintillation camera. It is recommended that images be made of the anterior, left anterior oblique and left lateral projections.

Blood Pool Imaging

CIS-PYRO may be reconstituted with sterile, non-pyrogenic isotonic saline containing no preservatives. Administer not less than one-third nor more than the total contents of one vial 30 minutes prior to the intravenous administration of 555 to 740 megabecquerels (15-20 mCi) Sodium Pertechnetate Tc 99m Injection. The non-radioactive reconstituted CIS-PYRO should be injected by direct venipuncture. Heparinized catheter systems should be avoided. Cardiac imaging should be done 10 to 30 minutes following the administration of Sodium Pertechnetate Tc 99m Injection utilizing a scintillation camera interfaced to an electrocardiographic gating device.

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

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

 Radiation Dosimetry 

 Bone and Cardiac Imaging 

The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average ADULT patient (70 kg) from an intravenous injection of a maximum of 555 megabecquerels (15 mCi) of Technetium Tc 99m Pyrophosphate Injection are shown in Table 4.

Table 4.Estimated Absorbed Radiation Doses Bone and Cardiac Imaging*

	Technetium Tc 99m Pyrophosphate Injection
Target Organ	mGy/555 MBq	rads/15 mCi
Total Body	1.8	0.18
Kidneys	3.6	0.36
Red Marrow	3.5	0.35
BoneSurfaces	21.1	2.11
BladderWall	13.3	1.33
Testes	1.4	0.14
Ovaries	2.1	0.21
Effective Dose Equivalent	3.3 mSv	0.33 rem

*Based on the model in MIRD Dose Estimate Report No. 13 (J Nucl Med 30:1117-1122, 1989).

Estimate calculated using phantoms of Cristy & Eckerman (Report ORNL/TM-8381/V1 & V7). Bone and marrow model of Eckerman (Aspects of dosimetry of radionuclides within the skeleton with particular emphasis on the active marrow, In Fourth International Radiopharmaceutical Dosimetry Symposium; A.T. Schlafke-Stelson and E.E. Watson eds. CONF-851113, Oak Ridge Associated Universities, Oak Ridge, TN 37831, 1986. pp 514-534.) used.

The effective dose equivalent is a quantity which may be suitable for comparing risks of different procedures in nuclear medicine, radiology, and other applications involving ionizing radiation, but should not be construed to give information about risks to individual patients and should not be applied to situations involving radiation therapy.

Blood Pool Imaging

The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous injection of 740 megabecquerels (20 mCi) of Sodium Pertechnetate Tc 99m Injection, 30 minutes after the intravenous administration of the non-radioactive reconstituted CIS-PYRO are shown in Table 5.

Table 5. Estimated Absorbed Radiation Doses Blood Pool Imagingª

		Sodium Pertechnetate Tc 99m 30 min Post Injection with Pyrophosphate
Target Organ	mGy/740 MBq	rads/20 mCi
Total Body	3.2	0.32
Spleen	3.6	0.36
Bladder Wallb	24.0	2.40
Testes	2.4	0.24
Ovaries	4.6	0.46
Blood	10.4	1.04
Red Marrow	4.4	0.44

aAssume 75% of the Sodium Pertechnetate Tc 99m labels red blood cells and the other 25% remains as pertechnetate. Method of calculation: MIRD Dose Estimate Report No. 8, J Nucl Med 17: 74-77, 1976.

bIf 25% excreted with 1 hour Tb

How is CIS-PYRO Supplied

The CIS-PYRO Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is supplied in packages of 5 or 30 sterile, non-pyrogenic, white capped 10mL vials. Each multidose vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted with hydrochloric acid to 5.3-5.7 prior to lyophilization. No bacteriostatic preservative is present. Sealed under nitrogen. Included in each 5-vial package are one package insert and 10 radiation labels. Included in each 30-vial package are one package insert and 60 radiation labels.

Store the kit as packaged at 20-25°C (68-77°F) [See USP]. Store the reconstituted vials at 20-25°C (68-77°) [See USP].

Directions for use

Bone and Cardiac Imaging

Technetium Tc 99m Pyrophosphate Injection is prepared from CIS-PYRO by the following aseptic procedure:

1. Waterproof gloves should be worn during the preparation procedure. Remove the white flip-off cap from the CIS-PYRO vial and swab the top of the vial closure with alcohol to sterilize the surface.


2. Complete the radiation label and affix to the vial. Place the vial in an appropriate
   
   radiation shield suitably labeled and identified.


3. With a sterile shielded syringe, aseptically obtain 1-10 milliliters of a suitable, oxidant- free, sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection containing no more than 3.7 gigabecquerels (100 mCi). Aseptically add the Sodium Pertechnetate Tc 99m Injection to the vial.


4. Swirl the contents of the vial for one minute and let stand for at least 10 minutes.


5. Record date and time of preparation.


6. It is recommended that the radiochemical purity of the prepared radiopharmaceutical be checked prior to patient administration.


7. Examine vial contents for particulates and discoloration prior to injection.


8. Withdrawals for administration must be made aseptically using a sterile shielded syringe and needle. Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from a vial, the replacement of contents with air should be minimized.


9. Aseptically withdraw material with a sterile lead shielded syringe for use within six (6) hours of preparation. For optimal results, this time should be minimized. The vial contains no bacteriostatic preservative. Store the reconstituted vial at 20-25°C (68-77°F) [See USP]. Discard the vial six (6) hours after reconstitution.


10. The patient dose should be measured by suitable radioactivity calibration system immediately prior to administration.

Blood Pool Imaging

The non-radioactive CIS-PYRO is prepared by adhering to the following aseptic procedure:

1. Remove the white flip-off cap from the CIS-PYRO and swab the top of the vial closure with alcohol to sterilize the surface.


2. Reconstitute the reaction vial with 3 milliliters of sterile, non-pyrogenic, isotonic saline containing no preservatives.


3. Swirl the contents of the vial for one minute and let stand for at least 10 minutes.


4. Record date and time of preparation.


5. Examine vial contents for particulates and discoloration prior to injection.


6. Withdrawals for administration must be made aseptically using a sterile syringe and needle. Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from a vial, the replacement of contents with air should be minimized.


7. Aseptically withdraw the reconstituted non-radioactive CIS-PYRO with a sterile syringe for use within six (6) hours of preparation. For optimal results, this time should be minimized. The vial contains no bacteriostatic preservative. Store the reconstituted vial at 20-25°C (68-77°F) [See USP]. Discard the vial six (6) hours after reconstitution.


8. Between one-third and a total vial of stannous pyrophosphate may be administered by direct venipuncture 30 minutes prior to intravenous administration of 555 to 740 megabecquerels (15-20 mCi) of Sodium Pertechnetate Tc 99m Injection. Heparinized catheter systems should not be used.


9. The patient dose of Sodium Pertechnetate Tc 99m Injection should be measured by a suitable radioactivity calibration system immediately prior to administration.

NDC # 45567-0060-1 for 5 vial kits

NDC # 45567-0060-2 for 30 vial kits

<p>This reagent kit for preparation of a radiopharmaceutical is approved for use by persons censed pursuant to Section 120.533, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State.</p>

CIS-PYRO   sodium pyrophosphate and stannous chloride  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45567-0060 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Sodium Pyrophosphate (Sodium Pyrophosphate) Active 12.0 MILLIGRAM  In 1 VIAL Stannous chloride (tin) Active 2.8 MILLIGRAM  In 1 VIAL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45567-0060-2 30 VIAL In 1 KIT contains a VIAL 1 1 VIAL In 1 VIAL This package is contained within the KIT (45567-0060-2) 2 45567-0060-1 5 VIAL In 1 KIT contains a VIAL 2 1 VIAL In 1 VIAL This package is contained within the KIT (45567-0060-1)

Revised: 05/2007CIS US Inc.

Inflamax

Inflamax may be available in the countries listed below.

Ingredient matches for Inflamax

Naproxen

Naproxen is reported as an ingredient of Inflamax in the following countries:

• Peru

International Drug Name Search

Neo-Synephrine Ophthalmic

Generic Name: phenylephrine (Ophthalmic route)

fen-il-EF-rin

Commonly used brand name(s)

In the U.S.

• AK-Dilate


• Altafrin


• Eye Cool


• Mydfrin


• Neofrin


• Neo-Synephrine


• Ocu-Phrin


• Prefrin Liquifilm

Available Dosage Forms:

• Solution

Therapeutic Class: Mydriatic-Cycloplegic

Pharmacologic Class: Sympathomimetic

Chemical Class: Alkylarylamine

Uses For Neo-Synephrine

Ophthalmic phenylephrine in strengths of 2.5 and 10% is used to dilate (enlarge) the pupil. It is used before eye examinations, before and after eye surgery, and to treat certain eye conditions. In the U.S., these preparations are available only with your doctor's prescription.

Before Using Neo-Synephrine

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

Allergies

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

Pediatric

Children may be especially sensitive to the effects of phenylephrine. This may increase the chance of side effects during treatment. In addition, the 10% strength is not recommended for use in infants. Also, the 2.5 and 10% strengths are not recommended for use in low birth weight infants.

Geriatric

Repeated use of 2.5 or 10% phenylephrine may increase the chance of problems during treatment with this medicine. In addition, heart and blood vessel problems have occurred more often in elderly patients than in younger adults.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clorgyline


• Iproniazid


• Isocarboxazid


• Nialamide


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline


• Amoxapine


• Clomipramine


• Desipramine


• Dothiepin


• Doxepin


• Furazolidone


• Imipramine


• Lofepramine


• Midodrine


• Nortriptyline


• Opipramol


• Pargyline


• Protriptyline


• Trimipramine

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.

• Guanethidine


• Propranolol

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Type 2 diabetes mellitus or


• Heart or blood vessel disease or


• High blood pressure—The 2.5 and 10% strengths of phenylephrine may make the condition worse

• Idiopathic orthostatic hypotension (a certain kind of low blood pressure)—Use of this medicine may cause a large increase in blood pressure to occur

Proper Use of phenylephrine

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

Do not use if the solution turns brown or becomes cloudy.

To use:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.


• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using the 2.5 or 10% eye drops:

• It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when this medicine is used in children or in patients with heart disease or high blood pressure, since high doses of this medicine may cause an irregular heartbeat and an increase in blood pressure.

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 ophthalmic solution (eye drops) dosage form:
  
  • For eye redness:
    
    • Adults and children—Use one drop of 0.12% solution every three or four hours as needed.
    
    
  
  
  • For eye exams:
    
    • Adults and children—Use one drop of 2.5% solution. Depending on the eye test to be done, it will take from fifteen minutes to one or two hours for the medicine to work before you can have the eye test.
    
    
  
  
  • For use before eye surgery:
    
    • Adults and teenagers—Use one drop of 2.5 or 10% solution thirty to sixty minutes before the start of eye surgery.
    
    
    • Children—Use one drop of 2.5% solution thirty to sixty minutes before the start of eye surgery.
    
    
  
  
  • For certain eye conditions:
    
    • Adults and teenagers—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5 or 10% solution in the eye from once a day to three times a day.
    
    
    • Children—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5% solution in the eye from once a day to three times a day.
    
    
  
  

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.

For non-prescription strength eye drops, follow the package directions.

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.

Precautions While Using Neo-Synephrine

If eye pain or change in vision occurs or if redness or irritation of the eye continues, gets worse, or lasts for more than 72 hours, stop using the medicine and check with your doctor.

For patients using the 2.5 or 10% eye drops:

• After you apply this medicine to your eyes, your pupils will become unusually large. This will cause your eyes to become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor. Also, if this effect continues for longer than 12 hours after you have stopped using this medicine, check with your doctor.

Neo-Synephrine Side Effects

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

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

Symptoms of too much medicine being absorbed into the body - Less common with 10% solution; rare with 2.5% or weaker solution

• Dizziness


• fast, irregular, or pounding heartbeat


• increased sweating


• increase in blood pressure


• paleness


• trembling

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 with 2.5 or 10% solution

• Burning or stinging of eyes


• headache or browache


• sensitivity of eyes to light


• watering of eyes

Less common

• Eye irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Neo-Synephrine Ophthalmic resources

• Neo-Synephrine Ophthalmic Use in Pregnancy & Breastfeeding
• Neo-Synephrine Ophthalmic Drug Interactions
• Neo-Synephrine Ophthalmic Support Group
• 0 Reviews for Neo-Synephrine Ophthalmic - Add your own review/rating

• Neo-Synephrine Ophthalmic Concise Consumer Information (Cerner Multum)


• AK-Dilate Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Altafrin Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Neo-Synephrine Ophthalmic with other medications

• Eye Dryness/Redness
• Eye Redness/Itching
• Pupillary Dilation

Verapamil Tablets 40mg, 80mg, 120mg, 160mg (Actavis UK Ltd)

Verapamil Tablets 40mg, 80mg, 120mg and 160mg

• 
  Please read this leaflet carefully before you start to take your medicine.
  


• 
  It gives you important information about your medicine.
  


• 
  If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.
  


• 
  Keep the leaflet until you have finished the medicine.
  

What's In Your Medicine

Verapamil Tablets are circular, yellow, film-coated tablets. Each tablet contains either 40mg, 80mg, 120mg or 160mg of Verapamil hydrochloride.

They also contain: cellulose, magnesium stearate, maize starch, propylene glycol, E104, E110, E171, E460, E463, E464, E553.

Verapamil Tablets are available in pack sizes of 28, 56, and 84.

Verapamil is one of a group of medicines called calcium channel blockers.

MA holder/Manufacturer:

Actavis

Barnstaple

EX32 8NS

UK

About Your Medicine

The name of your medicine is Verapamil Tablets which is the generic (common) name. Your doctor may have given you this medicine before from another company and it may have looked slightly different.

Either brand will have the same effect.

Verapamil Tablets may be used for:

• hypertension (high blood pressure), used alone or with other drugs for high blood pressure.


• angina.


• certain types of abnormal heart beats.

Before Taking Your Medicine

Make sure you have told your doctor if you:

• are pregnant, plan to become pregnant or are breast feeding.


• are sensitive to any ingredients in the product.


• have ever had a heart attack or heart failure.


• suffer from a slow heart rate.


• have low blood pressure.


• have Wolff-Parkinson-White syndrome (rapid heart rate sometimes associated with dizziness or faintness).


• have liver disease.


• are taking other medicines such as beta blockers, carbamazepine, cimetidine, ciclosporin, digitalis, digoxin, lithium, phenobarbital, phenytoin, rifampicin, theophylline, other drugs for high blood pressure, and including any that you can buy without prescription.

Do NOT eat or drink products containing grapefruit juice whilst taking this medicine. You should avoid excessive amounts of alcohol whilst taking Verapamil.

Verapamil may make you feel drowsy. Make sure you are not affected before you drive or operate machinery.

If you see another doctor, dentist or go into hospital, especially if you need an operation, tell the staff you are taking verapamil.

Taking Your Medicine

Your doctor has decided the dose which is best for you. Always follow your doctor’s instructions exactly, and those on the pharmacy label. If you do not understand anything, ask your doctor or pharmacist.

The usual dosage(s) are described below:

Dosages are usually reduced in elderly patients with heart or liver problems

• Adults:


• High blood pressure: Initially 120mg twice daily increasing to 160mg twice daily. In some cases 480mg daily in divided doses.


• Angina: Usually 120mg three times daily, or 80mg three times daily with angina of effort.


• Abnormal heart beats: 40-120mg three times daily.


• 
  


• Children:


• Up to 2 years: 20mg 2-3 times daily.


• 2 years and over: 40-120mg two or three times daily.

If you are elderly, especially with liver or kidney disease, you may be given a different dose. It is particularly important to take this medicine exactly as directed by the doctor.

These tablets should be taken as instructed swallowed with a glass of water. Continue to take them for as long as your doctor tells you to, it may be dangerous to stop without their advice.

If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. NEVER take two doses at the same time.

If you accidentally take more than your prescribed dose, contact your nearest hospital casualty department, or tell your doctor, immediately. Take any remaining tablets and the container with you.

After Taking Your Medicine

Like many medicines, Verapamil may occasionally cause side-effects in some patients, particularly when you first start taking it. These may include constipation, flushing, headache, nausea, vomiting, impairment of liver function or allergic reactions. Rarely, enlarged breasts in men, swollen gums and hair loss. You should consult your doctor if these are troublesome or continue or if you develop a skin rash, swelling, difficulty breathing or become jaundiced (yellow skin or eyes). If you get any other unusual effects, tell your doctor immediately and seek advice.

Storing Your Medicine

Do not use the tablets after the expiry date shown on the product packaging. Keep the tablets below 25°C in a dry place and in the original package. KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.

Date of last revision: May 2007

50107324

Actavis

Barnstaple

EX32 8NS

UK