HC Pram Cream

hydrocortisone acetate and pramoxine

Dosage Form: cream
HC Pram 2.5% Cream, HC Pram 1% Cream

HC Pram Cream Description

Topical corticosteroids are anti-inflammatory and anti-pruritic agents.

INGREDIENTS

River’s Edge HC Pram 2.5% Cream – 2.5% Hydrocortisone Acetate, 1% Pramoxine HCl

Contains hydrocortisone acetate 25mg w/w and pramoxine hydrochloride 10mg

ACTIVE INGREDIENTS:

HYDROCORTISONE ACETATE 2.5%

PRAMOXINE HCl 1%

INACTIVE INGREDIENTS: CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CETEARETH-20, CETEARYL ALCOHOL, DIMETHICONE, GLYCERIN, PHENOXYETHANOL, PENTYLENE GLYCOL, PURIFIED WATER, STEARIC ACID, STEARYL ALCOHOL, TETRASODIUM EDTA.

River’s Edge HC Pram 1% Cream – 1% Hydrocortisone Acetate, 1% Pramoxine HCl

Contains hydrocortisone acetate 10mg w/w and pramoxine hydrochloride 10mg

ACTIVE INGREDIENTS:

HYDROCORTISONE ACETATE 1%

PRAMOXINE HCl 1%

INACTIVE INGREDIENTS: CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CETEARETH-20, CETEARYL ALCOHOL, DIMETHICONE, GLYCERIN, PHENOXYETHANOL, PENTYLENE GLYCOL, PURIFIED WATER, STEARIC ACID, STEARYL ALCOHOL, TETRASODIUM EDTA.

HC Pram Cream - Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinicl efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.


Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

PHARMACOKINETICS

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.


Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE and ADMINISTRATION.)


Once absorbed through the skin, tipical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications and Usage for HC Pram Cream

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroids-responsive dermatoses.

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings and Precautions

General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.


Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area and under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation test. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.


Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See Precautions-Pediatric Use.)


If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.


In the presence of dermatological infections, the use of an appropriate antifungal or anti-bacterial agent should be instituted. If a favorable response does not occur promptly the corticosteroid should be discontinued until the infection has been adequately controlled.


Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions:

1.    This medication is to be used as directed by the physician. It is for external use only. Aviod contact with the eyes.

2.    Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

3.    The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

4.    Patients should report any signs of local adverse reactions especially under occlusive dressings.

5.    Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.


Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test, ACTH stimulation test.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydro-cortisone have revealed negative results.

Use in Pregnancy

Teratogenic Effects: Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systematically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

NURSING MOTHERS

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk.


Systemically administered corticosteroids are secreted into breast milk in quantities NOT likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing’s syndrome than mature patients because of a lager skin surface area to body weight ratio.


Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intra-cranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.


Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burining

Itching

Irritation

Dryness

Folliculitis

Hypertrichosis

Acneiform eruptions

Hypopigmentation

Perioral dermatitis

Allergic contact dermatitis

Maceration of the skin

Secondary infection

Skin atrophy

Striae

Miliaria


To report suspected adverse reactions, contact River’s Edge Pharmaceuticals, LLC at 770-886-3417 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

HC Pram Cream Dosage and Administration

Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

How is HC Pram Cream Supplied

HC Pram 2.5% Cream is a topical cream and is supplied in the following:

1 oz. tube (NDC 68032-426-01)

4 gram tube (NDC 68032-426-04)

12 x 4 gram tubes (NDC 68032-426-12)

30 x 4 gram tubes (NDC 68032-426-30)


HC Pram 1% Cream is a topical cream and is supplied in the following:

1 oz. tube (NDC 68032-425-01)


KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN


Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature].

PACKAGING

HC PRAM  hydrocortisone acetate, pramoxine hydrochloride  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-426 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 25 mg  in 1 g PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength SAFFLOWER OIL   POLYOXYL 20 CETOSTEARYL ETHER   CETOSTEARYL ALCOHOL   DIMETHICONE   GLYCERIN   PHENOXYETHANOL   PENTYLENE GLYCOL   WATER   STEARIC ACID   STEARYL ALCOHOL   EDETATE SODIUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-426-01 30 g In 1 TUBE None 2 68032-426-04 4 g In 1 TUBE None 3 68032-426-12 4 g In 1 TUBE None 4 68032-426-30 4 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2009	04/30/2012

HC PRAM  hydrocortisone acetate, pramoxine hydrochloride  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-425 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 10 mg  in 1 g PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength SAFFLOWER OIL   POLYOXYL 20 CETOSTEARYL ETHER   CETOSTEARYL ALCOHOL   DIMETHICONE   GLYCERIN   PHENOXYETHANOL   PENTYLENE GLYCOL   WATER   STEARIC ACID   STEARYL ALCOHOL   EDETATE SODIUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-425-01 30 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2009	07/31/2012

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2010River's Edge Pharmaceuticals, LLC

More HC Pram Cream resources

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

Compare HC Pram Cream with other medications

• Dermatitis
• Dermatological Disorders
• Hemorrhoids
• Psoriasis

chondroitin and glucosamine

Generic Name: chondroitin and glucosamine (kon DROI tin and gloo KOE sa meen)

Brand names: Cosamin DS, Osteo Bi-Flex, Osteo Bi-Flex Double Strength, Osteo Bi-Flex Triple Strength, Pryflex, Relamine, Schiff Move Free, Schiff Move Free Caplets, Cidaflex, OptiFlex Complete

What is chondroitin and glucosamine?

Chondroitin is a naturally occurring substance formed of sugar chains. Chondroitin is believed to help the body maintain fluid and flexibility in the joints.

Glucosamine is sugar protein that is believed to help develop and renew cartilage (the hard connective tissue mainly located on bones near joints in the body), and keep it lubricated for better joint movement and flexibility.

The combination of chondroitin and glucosamine is widely used to aid in maintaining healthy joints. It is also used as a nutritional supplement in people with osteoarthritis or other inflammatory joint disorders.

Not all uses for chondroitin and glucosamine have been approved by the FDA. Chondroitin and glucosamine should not be substituted for medications prescribed for you by your doctor.

Chondroitin and glucosamine is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Chondroitin and glucosamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about chondroitin and glucosamine?

Not all uses for chondroitin and glucosamine have been approved by the FDA. Chondroitin and glucosamine should not be substituted for medications prescribed for you by your doctor.

Chondroitin and glucosamine is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Before using chondroitin and glucosamine, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use chondroitin and glucosamine if you have diabetes, a bleeding or blood clotting disorder such as hemophilia, if you have allergies to certain drugs, if you are overweight, or if you are on a low-salt diet.

Use chondroitin and glucosamine as directed on the label, or as your healthcare provider has prescribed. Do not use this product in larger amounts or for longer than recommended.

Do not take chondroitin and glucosamine without the advice of a healthcare provider if you are using insulin, or a blood thinner such as warfarin (Coumadin). Avoid taking chitosan (usually marketed as a weight-loss product) while you are taking chondroitin and glucosamine. Chitosan can make it harder for your body to absorb chondroitin.

What should I tell my healthcare provider before taking chondroitin and glucosamine?

Before using chondroitin and glucosamine, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use chondroitin and glucosamine if you have:

• 
  

  diabetes;

  
  


• 
  

  a bleeding or blood clotting disorder such as hemophilia;

  
  


• 
  

  if you have allergies to certain drugs;

  
  


• 
  

  if you are overweight; or

  
  


• 
  

  if you are on a low-salt diet.

  
  

Chondroitin and glucosamine may or may not be harmful to an unborn baby. Do not use this product without talking to a healthcare provider if you are pregnant or plan to become pregnant during treatment. It is not known whether chondroitin and glucosamine can pass into breast milk or if it could harm a nursing baby. Ask your healthcare provider before using chondroitin and glucosamine if you are breast-feeding a baby.

How should I take chondroitin and glucosamine?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to take chondroitin and glucosamine, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of chondroitin and glucosamine than is recommended on the label.

Chondroitin and glucosamine is usually taken 1 or 2 times per day. You may need to take the medication 3 times per day for the first couple of months of treatment. Follow your doctor's instructions.

Glucosamine may increase the glucose (sugar) levels in your blood. If you have diabetes, you may need to check your blood sugar more often while taking this medication. You may also need to adjust your insulin dosage. Do not change your dose or medication schedule without advice from your doctor.

Chondroitin and glucosamine may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store this medication at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking chondroitin and glucosamine?

Avoid taking chitosan (usually marketed as a weight-loss product) while you are taking chondroitin and glucosamine. Chitosan can make it harder for your body to absorb chondroitin.

Chondroitin and glucosamine 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.

Less serious side effects may include:

• 
  

  mild nausea, upset stomach;

  
  


• 
  

  heartburn; or

  
  


• 
  

  diarrhea.

  
  

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

What other drugs will affect chondroitin and glucosamine?

Do not take chondroitin and glucosamine without the advice of a healthcare provider if you are using any of the following medications:

• 
  

  insulin; or

  
  


• 
  

  a blood thinner such as warfarin (Coumadin).

  
  

This list is not complete and other drugs may interact with chondroitin and glucosamine. Tell your healthcare provider 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 chondroitin and glucosamine resources

• Chondroitin and glucosamine Use in Pregnancy & Breastfeeding
• Chondroitin and glucosamine Drug Interactions
• Chondroitin and glucosamine Support Group
• 1 Review for Chondroitin and glucosamine - Add your own review/rating

Compare chondroitin and glucosamine with other medications

• Dietary Supplementation
• Osteoarthritis

Where can I get more information?

• Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

Ansaid

Generic Name: flurbiprofen (Oral route)

flur-bi-PROE-fen

Oral route(Tablet)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Flurbiprofen is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Ansaid

Available Dosage Forms:

• Tablet


• Capsule, Extended Release

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Ansaid

Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

Flurbiprofen may also be used for other problems as determined by your doctor.

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

Before Using Ansaid

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 flurbiprofen in the pediatric population. 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 flurbiprofen in the elderly. However, elderly patients are more likely to have age-related kidney and gastrointestinal problems, which may require caution and an adjustment in the dose for patients receiving flurbiprofen.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

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.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

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


• Acenocoumarol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dicumarol


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Phenprocoumon


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zofenopril

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:

• Anemia or


• Bleeding problems or


• Congestive heart failure or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease or


• Hypertension (high blood pressure) or


• Kidney disease or


• Liver disease (e.g., hepatitis) or


• Stomach or intestinal ulcers or bleeding, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or


• Aspirin sensitivity, history of—Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

Proper Use of Ansaid

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

To lessen stomach upset, you may take this medicine with food.

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 osteoarthritis and rheumatoid arthritis:
    
    • Adults—At first, 200 to 300 milligrams (mg) per day, divided into two to four equal doses. Your doctor may adjust your dose as needed. However, each dose usually is not more than 100 mg.
    
    
    • Children—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.

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 Ansaid

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines such as steroids or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without warning. However, possible warning signs are including black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, and/or lower legs; unusual bleeding or bruising; unusual weight gain; or yellow skin or eyes . Also, signs of serious heart problems could occur such as chest pain, fast or irregular heartbeat, slurring of speech, tightness in the chest, unusual flushing or warmth of the skin, or weakness. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Tell your doctor if you or your child have unexplained weight gain or edema (fluid retention or body swelling) with 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.

Ansaid 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:

Less common

• Abdominal or stomach pain


• bladder pain


• bloody or black, tarry stools


• bloody or cloudy urine


• constipation


• difficult, burning, or painful urination


• frequent urge to urinate


• lower back or side pain


• rash


• severe stomach pain


• swelling


• vomiting of blood or material that looks like coffee grounds

Rare

• Back or leg pains


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloody diarrhea


• bloody nose


• blurred vision


• burning feeling in the chest or stomach


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


• chest pain


• chills


• clay-colored stools


• cough


• cracks in the skin


• dark urine


• decreased urine output


• difficulty breathing


• difficulty swallowing


• dilated neck veins


• dizziness


• extreme fatigue


• fast heartbeat


• feeling faint, dizzy, or lightheaded


• feeling of warmth or heat


• fever with or without chills


• flushing or redness of the skin, especially on the face and neck


• general feeling of tiredness or weakness


• greatly decreased frequency of urination


• headache


• high fever


• hives


• hoarseness


• increased blood pressure


• increased sensitivity of the skin to sunlight


• increased thirst


• indigestion


• irregular breathing


• irregular heartbeat


• itching


• joint pain, stiffness, or swelling


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


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


• light-colored stools


• loss of appetite


• loss of heat from the body


• muscle pain


• nausea


• nervousness


• noisy breathing


• nosebleeds


• pale skin


• pinpoint red or purple spots on the skin


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• redness or other discoloration of the skin


• redness, swelling, or soreness of the tongue


• scaly skin


• severe or continuing stomach pain


• severe sunburn


• shakiness and unsteady walk


• shortness of breath


• skin rash, encrusted, scaly and oozing


• slow or fast heartbeat


• sore throat


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


• stomach bloating or cramping


• stomach upset


• sweating


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


• swelling or inflammation of the mouth


• swollen or painful glands


• tenderness in the stomach area


• tightness in the chest


• troubled breathing


• unpleasant breath odor


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


• unusual bleeding or bruising


• unusual tiredness or weakness


• upper right abdominal or stomach pain


• vomiting


• weight gain


• weight loss


• wheezing


• yellow eyes or skin

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

Symptom of overdose

• Change in consciousness


• fast or slow, or shallow breathing


• heartburn


• loss of consciousness


• pain or discomfort in the chest, upper stomach, or throat


• pale or blue lips, fingernails, or skin


• unusual drowsiness, dullness, or feeling of sluggishness

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


• changes in vision


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


• diarrhea


• discouragement


• excess air or gas in the stomach or intestines


• fear


• feeling of constant movement of self or surroundings


• feeling sad or empty


• full feeling


• general feeling of discomfort or illness


• hearing loss


• irritability


• lack of appetite


• lack or loss of strength


• lightheadedness


• loss of interest or pleasure


• loss of memory


• passing gas


• problems with memory


• runny nose


• sensation of spinning


• sleepiness


• sleeplessness


• sneezing


• stomach discomfort


• stuffy nose


• tremor


• trouble concentrating


• trouble sleeping


• unable to sleep

Rare

• Burning, dry, or itching eyes


• confusion


• discharge or excessive tearing


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


• transient, mild, pleasant aromatic odor


• twitching

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: Ansaid 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 Ansaid resources

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

• Ansaid Concise Consumer Information (Cerner Multum)


• Ansaid Prescribing Information (FDA)


• Ansaid MedFacts Consumer Leaflet (Wolters Kluwer)


• Ansaid Monograph (AHFS DI)


• Flurbiprofen Professional Patient Advice (Wolters Kluwer)


• Flurbiprofen Sodium eent Monograph (AHFS DI)

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Amino Acids/Sodium Propionate/Urea Cervical Cream

Pronunciation: uh-MEE-no AS-ids/SO-dee-uhm PRO-pee-oh-nate/you-REE-ah
Generic Name: Amino Acids/Sodium Propionate/Urea Cervical
Brand Name: Amino-Cerv

Amino Acids/Sodium Propionate/Urea Cervical Cream is used for:

Treating inflammation or injury of the cervix. It is usually used after childbirth or certain medical procedures. It may also be used to treat other conditions as determined by your doctor.

Amino Acids/Sodium Propionate/Urea Cervical Cream is an amino acid, antifungal, and urea combination. The amino acids help wounds to heal. They also help to increase cell growth. Sodium propionate kills sensitive fungi. Urea helps to break down dead tissue. It also increases new tissue growth.

Do NOT use Amino Acids/Sodium Propionate/Urea Cervical Cream if:

• you are allergic to any ingredient in Amino Acids/Sodium Propionate/Urea Cervical Cream

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

Before using Amino Acids/Sodium Propionate/Urea Cervical Cream:

Some medical conditions may interact with Amino Acids/Sodium Propionate/Urea Cervical Cream. 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 preparations, or dietary supplement


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

Some MEDICINES MAY INTERACT with Amino Acids/Sodium Propionate/Urea Cervical Cream. Because little, if any, of Amino Acids/Sodium Propionate/Urea Cervical Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amino Acids/Sodium Propionate/Urea Cervical Cream 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 Amino Acids/Sodium Propionate/Urea Cervical Cream:

Use Amino Acids/Sodium Propionate/Urea Cervical Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Amino Acids/Sodium Propionate/Urea Cervical Cream.


• Talk to your pharmacist if you have questions about this information.


• Use Amino Acids/Sodium Propionate/Urea Cervical Cream before going to bed unless directed otherwise by your doctor.


• If you are wearing a pessary, remove it before you use Amino Acids/Sodium Propionate/Urea Cervical Cream.


• Do not tape over the pinhole on the top of the bulb on the applicator.


• To use Amino Acids/Sodium Propionate/Urea Cervical Cream, attach the applicator to the tube. Squeeze the tube from the bottom until the medicine reaches the correct dose mark on the applicator.


• Detach the applicator from the tube. Insert it 3 4 inch into the vagina. Do NOT insert it all the way into the vagina.


• Squeeze the bulb firmly once. This will deposit the cream into the vagina. Do not release the bulb until you have removed the applicator from the vagina.


• Clean the applicator right away. Hold it under water and flush it (squeeze the bulb) several times. Wipe the threads of the tube and the inside of the cap. Recap the tube tightly.


• Do not use other feminine sprays or vaginal or cervical medicines. They may interact with Amino Acids/Sodium Propionate/Urea Cervical Cream.


• If you miss a dose of Amino Acids/Sodium Propionate/Urea Cervical Cream, use it as soon as possible. If you do not remember until the next day, skip the missed dose. Go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Amino Acids/Sodium Propionate/Urea Cervical Cream.

Important safety information:

• Amino Acids/Sodium Propionate/Urea Cervical Cream is for vaginal use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse at once with cool water.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amino Acids/Sodium Propionate/Urea Cervical Cream while you are pregnant. It is unknown if Amino Acids/Sodium Propionate/Urea Cervical Cream is found in breast milk. If you are or will be breast-feeding while you use Amino Acids/Sodium Propionate/Urea Cervical Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Amino Acids/Sodium Propionate/Urea Cervical Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Amino Acids/Sodium Propionate/Urea Cervical Cream. Seek medical attention right away if any of these SEVERE side effects occur:

Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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

If OVERDOSE is suspected:

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

Proper storage of Amino Acids/Sodium Propionate/Urea Cervical Cream:

Store Amino Acids/Sodium Propionate/Urea Cervical Cream 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 Amino Acids/Sodium Propionate/Urea Cervical Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Amino Acids/Sodium Propionate/Urea Cervical Cream, please talk with your doctor, pharmacist, or other health care provider.


• Amino Acids/Sodium Propionate/Urea Cervical Cream 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 Amino Acids/Sodium Propionate/Urea Cervical Cream. 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 Amino Acids/Sodium Propionate/Urea Cervical resources

• Amino Acids/Sodium Propionate/Urea Cervical Use in Pregnancy & Breastfeeding
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• Cervicitis

Periochip

chlorhexidine gluconate

Dosage Form: insert, extended release
Periochip, 2.5 mg (Chlorhexidine Gluconate)

Periochip Description

Periochip® (chlorhexidine gluconate) is a small, orange-brown, rectangular chip (rounded at one end) for insertion into periodontal pockets. Each Periochip weighs approximately 7.4 mg and contains 2.5 mg of chlorhexidine gluconate in a biodegradable matrix of hydrolyzed gelatin (cross-linked with glutaraldehyde). Periochip also contains glycerin and purified water.


Chlorhexidine gluconate is an antimicrobial agent. Chemically, it is designated as 1,1’-hexamethylenebis [5-(p-chlorophenyl)biguanide] di-D-gluconate, and its molecular formula is C22H30Cl2N10.2C6H12O7. The molecular weight is 897.8. The structural formula of chlorhexidine gluconate is:

Periochip - Clinical Pharmacology

Microbiology

Chlorhexidine gluconate is active against a broad spectrum of microbes. The chlorhexidine molecule, due to its positive charge, reacts with the microbial cell surface, destroys the integrity of the cell membrane, penetrates into the cell, precipiates the cytoplasm, and the cell dies. Studies with Periochip showed reductions in the numbers of the putative periodontopathic organisms Porphyromonas (Bacteroides) gingivalis, Prevotella (Bacteroides) intermedia, Bacteroides forsythus, and Campylobacter rectus (Wolinella recta) after placement of the chip. No overgrowth of opportunistic organisms or the adverse changes in the oral microbial ecosystem were noted. The relationship of the microbial findings to clinical outcome has not been established.

Pharmacokinetics

Periochip releases chlorhexidine in vitro in a biphasic manner, initially releasing approximately 40% of the chlorhexidine within the first 24 hours and then releasing the remaining chlorhexidine in an almost linear fashion for 7-10 days. This enzymatic release rate assay is an experimental collagenase assay that differs from the Regulatory Specification’s Agar Release Rate Assay. This release profile may be explained as an initial burst effect, dependent on diffusion of chlorhexidine from the chip, followed by a further release of chlorhexidine as a result of enzymatic degradation.

In an in vivo study of 18 evaluable adult patients, there were no detectable plasma or urine levels of chlorhexidine following the insertion of 4 Periochips under clinical conditions. The concentration of chlorhexidine released from the Periochip was determined in the gingival crevicular fluid (GCF) of these same subjects. In these subjects, a highly variable biphasic release profile for chlorhexidine was demonstrated, with GCF levels 4 hours after chip insertion (mean: 1444 ± 783 µg/mL), followed by a second peak at 72 hours (mean: 1902 ± 1073 µg/mL). In a second study involving the insertion of 1 Periochip under clinical conditions, the mean GCF level of chlorhexidine peaked at 1088 ± 678 µg/mL at 4 hours. The mean GCF levels then declined in a highly erratic fashion to levels of 482 ± 447 µg/mL at 72 hours without producing a true second peak.

The results of these studies confirm a high degree of intersubject variability in chlorhexidine release from the Periochip matrix in vivo that was not seen in vitro. Due to the nature and clinical use of the Periochip dosage form, dose proportionality was not and would not be expected to be demonstrated between the two studies.

Clinical Studies

SIn two double-blind, randomized, controlled clinical trials, 447 adult patients with periodontitis were entered who had at least 4 pockets with probing depth of 5-8 mm that bled on probing. Patients studied were in good general health. Diabetics were excluded from the studies. Periochip was not studied in acutely abscessed periodontal pockets. Patients were free of supragingival calculus prior to baseline. In these two studies, the effects of scaling and root planing (SRP) alone, and SRP followed by Periochip treatment, were compared. All patients received full mouth SRP at baseline. If the pocket depth remained ≥ 5 mm at 3 and/or 6 months after initial treatment, another chip was placed into the pocket. Teeth treated with Periochip were found to have significantly reduced probing pocket depth (PD) compared with those treated with SRP alone at 9 months after initial treatment, as shown in Table 1

Table 1

Probing pocket depth (PD) at baseline and reduction in PD at 9 months from 2 five-center U.S.clinical trials (in mm, mean ± SE)
	Study #94-002	Study #94-002	Study #94-003	Study #94-003
Time	SRP alone	SRP + Periochip	SRP alone	SRP + Periochip
PD at Baseline	5.69 ± 0.58 (n = 107)	5.79 ± 0.61 (n = 108)	5.56 ± 0.54 (n = 115)	5.67 ± 0.56 (N = 117)
PD Reduction at 9 months	0.78 ± 0.07 (n = 101)	1.06 ± 0.07* (n = 101)	0.52 ± 0.07 (n = 107)	0.84 ± 0.08** (n = 110)

SE = standard error; SRP = Scaling and Root Planing

Significantly different from SRP alone:  *(p = 0.006); **(p = 0.001)

Periochip treatment resulted in a greater percentage of pockets and patients that showed an improvement in PD of 2 mm or more compared with SRP alone at 9 months, as shown in Table 2. The differences in improvement were statistically significant when analyzed on a per patient basis (p less than 0.005).  Periochip treatment maintained probing attachment level (PAL) compared with baseline or with SRP alone at 9 months. The effects of Periochip on bleeding upon probing have not been established. In the two studies, there were no significant changes in plaque development or gingivitis. Smokers and non-smokers were enrolled in these studies; although non-smokers using Periochip demonstrated significant improvement in PD, smokers demonstrated a trend towards improvement that did not reach statistical significance. This finding is consistent with the consensus that smoking is a risk factor in periodontal diseases.

Table 2

Number (percentage) of pockets and patients with an improvement in PD ≥ 2 mm at 9 months from 2 five-center U.S. clinical trials
	Study #94-002	Study #94-002	Study #94-003	Study #94-003
	SRP alone	SRP + Periochip	SRP alone	SRP + Periochip
Pockets	21 / 202 (11%)	44 / 202 (22%)	12 / 214 (6%)	36 / 220 (16%)
Patients (one or both sites)	17 / 101 (17%)	36 / 101 (36%)	11 / 107 (10%)	28 / 110 (25%)

In the two clinical studies above and an additional study (619 patients), the adverse effects of tooth staining or altered taste perception were not reported after the use of Periochip.

Indications and Usage for Periochip

Periochip is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. Periochip may be used as a part of a periodontal maintenance program, which includes good oral hygiene and scaling and root planing.

Contraindications

Periochip should not be used in any patient who has a known sensitivity to chlorhexidine.

Precautions

General

The use of Periochip in an acutely abscessed periodontal pocket has not been studied and therefore is not recommended. Although rare, infectious events including abscesses and cellulitis, which have been reported after scaling and root planing alone, have also been reported with the adjunctive placement of the Periochip post scaling and root planing. Management of patients with periodontal disease should include consideration of potentially contributing medical disorders, such as cancer, diabetes, and immunocompromised status.

Information for Patients

Patients should avoid dental floss at the site of Periochip insertion for 10 days after placement, because flossing might dislodge the chip. All other oral hygiene may be continued as usual. No restrictions regarding dietary habits are needed. Dislodging of the Periochip is uncommon; however, patients should be instructed to notify the dentist promptly if the Periochip dislodges. Patients should be also be advised that, although some mild to moderate sensitivity is normal during the first week after placement of Periochip, they should notify the dentist promptly if pain, swelling, or other problems occur.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Chlorhexidine gluconate has not been evaluated for carcinogenic potential in connection with the Periochip. No evidence that chlorhexidine gluconate has potential to cause genetic toxicity was obtained in a battery of mutagenicity studies, including (in vitro) an Ames assay, a chromosome aberration assay in CHO cells, and (in vivo) a micronucleus assay conducted in mice.

Pregnancy

Teratogenic Effects: Pregnancy Category C – Animal reproduction studies have not been conducted in relation to Periochip, because animal models that would permit use of a clinically relevant route of administration are not available. Chlorhexidine gluconate did not induce harm to the fetus when administered to rats by gavage at dosages up to 68.5 mg/kg/day. While chlorhexidine is known to be very poorly absorbed from the GI tract, it may be absorbed following placement within a periodontal pocket. Therefore, it is unclear whether these data are relevant to clinical use of Periochip. In clinical studies, placement of four Periochips within periodontal pockets resulted in plasma concentrations of chlorhexidine that were at or below the limit of detection. However, it is not known whether Periochip can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Periochip should be used in a pregnant woman only if clearly needed.

Pediatric Use:  The safety and effectiveness of Periochip in pediatric patients have not been established.

Geriatric Use:  Although subjects aged 65 years and over were included in clinical studies of Periochip, there were not sufficient numbers of these subjects to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Overall differences in safety or effectiveness have not been identified between the elderly and younger patients.

Adverse Reactions

The most frequently observed adverse events in the two pivotal clinical trials were toothache, upper respiratory tract infection, and headache. Toothache was the only adverse reaction that was significantly higher (p = 0.042) in the Periochip group when compared to placebo. Most oral pain or sensitivity occurred within the first week of the initial chip placement following SRP procedures, was mild to moderate in nature, and spontaneously resolved within days. These reactions were observed less frequently with subsequent chip placement at 3 and 6 months.

Table 3 lists adverse events, occurring in ≥ 1% of 225 patients that received Periochip, pooled from the two pivotal clinical trials without regard to causality. Gingival bleeding was the only dental adverse event occurring at a rate of ≤ 1% in both groups.

Table 3

Adverse events (frequency ≥ 1% for the Periochip group) reported from 2 five-center U.S. clinical trials
	Periochip Total N = 225	Periochip Total N = 225	Periochip Total N = 222	Periochip Total N = 222
	N	%	N	%
All patients with Adverse Events	193	85.8	189	85.1
Toothache*	114	50.7	92	41.4
Upper resp tract infection	64	28.4	58	26.1
Headache	61	27.1	61	27.5
Sinusitis	31	13.8	29	13.1
Influenza-like symptoms	17	7.6	21	9.5
Back pain	15	6.7	25	11.3
Tooth disorder**	14	6.2	15	6.8
Bronchitis	14	6.2	7	3.2
Abscess	13	5.8	13	5.9
Pain	11	4.9	11	5.0
Allergy	9	4.0	13	5.9
Myalgia	9	4.0	9	4.1
Gum hyperplasia	8	3.6	5	2.3
Pharyngitis	8	3.6	5	2.3
Arthralgia	7	3.1	13	5.9
Dysmenorrhea	7	3.1	13	5.9
Dyspepsia	7	3.1	6	2.7
Rhinitis	6	2.7	11	5.0
Coughing	6	2.7	7	3.2
Arthrosis	6	2.7	4	1.8
Hypertension	5	2.2	6	2.7
Stomatitis ulcerative	5	2.2	1	0.5
Tendinitis	5	2.2	1	0.5

*  Includes dental, gingival or mouth pain, tenderness, aching, throbbing, soreness,

discomfort, or sensitivity

**  Includes broken, cracked or fractured teeth, mobile teeth, and lost bridges, crowns,

or fillings

Periochip Dosage and Administration

One Periochip is inserted into a periodontal pocket with probing pocket depth (PD) ≥ 5 mm. Up to 8 Periochips may be inserted in a single visit. Treatment is recommended to be administered once every three months in pockets with PD remaining ≥ 5 mm.


The periodontal pocket should be isolated and the surrounding area dried prior to chip insertion. The Periochip should be grasped using forceps (such that the rounded end points away from the forceps) and inserted into the periodontal pocket to its maximum depth. If necessary, the Periochip can be further maneuvered into position using the tips of the forceps or a flat instrument. The Periochip does not need to be removed since it biodegrades completely.


In the unlikely event of Periochip dislodgement (in the two pivotal clinical trials, only 8 chips were reported lost), several actions are recommended, depending on the day of Periochip loss. If dislodgement occurs 7 days or more after placement, the dentist should consider the subject to have received a full course of treatment. If dislodgement occurs within 48 hours after placement, a new Periochip should be inserted. If dislodgement occurs more than 48 hours after placement, the dentist should not replace the Periochip, but reevaluate the patient at 3 months and insert a new Periochip if the pocket depth has not been reduced to less than 5 mm.

How is Periochip Supplied

Periochip (chlorhexidine gluconate) 2.5 mg is supplied as a small, orange-brown, rectangular chip (rounded at one end), in cartons of 10 chips (NDC 52096-001-12) and 20 chips (NDC 52096-001-22). Each chip is individually packed in a separate compartment of an aluminum blister pack.

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

Rx only.

Instructions for Insertion

Periochip® 2.5 mg

(chlorhexidine gluconate)

Manufactured by:  DEXCEL PHARMA TECHNOLOGIES LTD., Jerusalem, Israel.

Distributed by:  Adrian Pharmaceuticals, 5331 Commercial Way - Suite 211, Spring Hill, FL 34606

Tel.:  1-866-Periochip

www.Periochip.com

458-01

1269350115

Iss. 12/09

Blister Label

Periochip® 2.5 mg

(chlorhexidine gluconate)

Store at controlled room

temperature 15°-25°C

(59°-77°F) (see USP)

Distributed by: 

Adrian Pharmaceuticals

Spring Hill, FL 34606

Exp:

Batch:

Carton Label

NDC 52096 - 001 - 22                    www.Periochip.com                    20 Chips

Periochip®

(chlorhexidine gluconate) 2.5 mg

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

Rx only

Manufactured by:  Dexcel Pharma Technologies LTD., Jerusalem, Israel

Distributed by:  Adrian Pharmaceuticals, 5331 Commercial Way - Suite 211, Spring Hill, FL 34606, Tel.:  1-866-Periochip

See package insert for full prescribing information.

Barcode

3 52096 00122 2

Each Periochip contains:  chlorhexidine gluconate 2.5 mg, hydrolyzed gelatin, glutaraldehyde, glycerin, and purified water.  Contains no preservatives.

Dexcel

Periochip®                                        20 Chips

(chlorhexidine gluconate) 2.5 mg

Periochip  chlorhexidine gluconate  insert, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52096-001 (64239-001) Route of Administration PERIODONTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine Gluconate (Chlorhexidine) Chlorhexidine Gluconate 2.5 mg

Inactive Ingredients Ingredient Name Strength Gelatin   Glutaral   Glycerin   Water

Product Characteristics Color orange (orange-brown) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52096-001-12 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 INSERT In 1 BLISTER PACK This package is contained within the CARTON (52096-001-12) 2 52096-001-22 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 20 INSERT In 1 BLISTER PACK This package is contained within the CARTON (52096-001-22)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020774	05/01/1998

Labeler - Adrian Pharmaceuticals, LLC (832967546)

Registrant - Dexcel Ltd. (600534200)

Establishment
Name	Address	ID/FEI	Operations
Dexcel Pharma Technologies Ltd.		600209951	analysis, manufacture

Revised: 03/2010Adrian Pharmaceuticals, LLC

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• Periochip Support Group
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Li-Liquid 10.8mmol / 5ml Oral Syrup

Li-Liquid 10.8mmol/5ml Oral Syrup

Lithium citrate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or your pharmacist.


• This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


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

In this leaflet

• 1. What is Li-Liquid and what is it used for


• 2. Before you take Li-Liquid


• 3. How to take Li-Liquid


• 4. Possible side effects


• 5. How to store Li-Liquid


• 6. Further information

What is Li-Liquid and what is it used for

The name of your medicine is Li-Liquid 10.8mmol/5ml Oral Syrup (referred to as Li-Liquid in this leaflet). It contains lithium citrate. This belongs to a group of medicines called ‘anti-manics’.

Lithium acts on the brain to calm your moods and emotions.

Lithium can be used to:

• treat mania (over-excitability and exaggerated emotions) and hypomania (a milder form of mania)


• treat bipolar depression. This is a condition where you have large mood swings from low mood and feelings of sadness (depression), to feeling excited and overactive. Lithium will be given when other antidepressant drugs have not worked


• prevent mood problems that happen a lot


• control aggressive feelings or if you have been intentionally harming yourself.

Before you take Li-Liquid

Do not take Li-Liquid and tell your doctor if:

• you are allergic (hypersensitive) to lithium or any other ingredients in this liquid (listed in section 6). The signs of allergic reaction can include a rash, itching or shortness of breath


• you have kidney problems or heart disease


• you have thyroid problems that are not being treated. The signs of these include tiredness, feeling weak, muscle weakness, cramps, feeling cold, a slow heart rate, dry and flaky skin, hair loss, a deep husky voice or weight gain


• you are on a low sodium diet or have low body sodium levels, including being dehydrated


• you have Addison’s disease. This is where your adrenal glands are not working properly. The signs of this are weakness, tiredness, weight loss and low blood pressure


• you are pregnant, think you are pregnant or breast-feeding.

Children must not take this medicine.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Li-Liquid.

Take special care with Li-Liquid.

Before you take Li-Liquid, tell your doctor if:

• you currently have an infection


• you feel sick, have been sick, or have diarrhoea.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Li-Liquid.

Having operations and tests

• if you are going into hospital for an operation under general anaesthetic, tell the nurse or doctor that you are taking lithium


• it is important to have blood tests before and whilst taking Li-Liquid. These show that you are taking the right dose. They also check whether your heart, thyroid and kidneys are working properly (see Section 3).

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because lithium can affect the way some other medicines work. Also some medicines can affect the way lithium works.

Tell your doctor if you are taking any of these medicines

• medicines used to treat infections, such as metronidazole or tetracyclines


• non-steroidal anti-inflammatory (NSAID) medicines, such as indometacin, ibuprofen or aspirin


• medicines to treat high blood pressure or heart problems, such as:
  
  
  • ACE inhibitors such as enalapril
  • calcium channel blockers such as diltiazem or verapamil
  • methyldopa
  • diuretics (water tablets). These also help the body get rid of excess water


• medicines for schizophrenia or other mental problems, such as haloperidol, flupentixol, diazepam, thioridazine, fluphenazine, chlorpromazine and clozapine


• medicines to treat depression, such as fluvoxamine or fluoxetine


• steroids


• medicines that contain sodium bicarbonate, such as treatments for acid indigestion


• medicines to treat gout such as allopurinol


• urea. This is given to people who have had a head injury or to lower pressure in the eye (glaucoma)


• medicines to treat epilepsy, such as phenytoin and carbamazepine.

Taking Li-Liquid with food and drink

It is important that you drink plenty of fluids whilst taking this medicine particularly in very hot weather or if your workplace is very hot.

Pregnancy and Breast-feeding:

• talk to your doctor before taking this medicine if you are pregnant or planning to become pregnant. You should not use this medicine during the first three months of pregnancy unless your doctor feels it is absolutely necessary


• you should make sure that you use adequate contraception whilst taking lithium


• if you are planning to become pregnant, talk to your doctor about stopping the medicine


• do not take this medicine if you are breastfeeding.

Driving and using machines:

This medicine may slow down your reactions or make you feel drowsy. If this happens to you, you should not drive or use any tools or machines.

Important information about what is in Li-Liquid:

This medicine contains:

• Methyl and propyl hydroxybenzoates (E218 and E216). These may cause an allergic reaction. This allergy may happen some time after starting the medicine


• Glucose and sorbitol (E420). If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine. It contains 1.7g of glucose in each 5ml. When taken according to dosage recommendations, the maximum dose supplies up to 10.2g of glucose. This should be taken into account in patients with diabetes mellitus and may be harmful to teeth


• Ethanol (alcohol). This product contains a small amount of alcohol, less than 100mg per dose.


• Sunset Yellow E110. This may cause an allergic reaction and is more common in those who are allergic to aspirin.

How to take Li-Liquid

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

Taking this medicine

• this medicine contains 1018mg of lithium citrate in each 5ml. This is the same as 400mg lithium carbonate


• take this medicine by mouth


• if you feel that the effect of your medicine is too strong or too weak, do not change the dose yourself, but talk to your doctor or pharmacist


• your doctor will check your blood levels while you are taking this medicine. These tests will be done just before you are due to take Li-Liquid and not less than 12 hours after your last dose. It is important that you do not miss these tests. The tests will be:
  
  
  • 4 to 5 days after you have started your treatment
  • then every week until your lithium levels are at a constant level in your blood
  • once the levels are stable, you will have this test every 3 months.

Adults

The usual dose for adults is:

• when first taking lithium, one to three 5ml spoonsful. This will be split into two doses, one in the morning and one in the evening.


• your doctor will then change your dose according to your blood levels.

Children

Children must not take this medicine.

Older people

If you are an older person you may be more sensitive to the medicine. This means you have more of a chance of getting some of the side effects listed in section 4. Your doctor will start you on a lower dose.

If you take more Li-Liquid than you should

Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Li-Liquid

Do not take a double dose (two doses at the same time) to make up for forgotten doses. Skip the missed dose then go on as before.

If you stop taking Li-Liquid

Keep taking Li-Liquid until your doctor tells you to stop. Do not stop taking your medicine suddenly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, lithium can cause side effects, although not everybody gets them.

Stop taking the medicine and contact your doctor or hospital casualty department straight away if you get:

• an allergic reaction to Li-Liquid such as skin rash, flaking skin, boils or sore lips and mouth, sudden wheezing, fluttering or tightness of the chest or collapse.


• high blood pressure, swollen hands and feet and swelling around the eyes, more infections than usual. These could be signs of a kidney problem called ‘nephrotic syndrome’


• a speech disorder, confusion, impaired consciousness or loss of consciousness


• loss of appetite, diarrhoea, vomiting, muscle weakness, difficulty in co-ordinating movements, drowsiness, tiredness, dizziness, ringing in your ears, blurred vision, slurred speech, muscle twitching and shaking or fits. The amount of lithium in your blood may be too high.

If any of the above applies to you, stop taking this medicine and contact your doctor or hospital casualty department straight away. This is especially important if you are an older person.

Tell your doctor as soon as possible if you get any of the following:

• changes in heart rate. The most common is a slow heart beat and low blood pressure


• change in thyroid function. This may show as underactive (feeling very tired and slow, sweaty, shaky and unable to tolerate heat) or overactive (bone pain or tenderness, tiredness and vomiting). You may also notice a swelling in the neck.

Tell your doctor if you get any of these side effects:

• shaking of your hands


• passing more water (urine) than normal or feeling thirsty


• loss of appetite with a strange taste in your mouth, feeling sick (nausea) or being sick (vomiting), diarrhoea, a dry mouth or produce too much saliva, stomach pain and swelling of the stomach lining


• increase in weight, water retention and swelling (particularly the feet and ankles)


• feeling dizzy, feeling very tired, feeling less alert or dazed, forgetful


• severe headache, blurred vision and rapid uncontrollable eye movements


• numbness, tingling and colour change (white, blue then red) in your fingers and toes when exposed to the cold


• hair loss, acne, skin rash, psoriasis or worsening of psoriasis and leg ulcers


• sexual problems.

A change in blood tests may occur, particularly high white blood cell counts, high blood sugar levels, and high magnesium or calcium levels. Your doctor will notice this when you have your blood tests.

Lithium taken for a long time can cause kidney damage. This can usually be avoided if your kidney function is tested regularly by your doctor. Drinking plenty of fluids while taking this medicine will also help avoid kidney damage.

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

How to store Li-Liquid

• Keep out of the reach and sight of children


• Store above 4°C and keep out of direct sunlight


• Do not use after the expiry date which is stated on the label and carton. (exp: month, year)


• The expiry date refers to the last day of that month


• Do not use Li-Liquid if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist


• Medicines should not be disposed of via wastewater or household waste. Take back to the pharmacy 6 months after you first open it. These measures will help to protect the environment.

Further information

What Li-Liquid contains

• The active ingredient is lithium citrate. Each 5ml contains 1018mg of lithium citrate. This is the same as 400mg lithium carbonate


• The other ingredients are citric acid (E330), saccharin sodium, sorbitol solution (E420), syrup liquid glucose, propylene glycol (E1520), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), colouring E110, cherry flavour (containing ethanol and propylene glycol) and purified water.

What Li-Liquid looks like and contents of the pack

A bright orange syrup with an odour of cherry.

It comes in a brown glass bottle holding 150ml of syrup.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

This leaflet was last revised in September 2009.

P0472