Vitamin A Acid Topical

Generic Name: tretinoin (Topical route)

TRET-i-noin

Commonly used brand name(s)

In the U.S.

• Atralin


• Avita


• Refissa


• Renova


• Retin-A


• Retin-A Micro


• Tretin-X

In Canada

• Rejuva-A


• Stieva-A Cream


• Stieva-A Cream Forte


• Stieva-A Gel


• Stieva-A Solution


• Vitamin A Acid

Available Dosage Forms:

• Gel/Jelly


• Solution


• Liquid


• Cream

Therapeutic Class: Dermatological Agent

Chemical Class: Retinoid

Uses For Vitamin A Acid

Tretinoin is used to treat acne. It works partly by keeping skin pores clear.

One of the tretinoin creams is used to treat fine wrinkles, dark spots, or rough skin on the face caused by damaging rays of the sun. It works by lightening the skin, replacing older skin with newer skin, and by slowing down the way the body removes skin cells that may have been harmed by the sun. Tretinoin works best when used within a skin care program that includes protecting the treated skin from the sun. However, it does not completely or permanently erase these skin problems or greatly improve more obvious changes in the skin, such as deep wrinkles caused by sun or the natural aging process.

Tretinoin may also be used to treat other skin diseases as determined by your doctor.

Tretinoin is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, tretinoin is used in certain patients with the following medical conditions:

• Keratosis follicularis (skin disorder of small, red bumps)


• Verruca plana (flat warts)

Before Using Vitamin A Acid

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups. Children are unlikely to have skin problems due to the sun. In older children treated for acne, tretinoin is not expected to cause different side effects or problems than it does in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of tretinoin in patients 50 years of age and older with use in other age groups.

Pregnancy

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

Breast Feeding

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.

• Aminocaproic Acid


• Aprotinin


• Tetracycline


• Tranexamic Acid

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.

• Fluconazole


• Ketoconazole


• Voriconazole

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:

• Dermatitis, seborrheic or


• Eczema or


• Sunburn—Use of this medicine may cause or increase the irritation associated with these problems

Proper Use of tretinoin

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

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin.

Do not apply this medicine to windburned or sunburned skin or on open wounds.

Do not use this medicine in or around the eyes or lips, or inside of the nose. Spread the medicine away from these areas when applying. If the medicine accidentally gets on these areas, wash with water at once.

This medicine usually comes with patient directions. Read them carefully before using the medicine.

Before applying tretinoin, wash the skin with a mild soap or cleanser and warm water by using the tips of your fingers. Then gently pat dry. Do not scrub your face with a sponge or washcloth. Wait 20 to 30 minutes before applying this medicine to make sure the skin is completely dry. Applying tretinoin to wet skin can irritate the skin.

To use the cream or gel form of this medicine:

• Apply just enough medicine to very lightly cover the affected areas, and rub in gently but well. A pea-sized amount is enough to cover the whole face.

To use the solution form of this medicine:

• Using your fingertips, a gauze pad, or a cotton swab, apply enough tretinoin solution to cover the affected areas. If you use a gauze pad or a cotton swab for applying the medicine, avoid getting it too wet. This will help prevent the medicine from running into areas not intended for treatment.

After applying the medicine, wash your hands to remove any medicine that might remain on them.

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 topical dosage forms (cream, gel, or solution):
  
  • For acne:
    
    • Adults and teenagers—Apply to the affected area(s) of the skin once a day, at bedtime.
    
    
  
  


• For cream dosage form (brand name Renova only):
  
  • For fine wrinkles, dark spots, or rough skin caused by the sun:
    
    • Adults up to 50 years of age—Apply to the affected area(s) of the skin once a day, at bedtime.
    
    
    • Adults 50 years of age and older—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

The gel product is flammable and should be kept away from fire or excessive heat.

Precautions While Using Vitamin A Acid

During the first 3 weeks you are using tretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. It may take longer than 12 weeks before you notice full improvement of your acne, even if you use the medicine every day. Check with your health care professional at any time skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.

You should avoid washing the skin treated with tretinoin for at least 1 hour after applying it.

Avoid using any topical medicine on the same area within 1 hour before or after using tretinoin. Otherwise, tretinoin may not work properly or skin irritation might occur.

Unless your doctor tells you otherwise, it is especially important to avoid using the following skin products on the same area as tretinoin:

• Any other topical acne product or skin product containing a peeling agent (such as benzoyl peroxide, resorcinol, salicylic acid, or sulfur)


• Hair products that are irritating, such as permanents or hair removal products


• Skin products that cause sensitivity to the sun, such as those containing spices or limes


• Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions


• Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers

Using these products along with tretinoin may cause mild to severe irritation of the skin. Although skin irritation can occur, some doctors sometimes allow benzoyl peroxide to be used with tretinoin to treat acne. Usually tretinoin is applied at night so that it does not cause a problem with any other topical products that you might use during the day. Check with your doctor before using topical medicines with tretinoin.

During the first 6 months of use, avoid overexposing the treated areas to sunlight, wind, or cold weather. The skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks. However, you should not stop using this medicine unless the skin irritation becomes too severe. Do not use a sunlamp .

To help tretinoin work properly, regularly use sunscreen or sunblocking lotions with a sun protection factor (SPF) of at least 15. Also, wear protective clothing and hats, and apply creams, lotions, or moisturizers often.

Check with your doctor at any time your skin becomes too dry and irritated. Your health care professional can help you choose the right skin products for you to reduce skin dryness and irritation and may include the following:

• For patients using tretinoin for the treatment of acne:
  
  • Regular use of water-based creams or lotions helps to reduce skin irritation or dryness that may be caused by the use of tretinoin.
  
  


• For patients using tretinoin for the treatment of fine wrinkling, dark spots, and rough skin caused by the sun:
  
  • This medicine should be used as part of an ongoing program to avoid further damage to your skin from the sun. This program includes staying out of the sun when possible or wearing proper clothing or hats to protect your skin from sunlight.
  
  
  • Regular use of oil-based creams or lotions helps to reduce skin irritation or dryness caused by the use of tretinoin.
  
  

Vitamin A Acid Side Effects

In some animal studies, tretinoin has been shown to cause skin tumors to develop faster when the treated area is exposed to ultraviolet light (sunlight or artificial sunlight from a sunlamp). Other studies have not shown the same result and more studies need to be done. It is not known if tretinoin causes skin tumors to develop faster in humans.

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

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Burning feeling or stinging skin (severe)


• lightening of skin of treated area, unexpected


• peeling of skin (severe)


• redness of skin (severe)


• unusual dryness of skin (severe)

Rare

• Darkening of treated 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:

More common

• Burning feeling, stinging, or tingling of skin (mild)—lasting for a short time after first applying the medicine


• chapping or slight peeling of skin (mild)


• redness of skin (mild)


• unusual dryness of skin (mild)


• unusually warm skin (mild)

The side effects will go away after you stop using tretinoin. On the rare chance that your skin color changes, this effect may last for several months before your skin color returns to normal.

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

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

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

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

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• Vitamin A Acid Topical Use in Pregnancy & Breastfeeding
• Vitamin A Acid Topical Drug Interactions
• Vitamin A Acid Topical Support Group
• 42 Reviews for Vitamin A Acid Topical - Add your own review/rating

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• Photoaging of the Skin

Creon Micro

1. Name Of The Medicinal Product

Creon^® Micro Pancreatin 60.12 mg Gastro-resistant Granules

2. Qualitative And Quantitative Composition

Each 100 mg of gastro-resistant granules (equivalent to one measuring spoonful) contains 60.12mg of pancreatin, containing the following pancreatic enzymes:

Lipase	5,000 PhEur units
Amylase	3,600 PhEur units
Protease	200 PhEur units

For excipients, see 6.1.

3. Pharmaceutical Form

Gastro-resistant granules.

Round, light brown gastro-resistant granules.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of pancreatic exocrine insufficiency.

4.2 Posology And Method Of Administration

Initially 100 mg (5000 lipase units) of gastro-resistant granules (one measure) should be taken with each feed or meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. The maximum daily dosage should not exceed 10,000 units lipase/kg/day. The required quantity of gastro-resistant granules should be dispensed using the measuring scoop contained in the pack which holds 100 mg.

In young infants, Creon Micro granules should be mixed with a small amount of apple juice and given from a spoon directly before the feed. In weaned infants, granules should be taken with acidic liquids or soft foods (e.g. mixed with apple juice or apple puree), but without chewing, directly before the meal. When giving Creon Micro to young or weaned infants the apple juice should not be diluted.

It is important to ensure adequate hydration of patients at all times whilst dosing with Creon.

Fibrosing colonopathy has been reported in patients with cystic fibrosis taking in excess of 10000 units of lipase/kg/day (see section 4.4).

4.3 Contraindications

Hypersensitivity to pancreatin of porcine origin or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. Case control studies did not reveal evidence for an association between Creon and the appearance of fibrosing colonopathy. As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10 000 units of lipase/kg/day.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

4.6 Pregnancy And Lactation

Pregnancy

For pancreatic enzymes no clinical data on exposed pregnancies are available.

Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected.

Caution should be exercised when prescribing to pregnant women.

Lactation

No effects on the suckling child are anticipated since animal studies suggest no systemic exposure of the breastfeeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breastfeeding.

If required during pregnancy or lactation Creon should be used in doses sufficient to provide adequate nutritional status

4.7 Effects On Ability To Drive And Use Machines

Creon has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

In clinical trials, more than 600 patients with pancreatic exocrine insufficiency, due to cystic fibrosis, chronic pancreatitis, and pancreatic surgery were exposed to Creon. The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity.

The following adverse reactions have been observed during placebo-controlled clinical trials with the below indicated frequencies

Gastrointestinal disorders

Common ( nausea, vomiting, constipation, diarrhoea and abdominal distension

Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for abdominal pain (very common,

Skin and subcutaneous tissue disorders

Uncommon( rash

Pruritus and urticaria have been additionally identified as adverse reactions during post-approval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.

Multiple clinical trials were conducted in other patient populations: HIV, acute pancreatitis, diabetes mellitus. No additional adverse drug reactions were identified compared to the above three patient groups.

Paediatric population

No specific adverse reactions were identified in the paediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.

4.9 Overdose

Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia.

Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are recommended.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The ATC code is A09A A (Enzyme preparations).

Replacement therapy in pancreatic enzyme deficiency states. The enzymes have hydrolytic activity on fat, carbohydrates and proteins.

5.2 Pharmacokinetic Properties

Pharmacokinetic data are not available as the enzymes act locally in the gastro-intestinal tract. After exerting their action, the enzymes are digested themselves in the intestine.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hypromellose phthalate

Macrogol 4000

Dimeticone

Cetyl alcohol

Triethyl citrate

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years. 12 weeks after first opening.

6.4 Special Precautions For Storage

Do not store above 30°C.

Keep the container tightly closed in order to protect from moisture.

6.5 Nature And Contents Of Container

Glass bottle with LDPE stopper. Containers hold 20 g of gastro-resistant granules.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

8. Marketing Authorisation Number(S)

PL 00512/0179

9. Date Of First Authorisation/Renewal Of The Authorisation

August 2004

10. Date Of Revision Of The Text

30/06/2011

LEGAL CATEGORY

P

Garamycin Eye Drops

gentamicin sulfate

Dosage Form: ophthalmic solution

DESCRIPTION:

Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group.

Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered with dibasic sodium phosphate and monobasic sodium phosphate to approximately pH 7 (pH range 6.5 - 7.5) for ophthalmic use.  Each mL contains gentamicin sulfate, USP (equivalent to 3 mg gentamicin base), sodium chloride and benzalkonium chloride (0.1 mg) as a preservative.

Gentamicin is obtained from cultures of Micromonospora purpurea.  It is a mixture of the sulfate salts of gentamicin C1, C2 and C1A.  All three components appear to have similar antimicrobial activities.  Gentamicin sulfate occurs as a white powder and is soluble in water and insoluble in alcohol.  The structure is as follows:

CLINICAL PHARMACOLOGY:

Microbiology:  Gentamicin sulfate is active in vitro against many strains of the following microorganisms:

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

INDICATIONS AND USAGE:

Garamycin® Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms:

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

CONTRAINDICATIONS:

Garamycin® Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

WARNINGS:

NOT FOR INJECTION INTO THE EYE.  Gentamicin Sulfate Ophthalmic Solution is not for injection.  It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

Precautions

General:

Prolonged use of topical antibiotics may give rise to overgrowth of non-susceptible organisms including fungi.  Bacterial resistance to gentamicin may also develop.  If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation, and appropriate therapy should be instituted.

Information For Patients:

To avoid contamination, do not touch tip of container to the eye, eyelid, or any surface.

Carcinogenesis, Mutagenesis and Impairment of Fertility:

There are no published carcinogenicity or impairment of fertility studies on gentamicin.  Aminoglycoside antibiotics have been found to be non-mutagenic.

Pregnancy:

Pregnancy Category C:  Gentamicin has been shown to depress body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose.  There are no adequate and well-controlled studies in pregnant women.  Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use:

Safety and effectiveness in neonates have not been established.

ADVERSE REACTIONS:

Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.

The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.

Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura, and hallucinations.

To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604, Monday-Friday 9am-5pm EST, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION:

Instill one or two drops into the affected eye(s) every four hours.  In severe infections, dosage may be increased to as much as two drops once per hour.

HOW SUPPLIED:

Garamycin® Ophthalmic Solution, 0.3% is a sterile solution supplied in a plactic dropper bottle, box of one.

NDC 48102-022-05                  5mL Bottle

Store at 20o-25oC (68o-77oF) [See USP Controlled room temperature].

GARAMYCIN® is a Registered Trademark of Fera Pharmaceuticals, LLC.

FERA

Mfd. for:

Fera Pharmaceuticals, LLC

Locust Valley, NY  11560

PF022A

R0411

PRINCIPAL DISPLAY PANEL - CARTON

FERA


NDC 48102-022-05

STERILE      Rx only

Garamycin®

gentamicin sulfate

Ophthalmic

Solution, USP, 0.3%

(equivalent to 3 mg

gentamicin base per mL)



FOR OPHTHALMIC USE ONLY


5mL


CF02202A

R0311

PRINCIPAL DISPLAY PANEL - BOTTLE

FERA


NDC 48102-022-05


Garamycin®


gentamicin sulfate


Opthalmic Solution USP, 0.3%


(equivalent to 3 mg gentamicin base per mL)


FOR OPHTHALMIC USE ONLY


Sterile   5mL   Rx only

GARAMYCIN  gentamicin sulfate  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48102-022 Route of Administration OPHTHALMIC DEA Schedule

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

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   SODIUM CHLORIDE   SODIUM PHOSPHATE, DIBASIC   SODIUM PHOSPHATE, MONOBASIC

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 48102-022-05 1 BOTTLE In 1 BOX contains a BOTTLE, DROPPER 1 5 mL In 1 BOTTLE, DROPPER This package is contained within the BOX (48102-022-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065121	05/15/2011

Labeler - Fera Pharmaceuticals, LLC (831023713)

Registrant - Fera Pharmaceuticals, LLC (831023713)

Revised: 04/2011Fera Pharmaceuticals, LLC

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• Garamycin Eye Drops Use in Pregnancy & Breastfeeding
• Garamycin Eye Drops Support Group
• 0 Reviews for Garamycin Eye - Add your own review/rating

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• Conjunctivitis, Bacterial

Sunmark Nicotine Lozenge

Dosage Form: lozenge
McKesson Nicotine Polacrilex Lozenge 4 mg (nicotine) Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 4 mg (nicotine)

Purpose

Stop smoking aid

Uses

• reduces withdrawal symptoms, including nicotine craving associated with quitting smoking

Warnings

If you are pregnant or breast-feeding,

only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Do not use

• if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

Ask a doctor before use if you have

• a sodium-restricted diet


• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.


• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.


• stomach ulcer or diabetes

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug


• taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

• mouth problems occur


• persistent indigestion or severe sore throat occurs


• irregular heartbeat or palpitations occur


• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• if you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed User’s Guide for complete directions and other important information


• stop smoking completely when you begin using the lozenge


• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge


• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

• nicotine lozenge is a medicine and must be used a certain way to get the best results


• place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge.


• you may feel a warm or tingling sensation


• occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes)


• do not eat or drink 15 minutes before using or while the lozenge is in your mouth


• to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks


• do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects


• do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.


• stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

Other information

• each lozenge contains: sodium 15 mg


• Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge


• sugar alcohol content: 1 g mannitol per lozenge


• store at 20-25°C (68-77°F)


• keep vial closed and protect from light

Inactive ingredients

aspartame, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-866-751-9303

Principal Display Panel

Compare to Commit® active ingredient

Nicotine Polacrilex Lozenge 4 mg (nicotine)

Stop Smoking Aid

4 mg

Includes User’s Guide

For those who smoke their first cigarette within 30 minutes of waking up.

If you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Lozenge, 2 mg

Mint Flavor

Actual Size

4 mg each

(# QuitTube™ containers of #)

Nicotine Polacrilex Lozenge 4 mg (nicotine) Carton

SUNMARK NICOTINE  nicotine polacrilex  lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 49348-853 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 4 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape ROUND Size 16mm Flavor MINT Imprint Code L873 Contains

Packaging # NDC Package Description Multilevel Packaging 1 49348-853-16 3 VIAL In 1 CARTON contains a VIAL 1 24 LOZENGE In 1 VIAL This package is contained within the CARTON (49348-853-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077007	04/30/2008

Labeler - McKesson (177667227)

Revised: 06/2009McKesson

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Isonitoll

Isonitoll may be available in the countries listed below.

Ingredient matches for Isonitoll

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Isonitoll in the following countries:

• Japan

International Drug Name Search

Sumycin

tetracycline

Dosage Form: Syrup

Sumycin Description

Sumycin for oral administration contains tetracycline, an antibiotic isolated from Streptomyces aureofaciens. Tetracycline is described chemically as 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a-octahydro-3, 6, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-2-napthacenecarboxamide; its structural formula is:

C22H24N2O8 MW=444.44

Sumycin Syrup (Tetracycline Oral Suspension, USP) is a suspension containing, in each 5 mL teaspoonful, tetracycline equivalent to 125 mg tetracycline hydrochloride. Inactive ingredients: citric acid, colorant (D&C Yellow No. 10), flavor, potassium citrate, potassium metaphosphate, purified water, saccharin sodium, sodium benzoate, sodium citrate, sodium metabisulfite, sorbitol solution, sucrose, and tragacanth.

Sumycin - Clinical Pharmacology

Tetracyclines are adequately but incompletely absorbed from the gastrointestinal tract. Approximately 65 percent of a short-acting tetracycline is bound to plasma proteins; the plasma protein binding for intermediate- and long-acting analogues is usually greater.

Penetration of the tetracyclines into most body fluids and tissues is excellent. Tetracyclines are distributed in varying degrees into bile, liver, lung, kidney, prostate, urine, cerebrospinal fluid, synovial fluid, mucosa of the maxillary sinus, brain, sputum, and bone. Tetracyclines cross the placenta and enter the fetal circulation and amniotic fluid.

Following a single oral dose, peak plasma concentrations are achieved in two to four hours.

Tetracyclines are concentrated by the liver in the bile. They are excreted in both the urine and feces at high concentrations in a biologically active form. Since renal clearance of tetracyclines is by glomerular filtration, excretion is significantly affected by the state of renal function. (See WARNINGS.)

Microbiology

The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracyclines is common. In addition, gram-negative bacilli made tetracycline-resistant, may also show cross-resistance to chloramphenicol.

GRAM-NEGATIVE BACTERIA

Bartonella bacilliformis

Brucella species

Calymmatobacterium granulomatis

Campylobacter fetus

Francisella tularensis

Haemophilus ducreyi

Haemophilus influenzae

Listeria monocytogenes

Neisseria gonorrhoeae

Vibrio cholerae

Yersinia pestis

Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are especially recommended:

Acinetobacter species

Bacteroides species

Enterobacter aerogenes

Escherichia coli

Klebsiella species

Shigella species

GRAM-POSITIVE BACTERIA

Enterococcus group [Enterococcus faecalis (formerly Streptococcus faecalis) and Enterococcus

faecium (formerly Streptococcus faecium)]

Streptococci viridans group

Streptococcus pneumoniae

Streptococcus pyogenes

Because many strains of these gram-positive microorganisms have been shown to be resistant to tetracycline, culture and susceptibility testing are recommended. Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Enterococcus faecalis (formerly Streptococcus faecalis) have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for treatment of streptococcal disease unless the organism is known to be susceptible.

OTHER MICROORGANISMS

Actinomyces species

Bacillus anthracis

Balantidium coli

Borrelia recurrentis

Chlamydia psittaci

Chlamydia trachomatis

Clostridium species

Entamoeba species

Fusobacterium fusiforme

Mycoplasma pneumoniae

Rickettsiae

Propionibacterium acnes

Treponema pallidum

Treponema pertenue

Ureaplasma urealyticum

Susceptibility Tests

DIFFUSION TECHNIQUES:

Quantitative methods that require measurement of zone diameters give the most precise estimate of the susceptibility of bacteria to antimicrobial agents. One such standard procedure1 that has been recommended for use with disks to test susceptibility of microorganisms to tetracycline uses the 30-mcg tetracycline disk. Interpretation involves the correlation of the zone diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for tetracycline.

Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30-mcg tetracycline disk should be interpreted according to the following criteria:

Zone diameter (mm)	Interpretation
≥ 19	Susceptible
15 – 18	Intermediate
≤ 14	Resistant

A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievableblood levels. A report of “Intermediate” suggests that the organism would be susceptible if high dosage isused or if the infection is confined to tissues or fluids in which high antibiotic (or antimicrobial) levels are attained. A report of “Resistant” indicates that achievable concentrations are unlikely to be inhibitory and other therapy should be selected.

Standardized procedures require the use of laboratory control organisms. The 30-mcg tetracycline disk should give the following zone diameters:

Organism	-	Zone Diameter (mm)
E. coli	ATCC25922	18 – 25
S. aureus	ATCC25923	19 - 18

DILUTION TECHNIQUES:

Use a standardized dilution method2 (broth, agar, microdilution) or equivalent with tetracycline powder. The MIC values obtained should be interpreted according to the following criteria:

MIC (mcg/mL)	Interpretation
≤ 4.0	Susceptible
> 4.0 < 16	Intermediate
≥ 16	Resistant

As with standard diffusion techniques, dilution methods require the use of laboratory control organisms. Standard tetracycline powder should provide the following MIC values:

Organism	-	Zone Diameter (mm)
E. coli	ATCC25922	1 – 4
S. aureus	ATCC29213	0.25 – 1
E. faecalis	ATCC29212	8 – 32
P. aeruginosa	ATCC27853	8 - 32

Indications and Usage for Sumycin

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sumycin Syrup (Tetracycline Oral Suspension, USP) and other antibacterial drugs, Sumycin Syrup (Tetracycline Oral Suspension, USP) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Tetracycline hydrochloride is indicated for the treatment of the following infections:

Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox and tick fevers caused by Rickettsiae

Respiratory tract infections caused by Mycoplasma pneumoniae

Lymphogranuloma venereum caused by Chlamydia trachomatis

Psittacosis and ornithosis due to Chlamydia psittaci

Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence

Inclusion conjunctivitis caused by Chlamydia trachomatis

Tetracycline hydrochloride is indicated for the treatment of uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis

Nongonococcal urethritis caused by Ureaplasma urealyticum

Relapsing fever due to Borrelia recurrentis

Tetracycline hydrochloride is also indicated for the treatment of infections caused by the following gramnegative microorganisms:

Chancroid caused by Haemophilus ducreyi

Plague due to Yersinia pestis (formerly Pasteurella pestis)

Tularemia due to Francisella tularensis (formerly Pasteurella tularensis)

Cholera caused by Vibrio cholerae (formerly Vibrio comma)

Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus)

Brucellosis due to Brucella species (in conjunction with streptomycin)

Bartonellosis due to Bartonella bacilliformis

Granuloma inguinale caused by Calymmatobacterium granulomatis

Because many strains of the following groups of microorganisms have been shown to be resistant to tetracycline hydrochloride, culture and susceptibility testing are recommended.

Tetracycline hydrochloride is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

Escherichia coli

Enterobacter aerogenes (formerly Aerobacter aerogenes)

Shigella species

Acinetobacter species (formally Mima species and Herellea species)

Respiratory tract infections caused by Haemophilus influenzae

Respiratory tract and urinary tract infections caused by Klebsiella species

Tetracycline hydrochloride is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicated appropriate susceptibility to the drug:

For upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae).

Skin and skin structure infections caused by Staphylococcus aureus.

Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.

When penicillin is contraindicated, tetracycline hydrochloride is an alternative drug in the treatment of the following infections:

Uncomplicated gonorrhea caused by Neisseria gonorrhoeae

Syphilis caused by Treponema pallidum

Yaws caused by Treponema pertenue

Listeriosis due to Listeria monocytogenes

Anthrax due to Bacillus anthracis

Vincent’s infection caused by Fusobacterium fusiforme

Actinomycosis caused by Actinomyces israelii

Infections caused by Clostridia species

In acute intestinal amebiasis, the tetracycline hydrochlorides may be a useful adjunctive therapy to amebicides.

In severe acne the tetracycline hydrochlorides may be useful adjunctive therapy.

Contraindications

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Warnings

TETRACYCLINE-CLASS ANTIBIOTICS CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY, OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS.

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).

This adverse reaction is more common during long term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

All tetracyclines form a stable calcium complex in any bone forming tissues. A decrease in fibula growth rate has been observed in young animals (rats and rabbits) given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.

Sumycin Syrup (Tetracycline Oral Suspension, USP) contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

The antianabolic action of tetracycline may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral dose may lead to excessive systemic accumulation of the drug and possible liver toxicity. Under such conditions, lower than usual doses are indicated and, if therapy is prolonged, serum level determinations of the drug may be advisable.

Photosensitivity, manifested by an exaggerated sunburn reaction, has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultra-violet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. NOTE: Photosensitization reactions have occurred most frequently with demeclocycline, less with chlortetracycline, and very rarely with oxytetracycline and tetracycline.

GENERAL PRECAUTIONS

Prescribing Sumycin Syrup (Tetracycline Oral Suspension, USP) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted. NOTE: Superinfection of the bowel by staphylococci may be life-threatening. Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve after discontinuation of the tetracycline, the possibility for permanent sequelae exists.

Since sensitivity reactions are more likely to occur in persons with a history of allergy, asthma, hay fever, or urticaria, the preparation should be used with caution in such individuals.

Cross-sensitization among the various tetracyclines is extremely common.

Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy, when indicated.

Under no circumstances should outdated tetracyclines be administered, as the degradation of tetracyclines are highly nephrotoxic and have, on occasion, produced a Fanconi-like syndrome.

Information for Patients

Patients should be counseled that antibacterial drugs including Sumycin Syrup (Tetracycline Oral Suspension, USP) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Sumycin Syrup (Tetracycline Oral Suspension, USP) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Sumycin Syrup (Tetracycline Oral Suspension, USP) or other antibacterial drugs in the future.

Laboratory Tests

During long-term therapy, periodic laboratory evaluation of organ system function, including renal, hepatic, and hematopoietic systems, should be performed.

All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with tetracycline should have a follow-up serologic test for syphilis after 3 months.

Drug Interactions

PENICILLIN - Since bacteriostatic drugs like tetracycline may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin.

ANTICOAGULANTS - Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

ANTACIDS AND IRON CONTAINING PRODUCTS - Absorption of tetracycline is impaired by antacids containing aluminum, calcium, or magnesium, and iron containing preparations.

ORAL CONTRACEPTIVES - Concurrent use of tetracycline may render oral contraceptives less effective.

METHOXYFLURANE - The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Carcinogenesis and Mutagenesis and Impairment of Fertility

Long-term studies conducted in rats and mice to determine whether tetracycline hydrochloride has carcinogenic potential were negative. Some related antibiotics (oxytetracycline, minocycline) have shown evidence of oncogenic activity in rats.

In two in vitro mammalian cell assay systems (L51784y mouse lymphoma and Chinese hamsterlung cells), there was evidence of mutagenicity at tetracycline hydrochloride concentrations of 60 and 10 μg/mL, respectively.

Tetracycline hydrochloride had no effect on fertility when administered in the diet to male and female rats at a daily intake of 25 times the human dose.

Pregnancy: Teratogenic effects: Pregnancy Category D (see WARNINGS.)

Pregnancy: Nonteratogenic effects: (see WARNINGS.)

Labor and Delivery

The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers

Tetracyclines are present in the milk of lactating women who are taking a drug in this class. Because of the potential for serious adverse reactions in nursing infants from tetracyclines, 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 (see WARNINGS.)

Pediatric Use

See WARNINGS and DOSAGE AND ADMINISTRATION.

Adverse Reactions

Gastrointestinal

Anorexia, epigastric distress, nausea, vomiting, diarrhea, bulky loose stools, stomatitis, sore throat, glossitis, black hairy tongue, dysphagia, hoarseness, enterocolitis, and inflammatory lesions (with candidal overgrowth) in the anogenital region, including proctitis and pruritus ani. Rare instances of esophagitis and esophageal ulceration have been reported in patients receiving particularly the capsule and also the tablet forms of tetracyclines. Most of the patients were reported to have medication immediately before going to bed (see DOSAGE AND ADMINISTRATION). These reactions have been caused by both the oral and parenteral administration of tetracyclines but are less frequent after parenteral use.

Skin and Skin Structures: maculopapular and erythematous rashes.

Exfoliative dermatitis has been reported but is uncommon. Onycholysis and discoloration of the nails have been reported rarely. Photosensitivity has occurred. (See WARNINGS.)

Renal Toxicity

Increases in BUN have been reported and are apparently dose-related. (See WARNINGS.)

Hepatic Cholestatis

Hepatic cholestatis has been reported rarely, and is usually associated with high dosage levels of tetracycline.

Hypersensitivity Reactions

Anaphylaxis; serum sickness-like reactions, as fever, rash, and arthralgia; urticaria, angioneurotic edema, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus.

Hematological

Blood: anemia, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia have been reported.

Miscellaneous

Dizziness and headache have been reported.

When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function are known to occur. Bulging fontanels in infants and intracranial hypertension in adults have been reported. (See PRECAUTIONS—General.)

Overdosage

In case of overdosage, treat symptomatically and institute supportive measures.

Sumycin Dosage and Administration

Adults: usual daily dose is 1 to 2 g: for mild to moderate infections: 500 mg bid or 250 mg qid; higher dosages such as 500 mg qid may be required for severe infections.

For children above eight years of age: usual daily dose is 10 to 20 mg/lb (25 to 50 mg/kg) body weight divided in four equal doses.

Representative pediatric dosages for the syrup on a qid basis are as follows:

20 lbs	2.5 mL	(1/2 teaspoonful)
40 lbs	5 mL	(1 teaspoon)
60 lbs	7.5 mL	(1–1/2 teaspoonfuls)
80 lbs	10 Ml	(2 teaspoonfuls)

Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided.

The treatment of brucellosis, 500 mg tetracycline four times daily for three weeks should be accompanied by streptomycin, 1 g intramuscularly twice daily the first week and once daily the second week.

For treatment of uncomplicated gonorrhea, 500 mg every six hours for seven days.

For treatment of syphilis, a total of 30 to 40 g in equally divided doses over a period of 10 to 15 days should be given. Close follow up, including laboratory tests, is recommended.

Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 500 mg by mouth, four times a day for at least seven days.

In cases of severe acne which in the judgment of the clinician, requires long-term treatment, the recommended initial dosage is 1 g daily in divided doses. When improvement is noted, usually within one week, dosage should be gradually reduced to maintenance levels ranging from 125 to 500 mg daily. In some patients it may be possible to maintain adequate remission of lesions with alternate-day or intermittent therapy. Tetracycline therapy of acne should augment the other standard measures known to be of value.

In patients with renal impairment (see WARNINGS) total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

In the treatment of streptococcal infections, a therapeutic dose of tetracycline should be administered for at least 10 days.

Concomitant therapy: Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron containing preparations.

Food and some dairy products also interfere with absorption.

How is Sumycin Supplied

Sumycin Syrup (Tetracycline Oral Suspension, USP) is available as a fruit-flavored suspension containing, in each 5 mL teaspoonful, tetracycline equivalent to 125 mg tetracycline hydrochloride. NDC 49884-799-33 Bottles of 473 mL (16 fl. oz.)

Storage

Keep tightly closed. Protect from light. Store below 30º C (86º F).

ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4 and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4 and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline), in chickens (chlortetracycline), and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

REFERENCES

REFERENCES

1. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests–Fourth Edition. Approved Standard NCCLS Document M2-A4, Vol. 10, No. 7 NCCLS, Villanova, PA, April 1990.

2. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically–Second Edition. Approved Standard NCCLS Document M7-A2, Vol. 10, No. 8 NCCLS, Villanova, PA, April 1990.

Manufactured by:

Bristol-Myers Squibb Company

Princeton, NJ 08543 USA

Manufactured for:

Par Pharmaceutical, Inc.

Spring Valley, NY 10977 USA

1016513A3 03/04

Sumycin  tetracycline  syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49884-799 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Tetracycline (Tetracycline) Active 125 MILLIGRAM  In 5 MILLILITER Sucrose Inactive   Tragacanth Powder Inactive   Sodium Benzoate Inactive   Sodium Saccharin Inactive   Citric Acid Inactive   Potassium Citrate Inactive   Sodium Citrate Inactive   Sorbitol Solution Inactive   Sodium Metabisulfate Inactive   D & C Yellow # 10 Inactive   Potassium Metaphosphate Inactive   Cherry Flavor Inactive   Grape Flavor Inactive   Tutti Frutti Flavor Inactive   Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49884-799-33 473 mL (MILLILITER) In 1 BOTTLE None

Revised: 10/2006Par Pharmaceutical, Inc.

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• Sumycin Side Effects (in more detail)
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• Acne
• Bladder Infection
• Bronchitis
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• Ehrlichiosis
• Epididymitis, Sexually Transmitted
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• Helicobacter Pylori Infection
• Lyme Disease, Arthritis
• Lyme Disease, Carditis
• Lyme Disease, Erythema Chronicum Migrans
• Lyme Disease, Neurologic
• Lymphogranuloma Venereum
• Nongonococcal Urethritis
• Ocular Rosacea
• Ornithosis
• Pelvic Inflammatory Disease
• Pemphigoid
• Pemphigus
• Pneumonia
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• Rickettsial Infection
• Syphilis, Early
• Syphilis, Latent
• Tertiary Syphilis
• Upper Respiratory Tract Infection