Apo-Nifed

Apo-Nifed may be available in the countries listed below.

Ingredient matches for Apo-Nifed

Nifedipine

Nifedipine is reported as an ingredient of Apo-Nifed in the following countries:

• Canada


• Guyana


• Singapore

International Drug Name Search

Bepotastine Eye Drops

Pronunciation: bep-oh-TAS-teen
Generic Name: Bepotastine
Brand Name: Bepreve

Bepotastine Eye Drops are used for:

Treating itchy eyes caused by allergies.

Bepotastine Eye Drops are an antihistamine eye drop. It works by blocking the release of histamine, which reduces the symptoms of an allergic reaction.

Do NOT use Bepotastine Eye Drops if:

• you are allergic to any ingredient in Bepotastine Eye Drops

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

Before using Bepotastine Eye Drops:

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

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


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


• if you have allergies to medicines or other substances

Some MEDICINES MAY INTERACT with Bepotastine Eye Drops. Because little, if any, of Bepotastine Eye Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Bepotastine Eye Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bepotastine Eye Drops:

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

• Bepotastine Eye Drops are only for the eye. Do not get it in your nose or mouth.


• Remove contact lenses before you use Bepotastine Eye Drops.


• To use Bepotastine Eye Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• Soft contact lenses may absorb a chemical in Bepotastine Eye Drops. Wait 10 minutes after you use Bepotastine Eye Drops before you put your contacts back in.


• If you miss a dose of Bepotastine Eye Drops, use 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 use 2 doses at once

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

Important safety information:

• Do not use Bepotastine Eye Drops for future eye problems without first checking with your doctor.


• Do not wear contact lenses if your eyes are red. Bepotastine Eye Drops should not be used to treat redness or irritation caused by contact lenses.


• Bepotastine Eye Drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Bepotastine Eye Drops should be used with extreme caution in CHILDREN younger than 2 years old; 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 Bepotastine Eye Drops while you are pregnant. It is not known if Bepotastine Eye Drops are found in breast milk. If you are or will be breast-feeding while you use Bepotastine Eye Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Bepotastine Eye Drops:

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:

Headache; mild taste in the mouth; sore throat.

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); new or worsening eye irritation or redness.

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: Bepotastine side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Bepotastine Eye Drops:

Store Bepotastine Eye Drops upright in the refrigerator or at room temperature between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze. Keep the bottle tightly closed. Store away from heat, moisture, and light. Keep Bepotastine Eye Drops out of the reach of children and away from pets.

General information:

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


• Bepotastine Eye Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Bepotastine Eye Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Bepotastine resources

• Bepotastine Side Effects (in more detail)
• Bepotastine Use in Pregnancy & Breastfeeding
• Bepotastine Support Group
• 10 Reviews for Bepotastine - Add your own review/rating

Compare Bepotastine with other medications

• Conjunctivitis, Allergic

Spirohexal

Spirohexal may be available in the countries listed below.

Ingredient matches for Spirohexal

Spironolactone

Spironolactone is reported as an ingredient of Spirohexal in the following countries:

• Austria

International Drug Name Search

Fareclox

Fareclox may be available in the countries listed below.

Ingredient matches for Fareclox

Flucloxacillin

Flucloxacillin sodium salt (a derivative of Flucloxacillin) is reported as an ingredient of Fareclox in the following countries:

• Italy

International Drug Name Search

Desmopressin

Generic Name: Desmopressin acetate

Dosage Form: injection, solution
Desmopressin

Acetate

Injection, USP

Rx only

Desmopressin Description

Desmopressin Acetate Injection, USP 4 mcg/mL is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:

Mol. Wt. 1183.31

Molecular Formula: C46H64N14O12S2 • C2H4O2 • 3H2O

1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.

Desmopressin Acetate Injection, USP 4 mcg/mL is provided as a sterile, aqueous solution for intravenous or subcutaneous use. Each mL contains Desmopressin acetate, 4 mcg (equivalent to 0.004 mg of Desmopressin) and sodium chloride, 9 mg. May contain hydrochloric acid for pH adjustment. The pH range is 3.5 to 6.0.

Desmopressin - Clinical Pharmacology

Desmopressin Acetate Injection 4 mcg/mL contains as active substance, Desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. One mL (4 mcg) of Desmopressin acetate solution has an antidiuretic activity of about 16 IU; 1 mcg of Desmopressin acetate is equivalent to 4 IU.

Desmopressin acetate has been shown to be more potent than arginine vasopressin in increasing plasma levels of factor VIII activity in patients with hemophilia and von Willebrand’s disease Type I.

Dose-response studies were performed in healthy persons, using doses of 0.1 to 0.4 mcg/kg body weight, infused over a 10-minute period. Maximal dose response occurred at 0.3 to 0.4 mcg/kg. The response to Desmopressin acetate of factor VIII activity and plasminogen activator is dose-related, with maximal plasma levels of 300 to 400 percent of initial concentrations obtained after infusion of 0.4 mcg/kg body weight. The increase is rapid and evident within 30 minutes, reaching a maximum at a point ranging from 90 minutes to two hours. The factor VIII related antigen and ristocetin cofactor activity were also increased to a smaller degree, but still are dose-dependent.

1. 
   

   The biphasic half-lives of Desmopressin acetate were 7.8 and 75.5 minutes for the fast and slow phases, respectively, compared with 2.5 and 14.5 minutes for lysine vasopressin, another form of the hormone. As a result, Desmopressin acetate provides a prompt onset of antidiuretic action with a long duration after each administration.

   
   


2. 
   

   The change in structure of arginine vasopressin to Desmopressin acetate has resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses are usually below threshold levels for effects on vascular or visceral smooth muscle.

   
   


3. 
   

   When administered by injection, Desmopressin acetate has an antidiuretic effect about ten times that of an equivalent dose administered intranasally.

   
   


4. 
   

   The bioavailability of the subcutaneous route of administration was determined qualitatively using urine output data. The exact fraction of drug absorbed by that route of administration has not been quantitatively determined.

   
   


5. 
   

   The percentage increase of factor VIII levels in patients with mild hemophilia A and von Willebrand’s disease was not significantly different from that observed in normal healthy individuals when treated with 0.3 mcg/kg of Desmopressin acetate infused over 10 minutes.

   
   


6. 
   

   Plasminogen activator activity increases rapidly after Desmopressin acetate infusion, but there has been no clinically significant fibrinolysis in patients treated with Desmopressin acetate.

   
   


7. 
   

   The effect of repeated Desmopressin acetate administration when doses were given every 12 to 24 hours has generally shown a gradual diminution of the factor VIII activity increase noted with a single dose. The initial response is reproducible in any particular patient if there are 2 or 3 days between administrations.

   
   

Human Pharmacokinetics: Desmopressin acetate is mainly excreted in the urine. A pharmacokinetic study conducted in healthy volunteers and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects in each group) receiving single dose Desmopressin acetate (2 mcg) injection demonstrated a difference in Desmopressin acetate terminal half-life. Terminal half-life significantly increased from 3 hours in normal healthy patients to 9 hours in patients with severe renal impairment. See CONTRAINDICATIONS.

Indications and Usage for Desmopressin

Hemophilia A: Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.

Desmopressin acetate will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.

Desmopressin acetate will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.

Desmopressin acetate is not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have factor VIII antibodies.

In certain clinical situations, it may be justified to try Desmopressin acetate in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.

von Willebrand’s Disease (Type I): Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with mild to moderate classic von Willebrand’s disease (Type I) with factor VIII levels greater than 5%. Desmopressin acetate will often maintain hemostasis in patients with mild to moderate von Willebrand’s disease during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.

Desmopressin acetate will usually stop bleeding in mild to moderate von Willebrand’s patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.

Those von Willebrand’s disease patients who are least likely to respond are those with severe homozygous von Willebrand’s disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels less than 1%. Other patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked during administration of Desmopressin acetate to ensure that adequate levels are being achieved.

Desmopressin acetate is not indicated for the treatment of severe classic von Willebrand’s disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen. See WARNINGS.

Diabetes Insipidus: Desmopressin Acetate Injection 4 mcg/mL is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus.

Desmopressin acetate is also available as an intranasal preparation. However, this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate. These include poor intranasal absorption, nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy, create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.

Contraindications

Desmopressin Acetate Injection 4 mcg/mL is contraindicated in individuals with known hypersensitivity to Desmopressin acetate or to any of the components of Desmopressin Acetate Injection 4 mcg/mL.

Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min).

Desmopressin acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.

Warnings

1. 
   

   Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with Desmopressin acetate. Desmopressin acetate is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required.

   
   


2. 
   

   When Desmopressin Acetate Injection is administered to patients who do not have need of antidiuretic hormone for its antidiuretic effect, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward to decrease the potential occurrence of water intoxication and hyponatremia. See PRECAUTIONS, Pediatric Use and Geriatric Use. All patients receiving Desmopressin acetate therapy should be observed for the following signs of symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma.

   
   


3. 
   

   Desmopressin acetate should not be used to treat patients with Type IIB von Willebrand’s disease since platelet aggregation may be induced.

   
   


4. 
   

   Desmopressin acetate should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.

   
   

Precautions

General:

For injection use only.

Desmopressin Acetate Injection 4 mcg/mL has infrequently produced changes in blood pressure causing either a slight elevation in blood pressure or a transient fall in blood pressure and a compensatory increase in heart rate. The drug should be used with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease.

Desmopressin Acetate Injection should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure and renal disorders, because these patients are prone to hyponatremia.

There have been rare reports of thrombotic events following Desmopressin Acetate Injection 4 mcg/mL in patients predisposed to thrombus formation. No causality has been determined; however, the drug should be used with caution in these patients.

Severe allergic reactions have been reported rarely. Anaphylaxis has been reported rarely with intravenous and intranasal Desmopressin acetate, including isolated cases of fatal anaphylaxis with intravenous Desmopressin acetate. It is not known whether antibodies to Desmopressin Acetate Injection 4 mcg/mL are produced after repeated injections.

Hemophilia A: Laboratory tests for assessing patient status include levels of factor VIII coagulant, factor VIII antigen and factor VIII ristocetin cofactor (von Willebrand factor) as well as activated partial thromboplastin time. Factor VIII coagulant activity should be determined before giving Desmopressin acetate for hemostasis. If factor VIII coagulant activity is present at less than 5% of normal, Desmopressin acetate should not be relied on.

von Willebrand’s Disease: Laboratory tests for assessing patient status include levels of factor VIII coagulant activity, factor VIII ristocetin cofactor activity, and factor VIII von Willebrand factor antigen. The skin bleeding time may be helpful in following these patients.

Diabetes Insipidus: Laboratory tests for monitoring the patient include urine volume and osmolality. In some cases, plasma osmolality may be required.

Drug Interactions:

Although the pressor activity of Desmopressin acetate is very low compared with the antidiuretic activity, use of doses as large as 0.3 mcg/kg of Desmopressin acetate with other pressor agents should be done only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.

Desmopressin acetate has been used with epsilon aminocaproic acid without adverse effects.

Carcinogenicity, Mutagenicity, Impairment of Fertility:

Studies with Desmopressin acetate have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy Category B:

Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 mcg/kg/day (approximately 0.1 times the maximum systemic human exposure in rats and up to 38 times the maximum systemic human exposure in rabbits based on surface area, mg/m2) revealed no harm to the fetus due to Desmopressin acetate. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Several publications of Desmopressin acetate’s use in the management of diabetes insipidus during pregnancy are available; these include a few anecdotal reports of congenital anomalies and low birth weight babies. However, no causal connection between these events and Desmopressin acetate has been established. A fifteen year, Swedish epidemiologic study of the use of Desmopressin acetate in pregnant women with diabetes insipidus found the rate of birth defects to be no greater than that in the general population; however, the statistical power of this study is low. As opposed to preparations containing natural hormones, Desmopressin acetate in antidiuretic doses has no uterotonic action and the physician will have to weigh the therapeutic advantages against the possible risks in each case.

Nursing Mothers:

There have been no controlled studies in nursing mothers. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable Desmopressin acetate in breast milk following an intranasal dose of 10 mcg. 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 Desmopressin acetate is administered to a nursing woman.

Pediatric Use:

Use in infants and pediatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient and/or guardian. See WARNINGS. Desmopressin Acetate Injection 4 mcg/mL should not be used in infants less than three months of age in the treatment of hemophilia A or von Willebrand’s disease; safety and effectiveness in pediatric patients under 12 years of age with diabetes insipidus have not been established.

Geriatric Use:

Clinical studies of Desmopressin Acetate Injection did not include sufficient numbers of subjects aged 65 and over 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. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min). See CLINICAL PHARMACOLOGY: Human Pharmacokinetics and CONTRAINDICATIONS.

Use of Desmopressin acetate injection in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient. See WARNINGS.

Adverse Reactions

Infrequently, Desmopressin acetate has produced transient headache, nausea, mild abdominal cramps and vulval pain. These symptoms disappeared with reduction in dosage. Occasionally, injection of Desmopressin acetate has produced local erythema, swelling or burning pain. Occasional facial flushing has been reported with the administration of Desmopressin acetate. Desmopressin Acetate Injection has infrequently produced changes in blood pressure causing either a slight elevation or a transient fall and a compensatory increase in heart rate. Severe allergic reactions including anaphylaxis have been reported rarely with Desmopressin Acetate Injection.

See WARNINGS for the possibility of water intoxication and hyponatremia.

Post Marketing: There have been rare reports of thrombotic events (acute cerebrovascular thrombosis, acute myocardial infarction) following Desmopressin Acetate Injection in patients predisposed to thrombus formation, and rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutynin and imipramine.

Overdosage

Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. See WARNINGS. In case of overdosage, the dosage should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition.

There is no known specific antidote for Desmopressin acetate or Desmopressin Acetate Injection 4 mcg/mL.

An oral LD50 has not been established. An intravenous dose of 2 mg/kg in mice demonstrated no effect.

Desmopressin Dosage and Administration

Hemophilia A and von Willebrand's Disease (Type I): Desmopressin Acetate Injection 4 mcg/mL is administered as an intravenous infusion at a dose of 0.3 mcg Desmopressin acetate/kg body weight diluted in sterile physiological saline and infused slowly over 15 to 30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended. Blood pressure and pulse should be monitored during infusion. If Desmopressin Acetate Injection 4 mcg/mL is used preoperatively, it should be administered 30 minutes prior to the scheduled procedure.

The necessity for repeat administration of Desmopressin acetate or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than every 48 hours should be considered in treating each patient.

Fluid restriction should be observed. See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.

Diabetes Insipidus: This formulation is administered subcutaneously or by direct intravenous injection. Desmopressin Acetate Injection 4 mcg/mL dosage must be determined for each patient and adjusted according to the pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.

The usual dosage range in adults is 0.5 mL (2 mcg) to 1 mL (4 mcg) daily, administered intravenously or subcutaneously, usually in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For patients who have been controlled on intranasal Desmopressin acetate and who must be switched to the injection form, either because of poor intranasal absorption or because of the need for surgery, the comparable antidiuretic dose of the injection is about one-tenth the intranasal dose.

Fluid restriction should be observed. See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. See CLINICAL PHARMACOLOGY: Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS: Geriatric Use.

How is Desmopressin Supplied

Desmopressin Acetate Injection, USP 4 mcg/mL is available as a clear colorless sterile solution as follows:

NDC No.	Container	Concentration	Fill	Quantity
0409–2265–01	Ampul	4 mcg/mL	1 mL	10 per Box

KEEP REFRIGERATED AT 2° to 8°C (36° to 46°F).

Protect from light.

Keep out of the reach of children.

Revised: September, 2007

Printed in USA	EN-1599
Hospira, Inc., Lake Forest, IL 60045 USA

RL-2298

Desmopressin ACETATE  Desmopressin acetate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-2265 Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Desmopressin ACETATE (Desmopressin) Desmopressin ACETATE 4 ug  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 9 mg  in 1 mL HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-2265-01 10 AMPULE In 1 BOX contains a AMPULE 1 1 mL In 1 AMPULE This package is contained within the BOX (0409-2265-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075220	10/19/2010

Labeler - Hospira, Inc. (141588017)

Revised: 07/2011Hospira, Inc.

More Desmopressin resources

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

• Desmopressin MedFacts Consumer Leaflet (Wolters Kluwer)


• desmopressin Concise Consumer Information (Cerner Multum)


• desmopressin Nasal, Oral, Injection Advanced Consumer (Micromedex) - Includes Dosage Information


• DDAVP Rhinal Tube nasal Concise Consumer Information (Cerner Multum)


• Desmopressin Acetate Monograph (AHFS DI)


• Minirin Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Stimate Spray MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Desmopressin with other medications

• Diabetes Insipidus
• Hemophilia A
• Primary Nocturnal Enuresis
• von Willebrand's Disease

Derma-Smoothe/FS Body Oil

Pronunciation: FLOO-oh-SIN-oh-lone
Generic Name: Fluocinolone
Brand Name: Derma-Smoothe/FS Body Oil and Derma-Smoothe/FS Scalp Oil

Derma-Smoothe/FS Body Oil is used for:

Treating certain inflammatory conditions of the skin. The body oil is used to treat inflammation of the skin. The scalp oil is used to treat psoriasis of the scalp. Derma-Smoothe/FS Body Oil may also be used for other conditions as determined by your doctor.

Derma-Smoothe/FS Body Oil is a topical corticosteroid. Exactly how it works is unknown.

Do NOT use Derma-Smoothe/FS Body Oil if:

• you are allergic to any ingredient in Derma-Smoothe/FS Body Oil

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

Before using Derma-Smoothe/FS Body Oil:

Some medical conditions may interact with Derma-Smoothe/FS Body Oil. 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 are allergic to peanuts


• if you have measles, chickenpox, or tuberculosis


• if you have hardening or thinning of the skin, or a skin infection


• if you have recently been vaccinated or you have had a positive tuberculin skin test

Some MEDICINES MAY INTERACT with Derma-Smoothe/FS Body Oil. Because little, if any, of Derma-Smoothe/FS Body Oil is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Derma-Smoothe/FS Body Oil 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 Derma-Smoothe/FS Body Oil:

Use Derma-Smoothe/FS Body Oil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• To use the body oil in adults: Apply a thin layer of Derma-Smoothe/FS Body Oil to the affected area 3 times a day or as directed by your doctor.


• To use the body oil in children: Moisten the affected area, and then apply a thin layer of Derma-Smoothe/FS Body Oil twice a day for up to 4 weeks or as directed by your doctor.


• To use the scalp oil: Wet or dampen hair and scalp thoroughly, and then apply a thin layer of Derma-Smoothe/FS Body Oil to the scalp. Massage the scalp well, and then cover the scalp with 1 of the shower caps provided. Leave the medicine on overnight or for a minimum of 4 hours before you wash it off of the scalp. Wash your hair with regular shampoo and rinse it thoroughly.


• Wash your hands after applying Derma-Smoothe/FS Body Oil, unless your hands are part of treated area.


• If you miss a dose of Derma-Smoothe/FS Body Oil, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Derma-Smoothe/FS Body Oil.

Important safety information:

• Derma-Smoothe/FS Body Oil is for external use only. Do not get it in your eyes. If you get Derma-Smoothe/FS Body Oil in your eyes, wash them right away with water.


• Derma-Smoothe/FS Body Oil contains refined peanut oil. However, Derma-Smoothe/FS Body Oil has not been known to cause an allergic reaction in patients who have a peanut allergy. If you are allergic to peanuts and have questions about using Derma-Smoothe/FS Body Oil, check with your doctor.


• If your condition does not improve within 2 weeks or if it gets worse, contact your doctor.


• Do not use Derma-Smoothe/FS Body Oil on the face, under the arms, or on the groin unless directed otherwise by your doctor.


• Derma-Smoothe/FS Body Oil has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not use Derma-Smoothe/FS Body Oil for any conditions other than the one for which it was prescribed.


• Check with your doctor before having vaccinations while using Derma-Smoothe/FS Body Oil.


• Derma-Smoothe/FS Body Oil is not approved to treat diaper rash. Do not apply Derma-Smoothe/FS Body Oil to the diaper area of a child.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Derma-Smoothe/FS Body Oil.


• The body oil should not be used in children younger than 3 months old. The scalp oil should not be used in CHILDREN younger than 2 years old. 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 Derma-Smoothe/FS Body Oil while you are pregnant. It is not known if Derma-Smoothe/FS Body Oil is found in breast milk after topical use. If you are or will be breast-feeding while you use Derma-Smoothe/FS Body Oil, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Derma-Smoothe/FS Body Oil:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the scalp oil after topical use. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; lightening of the skin; mild fever; nose or throat inflammation; runny nose.

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); acne-like rash; excessive hair growth; inflamed hair follicles; inflammation around the mouth; irritation, burning, redness, or swelling not present before using Derma-Smoothe/FS Body Oil; thinning, softening, or discoloration of the 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: Derma-Smoothe/FS Body 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Derma-Smoothe/FS Body Oil:

Store Derma-Smoothe/FS Body Oil 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 Derma-Smoothe/FS Body Oil out of the reach of children and away from pets.

General information:

• If you have any questions about Derma-Smoothe/FS Body Oil, please talk with your doctor, pharmacist, or other health care provider.


• Derma-Smoothe/FS Body Oil 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 Derma-Smoothe/FS Body Oil. 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 Derma-Smoothe/FS Body resources

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

Compare Derma-Smoothe/FS Body with other medications

• Atopic Dermatitis
• Dermatitis
• Lichen Sclerosus

Abovis

Abovis may be available in the countries listed below.

Ingredient matches for Abovis

Aclatonium Napadisilate

Aclatonium Napadisilate is reported as an ingredient of Abovis in the following countries:

• Japan

International Drug Name Search