Boots Cystitis Relief (Cranberry)

1. Name Of The Medicinal Product

Cystitis Relief

Care Cystitis Relief 4g granules for oral solution

Cystocalm 4g granules for oral solution

Cystofem

Caneten Oasis

Paramed Cystitis Relief Sachets

Cysto S

Teva Cystitis Relief 4g granules for oral solution

2. Qualitative And Quantitative Composition

Sodium Citrate Dihydrate BP 4.0g

3. Pharmaceutical Form

Granules to be reconstituted for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of the symptoms of cystitis in women.

4.2 Posology And Method Of Administration

Adult women:

The contents of one sachet dissolved in a glass of water, to be taken three times a day for two days.

Men and children:

Not recommended.

4.3 Contraindications

Patients with diabetes, heart disease, hypertension, history of renal disease or those on a low salt diet.

During pregnancy and lactation.

4.4 Special Warnings And Precautions For Use

If symptoms persist after the two day course of treatment is completed, medical attention should be sought.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Contraindicated during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

In the unlikely event of overdosage occurring with this product, treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The effect of sodium citrate is to render the urine less acidic.

5.2 Pharmacokinetic Properties

None relevant.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose BP (1.5 g)

Colloidal Silicon Dioxide BP

Saccharin Sodium BP

Cranberry Flavouring

6.2 Incompatibilities

None stated.

6.3 Shelf Life

The granules have a three year shelf life.

The reconstituted solution should be used immediately.

6.4 Special Precautions For Storage

Store below 25°C, in dry place.

6.5 Nature And Contents Of Container

Foil laminate sachets

or

paper (outer surface layer) /polyethylene (outer layer) /aluminium foil (outer layer) /ionomer resin (inner layer) sachets

Each sachet contains 5.575 g of granule enclosed in a cardboard outer.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon

EX33 2DL

United Kingdom

8. Marketing Authorisation Number(S)

PL 12063/0045.

9. Date Of First Authorisation/Renewal Of The Authorisation

4 December 2003.

10. Date Of Revision Of The Text

12 June 2010

Buscopan Ampoules

Buscopan Ampoules

20 mg/ml Solution

for Injection

(hyoscine butylbromide)

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 gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What BUSCOPAN Ampoules are and what they are used for


• 2. Before you receive BUSCOPAN Ampoules


• 3. How BUSCOPAN Ampoules will be given


• 4. Possible side effects


• 5. How to store BUSCOPAN Ampoules


• 6. Further information

What Buscopan Ampoules Are And What They Are Used For

The name of your medicine is BUSCOPAN Ampoules 20 mg/ml Solution for injection (called BUSCOPAN Ampoules in this leaflet).

BUSCOPAN Ampoules contain a medicine called ‘hyoscine butylbromide’. This belongs to a group of medicines called ‘antispasmodics’.

BUSCOPAN Ampoules are used to relieve cramps in the muscles of your:

• Stomach


• Gut (intestine)


• Bladder and the tubes leading to the outside of your body (urinary system)

BUSCOPAN Ampoules can also be used in some diagnostic and therapeutic medical procedures where spasm may be a problem for example barium enema.

Before You Receive Buscopan Ampoules

You should not be given BUSCOPAN Ampoules if:

• You are allergic (hypersensitive) to hyoscine butylbromide or any of the other ingredients (listed in Section 6)


• You have glaucoma (an eye problem)


• You have megacolon (a very enlarged bowel)


• You have something called ‘myasthenia gravis’ (a very rare muscle weakness problem)


• You have a very fast heart rate


• You have difficulty or pain passing water (urine) such as men with prostate problems


• You have gut blockage problems or a totally inactive gut


• You are pregnant, likely to get pregnant or are breast-feeding

You should not receive this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Take special care with BUSCOPAN Ampoules

Check with your doctor or pharmacist before having this medicine if:

• You have any heart problems


• You have a fever


• You have problems with your thyroid gland such as an overactive thyroid gland

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before receiving BUSCOPAN Ampoules.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because BUSCOPAN Ampoules can affect the way some other medicines work. Also some other medicines can affect the way BUSCOPAN Ampoules work.

In particular tell your doctor or pharmacist if you are taking any of the following:

• Medicines for depression called ‘tricyclic antidepressants’ such as doxepin


• Medicines for allergies and travel sickness called ‘antihistamines’


• Medicines to control your heart beat such as quinidine or disopyramide


• Medicines for severe mental illness such as haloperidol or fluphenazine


• Medicines for breathing problems such as salbutamol, ipratropium or tiotropium


• Amantadine - for Parkinson’s disease and flu


• Metoclopramide - for feeling sick (nausea)

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before receiving BUSCOPAN Ampoules.

Pregnancy and breast-feeding

You should not be given BUSCOPAN Ampoules if you are pregnant, likely to get pregnant or are breast-feeding.

Driving and using machines

Some people may have sight problems while taking this medicine. If this happens to you, wait until your sight returns to normal before driving or using any tools or machines.

Important information about some of the ingredients of BUSCOPAN Ampoules

BUSCOPAN Ampoules contain sodium chloride. The amount of sodium in a 1 ml ampoule is less than 1 mmol (23 mg), the total amount of sodium if you are given five ampoules in 24 hours is less than 1mmol (23 mg) this means that your medicine is essentially sodium free.

How Buscopan Ampoules Will Be Given

BUSCOPAN Ampoules are usually given by a doctor or nurse.

Receiving the injection

BUSCOPAN Ampoules may be given in two ways:

• By being slowly injected into a vein


• By an injection into a muscle


• BUSCOPAN Ampoules may be diluted with other solutions if needed

How much will you be given

• You will usually be given one ampoule, but you may be given a further ampoule after half an hour if required


• If you are being given BUSCOPAN Ampoules as part of an endoscopy your dose may need to be given more often


• You should not be given more than 5 ampoules in any 24-hour period

BUSCOPAN Ampoules are not recommended for children.

If you have more BUSCOPAN Ampoules than you should

It is unlikely that you will be given too much of this medicine. However, tell the doctor or nurse if you think that you have been given too much.

Buscopan Ampoules Side Effects

Like all medicines, BUSCOPAN Ampoules can cause side effects although not everybody gets them. The following side effects may happen with this medicine.

Stop taking your medicine and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

• Allergic reactions such as skin rash and itching


• Severe allergic reactions (anaphylaxis) such as difficulty breathing, feeling faint or dizzy (shock)


• Painful red eye with loss of vision

Other side effects

• Dry mouth


• Dizziness


• Blurred vision


• Making less sweat than usual


• Increased heart rate


• Constipation


• Small blisters on hands and feet


• Being unable to pass water (urine)


• Low blood pressure, for example feeling faint


• Flushing

Pain at the place you had the injection may occur if you have been given BUSCOPAN Ampoules into a muscle.

Although unlikely, in certain circumstances it may be possible that BUSCOPAN may pass into the brain and cause side effects, for example confusion.

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

How To Store Buscopan Ampoules

• Keep out of the reach and sight of children


• Store below 30°C, keep the ampoules in the outer carton in order to protect from light


• BUSCOPAN Ampoules should not be used after the expiry date which is printed on the carton and ampoules. The expiry date refers to the last day of that month

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 BUSCOPAN Ampoules contain

Each ampoule contains 20 mg of the active ingredient hyoscine butylbromide. The other ingredients are sodium chloride and water for injections.

What BUSCOPAN Ampoules looks like and contents of the pack

BUSCOPAN Ampoules are clear glass ampoules containing a colourless or almost colourless, clear solution. BUSCOPAN Ampoules are supplied in cartons containing 10 x 1 ml ampoules.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisations are held by:

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

and the ampoules are manufactured at:

Boehringer Ingelheim Spain

Turó de can Matas

Ctra. De. Rubi

San Cugat del Valles

Barcelona

Spain

This leaflet was revised in April 2008.

© Boehringer Ingelheim Limited 2008

20080218

22C911

Evista

Generic Name: Raloxifene Hydrochloride
Class: Estrogen Agonists-Antagonists
ATC Class: G03XC01
VA Class: HS900
Chemical Name: 6-Hydroxy-2-(p-hydroxyphenyl)benzo[b]thien-3-yl-p-(2-piperidinoethoxy)phenyl ketone hydrochloride
Molecular Formula: C₂₈H₂₇NO₄S•ClH
CAS Number: 82640-04-8

• 
  

  Increased risk for DVT and pulmonary embolism.¹ Contraindicated in women with active or past episodes of venous thrombosis.¹ (See Contraindications and Cardiovascular Effects under Cautions.)

  
  


• 
  

  Increased risk of fatal stroke reported in women with CHD or increased risk for CHD.¹ Weigh risks versus benefits in women at risk for stroke.¹ (See Cardiovascular Effects under Cautions.)

  
  

Introduction

Estrogen agonist-antagonist; a nonsteroidal benzothiophene derivative.^{1 2 3 13 14 15 16 17 55 69 70}

Uses for Evista

Osteoporosis

Prevention of osteoporosis in postmenopausal women.^{1 2 3 4 5 6 7 16 17 23 55 69 108}

Treatment of osteoporosis in postmenopausal women.^{1 53 69 98 99 108}

Use supplemental calcium and/or vitamin D concomitantly if daily dietary intake is considered inadequate.^{1 2 3 4 5 6 7 16 17 23 55 69 108}

Corticosteroid-induced Osteoporosis

May prevent or treat corticosteroid-induced bone loss†.¹⁰⁷ American College of Rheumatology states that raloxifene can be offered to selected postmenopausal corticosteroid-treated women who refuse hormone replacement therapy or other antiresorptive agents (e.g., bisphosphonates, calcitonin) or in whom such therapies are contraindicated.¹⁰⁷

Breast Cancer

Reduction in the incidence of invasive breast cancer in postmenopausal women with osteoporosis.^{1 93 100}

Reduction in the incidence of invasive breast cancer in postmenopausal women at high risk for developing the disease.^{1 109 113} Effect comparable to that of tamoxifen in reducing the risk of invasive breast cancer (STAR trial).^{1 109 113} No effect on the risk of lobular carcinoma in situ or ductal carcinoma in situ (STAR trial).¹¹³ Effect on breast cancer incidence in women with BRCA1 or BRCA2 genetic mutations not established.¹

Not indicated for the treatment of breast cancer or to reduce the risk of recurrence of breast cancer.¹ Not indicated for reduction in the risk of noninvasive breast cancer.¹

Evista Dosage and Administration

Administration

Oral Administration

Administer orally once daily without regard to meals or time of day.^{1 2 55}

Dosage

Available as raloxifene hydrochloride; dosage expressed in terms of the salt.¹

Adults

Osteoporosis

Prevention in Postmenopausal Women

Oral

60 mg daily.^{1 2 55}

Treatment in Postmenopausal Women

Oral

60 mg daily.^{1 98}

Breast Cancer

Reduction in the Incidence of Invasive Breast Cancer

Oral

60 mg daily.¹ Optimum duration of therapy unknown.¹

Cautions for Evista

Contraindications

• 
  

  Active or past episodes of venous thrombosis, including DVT, pulmonary embolism, or retinal vein thrombosis.^{1 52}

  
  


• 
  

  Women who are or may become pregnant.¹

  
  


• 
  

  Lactating women.¹

  
  

Warnings/Precautions

Warnings

Cardiovascular Effects

Increased risk of venous thromboembolic events (e.g., DVT, pulmonary embolism).^{1 55 69 72}

Discontinue raloxifene ≥72 hours before and during prolonged immobilization (e.g., postsurgery recovery, prolonged bed rest); resume therapy once patient is fully ambulatory.^{1 52}

Assess potential benefit versus risk in women at risk of thromboembolic disease secondary to CHF, superficial thrombophlebitis, or active malignancy.^{1 2}

Increased risk for fatal stroke reported in women with CHD or increased risk for CHD (RUTH study).^{1 115} Assess potential benefit versus risk in women at risk of stroke secondary to history of stroke or TIA, atrial fibrillation, hypertension, or cigarette smoking.¹

Not indicated for the primary or secondary prevention of cardiovascular disease.¹

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.^{1 58 59 60 61 62 63} Embryotoxic and teratogenic effects demonstrated in animals.^{1 60 61} If inadvertently used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.¹ (See Contraindications.)

General Precautions

Use in Premenopausal Women

Not indicated.¹ Safety not established.¹

Effects on Lipids

Potential for increased serum triglyceride concentrations in women with a history of substantial hypertriglyceridemia during oral estrogen therapy; monitor serum triglycerides in these women.¹

Effects on the Breast

Not studied in women with a history of breast cancer.¹

Investigate unexplained breast abnormality.¹ Does not eliminate risk of breast cancer.¹

Use in Men

Safety and efficacy not evaluated.¹

GU Effects

Not associated with endometrial proliferation.¹ Investigate unexplained uterine bleeding.¹

Specific Populations

Pregnancy

Category X.¹ (See Fetal/Neonatal Morbidity and Mortality and also Contraindications under Cautions.)

Lactation

Contraindicated.¹

Not known whether raloxifene is distributed into milk.¹

Pediatric Use

Not indicated.¹

Geriatric Use

No substantial differences in safety, efficacy, or pharmacokinetic profile relative to younger adults.¹

Hepatic Impairment

Use with caution; safety and efficacy not established in patients with hepatic impairment.¹ (See Special Populations under Pharmacokinetics.)

Renal Impairment

Use with caution in patients with moderate to severe renal impairment; safety and efficacy not established in these patients.¹ (See Special Populations under Pharmacokinetics.)

Common Adverse Effects

Hot flushes (flashes), leg cramps, peripheral edema, flu-like syndrome, arthralgia, sweating.^{1 2 23 69 72 88 93 96 98}

Interactions for Evista

Metabolism apparently not mediated by CYP isoenzymes.¹

Protein-bound Drugs

Concomitant administration with other highly protein-bound drugs not expected to affect plasma raloxifene concentrations.¹ Caution advised if used concomitantly with other highly protein-bound drugs.¹

Specific Drugs

Drug	Interaction	Comments
Amoxicillin and ampicillin	Ampicillin: Decreased peak plasma raloxifene concentrations; no change in systemic exposure to raloxifene1 Amoxicillin: No change in raloxifene concentrations1	Can be administered concomitantly1
Anion-exchange resins (cholestyramine)	Decreased absorption and enterohepatic cycling of raloxifene with concomitant cholestyramine administration; similar interaction expected with other anion-exchange resins1	Concomitant administration with cholestyramine not recommended1 52
Antacids (aluminum- and magnesium-containing, calcium carbonate)	No change in systemic exposure of raloxifene1	Can be administered concomitantly1
Anticoagulants, oral	Decreased warfarin effects; no effect on warfarin pharmacokinetics observed1	Monitor PT carefully1
Antilipemic agents	Concomitant use not specifically studied1
Diazepam	Potential for altered protein binding of diazepam1	Caution advised1
Diazoxide	Potential for altered protein binding of diazoxide1	Caution advised1
Digoxin	No change in digoxin pharmacokinetics1	Can be administered concomitantly1
Estrogens	Not studied1	Concomitant use not recommended1
Gemfibrozil	No substantial change in plasma raloxifene concentrations1
Lidocaine	Potential for altered protein binding of lidocaine1	Caution advised1
Methylprednisolone	No change in methylprednisolone pharmacokinetics1	Can be administered concomitantly with corticosteroids1
Phenytoin	No change in protein binding of phenytoin1

Evista Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from GI tract; 60% of an oral dose is absorbed, but absolute bioavailability as unchanged drug is only 2% because of extensive first-pass glucuronidation.^{1 27 33 34 35 45 69}

Following oral administration, peak plasma concentrations achieved at 6 hours (raloxifene) and 1 hour (glucuronide conjugates).^{33 35}

Food

High-fat meal increases peak plasma concentration and extent of absorption of raloxifene, but does not substantially affect systemic exposure.¹

Special Populations

Plasma raloxifene concentrations are 150% higher in patients with cirrhosis (Child-Pugh class A) and total serum bilirubin concentrations of 0.6–2 mg/dL than in individuals with normal hepatic function.¹ Pharmacokinetics not studied in individuals with moderate or severe hepatic impairment.¹

Plasma raloxifene concentrations in those with mild renal impairment are similar to values in women with normal renal function.^{1 96} AUC of raloxifene is 122% higher in individuals with moderate renal impairment (Cl_cr 31–50 mL/minute) or severe renal impairment (Cl_cr ≤30 mL/minute) than in individuals with normal renal function.¹

Distribution

Plasma Protein Binding

Raloxifene and its monoglucuronide conjugates: >95%.^{1 69 96} Raloxifene binds to albumin and α₁-acid glycoprotein but not to testosterone-estradiol binding globulin (sex hormone binding globulin).¹

Elimination

Metabolism

Undergoes extensive first-pass metabolism to glucuronide conjugates.^{1 27 33 34 35 36 55} Does not appear to be metabolized by CYP isoenzymes.¹ Conjugates converted back to the parent drug in various tissues.^{1 27}

Elimination Route

Excreted principally in feces as unabsorbed drug and via biliary elimination as glucuronide conjugates (subsequently metabolized by bacteria in GI tract to the parent drug).^{1 45 55 69 96}

Half-life

32.5 hours.^{1 55}

Stability

Storage

Oral

Tablets

20–25°C.¹

ActionsActions

• 
  

  Selective estrogen receptor modulator (SERM); exhibits estrogen agonist activity on bone, but estrogen antagonist activity on breast and uterine tissue.^{1 2 3 4 5 6 7 8 9 13 14 15 16 17 18 21 28 69 70 88 89 101}

  
  


• 
  

  Differs chemically and pharmacologically from naturally occurring estrogens, synthetic steroidal and nonsteroidal compounds with estrogenic activity, and agents described as antiestrogens (e.g., clomiphene, tamoxifen, toremifene).^{4 13 14 15 16 17}

  
  


• 
  

  In postmenopausal women or women who have undergone oophorectomy, principal action in bone is to decrease the rate of bone resorption, thus slowing the rate of bone loss.^{1 2 3 4 5 6 7 16 17 19 20 23 37}

  
  


• 
  

  Inhibits estradiol-dependent proliferation of MCF-7 human mammary tumor cells in vitro.^{7 16 17 43 69}

  
  

Advice to Patients

• 
  

  Importance of providing patient a copy of manufacturer’s patient information.¹

  
  


• 
  

  Risk of venous thromboembolic events.¹ Notify clinician if signs or symptoms of thromboembolic disorder occur.⁵² Avoid prolonged restrictions in movement while traveling.^{1 52} Discontinue raloxifene ≥72 hours before and during prolonged immobilization (e.g., postsurgery recovery, prolonged bed rest).¹

  
  


• 
  

  Potential for increased incidence of hot flushes (flashes); drug is not effective in reducing hot flushes associated with estrogen deficiency.¹

  
  


• 
  

  When used for osteoporosis, importance of taking supplemental calcium and/or vitamin D if daily dietary intake is inadequate.¹ Importance of weight-bearing exercise and modification of other risk factors for osteoporosis (e.g., smoking, alcohol intake) if needed.¹

  
  


• 
  

  When used to reduce the incidence of invasive breast cancer, advise patient regarding benefits and risks of therapy as well as appropriate indications.¹ Need for regular breast examinations and mammograms.¹

  
  


• 
  

  Importance for women who are or may become pregnant or who are lactating to avoid taking the drug.¹

  
  


• 
  

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

Raloxifene Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	60 mg	Evista	Lilly

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Evista 60MG Tablets (LILLY): 30/$139.99 or 90/$369.95

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 April 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Eli Lilly and Company. Evista (raloxifene hydrochloride) tablets prescribing information. Indianapolis, IN; 2007 Sep.

2. Delmas PD, Bjarnason NH, Mitlak BH et al. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med. 1997; 337:1641-7. [IDIS 397097] [PubMed 9385122]

3. Boss SM, Huster WJ, Neild JA et al. Effects of raloxifene hydrochloride on the endometrium of postmenopausal women. Am J Obstet Gynecol. 1997; 177:1458-64. [IDIS 399175] [PubMed 9423751]

4. Gradishar WJ, Jordan VC. Clinical potential of new antiestrogens. J Clin Oncol. 1997; 15:840-52. [IDIS 381300] [PubMed 9053512]

5. Purdie DW. Selective oestrogen receptor modulation: HRT replacement therapy? Br J Obstet Gynaecol. 1997; 104:1103-5. (IDIS 394047)

6. El-Hajj Fuleihan G. Tissue-specific estrogens—the promise for the future. N Engl J Med. 1997; 337:1686-7. [PubMed 9385130]

7. Compston JE. Designer oestrogens: fact or fantasy? Lancet. 1997; 350:676-7. (IDIS 390843)

8. Pennisi E. Drug’s link to genes reveals estrogen’s many sides. Science. 1996; 273:1171. [PubMed 8787121]

9. Yang NN, Venugopalan M, Hardikar S et al. Identification of an estrogen response element activated by metabolites of 17β-estradiol and raloxifene. Science. 1996; 273:1222-5. [PubMed 8703055]

10. Yang NN, Venugopalan M, Hardikar S et al. Correction: raloxifene response needs more than an element. Science. 1997; 275:1249. [PubMed 9064777]

11. Pennisi E. Differing roles found for estrogen’s two receptors. Science. 1997; 277:1439. [PubMed 9304214]

12. Paech K, Webb P, Kuiper GGJM et al. Differential ligand activation of estrogen receptors ERα and ERβ at AP1 sites. Science. 1997; 277:1508-10. [PubMed 9278514]

13. Grese TA, Cho S, Finley DR et al. Structure-activity relationships of selective estrogen receptor modulators: modifications to the 2-arylbenzothiophene core of raloxifene. J Med Chem. 1997; 40:146-67. [PubMed 9003514]

14. Brzozowski AM, Pike ACW, Dauter Z et al. Molecular basis of agonism and antagonism in the oestrogen receptor. Nature. 1997; 389:753-8. [PubMed 9338790]

15. Jones CD, Jevnikar MG, Pike AJ et al. Antiestrogens. 2. Structure-activity studies in a series of 3-aroyl-2-arylbenzo[b]thiophene derivatives leading to [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]-phenyl] methanone hydrochloride (LY156758), a remarkably effective estrogen antagonist with only minimal intrinsic estrogenicity. J Med Chem. 1984; 27:1057-66. [PubMed 6431104]

16. Mitlak BH, Cohen FJ. In search of optimal long-term female hormone replacement: the potential of selective estrogen receptor modulators. Horm Res. 1997; 48:155-63. [PubMed 9378461]

17. Bryant HU, Dere WH. Selective estrogen receptor modulators: an alternative to hormone replacement therapy. Proc Soc Exp Biol Med. 1998; 217:45-52. [PubMed 9421206]

18. Baker VL, Draper M, Paul S et al. Reproductive endocrine and endometrial effects of raloxifene hydrochloride, a selective estrogen receptor modulator, in women with regular menstrual cycles. J Clin Endocrinol Metab. 1998; 83:6-13. [IDIS 397364] [PubMed 9435408]

19. Williams CL, Stancel GM. Estrogens and progestins. In: Hardman JG, Limbird LE, Molinoff PB et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 9th ed. New York: McGraw-Hill; 1995:1411-40.

20. Finkelstein JS. Osteoporosis. In: Bennett JC, Plum F, eds. Cecil textbook of medicine. 20th ed. Philadelphia: W.B. Saunders Company; 1996:1379-84.

21. Black LJ, Sato M, Rowley ER et al. Raloxifene (LY139481 HCl) prevents bone loss and reduces serum cholesterol without causing uterine hypertrophy in ovariectomized rats. J Clin Invest. 1994; 93:63-9. [PubMed 8282823]

22. Zuckerman SH, Bryan N. Inhibition of LDL oxidation and myeloperoxidase dependent tyrosyl radical formation by the selective estrogen receptor modulator raloxifene (LY139481 HCL). Atherosclerosis. 1996; 126:65-75. [PubMed 8879435]

23. Draper MW, Flowers DE, Huster WJ et al. A controlled trial of raloxifene (LY139481) HCl: impact on bone turnover and serum lipid profile in healthy postmenopausal women. J Bone Miner Res. 1996; 11:835-42. [PubMed 8725181]

24. Thomas JL, Braus PA. Coronary artery disease in women: a historical perspective. Arch Intern Med. 1998; 158:333-7. [PubMed 9487230]

25. Cheskis BJ, Karathanasis S, Lyttle CR. Estrogen receptor ligands modulate its interaction with DNA. J Biol Chem. 1997; 272:11384-91. [PubMed 9111047]

26. Fiorelli G, Martineti V, Gori F et al. Heterogeneity of binding sites and bioeffects of raloxifene on the human leukemic cell line FLG 29.1. Biochem Biophys Res Commun. 1997; 240:573-9. [PubMed 9398606]

27. Dodge JA, Lugar CW, Cho S et al. Evaluation of the major metabolites of raloxifene as modulators of tissue selectivity. J Steroid Biochem Molec Biol. 1997; 61:97-106. [PubMed 9328215]

28. Frolik CA, Bryant HU, Black EC et al. Time-dependent changes in biochemical bone markers and serum cholesterol in ovariectomized rats: effects of raloxifene HCl, tamoxifen, estrogen, and alendronate. Bone. 1996; 18:621-7. [PubMed 8806005]

29. Buzdar AU, Marcus C, Holmes F et al. Phase II evaluation of Ly156758 in metastatic breast cancer. Oncology. 1988; 45:344-5. [PubMed 3412740]

30. Magee DE, Evans G, Sato M et al. Raloxifene (LY139481•HCl) does not antagonize the effects of estrogen on bone. J Bone Miner Res. 1996; 11:S446.

31. Heaney RP, Draper MW. Raloxifene and estrogen: comparative bone-remodeling kinetics. J Clin Endocrinol Metab. 1997; 82:3425-9. [IDIS 394863] [PubMed 9329380]

32. Powles TJ, Hickish T, Kanis JA et al. Effect of tamoxifen on bone mineral density measured by dual-energy x-ray absorptiometry in healthy premenopausal and postmenopausal women. J Clin Oncol. 1996; 14:78-84. [IDIS 358669] [PubMed 8558225]

33. Ni L, Allerheiligen SRB, Basson R et al. Pharmacokinetics of raloxifene in men and postmenopausal women volunteers. Pharm Res. 1996; 13:S-430. [PubMed 8932457]

34. Allerheiligen S, Geiser J, Knadler M et al. Raloxifene (RAL) pharmacokinetics and the associated endocrine effects in premenopausal women treated during the follicular, ovulatory, and luteal phases of the menstrual cycle. Pharm Res. 1996; 13:S-430.

35. Forgue ST, Rudy AC, Knadler MP et al. Raloxifene pharmacokinetics in healthy postmenopausal women. Pharm Res. 1996; 13:S-429.

36. Lindstrom TD, Whitaker NG, Whitaker GW. Disposition and metabolism of a new benzothiophene antiestrogen in rats, dogs and monkeys. Xenobiotica. 1984; 14:841-7. [PubMed 6506756]

37. McDonnell DP, Clemm DL, Hermann T et al. Analysis of estrogen receptor function in vitro reveals three distinct classes of antiestrogens. Mol Endocrinol. 1995; 9:659-69. [PubMed 8592512]

38. Katzenellenbogen BS, Montano MM, Le Goff P et al. Antiestrogens: mechanisms and actions in target cells. J Steroid Biochem Mol Biol. 1995; 53:387-93. [PubMed 7626486]

39. Bass KM, Newschaffer CJ, Klag MJ et al. Plasma lipoprotein levels as predictors of cardiovascular death in women. Arch Intern Med. 1993; 153:2209-16. [PubMed 8215724]

40. Seeman E. Osteoporosis: trials and tribulations. Am J Med. 1997; 103:74-89S. [PubMed 9236490]

41. Wyeth Laboratories. Prempro (conjugated estrogens/medroxyprogesterone acetate) tablets prescribing information. In: Physicians’ desk reference. 51st ed. Montvale, NJ: Medical Economics Company Inc; 1997:2905-9.

42. Grey AB, Stapleton JP, Evans MC et al. The effect of the antiestrogen tamoxifen on bone mineral density in normal late postmenopausal women. Am J Med. 1995; 99:636-41. [IDIS 360184] [PubMed 7503087]

43. Bryant HU, Glasebrook AL, Yang NN et al. A pharmacological review of raloxifene. J Bone Miner Metab. 1996; 14:1-9.

44. Hosking D, Chilvers CED, Christiansen C et al et al. Prevention of bone loss with alendronate in postmenopausal women under 60 years of age. N Engl J Med. 1998; 338:485-92. [IDIS 400119] [PubMed 9443925]

45. Knadler MP, Lantz RJ, Gillespie TA et al. The disposition and metabolism of¹⁴C-labeled raloxifene in humans. Pharm Res. 1995; 12(Suppl):S-372.

46. Hol T, Cox MB, Bryant HU et al. Selective estrogen receptor modulators and postmenopausal women’s health. J Womens Health. 1997; 6:523-31. [PubMed 9356975]

47. Hannover Bjarnason N, Haarbo J, Byrjalsen I et al. Raloxifene inhibits aortic accumulation of cholesterol in ovariectomized, cholesterol-fed rabbits. Circulation. 1997; 96:1964-9. [PubMed 9323087]

48. Scheele WH, Symanowski SM, Neale S et al. Raloxifene does not cause stimulatory effects on the uterus in healthy postmenopausal women. In: The Endocrine Society 79th annual meeting program, Minneapolis 1997 Jun 11–14. The Endocrine Society Press: Bethesda, MD; p. 498. Abstract No. P3-246.

49. Gunness M, Prestwood K, Lu Y et al. Histomorphometric, bone marker, and bone mineral density response to raloxifene HCl and premarin in postmenopausal women. In: The Endocrine Society 79th annual meeting program, Minneapolis 1997 Jun 11–14. The Endocrine Society Press: Bethesda, MD; p. 67. Abstract No. OR4-2.

50. Evans G, Bryant HU, Magee D et al. The effects of raloxifene on tibia histomorphometry in ovariectomized rats. Endocrinology. 1994; 134:2283-8. [PubMed 8156931]

51. Ajzenberg N, Depraetere H, Girma JP et al. Platelet aggregation induced by a monoclonal antibody to von Willebrand factor. Atherosclerosis. 1997; 134:182.

52. Eli Lilly and Company. Evista (raloxifene hydrochloride) tablets information for the patient. Indianapolis, IN; 1997 Dec 10.

53. Lufkin EG, Whitaker MD, Argueta R et al. Raloxifene treatment of postmenopausal osteoporosis. J Bone Miner Res. 1997; 12:S150.

54. Gize EA, Venugopalan M, Glasebrook AL et al. Characterization of raloxifene binding and transactivation properties of the estrogen receptor-beta (ERβ). J Bone Miner Res. 1997; 12:S460.

55. Anon. Raloxifene for postmenopausal osteoporosis. Med Lett Drug Ther. 1998; 40:29-30.

56. Goldberg RM, Loprinzi CL, O’Fallon JR et al. Transdermal clonidine for ameliorating tamoxifen-induced hot flashes. J Clin Oncol. 1994; 12:155-8. [IDIS 324702] [PubMed 8270972]

57. Food and Drug Administration. Prescription drug advertising; content and format for labeling of human prescription drugs. Fed Regist. 1979; 44:37434-67.

58. Hoyt JA, Fisher LF, Buelke-Sam JL et al. The selective estrogen receptor modulator, raloxifene: reproductive assessments following premating exposure in female rats. Teratology. 1996; 53:103.

59. Hoyt JA, Fisher LF, Swisher DK et al. The selective estrogen receptor modulator, raloxifene: reproductive assessments in male rats. Teratology. 1996; 53:103.

60. Clarke DO, Griffey KI, Buelke-Sam JL et al. The selective estrogen receptor modulator, raloxifene: reproductive assessments following preimplantation exposure in mated female rats. Teratology. 1996; 53:103-4.

61. Byrd RA, Francis PC. The selective estrogen receptor modulator, raloxifene: segment II studies in rats and rabbits. Teratology. 1996; 53:104.

62. Buelke-Sam J, Griffey KI, Schwier PW et al. The selective estrogen receptor modulator, raloxifene: a segment II/III delivery study in rats. I - maternal and preweaning offspring assessments. Teratology. 1996; 53:104.

63. Buelke-Sam J, Cohen I, Wierda D et al. The selective estrogen receptor modulator, raloxifene: a segment II/III delivery study in rats. II - postweaning offspring assessments. Teratology. 1996; 53:104.

64. McDonnell DP. Definition of the molecular mechanism of action of tissue-selective oestrogen-receptor modulators. Biochem Soc Transact. 1998; 26:54-60.

65. Gray JM, Ziemian L. Antiestrogen binding sites in brain and pituitary of ovariectomized rats. Brain Res. 1992; 578:55-60. [PubMed 1511289]

66. Eli Lilly and Company. Dear healthcare professional letter regarding questioning the safety of Evista (raloxifene hydrochloride). Indianapolis, IN: Eli Lilly and Company; 1998 Feb.

67. Eli Lilly and Company. Product information form for American hospital formulary service: Evista (raloxifene hydrochloride). Indianapolis, IN; 1998 Mar 31.

68. National Cancer Institute. Breast cancer prevention trial shows major benefit, some risk. Bethesda, MD; 1998 Apr 6. Press release.

69. Balfour JA, Goa KL. Raloxifene. Drugs Aging. 1998; 12:335-41. [PubMed 9571395]

70. Kauffman RF, Bensch WR, Roudebush RE et al. Hypocholesterolemic activity of raloxifene (LY139481): pharmacological characterization as a selective estrogen receptor modulator. J Pharmacol Exp Ther. 1997; 280:146-53. [PubMed 8996192]

71. Burton TM. New drugs give cause for hope in fight against breast cancer: preventive therapies show promise, but the testing has a long way to go: Lilly looks beyond Prozac. Wall Street J. 1998 20 Apr.

72. Delmas PD, Mitlak BH, Christiansen C. Effects of Raloxifene in Postmenopausal Women. N Engl J Med. 1998; 338:1313.

73. Wiznitzer I, Benz C. Tamoxifen vs. LY156758 for treatment of human breast and prostate cancer in vitro. Breast Cancer Res Treat. 1983; 3:305.

74. Sato M, Glasebrook AL, Bryant HU. Raloxifene: a selective estrogen receptor modulator. J Bone Miner Metab. 1995; 12(Suppl II):S9-20.

75. Labrie F, Veilleux R, Fournier A. Glucocorticoids stimulate the growth of mouse mammary carcinoma Shionogi cells in culture. Mol Cell Endocrinol. 1988; 58:207-11. [PubMed 2850248]

76. Thompson EW, Reich R, Shima TB et al. Differential regulation of growth and invasiveness of MCF-7 breast cancer cells by antiestrogens. Cancer Res. 1988; 48:6764-8. [PubMed 2846159]

77. Gottardis MM, Jordan VC. Antitumor actions of keoxifene and tamoxifen in the N-nitrosomethylurea-induced rat mammary carcinoma model. Cancer Res. 1987; 47:4020-4. [PubMed 3607747]

78. European Foundation for Osteoporosis and Bone Disease, National Osteoporosis Foundation, and National Institute of Arthritis and Muscoloskeletal and Skin Diseases. Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med. 1993; 94:646-50. [IDIS 316087] [PubMed 8506892]

79. Commonwealth Department of Health and Family Services, Australian National Consensus Conference 1996. The prevention and management of osteoporosis: consensus atatement. Med J Austral. 1997; 167(suppl):S1-15.

80. Osteoporosis Society of Canada Scientific Advisory Board. Clinical practice guidelines for diagnosis and mangement of osteoporosis. CMAJ. 1996; 155:1113-33. [IDIS 373678] [PubMed 8873639]

81. Ross PD. Osteoporosis: frequency, consequences, and risk factors. Arch Intern Med. 1996; 156:1399-411. [IDIS 370197] [PubMed 8678708]

82. Eastell R. Treatment of postmenopausal osteoporosis. N Engl J Med. 1998; 338:736-46. [IDIS 402219] [PubMed 9494151]

83. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride. Washington, DC: National Academy Press; 1997. (Uncorrected proofs.)

84. Cauley JA, Seeley DG, Ensrud K et al. Estrogen replacement therapy and fractures in older women. Ann Intern Med. 1995; 122:9-16. [IDIS 339879] [PubMed 7985914]

85. Schneider DL, Barrett-Connor LB, Morton DJ. Tming of postmenopausal estrogen for optimal bone mineral density: the Racncho Bernardo study. JAMA. 1997; 277:543-7. [IDIS 379894] [PubMed 9032160]

86. Maricic M. Early prevention vs late treatment for osteoporosis. Arch Intern Med. 1997; 157:2545-6. [IDIS 397757] [PubMed 9531221]

87. Heaney RP. Bone mass, bone loss, and osteoporosis prophylaxis. Ann Intern Med. 1998; 128:313-4. [IDIS 401677] [PubMed 9471936]

88. Walsh BW, Kuller LH, Wild RA et al. Effects of raloxifene on serum lipids and coagulation factors in healthy postmenopausal women. JAMA. 1998; 279:1445-51. [IDIS 405187] [PubMed 9600478]

89. Rifkind BM, Rossouw JE. Of designer drugs, magic bullets, and gold standards. JAMA. 1998; 279:1483-5. [IDIS 405190] [PubMed 9600485]

90. Powles TJ, Hickish T, Kanis JA et al. Effect of tamoxifen on bone mineral density measured by dual-energy x-ray absorptiometry in healthy premenopausal and postmenopausal women. J Clin Oncol. 1996; 14:78-84. [IDIS 358669] [PubMed 8558225]

91. Reviewers’ comments (personal observations).

92. Jordan VC, Glusman JE, Eckert S et al. Incident primary breast cancers are reduced by raloxifene: integrated data from multicenter, double-blind, randomized trials in 12,000 postmenopausal women. Proc Am Soc Clin Oncol. 1998; 17:122A.

93. Cummings SR, Eckert S, Krueger KA et al. The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial. JAMA. 1999; 281:2189-97. [IDIS 426871] [PubMed 10376571]

94. Gradishar WJ, Glusman JE, Vogel CL et al. Raloxifene HCl, a new endocrine agent, is active in estrogen receptor positive (ER+) metastatic breast cancer. Breast Cancer Research and Treatment; 20th Annual San Antonio Breast Cancer Symposium; 1997 Dec 3-6; San Antonio. Dordrecht/Boston/London: Kluwer Academic Publishers. Changes and additions to program. Abstract 209.

95. Gluer CC, Cummings SR, Bauer DC et al. Osteoporosis: assocation of recent fractures with quatititative US findings. Radiology. 1996; 199:725-32. [PubMed 8637996]

96. Eli Lilly and Company, Indianapolis, IN: Personal communication.

97. Vilches AR, Pérez V, Suchecki DE. Raloxifene-associated hepatitis. Lancet. 1998; 352:1524-5. [IDIS 415661] [PubMed 9820309]

98. Ettinger B, Black DM, Mitlak BH et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. JAMA. 1999; 282:637-45. [IDIS 430444] [PubMed 10517716]

99. McClung MR. Therapy for fracture prevention. JAMA. 1999; 282:687-9. [IDIS 430446] [PubMed 10517723]

100. Cauley JA, Norton L, Lippman ME et al. Continued breast cancer reduction in postmenopausal women treated with raloxifene: 4-year results from the MORE trial. Breast Ca Res Treat. 2001; 65:125-34.

101. Khovidhunkit W, Shoback DM. Clinical effects of raloxifene hydrochloride in women. Ann Intern Med. 1999; 130:431-9. [IDIS 421483] [PubMed 10068418]

102. Chlebowski RT, Col N, Winer EP at al. American Society of Clinical Oncology technology assessment of pharmacologic interventions for breast cancer risk reduction including tamoxifen, raloxifene, and aromatase inhibition. J Clin Oncol. 2002; 20:3328-43. [IDIS 486567] [PubMed 12149307]

103. Committee on Educational Bulletins of the American College of obstetricians and Gynecologists. ACOG Educational Bulletin: osteoporosis. Obstet Gynecol. 1998; 91:1-9. [IDIS 403501] [PubMed 9464711]

104. Eastell R. Treatment of postmenopausal osteoporosis. N Engl J Med. 1998; 338:736-46. [IDIS 402219] [PubMed 9494151]

105. National Osteoporosis Foundation. Physician’s guide to prevention and treatment of osteoporosis. Washington, DC; 1998.

106. World Health Organization. Guidelines for preclinical evaluation and clinical trials in osteoporosis. Geneva: World Health Organization; 1998:5-6.

107. American College of Rheumatology Ad Hoc Committee on Glucocorticoid-induced Osteoporosis. Recommendations for the prevention and treatment of gluococorticoid-induced osteoporosis: 2001 update. Arthritis Rheum. 2001; 44:1496-503. [IDIS 466759] [PubMed 11465699]

108. Anon. Drugs for prevention and treatment of postmenopausal osteoporosis. Med Lett Drugs Ther. 2000; 42:97-100. [PubMed 11035622]

109. National Cancer Institute (NCI). Questions & answers: the study of tamoxifen and raloxifene (STAR). Bethesda, MD. 2002 May 17.

110. Vogel VG, Costantino JP, Wickerham DL et al. The study of tamoxifen and raloxifene: preliminary enrollment data from a randomized breast cancer risk reduction trial. Clin Breast Cancer. 2002; 3:153-9. [PubMed 12123540]

111. American College of O

Nicotrol Oral, Transdermal

Generic Name: nicotine (Oral route, Transdermal route)

NIK-oh-teen

Commonly used brand name(s)

In the U.S.

• Habitrol


• Nicoderm CQ


• Nicotrol

In Canada

• Nicoderm

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Smoking Cessation Agent

Pharmacologic Class: Cholinergic

Uses For Nicotrol

Nicotine, in a flavored chewing gum, a lozenge, or a skin patch, is used to help you stop smoking. It is used for up to 12 weeks as part of a stop-smoking program. This program may include education, counseling, and psychological support.

As you chew nicotine gum or suck on the nicotine lozenge, nicotine passes through the lining of your mouth and into your blood stream. When you wear a nicotine patch, nicotine passes through your skin into your blood stream. This nicotine takes the place of nicotine that you would otherwise get from smoking. In this way, the withdrawal effects of not smoking are less severe. Then, as your body adjusts to not smoking, the use of the nicotine gum is decreased gradually until use is stopped altogether. For most brands of patches, the strength of the patch you use will be decreased over a few weeks until use is stopped. If you are using the brand of patch that is available in only one strength, use is stopped after the treatment period indicated on the label.

Children, pregnant women, and nonsmokers should not use nicotine gum or patches because of harmful effects.

Nicotine transdermal patches, gum, and lozenges are available without a prescription.

Before Using Nicotrol

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

Small amounts of nicotine can cause serious harm in children. Even nicotine patches that have been used still contain enough nicotine to cause problems in children. Although there is no specific information comparing use of nicotine in teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in nicotine-dependent teenagers than it does in adults.

Geriatric

Nicotine gum, lozenges, and patches have been used in a limited number of patients 60 years of age or older, and have not been shown to cause different side effects or problems in older people than in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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 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.

• Clozapine

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:

• Dental problems (with gum only) or


• Diabetes, type 1 (sugar diabetes) or


• Heart or blood vessel disease or


• High blood pressure or


• Inflammation of mouth or throat (with gum only) or


• Irritated skin (with patches only) or


• Overactive thyroid or


• Pheochromocytoma (PCC) or


• Stomach ulcer or


• Stroke, recent or


• Temporomandibular (jaw) joint disorder (TMJ) (with gum only)—Nicotine may make the condition worse.

Proper Use of nicotine

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

For patients using the chewing gum:

• Nicotine gum usually comes with patient directions. Read the directions carefully before using this medicine.


• Use nicotine gum exactly as directed on the label. Remember that it is also important to participate in a stop-smoking program during treatment. This may make it easier for you to stop smoking.


• When you feel the urge to smoke, chew one piece of gum very slowly until you taste it or feel a slight tingling in your mouth. Stop chewing, and place (“park”) the chewing gum between your cheek and gum until the taste or tingling is almost gone. Then chew slowly until you taste it again. Continue chewing and stopping (“parking”) in this way for about 30 minutes in order to get the full dose of nicotine.


• Do not chew too fast, do not chew more than one piece at a time, and do not chew more than one piece of gum within an hour. To do so may cause unpleasant side effects or an overdose. Also, slower chewing will reduce the possibility of belching.


• You should not drink acidic beverages, such as citrus fruit juices, coffee, soft drinks, or tea within 15 minutes before or while chewing a piece of gum. The acid will prevent the nicotine from being released from the gum.


• As your urge to smoke becomes less frequent, gradually reduce the number of pieces of gum you chew each day until you are chewing three to six pieces a day. This may be possible within 2 to 3 months.


• Remember to carry nicotine gum with you at all times in case you feel the sudden urge to smoke. One cigarette may be enough to start you on the smoking habit again.


• Using hard sugarless candy between doses of gum may help to relieve any nicotine cravings you may have between doses of gum.

For patients using the lozenge:

• Nicotine lozenges usually come with patient directions. Read the directions carefully before using this medicine.


• Use nicotine lozenges exactly as directed on the label. Remember that it is also important to participate in a stop-smoking program during treatment. This may make it easier for you to stop smoking.


• Do not eat or drink for 15 minutes before using a nicotine lozenge.


• When you feel the urge to smoke, suck one lozenge slowly until it dissolves. Do not bite or chew the lozenge like a hard candy. Do not swallow the lozenge.


• As your urge to smoke becomes less frequent, gradually reduce the number of lozenges you use each day until you are using three to six lozenges a day. This should be possible within 12 weeks.


• Remember to carry nicotine lozenges with you at all times in case you feel the sudden urge to smoke. One cigarette may be enough to start you on the smoking habit again.

For patients using the transdermal system (skin patch):

• Nicotine patches usually come with patient instructions. Read them carefully before using this medicine. Nicotine patches will work only if applied correctly.


• Remember that it is also important to participate in a stop-smoking program during treatment. This may make it easier for you to stop smoking.


• Do not remove the patch from its sealed pouch until you are ready to put it on your skin. The patch may not work as well if it is unwrapped too soon.


• Do not try to trim or cut the adhesive patch to adjust the dosage. Check with your doctor if you think the medicine is not working as it should.


• Apply the patch to a clean, dry area of skin on your upper arm, chest, or back. Choose an area that is not very oily, has little or no hair, and is free of scars, cuts, burns, or any other skin irritations.


• Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact with your skin, especially around the edges of the patch.


• The patch should stay in place even when you are showering, bathing, or swimming. Apply a new patch if one falls off.


• Rinse your hands with plain water after you have finished applying the patch to your skin. Nicotine on your hands could get into your eyes and nose and cause stinging, redness, or more serious problems. Using soap to wash your hands will increase the amount of nicotine that passes through your skin.


• After 16 or 24 hours, depending on which product you are using, remove the patch. Choose a different place on your skin to apply the next patch. Do not put a new patch in the same place for at least 1 week. Do not leave the patch on for more than 24 hours. It will not work as well after that time and it may irritate your skin.


• After removing a used patch, fold the patch in half with the sticky sides together. Place the folded, used patch in its protective pouch or in aluminum foil. Make sure to dispose of it out of the reach of children and pets.


• Try to change the patch at the same time each day. If you want to change the time when you put on your patch, just remove the patch you are wearing and put on a new patch. After that, apply a fresh patch at the new time each day.


• Nicotine patches should be removed from the skin during strenuous exercise. If a patch is left on, too much nicotine may pass through your skin into your blood stream.


• If you are using a 24-hour patch and begin having unusual dreams or disturbed sleep, you may take the patch off before going to bed and put a new one on after you wake up the next morning.

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 the oral dosage form (chewing gum):
  
  • To help you stop smoking:
    
    • Adults and teenagers—The usual dose is one piece of chewing gum every one to two hours for six weeks, one piece of chewing gum every two to four hours for three weeks, then one piece of chewing gum every four to eight hours for three weeks. You should not chew more than 24 pieces of gum a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For the oral dosage form (lozenge):
  
  • To help you stop smoking:
    
    • Adults and teenagers—The usual dose is suck slowly one lozenge until it dissolves every one to two hours for six weeks, suck one lozenge every two to four hours for three weeks, then suck one lozenge every four to eight hours for three weeks. You should not use more than 20 lozenges a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For the transdermal (stick-on) skin patch:
  
  • To help you stop smoking:
    
    • Adults and teenagers—The dose you receive will be based on your body weight, how often you have the urge to smoke, and the brand and strength of the patch you use. This dose will be provided on the package label.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Nicotrol

Do not smoke during treatment with nicotine gum, lozenges, or patches because of the risk of nicotine overdose.

Nicotine should not be used in pregnancy. If there is a possibility you might become pregnant, you may want to use some type of birth control. If you think you may have become pregnant, stop using this medicine immediately and check with your doctor.

Nicotine products must be kept out of the reach of children and pets. Even nicotine patches that have been used still contain enough nicotine to cause problems in children. If a child chews or swallows one or more pieces of nicotine gum or lozenges, contact your doctor or poison control center at once. If a child puts on a nicotine patch or plays with a patch that is out of the sealed pouch, take it away from the child and contact your doctor or poison control center at once.

For patients using the chewing gum:

• Do not chew more than 24 pieces of gum a day. Chewing too many pieces may be harmful because of the risk of overdose.


• Do not use nicotine gum for longer than 12 weeks. To do so may result in physical dependence on the nicotine. If you feel the need to continue using the gum after 12 weeks, contact your doctor.


• If the gum sticks to your dental work, stop using it and check with your medical doctor or dentist. Dentures or other dental work may be damaged because nicotine gum is stickier and harder to chew than ordinary gum.

For patients using the lozenges:

• Do not use more than 20 lozenges a day. Sucking too many pieces may be harmful because of the risk of overdose.


• Do not use nicotine lozenges for longer than 12 weeks. If you feel the need to continue using the lozenges after 12 weeks, contact your doctor.

For patients using the transdermal system (skin patch) :

• Mild itching, burning, or tingling may occur when the patch is first applied, and should go away within 24 hours. After a patch is removed, the skin underneath it may be red. It should not remain red for more than a day. If you get a skin rash from the patch, or if the skin becomes swollen or very red, call your doctor. Do not put on a new patch. If you become allergic to the nicotine in the patch, you could get sick from using cigarettes or other products that contain nicotine.


• Do not use nicotine patches for longer than 12 weeks if you have stopped smoking. If you feel the need to continue using nicotine patches after 12 weeks, contact your doctor.


• The patch may cause skin burns when used during a procedure called magnetic resonance imaging (MRI). To prevent skin burns, make sure the patch is removed before having an MRI .

Nicotrol 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:

More common

• Injury or irritation to mouth, teeth, or dental work—with chewing gum only

Less common

• High blood pressure

Rare

• Fast or irregular heartbeat


• hives, itching, rash, redness, or swelling of skin

Symptoms of overdose (may occur in the following order)

• Nausea and/or vomiting


• increased watering of mouth (severe)


• abdominal or stomach pain (severe)


• diarrhea (severe)


• pale skin


• cold sweat


• headache (severe)


• dizziness (severe)


• disturbed hearing and vision


• tremor


• confusion


• weakness (severe)


• extreme exhaustion


• fainting


• low blood pressure


• difficulty in breathing (severe)


• fast, weak, or irregular heartbeat


• convulsions (seizures)

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

• Belching—with chewing gum and lozenges


• headache (mild)


• increased appetite


• increased watering of mouth (mild)—with chewing gum only


• jaw muscle ache—with chewing gum only


• redness, itching, and/or burning at site of application of patch—usually stops within 24 hours


• sore mouth or throat—with chewing gum only

Less common or rare

• Abdominal or stomach pain (mild)


• change in sense of taste


• constipation


• coughing (increased)


• diarrhea


• dizziness or lightheadedness (mild)


• drowsiness


• dryness of mouth


• hiccups—with chewing gum and lozenges


• hoarseness—with chewing gum only


• indigestion (mild)


• loss of appetite


• menstrual pain


• muscle or joint pain


• nausea or vomiting (mild)


• passing of gas


• sweating (increased)


• trouble in sleeping or unusual dreams


• unusual irritability or nervousness

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

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

See also: Nicotrol Oral, Transdermal side effects (in more detail)

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

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 Nicotrol Oral, Transdermal resources

• Nicotrol Oral, Transdermal Side Effects (in more detail)
• Nicotrol Oral, Transdermal Use in Pregnancy & Breastfeeding
• Nicotrol Oral, Transdermal Drug Interactions
• Nicotrol Oral, Transdermal Support Group
• 15 Reviews for Nicotrol Oral, Transdermal - Add your own review/rating

Compare Nicotrol Oral, Transdermal with other medications

• Smoking Cessation

Stress-600

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

Stress-600 is used for:

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

Stress-600 is a vitamin supplement. It works by providing extra vitamins to the body.

Do NOT use Stress-600 if:

• you are allergic to any ingredient in Stress-600

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

Before using Stress-600:

Some medical conditions may interact with Stress-600. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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

Some MEDICINES MAY INTERACT with Stress-600.

Ask your health care provider if Stress-600 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 Stress-600:

Use Stress-600 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Stress-600 by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Stress-600, 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 Stress-600.

Important safety information:

• Do not take large doses of vitamins while you use Stress-600 unless your doctor tells you to.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Stress-600 while you are pregnant. It is not known if Stress-600 is found in breast milk. If you are or will be breast-feeding while you use Stress-600, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Stress-600:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Stress-600. Seek medical attention right away if any of these SEVERE side effects occur:

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

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

See also: Stress-600 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 nausea; vomiting.

Proper storage of Stress-600:

Store Stress-600 at room temperature. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Stress-600 out of the reach of children and away from pets.

General information:

• If you have any questions about Stress-600, please talk with your doctor, pharmacist, or other health care provider.


• Stress-600 is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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

This information is a summary only. It does not contain all information about Stress-600. 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 Stress-600 resources

• Stress-600 Side Effects (in more detail)
• Stress-600 Use in Pregnancy & Breastfeeding
• Stress-600 Drug Interactions
• Stress-600 Support Group
• 0 Reviews for Stress-600 - Add your own review/rating

Compare Stress-600 with other medications

• Dietary Supplementation

Pediacare Cough and Cold

Generic Name: chlorpheniramine, dextromethorphan, and pseudoephedrine (klor feh NEER a meen, dex tro meh THOR fan, and soo doe eh FEH drin)

Brand Names: AccuHist PDX Drops, Atuss DS, Children's NyQuil, Creomulsion Cough/Cold/Allergy, Creomulsion Pediatric, Dicel DM, Dicel DM Chewables, Entre-S, Esocor P, Kidcare Cough and Cold, M-End DM, Mesehist DM, Neutrahist PDX Drops, Nyquil Child Cough and Cold, Pediatric Cough & Cold Medicine, Rescon-DM, Robitussin Pediatric Night Relief, Robitussin PM Cough & Cold, Triaminic Cold and Cough, Triaminic Multi-Sympton, Triaminic Night Time, Triaminic Softchew Cold and Cough, Triaminic-D Multi-Symptom Cold, Vicks 44M Pediatric, Vicks Pediatric Formula 44M

What is Pediacare Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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

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

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

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

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

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

What is the most important information I should know about Pediacare Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist before taking this medicine if you have heart disease, high blood pressure, kidney disease, diabetes, glaucoma, a thyroid disorder, emphysema or bronchitis, an enlarged prostate, or urination problems.

Do not use cold or cough medicine without your doctor's advice if you are pregnant or breast-feeding. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine, dextromethorphan, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, cough suppressant, or decongestant. Do not take this medicine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my healthcare provider before taking Pediacare Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  kidney disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  emphysema or chronic bronchitis;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

FDA pregnancy category C. It is not known whether chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use this medication without medical advice if you are pregnant. Chlorpheniramine, dextromethorphan, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Do not use cold or cough medicine without medical advice if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Pediacare Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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

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

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

The chewable tablet should be chewed before you swallow it.

Shake the oral suspension well just before you measure a dose. Do not take this medicine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Pediacare Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease sweating and you may be more prone to heat stroke.

Drinking alcohol can increase certain side effects of this medication.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine, dextromethorphan, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, cough suppressant, or decongestant.

Pediacare Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine) side effects

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

• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  slow, shallow breathing;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

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

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  mild stomach pain, constipation;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dizziness, drowsiness, mild headache;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  feeling restless or excited (especially in children);

  
  


• 
  

  problems with memory or concentration; or

  
  


• 
  

  flushing (warmth, redness, or tingly feeling).

  
  

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 Pediacare Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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

Ask a doctor or pharmacist if it is safe for you to use chlorpheniramine, dextromethorphan, and pseudoephedrine if you are also using any of the following drugs:

• 
  

  glycopyrrolate (Robinul);

  
  


• 
  

  mepenzolate (Cantil);

  
  


• 
  

  atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

  
  


• 
  

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

  
  


• 
  

  bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  a diuretic (water pill), or blood pressure medicine;

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

  
  


• 
  

  salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others.

  
  

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

More Pediacare Cough and Cold resources

• Pediacare Cough and Cold Side Effects (in more detail)
• Pediacare Cough and Cold Use in Pregnancy & Breastfeeding
• Pediacare Cough and Cold Drug Interactions
• Pediacare Cough and Cold Support Group
• 3 Reviews for Pediacare Cough and Cold - Add your own review/rating

• AccuHist PDX Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• AccuHist PDX Drops Prescribing Information (FDA)


• Dicel DM Chewables Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Entre-S Prescribing Information (FDA)

Compare Pediacare Cough and Cold with other medications

• Cough and Nasal Congestion

Where can I get more information?

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

See also: Pediacare Cough and Cold side effects (in more detail)