Calcitriol Injection

Dosage Form: injection
Calcitriol Injection, 1 mcg/mL

Rx Only

DESCRIPTION

Calcitriol Injection is synthetically manufactured calcitriol and is available as a sterile, isotonic, clear, colorless to yellow, aqueous solution for intravenous injection. Calcitriol is available in 1 mL ampules. Each 1 mL contains: Calcitriol 1 mcg; Polysorbate 20, 4 mg; Sodium Chloride 1.5 mg; Sodium Ascorbate 10 mg added; Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Edetate Disodium, Dihydrate 1.1 mg added; Water for Injection q.s. pH range 6.7-7.7.

Calcitriol is a crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water. Calcitriol is chemically designated (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol and has the following structural formula:

Molecular Formula: C27H44O3

The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1α,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.

CLINICAL PHARMACOLOGY

Calcitriol is the active form of vitamin D3 (cholecalciferol). The natural or endogenous supply of vitamin D in man mainly depends on ultraviolet light for conversion of 7-dehydrocholesterol to vitamin D3 in the skin. Vitamin D3 must be metabolically activated in the liver and the kidney before it is fully active on its target tissues. The initial transformation is catalyzed by a vitamin D3-25-hydroxylase enzyme present in the liver, and the product of this reaction is 25-(OH)D3 (calcifediol). The latter undergoes hydroxylation in the mitochondria of kidney tissue, and this reaction is activated by the renal 25-hydroxyvitamin D3-1-α-hydroxylase to produce 1,25-(OH)2D3 (calcitriol), the active form of vitamin D3.

The known sites of action of calcitriol are intestine, bone, kidney and parathyroid gland. Calcitriol is the most active known form of vitamin D3 in stimulating intestinal calcium transport. In acutely uremic rats, calcitriol has been shown to stimulate intestinal calcium absorption. In bone, calcitriol, in conjunction with parathyroid hormone, stimulates resorption of calcium; and in the kidney, calcitriol increases the tubular reabsorption of calcium. In-vitro and in-vivo studies have shown that calcitriol directly suppresses secretion and synthesis of PTH. A vitamin D-resistant state may exist in uremic patients because of the failure of the kidney to adequately convert precursors to the active compound, calcitriol.

Calcitriol when administered by bolus injection is rapidly available in the blood stream. Vitamin D metabolites are known to be transported in blood, bound to specific plasma proteins. The pharmacologic activity of an administered dose of calcitriol is about 3 to 5 days. Two metabolic pathways for calcitriol have been identified, conversion to 1,24,25-(OH)3D3 and to calcitroic acid.

INDICATIONS AND USAGE

Calcitriol Injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.

CONTRAINDICATIONS

Calcitriol Injection should not be given to patients with hypercalcemia or evidence of vitamin D toxicity.

WARNINGS

Since calcitriol is the most potent metabolite of vitamin D available, vitamin D and its derivatives should be withheld during treatment.

A non-aluminum phosphate-binding compound should be used to control serum phosphorus levels in patients undergoing dialysis.

Overdosage of any form of vitamin D is dangerous (see also OVERDOSAGE). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis and other soft-tissue calcification. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70. Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition.

PRECAUTIONS

1.  General

Excessive dosage of Calcitriol Injection induces hypercalcemia and in some instances hypercalciuria; therefore, early in treatment during dosage adjustment, serum calcium and phosphorus should be determined at least twice weekly. Should hypercalcemia develop, the drug should be discontinued immediately.

Calcitriol Injection should be given cautiously to patients on digitalis, because hypercalcemia in such patients may precipitate cardiac arrhythmias.

2.  Information for Patients

The patient and his or her parents should be informed about adherence to instructions about diet and calcium supplementation and avoidance of the use of unapproved non-prescription drugs, including magnesium-containing antacids. Patients should also be carefully informed about the symptoms of hypercalcemia (see ADVERSE REACTIONS).

3.  Essential Laboratory Tests

Serum calcium, phosphorus, magnesium and alkaline phosphatase and 24-hour urinary calcium and phosphorus should be determined periodically. During the initial phase of the medication, serum calcium and phosphorus should be determined more frequently (twice weekly).

Adynamic bone disease may develop if PTH  levels are suppressed to abnormal levels. If biopsy is not being done for other (diagnostic) reasons, PTH levels may be used to indicate the rate of bone turnover. If PTH levels fall below recommended target range (1.5 to 3 times the upper limit of normal), in patients treated with Calcitriol Injection, the Calcitriol Injection dose should be reduced or therapy discontinued. Discontinuation of Calcitriol Injection therapy may result in rebound effect, therefore, appropriate titration downward to a maintenance dose is recommended.

4.  Drug Interactions

Magnesium-containing antacid and Calcitriol Injection should not be used concomitantly, because such use may lead to the development of hypermagnesemia.

5.  Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of Calcitriol Injection. Calcitriol was not mutagenic in vitro in the Ames test nor was oral calcitriol genotoxic in vivo in the Mouse Micronucleus Test. No significant effects on fertility and/or general reproductive performances were observed in a Segment I study in rats using oral calcitriol at doses of up to 0.3 mcg/kg.

6.  Pregnancy

Teratogenic Effects

Pregnancy Category C:

Calcitriol has been found to be teratogenic in rabbits when given orally at doses of 0.08 and 0.3 mcg/kg. All 15 fetuses in 3 litters at these doses showed external and skeletal abnormalities. However, none of the other 23 litters (156 fetuses) showed external and skeletal abnormalities compared with controls. Teratogenicity studies in rats at doses up to 0.45 mcg/kg orally showed no evidence of teratogenic potential. There are no adequate and well-controlled studies in pregnant women. Calcitriol Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: In the rabbit, oral dosages of 0.3 mcg/kg/day administered on days 7 to 18 of gestation resulted in 19% maternal mortality, a decrease in mean fetal body weight and a reduced number of newborns surviving to 24 hours. A study of the effects on orally administered calcitriol on peri- and postnatal development in rats resulted in hypercalcemia in the offspring of dams given calcitriol at doses of 0.08 or 0.3 mcg/kg/day, hypercalcemia and hypophosphatemia in dams given calcitriol at a dose of 0.08 or 0.3 mcg/kg/day and increased serum urea nitrogen in dams given calcitriol at a dose of 0.3 mcg/kg/day. In another study in rats, maternal weight gain was slightly reduced at an oral dose of 0.3 mcg/kg/day administered on days 7 to 15 of gestation.

The offspring of a woman administered oral calcitriol at 17 to 36 mcg/day during pregnancy manifested mild hypercalcemia in the first 2 days of life which returned to normal at day 3.

7.  Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from calcitriol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.  Pediatric Use

The safety and effectiveness of Calcitriol Injection were examined in a 12-week randomized, double-blind, placebo-controlled study of 35 pediatric patients, aged 13-18 years, with end-stage renal disease on hemodialysis.  Sixty-six percent of the patients were male, 57% were African-American, and nearly all had received some form of vitamin D therapy prior to the study.  The initial dose of Calcitriol Injection was 0.5 mcg, 1 mcg, or 1.5 mcg, 3 times per week, based on baseline iPTH level of less than 500 pg/mL, 500-1000 pg/mL, or greater than 1000 pg/mL, respectively.  The dose of Calcitriol Injection was adjusted in 0.25 mcg increments based on the levels of serum iPTH, calcium, and Ca x P.  The mean baseline levels of iPTH were 769 pg/mL for the 16 Calcitriol Injection-treated patients and 897 pg/mL for the 19 placebo-treated subjects.  The mean weekly dose of Calcitriol Injection ranged from 1 mcg to 1.4 mcg.  In the primary efficacy analysis, 7 of 16 (44%) subjects in the Calcitriol Injection group had 2 consecutive 30% decreases from baseline iPTH compared with 3 of 19 (16%) patients in the placebo group (95% CI for the difference between groups -6%, 62%).  One Calcitriol Injection-treated patient experienced transient hypercalcemia (>11 mg/dL), while 6 of 16 (38%) Calcitriol Injection-treated patients vs. 2 of 19 (11%) placebo-treated patients experienced Ca x P >75.

9.  Geriatric Use

Clinical studies of Calcitriol 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 for an elderly patient should be cautious, usually starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

Adverse effects of Calcitriol Injection are, in general, similar to those encountered with excessive vitamin D intake. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:

1. EarlyWeakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain and metallic taste.


2. LatePolyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT and SGPT, ectopic calcification, hypertension, cardiac arrhythmias and, rarely, overt psychosis.

Occasional mild pain on injection has been observed.

Post-Marketing Experience Rare cases of hypersensitivity reactions have been reported, including anaphylaxis.

OVERDOSAGE

Administration of Calcitriol Injection to patients in excess of their requirements can cause hypercalcemia, hypercalciuria and hyperphosphatemia. High intake of calcium and phosphate concomitant with calcitriol  injection may lead to similar abnormalities.

1.  Treatment of Hypercalcemia and Overdosage in Patients on Hemodialysis

General treatment of hypercalcemia (greater than 1 mg/dL above the upper limit of normal range) consists of immediate discontinuation of Calcitriol Injection therapy, institution of a low calcium diet and withdrawal of calcium supplements. Serum calcium levels should be determined daily until normocalcemia ensues. Hypercalcemia usually resolves in two to seven days. When serum calcium levels have returned to within normal limits, Calcitriol Injection therapy may be reinstituted at a dose 0.5 mcg less than prior therapy. Serum calcium levels should be obtained at least twice weekly after all dosage changes.

Persistent or markedly elevated serum calcium levels may be corrected by dialysis against a calcium-free dialysate.

2.  Treatment of Accidental Overdosage of Calcitriol Injection The treatment of acute accidental overdosage of Calcitriol Injection should consist of general supportive measures. Serial serum electrolyte determinations (especially calcium), rate of urinary calcium excretion and assessment of electrocardiographic abnormalities due to hypercalcemia should be obtained. Such monitoring is critical in patients receiving digitalis. Discontinuation of supplemental calcium and low calcium diet are also indicated in accidental overdosage. Due to the relatively short duration of the pharmacological action of calcitriol, further measures are probably unnecessary. Should, however, persistent and markedly elevated serum calcium levels occur, there are a variety of therapeutic alternatives which may be considered, depending on the patients’ underlying condition. These include the use of drugs such as phosphates and corticosteroids as well as measures to induce an appropriate forced diuresis. The use of peritoneal dialysis against a calcium-free dialysate has also been reported.

DOSAGE AND ADMINISTRATION

The optimal dose Calcitriol Injection must be carefully determined for each patient.

The effectiveness of Calcitriol Injection therapy is predicated on the assumption that each patient is receiving an adequate and appropriate daily intake of calcium. The RDA for calcium in adults is 800 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

The recommended initial dose of Calcitriol Injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals. During this titration period, serum calcium and phosphorus levels should be obtained at least twice weekly. If hypercalcemia or a serum calcium times phosphate product greater than 70 is noted, the drug should be immediately discontinued until these parameters are appropriate. Then, the Calcitriol Injection dose should be reinitiated at a lower dose. Doses may need to be reduced as the PTH levels decrease in response to the therapy. Thus, incremental dosing must be individualized and commensurate with PTH, serum calcium and phosphorus levels.

The following is a suggested approach in dose titration:

PTH Levels	Calcitriol Dose
the same or increasing	increase
decreasing by <30%	increase
decreasing by >30%, <60%	maintain
decreasing by >60%	decrease
one and one-half to three times the upper limit of normal	maintain

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

Discard unused portion

WARNING: PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).

HOW SUPPLIED

Calcitriol Injection NDC 0517-0132-25       1 mcg/mL       1 mL ampules         Boxed in 25

AMERICAN REGENT, INC.

SHIRLEY, NY  11967

IN0132

Rev. 6/08

MG #15726

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 1 mL Carton

Calcitriol Injection

1 mcg/mL

NDC 0517-0132-25

25 x 1 mL Ampules

FOR INTRAVENOUS USE

Rx Only

Each mL contains: Calcitriol 1 mcg; Polysorbate 20, 4 mg; Sodium Chloride 1.5 mg; Sodium Ascorbate 10 mg added; Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Edetate Disodium, Dihydrate 1.1 mg added; Water for Injection q.s.  pH range 6.7 to 7.7. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) (See USP Controlled RoomTemperature).

WARNING: Protect from light. Retain ampules in carton until time of use.

Directions for Use: See Package Insert.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

CALCITRIOL  calcitriol  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0517-0132 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCITRIOL (CALCITRIOL) CALCITRIOL 1 ug  in 1 mL

Inactive Ingredients Ingredient Name Strength POLYSORBATE 20 4 mg  in 1 mL SODIUM CHLORIDE 1.5 mg  in 1 mL SODIUM ASCORBATE 10 mg  in 1 mL SODIUM PHOSPHATE, DIBASIC ANHYDROUS 7.6 mg  in 1 mL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.8 mg  in 1 mL EDETATE DISODIUM 1.1 mg  in 1 mL WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0517-0132-25 25 AMPULE In 1 CARTON contains a AMPULE 1 1 mL In 1 AMPULE This package is contained within the CARTON (0517-0132-25)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075746	03/14/2005

Labeler - American Regent, Inc. (622781813)

Revised: 09/2011American Regent, Inc.

More Calcitriol Injection resources

• Calcitriol Injection Use in Pregnancy & Breastfeeding
• Drug Images
• Calcitriol Injection Drug Interactions
• Calcitriol Injection Support Group
• 4 Reviews for Calcitriol Injection - Add your own review/rating

Compare Calcitriol Injection with other medications

• Hypocalcemia
• Hypoparathyroidism
• Renal Osteodystrophy
• Rickets
• Secondary Hyperparathyroidism

Stimate nasal

Generic Name: desmopressin (nasal) (DEZ mo press in)

Brand Names: DDAVP Nasal, DDAVP Rhinal Tube, Stimate

What is Stimate (desmopressin (nasal))?

Desmopressin is a man-made form of a hormone that occurs naturally in the pituitary gland. This hormone is important for many functions including blood flow, blood pressure, kidney function, and regulating how the body uses water.

Desmopressin nasal is used to treat central cranial diabetes insipidus, and increased thirst and urination caused by head surgery or head trauma.

Desmopressin nasal is also used to treat hemophilia A or von Willebrand's disease Type I.

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

What is the most important information I should know about Stimate (desmopressin (nasal))?

It is very important to reduce your intake of water and other fluids while you are using desmopressin. Drinking too much water can cause your body to lose sodium, which may lead to a serious, life-threatening electrolyte imbalance.

Fluid restriction is especially important in children and older adults using desmopressin nasal. Follow your doctor's instructions about the type and amount of liquids you should drink.

You should not use this medication if you have severe kidney disease or if you have ever had hyponatremia (low sodium levels in your body).

Before using desmopressin nasal, tell your doctor if you have heart disease, coronary artery disease, congestive heart failure, kidney disease, cystic fibrosis, high or low blood pressure, an electrolyte imbalance, or a psychological disorder that causes extreme or unusual thirst.

Desmopressin nasal may be less effective if you have any swelling or scarring inside your nose, or any nasal or sinus problems (such as deviated septum).

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To be sure desmopressin nasal is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with this medication. Do not miss any scheduled appointments.

What should I discuss with my healthcare provider before using Stimate (desmopressin (nasal))?

You should not use this medication if you are allergic to desmopressin, or if you have:

• 
  

  severe kidney disease; or

  
  


• 
  

  if you have ever had hyponatremia (low sodium levels in your body).

  
  

Before using desmopressin nasal, tell your doctor if you are allergic to any medications, or if you have:

• 
  

  heart disease, coronary artery disease;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  kidney disease;

  
  


• 
  

  cystic fibrosis;

  
  


• 
  

  high or low blood pressure;

  
  


• 
  

  an electrolyte imbalance; or

  
  


• 
  

  a psychologic disorder that causes extreme or unusual thirst.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely use desmopressin.

Desmopressin nasal may be less effective if you have any swelling or scarring inside your nose, or any nasal or sinus problems (such as deviated septum).

FDA pregnancy category B. This medication is not expected to harm an unborn baby. Do not use desmopressin nasal without telling your doctor if you are pregnant. It is not known whether desmopressin nasal passes into breast milk, or if it could harm a nursing baby. Do not use desmopressin nasal without telling your doctor if you are breast-feeding a baby.

How should I use Stimate (desmopressin (nasal))?

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

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

It is very important to reduce your intake of water and other fluids while you are using desmopressin. Drinking too much water can cause your body to lose sodium, which may lead to a serious, life-threatening electrolyte imbalance.

Fluid restriction is especially important in children and older adults using desmopressin nasal. Follow your doctor's instructions about the type and amount of liquids you should drink.

Before using desmopressin nasal spray for the first time, prime the spray pump by pressing down on the pump 4 times.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with desmopressin nasal. Do not miss any scheduled appointments.

Keep track of how many sprays have been used from each bottle of desmopressin nasal spray. Stimate nasal spray contains enough desmopressin for the priming spray plus 25 full sprays. DDAVP nasal spray contains enough desmopressin for the priming spray plus 50 sprays. Your patient instructions may include a check-off chart to help you keep an accurate record or sprays you use. If you are treating hemophilia or von Willebrand's disease, call your doctor if your bleeding is not controlled during treatment with desmopressin nasal.

The desmopressin nasal spray bottle should be thrown away after the specified number of sprays have been used, even if there is medicine leftover in the bottle. Do not try to pour solution from one bottle to another.

Store DDAVP nasal spray at room temperature away from moisture and heat. Keep the bottle in an upright position when not in use. Store Stimate nasal spray or DDAVP Rhinal Tube in the refrigerator. Do not freeze. If refrigeration is not available, you may keep the closed bottles at room temperature for up to 3 weeks.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed 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.

Overdose symptoms may include headache, confusion, drowsiness, rapid weight gain, or urination problems.

What should I avoid while using Stimate (desmopressin (nasal))?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using desmopressin.

Stimate (desmopressin (nasal)) side effects

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

• 
  

  nausea, vomiting, weakness, loss of appetite, headache, feeling restless or irritable, confusion, hallucinations, muscle pain or weakness, and/or seizure;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  swelling;

  
  


• 
  

  chest pain, fast or pounding heart rate;

  
  


• 
  

  vaginal pain;

  
  


• 
  

  nosebleed; or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  runny or stuffy nose;

  
  


• 
  

  sore throat, cough, or other cold symptoms;

  
  


• 
  

  eye redness or watering;

  
  


• 
  

  eye itching or increased sensitivity to light;

  
  


• 
  

  headache, weakness;

  
  


• 
  

  feeling dizzy or agitated;

  
  


• 
  

  nausea, vomiting, stomach pain;

  
  


• 
  

  hot or cold feeling; or

  
  


• 
  

  warmth, redness, or tingly feeling in your face.

  
  

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 Stimate (desmopressin (nasal))?

Many drugs can interact with desmopressin nasal. Below is just a partial list. Tell your doctor if you are using:

• 
  

  carbamazepine (Carbatrol, Tegretol);

  
  


• 
  

  chlorpromazine (Thorazine);

  
  


• 
  

  lamotrigine (Lamictal);

  
  


• 
  

  oxybutynin (Ditropan, Urotrol, Oxytrol);

  
  


• 
  

  vasopressin (Pitressin);

  
  


• 
  

  a narcotic pain medicine such as fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), oxycodone (Oxycontin), and others;

  
  


• 
  

  an "SSRI" antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft);

  
  


• 
  

  a tricyclic antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), and others;

  
  


• 
  

  medicine to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);

  
  


• 
  

  drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), and others.

  
  

This list is not complete and there may be other drugs that can interact with desmopressin nasal. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Stimate resources

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

Compare Stimate with other medications

• Hemophilia A
• von Willebrand's Disease

Where can I get more information?

• Your pharmacist can provide more information about desmopressin nasal.

See also: Stimate side effects (in more detail)

Proctocream HC

Generic Name: hydrocortisone

Dosage Form: cream
proctocream® HC 2.5%

(hydrocortisone cream, USP 2.5%)

Rx only topical 6-141-30-01-0510

Rev 05/10

DESCRIPTION: proctocream®•HC 2.5% contains Hydrocortisone [Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β-] with the molecular formula C21H30O5 and a molecular weight of 362.47, CAS 50-23-7. Each gram for topical administration contains: 25 mg of hydrocortisone in a base of glyceryl monostearate. polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water.

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

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

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

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus occlusive dressings may be a valuable therapeutic adjunct for treatment of resistance dermatoses (See DOSAGE AND ADMINISTRATION).

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

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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

PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

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

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS – Pediatric Use).

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

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

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

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


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


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


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


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

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

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

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

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

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

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

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

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

DOSAGE AND ADMINISTRATION: Apply to the affected area as a thin film 2 to 4 times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED: proctocream®•HC 2.5% (hydrocortisone cream USP, 2.5%) is supplied in 30 gram tubes.

                             30 g                              NDC 68220-141-30

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

Manufactured for:

ALAVEN Pharmaceutical LLC

Marietta, GA 30062, USA                                                                                                                  6 - 141 - 30 - 01 - 0510

By: Nycomed US Inc.                                                                                                                                     Rev. 05/10

Melville, New York 11747                                                                                                               I5607 ALAVEN R5/10

For Medical Inquiries, call 1-888-317-0001                                                                                                       #49

Principal Display Panel – 30 g Tube

NDC 68220-141-30

proctocream® HC 2.5%

(hydrocortisone cream, USP 2.5%)

30 grams net wt                   ALAVEN®

Pharmaceutical LLC

Rx only

KEEP OUT OF REACH OF CHILDREN            FOR EXTERNAL USE ONLY            NOT FOR OPHTHALMIC USE

SEE CRIMP OF TUBE FOR LOT NUMBER AND EXPIRATION DATE.

SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.

DESCRIPTION: proctocream® HC 2.5% is a topical preparation containing 25 mg of hydrocortisone per gram in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water.

DIRECTIONS: 2 to 4 APPLICATIONS DAILY.                                                                  6 - 141 - 30 - 09 - 0810

IMPORTANT: Do not use if seal has been punctured or is not visible.                              W5607 R8/10

TO OPEN: Use cap to puncture seal.

Store at 25°C (77°F); excursions 15-30°C (59-86°F)

Manufactured for:                                            By:

ALAVEN Pharmaceutical LLC                      Nycomed US Inc.

Marietta, GA 30062, USA                              Melville, New York 11747

PROCTOCREAM  HC hydrocortisone  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68220-141 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE   POLYOXYL 40 STEARATE   GLYCERIN   PARAFFIN   STEARYL ALCOHOL   ISOPROPYL PALMITATE   SORBITAN MONOSTEARATE   BENZYL ALCOHOL   POTASSIUM SORBATE   LACTIC ACID   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68220-141-30 1 TUBE In 1 CARTON contains a TUBE 1 30 g In 1 TUBE This package is contained within the CARTON (68220-141-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA089414	03/18/2011

Labeler - Alaven Pharmaceutical LLC (140210829)

Revised: 03/2011Alaven Pharmaceutical LLC

More Proctocream HC resources

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

• Proctocream HC Concise Consumer Information (Cerner Multum)


• Analpram E Concise Consumer Information (Cerner Multum)


• Analpram-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Epifoam Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Novacort MedFacts Consumer Leaflet (Wolters Kluwer)


• Pramosone Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctofoam HC Foam MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Proctocream HC with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Ulcerative Colitis, Active

tesamorelin

Generic Name: tesamorelin (TES a moe REL in)

Brand Names: Egrifta

What is tesamorelin?

Tesamorelin is made with growth hormone-releasing factor (GRF).

Tesamorelin is used to reduce excess fat around the stomach that is caused by taking certain HIV medications. This condition is also called lipodystrophy (LYE-poe-DIS-troe-fee).

Tesamorelin is not a weight-loss medication and should not be used to treat obesity.

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

Tesamorelin can harm an unborn baby or cause birth defects. Do not use if you are pregnant. You should not use tesamorelin if you are allergic to it, or if you have a history of tumor or surgery of your pituitary gland, a history of head injury or radiation treatment,

Before using tesamorelin, tell your doctor if you have heart disease, high blood pressure, kidney disease, diabetes, epilepsy, asthma, migraines, an adrenal gland disorder, or if you have ever had cancer, any type of tumor, or open heart surgery.

Also tell your doctor about any major illness or recent trauma or medical emergency.

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

You should not use tesamorelin if you are allergic to it, or if you have:

• 
  

  cancer;

  
  


• 
  

  a pituitary gland disorder;

  
  


• 
  

  a history of pituitary gland tumor or surgery;

  
  


• 
  

  a history of head injury or radiation treatment; or

  
  


• 
  

  if you are pregnant.

  
  

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

• 
  

  a history of cancer or any tumor (either benign or malignant);

  
  


• 
  

  heart disease, high blood pressure;

  
  


• 
  

  kidney disease;

  
  


• 
  

  diabetes, eye problems caused by diabetes;

  
  


• 
  

  epilepsy

  
  


• 
  

  asthma;

  
  


• 
  

  migraine headaches;

  
  


• 
  

  adrenal gland disorder;

  
  


• 
  

  if you have ever had open heart surgery; or

  
  


• 
  

  if you have any major illness, or a recent trauma or medical emergency.

  
  

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use tesamorelin if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Do not give this medicine to a child without medical advice.

How tesamorelin given?

Tesamorelin is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with injection instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Tesamorelin is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. After mixing tesamorelin with a diluent, you must use it right away. Do not store the mixture for later use.

Tesamorelin is usually given once per day. Follow your doctor's dosing instructions very carefully.

Use a different place on your stomach each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Never share a tesamorelin syringe with another person, even if you change the needle. Sharing syringes or needles can allow HIV or other diseases to pass from one person to another.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any follow-up visits to your doctor.

Store vials of tesamorelin powder in the refrigerator, do not freeze. Store the diluent at room temperature away from moisture, heat, and light.

Throw away any unused vials after the expiration date on the label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of tesamorelin.

What happens if I overdose?

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

What should I avoid while using tesamorelin?

Do not inject this medicine into scar tissue or on skin that is bruised. Do not inject directly into your navel (belly-button).

Tesamorelin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using tesamorelin and call your doctor at once if you have a serious side effect such as:

• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  pain or stiffness in your muscles or joints;

  
  


• 
  

  pain in your arms or legs;

  
  


• 
  

  wrist pain or numbness;

  
  


• 
  

  numbness or tingling in your hands or fingers;

  
  


• 
  

  pounding heartbeats or fluttering in your chest;

  
  


• 
  

  high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

  
  

Less serious side effects may include:

• 
  

  depressed mood, sleep problems (insomnia);

  
  


• 
  

  night sweats;

  
  


• 
  

  mild rash or itching;

  
  


• 
  

  muscle spasm;

  
  


• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  pain, redness, itching, swelling, bruising, bleeding, or other irritation where the injection was given;

  
  

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

Tesamorelin Dosing Information

Usual Adult Dose for Lipodystrophy:

For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy:
2 mg injected subcutaneously once a day.

What other drugs will affect tesamorelin?

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

• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  testosterone or hormone replacement therapy;

  
  


• 
  

  seizure medication;

  
  


• 
  

  steroids (prednisone and others);

  
  

This list is not complete and there are many other drugs that can interact with tesamorelin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More tesamorelin resources

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

• tesamorelin Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information


• Tesamorelin Professional Patient Advice (Wolters Kluwer)


• Tesamorelin MedFacts Consumer Leaflet (Wolters Kluwer)


• Egrifta Prescribing Information (FDA)


• Egrifta Consumer Overview

Compare tesamorelin with other medications

• Lipodystrophy

Where can I get more information?

• Your pharmacist can provide more information about tesamorelin.

See also: tesamorelin side effects (in more detail)

Major Pharmaceuticals

Address Major Pharmaceuticals, 31778 Enterprise Drive Livonia MI 48150 Contact Details Phone: (734) 743-6161 Website: http://www.majorpharmaceuticals.com/ Careers: http://www.majorpharmaceuticals.com...

Albumin (Human) 20%

FULL PRESCRIBING INFORMATION

Indications and Usage for Albumin (Human) 20%

Hypovolemia

Albumin (Human) 20% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [1, 2]

When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [1 ]

Hypoalbuminemia

For subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, ALBUMIN (HUMAN) 20% infusions may be indicated. [3 ] When albumin deficit is the result of excessive protein loss, the effect of administration of Albumin (Human) 20% will be temporary unless the underlying disorder is reversed.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites (Treatment Adjunct)

Albumin (Human) 20% may be used to maintain cardiovascular function following the removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites. [2 ]

Ovarian Hyperstimulation Syndrome (OHSS)

Albumin (Human) 20% may be used as a plasma expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome (OHSS). [7, 8]

Adult Respiratory Distress Syndrome (ARDS) (Treatment Adjunct)

Albumin (Human) 20% infusions may be indicated in conjunction with diuretics to correct the fluid volume overload associated with ARDS. [5 ]

Acute Nephrosis (Treatment Adjunct)

Albumin (Human) 20% may be used to treat edema in patients with acute nephrosis who are refractory to cyclophosphamide and corticosteroid therapy. [1 ]

Hemolytic Disease of the Newborn (HDN)

Albumin (Human) 20% is indicated in the treatment of hyperbilirubinemia. It may be used prior to or during an exchange procedure in an attempt to bind free and to enhance its removal. [6 ]

Albumin (Human) 20% Dosage and Administration

Dosage

General Recommendations

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.

The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.

The daily dose should not exceed 2 g of Albumin (Human) 20% per kg of body weight.

Hypovolemia

In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

Hemodilution may follow administration of Albumin (Human) 20%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.

Hypoalbuminemia

In adults, intravenous infusion of 50 to 75 g of Albumin (Human) 20% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.

In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, Albumin (Human) 20% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites

In adults, intravenous infusion of 8 g of Albumin (Human) 20% may be given for every 1,000 mL of ascitic fluid removed.

Ovarian Hyperstimulation Syndrome

In adults, as a guideline, doses of 50 – 100 g of Albumin (Human) 20% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [7 ]

Adult Respiratory Distress Syndrome (ARDS)

In adults, a dose of 25 g of Albumin (Human) 20% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [5 ]

Induction of Diuresis in Patients with Acute Nephrosis

In adults, a dose of 25 g of Albumin (Human) 20% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.

Hemolytic Disease of the Newborn

In newborns, Albumin (Human) 20% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [6 ]

Administration

Intravenous use only.

Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.

Do not dilute with sterile water for injection.

Do not use solutions of Albumin (Human) 20% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of Albumin (Human) 20% is not required.

The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.

If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.

Dosage Forms and Strengths

Albumin (Human) 20% is supplied in

• 10 g in 50 mL infusion bottle


• 20 g in 100 mL infusion bottle

Do not use in individuals who are hypersensitive to albumin preparations, any ingredient in the formulation, or components of the container.

Warnings and Precautions

Hypersensitivity

Hypersensitivity or allergic reactions have been observed, and may in some cases progress to severe anaphylaxis. Epinephrine should be available immediately to treat any acute hypersensitivity reaction.

Hypervolemia/Hemodilution

Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. At the first clinical signs of possible cardiovascular overload, e.g., headache, dyspnea, increased blood pressure, jugular venous distention, elevated central venous pressure, pulmonary edema, the infusion should be stopped immediately and the patient reevaluated. Albumin should be used with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk for the patient. Examples of such conditions are:

• Decompensated cardiac insufficiency


• Hypertension


• Esophageal varices


• Pulmonary edema


• Hemorrhagic diathesis


• Severe anemia


• Renal and post-renal anuria.

20-25% Albumin (Human) is relatively low in electrolytes compared to the 4-5% Albumin (Human) solutions. When albumin is given, monitor the electrolyte status of the patient and take appropriate steps to restore or maintain the electrolyte balance.

Coagulation Abnormalities

If comparatively large volumes are to be replaced, monitoring of coagulation and hematocrit is necessary. Ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).

Laboratory Monitoring

If Albumin (Human) 20% is to be administered, monitor hemodynamic performance regularly; this may include:

• Arterial blood pressure and pulse rate


• Central venous pressure


• Pulmonary artery occlusion pressure


• Urine output


• Electrolytes


• Hematocrit/hemoglobin.

Albumin (Human) 20% must not be diluted with sterile water for injection as this may cause hemolysis in recipients.

Infection Risk from Human Plasma

This product is a derivative of human plasma. Based on effective donor screening and product manufacturing processes it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have been identified for Albumin (Human) 20%.

Adverse Reactions

General

The most serious events are anaphylactic shock, circulatory failure, cardiac failure, and pulmonary edema.

The most common adverse events are anaphylactoid type of reactions.

Adverse reactions for Albumin (Human) 20% normally resolve when the infusion rate is slowed down or the infusion is stopped. In case of severe reactions, the infusion should be stopped and appropriate treatment should be initiated.

Clinical Studies Experience

No clinical studies were done using Albumin (Human) 20%

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ALBUMIN (HUMAN) (any strength). Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency.

Table 1 Adverse reactions observed for ALBUMIN HUMAN (any strength) during post-marketing phase (in decreasing order of severity)

Observed Adverse Reactions
anaphylactic shock
cardiac failure
loss of consciousness
circulatory failure
hypersensitivity
congestive heart failure
pulmonary edema
dyspnea
hypotension
hypertension
tachycardia
bradycardia
vomiting
urticaria
angioneurotic edema
rash erythematous
confusional state
headache
chills
pyrexia
flushing
nausea
pruritus
hyperhidrosis

No drug interaction studies have been conducted.

Drug Interactions

No drug interaction studies have been conducted.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been performed with Albumin (Human) 20%. It is also not known whether Albumin (Human) 20% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albumin (Human) 20% should be given to a pregnant woman only if necessary.

Labor and Delivery

It is also not known whether Albumin (Human) 20% can cause fetal harm when administered to a woman during labor or delivery of if it will affect reproductive capacity. Albumin (Human) 20% should be given during labor or delivery only if necessary.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Albumin (Human) 20% should be given to nursing mothers only if necessary. Because many drugs are excreted in human milk, caution should be exercised when Albumin (Human) 20% is administered to a lactating woman.

Pediatric Use

Data on the use of Albumin (Human) 20% in children including premature babies are very limited. The product should be administered to pediatric patients only if needed.

Geriatric Use

Clinical studies did not include a sufficient number of subjects aged 65 and older to determine whether they respond differently from younger subjects.

Albumin (Human) 20% Description

Albumin (Human) 20% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of Albumin (Human) 20% are provided by FDA approved blood establishments only.

The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The Albumin (Human) 20% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including Cohn fractionation and final container pasteurization.

No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma.[see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]

Table 2 In vitro reduction factor during Albumin (Human) 20% manufacturing

PRV:Pseudorabies Virus

SBV: Sindbis Virus

HIV-1:Human Immunodeficiency Virus - 1

Reo 3:Reovirus Type 3

PPV:Porcine Parvovirus

HAV:Hepatitis A Virus

Albumin (Human) 20% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green.

The composition of Albumin (Human) 20% is as follows:

Component		Quantity/1000 ml
Protein, of which greater than or equal to
96% is human albumin		200 g
Sodium		130 – 160 mmol
Potassium		less than or equal to 2 mmol
N-acetyl-DL-tryptophan		0.064 - 0.096 mmol/g protein
Caprylic acid		0.064 - 0.096 mmol/g protein
Water for Injection		ad. 1000 ml

Albumin (Human) 20% contains no preservatives and components used in its packaging are latex-free.

Albumin (Human) 20% - Clinical Pharmacology

No pharmacokinetic or pharmacodynamic studies with Albumin (Human) 20% have been conducted.

Mechanism of Action

Albumin is responsible for 75-80% of the colloid osmotic pressure of normal plasma. Albumin stabilizes circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins. [3 ]

Albumin is a protein with a total extravascular mass of approximately 160 g and an intravascular mass of about 120 g. [3 ]

Pharmacodynamics

The colloid osmotic effect of Albumin (Human) 20% and 25% is approximately 5 times the volume administered. When injected intravenously, it will increase circulating plasma volume by approximately 3.5 times the volume infused within 15 minutes if the patient is adequately hydrated. This extra fluid reduces hemoconcentration and blood viscosity. The degree and duration of volume expansion depends upon the initial blood volume. When treating patients with diminished blood volume, the effect of infused albumin may persist for many hours. The hemodilution lasts for a shorter time when albumin is administered to individuals with normal blood volume. [4 ]

NON-CLINICAL TOXICOLOGY

No non-clinical toxicology studies with Albumin (Human) 20% have been conducted. Human Albumin is a normal constituent of human plasma and acts like physiological albumin.

Clinical Studies

No clinical studies with Albumin (Human) 20% have been conducted.

REFERENCES

1. Tullis JL: Albumin 2.Guidelines for Clinical Use. JAMA 1977; 237:460-463


2. Vermeulen LC et al.: A Paradigm for Consensus. Arch. Intern. Med. 1995; 155:373-379


3. Mendez CM, McClain CJ, Marsano LS: Albumin Therapy in Clinical Practice. Nutrition in Clinical Practice 2005; 20: 314-320


4. Janeway, C. A. "Human Serum Albumin: Historical Review" in: Proceedings of the Workshop on Albumin. DHEW Publication No. (NIH) 76-925. Sgouris, J. T. and René A. (eds.), Washington, D.C., U.S. Government Printing Office. 1976, pp 3-21.


5. Martin GS et al.: A randomized, controlled trail of furosemide with or without albumin in hypoproteinemic patients with acute lung injury. Crit. Care Med. 2005; 33: 1681-1687


6. Tsao YC, Yu VY: Albumin in management of neonatal hyperbilirubinaemia. Arch Dis.Child 1972;47:250-256.


7. Practice Committee of the American Society for Reproductive Medicine. Ovarian hyperstimulation syndrome. Fertil.Steril. 2006;86:S178-S183.


8. Aboulghar M, Evers JH, Al Inany H: Intravenous albumin for preventing severe ovarian hyperstimulation syndrome: a Cochrane review. Hum.Reprod. 2002;17:3027-3032.

How Supplied/Storage and Handling

Albumin (Human) 20% is supplied in 10 g in 50 mL or 20 g in 100 mL single use bottles.

NDC Number	NDC Number	Size	Grams protein
Octapharma Pharmazeutika Produktionsges.m.b.H	Octapharma AB
67467-633-01	68209-633-01	50 ml	10
67467-633-02	68209-633-02	100 ml	20

Albumin (Human) 20% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture.

Store protected from light.

Do not freeze.

Do not use after expiration date.

Do not use if turbid.

Patient Counseling Information

Information for Patients

This product is usually given in a hospital setting.

Inform patients being treated with Albumin (Human) 20% about the potential risks and benefits with its use [see Adverse Reactions (6)].

Discontinue immediately if allergic symptoms occur (e.g. skin rashes, hives, itching, breathing difficulties, coughing, nausea, vomiting, fall in blood pressure, increased heart rate).

Inform patients that Albumin (Human) 20% is a derivative of human plasma and may contain infectious agents that cause disease (e.g., viruses, and theoretically, CJD agent). Inform patients that the risk that Albumin (Human) 20% may transmit an infections agent has been reduced by screening plasma donors for prior exposure for certain viruses, by testing the donated plasma for certain virus infections and by inactivating and/or removing certain viruses during manufacturing [see Warnings and Precautions (5.7)].

Manufactured by:

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235

A-1100 Vienna, Austria

Octapharma AB

Elersvägen 40

SE- 112 75, Sweden

U.S. License No. 1646

Distributed by:

Octapharma USA Inc.

121 River Street, 12 th floor

Hoboken, NJ 07030

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Albumin (Human) 20%

10 g in 50 mL

Octapharma Pharmazeutika Produktionsges.m.b.H

NDC 67467-633-01

Octapharma AB

NDC 68209-633-01

Albumin (Human) 20%

20 g in 100 mL

Octapharma Pharmazeutika Produktionsges.m.b.H

NDC 67467-633-02

Octapharma AB

NDC 68209-633-02

ALBUMIN (HUMAN)  albumin human  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67467-633 Route of Administration Intravenous DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALBUMIN (HUMAN) (ALBUMIN (HUMAN)) ALBUMIN (HUMAN) 200 g  in 1000 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67467-633-01 50 mL In 1 BOTTLE, GLASS None 2 67467-633-02 100 mL In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA125154	10/17/2006

Labeler - Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. (301119178)

Revised: 01/2010Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.

More Albumin (Human) 20% resources

• Albumin (Human) 20% Use in Pregnancy & Breastfeeding
• Albumin (Human) 20% Support Group
• 0 Reviews for Albumin (Human) 20% - Add your own review/rating

Compare Albumin (Human) 20% with other medications

• Burns, External
• Hypoproteinemia
• Pancreatitis
• Peritonitis
• Postoperative Albumin Loss
• Shock