Valni XL 30mg & 60mg Prolonged Release Tablets

VALNI XL 30MG & 60MG PROLONGED RELEASE TABLETS

Nifedipine

Read all of this leaflet carefully before you start taking this medicine.

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


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


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


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

In this leaflet:

• 1. What VALNI XL is and what it is used for


• 2. Before you take VALNI XL


• 3. How to take VALNI XL


• 4. Possible side effects


• 5. How to store VALNI XL


• 6. Further information

What Valni Xl Is And What It Is Used For

VALNI XL Prolonged Release Tablets contain nifedipine which belongs to a group of medicines called calcium-channel blockers that act on the cardiovascular system (the heart and blood vessels). VALNI XL has been prescribed by your doctor to treat your high blood pressure or to reduce the frequency of your anginal attacks. They are called prolonged release tablets because they are manufactured in a way that allows the nifedipine to be released and slowly absorbed by your body over a period of several hours.

In high blood pressure, nifedipine works by widening the blood vessels. This creates less resistance to the blood flow, and results in lower blood pressure, which in turn reduces the strain on your heart.

In angina, nifedipine works by opening up the arteries supplying the heart muscle and this allows more blood and oxygen to reach the muscle, decreasing the chances of angina (chest pains) occuring when extra strain is placed upon the heart.

Before You Take Valni Xl

Do not take VALNI XL:

• if you are allergic to nifedipine, other calcium-channel blockers (e.g verapamil, diltiazem or felodipine) or any of the other ingredients of VALNI XL


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


• if you have been told that you have a narrowing (stenosis) of the aortic valve in your heart


• if you have experienced a collapse which was caused by a heart problem (cardiogenic shock)


• if the severity or frequency of your angina has rapidly worsened over a matter of hours or days


• to treat an angina attack as it occurs, but rather to reduce the frequency of the angina you experience over time


• if you suffer from inflammation of the bowel or intestines (such as Crohn’s disease), oesophageal (gullet) obstruction or have in the past had an obstruction or narrowing of the intestine


• if you have a liver disease


• if you have had a heart attack during the last month or to treat a heart attack


• if you are taking the antibiotic rifampicin (used to treat tuberculosis)


• if your blood pressure continues to rise despite treatment (malignant hypertension)

Take special care with VALNI XL:

It is important that you tell your doctor if any of the following applies to you.

• if you suffer from low blood pressure


• if you experience chest pains when you first start taking VALNI XL, contact your doctor immediately


• if you are diabetic, the treatment for your diabetes may need to be adjusted


• if you are receiving kidney dialysis and have very high blood pressure with low blood volume


• if you are taking other drugs to treat high blood pressure (e.g. beta-blockers). If you are changing from a beta-blocker to nifedipine, you should gradually reduce your beta-blocker after discussion with your doctor


• if you have a Kock pouch (a type of ileostomy)


• if you have to give a urine sample, have an x-ray or undergo surgery

Your doctor may, under certain conditions, think it necessary to keep you on VALNI XL whilst you are pregnant. If this is the case particular care must be taken if you are also receiving magnesium sulphate injections.

Taking other medicines:

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

In particular, tell your doctor if you are taking:

• other drugs to treat high blood pressure


• cimetidine, to treat stomach ulcers


• the medicines digoxin, diltiazem, quinidine, or beta-blockers, used to treat heart conditions


• the anti-epileptic drug phenytoin


• the antibiotic rifampicin and combination treatment quinupristin/dalfopristin


• cisapride, a drug used to treat reduced movements of the gullet and stomach

The effect of the following drugs on VALNI XL is uncertain. Therefore, as a additional precaution, please tell your doctor if you are taking:

• the antibiotics erythromycin, ketoconazole, itraconazole or fluconazole


• the HIV protease inhibitors indinavir, nelfinavir, ritonavir or saquinavir


• the antidepressant drugs fluoxetine and nefazodone


• tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs


• carbamazepine and valproic acid, used for the treatment of epilepsy


• the barbiturate phenobarbital, used primarily to treat insomnia and anxiety

The following drugs do not interact with VALNI XL: aspirin, benazepril, candesartan cilexetil, orlistat, debrisoquine, doxazosin, irbesartan, omeprazole, pantoprazole, ranitidine, rosiglitazone and triamterene hydrochlorothiazide.

Taking VALNI XL with food and drink:

Do not drink grapefruit juice at the same time or soon after taking VALNI XL because grapefruit juice can increase the blood levels of nifedipine.

Pregnancy and breast-feeding:

Do not take VALNI XL if you are pregnant, trying to become pregnant or are breast-feeding.

Drugs like VALNI XL have been shown in laboratory experiments to impair sperm function. If you are male and have been unsuccessful in fathering a child please consult your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

It is possible that you may react to VALNI XL. Reactions can vary in intensity from individual to individual and may affect your concentration. If you are unable to concentrate or remain alert after taking VALNI XL, then do not drive or operate machinery or perform any activity for which you need to be attentive. This applies particularly at the start of treatment, on changing medication or in combination with alcohol.

Important information about some of the ingredients of VALNI XL:

VALNI XL contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How To Take Valni Xl

Always take VALNI XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

VALNI XL is specially formulated so that you only have to take your tablets once a day, preferably in the morning. Your tablet must be swallowed whole with a glass of water and not with grapefruit juice. Do not break or chew your tablets.

The usual adult dose for treating high blood pressure or preventing angina is 30mg or 60mg once a day.

Your doctor may decide to increase your dose to a maximum of 90mg of nifedipine once a day.

If you are elderly, lower doses of this medicine may be prescribed by your doctor.

Do not stop taking your medicine until your doctor tells you.

Children must not take this medicine.

If you take more VALNI XL than you should:

If you take more VALNI XL than you should, immediately contact your doctor or pharmacist. Elimination of the product and the restoration of stable cardiovascular conditions may be needed. If you take too much nifedipine low blood pressure (hypotension) can occur, which can be recognised from symptoms like dizziness, nausea, vomiting, drowsiness, confusion, lethargy, flushing, a lack of oxygen (hypoxia), headache or red spots on the face. Eventually, unconsiousness can occur. Increased or decreased heart rates are also a symptom of overdose. In the event of overdose it is recommended to lay the patient down with elevated legs, for instance by using some pillows.

If you forget to take VALNI XL:

Do not take a double dose to make up for a forgotten dose.

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

If you stop taking VALNI XL:

If you suddenly stop using this medicine, the symptoms that you had before you started taking this medicine can come back.

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

Possible Side Effects

Like all medicines, VALNI XL can cause side effects, although not everyone gets them. If you do experience any of these effects they will usually go away when treatment is stopped.

If you experience chest pains when you first start taking VALNI XL, contact your doctor immediately.

The most common side effects that may affect 1 person in 10 are: headache, an irregular heartbeat (palpitations), flushing, general weakness or loss of strength and energy, constipation, dizziness and swelling particularly of the ankles and legs.

Less common side effects which may affect less than 1 person in 100 are: pain particularly in the stomach area (abdomen), chest and legs, general feeling of being unwell, a low blood pressure when rising to the standing position (hypotension), fainting, a fast heart beat (tachycardia), diarrhoea, a dry mouth, indigestion, wind (flatulence), feeling sick, leg cramps, sleep disorders, nervousness, pins and needles, dizziness (vertigo), difficulty in breathing, itching, rash, an increase in the need to pass water and bed wetting.

Rare side effects which may affect less than 1 person in 1,000 are: allergic reactions which may appear as a yellowing of the skin (jaundice), chills, swelling of the face, fever, problems with your circulatory system, loss of appetite (anorexia), belching, problems with your gut, inflammation of the gums, tender or swollen gums which may bleed, an increase in gamma glutamyl-transferase (an enzyme that occurs naturally in the body), liver function abnormalities, vomiting, problems with your joints that may be painful, muscle pain, increased sensitivity particularly in the skin, trembling, mood changes, nose bleeds, hives that appear on the body, lips, eyes, or tongue, sweating, problems with the eyes that may be painful or cause blurred vision, difficulty in passing water that may be painful and a failure to achieve or maintain an erection (impotence).

Very rare side effects which may affect approximately 1 person in 10,000 are: an allergic reaction that may become severe, a mass of foreign material found in the stomach which may require surgery for removal, difficulty in swallowing, inflammation of the gullet, problems with the gums, obstruction of the gut, ulcers in the gut, jaundice, an increase in serum glutamate pyruvate transaminase (an enzyme that occurs naturally in the body), a reduction in the number of white blood cells, weight loss, muscle cramps and blistering of the skin when exposed to sunlight. Too much glucose in the blood (hyperglycaemia) may also occur. Symptoms of hyperglycaemia include thirst, resulting in need to pass water more frequently, weight loss and tiredness.

A slight development in breast tissue has also been reported in older men on long term therapy.

As with similar drugs which act on blood vessels, chest (anginal) pain may occur rarely at the start of treatment with VALNI XL.

Because of the nature of coronary artery disease, heart attacks have occurred in patients treated with the active ingredient, nifedipine. It has not been shown that these heart attacks were due to treatment with nifedipine.

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

How To Store Valni Xl

• Keep out of the reach and sight of children.


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


• Do not use VALNI XL after the expiry date which is stated on the blister and carton.


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

Further Information.

What VALNI XL contains:

• The active substance is nifedipine.


• The other ingredients are povidone K30, lactose monohydrate, talc, hypromellose (E464), magnesium stearate, carbomer 974P, colloidal anhydrous silica, macrogol 4000, dimethylaminoethyl methacrylate-butyl methacrylate-methyl methacrylate copolymer, red iron oxide (E172) and titanium dioixide (E171).

What VALNI XL look like and the contents of the pack:

Valni XL 30mg and 60 mg Prolonged Release Tablets are pale red with a round and biconvex shape, marked on one side with “30” or “60” respectively. They are available in calendar blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer.

Marketing Authorisation Holder:

Winthrop Pharmaceuticals

PO Box 611

Guildford

Surrey

GU1 4YS

Manufacturer:

Chester Medical Solutions

3-4 Apex Court

Bassendale Road

Bromborough

Wirral

CH62 3RE

This leaflet was last revised in October 2007

'Winthrop' is a registered trademark. © 2007 Winthrop Pharmaceuticals.

LF00000019

Xibrom

Generic Name: Bromfenac Sodium
Class: Nonsteroidal Anti-inflammatory Agents
VA Class: CN104
Chemical Name: 2-amino-3-(4-bromobenzoyl)benzeneacetic acid sesquihydrate monosodium salt
Molecular Formula: C₁₅H₁₁BrNNaO₃
CAS Number: 120638-55-3

Introduction

Prototypical NSAIA.¹

Uses for Xibrom

Postoperative Ocular Inflammation and Pain

Management of ocular inflammation and pain associated with cataract extraction.¹

Xibrom Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.¹

Avoid contamination of the solution container.²

Do not administer while wearing contact lenses.¹ (See Advice to Patients.)

Dosage

Available as bromfenac sodium sesquihydrate; dosage expressed in terms of bromfenac.¹

Adults

Postoperative Ocular Inflammation and Pain

Ophthalmic

1 drop of a 0.09% solution in the affected eye(s) twice daily, beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.¹

Cautions for Xibrom

Contraindications

• 
  

  Known hypersensitivity to bromfenac sodium or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Bleeding

May inhibit platelet aggregation and prolong bleeding time.¹

May cause increased bleeding of ocular tissues (including hyphemas) when used in conjunction with ocular surgery.¹

Use with caution in patients with underlying bleeding tendencies or in those receiving drugs known to prolong bleeding time.¹

Sensitivity Reactions

Hypersensitivity Reactions

Possible cross-sensitivity with aspirin, phenylacetic acid derivatives, and other NSAIAs.¹ Use with caution in patients with history of hypersensitivity to these drugs.¹

Sulfite Sensitivity

Formulation contains sodium sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.¹

General Precautions

Wound-healing Complications

May slow or delay wound healing.¹ (See Specific Drugs under Interactions.)

Ocular Effects

Use may result in keratitis.¹ In some susceptible patients, continued use may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation; these events may be sight-threatening.¹ If manifestations of corneal epithelial breakdown occur, discontinue therapy immediately and monitor for corneal health.¹

Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for developing adverse corneal effects that may become sight-threatening.¹ Use with caution in these patients.¹

Use >24 hours prior to surgery or use beyond 14 days postoperatively may precipitate or exacerbate adverse corneal effects.¹

Specific Populations

Pregnancy

Category C.¹

Avoid use in late pregnancy (i.e., third trimester) because of known effects on the fetal cardiovascular system (possible premature closure of the ductus arteriosus).^{1 2}

Lactation

Not known whether distributed into milk following ophthalmic administration.² Use with caution.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹

Common Adverse Effects

Abnormal ocular sensation, conjunctival hyperemia, ocular redness or irritation (e.g., pruritus, burning, stinging, pain), headache, iritis.¹

Interactions for Xibrom

No formal drug interaction studies to date.³

Specific Drugs

Drug	Interaction	Comments
Corticosteroids, topical	Increased potential for wound-healing complications1

Xibrom Pharmacokinetics

Absorption

Bioavailability

Systemic concentration at steady state in humans estimated to be below limit of quantification (50 ng/mL).¹

Stability

Storage

Ophthalmic

Solution

15–25°C.¹

ActionsActions

• 
  

  Inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase (COX), including both COX-1 and COX-2 isoenzymes.¹

  
  


• 
  

  Ocular effects associated principally with inhibition of ocular prostaglandin synthesis.^{1 2}

  
  

Advice to Patients

• 
  

  Risk of ocular bleeding.¹ Risk of anaphylactoid and other sensitivity reactions.¹

  
  


• 
  

  Importance of learning and adhering to proper administration techniques to avoid contamination of the ophthalmic solution with common bacteria that can cause ocular infections.²

  
  


• 
  

  Importance of removing contact lenses before administration.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Risk of use during late pregnancy.¹

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

Bromfenac Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	0.09% (of bromfenac)	Xibrom (with benzalkonium chloride, povidone, and sodium sulfite)	ISTA

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. ISTA Pharmaceuticals, Inc. Xibrom (bromfenac ophthalmic solution) 0.09% prescribing information. Irvine, CA; 2006 Feb.

2. ISTA Pharmaceuticals, Inc., Irvine, CA: Personal communication.

3. ISTA Pharmaceuticals, Inc. Xibrom (bromfenac ophthalmic solution 0.09%) formulary submission dossier. Irvine, CA; 2005.

More Xibrom resources

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

• Xibrom Prescribing Information (FDA)


• Xibrom Advanced Consumer (Micromedex) - Includes Dosage Information


• Xibrom MedFacts Consumer Leaflet (Wolters Kluwer)


• Xibrom Consumer Overview


• Bromday Prescribing Information (FDA)


• Bromday Consumer Overview

Compare Xibrom with other medications

• Postoperative Ocular Inflammation

Carbamate anticonvulsants

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Carbamate anticonvulsant agents are newer antiepileptic drugs whose exact mechanism of action is uncertain. It has some inhibitory effect at the N-methyl-D-aspartate (NMDA) receptors and slightly potentiates gamma-aminobutyric acid (GABA) activity. It has a broad spectrum of activity but is only used in patients who are unresponsive to other anticonvulsant drugs, as it can cause severe reactions such as aplastic anemia, hepatitis and liver failure.

See also

Medical conditions associated with carbamate anticonvulsants:

• Epilepsy
• Lennox-Gastaut Syndrome

Drug List:

Felbatol

Touro HC

Generic Name: guaifenesin and hydrocodone (gwye FEN e sin and HYE droe KOE done)

Brand Names: A-Cof DH, Canges-XP, Codiclear DH, Condasin, Cotuss V, Execlear, Extendryl HC, Hycotuss Expectorant, Hydrocod-GF, Kwelcof, Monte-G HC, Narcof, Pancof XP, Pneumotussin 2.5, Relasin-HCX, Touro HC, Tussicle, Tusso-DF, Vi-Q-Tuss, Vitussin Expectorant, Xpect-HC, Z-Cof HCX

What is Touro HC (guaifenesin and hydrocodone)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Hydrocodone is a narcotic cough suppressant.

Guaifenesin and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.

Guaifenesin and hydrocodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Touro HC (guaifenesin and hydrocodone)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my healthcare provider before taking Touro HC (guaifenesin and hydrocodone)?

Hydrocodone may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Do not use this medicine if you are allergic to hydrocodone or guaifenesin.

To make sure you can safely take guaifenesin and hydrocodone, tell your doctor if you have any of these other conditions:

• 
  

  liver or kidney disease;

  
  


• 
  

  asthma;

  
  


• 
  

  urination problems;

  
  


• 
  

  an enlarged prostate;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  a head injury; or

  
  


• 
  

  Addison's disease.

  
  

FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Guaifenesin and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Touro HC (guaifenesin and hydrocodone)?

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

Guaifenesin and hydrocodone can be taken with or without food.

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

Call your doctor if your symptoms do not improve, or if they get worse. Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Guaifenesin and hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dry mouth, confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, seizure (convulsions), weak or shallow breathing, or breathing that stops.

What should I avoid while taking Touro HC (guaifenesin and hydrocodone)?

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

Ask a doctor or pharmacist before using any other cough, cold, allergy, pain, or sleep medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains guaifenesin.

Touro HC (guaifenesin and hydrocodone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  slow heart rate, weak or shallow breathing;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  confusion, fear, unusual thoughts or behavior;

  
  


• 
  

  seizure (convulsions); or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  blurred vision;

  
  


• 
  

  constipation;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  sweating.

  
  

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 Touro HC (guaifenesin and hydrocodone)?

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

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

• 
  

  antidepressants such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;

  
  


• 
  

  atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


• 
  

  a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

  
  

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

More Touro HC resources

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

• CodiCLEAR DH Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Entuss Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Tusso-HC Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Touro HC with other medications

• Cough

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and hydrocodone.

See also: Touro HC side effects (in more detail)

physostigmine Ophthalmic

fye-soe-STIG-meen

Commonly used brand name(s)

In the U.S.

• Eserine


• Isopto Eserine

Available Dosage Forms:

• Ointment


• Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Cholinesterase Inhibitor

Uses For physostigmine

Physostigmine is used to treat certain types of glaucoma.

physostigmine is available only with your doctor's prescription.

Before Using physostigmine

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 physostigmine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to physostigmine 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

Although there is no specific information comparing use of physostigmine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

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

• Succinylcholine

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 physostigmine. Make sure you tell your doctor if you have any other medical problems, especially:

• Eye disease or problems (other)—Physostigmine may make the condition worse

Proper Use of physostigmine

To use the ophthalmic solution (eye drops) form of physostigmine:

• Do not use if the solution becomes discolored.


• First, wash your hands. With the middle finger, apply pressure to the inside corner of the eye (and continue to apply pressure for 1 or 2 minutes after the medicine has been placed in the eye). Tilt the head back and with the index finger of the same hand, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed.


• 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.

To use the ointment form of physostigmine:

• First, wash your hands. Pull the lower eyelid away from the eye to form a pouch. Squeeze a thin strip of ointment into the pouch. A 1-cm (approximately 1/3-inch) strip of ointment is usually enough unless otherwise directed by your doctor. Gently close the eyes and keep them closed for 1 or 2 minutes to allow the medicine to be absorbed.


• Immediately after using the eye ointment, 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). After using the eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

Use physostigmine 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.

Dosing

The dose of physostigmine 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 physostigmine. 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 glaucoma:
  
  • For ophthalmic ointment dosage form:
    
    • Adults and children—Use in each eye one to three times a day.
    
    
  
  
  • For ophthalmic solution (eye drops) dosage form:
    
    • Adults and children—One drop in each eye up to four times a day.
    
    
  
  

Missed Dose

If you miss a dose of physostigmine, apply 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.

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 physostigmine

Your doctor should check your eye pressure at regular visits.

For a short time after you apply physostigmine, your vision may be blurred or there may be a change in your near or distant vision, especially at night. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well .

physostigmine 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

• Increased sweating


• loss of bladder control


• muscle weakness


• nausea, vomiting, diarrhea, or stomach cramps or pain


• shortness of breath, tightness in chest, or wheezing


• slow or irregular heartbeat


• unusual tiredness or weakness


• watering of mouth

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

• Blurred vision or change in near or distant vision


• eye pain

Less common

• Burning, redness, stinging, or other eye irritation


• headache or browache


• twitching of eyelids


• watering of eyes

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 physostigmine Ophthalmic resources

• Physostigmine Ophthalmic Drug Interactions
• Physostigmine Ophthalmic Support Group
• 0 Reviews for Physostigmine Ophthalmic - Add your own review/rating

• physostigmine ophthalmic Concise Consumer Information (Cerner Multum)

Compare physostigmine Ophthalmic with other medications

• Glaucoma

Methscopolamine

Pronunciation: meth-skoe-POL-uh-meen
Generic Name: Methscopolamine
Brand Name: Pamine and Pamine Forte

Methscopolamine is used for:

Treating peptic ulcers in combination with other medicines. It also may be used for other conditions as determined by your doctor.

Methscopolamine is an anticholinergic. It works by decreasing stomach acid production and by relaxing the muscles in the stomach and intestines.

Do NOT use Methscopolamine if:

• you are allergic to any ingredient in Methscopolamine


• you have glaucoma, blockage of the bladder, certain problems with your esophagus (eg, decreased esophageal motility, severe irritation caused by reflux), certain stomach or intestinal problems (eg, blockage, lack of muscle tone, or ulcerative colitis), heart problems caused by blood loss, or muscle problems (eg, myasthenia gravis)

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

Before using Methscopolamine:

Some medical conditions may interact with Methscopolamine. 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 nerve problems, severe bowel problems, prostate problems, heart problems, heart failure, a hernia, a predisposition of glaucoma or open-angle glaucoma, or urinary retention

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

• Anticholinergic medicines (eg, benztropine, hyoscyamine, or trihexyphenidyl), certain medicines for mental or mood disorders (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Methscopolamine's side effects


• Beta-blockers (eg, propanolol) or digoxin because the risk of their side effects may be increased by Methscopolamine

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

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

• Take Methscopolamine by mouth 30 minutes before meals and at bedtime, or as directed by your health care provider.


• Do not take an antacid within 1 hour before or 2 hours after you take Methscopolamine.


• If you miss a dose of Methscopolamine, 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 Methscopolamine.

Important safety information:

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


• Methscopolamine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Methscopolamine may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Methscopolamine without checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Antacids may decrease the effectiveness of Methscopolamine. Talk to your doctor before taking any antacids while taking Methscopolamine.


• Use Methscopolamine with caution in the ELDERLY; they may be more sensitive to its effects, especially if they have weak intestines or constipation.


• Methscopolamine 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 Methscopolamine while you are pregnant. It is not known if Methscopolamine is found in breast milk. Do not breast-feed while taking Methscopolamine.

Possible side effects of Methscopolamine:

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:

Bloated feeling; blurred vision; constipation; decreased sweating; difficulty sleeping; dilation of pupils; dizziness; drowsiness; dry mouth; headache; loss of taste; nausea; nervousness; urinary hesitancy or retention.

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); changes in heartbeat; diarrhea; difficulty focusing your eyes; difficulty urinating; pounding in the chest; rapid heart rate; unusual weakness; 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: Methscopolamine 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 abnormal behavior; blurred vision; circulatory problems; coma; difficulty breathing; dilated pupils; disorientation; excessive thirst; excitement; flushing; low blood pressure; muscle weakness; nausea; paralysis; restlessness; seizures; unusual dizziness or drowsiness; unusually dry mouth; vomiting.

Proper storage of Methscopolamine:

Store Methscopolamine 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 Methscopolamine out of the reach of children and away from pets.

General information:

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


• Methscopolamine 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 Methscopolamine. 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 Methscopolamine resources

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

• Methscopolamine Prescribing Information (FDA)


• methscopolamine Concise Consumer Information (Cerner Multum)


• Methscopolamine Bromide Monograph (AHFS DI)


• Pamine Prescribing Information (FDA)

Compare Methscopolamine with other medications

• Irritable Bowel Syndrome
• Peptic Ulcer

Boots Congestion Relief Capsules

1. Name Of The Medicinal Product

Boots Blocked Nose Relief 12mg Capsules

2. Qualitative And Quantitative Composition

Active ingredient	mg/cap
Phenylephrine Hydrochloride	12.00

3. Pharmaceutical Form

Capsule, hard (capsule)

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of nasal congestion associated with colds and hayfever.

4.2 Posology And Method Of Administration

Adults and children over 12 years: One capsule if necessary, up to four times daily.

Children under 12 years: Not recommended.

Elderly: There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, high blood pressure, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma. Patients being treated with monoamine oxidase inhibitors or within 14 days of ceasing such treatment (see section 4.5).

4.4 Special Warnings And Precautions For Use

This medicine should be used with caution in patients with occlusive vascular disease including Raynaud's Phenomenon.

Do not take for longer than 7 days, unless your doctor agrees.

If symptoms do not go away talk to your doctor.

Keep all medicines out of the reach of children.

Warning: Do not exceed the stated dose.

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May enhance the effects of anticholinergic drugs such as tricyclic antidepressants. May increase the possibility of arrhythmias in digitalised patients. May enhance the cardiovascular effects of other sympathomimetic amines (e.g. decongestants).

This medicine should not be taken together with vasodilators, Beta-blockers or enzyme inducers such as alcohol.

4.6 Pregnancy And Lactation

The safety of this medicine during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be avoided. In addition, because phenylephrine may reduce placental perfusion, the product should not be used in patients with a history of pre-eclampsia. In view of the lack of data on the use of phenylephrine during lactation, this medicine should not be used during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Adverse effects may include tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting, headache and occasionally urinary retention in males.

4.9 Overdose

Symptoms of overdosage include irritability, restlessness, palpitations, hypertension, difficulty in micturition, nausea, vomiting, thirst and convulsions. In severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive measures should be undertaken, particularly with regard to cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta blocker may be required to control cardiac arrhythmias.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha adrenergic activity and is without stimulating effects on the central nervous system. The sympathomimetic effect of phenylephrine produces vasoconstriction which in turn relieves nasal congestion.

5.2 Pharmacokinetic Properties

Phenylephrine is readily absorbed after oral administration but is subject to extensive presystemic metabolism, much of which occurs in the enterocytes. As a consequence, systemic bioavailability is only about 40%. Following oral administration, peak plasma concentrations are achieved in 1-2 hours. The mean plasma half life is in the range 2-3 hours. Penetration into the brain appears to be minimal.

Following absorption, the drug is extensively metabolised in the liver. Both phenylephrine and its metabolites are excreted in the urine.

The volume of distribution is between 200 and 500 litres, but there are no data on the extent of plasma protein binding.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pregelatinised maize starch

Dried maize starch

Lactose monohydrate

Magnesium stearate

Hard Gelatin Capsule (Gelatin, Quinoline Yellow E104, Titanium dioxide E171)

Ink (Black Iron Oxide E172, Shellac, Propylene glycol)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

Blister pack of pigmented 250 micron PVC coated with 40gsm PVdC and 20 micron aluminium foil.

Pack sizes: 5, 6, 7, 10, 12, 14, 18, 20, 21, 24, 25, 28, 30, 36, 48, 50.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

The Boots Company PLC

Nottingham

NG2 3AA

Trading as: BCM

8. Marketing Authorisation Number(S)

PL 00014/0593

9. Date Of First Authorisation/Renewal Of The Authorisation

16 May 2000

10. Date Of Revision Of The Text

October 2010

Terbutaline

Dosage Form: injection, solution
Terbutaline Sulfate Injection, USP 1mg/mL 1mL single dose vial

Terbutaline Description

Rx only

A sterile aqueous solution for subcutaneous injection.

WARNING: PROLONGED TOCOLYSIS

Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, Terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of Terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration (see CONTRAINDICATIONS, Prolonged Tocolysis).

DESCRIPTION

Terbutaline Sulfate Injection, USP, is a beta-adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. Each mL of solution contains: 1 mg of Terbutaline sulfate USP (0.82 mg of the free base), and Water for Injection, USP. Sodium chloride is used for isotonicity, and hydrochloric acid for adjustment to a pH of 3.0 to 5.0. Terbutaline sulfate is (±)-a-[(tert-butyl-amino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The structural formula is:

Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform.

Terbutaline - Clinical Pharmacology

Terbutaline is a beta-adrenergic receptor agonist. In vitro and in vivo pharmacologic studies have demonstrated that Terbutaline exerts a preferential effect on beta2-adrenergic receptors. While it is recognized that beta2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta2-receptors in the human heart, existing in a concentration between 10% to 50%. The precise function of these receptors has not been established (see WARNINGS). Controlled clinical studies in patients given Terbutaline subcutaneously have not revealed a preferential beta2-adrenergic effect. The pharmacologic effects of beta-adrenergic agonists, including Terbutaline, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic 3’,5’-adenosine monophosphate (cAMP). Increased cAMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. Controlled clinical studies have shown that Terbutaline relieves bronchospasm in acute and chronic obstructive pulmonary disease by significantly increasing pulmonary flow rates (e.g., an increase of 15% or more in FEV1). After subcutaneous administration of 0.25 mg of Terbutaline, a measurable change in expiratory flow rate usually occurs within 5 minutes, and a clinically significant increase in FEV1 occurs within 15 minutes. The maximum effect usually occurs within 30 to 60 minutes, and clinically significant bronchodilator activity may continue for 1.5 to 4 hours. The duration of clinically significant improvement is comparable to that observed with equimilligram doses of epinephrine.

Preclinical

Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histological evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. The clinical significance of these findings is unknown.

Pharmacokinetics

Subcutaneous administration of 0.5 mg of Terbutaline to 17 healthy, adult, male subjects resulted in mean (SD) peak plasma Terbutaline concentration of 9.6 (3.6) ng/mL, which was observed at a median (range) time of 0.5 (0.08 to 1) hours after dosing. The mean (SD) AUC (0 to 48) and total body clearance values were 29.4 (14.2) hr • ng/mL, and 311 (112) mL/min respectively. The terminal halflife was determined in 9 of the 17 subjects and had a mean (SD) of 5.7 (2) hours. After subcutaneous administration of 0.25 mg of Terbutaline to two male subjects, peak Terbutaline serum concentrations of 5.2 and 5.3 ng/mL were observed at about 20 minutes after dosing.

Elimination half-life of the drug in 10 of 14 patients was approximately 2.9 hours after subcutaneous administration, but longer elimination half-lives (between 6 to 14 hours) were found in the other 4 patients. About 90% of the drug was excreted in the urine at 96 hours after subcutaneous administration, with about 60% of this being unchanged drug. It appears that the sulfate conjugate is a major metabolite of Terbutaline and urinary excretion is the primary route of elimination.

INDICATIONS & USAGE

Terbutaline Sulfate Injection, USP is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.

Contraindications

Prolonged Tocolysis

Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, Terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting (see BOXED WARNING: PROLONGED TOCOLYSIS).

Hypersensitivity

Terbutaline sulfate injection is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.

WARNINGS

Deterioration of Asthma

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Terbutaline than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

Use of Anti-Inflammatory Agents

The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.

Cardiovascular Effects

Terbutaline, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Terbutaline at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Terbutaline, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Seizures

There have been rare reports of seizures in patients receiving Terbutaline; seizures did not recur in these patients after the drug was discontinued.

Precautions

General

Terbutaline, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, and cardiac arrhythmias; in patients with hyperthyroidism or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure have been seen and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

Immediate hypersensitivity reactions and exacerbations of bronchospasm have been reported after Terbutaline administration. Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation. Large doses of intravenous Terbutaline have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis.

Drug Interactions

The concomitant use of Terbutaline with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient.

Monoamine Oxidase Inhibitors or Tricyclic Antidepressants

Terbutaline should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, since the action of Terbutaline on the vascular system may be

potentiated.

Beta-Blockers

Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Terbutaline, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

Diuretics

The ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year study in Sprague-Dawley rats, Terbutaline sulfate caused a significant and dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of 50 mg/kg and above (approximately 810 times the maximum recommended daily subcutaneous (sc) dose for adults on a mg/m2 basis). In a 21-month study in CD-1 mice, Terbutaline showed no evidence of tumorigenicity at dietary doses up to 200 mg/kg (approximately 1,600 times the maximum recommended daily sc dose for adults on a mg/m2 basis). The mutagenicity potential of Terbutaline has not been determined.

Reproduction studies in rats using Terbutaline demonstrated no impairment of fertility at oral doses up to 50 mg/kg (approximately 810 times the maximum recommended daily sc dose for adults on a mg/m2 basis).

Pregnancy: Teratogenic Effects

Pregnancy Category C

There are no adequate and well-controlled studies of Terbutaline sulfate in pregnant women. Published animal studies show that rat offspring exhibit alterations in behavior and brain development, including decreased cellular proliferation and differentiation when dams were treated subcutaneously with Terbutaline during the late stage of pregnancy and lactation period. Terbutaline exposures in rat dams were approximately 24 to 48 times the common human dose in adults of 2 to 4 mg/day, on a mg/m2 basis. Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, Terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of Terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia.

Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration (see BOXED WARNING:

PROLONGED TOCOLYSIS and CONTRAINDICATIONS, Prolonged Tocolysis). In animal embryofetal developmental studies, no teratogenic effects were observed in offspring when pregnant rats and rabbits received Terbutaline sulfate at oral doses up to 50 mg/kg/day, approximately 810 and 1600 times, respectively, the maximum recommended daily subcutaneous dose for adults, on a mg/m2 basis. Terbutaline sulfate should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.

Use in Labor and Deivery

Because of the potential for beta-agonist interference with uterine contractility, use of Terbutaline for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Terbutaline crosses the placenta. After single dose IV administration of Terbutaline to 22 women in late pregnancy who were delivered by elective Cesarean section due to clinical reasons, umbilical blood levels of Terbutaline were found to range from 11% to 48% of the maternal blood levels.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Therefore, Terbutaline should be used during nursing only if the potential benefit justifies the possible risk to the newborn.

Pediatric Use

Terbutaline is not recommended for patients under the age of 12 years because of insufficient clinical data to establish safety and effectiveness.

Geriatric Use

Clinical studies of Terbutaline Sulfate Injection, USP 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.

Adverse Reactions

Adverse reactions observed with Terbutaline are similar to those commonly seen with other sympathomimetic agents. All these reactions are transient in nature and usually do not require treatment.

The following table compares adverse reactions seen in patients treated with Terbutaline (0.25 mg and 0.5 mg), with those seen in patients treated with epinephrine injection (0.25 mg and 0.5 mg), during eight double-blind crossover studies involving a total of 214 patients.

	Incidence (%) of Adverse Reactions
	Terbutaline (%)	Terbutaline (%)
	0.25 mg  N=77	0.5 mg  N=205
Reaction
Central Nervous System
Tremor	7.8	38
Nervousness	16.9	30.7
Dizziness	1.3	10.2
Headache	7.8	8.8
Drowsiness	11.7	9.8
Cardiovascular
Palpitations	7.8	22.9
Tachycardia	1.3	1.5
Respiratory
Dyspnea	0	2
Chest discomfort	1.3	1.5
Gastrointestinal
Nausea/vomiting	1.3	3.9
Systemic
Weakness	1.3	0.5
Flushed feeling	0	2.4
Sweating	0	2.5
Pain at injection site	2.6	0.5
	Epinephrine (%)	Epinephrine (%)
	0.25 mg  N=153	0.5 mg  N=61
Reaction
Central Nervous System
Tremor	16.3	18
Nervousness	8.5	31.1
Dizziness	7.8	3.3
Headache	3.3	9.8
Drowsiness	14.4	8.2
Cardiovascular
Palpitations	7.8	29.5
Tachycardia	2.6	0
Respiratory
Dyspnea	2	0
Chest discomfort	2.6	0
Gastrointestinal
Nausea/vomiting	1.3	11.5
Systemic
Weakness	2.6	1.6
Flushed feeling	1.3	0
Sweating	0	0
Pain at injection site	2.6	1.6

Note: Some patients received more than one dosage strength of Terbutaline and epinephrine. In addition, there were reports of anxiety, muscle cramps, and dry mouth (less than 0.5%). There have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis with Terbutaline administration.

Overdosage

The median sc lethal dose of Terbutaline in mature rats was approximately 165 mg/kg (approximately 2,700 times the maximum recommended daily sc dose for adults on a mg/m2 basis). The median sc lethal dose of Terbutaline in young rats was approximately 2,000 mg/kg (approximately 32,000 times the maximum recommended daily sc dose for adults on a mg/m2 basis). The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Hypokalemia may also occur. There is no specific antidote. Treatment consists of discontinuation of Terbutaline together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Terbutaline.

DOSAGE & ADMINISTRATION

Terbutaline Sulfate Injection, USP should be used only for subcutaneous administration and not intravenous infusion. Sterility and accurate dosing cannot be assured if the vials are not used in accordance with DOSAGE AND ADMINISTRATION.

Discard unused portion after single patient use.

The usual subcutaneous dose of Terbutaline Sulfate Injection, USP is 0.25 mg injected into the lateral deltoid area. If significant clinical improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg may be administered. If the patient then fails to respond within another 15 to 30 minutes, other therapeutic measures should be considered. The total dose within 4 hours should not exceed 0.5 mg.

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

How is Terbutaline Supplied

Product No.	NDC No.
660501	63323-665-01	Terbutaline Sulfate Injection, USP, 1 mg/mL in a 2 mL amber, Type 1 glass vial, 25 vials per tray

Discard unused portion after single patient use.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light. Do not use if solution is discolored.

Vial stoppers do not contain natural rubber latex.


APP

APP Pharmaceuticals, LLC

Schaumburg, IL 60173


451001D

Revised: February 2011

PACKAGE LABEL.PRINCIPAL

Terbutaline SULFATE  Terbutaline sulfate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52584-665 (63323-665) Route of Administration SUBCUTANEOUS DEA Schedule

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

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 52584-665-01 1 VIAL In 1 BAG contains a VIAL 1 1 mL In 1 VIAL This package is contained within the BAG (52584-665-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076887	11/16/2011

Labeler - General Injectables & Vaccines, Inc (108250663)

Revised: 11/2011General Injectables & Vaccines, Inc

More Terbutaline resources

• Terbutaline Side Effects (in more detail)
• Terbutaline Use in Pregnancy & Breastfeeding
• Drug Images
• Terbutaline Drug Interactions
• Terbutaline Support Group
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• Terbutaline MedFacts Consumer Leaflet (Wolters Kluwer)


• terbutaline Advanced Consumer (Micromedex) - Includes Dosage Information


• terbutaline Concise Consumer Information (Cerner Multum)


• Brethaire Concise Consumer Information (Cerner Multum)


• Terbutaline Sulfate Monograph (AHFS DI)

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