PerioGard

chlorhexidine gluconate

Dosage Form: oral rinse
PerioGard®

(Chlorhexidine Gluconate

Oral Rinse, 0.12%)

PerioGard Description

PerioGard (Chlorhexidine Gluconate Oral Rinse, 0.12%) is an oral rinse containing 0.12% chlorhexidine gluconate [N,N" -bis (4-chlorophenyl)-3, 12-diimino-2, 4, 11, 13-tetraazatetradecanediimidamide di-D-gluconate] in a base containing water, 11.6% alcohol, glycerin, polysorbate 20, flavor, sodium saccharin and FD&C blue no. 1. PerioGard Oral Rinse is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid, with a molecular formula of C22H30Cl2N1O•2C6H12O7 and a molecular weight calculated to be 897.77.

Its chemical structure is:

PerioGard - Clinical Pharmacology

PerioGard Oral Rinse provides antimicrobial activity during oral rinsing. The clinical significance of 0.12% chlorhexidine gluconate oral rinse's antimicrobial activities is not clear. Microbiological sampling of plaque has shown a general reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54-97% through six months' use. Use of chlorhexidine gluconate oral rinse in a six-month clinical study did not result in any significant changes in bacterial resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine gluconate use was discontinued, the number of bacteria in plaque had returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline.

Pharmacokinetics

Pharmacokinetic studies with a 0.12% chlorhexidine gluconate oral rinse indicate approximately 30% of the active ingredient is retained in the oral cavity following rinsing. This retained drug is slowly released into the oral fluids. Studies conducted on human subjects and animals demonstrate chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. The mean plasma level of chlorhexidine gluconate reached a peak of 0.206 µg/g in humans 30 minutes after they ingested a 300 mg dose of the drug. Detectable levels of chlorhexidine gluconate were not present in the plasma of these subjects 12 hours after the compound was administered.

Excretion of chlorhexidine gluconate occurred primarily through the feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

Indications and Usage for PerioGard

PerioGard Oral Rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. PerioGard Oral Rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

Contraindications

PerioGard Oral Rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Warnings

The effect of PerioGard Oral Rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing with users of chlorhexidine gluconate oral rinse compared with control users. It is not known if chlorhexidine gluconate use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Hypersensitivity and generalized allergic reactions have occurred. See CONTRAINDICATIONS.

Precautions

General

1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with PerioGard Oral Rinse should not be used as a major indicator of underlying periodontitis.


2. PerioGard Oral Rinse can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in tooth staining. In clinical testing, 56% of the chlorhexidine gluconate oral rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of the chlorhexidine gluconate users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from the use of PerioGard Oral Rinse does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis.
   

   Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from the PerioGard Oral Rinse treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations.

   
   


3. Some patients may experience an alteration in taste perception while undergoing treatment with a chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via postmarketing surveillance.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagensis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PerioGard Oral Rinse is administered to nursing women. In parturition and lactation studies with rats, no evidence of impaired parturation or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than that which would result from a person's ingesting 30 mL (2 capfuls) of PerioGard Oral Rinse per day.

Pediatric Use

Clinical effectiveness and safety of PerioGard Oral Rinse have not been established in children under the age of 18.

Adverse Reactions

The most common side effects associated with chlorhexidine gluconate oral rinses are: (1) an increase in staining of teeth and other oral surfaces, (2) an increase in calculus formation, and (3) an alteration in taste perception; see WARNINGS and PRECAUTIONS. Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%.

Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, uIcer, dry mouth, hypesthesia, glossal edema, and paresthesia.

Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinses.

There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadentitis) reported in patients using chlorhexidine gluconate oral rinse.

Overdosage

Ingestion of 1 or 2 ounces of PerioGard Oral Rinse by a small child (~10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of PerioGard Oral Rinse is ingested by a small child or if signs of alcohol intoxication develop.

PerioGard Dosage and Administration

PerioGard Oral Rinse therapy should be initiated directly following a dental prophylaxis. Patients using PerioGard Oral Rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 1/2 fl. oz. ("15 mL" line on dosage cap) of undiluted PerioGard Oral Rinse. Patients should be instructed not to rinse with water or other mouthwashes, brush teeth, or eat immediately after using PerioGard Oral Rinse. PerioGard Oral Rinse is not intended for ingestion and should be expectorated after rinsing.

How is PerioGard Supplied

PerioGard Oral Rinse is supplied as a blue liquid in 16 fluid ounce amber plastic bottle with child-resistant dosage cap. Store above freezing (32°F).

Colgate Oral Pharmaceuticals, Inc., a subsidiary of Colgate-Palmolive Company

New York, NY 10022 U.S.A.

Questions/Comments: 1-800-962-2345

www.colgateprofessional.com

P10000593

Rev. 12/08

PRINCIPAL DISPLAY PANEL - 473 mL Label

Colgate®

NDC 0126-0271-16

PerioGard®

(Chlorhexidine Gluconote

Oral Rinse, 0.12%)

For questions or comments contact

your dentist or pharmacist.

KEEP OUT OF REACH OF CHILDREN

PLACE PHARMACY

LABEL HERE

Dispense in original container

or in amber glass.

16 fl oz (473 mL)

Rx ONLY

PerioGard  chlorhexidine gluconate  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0126-0271 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine Gluconate (Chlorhexidine) Chlorhexidine Gluconate 1.2 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE (Clear, light blue fluid with no precipates and/or contamination (suspended solids)) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0126-0271-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073695	03/02/2010

Labeler - Colgate-Palmolive Company (055002195)

Revised: 03/2010Colgate-Palmolive Company

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• PerioGard Dosage
• PerioGard Use in Pregnancy & Breastfeeding
• PerioGard Support Group
• 0 Reviews for PerioGard - Add your own review/rating

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Compare PerioGard with other medications

• Gingivitis
• Mucositis
• Periodontitis

Clarifoam EF

sulfur,sulfacetamide sodium

Dosage Form: aerosol, foam



Clarifoam EF


FOR EXTERNAL USE ONLY

Rx Only

Clarifoam EF Description

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]- acetamide, monosodium salt, monohydrate.

The structural formula is:

Each gram of CLARIFOAM® EF (sodium sulfacetamide 10% and sulfur 5%) Emollient Foam contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in an aqueous based emollient foam vehicle containing cetyl alcohol NF, emulsifying wax NF, lactic acid USP, methylparaben NF, propylene glycol USP, propylparaben NF, steareth-10, water USP. Also contains: Propellant HFA-134A (1,1,1,2-tetrafluoroethane).

Clarifoam EF - Clinical Pharmacology

Sodium sulfacetamide exhibits antibacterial activity. The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours.

It is estimated that 1% of topically applied sulfur is absorbed. Although the exact mode of keratolytic activity of sulfur is unknown, it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfur has been reported to inhibit the growth of Propionibacterium acnes thereby reducing the associated inflammation.

INDICATIONS

Clarifoam EF Emollient Foam is indicated in the topical control of acne vulgaris,acne rosacea and seborrheic dermatitis.

Contraindications

Clarifoam EF Emollient Foam is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Clarifoam EF Emollient Foam is not to be used by patients with kidney disease.

Warnings

Although rare, hypersensitivity reactions to products containing sodium sulfacetamide may occur, including Stevens-Johnson syndrome and exfoliative dermatitis. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120ºF (49ºC).

Precautions

General
The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy.

Information for Patients

Avoid contact with eyes, eyelids, lips, and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Category C. Animal reproduction studies have not been conducted with Clarifoam EF Emollient Foam. It is also not known whether Clarifoam EF Emollient Foam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Clarifoam EF Emollient Foam should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Clarifoam EF Emollient Foam. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Clarifoam EF Emollient Foam is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children under the age of 12 have not been established.

Adverse Reactions

Although rare, sodium sulfacetamide may cause local irritation.

Clarifoam EF Dosage and Administration

Shake Vigorously, Tap Bottom of Can and Prime Before Initial Use. Shake Vigorously and Tap Before Each Use.

To Prime: After shaking, gently tap bottom of can onto palm of other hand or a solid surface at least 3 times. Hold the can upright, direct away from patient, and firmly depress the actuator for 1 to 3 seconds or until foam begins to dispense. (If foam does not dispense within 3 seconds: re-shake can, gently tap bottom of can onto a solid surface at least 3 times, and depress the actuator again until foam begins to dispense.)

Before Each Use: Cleanse affected skin thoroughly and pat dry before each application. Shake vigorously and gently tap bottom of can onto palm of other hand or a solid surface at least 3 times.

During Use: Holding can upright, dispense Clarifoam EF Emollient Foam onto the fingertips.

WASH-OFF APPLICATION: Massage the dispensed foam into the affected area and

wait 10 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 3

times daily, or as directed by a physician.

LEAVE-ON APPLICATION: Massage the foam into the affected area 1 to 3 times

daily, or as directed by a physician.

Wipe off any excess foam from actuator after use.

How is Clarifoam EF Supplied

Clarifoam EF Emollient Foam is supplied in a 60g (NDC 16781-154-60) aluminum can.

Store between 59° and 86°F (15° and 30°C).

Protect from freezing.

Store upright.

Manufactured For:

Onset Therapeutics

Cumberland, RI 02864

www.onsettx.com

888-713-8154

PATENT PENDING
P/N 2603-pf Rev. 4

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Outer Package - 5g

NDC 16781-154-06

Rx Only


Clarifoam®™ EF Emollient Foam

Sodium Sulfactetamide (10%), Sulfur (5%)

For topical control of acne vulgaris, acne rosacea, and senhorrheic dermatitis

See prescribing information enclosed


LEAVE-ON

OR

WASH-OFF

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Inner Label - 5g

NDC 16781-154-06

Rx Only

Professional Sample

Not for Sale

Net Weight 5g


Clarifoam®™ EF Emollient Foam

Sodium Sulfactetamide (10%), Sulfur (5%)


LEAVE-ON
OR

WASH-OFF


Sample will not dispense entire contents.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Outer Package  - 60g

NDC 16781-154-60

Rx Only


Clarifoam®™ EF Emollient Foam

Sodium Sulfactetamide (10%), Sulfur (5%)

For topical control of acne vulgaris, acne rosacea, and senhorrheic dermatitis


LEAVE-ON

OR

WASH-OFF


Net Weight 60g

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Inner Label - 60g

NDC 16781-154-60

Rx Only


Clarifoam®™ EF Emollient Foam

Sodium Sulfactetamide (10%), Sulfur (5%)


Net Weight 60g

Clarifoam EF  sulfur,sulfacetamide sodium  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16781-154 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (SULFUR) SULFUR 5 g  in 100 g SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 10 g  in 100 g

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL   CETYL ALCOHOL   LACTIC ACID   METHYLPARABEN   PROPYLPARABEN   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 16781-154-06 5 g In 1 CAN None 2 16781-154-11 10 g In 1 CAN None 3 16781-154-60 60 g In 1 CAN None 4 16781-154-96 100 g In 1 CAN None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/01/2007

Labeler - Onset Dermatologics LLC (793223707)

Registrant - Onset Dermatologics LLC (964275155)

Establishment
Name	Address	ID/FEI	Operations
Onset Dermatologics LLC		793223707	Manufacture

Revised: 06/2011Onset Dermatologics LLC

More Clarifoam EF resources

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• Clarifoam EF Use in Pregnancy & Breastfeeding
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AeroBid

Generic Name: flunisolide inhalation (flew NISS oh lide)

Brand Names: AeroBid, AeroBid-M

What is AeroBid (flunisolide inhalation)?

Flunisolide is a steroid. It prevents the release of substances in the body that cause inflammation.

Flunisolide inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Flunisolide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about AeroBid (flunisolide inhalation)?

Do not use flunisolide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

Contact your doctor if your asthma symptoms do not improve after using flunisolide inhalation for 4 weeks.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack. If you were switched from an oral (taken by mouth) steroid to flunisolide inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

What should I discuss with my healthcare provider before using AeroBid (flunisolide inhalation)?

Before using this medication, tell your doctor if you have been sick or had an infection of any kind (especially tuberculosis). You may not be able to use flunisolide inhalation until you are well.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether flunisolide passes into breast milk or if it could harm a nursing baby. Do not use flunisolide inhalation without telling your doctor if you are breast-feeding a baby.

Flunisolide can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Do not give this medicine to a child younger than 5 years old.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

How should I use AeroBid (flunisolide inhalation)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Flunisolide comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not use flunisolide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using flunisolide inhalation. Do not swallow.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

It is important to use flunisolide inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Contact your doctor if your asthma symptoms do not improve after using flunisolide inhalation for 4 weeks.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack. If you were switched from an oral (taken by mouth) steroid to flunisolide inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency. Store flunisolide inhalation at room temperature away from moisture and heat. Keep the medicine canister away from high heat, such as open flame or in a car on a hot day. The canister may explode if it gets too hot.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of flunisolide inhalation is not expected to produce life-threatening symptoms.

What should I avoid while using AeroBid (flunisolide inhalation)?

Steroid medication can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Avoid being near people who are sick or have infections. Contact your doctor if you have been exposed to someone with measles or chicken pox.

AeroBid (flunisolide inhalation) side effects

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

• 
  

  weakness, tired feeling, nausea, loss of appetite, weight loss;

  
  


• 
  

  fast or pounding heartbeats, pain or fluttering in your chest;

  
  


• 
  

  wheezing or breathing problems after using this medication;

  
  


• 
  

  skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);

  
  


• 
  

  worsening asthma symptoms.

  
  

Less serious side effects may include:

• 
  

  nausea, diarrhea, upset stomach;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  dryness in your mouth, nose, or throat;

  
  


• 
  

  white patches or sores inside your mouth or on your lips;

  
  


• 
  

  stuffy nose, sinus pain, sore throat, cough; or

  
  


• 
  

  hoarseness or deepened voice.

  
  

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

What other drugs will affect AeroBid (flunisolide inhalation)?

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

More AeroBid resources

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

• AeroBid Monograph (AHFS DI)


• Flunisolide Prescribing Information (FDA)


• Flunisolide Professional Patient Advice (Wolters Kluwer)


• Aerobid Aerosol Inhaler MedFacts Consumer Leaflet (Wolters Kluwer)


• Aerobid Prescribing Information (FDA)

Compare AeroBid with other medications

• Asthma

Where can I get more information?

• Your pharmacist can provide more information about flunisolide inhalation.

See also: AeroBid side effects (in more detail)

Tylenol NightTime Cold & Flu Liquid

Pronunciation: a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/dox-IL-a-meen/sue-do-eh-FED-rin
Generic Name: Acetaminophen/Dextromethorphan/Doxylamine/Pseudoephedrine
Brand Name: Examples include NyQuil and Tylenol NightTime Cold & Flu

Tylenol NightTime Cold & Flu Liquid is used for:

Relieving symptoms of pain, sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Tylenol NightTime Cold & Flu Liquid is a decongestant, antihistamine, cough suppressant, and analgesic combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The analgesic and cough suppressant work in the brain to decrease pain and to reduce dry or unproductive cough.

Do NOT use Tylenol NightTime Cold & Flu Liquid if:

• you are allergic to any ingredient in Tylenol NightTime Cold & Flu Liquid


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Tylenol NightTime Cold & Flu Liquid:

Some medical conditions may interact with Tylenol NightTime Cold & Flu Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; liver problems; or if you consume more than 3 alcohol-containing drinks per day


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Tylenol NightTime Cold & Flu Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Tylenol NightTime Cold & Flu Liquid may be increased


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Tylenol NightTime Cold & Flu Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Tylenol NightTime Cold & Flu Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol NightTime Cold & Flu Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tylenol NightTime Cold & Flu Liquid:

Use Tylenol NightTime Cold & Flu Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tylenol NightTime Cold & Flu Liquid may be taken with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Tylenol NightTime Cold & Flu Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol NightTime Cold & Flu Liquid.

Important safety information:

• Tylenol NightTime Cold & Flu Liquid may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tylenol NightTime Cold & Flu Liquid. Using Tylenol NightTime Cold & Flu Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take diet or appetite control medicines while you are taking Tylenol NightTime Cold & Flu Liquid without checking with your doctor.


• Tylenol NightTime Cold & Flu Liquid contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Tylenol NightTime Cold & Flu Liquid for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Tylenol NightTime Cold & Flu Liquid may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tylenol NightTime Cold & Flu Liquid. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• Tylenol NightTime Cold & Flu Liquid may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Tylenol NightTime Cold & Flu Liquid or other pain relievers/fever reducers. Alcohol use combined with Tylenol NightTime Cold & Flu Liquid may increase your risk for liver damage.


• If you are scheduled for allergy skin testing, do not take Tylenol NightTime Cold & Flu Liquid for several days before the test because it may decrease your response to the skin tests.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tylenol NightTime Cold & Flu Liquid.


• Use Tylenol NightTime Cold & Flu Liquid with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Tylenol NightTime Cold & Flu Liquid in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tylenol NightTime Cold & Flu Liquid, discuss with your doctor the benefits and risks of using Tylenol NightTime Cold & Flu Liquid during pregnancy. It is unknown if Tylenol NightTime Cold & Flu Liquid is excreted in breast milk. Do not breast-feed while taking Tylenol NightTime Cold & Flu Liquid.

Possible side effects of Tylenol NightTime Cold & Flu Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.

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

See also: Tylenol NightTime Cold & Flu side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; and vomiting.

Proper storage of Tylenol NightTime Cold & Flu Liquid:

Store Tylenol NightTime Cold & Flu Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol NightTime Cold & Flu Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Tylenol NightTime Cold & Flu Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Tylenol NightTime Cold & Flu Liquid 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 Tylenol NightTime Cold & Flu Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tylenol NightTime Cold & Flu resources

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

Compare Tylenol NightTime Cold & Flu with other medications

• Cold Symptoms

Adcirca

Pronunciation: ta-DAL-a-fil
Generic Name: Tadalafil
Brand Name: Adcirca

Adcirca is used for:

Treating high blood pressure in the lungs (pulmonary arterial hypertension [PAH]. It may also be used for other conditions as determined by your doctor.

Adcirca is a phosphodiesterase type 5 (PDE5) inhibitor. It works by relaxing and dilating the vessels in the lungs. This lowers the blood pressure in the lungs and helps to improve your ability to exercise.

Do NOT use Adcirca if:

• you are allergic to any ingredient in Adcirca


• you have severe kidney or liver problems, certain hereditary eye problems (eg, retinitis pigmentosa), or if you are on dialysis


• you have pulmonary veno-occlusive disease (PVOD)


• you take a nitrate (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, patch, spray, ointment), or nitroprusside


• you take another medicine that contains tadalafil, another PDE5 inhibitor (eg, sildenafil, vardenafil), an azole antifungal (eg, itraconazole, ketoconazole), or rifampin


• you use certain recreational drugs called "poppers" (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)

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

Before using Adcirca:

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

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


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


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


• if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)


• if you have a deformed penis (eg, Peyronie disease, cavernosal fibrosis), certain blood cell problems (eg, sickle cell anemia, leukemia, multiple myeloma), or other conditions that may increase the risk of a prolonged or painful erection (priapism)


• if you have low blood pressure, uncontrolled high blood pressure, blood vessel problems, angina (chest pain), heart problems (eg, heart valve disease, congestive heart failure, irregular heartbeat) or a history of these conditions


• if you have a history of heart attack, stroke, life-threatening irregular heartbeat, liver or kidney problems, dialysis, ulcers, or bleeding problems


• if you have a history of eye or vision problems (eg, decreased vision or vision loss, optic nerve problems, retina problems) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)


• if you take medicine for erectile dysfunction (ED)

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

• Alpha-blockers (eg, doxazosin), medicines for high blood pressure, or nitrates (eg, isosorbide, nitroglycerin) because severe low blood pressure with dizziness, lightheadedness, and fainting may occur


• Azole antifungals (eg, itraconazole, ketoconazole), HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of Adcirca's side effects


• Barbiturates (eg, phenobarbital), bosentan, carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Adcirca's effectiveness

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

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

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


• Take Adcirca by mouth with or without food.


• Adcirca works best if it is taken at the same time each day.


• Check with your doctor before you eat grapefruit or drink grapefruit juice while you are taking Adcirca.


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

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

Important safety information:

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


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


• Do not drink large amounts of alcohol (eg, 4 or 5 drinks or more) while you take Adcirca. Doing so may increase your risk of dizziness, headache, fast heartbeat, and low blood pressure.


• Patients with heart problems who take Adcirca may be at increased risk for heart-related side effects, including heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion; vision or speech changes; one-sided weakness; or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.


• Adcirca may rarely cause a prolonged (eg, longer than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.


• Adcirca may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.


• Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took Adcirca. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.


• Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken Adcirca. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.


• Do not use medicines or treatments for ED while you are taking Adcirca without first checking with your doctor.


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


• Use Adcirca with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


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

Possible side effects of Adcirca:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Flushing; headache; heartburn; mild pain in the arms, legs, or back; muscle pain; nausea; stomach upset; stuffy nose.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast or irregular heartbeat; memory loss; numbness in arm or leg; one-sided weakness; prolonged, painful erection; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent back or muscle pain; severe or persistent dizziness; severe or persistent vision changes; shortness of breath or wheezing; slurred speech; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes; sudden, severe headache or vomiting.

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

See also: Adcirca side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; prolonged erection; severe dizziness; severe or persistent back or muscle pain; severe or persistent vision changes.

Proper storage of Adcirca:

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

General information:

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


• Adcirca 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 Adcirca. 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 Adcirca resources

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

• Adcirca Consumer Overview


• Adcirca Prescribing Information (FDA)


• Adcirca Advanced Consumer (Micromedex) - Includes Dosage Information


• Tadalafil Professional Patient Advice (Wolters Kluwer)


• Cialis Prescribing Information (FDA)


• Cialis Monograph (AHFS DI)


• Cialis Consumer Overview

Compare Adcirca with other medications

• Pulmonary Arterial Hypertension

Cyproheptadine

Pronunciation: SYE-proe-HEP-ta-deen
Generic Name: Cyproheptadine
Brand Name: Generic only. No brands available.

Cyproheptadine is used for:

Treating symptoms of allergic reactions (eg, caused by seasonal allergies, food, blood or plasma). It is also used to treat mild, uncomplicated hives. It may also be used for other conditions as determined by your doctor.

Cyproheptadine is an antihistamine. It works by blocking the action of histamine to reduce allergy symptoms.

Do NOT use Cyproheptadine if:

• you are allergic to any ingredient in Cyproheptadine


• you are breast-feeding


• the patient is a newborn baby or premature infant


• you are elderly and in poor health


• you have narrow-angle glaucoma; a peptic ulcer; an enlarged prostate; or bladder, stomach, or bowel blockage


• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or you have taken an MAOI within the last 14 days

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

Before using Cyproheptadine:

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

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


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


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


• if you have a history of asthma; bladder, stomach, or bowel blockage; glaucoma or increased pressure in the eye; difficulty urinating; prostate problems; kidney problems; overactive thyroid; heart problems; high blood pressure; or seizures

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

• MAOIs (eg, phenelzine) because they may increase the risk of Cyproheptadine's side effects


• Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because their effectiveness may be decreased by Cyproheptadine

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

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

• Take Cyproheptadine by mouth with or without food.


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

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

Important safety information:

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


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Cyproheptadine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Cyproheptadine may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Cyproheptadine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Cyproheptadine may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Cyproheptadine for a few days before the tests.


• Use Cyproheptadine with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness, drowsiness, and low blood pressure.


• Caution is advised when using Cyproheptadine in CHILDREN; they be more sensitive to its effects, especially excitability.


• Cyproheptadine should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• Cyproheptadine should not be used in NEWBORNS and PREMATURE INFANTS; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cyproheptadine while you are pregnant. It is not known if Cyproheptadine is found in breast milk. Do not breast-feed while taking Cyproheptadine.

Possible side effects of Cyproheptadine:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; dizziness; drowsiness; dry mouth, throat, or nose; excitability; nausea; nervousness; restlessness.

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); confusion; dark urine; decreased coordination; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes; seizures; severe or persistent dizziness, tiredness, or weakness; severe or persistent loss of appetite; severe or persistent trouble sleeping; tremor; trouble urinating; unusual bruising or bleeding; unusual back or stomach pain; yellowing of the eyes or skin.

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

See also: Cyproheptadine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dilated pupils; flushing; hallucinations; overexcitement; seizures; severe drowsiness; severe dry mouth; vomiting.

Proper storage of Cyproheptadine:

Store Cyproheptadine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cyproheptadine out of the reach of children and away from pets.

General information:

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


• Cyproheptadine 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 Cyproheptadine. 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 Cyproheptadine resources

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

• Cyproheptadine Prescribing Information (FDA)


• cyproheptadine Concise Consumer Information (Cerner Multum)


• Cyproheptadine Hydrochloride Monograph (AHFS DI)

Compare Cyproheptadine with other medications

• Allergic Reactions
• Anorexia
• Anorexia Nervosa
• Cluster Headaches
• Cushing's Syndrome
• Failure to Thrive
• Hay Fever
• Migraine
• Pruritus
• Sexual Dysfunction, SSRI Induced
• Urticaria

Sandocal 1000

1. Name Of The Medicinal Product

Sandocal 1000 Effervescent Tablets

2. Qualitative And Quantitative Composition

Each effervescent tablet of 1000 mg contains:

2263 mg of calcium lactate gluconate and 1750 mg of calcium carbonate (equivalent to 1000 mg or 25 mmol of calcium).

Excipients: 3323mg of citric acid anhydrous (fine granulate), 30mg of aspartame (E 951), 500 mg of sodium hydrogen carbonate, 30 mg of Orange flavour powder (containing sorbitol (E 420) and dextrose).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Effervescent tablet

White, circular, flat faced, bevelled edge effervescent tablets with an orange odour

4. Clinical Particulars

4.1 Therapeutic Indications

- Prevention and treatment of calcium deficiency

- Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis

- Rickets and osteomalacia, in addition to vitamin D₃ therapy

4.2 Posology And Method Of Administration

Adults and children: 1000mg per day.

The effervescent tablets should be dissolved in a glass of water (approx. 200 ml) and drunk immediately. Sandocal 1000 effervescent tablet may be taken with or without food.

4.3 Contraindications

- Hypersensitivity to the active substances or to any of the excipients of the effervescent tablet

- Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria

- Nephrocalcinosis, nephrolithiasis

4.4 Special Warnings And Precautions For Use

For patients with mild hypercalciuria (exceeding 300 mg/24 hours or 7.5 mmol/24 hours), or with a history of urinary calculi, monitoring of calcium excretion in the urine is required. If necessary, the calcium dose should be reduced or therapy should be discontinued. An increased fluid intake is recommended for patients prone to formation of calculi in the urinary tract.

In patients with impaired renal function, calcium salts should be taken under medical supervision with monitoring of calcium and phosphate serum levels.

During high dose therapy and especially during concomitant treatment with vitamin D, there is a risk of hypercalcaemia with subsequent kidney function impairment. In these patients serum calcium levels should be followed and renal function should be monitored.

There have been literature reports alluding to possible increased absorption of aluminium with citrate salts. Sandocal 1000 effervescent tablet (which contains citric acid) should be used with caution in patients with severely impaired renal function, especially those also receiving aluminium-containing preparations.

Each Sandocal 1000 effervescent tablet contains aspartame, a source of phenylalanine equivalent to 15 mg/dose, and may be harmful for people with phenylketonuria.

Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.

Sandocal 1000 contains 5.95 mmol (corresponding to 136.90 mg) of sodium per tablet.

Sandocal 1000 effervescent tablets should be kept out of the reach of children.

Information for diabetics:

One effervescent tablet contains 0.002 Carbohydrate Units and is therefore suitable for diabetics.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Sandocal 1000.

Tetracycline preparations administered concomitantly with calcium preparations may not be well-absorbed. For this reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium.

Cardiac glycoside toxicity may increase with hypercalcaemia resulting from treatment with calcium. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.

If an oral bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of Sandocal 1000 since gastrointestinal absorption of either oral bisphosphonate or sodium fluoride may be reduced.

Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble compounds with calcium ions. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.

4.6 Pregnancy And Lactation

The adequate daily intake (including food and supplementation) for normal pregnant and lactating women is 1000-1300 mg calcium.

During pregnancy, the daily intake of calcium should not exceed 1500 mg. Significant amounts of calcium are secreted in milk during lactation but do not cause any adverse effects to the neonate.

Sandocal 1000 effervescent tablets can be used during pregnancy and lactation in case of a calcium deficiency

4.7 Effects On Ability To Drive And Use Machines

Sandocal 1000 has no influence on the ability to drive and use machines.

4.8 Undesirable Effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) or very rare (<1/10,000), including isolated reports.

Immune system disorders:

Rare: Hypersensitivity, such as rash, pruritus, urticaria.

Very rare: Isolated cases of systemic allergic reactions (anaphylactic reaction, face oedema, angioneurotic oedema) have been reported

Metabolism and nutrition disorders:

Uncommon: Hypercalcaemia, hypercalciuria

Gastrointestinal disorders:

Rare: flatulence, constipation, diarrhoea, nausea, vomiting, abdominal pain

4.9 Overdose

Overdose leads to hypercalciuria and hypercalcaemia. Symptoms of hypercalcaemia may include: nausea, vomiting, thirst, polydipsia, polyuria, dehydration and constipation. Chronic overdose with resulting hypercalcaemia can cause vascular and organ calcification.

The threshold for calcium intoxication is from supplementation in excess of 2000 mg per day, taken for several months.

Treatment of overdose:

In the case of an intoxication, treatment should be stopped immediately and the fluid deficiency should be corrected.

In case of chronic overdose where hypercalcaemia is present, the initial therapeutic step is hydration with saline solution. A loop diuretic (e.g., furosemide) may then be used to further increase calcium excretion and to prevent volume overload, but thiazide diuretics should be avoided. In patients with renal failure, hydration is ineffective and they should undergo dialysis. In the case of persistent hypercalcaemia, contributing factors should be excluded, e.g., vitamin A or D hypervitaminosis, primary hyperparathyroidism, malignancies, renal failure, or immobilisation.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Mineral supplements

ATC codes: Calcium carbonate (A 12 AA 04), Calcium lactate gluconate (A 12 AA 06)

Calcium is an essential mineral, necessary for bone formation and maintenance, for electrolyte equilibrium in the body and for the proper functioning of numerous regulatory mechanisms.

5.2 Pharmacokinetic Properties

Sandocal 1000 contains two calcium salts, calcium lactate gluconate and calcium carbonate, which readily dissolve in water to make the active ionised form of calcium freely usable.

Absorption:

Some 25-50% of the ingested dose of calcium is absorbed, predominantly in the proximal part of the small intestine, and delivered to the exchangeable calcium pool.

Distribution and metabolism:

The mineral component of bones and teeth contains 99% of the body's calcium. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form, with approximately 5% being complexed to citrate, phosphate or other anions. The remaining 45% of serum calcium is bound to proteins, principally albumin.

Elimination:

Calcium is excreted in the urine, faeces and sweat. Urinary excretion depends on glomerular filtration and tubular reabsorption.

5.3 Preclinical Safety Data

There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric acid anhydrous (fine granulate)

Orange flavour powder (contains: orange essential oils, maltodextrin, arabic gum, sorbitol (E 420), dextrose)

Aspartame (E951)

Macrogol 6000

Sodium hydrogen carbonate

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Keep the tube tightly closed. Store in the original package.

6.5 Nature And Contents Of Container

The effervescent tablets are packed in polypropylene tubes and tamperproof polyethylene stoppers with desiccant, each containing 10 or 20 tablets. The tubes are packed in boxes containing 10, 20, 30, 40, 60, 80, 100 and 600 (for 500 mg only) tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Novartis Consumer Health (UK) Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UK

Trading as Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0179

9. Date Of First Authorisation/Renewal Of The Authorisation

4 September 2000 / 14 May 2007

10. Date Of Revision Of The Text

14 May 2007

LEGAL CATEGORY

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