tetracaine topical

Generic Name: tetracaine topical (TET ra kane TOP ik al)

Brand names: Pontocaine, Viractin, Dermocaine

What is tetracaine topical?

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

Tetracaine topical cream or ointment is used to reduce pain or discomfort caused by minor skin irritations, cold sores or fever blisters, sunburn or other minor burns, insect bites or stings, and many other sources of minor pain on a surface of the body.

Tetracaine topical solution is used to numb the skin or surfaces inside the mouth, nose, and throat to lessen the pain of inserting a medical instrument such as a tube or scope. The solution may also be used to numb the surface of the eyes before a diagnostic or procedure.

Tetracaine topical may also be used for purposes other than those listed in this medication guide.

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

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of tetracaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Do not use this medication if you are allergic to tetracaine or other numbing medicines such as lidocaine, benzocaine, or prilocaine.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using tetracaine topical. Also call your doctor if your symptoms had cleared up but then came back.

What should I discuss with my health care provider before using tetracaine topical?

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). Do not use this medication if you are allergic to tetracaine or similar numbing medications such as lidocaine, benzocaine, or prilocaine.

Before using tetracaine topical, tell your doctor about all of your medical conditions. You may not be able to use tetracaine topical, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether tetracaine 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 tetracaine topical?

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

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of tetracaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

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

To treat minor skin conditions, apply a thin layer of tetracaine topical to the affected area up to 4 times per day.

Do not use tetracaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using tetracaine topical. Also call your doctor if your symptoms had cleared up but then came back.

Store tetracaine topical cream or ointment at room temperature away from moisture and heat. Tetracaine topical solution should be stored in the refrigerator and kept from freezing.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of tetracaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking tetracaine topical?

Tetracaine topical is for use only on the surface of your body. Avoid swallowing the medication, or getting the cream or ointment in your eyes while applying it.

If tetracaine topical solution has been used in your eyes, avoid rubbing the eyes or exposing them to irritating chemicals or pollutants. Follow your doctor's instructions about covering the eye(s) for a short period of time.

Tetracaine topical side effects

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

• 
  

  severe burning, stinging, or sensitivity where the medicine is applied;

  
  


• 
  

  swelling, warmth, or redness;

  
  


• 
  

  oozing, blistering, or any signs of infection; or

  
  


• 
  

  eye irritation, watering, or increased sensitivity to light.

  
  

Rare but serious side effects may include:

• 
  

  nervousness, dizziness, blurred vision;

  
  


• 
  

  drowsiness, feeling like you might pass out;

  
  


• 
  

  breathing problems;

  
  


• 
  

  fast or slow heart rate; and

  
  


• 
  

  weak pulse, fainting, slow breathing (breathing may stop).

  
  

Less serious side effects may include:

• 
  

  mild stinging, burning, or itching where the medicine is applied;

  
  


• 
  

  skin tenderness or redness; or

  
  


• 
  

  dry white flakes where the medicine was applied.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tetracaine topical?

There may be other drugs that can affect tetracaine topical. Do not apply other medications to the same affected areas you treat with tetracaine topical, unless your doctor has told you otherwise.

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

More tetracaine topical resources

• Tetracaine topical Support Group
• 1 Review for Tetracaine - Add your own review/rating

• Pontocaine Advanced Consumer (Micromedex) - Includes Dosage Information

Compare tetracaine topical with other medications

• Allergic Urticaria
• Cold Sores
• Local Anesthesia
• Skin Rash
• Urticaria

Where can I get more information?

• Your pharmacist can provide more information about tetracaine topical.

Cholestyramine Resin

Class: Bile Acid Sequestrants
VA Class: CV350
CAS Number: 11041-12-6
Brands: Prevalite, Questran, Questran Light

Introduction

Antilipemic agent; bile acid sequestrant.¹⁰⁰

Uses for Cholestyramine Resin

Dyslipidemias

Adjunct to dietary therapy to decrease elevated serum total and LDL-cholesterol concentrations in the management of primary hypercholesterolemia in patients who do not respond adequately to diet.¹⁰⁰ May be useful in decreasing LDL-cholesterol concentrations in patients who also have hypertriglyceridemia but should not be used in those whose hypertriglyceridemia is the abnormality of most concern.¹⁰⁰

As effective as colestipol in lowering serum cholesterol concentrations.^b Select bile acid sequestrant based on patient tolerance, including palatability and taste preference, and cost.^{148 181}

Pruritus Associated with Partial Cholestasis

Relief of pruritus associated with partial cholestasis.¹⁰⁰ Effects on serum cholesterol in these patients is variable.¹⁰⁰

Cholestyramine Resin Dosage and Administration

General

• 
  

  Patients should be placed on a standard lipid-lowering diet before initiation of cholestyramine therapy and should remain on this diet during treatment with the drug.¹⁰⁰

  
  

Monitoring during Antilipemic Therapy

• 
  

  Monitor lipoprotein concentrations periodically to ensure that target LDL-cholesterol goals are achieved and maintained at <100 mg/dL (optional goal: <70 mg/dL) for patients with CHD or CHD risk equivalents; <130 mg/dL (optional goal: <100 mg/dL) for patients with ≥2 risk factors and 10-year risk of 10–20%; <130 mg/dL for patients with ≥2 risk factors and 10-year risk <10%; or <160 mg/dL for patients with 0–1 risk factor.

  
  

Administration

Oral Administration

Administer orally at mealtime.¹⁰⁰

Do not administer the powder in its dry form; always mix with water or other fluids before ingesting.^{100 187 188}

Mix cholestyramine powder for oral suspension with an adequate amount (60–180 mL for 1 packet or level scoop of powder) of a liquid (e.g., water, fruit juice, other noncarbonated beverage) and stir to uniform consistency.^{100 186 187 188}

Palatability and compliance may be increased if the entire next-day’s dose is mixed in one of these liquids in the evening and then refrigerated.¹²⁷

Use of a heavy or pulpy fruit juice may minimize complaints about consistency of suspensions of the drug.¹⁴⁸

If a carbonated beverage is used, mix the powder slowly in a large glass to minimize excessive foaming.^b To minimize excessive swallowing of air, advise patients to avoid rapid ingestion of suspensions of the drug.¹⁴⁸

Alternatively, mix cholestyramine powder with a highly fluid soup or a pulpy fruit with a high moisture content such as applesauce or crushed pineapple.^{100 157 173}

Instruct patients to take other drugs at least 1 hour before or 4–6 hours after taking cholestyramine to minimize possible interference with absorption.^{100 157 173 187 188} (See Effects on GI Absorption of Drugs under Interactions.)

Dosage

Available as cholestyramine resin; dosage expressed in terms of anhydrous (i.e., dried) cholestyramine resin.¹⁰⁰

Each 9 g of Questran¹⁰⁰ or generic cholestyramine (1 dose, 1 packet, or 1 level scoop),¹⁸⁸ 5.5 g of Prevalite (1 dose, 1 packet, or 1 level scoop),¹⁸⁷ or 5 g of Questran Light¹⁰⁰ or generic cholestyramine light (1 dose, 1 packet, or 1 level scoop)¹⁸⁸ contains about 4 g of anhydrous cholestyramine resin.^{100 187 188}

In calculating pediatric dosages, each 100 mg of the commercially available powders contains either 44.4 mg (e.g., Questran, generic cholestyramine), 72.7 mg (e.g., Prevalite), or 80 mg (e.g., Questran Light, generic cholestyramine light) of anhydrous cholestyramine resin.^{100 187 188}

Pediatric Patients

Dyslipidemias†

Oral

240 mg/kg daily in 2–3 divided doses suggested by manufacturers and some clinicians.^{100 187 188 c}

Adults

Dyslipidemias or Pruritus Associated with Partial Cholestasis

Oral

Initially, 4 g of anhydrous resin (1 packet or 1 level scoop) once or twice daily at mealtime.^{100 187 188}

Increase dosage gradually to minimize adverse GI effects (e.g., fecal impaction).^{100 187 188}

Usual maintenance dosage recommended by manufacturers is 8–16 g daily, given in 2 divided doses.^{100 187 188} Usual dosage range suggested by National Cholesterol Education Program (NCEP) expert panel is 4–16 g daily.¹⁸⁶

Although the recommended dosing schedule is twice daily, may be administered in 1–6 doses per day.^{100 187 188}

In patients with preexisting constipation: Initially, 4 g of anhydrous resin (1 packet or 1 level scoop) once daily for 5–7 days; then increase dosage to 4 g twice daily and monitor constipation and serum lipoprotein values, at least twice, 4–6 weeks apart.^{100 187 188} Thereafter, increase dosage as needed by 1 dose (i.e., 4 g) per day (at monthly intervals) with periodic monitoring of serum lipoprotein values.^{100 187 188}

If constipation worsens or the desired effect is not achieved with acceptable adverse effects with the usual dosage of 1–6 doses (i.e., 4–24 g) per day, consider combined therapy or alternative treatment.^{100 187 188}

Prescribing Limits

Pediatric Patients

Oral

Maximum 8 g daily.^{100 187 188}

Adults

Oral

Maximum 24 g (6 packets or 6 level scoops) daily.^{100 187 188}

Cautions for Cholestyramine Resin

Contraindications

• 
  

  Complete biliary obstruction in which no bile products reach the intestine.¹⁰⁰

  
  


• 
  

  Known hypersensitivity to cholestyramine or any ingredient in the formulation.¹⁰⁰

  
  

Warnings/Precautions

Warnings

Phenylketonuria

Individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine should be warned that each 5-g dose of Questran Light, 5-g dose of generic cholestyramine light, or 5.5-g dose of Prevalite contains aspartame (NutraSweet), which is metabolized in the GI tract to provide about 14, 14, or 14.1 mg, respectively, of phenylalanine following oral administration.^{100 187 188}

Major Toxicities

GI Effects

Mild constipation has occurred, especially after high doses and in patients >60 years of age.¹⁰⁰ Exacerbation of preexisting constipation and aggravation of hemorrhoids secondary to constipation may occur.¹⁰⁰

Encourage increased fluid and fiber intake to alleviate constipation;¹⁰⁰ a stool softener can be added if necessary.¹⁰⁰ In addition, adjust dosage carefully and titrate slowly to minimize adverse GI effects (e.g., fecal impaction).¹⁰⁰ (See Dosage under Dosage and Administration.)

Make particular effort to avoid constipation in patients with symptomatic CHD.^{100 167}

Discontinuance of cholestyramine therapy may be required in some patients.¹⁰⁰

Abdominal discomfort and/or pain, flatulence, nausea, vomiting, diarrhea, eructation, anorexia, biliary colic, and steatorrhea also reported.¹⁰⁰ Intestinal obstruction, which rarely has been fatal, reported in pediatric patients.¹⁰⁰

General Precautions

Fat-soluble Vitamin Deficiency

May interfere with the absorption of fat-soluble vitamins (e.g., vitamins A, D, E, K).¹⁰⁰ Bleeding tendency due to hypoprothrombinemia secondary to vitamin K deficiency, night blindness secondary to vitamin A deficiency, and vitamin D deficiency have been reported.¹⁰⁰ (See Specific Drugs under Interactions.)

Hyperchloremic Acidosis

Because cholestyramine is the chloride form of an anion-exchange resin, there is a possibility that prolonged use may lead to the development of hyperchloremic acidosis.¹⁰⁰ Hyperchloremic acidosis reported in children.¹⁰⁰

Caution during long-term therapy in patients with renal impairment or volume depletion and in patients receiving concomitant spironolactone.^{100 187 188}

Specific Populations

Pregnancy

Category C.^{100 187 188}

Interferes with absorption of fat-soluble vitamins, and regular prenatal supplementation may not be adequate.^{100 187 188} (See Specific Drugs under Interactions.)

Lactation

Use with caution; possible lack of proper vitamin absorption associated with cholestyramine therapy may have an effect on nursing infants.¹⁰⁰

Pediatric Use

Safety and efficacy of long-term administration not established.¹⁰⁰ The potential effect of cholestyramine on vitamin absorption and on electrolytes should be considered.^{100 116 117 118 119 120 121 122 123 124 125 157 173 181}

Common Adverse Effects

Constipation, osteoporosis, rash, irritation of the skin/tongue/perianal area.¹⁰⁰

Interactions for Cholestyramine Resin

Effects on GI Absorption of Drugs

May bind to a number of drugs (e.g., phenylbutazone, warfarin, propranolol, tetracycline, penicillin G, phenobarbital, thyroid and thyroxine preparations, estrogens and progestins, digoxin, iron salts, loperamide) in the GI tract and may delay or reduce their absorption.¹⁰⁰ Instruct patients to administer other drugs at least 1 hour before or 4–6 hours after cholestyramine (or allow as long a time interval as possible between ingestion of other drugs and cholestyramine).¹⁰⁰

May interfere with the pharmacokinetics of drugs that undergo enterohepatic circulation.¹⁰⁰

Consider the possibility that discontinuance of cholestyramine in patients stabilized on potentially toxic drugs that bind to the resin may lead to toxicity and that administration of cholestyramine to patients stabilized on other drugs may reduce the effect of these drugs.¹⁰⁰

Specific Drugs

Drug	Interaction	Comments
Amiodarone	Decreased elimination half-life and plasma concentrations of amiodarone139 147
Fat-soluble Vitamins (i.e., vitamins A, D, E, K)	Decreased absorption of fat-soluble vitamins100	Consider supplemental administration of water-miscible (or parenteral) forms of fat-soluble vitamins if cholestyramine is to be given for a prolonged period.100 Bleeding secondary to vitamin K deficiency usually responds promptly to parenteral administration of phytonadione; recurrences can be prevented by oral administration of phytonadione100
Phosphate supplements, oral	Other bile acid binding resins reported to interfere with the absorption of oral phosphate supplements100
Propranolol	May decrease GI absorption of propranolol100 144 157 173 180	When cholestyramine therapy is initiated or discontinued in patients receiving oral propranolol, dosage adjustment of the β-adrenergic blocking agent may be necessary144 146
Thiazide diuretics (e.g., chlorothiazide, hydrochlorothiazide)	May decrease GI absorption of diuretic100 140 141 142 143

Cholestyramine Resin Pharmacokinetics

Absorption

Bioavailability

Not absorbed from the GI tract.¹⁰⁰

Onset

Antilipemic response usually occurs within 1 month.¹⁰⁰ In patients with pruritus associated with partial cholestasis, relief of pruritus usually occurs within 1–3 weeks after initiation of therapy.^b

Elimination

Elimination Route

Binds to bile acids in the intestine and forms a nonabsorbable complex that is excreted in feces.¹⁰⁰

Stability

Storage

Oral

Powder for Oral Suspension

20–25°C (may be exposed to 15–30°C).^{100 187 188}

Actions and SpectrumActions

• 
  

  Binds to bile acids in the intestine and forms a nonabsorbable complex that is excreted in feces.¹⁰⁰ Partial removal of bile acids from the enterohepatic circulation results in increased conversion of cholesterol to bile acids in the liver.¹⁰⁰ This causes an increased demand for cholesterol in liver cells, resulting in a compensatory increase in hepatic uptake (and thus systemic clearance) of circulating LDL-cholesterol.¹⁰⁰

  
  


• 
  

  Reduces serum total and LDL-cholesterol concentrations.¹⁰⁰

  
  


• 
  

  In patients with partial biliary obstruction, reduction of serum bile acid concentrations reduces excess bile acids deposited in dermal tissues, resulting in relief of pruritus.¹⁰⁰

  
  

Advice to Patients

• 
  

  Importance of advising patients that sipping or holding cholestyramine suspension in the mouth for prolonged periods may lead to changes in the surface of the teeth, resulting in discoloration, erosion of enamel, or decay.^{100 187 188} Maintain good oral hygiene.^{100 187 188}

  
  


• 
  

  Importance of adhering to nondrug therapies and measures, including dietary management, weight control, physical activity, and management of potentially contributory disease (e.g., diabetes mellitus).^{184 186}

  
  


• 
  

  For phenylketonurics, importance of informing them that Questran Light, generic cholestyramine light, and Prevalite contain aspartame.^{100 187 188}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰⁰

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹⁰⁰

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹⁰⁰ (See Cautions.)

  
  

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cholestyramine Resin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For suspension	4 g (of dried cholestyramine resin) per 9 g*	Cholestyramine	Par, Sandoz
			Questran	Par
		4 g (of dried cholestyramine resin) per 5.5 g	Prevalite (with aspartame)	Upsher-Smith
		4 g (of dried cholestyramine resin) per 5 g*	Cholestyramine Light (with aspartame)	Par, Sandoz
			Questran Light (with aspartame)	Par

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.

Cholestyramine 4GM Packet (SANDOZ): 60/$122.99 or 180/$362.96

Cholestyramine 4GM/DOSE Powder (PAR): 378/$36.99 or 1134/$104.97

Cholestyramine Light 4GM Packet (SANDOZ): 60/$102 or 180/$285.97

Prevalite 4GM Packet (UPSHER-SMITH): 60/$144.76 or 180/$425.82

Prevalite 4GM/DOSE Powder (UPSHER-SMITH): 231/$67.99 or 693/$195.98

Questran 4GM Packet (PAR): 60/$215.96 or 180/$630.97

Questran 4GM/DOSE Powder (PAR): 378/$109.99 or 1134/$309.96

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 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

100. Par Pharmaceutical Companies, Inc. Questran Powder (cholestyramine for oral suspension) and Questran Light (cholestyramine for oral suspension) prescribing information. Spring Valley, NY; 2005 Feb.

101. National Heart, Lung and Blood Institute Lipid Metabolism-Atherogenesis Branch. The Lipid Research Clinics Coronary Primary Prevention Trial results. Part I: reduction in incidence of coronary heart disease. JAMA. 1984; 251:351-64. [IDIS 180094] [PubMed 6361299]

102. National Heart, Lung and Blood Institute Lipid Metabolism-Atherogenesis Branch. The Lipid Research Clinics Coronary Primary Prevention Trial results. Part II: relationship of reduction in incidence of coronary heart disease to cholesterol lowering. JAMA. 1984; 251:365-74. [IDIS 180095] [PubMed 6361300]

103. Anon. Addition to labeling of cholestyramine. FDA Drug Bull. 1985; 15:7-8. [PubMed 3858190]

104. National Institutes of Health Office of Medical Applications of Research. Consensus conference: lowering blood cholesterol to prevent heart disease. JAMA. 1985; 25:2080-6.

105. Rahimtoola SH. Cholesterol and coronary heart disease: a perspective. JAMA. 1985; 253:2094-5. [PubMed 3974101]

106. American Heart Association Committee to Design a Dietary Treatment of Hyperlipoproteinemia. Recommendations for treatment of hyperlipidemia in adults: a joint statement of the Nutrition Committee and the Council on Arteriosclerosis. Circulation. 1984; 69:1065-90A. [PubMed 6713610]

107. Detre KM, Levy RI, Kelsey SF et al. Secondary prevention and lipid lowering: results and implications. Am Heart J. 1985; 110:1123-7. [IDIS 208440] [PubMed 3904378]

108. Glueck CJ. Nonpharmacologic and pharmacologic alteration of high-density lipoprotein cholesterol: therapeutic approaches to prevention of atherosclerosis. Am Heart J. 1985; 110:1107-15. [IDIS 208439] [PubMed 2865887]

109. Kronmal RA. Commentary on the published results of the lipid research clinics coronary primary prevention trial. JAMA. 1985; 253:2091-3. [PubMed 3883022]

110. Oliver MF. Hypercholesterolaemia and coronary heart disease: an answer. BMJ. 1984; 288:423-4. [IDIS 182823] [PubMed 6419948]

111. Brensike JF, Levy RI, Kelsey SF et al. Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI Type II Coronary Intervention Study. Circulation. 1984; 69:313-24. [IDIS 180722] [PubMed 6360414]

112. Levy RI, Brensike JF, Epstein SE et al. The influence of changes in lipid values induced by cholestyramine and diet on progression of coronary artery disease: results of the NHLBI Type II Coronary Intervention Study. Circulation. 1984; 69:325-37. [IDIS 180723] [PubMed 6360415]

113. American Medical Association Council on Scientific Affairs. Dietary and pharmacologic therapy for the lipid risk factors. JAMA. 1983; 250:1873-9. [IDIS 176576] [PubMed 6620484]

114. Garrettson LK, Guzelian PS, Blanke RV. Subacute chlordane poisoning. J Toxicol Clin Toxicol. 1984-85; 22:565-71.

115. Rubenstein C, Romhilt D, Segal P et al. Dyslipoproteinemias and manifestations of coronary heart disease: the Lipid Research Clinics Program Prevalence Study. Circulation. 1986; 73(Suppl I):I-91-9.

116. West RJ, Lloyd JK. Long-term follow-up of children with familial hypercholesterolaemia treated with cholestyramine. Lancet. 1980; 2:873-5. [IDIS 125400] [PubMed 6107543]

117. Glueck CJ. Therapy of familial and acquired hyperlipoproteinemia in children and adolescents. Prev Med. 1983; 12:835-47. [PubMed 6676731]

118. Mancini M, Postiglione A, Farinaro E et al. Diet, drugs, and plasma exchange in the treatment of hyperlipidemia in childhood. Prev Med. 1983; 12:848-53. [PubMed 6676732]

119. Glueck CJ, Tsang RC, Fallat RW et al. Therapy of familial hypercholesterolemia in childhood: diet and cholestyramine resin for 24 to 36 months. Pediatrics. 1977; 59:433-41. [IDIS 83076] [PubMed 840563]

120. Glueck CJ, Fallat R, Tsang R. Pediatric familial type II hyperlipoproteinemia: therapy with diet and cholestyramine resin. Pediatrics. 1973; 52:669-79. [IDIS 37416] [PubMed 4355362]

121. Glueck CJ, Tsang RC, Fallat RW et al. Plasma vitamin A and E levels in children with familial type II hyperlipoproteinemia during therapy with diet and cholestyramine resin. Pediatrics. 1974; 54:51-5. [IDIS 42587] [PubMed 4365953]

122. West RJ, Lloyd JK. The effect of cholestyramine on intestinal absorption. Gut. 1975; 16:93-8. [IDIS 50401] [PubMed 1168607]

123. Glueck CJ. Pediatric primary prevention of atherosclerosis. N Engl J Med. 1986; 314:175-7. [PubMed 3941697]

124. Farah JR, Kwiterovich PO, Neill CA. Dose-effect relationship of cholestyramine in children and young adults with familial hypercholesterolaemia. Lancet. 1977; 1:59-63. [IDIS 68247] [PubMed 63709]

125. Levy RI, Rifkind BM. Diagnosis and management of hyperlipoproteinemia in infants and children. Am J Cardiol. 1973; 31:547-56. [IDIS 34550] [PubMed 4348998]

126. American Health Foundation. Summary and recommendations of the Conference on Blood Lipids in Children: optimal levels for early prevention of coronary artery disease. Prev Med. 1983; 12:728-40. [PubMed 6676727]

127. Hoeg JM, Gregg RE, Brewer HB. An approach to the management of hyperlipoproteinemia. JAMA. 1986; 255:512-21. [IDIS 209539] [PubMed 3510334]

128. National Institutes of Health Office of Medical Applications of Research. Consensus conference: treatment of hypertriglyceridemia. JAMA. 251:1196-200.

129. Forman MB, Baker SG, Mieny CJ et al. Treatment of homozygous familial hypercholesterolaemia with portacaval shunt. Atherosclerosis. 1982; 41:349-61. [PubMed 7066082]

130. Thompson GR, Lowenthal R, Myant NB. Plasma exchange in the management of homozygous familial hypercholesterolaemia. Lancet. 1975; 1:1208-11. [PubMed 48833]

131. Postiglione A, Thompson GR. Experience with plasma-exchange in homozygous familial hypercholesterolaemia. Prog Clin Biol Res. 1985; 188:213-20. [PubMed 3903770]

132. Starzl TE, Chase HP, Ahrens EH Jr et al. Portacaval shunt in patients with familial hypercholesterolemia. Ann Surg. 1983; 198:273-83. [PubMed 6615051]

133. King MEE, Breslow JL, Lees RS. Plasma-exchange therapy of homozygous familial hypercholesterolemia. N Engl J Med. 1980; 302:1457-9. [PubMed 7374711]

134. Hoeg JM, Demosky SJ Jr, Schaefer EJ et al. The effect of portacaval shunt on hepatic lipoprotein metabolism in familial hypercholesterolemia. J Surg Res. 1985; 39:369-77. [PubMed 4057999]

135. Schaefer EJ, Levy RI. Pathogenesis and management of lipoprotein disorders. N Engl J Med. 1985; 312:1300-10. [IDIS 199398] [PubMed 3887163]

136. Bilheimer DW, Goldstein JL, Grundy SM et al. Liver transplantation to provide low-density-lipoprotein receptors and lower plasma cholesterol in a child with homozygous familial hypercholesterolemia. N Engl J Med. 1984; 311:1658-64. [PubMed 6390206]

137. American Heart Association Committee on Atherosclerosis and Hypertension in Childhood of the Council of Cardiovascular Disease in the Young and the Nutrition Committee. Diagnosis and treatment of primary hyperlipidemia in childhood: a joint statement for physicians by the Committee on Atherosclerosis and Hypertension in Childhood of the Council of Cardiovascular Disease in the Young and the Nutrition Committee. Circulation. 1986; 74:1181-8A. [IDIS 224232] [PubMed 3779908]

138. Gordon DJ, Knoke J, Probstfield JL et al. High-density lipoprotein cholesterol and coronary heart disease in hypercholesterolemic men: the Lipid Research Clinics Coronary Primary Prevention Trial. Circulation. 1986; 74:1217-25. [IDIS 224234] [PubMed 3536151]

139. Nitsch J, Lüderitz B. Beschleunigte Elimination von Amiodaron durch Colestyramin. (German; with English abstract.) Deutsche Med Wochenschr. 1986; 111:1241-4.

140. Hunninghake DB, Hibbard DM. Influence of time intervals for cholestyramine dosing on the absorption of hydrochlorothiazide. Clin Pharmacol Ther. 1986; 39:329-34. [IDIS 213994] [PubMed 3948472]

141. Hunninghake DB, King S, LaCroix K. The effect of cholestyramine and colestipol on the absorption of hydrochlorothiazide. Int J Clin Pharmacol Ther Toxicol. 1982; 20:151-4. [PubMed 7076343]

142. Mangini RJ, ed. Drug interaction facts. St. Louis: JB Lippincott Co; 1984(Jul):583.

143. Hansten PD. Drug interactions. 5th ed. Philadelphia: Lea & Febiger; 1985:295.

144. Hibbard DM, Peters JR, Hunninghake DB. Effects of cholestyramine and colestipol on the plasma concentrations of propranolol. Br J Clin Pharmacol. 1984; 18:337-42. [IDIS 191419] [PubMed 6487473]

145. Schwartz DE, Schaeffer E, Brewer HB et al. Bioavailability of propranolol following administration of cholestyramine. Clin Pharmacol Ther. 1982; 31:268.

146. Mangini RJ, ed. Drug interaction facts. St. Louis: JB Lippincott Co; 1985(Jan):109a.

147. Hansten PD, Horn JR, eds. Amiodarone drug interactions. Drug Interact Newsl. 1987; 7:13-6.

148. The Expert Panel (coordinated by the National Heart, Lung, and Blood Institute). Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Arch Intern Med. 1988; 148:36-69. [IDIS 236890] [PubMed 3422148]

149. Bilheimer DW. Familial hypercholesterolemia: there is a need for early detection and treatment. JAMA. 1987; 257:69-70. [PubMed 3783906]

150. Vega GL, Grundy SM. Treatment of primary moderate hypercholesterolemia with lovastatin (mevinolin) and colestipol. JAMA. 1987; 257:33-8. [IDIS 223496] [PubMed 3537351]

151. Witztum JL. Intensive drug therapy of hypercholesterolemia. Am Heart J. 1987; 113(2 Part 2):603-9. [IDIS 226100] [PubMed 3544777]

152. Blankenhorn DH, Nessim SA, Johnson RL et al. Beneficial effects of colestipol-niacin therapy on coronary atherosclerosis and coronary bypass grafts. JAMA. 1987; 257:3233-40. [IDIS 230814] [PubMed 3295315]

153. Illingworth DR. Mevinolin plus colestipol in therapy for severe heterozygous familial hypercholesterolemia. Ann Intern Med. 1984; 101:598-604. [IDIS 191769] [PubMed 6567462]

154. Mabuchi H, Sakai T, Sakai Y et al. Reduction of serum cholesterol in heterozygous patients with familial hypercholesterolemia: additive effects of compactin and cholestyramine. N Engl J Med. 1983; 308:609-13. [IDIS 166852] [PubMed 6828091]

155. Malloy MJ, Kane JP, Kunitake ST et al. Complementarity of colestipol, niacin, and lovastatin in treatment of severe familial hypercholesterolemia. Ann Intern Med. 1987; 107:616-23. [IDIS 235737] [PubMed 3662275]

156. Kane JP, Malloy MJ, Tun P et al. Normalization of low-density-lipoprotein levels in heterozygous familial hypercholesterolemia with a combined drug regimen. N Engl J Med. 1981; 304:251-8. [IDIS 126648] [PubMed 7003391]

157. Parke-Davis. Cholybar (Cholestyramine resin bar) prescribing information. In: Barnhart ER, publisher. Physicians’ desk reference. 45th ed. Oradell, NJ: Medical Economics Company Inc; 1991:1637-8.

158. Reviewers’ comments on lovastatin (personal observations); 1988 Jul.

159. Illingworth DR, Bacon SP, Larsen KK. Long-term experience with HMG-CoA reductase inhibitors in the therapy of hypercholesterolemia. Atheroscler Rev. 1988; 18:161-87.

160. Tobert JA. New developments in lipid-lowering therapy: the role of inhibitors of hydroxymethylglutaryl-coenzyme A reductase. Circulation. 1987; 76:534-8. [IDIS 252224] [PubMed 3113763]

161. Brown MS, Goldstein JL. The hyperlipoproteinemias and other disorders of lipid metabolism. In: Harrison’s principles of internal medicine. 11th ed. New York: McGraw-Hill Book Co; 1987; 1650-61.

162. Goldstein JL, Brown MS. The low-density lipoprotein pathway and its relation to atherosclerosis. Ann Rev Biochem. 1977; 46:897-930. [PubMed 197883]

163. Brown MS, Goldstein JL. Lipoprotein receptors in the liver: control signals for plasma cholesterol traffic. J Clin Invest. 1983; 72:743-7. [PubMed 6309907]

164. Heber D, Koziol BJ, Henson LC. Low density lipoprotein receptor regulation and cellular basis of atherosclerosis: implications for nutritional and pharmacologic treatment of hypercholesterolemia. Am J Cardiol. 1987; 60(Suppl):4-8G.

165. Thompson GR, Ford J, Jenkinson M et al. Efficacy of mevinolin as adjuvant therapy for refractory familial hypercholesterolaemia. Q J Med. 1986; 60:803-11. [IDIS 222246] [PubMed 3640503]

166. East C, Grundy SM, Bilheimer DW. Normal cholesterol levels with lovastatin (mevinolin) therapy in a child with homozygous familial hypercholesterolemia following liver transplantation. JAMA. 1986; 256:2843-8. [IDIS 222763] [PubMed 3534334]

167. Grundy SM. HMG-CoA reductase inhibitors for treatment of hypercholesterolemia. N Engl J Med. 1988; 319:24-33. [IDIS 243240] [PubMed 3288867]

168. McNamara DJ, Ahrens EH Jr, Kolb R et al. Treatment of familial hypercholesterolemia by portcaval anastomosis: effect on cholesterol metabolism and pool sizes. Proc Natl Acad Sci USA. 1983; 80:564-8. [PubMed 6572906]

169. Witztum JL, Williams JC, Ostlund R et al. Successful plasmapheresis in a 4-year-old child with homozygous familial hypercholesterolemia. J Pediatr. 1980; 97:615-8. [PubMed 6775065]

170. Graisely B, Cloarec M, Salmon S et al. Extracorporeal plasma therapy for homozygous familial hypercholesterolaemia. Lancet. 1980; 2:1147. [PubMed 6107765]

171. Stoffel W, Borberg H, Greve V. Application of specific extracorporeal removal of low density lipoprotein in familial hypercholesterolaemia. Lancet. 1981; 2:1005-7. [PubMed 6118475]

172. Thompson GR, Miller JP, Breslow JL. Improved survival of patients with homozygous familial hypercholesterolaemia treated with plasma exchange. BMJ. 1985; 291:1671-3. [PubMed 3935235]

173. Bristol Laboratories, Div. of Bristol-Myers Co. Questran Light (cholestyramine for oral suspension) prescribing information. Evansville, IN; 1988 Feb.

174. Gossel TA. A review of aspartame: characteristics, safety and uses. US Pharm. 1984; 9:26,28-30.

175. Food and Drug Administration. Asparatame as an inactive ingredient in human drug products; labeling requirements. Proposed rule. [21 CFR Part 201] Fed Regist. 1983; 48:54993-5. (IDIS 178728)

176. Food and Drug Administration. Food additives permitted for direct addition to food for human consumption; aspartame. Final rule. [21 CFR Part 172] Fed Regist. 1983; 48:31376-82. (IDIS 172957)

177. Anon. Aspartame and other sweeteners. Med Lett Drugs Ther. 1982; 24:1-2. [PubMed 7054648]

178. American Medical Association Council on Scientific Affairs. Aspartame: review of safety issues. JAMA. 1985; 254:400-2. [IDIS 202002] [PubMed 2861297]

179. American Heart Association. AHA conference report on cholesterol. Circulation. 1989; 80:715-48. [PubMed 2670320]

180. Parke-Davis. Cholybar (cholestyramine resin bar) prescribing information. In: Physician’s desk reference. 45th ed. Medical Economics Company Inc. Oradell, NJ: 1991 (Suppl A):A41.

181. The Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 1992; 89(Suppl):525-84. [PubMed 1538956]

182. American Academy of Pediatrics Committee on Nutrition. Statement on cholesterol. Pediatrics. 1992; 90:469-73. [PubMed 1518712]

183. The Expert Panel. Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Circulation. 1994; 89:1329-1445.

184. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of high Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001; 285:2486-97. [IDIS 464555] [PubMed 11368702]

185. Anon. Choice of lipid-regulating drugs. Med Lett Drugs Ther. 2001; 43:43-8. [PubMed 11378632]

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187. Upsher Smith. Prevalite (cholestyramine for oral suspension) prescribing information. Minneapolis, MN; 2001 Jun.

188. Par Pharmaceutical Companies, Inc. Cholestyramine powder (cholestyramine for oral suspension) and Cholestyramine Light (cholestyramine for oral suspension) prescribing information. Spring Valley, NY; 2005 Feb.

b. AHFS Drug Information 2003. McEvoy GK , ed. cholestyramine hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1594-6.

c. Medications. In: Behrman RE, Kliegman RM, Jenson HB, eds. Nelson textbook of pediatrics. 16th ed. Philadelphia: WB Saunders Company; 2000:2247.

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Acnisal

1. Name Of The Medicinal Product

Acnisal 2%w/w Cutaneous Solution

2. Qualitative And Quantitative Composition

Salicylic acid 2.0% w/w.

For excipients, see 6.1.

3. Pharmaceutical Form

Cutaneous solution

An opaque off-white cutaneous emollient solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Acnisal is for the management of acne. It helps prevent new comedones (blackheads and whiteheads) papules and pustules (acne pimples).

4.2 Posology And Method Of Administration

For topical administration.

Adults:

Acnisal is used to wash the affected area 2 to 3 times daily. Lather with warm water, massage into skin, rinse and dry.

Children:

As for adults.

Elderly:

As for adults.

4.3 Contraindications

Acnisal is contra-indicated in persons with a sensitivity to salicylic acid.

4.4 Special Warnings And Precautions For Use

For external use only. Avoid contact with the mouth, eyes and other mucous membranes to avoid irritation.

As with other topical preparations containing salicylic acid, excessive prolonged use may result in symptoms of salicylism.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No limitations to the use of Acnisal during pregnancy or lactation are known.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Salicylic acid is a mild irritant and may cause skin irritation. If undue skin irritation develops or increases adjust the usage schedule or consult your physician.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Human comedones, naturally or coal tar induced, are firmly anchored and are dislodged with great difficulty. Most classic "peeling" agents are ineffective: they are merely irritants which cause scaling, creating the illusion of comedolysis. While salicylic acid is an irritant its efficacy is dependent on specific pharmacological effects. It seems to detach horny cells from each other by weakening the intercellular cement. As a result, the comedones tend to undergo disorganisation. The effect is probably a good deal more complex. Salicylic acid penetrates skin readily and increases turnover which also favours exfoliation of the comedo. In concentrations of 0.5 to 2% it significantly reduces the formation of microcomedones, which are the precursors of all other acne lesions.

5.2 Pharmacokinetic Properties

There is no evidence of any systemic absorption from the use of Acnisal.

5.3 Preclinical Safety Data

None presented.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water

Benzyl alcohol

Sodium chloride

Sodium C14-C16 olefin sulphonate

Lauramide DEA (monoamide 716)

PEG-7 Glyceryl cocoate

Acrylic styrene copolymer

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 25^oC.

6.5 Nature And Contents Of Container

Acnisal is supplied in a white HDPE bottle with a white polypropylene screw cap. Each bottle contains either 30ml or 177ml of Acnisal.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

8. Marketing Authorisation Number(S)

PL 16853/0070

9. Date Of First Authorisation/Renewal Of The Authorisation

11^th September 1998.

10. Date Of Revision Of The Text

18^th May 2010

Urofollitropin Purified

Pronunciation: yoor-oh-fol-li-TROE-pin
Generic Name: Urofollitropin Purified
Brand Name: Bravelle

Urofollitropin Purified is used for:

Treating infertility in women who have not responded to other therapy.

Urofollitropin Purified is a human follicle-stimulating hormone. It works by stimulating the ovaries to produce eggs.

Do NOT use Urofollitropin Purified if:

• you are allergic to any ingredient in Urofollitropin Purified


• you are pregnant


• you have uncontrolled thyroid or adrenal gland problems; hormone-sensitive tumors; infertility for reasons other than absence of ovulation; heavy or irregular vaginal bleeding of unknown cause; ovarian failure, cysts, or enlargement of unknown cause; or a brain lesion or tumor

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

Before using Urofollitropin Purified:

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

• if you are breast-feeding


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


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


• if you have adrenal gland or thyroid disease

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

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

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

• Urofollitropin Purified is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Urofollitropin Purified at home, carefully follow the injection procedures taught to you by your health care provider.


• To use Urofollitropin Purified, first break open the diluent ampule by snapping it at the neck, keeping the dot on the ampule facing away from you. When breaking open ampules, you may use gauze, paper towels, or tissues to protect your fingers.


• Draw up the recommended amount of diluent into a syringe, then break open the ampule containing the powder (using the same technique as above) and add the diluent to the powder by slowly pushing in the plunger of the syringe. Gently roll the ampule between your fingers but do not shake. The solution should be clear and free of particles.


• Draw up the solution for injection. The ampule can be held at an angle or turned upside down to remove all the solution. Use a different syringe for this or switch needles just prior to injection. Needles with a higher gauge (25 and higher) are smaller and more comfortable to the patient. Be sure all air bubbles are tapped out of the syringe.


• Wipe the injection site with an alcohol swab, then insert the syringe through the skin in the appropriate injection site (usually the upper thigh or buttocks).


• If using this as an intramuscular (IM; into a muscle) injection, be sure that the needle is not in a vein. After inserting the needle into the skin, pull back on the plunger of the syringe while holding the syringe in place. If the syringe begins to fill with blood, the needle is in a vein. If this happens, remove the needle from the skin, throw the syringe away, and start the procedure again using new materials (medicine, syringes, etc.)


• After giving the injection, cover the injection site with a small bandage if necessary.


• If Urofollitropin Purified contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Use immediately after mixing. Throw away any unused portion.


• 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. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Urofollitropin Purified, contact your doctor for instructions.

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

Important safety information:

• You and your partner should have had a complete gynecological and hormone evaluation prior to starting therapy with Urofollitropin Purified.


• Contact your doctor immediately if any of the following occur: severe stomach pain or bloating, nausea, vomiting, diarrhea, weight gain, difficulty breathing, infrequent urination.


• Urofollitropin Purified may cause multiple births (eg, twins). Talk with your health care provider about the risk of multiple births.


• LAB TESTS, such as estradiol levels and ultrasounds, will be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Urofollitropin Purified is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Urofollitropin Purified in excreted in breast milk. Do not breast-feed while using Urofollitropin Purified.

Possible side effects of Urofollitropin Purified:

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:

Breast tenderness; headache; hot flashes; nausea; stomach pain; vaginal bleeding.

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); bloating; chills; continuing diarrhea; fever; infrequent urination; nausea; pain or redness at the injection site; severe headache; severe pelvic pain; severe stomach pain or swelling; shortness of breath; swelling of the lower legs; vomiting; weakness; weight gain.

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: Urofollitropin Purified side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Urofollitropin Purified:

Store Urofollitropin Purified at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Use immediately after mixing. Discard unused material. Keep Urofollitropin Purified, as well as needles and syringes, out of the reach of children and away from pets.

General information:

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


• Urofollitropin Purified 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 Urofollitropin Purified. 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.

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Metipranolol

Metipranolol

Ophthalmic Solution 0.3%

Sterile Ophthalmic Solution

Rx Only

DESCRIPTION

Metipranolol ophthalmic solution 0.3% is a sterile solution that contains Metipranolol, a non-selective beta-adrenergic receptor blocking agent. Metipranolol is a white, odorless, crystalline powder. The chemical name of Metipranolol is (±)-1-(4-Hydroxy-2, 3,5-trimethylphenoxy)-3-(isopropylamino)-2-propanol-4-acetate.

The chemical structural of Metipranolol is:

Each mL of Metipranolol ophthalmic solution, for ophthalmic administration, contains 3 mg Metipranolol. INACTIVES: povidone, glycerol, hydrochloric acid, sodium chloride, edetate disodium, and purified water. Sodium Hydroxide may be added to adjust pH. PRESERVATIVE ADDED: Benzalkonium chloride 0.004%.              DM-00

CLINICAL PHARMACOLOGY

Metipranolol blocks beta1 and beta2 (non-selective) adrenergic receptors. It does not have significant intrinsic sympathomimetic activity, and has only weak local anesthetic (membrane-stabilizing) and myocardial depressant activity.

Orally administered beta-adrenergic blocking agents reduce cardiac output in both healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor antagonists may inhibit the sympathetic stimulatory effect necessary to maintain adequate cardiac output.

Beta-adrenergic receptor blockade in the bronchi and bronchioles may result in significantly increased airway resistance from unopposed para-sympathetic activity. Such an effect is potentially dangerous in patients with asthma or other bronchospastic conditions (see CONTRAINDICATIONS and WARNINGS).

Metipranolol when applied topically in the eye, has the action of reducing elevated as well as normal intraocular pressure (IOP), whether or not accompanied by glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss. The higher the level of intraocular pressure, the greater the likelihood of glaucomatous visual field loss and optic nerve damage.

The primary mechanism of the ocular hypotensive action of Metipranolol is most likely due to reduction in aqueous humor production. A slight increase in outflow may be an additional mechanism. Metipranolol reduces IOP with little or no effect on pupil size or accommodation.

In controlled studies of patients with intraocular pressure greater than 24 mmHg at baseline, Metipranolol ophthalmic solution reduced the average intraocular pressure approximately 20 - 26%.

The onset of action of Metipranolol ophthalmic solution, as measured by a reduction in intraocular pressure, occurs within 30 minutes after a single administration. The maximum effect occurs at about 2 hours. A reduction in intraocular pressure can be demonstrated 24 hours after a single dose. Clinical studies in patients with glaucoma treated for up to two years indicate that an intraocular pressure lowering effect is maintained.

ANIMAL PHARMACOLOGY

In rabbits administered Metipranolol in one eye at 2 to 4 fold increased concentrations, multi-focal interstitial nephritis was observed in male animals, and lympho-hystiocytic and heterophilic interstitial pneumonia was observed in female animals. The clinical relevance of these findings is unknown.

INDICATIONS AND USAGE

Metipranolol ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma.

CONTRAINDICATIONS

Hypersensitivity to any component of this product.

Metipranolol ophthalmic solution is contraindicated in patients with bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease; symptomatic sinus bradycardia; greater than a first degree atrioventricular block; cardiogenic shock; or overt cardiac failure.

WARNINGS

As with other topically applied ophthalmic drugs, this drug may be absorbed systemically. Thus, the same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely, death in association with cardiac failure, have been reported following topical application of beta-adrenergic blocking agents (see CONTRAINDICATIONS).

Since Metipranolol ophthalmic solution had a minor effect on heart rate and blood pressure in clinical studies, caution should be observed in treating patients with a history of cardiac failure. Treatment with Metipranolol ophthalmic solution should be discontinued at the first evidence of cardiac failure.

Metipranolol ophthalmic solution, or other beta-blockers, should not, in general, be administered to patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity (see CONTRAINDICATIONS). However, if the drug is necessary in such patients, then it should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta2 receptors.

PRECAUTIONS

General

Because of potential effects of beta-adrenergic receptor blocking agents relative to blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with Metipranolol ophthalmic solution, alternative therapy should be considered.

Some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents in patients undergoing elective surgery. If necessary during surgery, the effects of beta-adrenergic receptor blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol.

While Metipranolol ophthalmic solution has demonstrated a low potential for systemic effect, it should be used with caution in patients with diabetes (especially labile diabetes) because of possible masking of signs and symptoms of acute hypoglycemia.

Beta-adrenergic receptor blocking agents may mask certain signs and symptoms of hyperthyroidism, and their abrupt withdrawal might precipitate a thyroid storm.

Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness).

Risk of anaphylactic reaction: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Information for Patients

Patients should be instructed to avoid allowing the tip of the dispensing containers to contact the eye or surrounding structures. Patients should be advised that Metipranolol contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following Metipranolol administration.

Drug Interactions

Metipranolol ophthalmic solution should be used with caution in patients who are receiving a beta-adrenergic blocking agent orally, because of the potential for additive effects on systemic beta-blockade.

Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia.

Caution should be used in the coadministration of beta-adrenergic receptor blocking agents, such as Metipranolol, and oral or intravenous calcium channel antagonists, because of possible precipitation of left ventricular failure, and hypotension. In patients with impaired cardiac function, who are receiving calcium channel antagonists, coadministration should be avoided.

The concomitant use of beta-adrenergic receptor blocking agents with digitalis and calcium channel antagonists may have additive effects, prolonging atrioventricular conduction time.

Caution should be used in patients using concomitant adrenergic psychotropic drugs.

Ocular: In patients with angle-closure glaucoma, the immediate treatment objective is to re-open the angle by constriction of the pupil with a miotic agent. Metipranolol ophthalmic solution has little or no effect on the pupil, therefore, when it is used to reduce intraocular pressure in angle-closure glaucoma, it should be used only with concomitant administration of a miotic agent.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime studies with Metipranolol have been conducted in mice at oral doses of 5, 50 and 100 mg/kg/day and in rats at oral doses of up to 70 mg/kg/day. Metipranolol demonstrated no carcinogenic effect. In the mouse study, female animals receiving the low, but not the intermediate or high dose, had an increased number of pulmonary adenomas. The significance of this observation is unknown. In a variety of in vitro and in vivo bacterial and mammalian cell assays, Metipranolol was nonmutagenic.

Reproduction and fertility studies of Metipranolol in rats and mice showed no adverse effect on male fertility at oral doses of up to 50 mg/kg/day, and female fertility at oral doses of up to 25 mg/kg/day.

Pregnancy

Teratogenic Effects

Pregnancy Category C: No drug related effects were reported for the segment II teratology study in fetal rats after administration, during organogenesis, to dams of up to 50 mg/kg/day. Metipranolol ophthalmic solution has been shown to increase fetal resorption, fetal death, and delayed development when administered orally to rabbits at 50 mg/kg/day during organogenesis.

There are no adequate and well-controlled studies in pregnant women. Metipranolol ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Metipranolol ophthalmic solution is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Metipranolol ophthalmic solution is administered in nursing women.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

In clinical trials, the use of Metipranolol ophthalmic solution has been associated with transient local discomfort.

Other ocular adverse reactions, such as abnormal vision, blepharitis, blurred vision, browache, conjunctivitis, edema, eyelid dermatitis, photophobia, tearing, and uveitis have been reported in small numbers of patients.

Other systemic adverse reactions, such as allergic reaction, angina, anxiety, arthritis, asthenia, atrial fibrillation, bradycardia, bronchitis, coughing, depression, dizziness, dyspnea, epistaxis, headache, hypertension, myalgia, myocardial infarct, nausea, nervousness, palpitation, rash, rhinitis, and somnolence have also been reported in small numbers of patients.

OVERDOSAGE

No information is available on overdosage of Metipranolol ophthalmic solution in humans. The symptoms which might be expected with an overdose of a systemically administered beta-adrenergic receptor blocking agent are bradycardia, hypotension and acute cardiac failure.

DOSAGE AND ADMINISTRATION

The recommended dose is one drop of Metipranolol ophthalmic solution in the affected eye(s) twice a day.

If the patient's IOP is not at a satisfactory level on this regimen, use of more frequent administration or a larger dose of Metipranolol ophthalmic solution is not known to be of benefit. Concomitant therapy to lower intraocular pressure can be instituted.

In clinical trials, Metipranolol ophthalmic solution was safely used during concomitant therapy with pilocarpine, epinephrine, or acetazolamide.

HOW SUPPLIED

Metipranolol ophthalmic solution 0.3% is supplied in a plastic bottle with a controlled drop tip and a white plastic screw-top cap as follows:

5mL: NDC 61314-447-05

10mL: NDC 61314-447-10

Storage: Store at controlled room temperature, 15°-30°C (59°-86°F). Replace cap immediately after use.

FOR TOPICAL OPHTHALMIC USE ONLY

Falcon Pharmaceuticals, Ltd.

Fort Worth, TX 76134 USA

Mfd. By:

ALCON LABORATORIES, INC

Fort Worth, TX 76134 USA

340067-0201

PRINCIPAL DISPLAY PANEL

NDC 61314-447-10       Rx Only

FALCON PHARMACEUTICALS®

Metipranolol

Ophthalmic

Solution

0.3%

10 mL STERILE

AFFILIATE OF

ALCON LABORATORIES, INC

QUALITY RX

Metipranolol  Metipranolol  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61314-447 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Metipranolol (Metipranolol) Metipranolol 3 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   POVIDONE   GLYCERIN   HYDROCHLORIC ACID   SODIUM CHLORIDE   EDETATE DISODIUM   WATER   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61314-447-05 5 mL In 1 BOTTLE, PLASTIC None 2 61314-447-10 10 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075720	08/09/2001

Labeler - Falcon Pharmaceuticals, Ltd. (874345820)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 08/2011Falcon Pharmaceuticals, Ltd.

More Metipranolol resources

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

• metipranolol ophthalmic Concise Consumer Information (Cerner Multum)


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• Intraocular Hypertension

Prevident 5000 Enamel Protect

Dosage Form: gel, dentifrice
Colgate®

PreviDent® 5000 ppm

ENAMEL PROTECT

Rx ONLY

1.1% Sodium Fluoride, 5% Potassium Nitrate

Prescription Strength Toothpaste For Sensitive Teeth

Prevident 5000 Enamel Protect Description

Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.

Active Ingredients

Sodium fluoride 1.1% (w/w), Potassium nitrate 5%

Inactive Ingredients

water, hydrated silica, sorbitol, PEG-12, carrageenan, sodium lauryl sulfate, flavor, poloxamer 407, titanium dioxide, cocamidopropyl betaine, sodium saccharin, sodium hydroxide

Prevident 5000 Enamel Protect - Clinical Pharmacology

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

Indications and Usage for Prevident 5000 Enamel Protect

A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Contraindications

Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.

Warnings

Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician.

Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Precautions

General

Not for systemic treatment. DO NOT SWALLOW.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.

Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.

Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Pregnancy

Teratogenic Effects

Pregnancy Category B

It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers

It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

Geriatric Use

Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5

Adverse Reactions

Allergic reactions and other idiosyncrasies have been rarely reported.

Overdosage

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of PreviDent® 5000 Enamel Protect contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.

Prevident 5000 Enamel Protect Dosage and Administration

Follow these instructions unless otherwise instructed by your dental professional:

1. Adults and children 12 years of age and older: Apply at least a 1 inch strip of PreviDent® 5000 Enamel Protect onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly.


2. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician.

How is Prevident 5000 Enamel Protect Supplied

3.4 FL OZ (100 mL) in plastic bottles. Mint: NDC 0126-0022-92

STORAGE

Store at Controlled Room Temperature, 68-77°F (20-25°C)

REFERENCES

1. American Dental Association, Accepted Dental Therapeutics Ed. 40 (Chicago, 1984): 405-407.


2. H.R. Englander et al., JADA 75 (1967): 638-644.


3. H.R. Englander et al., JADA 78 (1969): 783-787.


4. H.R. Englander et al., JADA 83 (1971): 354-358.


5. Data on file, Colgate Oral Pharmaceuticals.

Questions? Comments? Please Call: 1-800-962-2345

www.colgateprofessional.com

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

NDC 0126-0022-92

Colgate®

PreviDent®

5000 ppm

ENAMEL

PROTECT

1.1% Sodium Fluoride

5% Potassium Nitrate

PRESCRIPTION STRENGTH

TOOTHPASTE FOR SENSITIVE TEETH

MINT

3.4 FL OZ (100 mL)

Rx ONLY

P10001770

Prevident 5000 Enamel Protect  sodium fluoride and potassium nitrate  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0126-0022 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 12.7 mg  in 1 mL POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 57.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0126-0022-92 100 mL In 1 BOTTLE None 2 0126-0022-12 3.5 mL In 1 PACKET None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		03/30/2011

Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)

Revised: 07/2011Colgate Oral Pharmaceuticals, Inc.