Trusopt

Generic Name: Dorzolamide Hydrochloride
Class: Carbonic Anhydrase Inhibitors
ATC Class: S01EC03
Chemical Name: (4S,6S)-4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride
Molecular Formula: C₁₀H₁₆N₂O₄S₃•HCl
CAS Number: 130693-82-2

Introduction

Carbonic anhydrase inhibitor;^{1 2 3 4 5 6 7 8 9 10} nonbacteriostatic sulfonamide derivative.^{1 2 3 4 5 6 7 8 9}

Uses for Trusopt

Ocular Hypertension and Glaucoma

Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.^{1 2 3 4 5 6 7 8 9 10}

Fixed-combination preparation containing dorzolamide and timolol (Cosopt) used topically to reduce elevated IOP in patients with open-angle glaucoma or ocular hypertension who have not responded adequately (i.e., failed to achieve target IOP as determined after multiple measurements over time) to a topical β-adrenergic blocking agent.³² Fixed-combination preparation associated with slightly smaller decrease in IOP than combination therapy with dorzolamide (administered 3 times daily) and timolol (administered twice daily).³²

A first-line “add-on” agent when more than one drug is needed.⁵ Add-on therapy with dorzolamide to existing timolol therapy is as effective and better tolerated than add-on therapy with pilocarpine.¹⁴

Safety and efficacy not established for the treatment of acute angle-closure glaucoma.¹

Inhibition of Perioperative IOP Increases

Used prophylactically before neodymium yttrium aluminum garnet (Nd:YAG) laser posterior capsulotomy†.²⁵

Administration of 1 drop (20 mcL) of dorzolamide 2% 1 hour prior to capsulotomy is more effective in preventing postoperative increases in IOP than placebo and as effective as oral acetazolamide 125 mg administered 1 hour prior to the procedure.²⁵

Trusopt Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the affected eye(s) as an ophthalmic solution.^{1 2 3 4 5 6 7 8 9 10 13 14 15}

Avoid contamination of the solution container.¹

Remove soft contact lenses prior to administration of each dose (since benzalkonium chloride preservative may be absorbed by the lenses); may reinsert lenses 15 minutes after administration.^{1 32}

If more than one topical ophthalmic drug is used, administer the drugs at least 10 minutes apart.^{1 32}

Dosage

Available as dorzolamide hydrochloride; dosage expressed in terms of dorzolamide.^{1 32}

Adults

Ocular Hypertension and Glaucoma

Ophthalmic

Dorzolamide 2% solution: 1 drop in the affected eye(s) 3 times daily.^{1 2 5 6 7 9 10}

Fixed-combination with timolol: 1 drop in the affected eye(s) twice daily.³²

Cautions for Trusopt

Contraindications

• 
  

  Known hypersensitivity to dorzolamide or any ingredient in the formulations (e.g., benzalkonium chloride).^{1 32}

  
  


• 
  

  Fixed-combination preparation with timolol also contraindicated in patients with bronchial asthma or a history of bronchial asthma and in patients with severe chronic obstructive pulmonary disease, sinus bradycardia, atrioventricular block greater than first degree, overt cardiac failure, or cardiogenic shock.³²

  
  

Warnings/Precautions

Warnings

Timolol Component

When using fixed-combination preparation containing timolol maleate, consider the warnings, cautions, precautions, and contraindications associated with timolol.³²

Sensitivity Reactions

Sulfonamide Sensitivity Reactions

Serious adverse events (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, other blood dyscrasias) associated with sulfonamide therapy possible.^{1 32}

Usual precautions associated with systemic use of sulfonamides apply.^{1 32} Discontinue dorzolamide if serious reactions or signs or symptoms of hypersensitivity occur.^{1 32}

Major Toxicities

Ocular Effects

Conjunctivitis or lid reactions reported with long-term therapy;^{1 32} may resolve upon discontinuance of therapy.^{1 32} If these reactions occur, discontinue therapy and evaluate patient before restarting dorzolamide (since a more serious allergic-type reaction may occur).^{1 29 32}

Choroidal detachment reported with administration of aqueous suppressant therapy (e.g., dorzolamide, timolol) following filtration procedures.^{1 32 a}

Specific Populations

Pregnancy

Category C.^{1 32}

Lactation

Not known whether distributed into human milk following topical application to eye.^{1 32} Discontinue nursing or the drug.^{1 32}

Pediatric Use

Safety and efficacy not established.^{1 9}

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults,^{1 30 32 33} but increased sensitivity cannot be ruled out.^{30 33}

Hepatic Impairment

Not studied in patients with hepatic impairment; use with caution.^{1 32}

Renal Impairment

Not studied in patients with severe renal impairment (Cl_cr<30 mL/minute).^{1 32} Not recommended in such patients, since dorzolamide and its metabolite are excreted mainly by the kidneys.¹

Common Adverse Effects

Ocular burning or stinging, taste disturbances (bitter, sour, or unusual taste), superficial punctate keratitis, conjunctival hyperemia, blurred vision, ocular itching.^{1 32}

Interactions for Trusopt

When using fixed-combination preparation containing timolol maleate, consider the drug interactions associated with timolol.³²

Dorzolamide is metabolized by CYP isoenzymes.^{1 9 10}

Specific Drugs

Drug	Interaction	Comments
Carbonic anhydrase inhibitors, oral	Additive systemic effects1 32	Concomitant use not recommended1
β-adrenergic blocking agents	Additive systemic β-adrenergic blockade when used with fixed-combination preparation32	Concomitant use with fixed-combination preparation not recommended32
Ocular hypotensive agents	Additive IOP-lowering effects1 5 7 9 10 13 14 15	Use to therapeutic advantage.1 5 7 9 10 13 14 15 If more than one topical ophthalmic drug is used, administer the drugs at least 10 minutes apart1 32
Salicylates	Rare reports of toxicity associated with acid-base disturbances in patients receiving oral carbonic anhydrase inhibitors with high-dose salicylates1 32	Consider possibility of similar interaction with ophthalmic dorzolamide1 32

Trusopt Pharmacokinetics

Absorption

Bioavailability

Peak concentrations in cornea, iris/ciliary body, and aqueous humor achieved within 1–2 hours following ocular instillation in rabbits.^{9 10}

Some systemic absorption may occur; low potential for causing systemic effects.^{1 3 6 9 10 21}

Onset

Reduction in IOP generally peaks within 2–3 hours after topical administration.^{4 6 8 10}

Duration

Reduction in IOP persists for 8 hours or longer.^{4 6 8 10}

Distribution

Extent

Distributed into cornea, aqueous humor, iris/ciliary body, and retina following ocular instillation in rabbits.^{9 10}

Approximately 19% bound to ocular pigment (isolated from bovine iris/ciliary body).⁹

Systemically absorbed dorzolamide is preferentially distributed into erythrocytes.^{1 3 9 10 20}

Not known whether dorzolamide crosses the placenta or is distributed into human milk.¹

Plasma Protein Binding

Approximately 33%.^{1 10 32}

Elimination

Metabolism

Metabolized in liver by cytochrome P-450 isoenzymes to N-desethyldorzolamide (active).^{1 9 10}

Elimination Route

Excreted in urine, principally (about 80%) as unchanged drug.^{1 10 20}

Half-life

Nonlinear elimination from erythrocytes.^{1 32} Initial elimination half-life is rapid; terminal elimination half-life is 120 days.^{1 3 10}

Stability

Storage

Ophthalmic

Solution

Dorzolamide 2% solution: 15–30°C.¹ Protect from light.¹

Fixed-combination preparation: 15–25°C.³² Protect from light.³²

ActionsActions

• 
  

  Potent ocular hypotensive agent;^{1 2 3 4 5 6 7 8 9 10} can produce mean IOP reductions of about 17–23% in patients with elevated IOP.^{1 4 5 7}

  
  


• 
  

  Highly specific inhibitor of CA-II, the main carbonic anhydrase isoenzyme involved in aqueous humor secretion.^{1 3 4 9 10 15}

  
  

  Inhibition of carbonic anhydrase in the ciliary process of the eye decreases the rate of aqueous humor secretion and IOP by slowing bicarbonate formation and reducing sodium and fluid transport.^{1 9 10 18}

  
  


• 
  

  Tolerance does not occur; reduction in mean IOP maintained over at least 12 months after initial stabilization.^{7 30}

  
  


• 
  

  Accumulates in erythrocytes after long-term topical administration as a result of CA-II binding; however, sufficient CA-II activity remains so that adverse effects resulting from systemic carbonic anhydrase inhibition are not observed.^{1 9 21}

  
  

Advice to Patients

• 
  

  Risk of adverse effects, including sensitivity reactions; discontinue therapy and consult clinician if serious or unusual ocular or systemic reactions (e.g., conjunctivitis, lid reactions) or signs of sensitivity occur.^{1 32}

  
  


• 
  

  Importance of learning and adhering to proper administration techniques to avoid contamination of the solution with common bacteria that can cause ocular infections (e.g., bacterial keratitis).^{1 32} Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic solutions.^{1 8}

  
  


• 
  

  Importance of informing clinicians if an intercurrent ocular condition (e.g., trauma, infection) develops or ocular surgery is planned.^{1 32}

  
  


• 
  

  Importance of administering different topical ophthalmic preparations at least 10 minutes apart.^{1 32}

  
  


• 
  

  Importance of removing soft contact lenses prior to administering the drug and of delaying reinsertion of the lenses for at least 15 minutes after administration.^{1 32}

  
  


• 
  

  Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{1 32}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 32}

  
  


• 
  

  Importance of informing patient of other important precautionary information.^{1 32} (See Cautions.)

  
  

Preparations

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

Dorzolamide Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	2% (of dorzolamide)	Trusopt Ocumeter Plus (with benzalkonium chloride)	Merck

Dorzolamide Hydrochloride Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	2% (of dorzolamide) with Timolol Maleate 0.5% (of timolol)	Cosopt Ocumeter Plus (with benzalkonium chloride)	Merck

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.

Cosopt 2-0.5% Solution (MERCK SHARP &amp; DOHME): 10/$134.67 or 30/$391.19

Dorzolamide HCl 2% Solution (PRASCO LABORATORIES): 10/$59.99 or 30/$159.98

Dorzolamide-Timolol 2-0.5% Solution (HI-TECH): 10/$99.99 or 30/$279.97

Trusopt 2% Solution (MERCK SHARP &amp; DOHME): 10/$79.25 or 30/$215.09

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 July 2007. 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. Merck & Company. Trusopt (dorzolamide hydrochloride) sterile ophthalmic solution 2% prescribing information. West Point, PA; 2001 Jan.

2. Serle JB. Pharmacological advances in the treatment of glaucoma. Drugs Aging. 1994; 5:156-70. [PubMed 7803944]

3. Biollaz J, Munafo A, Buclin T et al. Whole-blood pharmacokinetics and metabolic effects of the topical carbonic anhydrase inhibitor dorzolamide. Eur J Clin Pharmacol. 1995; 47:453-60.

4. Lippa EA, Carlson LE, Ehinger B et al. Dose response and duration of action of dorzolamide, a topical carbonic anhydrase inhibitor. Arch Ophthalmol. 1992; 110:495-99. [IDIS 294438] [PubMed 1562255]

5. Anon. A topical carbonic anhydrase inhibitor for glaucoma. Med Lett Drug Ther. 1995; 37:76-7.

6. Wilkerson M, Cyrlin M, Lippa EA et al. Four-week safety and efficacy study of dorzolamide, a novel, active topical carbonic anhydrase inhibitor. Arch Ophthalmol. 1993; 111:1343-50. [IDIS 320630] [PubMed 8216014]

7. Strahlman E, Tipping R, Vogel R and the International Dorzolamide Study Group. A double-masked, randomized 1-year study comparing dorzolamide (Trusopt), timolol, and betaxolol. Arch Ophthalmol. 1995; 113:1009-16. [IDIS 352153] [PubMed 7639651]

8. Yamazaki Y, Miyamoto S, Sawa M. Effect of MK-507 on aqueous humor dynamics in normal human eyes. Jpn J Ophthalmol. 1994; 38:92-6. [PubMed 7933704]

9. Sugrue MF, Harris A, Adamsons I. Dorzolamide hydrochloride a topically active, carbonic anhydrase inhibitor for the treatment of glaucoma. Drugs Today. 1997; 33:283-98.

10. Balfour JA, Wilde MI. Dorzolamide: a review of its pharmacology and therapeutic potential in the management of glaucoma and ocular hypertension. Drugs Aging. 1997; 10:384-403. [PubMed 9143858]

11. Heijl A, Strahlman E, Sverrisson T et al. A comparison of dorzolamide and timolol in patients with pseudoexfoliation and glaucoma or ocular hypertension. Ophthalmology. 1997; 104:137-42. [IDIS 381530] [PubMed 9022118]

12. Wang RF, Serle JB, Podos SM et al. MK-507 (L-671,152), a topically active carbonic anhydrase inhibitor, reduces aqueous humor production in monkeys. Arch Ophthalmol. 1991; 109:1297-99. [PubMed 1929960]

13. Strahlman ER, Vogel R, Tipping R et al et al. The use of dorzolamide and pilocarpine as adjunctive therapy to timolol in patients with elevated intraocular pressure. Ophthalmology. 1996; 103:1283-93. [IDIS 372463] [PubMed 8764800]

14. Laibovitz R, Boyle J, Snyder E et al. Dorzoloamide versus pilocarpine as adjunctive therapies to timolol: a comparison of patient preference and impact on daily life. Clin Ther. 1996; 18:821-32. [IDIS 376626] [PubMed 8930426]

15. Hartenbaum D. The efficacy of dorzolamide, a topical carbonic anhydrase inhibitor, in combination with timolol in the treatment of patients with open-angle glaucoma and ocular hypertension. Clin Ther. 1996; 18:460-5. [IDIS 370951] [PubMed 8829021]

16. Maus TL, Larsson LI, McLaren JW et al. Comparison of dorzolamide and acetazolamide as suppressors of aqueous humor flow in humans. Arch Ophthalmol. 1997; 115:45-9. [IDIS 379686] [PubMed 9006424]

17. Podos SM, Serle JB. Topically active carbonic anhydrase inhibitors for glaucoma. Arch Ophthalmol. 1991; 109:38-40. [IDIS 276557] [PubMed 1987945]

18. Derick RJ. Glaucoma therapy: carbonic anhydrase inhibitors. In: Havener WH. Havener’s ocular pharmacology. 6th ed. St. Louis: The CV Mosby Company; 1983:172-80.

19. Harris A, Arend O, Arend S et al. Effects of topical dorzolamide on retinal and retrobulbar hemodynamics. Acta Ophthalmol Scand. 1996; 74:569-72. [PubMed 9017044]

20. Maren TH, Conroy CW, Wynns GC et al. Ocular absorption, blood levels, and excretion of dorzolamide, a topically active carbonic anhydrase inhibitor. J Ocular Pharmacol Ther. 1997; 13:23-30.

21. Strahlman E, Tipping R, Vogel R et al. A six-week dose-response study of the ocular hypotensive effect of dorzolamide with a one-year extension. Am J Ophthalmol. 1996; 122:183-94. [IDIS 370635] [PubMed 8694086]

22. Hasegawa T, Hara K, Hata S. Binding of dorzolamide and its metabolite, n-deethylated dorzolamide, to human erythrocytes in vitro. Drug Metabol Dispos. 1994; 22:377-82.

23. Matuszewski BK, Constanzer ML, Woolf EJ et al. Determination of MK-507, a novel topically effective carbonic anhydrase inhibitor, and its de-ethylated metabolite in human whole blood, plasma, and urine by high-performance liquid chromatography. J Chromatogr. 1994; 653:77-85.

24. Kohlhaas M, Mammen A, Richard G. Change in corneal sensitivity after topical dorzolamide administration: a comparative study. Ophthalmologe. 1997; 94:424-7. [PubMed 9312318]

25. Ladas ID, Baltatzis S, Panagiotidis D et al. Topical 2.0% dorzolamide vs oral acetazolamide for prevention of intraocular pressure rise after neodymium: YAG laser posterior capsulotomy. Arch Ophthalmol. 1997; 115:1241-4. [IDIS 396001] [PubMed 9338667]

26. Fineman MS, Katz LJ, Wilson RP. Topical dorzolamide-induced hypotony and ciliochoroidal detachment in patients with previous filtration surgery. Arch Ophthalmol. 1996; 114:1031-2. [IDIS 371003] [PubMed 8694722]

27. Konowal A, Epstein RJ, Dennis RF et al. Irreversible corneal decompensation in patients treated with topical dorzolamide. Invest Ophthalmol Vis Sci. 1996; 37:S79.

28. Sugrue MF, Mallorga P, Schwam H et al. Preclinical studies on L-671,152, a topically effective ocular hypotensive carbonic anhydrase inhibitor. Br J Pharmacol. 1989; 98(Suppl):820P. [PubMed 2611526]

29. Reviewers’ comments (personal observations).

30. Merck, West Point, PA; Personal communication.

31. Kohlhaas H, Mammen A, Richard G. Change in corneal sensitivity after topical dorzolamide administration: a comparative study. Ophthalmology. 1997; 94:424-7.

32. Merck & Company. Cosopt (dorzolamide hydrochloride and timolol maleate) sterile ophthalmic solution prescribing information. West Point, PA; 2000 Aug.

33. Diamond JP. Systemic adverse effects of topical ophthalmic agents: implications for older patients. Drugs Aging. 1997; 11:352-60. [PubMed 9359022]

a. Merck & Company. Trusopt (dorzolamide hydrochloride) sterile ophthalmic solution 2% prescribing information. West Point, PA; 2001 Oct.

More Trusopt resources

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

• Trusopt Prescribing Information (FDA)


• Trusopt Concise Consumer Information (Cerner Multum)


• Trusopt Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Trusopt with other medications

• Glaucoma, Open Angle
• Intraocular Hypertension

Genotropin

Pronunciation: SOE-ma-TROE-pin
Generic Name: Somatropin (rDNA origin - Refrigerated)
Brand Name: Genotropin

Genotropin is used for:

Treating certain children or adults whose bodies do not produce enough growth hormone. It is also used to treat certain children who are not growing normally due to Turner syndrome or Prader-Willi syndrome, or who were born small for gestational age (SGA). It may also be used for other conditions as determined by your doctor.

Genotropin is a growth hormone. It works by stimulating growth in patients who do not make enough natural growth hormone.

Do NOT use Genotropin if:

• you are allergic to any ingredient in Genotropin


• you have active or recurring cancer, a brain tumor, or other unusual growths


• you have severe breathing problems (eg, respiratory failure) or serious illness caused by complications from surgery or injury


• you have a certain type of eye problem caused by diabetes (diabetic retinopathy)


• the patient is a child who has Prader-Willi syndrome and is severely overweight or has severe breathing problems (eg, airway blockage, respiratory infection, sleep apnea)


• the patient is a child who has epiphyseal closure (bone growth is complete)

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

Before using Genotropin:

Some medical conditions may interact with Genotropin. 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 are allergic to a preservative called m-cresol


• if you have a history of kidney problems, lung or breathing problems (eg, airway blockage, sleep apnea), an underactive thyroid, heart problems, ear or hearing problems (eg, repeated ear infections), or endocrine problems (eg, pituitary or adrenal gland problems)


• if you have a history of diabetes or high blood sugar levels, or if a member of your family has had diabetes


• if you have a history of leukemia, other types of cancer, or any unusual growths or tumors (especially in the brain)


• if you have curvature of the spine (scoliosis), are very overweight, or have had recent major surgery or injury

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

• Corticosteroids (eg, prednisone) or estrogens because they may decrease Genotropin's effectiveness


• Anticonvulsants (eg, carbamazepine) or cyclosporine because the risk of their side effects may be increased by Genotropin


• Insulin or other medicines for diabetes because their effectiveness may be decreased by Genotropin

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

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

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


• Genotropin is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Genotropin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do NOT shake Genotropin.


• Do not use Genotropin if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.


• Be sure to rotate your injection site as directed to help avoid thickening or hardening of the skin.


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


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

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

Important safety information:

• Severe and sometimes fatal lung and breathing problems have occurred with use of Genotropin in certain children with Prader-Willi syndrome. These children were usually either very overweight or had severe breathing problems (eg, airway blockage, sleep apnea, lung or airway infection). The risk may be greater in boys. Children with Prader-Willi syndrome should have certain breathing tests before they start Genotropin. They should be monitored for signs of lung or airway infection. They should also have effective weight control. Contact the doctor at once if the patient develops irregular breathing during sleep, new or increased snoring, or symptoms of lung or airway infection (eg, fever, coughing, sore throat, shortness of breath, chest pain or discomfort).


• Rarely, children using Genotropin have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.


• Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Genotropin. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.


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


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


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


• Caution is advised when using Genotropin in CHILDREN; they may be more sensitive to its effects, especially pancreas inflammation.


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

Possible side effects of Genotropin:

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:

Fatigue; headache; increased appetite; mild arm or leg pain or stiffness; mild swelling (eg, of the hands or feet); muscle or joint pain; prickling sensation of the skin; redness or itching at the injection site; stuffy nose.

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); blood in the urine; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain or discomfort; confusion; ear pain, discharge, or discomfort; fast heartbeat; flu-like symptoms (chills, fever); hearing problems; hip or knee pain; limp; mental or mood changes; nausea or vomiting; new growth on the skin; one-sided weakness; persistent or severe cough or sore throat; severe or persistent stomach or back pain; severe or persistent swelling of the hands, ankles, or feet; shortness of breath; slurred speech; snoring or irregular breathing during sleep; sudden, severe, or persistent headache or dizziness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; vision changes.

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

See also: Genotropin 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 dizziness; excessive thirst or hunger; fainting; fast heartbeat; frequent urination.

Proper storage of Genotropin:

Cartridges: Store new (unopened) cartridges in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use Genotropin past the expiration date on the product label.

For 1.5 mg cartridge: After the medicine is mixed, it may be stored in the refrigerator for up to 24 hours. Throw away any medicine left in the cartridge after 24 hours.

For 5.8 mg and 13.8 mg cartridges: After the medicine is mixed, it may be stored in the refrigerator for up to 28 days. Throw away any unused medicine left in the cartridge after 28 days.

MiniQuick devices: Store new (unopened) devices in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Unopened devices may also be stored at or below 77 degrees F (25 degrees C) for up to 3 months. Do not use Genotropin past the expiration date on the product label. After the medicine is mixed, it may be stored in the refrigerator for up to 24 hours. Throw away any medicine left in the device after 24 hours.

Contact your pharmacist if you have any questions about how to properly store Genotropin. Keep Genotropin out of the reach of children and away from pets.

General information:

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


• Genotropin 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 Genotropin. 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 Genotropin resources

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

Compare Genotropin with other medications

• Adult Human Growth Hormone Deficiency
• Hypopituitarism
• Pediatric Growth Hormone Deficiency
• Short Stature for Age
• Turner's Syndrome

Dr. Reddy's Laboratories Inc.

Address Dr. Reddy's Laboratories Inc., 200 Somerset Corporate Boulevard, 7th Floor, Bridgewater, NJ 08807 Contact Details Phone: (908) 203-4900 Website: http://www.drreddys.com/ Careers: http://www.drreddys.com/careers...

Betaloc I.V. Injection

1. Name Of The Medicinal Product

Betaloc I.V. Injection

2. Qualitative And Quantitative Composition

Each ampoule of 5 ml contains 5 mg Metoprolol tartrate Ph. Eur.

3. Pharmaceutical Form

Solution for Injection

4. Clinical Particulars

4.1 Therapeutic Indications

Control of tachyarrhythmias, especially supraventricular tachyarrhythmias.

Early intervention with Betaloc in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics.

Betaloc has been shown to reduce mortality when administered to patients with acute myocardial infarction.

4.2 Posology And Method Of Administration

The dose must always be adjusted to the individual requirements of the patient. The following are guidelines:

Cardiac arrhythmias:

Initially up to 5 mg injected intravenously at a rate of 1-2 mg per minute. The injection can be repeated at 5 minute intervals until a satisfactory response has been obtained. A total dose of 10-15 mg generally proves sufficient.

Because of the risk of a pronounced drop of blood pressure, the I.V. administration of Betaloc to patients with a systolic blood pressure below 100 mmHg should only be given with special care.

During Anaesthesia:

2-4 mg injected slowly I.V. at induction is usually sufficient to prevent the development of arrhythmias during anaesthesia. The same dosage can also be used to control arrhythmias developing during anaesthesia. Further injections of 2 mg may be given as required to a maximum overall dose of 10 mg.

Myocardial infarction:

Intravenous Betaloc should be initiated in a coronary care or similar unit when the patient's haemodynamic condition has stabilised. Therapy should commence with 5 mg I.V. every 2 minutes to a maximum of 15 mg total as determined by blood pressure and heart rate. The second or third dose should not be given if the systolic blood pressure is <90 mmHg, the heart rate is <40 beats/min and the P-Q time is>0.26 seconds, or if there is any aggravation of dyspnoea or cold sweating. Oral therapy should commence 15 minutes after the last injection with 50 mg every 6 hours for 48 hours. Patients who fail to tolerate the full intravenous dose should be given half the suggested oral dose.

Impaired Renal Function:

Dose adjustment is generally not needed in patients with impaired renal function.

Impaired Hepatic Function:

Dose adjustment is normally not needed in patients suffering from liver cirrhosis because metoprolol has a low protein binding (5 – 10 %). However, in patients with severe hepatic dysfunction a reduction in dosage may be necessary.

Elderly:

Several studies indicate that age related physiological changes have negligible effects on the pharmacokinetics of metoprolol. Dose adjustment is not needed in the elderly, but careful dose titration is important in all patients.

Children:

The safety and efficacy of metoprolol in children has not been established.

4.3 Contraindications

Betaloc Injection, as with other beta blockers, should not be used in patients with any of the following:

• Hypotension,

• AV block of second- or third-degree,

• Decompensated cardiac failure (pulmonary oedema, hypoperfusion or hypotension),

• Continuous or intermittent inotropic therapy acting through beta-receptor agonism,

• Bradycardia (<45 bpm),

• Sick sinus syndrome,

• Cardiogenic shock,

• Severe peripheral arterial circulatory disorder

• Untreated phaeochromocytoma,

• Metabolic acidosis.

Known hypersensitivity to any component of Betaloc Injection or other beta-blockers.

Betaloc Injection is also contra-indicated when suspected acute myocardial infarction is complicated by bradycardia (<45 bpm), first-degree heart block or systolic blood pressure <100 mmHg and/or severe heart failure.

4.4 Special Warnings And Precautions For Use

When treating patients with suspected or definite myocardial infarction the haemodynamic status of the patient should be carefully monitored after each of the three 5 mg intravenous doses. The second or third dose should not be given if the heart rate is <40 beats/min, the systolic blood pressure is <90 mmHg and the P-Q time is>0.26 sec, or if there is any aggravation of dyspnoea or cold sweating.

Betaloc, as with other beta blockers:

• should not be withdrawn abruptly during oral treatment. When possible, Betaloc should be withdrawn gradually over a period of 10 – 14 days, in diminishing doses to 25 mg daily for the last 6 days. During its withdrawal patients should be kept under close surveillance, especially those with known ischaemic heart disease. The risk for coronary events, including sudden death, may increase during the withdrawal of beta-blockade.

• must be reported to the anaesthetist prior to general anaesthesia. It is not generally recommended to stop Betaloc treatment in patients undergoing surgery. If withdrawal of metoprolol is considered desirable, this should, if possible, be completed at least 48 hours before general anaesthesia. Routine initiation of high-dose metoprolol to patients undergoing non-cardiac surgery should be avoided, since it has been associated with bradycardia, hypotension ,stroke and increased mortality in patients with cardiovascular risk factors. However in some patients it may be desirable to employ a beta-blocker as premedication. In such cases an anaesthetic with little negative inotropic activity should be selected to minimise the risk of myocardial depression.

• although contra-indicated in severe peripheral arterial circulatory disturbances (see Section 4.3), may also aggravate less severe peripheral arterial circulatory disorders.

• may be administered when heart failure has been controlled. Digitalisation and/or diuretic therapy should also be considered for patients with a history of heart failure, or patients known to have a poor cardiac reserve. Betaloc should be used with caution in patients where cardiac reserve is poor.

• may cause patients to develop increasing bradycardia, in such cases the Betaloc Injection dosage should be reduced or gradually withdrawn.

• due to the negative effect on conduction time, should only be given with caution to patients with first-degree heart block.

• may increase the number and duration of angina attacks in patients with Prinzmetal's angina, due to unopposed alpha-receptor mediated coronary artery vasoconstriction. Betaloc Injection is a beta₁-selective beta-blocker; consequently, its use may be considered although utmost caution must be exercised.

• may mask the early signs of acute hypoglycaemia, in particular tachycardia. During treatment with Betaloc Injection, the risk of interfering with carbohydrate metabolism or masking hypoglycaemia is less than with non-selective beta-blockers.

• may mask the symptoms of thyrotoxicosis.

• may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions.

Although cardioselective beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with reversible obstructive airways disease unless there are compelling clinical reasons for their use. When administration is necessary, these patients should be kept under close surveillance. The use of a beta₂-bronchodilator (e.g. terbutaline) may be advisable in some patients. The dosage of the beta₂-agonist may require an increase when treatment with Betaloc Injection is commenced.

The label shall state - “Use with caution in patients who have a history of wheezing, asthma or any other breathing difficulties, see enclosed user leaflet.”

Like all beta-blockers, careful consideration should be given to patients with psoriasis before Betaloc i.v. is administered.

In patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly.

In labile and insulin-dependent diabetes it may be necessary to adjust the hypoglycaemic therapy.

Intravenous administration of calcium antagonists of the verapamil type should not be given to patients treated with beta-blockers.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Metoprolol is a metabolic substrate for the Cytochrome P450 isoenzyme CYP2D6. Drugs that act as enzyme-inducing and enzyme-inhibiting substances may exert an influence on the plasma level of metoprolol. Enzyme inducing agents (e.g. rifampicin) may reduce plasma concentrations of Betaloc whereas enzyme inhibitors (e.g. cimetidine, alcohol and hydralazine) may increase plasma concentrations.

Patients receiving concomitant treatment with sympathetic ganglion blocking agents, other beta blockers (i.e. eye drops), or Mono Amine Oxidase (MAO) inhibitors should be kept under close surveillance.

If concomitant treatment with clonidine is to be discontinued, Betaloc Injection should be withdrawn several days before clonidine.

Increased negative inotropic and chronotropic effects may occur when metoprolol is given together with calcium antagonists of the verapamil and diltiazem type. In patients treated with beta-blockers intravenous administration of calcium antagonists of the verapamil-type should not be given.

Beta-blockers may enhance the negative inotropic and negative dromotropic effect of antiarrhythmic agents (of the quinidine type and amiodarone).

Digitalis glycosides, in association with beta-blockers, may increase atrioventricular conduction time and may induce bradycardia.

In patients receiving beta-blocker therapy, inhalation anaesthetics enhance the cardiodepressant effect.

Concomitant treatment with indometacin and other prostaglandin synthetase inhibiting drugs may reduce the antihypertensive effect of beta-blockers.

The administration of adrenaline (epinephrine) to patients undergoing beta-blockade can result in an increase in blood pressure and bradycardia although this is less likely to occur with beta₁-selective drugs.

Betaloc Injection will antagonise the beta₁-effects of sympathomimetic agents but should have little influence on the bronchodilator effects of beta₂-agonists at normal therapeutic doses.

Metoprolol may impair the elimination of lidocaine.

As with other beta-blockers, concomitant therapy with dihydropyridines e.g. nifedipine, may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.

The dosages of oral antidiabetic agents and also of insulin may have to be readjusted in patients receiving beta-blockers.

As beta-blockers may affect the peripheral circulation, care should be exercised when drugs with similar activity e.g. ergotamine are given concurrently.

The effects of Betaloc Injection and other drugs with an antihypertensive effect on blood pressure are usually additive. Care should be taken when combining with other antihypertensive drugs or drugs that might reduce blood pressure such as tricyclic antidepressants, barbiturates and phenothiazines. However, combinations of antihypertensive drugs may often be used with benefit to improve control of hypertension.

4.6 Pregnancy And Lactation

Pregnancy

Betaloc should not be used in pregnancy or nursing mothers unless the physician considers that the benefit outweighs the possible hazard to the foetus/infant. Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. As with all beta-blockers, Betaloc Injection may cause side-effects especially bradycardia and hypoglycaemia in the foetus, and in the newborn and breastfed infant. There is an increased risk of cardiac and pulmonary complications in the neonate. Betaloc Injection has, however, been used in pregnancy-associated hypertension under close supervision, after 20 weeks gestation. Although Betaloc crosses the placental barrier and is present in cord blood, no evidence of foetal abnormalities has been reported.

Lactation

Breast feeding is not recommended. The amount of metoprolol ingested via breast milk should not produce significant beta-blocking effects in the neonate if the mother is treated with normal therapeutic doses.

4.7 Effects On Ability To Drive And Use Machines

When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or fatigue may occur.

4.8 Undesirable Effects

The following events have been reported as adverse events in clinical trials or reported from routine use.

The following definitions of frequencies are used:

Very common (

Infections and infestations
Very rare:	Gangrene in patients with pre existing severe peripheral circulatory disorders.
Blood and lymphatic system disorders
Very rare:	Thrombocytopenia.
Psychiatric disorders
Uncommon:	Depression, insomnia, nightmares.
Rare:	Nervousness, anxiety.
Very rare:	Confusion, hallucinations.
Nervous system disorders
Common:	Dizziness, headache.
Uncommon:	Concentration impairment, somnolence, paraesthesiae.
Very rare:	Amnesia/memory impairment, taste disturbances.
Eye disorders
Rare:	Disturbances of vision, dry and/or irritated eyes, conjunctivitis.
Ear and labyrinth disorders
Very rare:	Tinnitus.
Cardiac disorders
Common:	Bradycardia, palpitations.
Uncommon:	Deterioration of heart failure symptoms, cardiogenic shock in patients with acute myocardial infarction*, first degree heart block.
Rare:	Disturbances of cardiac conduction, cardiac arrhythmias, increased existing AV block.

* Excess frequency of 0.4 % compared with placebo in a study of 46,000 patients with acute myocardial infarction where the frequency of cardiogenic shock was 2.3 % in the metoprolol group and 1.9 % in the placebo group in the subset of patients with low shock risk index. The corresponding excess frequency for patients in Killip class I was 0.7% (metoprolol 3.5% and placebo 2.8%). The shock risk index was based on the absolute risk of shock in each individual patient derived from age, sex, time delay, Killip class, blood pressure, heart rate, ECG abnormality, and prior history of hypertension. The patient group with low shock risk index corresponds to the patients in which metoprolol is indicated for use in acute myocardial infarction.

Vascular disorders
Common:	Postural disorders (very rarely with syncope).
Rare:	Raynauds phenomenon.
Very rare:	Increase of pre-existing intermittent claudication.
Respiratory, thoracic and mediastinal disorders
Common:	Dyspnoea on exertion.
Uncommon:	Bronchospasm.
Rare:	Rhinitis.
Gastrointestinal disorders
Common:	Nausea, abdominal pain, diarrhoea, constipation.
Uncommon:	Vomiting.
Rare:	Dry mouth.
Hepato-biliary disorders
Very rare:	Hepatitis.
Skin and subcutaneous tissue disorders
Uncommon:	Rash (in the form of psoriasiform urticaria and dystrophic skin lesions), increased sweating.
Rare:	Loss of hair.
Very rare:	Photosensitivity reactions, aggravated psoriasis.
Musculoskeletal and connective tissue disorders
Very rare:	Arthralgia.
Uncommon:	Muscle cramps.
Reproductive system and breast disorders
Rare:	Impotence/sexual dysfunction.
General disorders and administration site disorders
Very common:	Fatigue.
Common:	Cold hands and feet.
Uncommon:	Precordial pain, oedema.
Investigations
Uncommon:	Weight gain.
Rare:	Liver function test abnormalities, positive anti-nuclear antibodies (not associated with SLE).

4.9 Overdose

The symptoms of overdose may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.

General treatment should include:

Close supervision, treatment in an intensive care ward and the use of plasma or plasma substitutes to treat hypotension and shock.

Excessive bradycardia can be countered with atropine 1-2 mg intravenously and/or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously. If required, this may be repeated or followed by an intravenous infusion of glucagon 1-10 mg/hour depending on response. If no response to glucagon occurs or if glucagon is unavailable, a beta adrenoceptor stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by intravenous infusion may be given.

Dobutamine, because of its positive inotropic effect could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta blockade if a large overdose has been taken. The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient.

Administration of calcium ions may also be considered. Bronchospasm can usually be reversed by bronchodilators.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Beta blocking agents, selective

ATC code: C07AB02

Metoprolol is a competitive beta-adrenoceptor antagonist. It acts preferentially to inhibit beta-adrenoceptors (conferring some cardioselectivity), is devoid of intrinsic sympathomimetic activity (partial agonist activity) and possesses beta-adrenoceptor blocking activity comparable in potency with propranolol.

A negative chronotrophic effect on the heart is a consistent feature of metoprolol administration. Thus, cardiac output and systolic blood pressure rapidly decrease following acute administration.

The intention to treat trial COMMIT included 45,852 patients admitted to hospital within 24 hours of the onset of symptoms of suspected acute myocardial infarction with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block). Patients were randomly allocated to metoprolol (up to 15 mg intravenous then 200 mg oral) or placebo and treated until discharge or up to 4 weeks in hospital. The two co-primary outcomes were: (1) composite of death, reinfarction or cardiac arrest; and (2) death from any cause during the scheduled treatment period. Neither of the co-primary outcomes was significantly reduced by metoprolol. However, metoprolol treatment was associated with fewer people having reinfarction and ventricular fibrillation but an increased rate of cardiogenic shock during the first day after admission. There was substantial net hazard in haemodynamically unstable patients. There was moderate net benefit in those who were stable, particularly after days 0-1.

5.2 Pharmacokinetic Properties

Metoprolol is eliminated mainly by hepatic metabolism, the average elimination half-life is 3.5 hours (range 1-9 hours). Rates of metabolism vary between individuals, with poor metabolisers (approximately 10%) showing higher plasma concentrations and slower elimination than extensive metabolisers. Within individuals, however, plasma concentrations are stable and reproducible.

Metoprolol undergoes oxidative metabolism in the liver primarily by the CYP2D6 isoenzyme.

5.3 Preclinical Safety Data

Pre-clinical information has not been included because the safety profile of metoprolol tartrate has been established after many years of clinical use. Please refer to section 4.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride and water for injections.

6.2 Incompatibilities

None known.

6.3 Shelf Life

4 years.

6.4 Special Precautions For Storage

Protect from light. Store below 25°C.

6.5 Nature And Contents Of Container

5 ml glass ampoule.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

AstraZeneca UK Ltd.,

600 Capability Green,

Luton, LU1 3LU, UK.

8. Marketing Authorisation Number(S)

PL 17901/0106

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 28^th May 2002

Date of renewal of authorisation: 16^th July 2005

10. Date Of Revision Of The Text

1^st September 2010

clotrimazole topical

Generic Name: clotrimazole topical (kloe TRIM a zole)

Brand Names: Anti-Fungal Liquid, Desenex AF Prescription Strength, FungiCURE Pump Spray, Lotrimin AF Cream, Lotrimin AF For Her, Lotrimin AF Jock Itch, Lotrimin AF Solution, Lotrimin Jock Itch Powder, MPM Anti-Fungal, Prescription Strength Cruex

What is clotrimazole topical?

Clotrimazole topical is an antifungal antibiotic that fights infections caused by fungus.

Clotrimazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections.

Clotrimazole topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about clotrimazole topical?

You should not use clotrimazole topical if you are allergic to it.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

What should I discuss with my healthcare provider before using clotrimazole topical?

You should not use clotrimazole topical if you are allergic to it. FDA pregnancy category B. Clotrimazole topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether clotrimazole topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use clotrimazole topical?

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.

Wash your hands before and after using this medication, unless you are using it to treat a hand infection.

Clean and dry the affected area. Apply a small amount of the cream (usually twice daily) for 2 to 4 weeks.

Do not take this medication by mouth.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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.

What should I avoid while using clotrimazole topical?

Avoid getting this medication in your eyes, nose, or mouth.

Avoid using other medications on the areas you treat with clotrimazole topical unless you doctor tells you to.

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear clothing made of loose cotton and other natural fibers until the infection is healed.

Clotrimazole topical 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 clotrimazole topical and call your doctor at once if you have unusual or severe blistering, itching, redness, peeling, dryness, swelling, or irritation of the skin.

Less serious side effects are more likely, and you may have none at all.

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.

Clotrimazole topical Dosing Information

Usual Adult Dose for Tinea Corporis:

Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 4 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Tinea Cruris:

Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Tinea Pedis:

Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 4 to 8 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Cutaneous Candidiasis:

Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 to 4 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Tinea Versicolor:

Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 to 4 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Vaginal Candidiasis:

Regimen 1: 100 mg (one 100 mg vaginal suppository) intravaginally once a day for 7 consecutive days alone or in combination with topical application of 1% clotrimazole cream to affected area two times daily for 7 consecutive days.

Regimen 2: 200 mg (one 200 mg vaginal suppository) intravaginally once a day for 3 consecutive days alone or in combination with topical application of 1% clotrimazole cream to affected area two times daily for 7 consecutive days.

Regimen 3: 500 mg (one 500 mg vaginal suppository) intravaginally once.

Regimen 4: One applicatorful of 1% clotrimazole vaginal cream intravaginally once daily (preferably at bedtime) for 7 consecutive days.

Regimen 5: One applicatorful of 2% clotrimazole vaginal cream intravaginally once daily (preferably at bedtime) for 3 consecutive days.

Studies have shown the three and seven day courses of clotrimazole to be equally effective. Patient compliance may be increased with a three day course. Patients who fail to achieve a cure with a single 500 mg dose should be treated with a 3 or 7 day course of clotrimazole.

Weekly or monthly clotrimazole vaginal suppositories appear to be effective topical regimens for chronic suppressive therapy in female patients with HIV.

Usual Pediatric Dose for Tinea Corporis:

> 3 years: Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 4 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Tinea Cruris:

> 3 years: Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Tinea Pedis:

> 3 years: Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 4 to 8 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Cutaneous Candidiasis:

> 3 years: Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 to 4 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Tinea Versicolor:

> 3 years: Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 to 4 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Vaginal Candidiasis:

> 12 years: Regimen 1: 100 mg (one 100 mg vaginal suppository) intravaginally once a day for 7 consecutive days alone or in combination with topical application of 1% clotrimazole cream to affected area two times daily for 7 consecutive days.

Regimen 2: 200 mg (one 200 mg vaginal suppository) intravaginally once a day for 3 consecutive days alone or in combination with topical application of 1% clotrimazole cream to affected area two times daily for 7 consecutive days.

Regimen 3: 500 mg (one 500 mg vaginal suppository) intravaginally once.

Regimen 4: One applicatorful of 1% clotrimazole vaginal cream intravaginally once daily (preferably at bedtime) for 7 consecutive days.

Studies have shown the three and seven day courses of clotrimazole to be equally effective. Patient compliance may be increased with a three day course. Patients who fail to achieve a cure with a single 500 mg dose should be treated with a 3 or 7 day course of clotrimazole.

Weekly or monthly clotrimazole vaginal suppositories appear to be effective topical regimens for chronic suppressive therapy in female patients with HIV.

What other drugs will affect clotrimazole topical?

There may be other drugs that can interact with clotrimazole topical. 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 clotrimazole topical resources

• Clotrimazole topical Use in Pregnancy & Breastfeeding
• Clotrimazole topical Support Group
• 2 Reviews for Clotrimazole - Add your own review/rating

Compare clotrimazole topical with other medications

• Cutaneous Candidiasis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor
• Vaginal Yeast Infection

Where can I get more information?

• Your pharmacist can provide more information about clotrimazole topical.

Boots Ibuprofen Long Lasting 200mg Capsules

Boots Ibuprofen Long Lasting 200 mg Capsules

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take

it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again


• Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Ibuprofen which belongs to a group called non-steroidal anti-inflammatory medicines,

which act to relieve pain and reduce swelling.

The Ibuprofen in the capsule is released slowly over 12 hours. It can be used to relieve headaches,

rheumatic and muscular pain, backache, migraine, period pain, dental pain and neuralgia. It can also be used

to reduce fever and relieve the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not

take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

• 
  If you have a stomach ulcer, perforation or bleeding of the stomach, or have had one in the
  
  past (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed
  
  blood in your stools or passed black tarry stools)


• 
  If you have had perforation or a bleeding stomach after taking a non-steroidal
  
  anti-inflammatory medicine


• 
  If you are allergic to ibuprofen or any other ingredients in the product, aspirin or other
  
  non-steroidal anti-inflammatory medicines (you have ever had asthma, runny nose, itchy skin or swelling of the
  
  lips, face or throat after taking these medicines)


• 
  If you are taking aspirin with a daily dose above 75 mg, or other non-steroidal
  
  anti-inflammatory medicines


• 
  If you have severe heart, kidney or liver failure
  


• 
  If you are pregnant
  

Talk to your pharmacist or doctor:

• If you have asthma, a history of asthma or other allergic disease, stomach or bowel
  
  problems


• If you have other kidney or liver problems


• If you are elderly – you may get more side effects


• If you are taking any other painkillers or receiving regular treatment from your doctor


• If you have had a stroke, or have heart problems, high blood pressure, diabetes, high cholesterol,
  
  or you smoke – see ‘Risk of heart attack or stroke’

Other important information

Risk of heat attack or stroke: Ibuprofen may increase the risk if you take large amounts for a long

time. The risk is small. Take the lowest amount for the shortest possible time to reduce this risk.

Breastfeeding: You can use this medicine.

Women of childbearing age: If you take this medicine, it may reduce your ability to become pregnant.

This effect will be reversed when you stop the medicine.

If you take other medicines

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might

be using at the same time, particularly the following:

• Aspirin 75 mg (to prevent heart attacks and strokes) – the protection may be reduced when you take
  
  ibuprofen


• Other pain killers


• Tablets to thin your blood (e.g. warfarin)


• Mifepristone (for termination of pregnancy) – do not take ibuprofen if you have taken mifepristone
  
  in the last 12 days


• Water tablets (diuretics), medicines to treat high blood pressure, medicines for heart
  
  problems


• Corticosteroids, lithium, methotrexate, zidovudine


• Quinolone antibiotics (for infections)


• Medicines for depression


• Ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or
  
  rheumatism)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes

medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and

homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that capsule.

Adults and children of 12 years and over: Take two capsules morning and evening, if you need to. Don’t take more than 4 capsules in 24 hours.

Take the lowest amount for the shortest possible time to relieve your symptoms.

Swallow each capsule whole with water.

Do not give to children under 12 years.

Do not take more than the amount recommended.

If your symptoms worsen at any time, talk to your pharmacist or doctor.

If your symptoms do not go away within 10 days, talk to your pharmacist or doctor.

If you take too many capsules: Talk to a doctor straight away. Take your medicine and this leaflet

with you.

Possible side effects

Most people will not have problems, but some may get some.

If you are elderly you may be more likely to have some of these side effects.

If you get any of these serious side effects, stop taking the capsules. See a doctor at once:

• You are sick and it contains blood or dark particles that look like coffee grounds


• Pass blood in your stools or pass black tarry stools


• Stomach problems including pain, indigestion or heartburn


• Allergic reactions such as skin rash (which can sometimes be severe and include peeling and
  
  blistering of the skin), swelling of the face, neck or throat, worsening of asthma, difficulty in
  
  breathing

These other effects are less serious.

If they bother you talk to a pharmacist:

• Kidney problems, which may lead to kidney failure


• Feeling sick or being sick


• Headache, hearing problems


• Fluid retention, which may cause swelling of the limbs


• Rarely, liver problems, diarrhoea, wind, constipation, worsening of colitis or Crohn’s disease,
  
  meningitis (e.g. stiff neck, fever and disorientation)


• Very rarely, tiredness or severe exhaustion, changes in the blood which may cause unusual bruising
  
  and an increase in the number of infections that you get (e.g. sore throats, mouth ulcers, flu-like
  
  symptoms)


• A small increased risk of heart attack or stroke if you take large amounts for a long
  
  time

If any side effect becomes severe, or if you notice any side effect not listed here, please tell your

pharmacist or doctor.

How to store this medicine

Store below 25°C.

Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked

cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each modified release hard capsule contains Ibuprofen 200 mg, which is the active ingredient.

As well as the active ingredient, the capsules also contain microcrystalline cellulose, Eudragit NE 30D,

hypromellose, talc, colloidal silicon dioxide. The capsule shell contains gelatin, titanium dioxide (E171),

patent blue V (E131), erythrosine (E127).

The pack contains 8 or 16 pale blue and clear coloured capsules, containing white beads.

Who makes this medicine

Manufactured for

The Boots Company PLC

Nottingham

NG2 3AA

by

Galpharm International Ltd

Upper Cliffe Road

Dodworth Business Park

Dodworth South Yorkshire

S75 3SP

Marketing Authorisation held by

Galpharm Healthcare Ltd

Upper Cliffe Road

Dodworth Business Park

Dodworth South Yorkshire

S75 3SP

Leaflet prepared July 2009

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Ibuprofen Long Lasting 200 mg Capsules

Reference number: 16028/0120

This is a service provided by the Royal National Institute for Blind People.

3996eMC