Salicylic Acid Foam

Salicylic Acid

Salicylic Acid Foam Description

Salicylic Acid 6% Emollient Foam is a keratolytic that contains 6% salicylic acid USP incorporated into an aqueous based ammonium lactate vehicle. Each gram of Salicylic Acid 6% Emollient Foam contains 6% w/w salicylic acid USP, aloe, ammonium lactate, ceteth-10 phosphate, ceteth-20 phosphate, cetostearyl alcohol NF, dicetyl phosphate, dl alpha tocopheryl acetate USP, edetate disodium dihydrate USP, glycerin USP, methylparaben NF, propylene glycol USP, propylparaben NF, purified water USP, sodium hydroxide NF, white petrolatum USP.

Also contains: Propellant HFA-134a(1,1,1,2-tetrafluo-roethane).

Salicylic Acid USP is the 2-hydroxy derivative of benzoic acid having the following Structure:

Salicylic Acid Foam - Clinical Pharmacology

Salicylic acid has been shown to produce desquamation of the horny layer of skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis.1,2 The meachanism of action has been attributed to a dissolution of intercellular cement substance.3 In a study of the percutaneous absorption of salicylic acid in a 6% salicylic acid gel in four patients with extensive active psoriasis, Taylor and Halprin4 showed that the peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). Peak serum levels occurred within five hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space.5 (See PRECAUTIONS.)

The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic acid (6%).4 The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more salicylate glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space.5

Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs; by similar competitive mechanisms other drugs can influence the serum levels of salicylate.5 (See WARNINGS.) Ammonium lactate, a salt of lactic acid, is a powerful humectant with exfoliating properties.

Indications and Usage for Salicylic Acid Foam

For Dermatologic Use: Salicylic Acid 6% Emollient Foam is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles).

For Podiatric Use: Salicylic Acid 6% Emollient Foam is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.

Contraindications

Salicylic Acid 6% Emollient Foam should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. Salicylic Acid 6% Emollient Foam should not be used in children under 2 years of age.

Warnings

Prolonged and repeated daily use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Excessive application of the product other than is needed to cover the affected area will not result in a more rapid therapeutic benefit. Concomitant use of others drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances. In the event of salicylic acid toxicity, the use of Salicylic Acid 6% Emollient Foam should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports injury creams, to avoid additional excessive exposure to salicylic acid. Where needed, aspirin  should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based.

Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by a physician.

Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120°F (49°C).

FOR DERMATOLOGICAL USE ONLY. NOT FOR OPTHALMIC, ORAL OR INTRAVAGINAL USE.

Precautions

For EXTERNAL USE ONLY. Avoid contact with eyes and other mucous membranes. Mild burning or stinging may occur. Peeling of the skin may increase as the salicylic acid works to loosen excessive keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician. Keep this and all medications out of reach of children.

Drug Interactions

The following interactions are from a published review5 and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% Emollient Foam is not known. 

I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur:

DRUG	DESCRIPTION OF INTERACTION
Tolbutamide; Sulfonylureas	Hypoglycemia potentiated.
Methotrexate	Decreases tubular reabsorption; clinical toxicity from  methotrexate can result.
Oral Anticoagulants	Increased bleeding.

II. Drugs changing salicylate levels by altering renal tubular reabsorption:

DRUG	DESCRIPTION OF INTERACTION
Corticosteroids	Decreases plasma salicylate level; tapering doses of  steroids may promote salicylism.
Acidifying Agents	Increases plasma salicylate level.
Alkanizing Agents	Decreased plasma salicylate levels.

III. Drugs with complicated interactions with salicylates:

DRUG	DESCRIPTION OF INTERACTION
Heparin	Salicylate decreases platelet adhesiveness and interferes  with hemostasis in heparin treated patients.
Pyrazinamide	Inhibits pyrazinamide induced hyperuricemia.
Uricosuric Agents	Effect of probenemide, sulfinpyrazone and phenylbultazone  inhibited.

The following alterations of laboratory tests have been reported during salicylate therapy6: 

LABORATORY TESTS	EFFECT OF SALICYLATES
Thyroid Function	Decreased PBI; increased T3 uptake.
Urinary Sugar	False negative with glucose oxidase; False positive with  Clinitest with high-dose salicylate therapy (2-5g q.d.).
5-Hydroxyindole acetic acid	False negative with fluorometric test.
Acetone ketone bodies	False positive FeCl3 in Gerhardt reaction; red color  persists with boiling.
17-OH corticosteroids	False reduced values with >4.8g q.d. Salicylate.
Vanilmandelic acid	False reduced values.
Uric acid	May increase or decrease depending on dose.
Prothrombin	Decreased levels; slightly increased prothrombin time.

PREGNANCY (Category C)

Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicylic Acid 6% Emollient Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salicylic Acid 6% Emollient Foam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used on the chest area to avoid the accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% Emollient Foam. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.

Adverse Reactions

Excessive erythema and scaling conceivably could result from use on open skin lesions.

Overdosage

See Warnings.

Salicylic Acid Foam Dosage and Administration

Important: Prime Can Before Initial Use.

To Prime can: Grasp can in one hand. Shake can vigorously (until product moves inside can). Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times. Hold can upright and direct initial spray to a non-skin surface, such as into cap of can. DO NOT spray directly on the skin as the initial spray may expel cold, liquid propellant. Press down on actuator for 1 to 3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.

Before Each Use: Shake can vigorously. Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times.

During Use: Holding can upright, dispense Salicylic Acid 6% Emollient Foam into palm of hand and apply thoroughly to affected area twice per day, or as directed by a physician. Rub in completely. Wipe off any excess foam from actuator after use. The preferable method of use is to apply Salicylic Acid 6% Emollient Foam thoroughly to the affected area and to cover the treated area at night, after washing and before retiring. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salicylic Acid 6% Emollient Foam will usually maintain the remission. In those areas where the placement of a protective covering is difficult or impossible, application of Salicylic Acid 6% Emollient Foam may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. (See WARNINGS.) Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salicylic Acid 6% Emollient Foam will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism. 

How is Salicylic Acid Foam Supplied

Salicylic Acid 6% Emollient Foam is supplied in 60g (NDC# 49808-167-60) aluminum cans.

Store at room temperature 59° - 77°F (15° - 25°C).

Protect from freezing.

Store upright.

REFERENCES

1. Davies M, Marks R: Br J Dermatol 95: 187–192, 1976.


2. Marks R, Davies M, Cattel A: J Invest Dermatol 64: 283, 1975.


3. Huber C, Christophers E: Arch Derm Res 257: 293-297, 1977.


4. Taylor JR, Halprin KM: Arch Dermatol 111: 740-743, 1975. 


5. Goldsmith LA: Int J Dermatol 18: 32-36, 1979.


6. Wilson JG, Ritter EJ, Scott WJ, Fradlein R: Tox Appl Pharmacol 41: 67-78, 1977.

Manufactured for :

Metacon Labs

866-777-4633

www.metaconlabs.com

Patent Pending

P/N 2619 Rev. 0

Rx only

Salicylic Acid 6% 

Emollient Foam

In An Ammonium Lactate Vehicle

NDC 49808-167-60

Net Weight 60g

SALICYLIC ACID  salicylic acid  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49808-167 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 6 g  in 100 g

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL   CETOSTEARYL ALCOHOL   ALPHA-TOCOPHEROL ACETATE   METHYLPARABEN   PROPYLPARABEN   WATER   PETROLATUM   GLYCERIN   EDETATE SODIUM   ALOE   SODIUM HYDROXIDE   AMMONIUM LACTATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49808-167-60 1 CAN In 1 CARTON contains a CAN 1 60 g In 1 CAN This package is contained within the CARTON (49808-167-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/01/2010	12/31/2011

Labeler - Metacon Labs (793223707)

Registrant - Onset Dermatologics LLC (964275155)

Establishment
Name	Address	ID/FEI	Operations
Metacon Labs		793223707	Manufacture

Revised: 11/2011Metacon Labs

More Salicylic Acid Foam resources

• Salicylic Acid Foam Side Effects (in more detail)
• Salicylic Acid Foam Use in Pregnancy & Breastfeeding
• Salicylic Acid Foam Drug Interactions
• Salicylic Acid Foam Support Group
• 1 Review for Salicylic Acid - Add your own review/rating

Compare Salicylic Acid Foam with other medications

• Acne
• Dermatological Disorders
• Warts

Tranexamic acid

Generic Name: tranexamic acid (Cyklokapron) (tran ex AM ik AS id)

Brand Names: Cyklokapron

What is tranexamic acid (Cyklokapron)?

Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots.

Cyklokapron is used to prevent bleeding in people with hemophilia who need to have a tooth pulled. This medication is usually given just before the dental procedure, and daily for up to 8 days afterward.

Tranexamic acid may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Cyklokapron?

You should not use Cyklokapron if you are allergic to tranexamic acid, if you are color blind, or if you have ever had a stroke, blood clot, or bleeding in your brain.

Before using this medicine, tell your doctor if you have kidney disease, blood in your urine, or leukemia.

To be sure this medication is not causing harmful effects, your vision may need to be tested while you are using tranexamic acid. Follow your doctor's instructions.

What should I discuss with my healthcare provider before using Cyklokapron?

You should not use Cyklokapron if you are allergic to tranexamic acid, or if you have:

• 
  

  color blindness (only if you are receiving the injectable form of tranexamic acid);

  
  


• 
  

  problems with the blood vessels in your eyes;

  
  


• 
  

  a history of stroke;

  
  


• 
  

  if you have a history of bleeding in your brain; or

  
  


• 
  

  if you have recently had a blood clot.

  
  

To make sure you can safely use Cyklokapron, tell your doctor if you have any of these other conditions:

• kidney disease;


• 
  

  a bladder or kidney infection; or

  
  


• 
  

  leukemia.

  
  

It is not known whether tranexamic acid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Tranexamic acid can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is Cyklokapron given?

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

Cyklokapron is injected into a vein through an IV just before your tooth is pulled. You may need to keep using the medication for up to 8 days afterward.

You may be shown how to use an IV at home. Do not self-inject Cyklokapron if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

To be sure this medication is not causing harmful effects, your vision may need to be tested while you are using tranexamic acid. Follow your doctor's instructions. Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

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

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

What should I avoid while using Cyklokapron?

This medication may impair your vision. Be careful if you drive or do anything that requires you to be able to see clearly.

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

• 
  

  problems with your vision (including color vision);

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  painful or difficult urination;

  
  


• 
  

  blood in your urine; or

  
  


• 
  

  feeling like you might pass out.

  
  

Less serious side effects include:

• 
  

  nausea, vomiting, diarrhea;

  
  


• 
  

  mild itching or rash; or

  
  


• 
  

  feeling unusually happy.

  
  

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.

Tranexamic acid Dosing Information

Usual Adult Dose for Bleeding:

For the treatment of cyclic heavy menstrual bleeding:
1,300 mg (two 650 mg tablets) orally three times a day (3,900 mg/day) for a maximum of 5 days during monthly menstruation.

For patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction:
Immediately before dental extraction in patients with hemophilia, administer 10 mg per kg body weight intravenously. Following surgery, a dose of 10 mg per kg body weight intravenously three to four times daily, may be used for 2 to 8 days.

Usual Pediatric Dose for Bleeding:

Tranexamic acid has had limited use in pediatric patients, principally in connection with tooth extraction. The limited data suggest that dosing instructions for adults can be used for pediatric patients needing therapy.

For patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction:
Immediately before dental extraction: 10 mg per kg body weight intravenously
Following surgery: 10 mg per kg body weight intravenously three to four times daily, may be used for 2 to 8 days.

Surgery for congenital heart disease (to reduce perioperative blood loss and need for transfusions):
(not FDA approved, limited data available, dose not established, variable dosing regimens reported)
2 months to 15 years:
loading dose: 100 mg/kg intravenously, followed by 10 mg/kg/hour infusion (continued until ICU transport) and 100 mg/kg priming dose when bypass initiated;
or
loading dose: 10 mg/kg intravenously, priming dose: 10 mg/kg and 10 mg/kg after protamine.

Surgery for scoliosis (to reduce perioperative blood loss and need for transfusions):
(not FDA approved, limited data available, dose not established, variable dosing regimens reported)
18-18 years:
loading dose: 100 mg/kg intravenously, followed by infusion: 10 mg/kg/hour until skin closure
or
loading dose: 20 mg/kg intravenously, followed by 10 mg/kg/hour infusion
or
loading dose: 10 mg/kg intravenously and 1 mg/kg/hour infusion.

What other drugs will affect Cyklokapron?

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

• 
  

  any type of medication to treat a bleeding episode or a blood clot; or

  
  


• 
  

  factor IX (Bebulin VH, Konyne 80, Profilnine SD, Proplex T, and others).

  
  

This list is not complete and other drugs may interact with Cyklokapron. 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 tranexamic acid resources

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

Compare tranexamic acid with other medications

• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Menorrhagia
• Menstrual Disorders

Where can I get more information?

• Your doctor or pharmacist can provide more information about tranexamic acid (Cyklokapron).

See also: tranexamic acid side effects (in more detail)

Norvasc

Generic Name: amlodipine (Oral route)

am-LOE-di-peen

Commonly used brand name(s)

In the U.S.

• Norvasc

Available Dosage Forms:

• Tablet


• Tablet, Disintegrating

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Dihydropyridine

Uses For Norvasc

Amlodipine is used alone or together with other medicines to treat angina (chest pain) and high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

This medicine is available only with your doctor's prescription.

Before Using Norvasc

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine to treat high blood pressure in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving amlodipine.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

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

• Amiodarone


• Atazanavir


• Conivaptan


• Dantrolene


• Droperidol


• Simvastatin


• Telaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Clopidogrel


• Dalfopristin


• Dilevalol


• Diltiazem


• Esmolol


• Fluconazole


• Imatinib


• Indinavir


• Itraconazole


• Ketoconazole


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Quinupristin


• Rifapentine


• Ritonavir


• Sotalol


• St John's Wort


• Talinolol


• Tertatolol


• Timolol

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Angina (chest pain) or


• Heart attack, acute or


• Heart or blood vessel disease (e.g., coronary artery disease) or


• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Heart disease or other heart problems (e.g., aortic stenosis)—Use with caution. The blood pressure-lowering effects of this medicine may be increased.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Norvasc

Take this medicine exactly as directed even if you feel well and do not notice any chest pain. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not miss any doses.

For patients taking this medicine for high blood pressure:

• In addition to the use of the medicine, treatment for your high blood pressure may include weight control and a change in the types of food you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.


• Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.


• Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

Take this medicine at the same time each day.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For angina (chest pain):
    
    • Adults—5 to 10 milligrams (mg) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For high blood pressure:
    
    • Adults—At first, 2.5 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg once a day.
    
    
    • Children 6 to 17 years of age—2.5 to 5 mg once a day.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take this medicine if it has been more than 12 hours since you missed your last dose.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Norvasc

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects. a

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

If you have been using this medicine regularly for several weeks, do not suddenly stop using it. Stopping suddenly may cause your chest pain or high blood pressure to come back or get worse. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

Chest pain resulting from exercise or physical exertion is usually reduced or prevented by this medicine. This may tempt you to be too active. Make sure you discuss with your doctor a safe amount of exercise for your medical problem.

After taking a dose of this medicine you may get a headache that lasts for a short time. This should become less noticeable after you have taken this medicine for a while. If this effect continues, or if the headaches are severe, check with your doctor.

In some patients, tenderness, swelling, or bleeding of the gums may appear soon after treatment with this medicine is started. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

Norvasc Side Effects

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

Check with your doctor immediately if any of the following side effects occur:

More common

• Swelling of the ankles or feet

Less common

• Difficult or labored breathing


• dizziness


• fast, irregular, pounding, or racing heartbeat or pulse


• feeling of warmth


• redness of the face, neck, arms, and occasionally, upper chest


• shortness of breath


• tightness in the chest


• wheezing

Rare

• Black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• blood in the urine or stools


• blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain or discomfort


• chills


• cold and clammy skin


• cold sweats


• confusion


• dark yellow urine


• cough


• diarrhea


• dilated neck veins


• dizziness or lightheadedness when getting up from a lying or sitting position


• extra heartbeats


• extreme fatigue


• fainting


• fever


• itching of the skin


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• numbness and tingling of the face, fingers, or toes


• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion


• painful or difficult urination


• pale, bluish-colored, or cold hands or feet


• pinpoint red or purple spots on the skin


• red, irritated eyes


• redness of the face, neck, arms, and occasionally, upper chest


• redness, soreness or itching skin


• shakiness in the legs, arms, hands, or feet


• slow or irregular heartbeat


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sores, welting, or blisters


• sudden sweating


• sweating


• swelling of the face, fingers, feet, or lower legs


• swollen glands


• trembling or shaking of the hands or feet


• unsteadiness or awkwardness


• unusual bleeding or bruising


• unusual tiredness or weakness


• weak or absent pulses in the legs


• weakness in the arms, hands, legs, or feet


• weight gain


• yellow eyes or skin

Incidence not known

• Abdominal or stomach pain


• clay-colored stools


• diarrhea


• headache


• loss of appetite


• nausea


• rash


• unpleasant breath odor


• vomiting of blood


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• lack or loss of strength


• muscle cramps


• sleepiness or unusual drowsiness


• stomach discomfort, upset, or pain

Rare

• Abnormal dreams


• anxiety


• back pain


• bad unusual or unpleasant (after) taste


• bleeding gums


• blistering, crusting, irritation, itching, or reddening of the skin


• bloating


• bloody nose


• burning feeling in the chest or stomach


• burning while urinating


• burning, dry, or itching eyes


• change in color of the treated skin


• change in sense of smell


• change in taste


• changes in vision


• constipation


• continuing ringing or buzzing or other unexplained noise in the ears


• cracked, dry, or scaly skin


• decreased sexual performance or desire


• depression


• difficulty with moving


• difficulty with swallowing


• discharge, excessive tearing


• double vision


• dry mouth


• dryness of the skin


• excess air or gas in the stomach or intestines


• excessive muscle tone


• eye pain


• feeling of constant movement of self or surroundings


• feeling of unreality


• feeling unusually cold


• flushed, dry skin


• fruit-like breath odor


• full feeling


• general feeling of discomfort or illness


• hair loss or thinning of the hair


• headache, severe and throbbing


• hearing loss


• hyperventilation


• increased appetite


• increased hunger


• increased sweating


• increased thirst


• increased urge to urinate during the night


• increased urination


• irritability


• irritation in the mouth


• lack of feeling or emotion


• loose stools


• loss of memory


• muscle pains or stiffness


• muscle tension or tightness


• muscle weakness


• nervousness


• pain


• pains in the stomach, side, or abdomen, possibly radiating to the back


• passing gas


• problems with memory


• redness and swelling of the gums


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• restlessness


• runny nose


• seeing double


• sensation of spinning


• sense of detachment from self or body


• shakiness and unsteady walk


• shivering


• sleeplessness


• sneezing


• stuffy nose


• sweating


• swollen joints


• tenderness in the stomach area


• thirst


• trouble in holding or releasing urine


• trouble sleeping


• twitching


• unable to sleep


• uncaring


• unexplained weight loss


• unsteadiness, trembling, or other problems with muscle control or coordination


• waking to urinate at night


• weight loss

Incidence not known

• Swelling of the breasts or breast soreness in both females and males

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

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

See also: Norvasc side effects (in more detail)

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

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

More Norvasc resources

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

• Norvasc Prescribing Information (FDA)


• Norvasc Consumer Overview


• Norvasc MedFacts Consumer Leaflet (Wolters Kluwer)


• Amlodipine Prescribing Information (FDA)


• Amlodipine Professional Patient Advice (Wolters Kluwer)


• Amlodipine Besylate Monograph (AHFS DI)

Compare Norvasc with other medications

• Angina
• Coronary Artery Disease
• Heart Failure
• High Blood Pressure
• Migraine Prevention
• Raynaud's Syndrome

Nutropin Subcutaneous, Injection

Generic Name: somatropin, e-coli derived (Subcutaneous route, Injection route)

soe-ma-TROE-pin, E-KOH-lye dee-rived

Commonly used brand name(s)

In the U.S.

• Accretropin


• Genotropin


• Genotropin Miniquick


• Humatrope


• Norditropin


• Norditropin Flexpro


• Nutropin


• Nutropin AQ NuSpin 10


• Nutropin AQ NuSpin 5


• Nutropin AQ Pen


• Omnitrope


• Tev-Tropin

In Canada

• Nutropin Aq


• Saizen

Available Dosage Forms:

• Solution


• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Somatropin

Uses For Nutropin

Somatropin is a man-made version of human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children. Man-made growth hormone may be used in adults or children who have certain conditions that prevent normal growth. These conditions include growth hormone deficiency (inability to produce enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), Noonan syndrome, Turner syndrome, short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age.

This medicine is available only with your doctor's prescription.

Before Using Nutropin

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of somatropin in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of somatropin in the elderly. However, elderly patients are more sensitive to the effects of somatropin, which may require a dose adjustment in patients receiving somatropin.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Brain tumor or


• Cancer, active or


• Closed epiphyses (normal bone growth stopped) in children or


• Diabetic retinopathy (eye condition) or


• Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing problems or


• Severe illness after surgery or major medical emergency (e.g., open heart surgery, abdominal surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions.

• Cancer, history of or


• Hypopituitarism (pituitary gland produces low hormone levels) or


• Hypothyroidism (underactive thyroid gland) or


• Otitis media (ear infection) in children, history of or


• Scoliosis (abnormally curved spine)—Use with caution. May make these conditions worse.

• Diabetes, or a family history of—Use with caution. May prevent insulin or other drugs for diabetes from working properly.

• Turner syndrome—Use with caution. May increase risk of having serious problems (e.g., pancreas, thyroid, or heart and blood vessel problems; ear or hearing disorders; diabetes; increased pressure in the head; and bone problems such as dislocation in the hip bone or scoliosis).

Proper Use of somatropin, e-coli derived

This section provides information on the proper use of a number of products that contain somatropin, e-coli derived. It may not be specific to Nutropin. Please read with care.

This medicine is given as a shot under your skin. Somatropin may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

There are many different forms (e.g., vial, cartridge, injection device) available for this medicine. Read all instructions carefully to be sure you know how to use your device.

Each time you get your medicine, check to be sure you have received the proper device. Talk to your pharmacist if you have questions about the device that you were given.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

Use a new needle, unopened vial, or syringe each time you inject your medicine.

You might not use all of the medicine in each vial (glass container) or prefilled syringe. Use each vial or syringe only one time. Do not save an open vial or syringe. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For all indications:
    
    • Adults—Dose is usually based on body weight (depending on the brand of somatropin you are using) and dose must be determined by your doctor. Your doctor will adjust your dose as needed.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. Your doctor will adjust your child's dose as needed.
    
    
  
  

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Store this medicine in the refrigerator, away from direct light. Do not freeze or shake.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Nutropin

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause a serious allergic reaction that requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, or throat; trouble with breathing; or chest pain after you receive the medicine.

This medicine may cause a dislocation in the hip bone, especially in patients with growth hormone deficiency or Turner syndrome. Check with your doctor right away if you or your child has a limp or pain in the hip or knee.

This medicine may affect blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests or if you have any questions.

This medicine may cause an increased pressure in the head. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause fluid retention (extra water in the body). Tell your doctor if you have burning, numbness, pain, or tingling in all fingers except the smallest finger; swelling of the hands and feet; or pain, swelling, or stiffness of the muscles. Your doctor may adjust your dose to reduce these side effects.

Pancreatitis has occurred rarely in some patients receiving somatropin. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Before you have any medical tests, tell the medical doctor in charge that you are using this certain brand of somatropin (Humatrope®). The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Nutropin Side Effects

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

Check with your doctor immediately if any of the following side effects occur:

More common

• Bleeding gums


• bloating or swelling of the face, arms, hands, ankles, lower legs, or feet


• burning, numbness, pain, or tingling in all fingers except smallest finger


• coughing up blood


• difficulty with breathing or swallowing


• difficulty with moving


• dizziness


• increased menstrual flow or vaginal bleeding


• muscle pain or stiffness


• nosebleeds


• not able to move


• pain, swelling, or redness in joints


• prolonged bleeding from cuts


• rapid weight gain


• red or black, tarry stools


• red or dark brown urine


• tingling of the hands or feet


• unusual weight gain or loss

Rare

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• blurred vision


• bone pain


• change in ability to see colors, especially blue or yellow


• change in personality


• changes in vision


• chills


• confusion


• constipation


• curved spine


• darkened urine


• dry mouth


• fast heartbeat


• fever


• flushed, dry skin


• fracture


• fruit-like breath odor


• headache


• increased hunger


• increased thirst


• increased urination


• indigestion


• limp pain in the hip or knee


• loss of appetite


• loss of consciousness


• nausea


• pains in the stomach, side, or abdomen, possibly radiating to the back


• problems with walking or talking


• seizures


• stomachache


• sweating


• troubled breathing


• tumor


• unusual tiredness or weakness


• vomiting


• weakness


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Backache


• excessive sweating


• extreme weakness


• increase in hands and feet size


• increased volume of pale, diluted urine


• pain in extremities


• stop in menstruation

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Large, flat, blue, or purplish patches in the skin


• unusually warm skin

Rare

• Increased growth of skin lesions


• swelling of the breasts or breast soreness in both females and males

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

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

See also: Nutropin Subcutaneous, Injection side effects (in more detail)

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

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

More Nutropin Subcutaneous, Injection resources

• Nutropin Subcutaneous, Injection Side Effects (in more detail)
• Nutropin Subcutaneous, Injection Use in Pregnancy & Breastfeeding
• Nutropin Subcutaneous, Injection Drug Interactions
• Nutropin Subcutaneous, Injection Support Group
• 1 Review for Nutropin Subcutaneous, Injection - Add your own review/rating

Compare Nutropin Subcutaneous, Injection with other medications

• Adult Human Growth Hormone Deficiency
• Growth Retardation, Chronic Renal Failure
• Hypopituitarism
• Idiopathic Short Stature
• Pediatric Growth Hormone Deficiency
• Short Stature for Age
• Turner's Syndrome

Silodosin

Pronunciation: sil-OH-doe-sin
Generic Name: Silodosin
Brand Name: Rapaflo

Silodosin is used for:

Treating the signs and symptoms of enlarged prostate (benign prostatic hyperplasia [BPH]).

Silodosin is an alpha-blocker. It works by relaxing muscles in the prostate and bladder, which helps to improve urine flow and reduce symptoms of BPH.

Do NOT use Silodosin if:

• you are allergic to any ingredient in Silodosin


• you have severe kidney or liver problems


• you are taking ketoconazole, clarithromycin, itraconazole, nefazodone, or ritonavir


• you are taking another alpha-blocker (eg, prazosin)

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

Before using Silodosin:

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

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


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


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


• if you have a history of blood pressure problems and you are taking blood pressure medication


• if you have a history of prostate cancer


• if you have kidney or liver problems


• if you will be having eye surgery (eg, cataract surgery)

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

• Alpha-blockers (eg, prazosin) or phosphodiesterase inhibitors (eg, sildenafil) because symptoms of low blood pressure (eg, severe dizziness, lightheadedness, and fainting) may occur


• Azole antifungals (eg, itraconazole, ketoconazole), clarithromycin, cyclosporine, diltiazem, erythromycin, fluconazole, nefazodone, probenecid, ritonavir, valproic acid, or verapamil because they may increase the risk of Silodosin's side effects

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

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

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


• Take Silodosin by mouth with a meal.


• If you miss a dose of Silodosin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than 2 dose of Silodosin, contact your doctor for instructions.

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

Important safety information:

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


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


• Do not drive or perform other possibly unsafe tasks for 12 hours after your first dose of Silodosin or after any dose increase.


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


• Silodosin may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.


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


• Silodosin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Silodosin can cause harm to the fetus. It is not known if Silodosin is found in breast milk. Silodosin is not approved for use in women.

Possible side effects of Silodosin:

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:

Decreased sexual ability; diarrhea; dizziness; headache; lightheadedness; runny or stuffy nose; sinus inflammation; stomach pain; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; fainting; irregular heartbeat; prolonged, painful erection; severe of persistent dizziness; unusual bruising; yellowing of the skin or eyes.

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: Silodosin 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 fainting; severe or persistent dizziness or lightheadedness.

Proper storage of Silodosin:

Store Silodosin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Silodosin out of the reach of children and away from pets.

General information:

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


• Silodosin 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 Silodosin. 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 Silodosin resources

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

• Silodosin Professional Patient Advice (Wolters Kluwer)


• Silodosin Monograph (AHFS DI)


• silodosin Advanced Consumer (Micromedex) - Includes Dosage Information


• Rapaflo Prescribing Information (FDA)


• Rapaflo Consumer Overview

Compare Silodosin with other medications

• Benign Prostatic Hyperplasia

Tylenol Infants Suspension Drops

Pronunciation: a-seet-a-MIN-oh-fen
Generic Name: Acetaminophen
Brand Name: Examples include Mapap Infants and Tylenol Infants

Tylenol Infants Suspension Drops are used for:

Treating minor aches and pains due to the common cold, flu, headaches, sore throat, immunizations, and toothaches, and for temporarily reducing fever.

Tylenol Infants Suspension Drops are an analgesic and antipyretic (lowers fever). It works by lowering a chemical in the brain that stimulates pain nerves and the heat-regulating center in the brain.

Do NOT use Tylenol Infants Suspension Drops if:

• you are allergic to any ingredient in Tylenol Infants Suspension Drops

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

Before using Tylenol Infants Suspension Drops:

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

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


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


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


• if you have a history of alcohol abuse or if you drink 3 or more alcohol-containing drinks every day


• if you have liver or kidney problems or hepatitis

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

• Isoniazid because the risk of liver problems may be increased


• Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Tylenol Infants Suspension Drops

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

Use Tylenol Infants Suspension Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tylenol Infants Suspension Drops by mouth with or without food.


• Shake well before each use.


• Find the right dose on chart that comes with Tylenol Infants Suspension Drops. If possible, use weight to dose; otherwise use age.


• Use the dropper that comes with Tylenol Infants Suspension Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Replace original bottle cap to maintain child resistance.


• If you miss a dose of Tylenol Infants Suspension Drops and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Infants Suspension Drops.

Important safety information:

• Tylenol Infants Suspension Drops has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Tylenol Infants Suspension Drops may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylenol Infants Suspension Drops. Talk to your doctor before you take Tylenol Infants Suspension Drops or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use for more than 2 days or give to children younger than 3 years old unless directed by a doctor.


• Tylenol Infants Suspension Drops may cause the results of some in-home test kits for blood cholesterol to be wrong. Check with your doctor or pharmacist if you are taking Tylenol Infants Suspension Drops and need to check your blood cholesterol at home.


• For pain and fever in ADULTS: Stop use of Tylenol Infants Suspension Drops and ask your doctor if pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, or new symptoms occur or redness or swelling is present.


• For pain and fever in CHILDREN: Stop use and ask a doctor if fever gets worse or lasts more than 3 days, pain gets worse or lasts more than 5 days, or redness or swelling is present or any new symptoms appear.


• Different brands of Tylenol Infants Suspension Drops may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylenol Infants Suspension Drops while you are pregnant. Tylenol Infants Suspension Drops are found in breast milk. If you are or will be breast-feeding while you use Tylenol Infants Suspension Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tylenol Infants Suspension Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); dark urine or pale stools; unusual fatigue; yellowing of the skin or eyes.

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: Tylenol Infants 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 dark urine; excessive sweating; extreme fatigue; nausea and vomiting; stomach pain.

Proper storage of Tylenol Infants Suspension Drops:

Store Tylenol Infants Suspension Drops 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. Keep Tylenol Infants Suspension Drops out of the reach of children and away from pets.

General information:

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


• Tylenol Infants Suspension Drops are 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 Tylenol Infants Suspension Drops. 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 Tylenol Infants resources

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

Compare Tylenol Infants with other medications

• Fever
• Pain

Tucks HC cream, ointment, suppository

Generic Name: hydrocortisone rectal (cream, ointment, suppository) (hye dro KORT i zone REK tal)

Brand Names: Anucort-HC, Anumed-HC, Anusol-HC, Cortizone-10 Anal Itch Cream, Hemorrhoidal HC, Hemril-30, Hemril-HC Uniserts, Preparation H Hydrocortisone, Procto-Kit 1%, Procto-Kit 2.5%, Procto-Pak 1%, Proctocort, Proctocream-HC, Proctosert HC, Proctosol-HC, Proctozone HC, Proctozone-H, Recort Plus, Rectasol-HC, Tucks HC

What is hydrocortisone rectal?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Hydrocortisone rectal is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrocortisone rectal?

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. 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.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

What should I discuss with my health care provider before using hydrocortisone rectal?

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

• 
  

  congestive heart failure;

  
  


• 
  

  a history of tuberculosis;

  
  


• 
  

  stomach ulcer or diverticulitis;

  
  


• 
  

  a colostomy or ileostomy;

  
  


• 
  

  fever or any type of infection;

  
  


• 
  

  kidney disease;

  
  


• 
  

  high blood pressure; or

  
  


• 
  

  myasthenia gravis.

  
  

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether hydrocortisone rectal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hydrocortisone 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 hydrocortisone rectal?

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

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using hydrocortisone rectal.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. The rectal suppository can stain clothing or other fabrics it comes into contact with.

For best results from the suppository, lie down after inserting it and hold in the suppository. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

For best results from the cream, use only the applicator provided with the medication. Otherwise, follow the directions provided with your rectal cream.

Avoid using the bathroom for one to three hours after inserting the cream or suppository.

Apply the ointment to the rectum and surrounding skin of the rectal area as directed on the package label.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Store the rectal cream at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them.

What happens if I miss a dose?

Use 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.

An overdose of hydrocortisone rectal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone rectal ?

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Hydrocortisone rectal 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling of your ankles or feet;

  
  


• 
  

  muscle weakness;

  
  


• 
  

  rapid weight gain, especially in your face and midsection;

  
  


• 
  

  severe rectal pain or burning;

  
  


• 
  

  bleeding from your rectum;

  
  


• 
  

  severe stomach pain;

  
  


• 
  

  sudden and severe headache or pain behind your eyes; or

  
  


• 
  

  seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  mild rectal pain or burning;

  
  


• 
  

  acne;

  
  


• 
  

  changes in your menstrual periods;

  
  


• 
  

  increased sweating; or

  
  


• 
  

  increased facial or body hair growth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect hydrocortisone rectal ?

Before using hydrocortisone rectal, tell your doctor if you also use insulin or take oral diabetes medication.

There may be other drugs that can interact with hydrocortisone rectal. 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 Tucks HC resources

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

Compare Tucks HC with other medications

• Anal Itching

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone rectal cream, ointment, or suppository.

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