Nasacort eent

Generic Name: Triamcinolone Acetonide eent
Class: Corticosteroids
ATC Class: S02CA04
VA Class: NT200
Chemical Name: (11β,16α) - 9 - Fluoro - 11,21 - dihydroxy - 16,17 - [(1 - methylethylidene)bis(oxy)] - pregna - 1,4 - diene - 3,20 - dione
Molecular Formula: C₂₄H₃₁FO₆
CAS Number: 76-25-5

Introduction

Synthetic corticosteroid.^{1 2 3}

Uses for Nasacort

Allergic Rhinitis

Symptomatic treatment of seasonal or perennial allergic rhinitis.^{1 2 3 4 5 6 7 8 9 10 11 17}

Nasacort Dosage and Administration

General

• 
  

  For therapeutic effectiveness, use at regular intervals.^b

  
  

Administration

Intranasal Administration

Administer by nasal inhalation using a metered-dose nasal spray pump.^{2 3 4 5 8 b}

Shake inhaler gently immediately prior to use.^b

Prior to initial use, the metered-dose pump spray must be primed with 5 actuations or until a fine mist appears.^c Prime pump after a period of nonuse (i.e., > 2 weeks) by actuating once.²

Clear nasal passages prior to administration.^c

Tilt the head slightly forward, insert the spray tip into one nostril, and point the tip toward the back of the nose.^c Pump the drug into one nostril while holding the other nostril closed and concurrently inspire through the nose.^c Repeat this procedure for the other nostril.^c

Dosage

After priming, nasal spray pump delivers about 55 mcg of triamcinolone acetonide per metered spray and about 30 or 120 metered doses per 6.5-g or 16.5-g container, respectively.^{2 b}

Once optimal symptomatic relief is achieved, reduce dosage gradually to the lowest effective level.^{1 2 3}

Intranasal triamcinolone acetonide should not be continued beyond 3 weeks in the absence of adequate symptomatic improvement.^{1 2 16 b}

Pediatric Patients

Seasonal Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: Initially 55 mcg (1 spray) in each nostril once daily (110 mcg total).² May be increased to 110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Children ≥12 years of age: 110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Perennial Allergic Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Initially 55 mcg (1 spray) in each nostril once daily (110 mcg total).^{2 b} Maximum, 110 mcg (2 sprays) in each nostril once daily (220 mcg total).^{2 b}

Children ≥12 years of age: Initially 110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Adults

Seasonal Allergic Rhinitis

Intranasal Inhalation

110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Perennial Allergic Rhinitis

Intranasal Inhalation

110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Prescribing Limits

Pediatric Patients

Seasonal or Perennial Allergic Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Maximum 220 mcg (2 sprays in each nostril) daily.^{2 b}

Adults

Seasonal or Perennial Allergic Rhinitis

Intranasal Inhalation

Maximum 220 mcg (2 sprays in each nostril) daily.^b

Perennial Allergic Rhinitis

Intranasal Inhalation

Maximum 220 mcg (2 sprays in each nostril) daily.^b

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.^{1 2 17}

Renal Impairment

No specific dosage recommendations at this time.^{1 2 17}

Geriatric Patients

No specific dosage recommendations at this time.^{1 2 17}

Cautions for Nasacort

Contraindications

• 
  

  Known hypersensitivity to triamcinolone acetonide or any ingredient in the formulation.^{1 2 17}

  
  

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Possible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, or severe symptomatic exacerbation of asthma or other clinical conditions if prolonged systemic corticosteroid therapy is replaced with topical corticosteroid therapy; careful monitoring recommended.^{1 2 3 17}

Use particular caution in patients with associated asthma or other conditions that may be exacerbated by too rapid a reduction in systemic corticosteroid dosage.^b

Taper the dosage of the systemic corticosteroid, and carefully monitor patients during dosage reduction.^{1 2 17} In general, the greater the dosage and duration of systemic corticosteroid therapy, the greater the time required for withdrawal of systemic corticosteroids and replacement by intranasal corticosteroids.¹⁶

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs.^{1 2 17} Certain infections (e.g., varicella [chickenpox], measles) can be serious or fatal in such patients, particularly in children.^{1 2 17}

Exposure to varicella and measles should be avoided in previously unexposed patients.^{1 2 17} If exposure to varicella (chickenpox) or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled IM immune globulin (IG) respectively.^{1 2 17} Consider treatment with antiviral agents if varicella (chickenpox) develops.^{1 2}

General Precautions

Systemic Corticosteroid Effects

Possible growth suppression in pediatric patients.^{1 2 17} (See Pediatric Use under Cautions.)

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may increase risk of systemic corticosteroid effects (e.g., hypercortism or adrenal suppression).^b Avoid exceeding the recommended dosages.^{1 2 17}

Nasopharyngeal Effects

Rarely, localized candidial infections of the nose and/or pharynx has been reported.^{1 2 17} Local treatment of such infections and/or discontinuance of intranasal therapy may be required.^{1 2 17}

Nasal septal perforations have been reported rarely.^{1 2 17}

Use with caution until healing occurs in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma.^{1 2 3 17}

Concomitant Infections

Use with extreme caution, if at all, in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated fungal or bacterial infections; or ocular herpes simplex; or untreated, systemic viral infections.^{1 2 3 16 17}

Specific Populations

Pregnancy

Category C.^b Use during pregnancy may result in hypoadrenalism in infants;^b monitor these infants carefully.^b

Lactation

Not known whether triamcinolone acetonide is distributed in milk.^{1 2 17} Caution if used in nursing women.^{1 2 17}

Pediatric Use

Safety and efficacy not established in children <6 years of age.^{1 2}

Corticosteroids, particularly with high doses for extended periods may cause growth suppression in pediatric patients.^{1 2 17} Titrate dosage to the lowest possible effective level.^b

Geriatric Use

Response similar to that in younger adults.^b

Common Adverse Effects

Pharyngitis, epistaxis, increased cough.^{2 3}

Nasacort Pharmacokinetics

Absorption

Bioavailability

Systemic absorption is minimal.^{1 2 3} Mean peak plasma concentrations achieved at 1.5 hours following nasal inhalation.^{2 3}

Onset

Symptomatic relief may be evident 10–16 hours following initiation of therapy.^{4 5 8 12 16} Maximum benefit is usually achieved within 1 week.^b

Distribution

Extent

The volume of distribution is 99.5 L.^b

Special Populations

In pediatric patients, similar extent of absorption, peak concentrations, and time to peak concentrations compared to adult patients.^b

Elimination

Metabolism

Metabolized to metabolites that are substantially less active than the parent drug.^b

Half-life

3.1 hours.^b

Stability

Storage

Intranasal Suspension

20–25°C.^b

ActionsActions

• 
  

  Potent glucocorticoid^{1 2 17 b} and weak mineralocorticoid effects.^{3 16}

  
  


• 
  

  May reduce the number of mediator cells (basophils, eosinophils, T-helper cells, mast cells, and neutrophils) in the nasal mucosa.

  
  


• 
  

  Decreases nasal reactivity to allergens and decreases release of inflammatory mediators and proteolytic enzymes.

  
  

Advice to Patients

• 
  

  Provide copy of manufacturer’s patient information.^b

  
  


• 
  

  Importance of understanding proper storage, preparation, and administration techniques.^{1 2 17}

  
  


• 
  

  Importance of shaking container gently prior to each use.^{1 2}

  
  


• 
  

  Importance of avoiding spraying drug directly onto nasal septum.^{1 17}

  
  


• 
  

  Advise patients that containers of triamcinolone acetonide nasal spray should be discarded after 120 actuations.^{1 2}

  
  


• 
  

  Importance of taking as directed and not exceeding prescribed dosage.^{1 2 17}

  
  


• 
  

  Importance of regular use to obtain therapeutic effectiveness.^b

  
  


• 
  

  Importance of contacting a clinician if symptoms worsen or fail to improve after 3 weeks.^{1 2 17 b}

  
  


• 
  

  Necessity of reporting recurrent epistaxis, nasal septum discomfort, irritation, burning, and/or stinging to clinicians.^{1 2 17}

  
  


• 
  

  Importance of avoiding exposure to chickenpox or measles in patients receiving immunosuppressant doses of corticosteroids and, if exposure occurs, consulting a clinician.^{1 2 17 b}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{1 2 17}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.^{1 2 17}

  
  


• 
  

  Importance of advising patients of other important precautionary information.^b (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Triamcinolone Acetonide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Nasal	Suspension	55 mcg/metered spray	Nasacort AQ Nasal Spray (with benzalkonium chloride)	Aventis

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2004. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

1. Aventis. Nasacort (triamcinolone acetonide) nasal inhaler prescribing information. In: Physicians’ desk reference. 55th ed. Montvale, NJ; Medical Economics Company Inc; 2001:717-9.

2. Aventis. Nasacort AQ (triamcinolone acetonide) prescribing information (dated 1997 Oct). In: Physician’s desk reference. 55th ed. Montvale, NJ: Medical Economics Company, Inc; 2001:719-20.

3. Jeal W, Faulds D. Triamcinolone acetonide: a review of its pharmacological properties and therapeutic efficacy in the management of allergic rhinitis. Drugs. 1997; 53:257-80.

4. Settipane G, Korenblat PE, Winder J et al. Triamcinolone acetonide aqueous nasal spray in patients with seasonal ragweed allergic rhinitis: a placebo-controlled, double-blind study. Clin Ther. 1995; 17:252-63.

5. Munk ZM, LaForce C, Furst JA et al. Efficacy and safety of triamcinolone acetonide aqueous nasal spray in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 1996; 77:277-81.

6. Findlay S, Huber F, Garcia J et al. Efficacy of once-a-day intranasal administration of triamcinolone acetonide in patients with seasonal allergic rhinitis. Ann Allergy. 1992; 68:228-32.

7. Banov CH, Silvers WS, Green AW et al. Placebo-controlled, double-blind study of the efficacy and safety of triamcinolone acetonide aerosol nasal inhaler in pediatric patients with seasonal allergic rhinitis. Clin Ther. 1996; 18:265-72.

8. Kobayashi RH, Beaucher WN, Koepke JW et al. Triamcinolone acetonide aqueous nasal spray for the treatment of patients with perennial allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 1995; 17:503-13.

9. Spector S, Bronsky E, Chervinsky P et al. Multicenter, double-blind, placebo-controlled trial of triamcinolone acetonide nasal aerosol in the treatment of perennial allergic rhinitis. Ann Allergy. 1990; 64:300-5.

10. Storms W, Bronsky E, Findlay S et al. Once daily triamcinolone acetonide nasal spray is effective for the treatment of perennial allergic rhinitis [published erratum appears in Ann Allergy 1991; 66:457]. Ann Allergy. 1991; 66:329-34.

11. Welch MJ, Bronsky EA, Grossman J et al. Clinical evaluation of triamcinolone acetonide nasal aerosol in children with perennial allergic rhinitis.Ann Allergy. 1991; 67:493-8.

12. Day JH, Buckeridge DL, Clark RH et al. A randomized, double-blind, placebo-controlled, controlled antigen delivery study of the onset of action of aerosolized triamcinolone acetonide nasal spray in subjects with ragweed-induced allergic rhinitis. J Allergy Clin Immunol. 1996; 97:1050-7.

13. Howland WC III, Dockhorn R, Gillman S et al. A comparison of effects of triamcinolone acetonide aqueous nasal spray, oral prednisone, and placebo on adrenocortical function in male patients with allergic rhinitis. J Allergy Clin Immunol. 1996; 98:32-8.

14. Feiss G, Morris R, Rom D et al. A comparative study of the effects of intranasal triamcinolone acetonide aerosol (ITAA) and prednisone on adrenocortical function. J Allergy Clin Immunol. 1992; 89:1151-6.

15. Nayak AS, Ellis MH, Gross GN et al. The effects of triamcinolone acetonide aqueous nasal spray on adrenocortical function in children with allergic rhinitis. J Allergy Clin Immunol. 1998; 101(2 Pt 1):157-62.

16. Aventis, Bridgewater, NJ: Personal communication.

17. Muro. Tri-Nasal (triamcinolone acetonide) nasal spray prescribing information. Tewksbury, MA; 2000 Feb.

b. Aventis. Nasacort AQ (triamcinolone acetonide) prescribing information. Bridgewater, NJ; 2004 Mar.

c. Aventis. Nasacort AQ (triamcinolone acetonide) patient information. Bridgewater, NJ; 2004 Mar.

More Nasacort eent resources

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

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• Hay Fever

Boots Paracetamol 500 mg Tablets

Paracetamol 500 mg Tablets

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again


• Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Paracetamol which belongs to a group of medicines called analgesics, which act to relieve pain and reduce fever.

It can be used to relieve mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pain, rheumatic and muscular aches and pains, sciatica, fibrositis, lumbago, joint swelling and stiffness.

It can also be used to relieve the symptoms of colds & flu and reduce a fever.

Before you take this medicine

This medicine can be taken by adults and children aged 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

• If you are allergic to any of the ingredients

Talk to your pharmacist or doctor:

• If you have severe kidney problems or liver problems (including a disease caused by drinking alcohol)


• If you are pregnant

You can take this medicine if you are breastfeeding.

Other important information

Information about some of the ingredients in this medicine: Sodium metabisulphite (E223) may rarely cause severe allergic reactions, tightness of the chest or difficulty in breathing.

If you take other medicines

This medicine contains paracetamol. Do not take with any other paracetamol-containing products.

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Metoclopramide or domperidone (for feeling sick)


• Colestyramine (to reduce blood fat levels)


• Warfarin or other blood thinners – if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that tablet.

Adults and children of 12 years and over: Take one or two tablets, up to four times a day if you need to. Don’t take more than 8 tablets in any 24 hours. Don’t take more often than every 4 hours.

Children of 6 to 11 years: Take half to one tablet, up to four times a day, if you need to. Don’t take more than 4 tablets in any 24 hours. Don’t take more often than every 4 hours.

Swallow each tablet with water.

Do not give to children under 6 years, unless your doctor tells you to.

Do not take more than the amount recommended above.

Do not take this medicine for more than 3 days, unless your doctor tells you to.

If symptoms do not go away talk to your doctor.

If you take too many tablets: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the tablets. See a doctor at once:

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)


• Skin rash


• Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood

If you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each tablet contains Paracetamol 500 mg, which is the active ingredient.

As well as the active ingredient, the tablets also contain pregelatinised maize starch, sodium metabisulphite (E223), magnesium stearate.

The pack contains 16 or 32 white, round, flat bevelled edge tablets with a break line on one side.

Who makes this medicine

Manufactured for

The Boots Company PLC

Nottingham

NG2 3AA

by

Galpharm International Ltd

Upper Cliffe Road

Dodworth Business Park

Dodworth South

Yorkshire

S75 3SP

Marketing Authorisation held by

Galpharm Healthcare Ltd

Upper Cliffe Road

Dodworth Business Park

Dodworth South

Yorkshire

S75 3SP

Leaflet prepared November 2007

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

3478x-pil

Ibritumomab Tiuxetan

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

V10XX02

CAS registry number (Chemical Abstracts Service)

0206181-63-7

Chemical Formula

C6382-H9830-N1672-O1979-S54

Molecular Weight

143376

Therapeutic Categories

Antineoplastic agent

Immunomodulator

Chemical Name

Immunoglobulin G1, anti-(human CD20 (antigen)) (mouse monoclonal IDEC-Y2B8 gamma1-chain), disulfide with mouse monoclonal IDEC-Y2B8 kappa 63-chain, dimer, N-[2-bis-(carboxymethyl)amino]-3-(4-isothiocyanatophenyl)propyl]-N-[2-[bis(carboxymethyl)- amino]pro (WHO)

Foreign Names

• Ibritumomabum Tiuxetanum (Latin)
• Ibritumomab Tiuxetan (German)
• Ibritumomab Tiuxétan (French)
• Ibritumomab Tiuxetán (Spanish)

Generic Names

• Ibritumomab Tiuxetan (OS: USAN, BAN)
• IDEC 129 (IS: IDEC)
• IDEC Y2B8 (IS: IDEC)

Brand Names

• Zevalin Indium
  Bayer Yakuhin, Japan



• Zevalin Yttrium
  Bayer Yakuhin, Japan



• Zevalin
  Bayer, Belgium; Bayer, Canada; Bayer, Switzerland; Bayer, Germany; Bayer, United Kingdom; Bayer, Croatia (Hrvatska); Bayer, Sweden; Bayer, Turkey; Bayer Schering, Austria; Bayer Schering, Finland; Bayer Schering, France; Bayer Schering, Netherlands; Bayer Schering, South Africa; Bayer Schering Pharma, Norway; Biogen, United States; Pfizer, Israel; Schering, Hungary; Schering, Ireland; Schering, Italy; Schering, Luxembourg; Schering, Poland; Schering, Romania; Schering, Slovenia



• Zevamab
  Schering, Argentina

International Drug Name Search

Glossary

BAN	British Approved Name
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Nutropin Depot

somatropin (rDNA origin)

Dosage Form: for Injectable Suspension

Nutropin Depot Description

Nutropin Depot® [somatropin (rDNA origin) for injectable suspension] is a long‑acting dosage form of recombinant human growth hormone (rhGH). Somatropin has 191 amino acid residues and a molecular weight of 22,125 daltons. The amino acid sequence of the product is identical to that of pituitary‑derived human growth hormone. The protein is synthesized by a specific laboratory strain of E. coli as a precursor consisting of the rhGH molecule preceded by the secretion signal from an E. coli protein. This precursor is directed to the plasma membrane of the cell. The signal sequence is removed and the native protein is secreted into the periplasm so that the protein is folded appropriately as it is synthesized.

Somatropin is a highly purified preparation. Biological potency is determined using a cell proliferation bioassay.

The Nutropin Depot formulation consists of micronized particles of rhGH embedded in biocompatible, biodegradable polylactide‑coglycolide (PLG) microspheres. Nutropin Depot is packaged in vials as a sterile, white to off‑white, preservative‑free, free‑flowing powder. Before administration, the powder is suspended in Diluent for Nutropin Depot (a sterile aqueous solution).

Each 13.5 mg 3 cc single‑use vial of Nutropin Depot contains 13.5 mg somatropin, 1.2 mg zinc acetate, 0.8 mg zinc carbonate, and 68.9 mg PLG.

Each 18 mg 3 cc single‑use vial of Nutropin Depot contains 18 mg somatropin, 1.6 mg zinc acetate, 1.1 mg zinc carbonate, and 91.8 mg PLG.

Each 22.5 mg 3 cc single‑use vial of Nutropin Depot contains 22.5 mg somatropin, 2.0 mg zinc acetate, 1.4 mg zinc carbonate, and 114.8 mg PLG.

Each dosage size contains an overage of rhGH microspheres to ensure delivery of labeled contents.

Each 1.5 mL single‑use vial of Diluent for Nutropin Depot contains 30 mg/mL carboxymethylcellulose sodium salt, 1 mg/mL polysorbate 20, 9 mg/mL sodium chloride, and sterile water for injection; pH 5.8–7.2.

Nutropin Depot - Clinical Pharmacology

General

In vivo preclinical and clinical testing has demonstrated that growth hormone (GH) stimulates longitudinal bone growth and elevates insulin‑like growth factor‑I (IGF‑I) levels.

Actions that have been demonstrated for hGH include:

A.

Tissue Growth - 1) Skeletal Growth: GH stimulates skeletal growth in pediatric patients with growth failure due to a lack of adequate secretion of endogenous GH. Skeletal growth is accomplished at the epiphyseal plates at the ends of a growing bone. Growth and metabolism of epiphyseal plate cells are directly stimulated by GH and one of its mediators, IGF‑I. Serum levels of IGF‑I are low in children and adolescents who are growth hormone deficient (GHD), but increase during treatment with GH. In pediatric patients, new bone is formed at the epiphyses in response to GH and IGF‑I. This results in linear growth until these growth plates fuse at the end of puberty. 2) Cell Growth: Treatment with hGH results in an increase in both the number and the size of skeletal muscle cells. 3) Organ Growth: GH increases the size of internal organs, including kidneys, and increases red cell mass. Treatment of hypophysectomized or genetic dwarf rats with GH results in increases in organ and overall body growth. In normal rats subjected to nephrectomy‑induced uremia, GH promoted skeletal and body growth.

B.

Protein Metabolism - Linear growth is facilitated in part by GH‑stimulated protein synthesis. This is reflected by nitrogen retention as demonstrated by a decline in urinary nitrogen excretion and blood urea nitrogen during GH therapy.

C.

Carbohydrate Metabolism - GH is a modulator of carbohydrate metabolism. Patients with inadequate endogenous secretion of GH sometimes experience fasting hypoglycemia that is improved by treatment with GH. GH therapy may decrease insulin sensitivity. Administration of hGH formulated for daily dosing resulted in increased mean fasting and postprandial insulin levels, more commonly in overweight or obese individuals. Mean trough levels for fasting and postprandial insulin were unchanged after 3 or 6 months of Nutropin Depot therapy in GHD children. As with daily GH, mean trough levels for fasting glucose, postprandial glucose, and hemoglobin A1c remained unchanged after 3 or 6 months of Nutropin Depot therapy.

D.

Lipid Metabolism - In GHD patients, administration of GH formulated for daily dosing resulted in lipid mobilization, reduction in body fat stores, increased plasma fatty acids, and decreased plasma cholesterol levels.

E.

Mineral Metabolism - The retention of total body potassium in response to GH administration apparently results from cellular growth. Serum levels of inorganic phosphorus may increase slightly in patients with inadequate secretion of endogenous GH due to metabolic activity associated with bone growth as well as increased tubular reabsorption of phosphate by the kidney. Serum calcium is not significantly altered in these patients. Sodium retention also occurs. (See PRECAUTIONS: Laboratory Tests.) GH therapy results in increases in serum alkaline phosphatase.

F.

Connective Tissue Metabolism - GH stimulates the synthesis of chondroitin sulfate and collagen as well as the urinary excretion of hydroxyproline.

Pharmacokinetics

Nutropin Depot is a long‑acting dosage form of somatropin designed to be administered by subcutaneous (SC) injection once or twice monthly. Following the injection, bioactive rhGH is released from the microspheres into the SC environment initially by diffusion, followed by both polymer degradation and diffusion. Although no studies have been performed that address the distribution, elimination, or metabolism of Nutropin Depot, once released and absorbed the rhGH is believed to be distributed and eliminated in a manner similar to somatropin formulated for daily administration.

The serum hGH concentration‑time profiles of single doses of 0.75 mg/kg and 1.5 mg/kg of Nutropin Depot have been characterized in pediatric GHD patients (refer to Figure 1). The in vivo profiles are characterized by an initial rapid release followed by a slow decline in GH concentration. Both the maximum concentrations achieved (Cmax) and total exposure (AUC0–28 days) appear to be proportional to dose. Serum hGH levels greater than 1 µg/L persist for approximately 11–14 days postdose for the two doses. Repeated dosing of Nutropin Depot over 6 months showed no progressive accumulation of GH.

Absorption—In a study of Nutropin Depot in pediatric patients with GHD, an SC dose of 0.75 mg/kg (n = 12) or 1.5 mg/kg (n = 8) was administered. The mean ± SD hGH Cmax values were 48±26 µg/L and 90±23 µg/L, respectively, at 12–13 hours postdose. The corresponding AUC0–28 days values were 83±49 µg ∙ day/L and 140±34 µg ∙ day/L, respectively, for the two doses. For the 0.75 mg/kg and 1.5 mg/kg doses,

the AUC0–2 days accounted for approximately 52±16 percent and 61±10 percent of the total AUC0–28 days, respectively. Estimates of relative bioavailability in GHD children for a single dose of Nutropin Depot ranged from 33% to 38% when compared to a single dose of Nutropin AQ® [somatropin (rDNA origin) injection] in healthy adults, and from 48% to 55% when compared to chronically dosed Protropin® (somatrem for injection) in GHD children.

Distribution—Animal studies with rhGH formulated for daily administration showed that GH localizes to highly perfused organs, particularly the liver and kidney. The volume of distribution at steady state for rhGH formulated for daily administration in healthy adult males is about 50 mL/kg body weight, approximating the serum volume.

Metabolism—Both the liver and kidney have been shown to be important metabolizing organs for GH. Animal studies using rhGH formulated for daily administration suggest that the kidney is the dominant organ of clearance. GH is filtered at the glomerulus and reabsorbed in the proximal tubules. It is then cleaved within renal cells into its constituent amino acids, which return to the systemic circulation.

Elimination—The mean terminal t1/2 after intravenous (IV) administration of rhGH formulated for daily administration in healthy adult males is estimated to be 19.5±3.1 minutes. Clearance of rhGH after IV administration in healthy adults and children is reported to be in the range of 116–174 mL/hr/kg.

Figure 1

Single‑Dose Mean (SD) GH Concentrations in Pediatric GHD Patients

Special Populations

Pediatric—Available literature data suggest that rhGH clearances are similar in adults and children.

Gender—Following administration of either 0.75 mg/kg or 1.5 mg/kg Nutropin Depot, Day 1 GH levels were higher in females compared to males. No relationship was observed between gender and pharmacodynamic marker (IGF‑I and IGFBP‑3) levels.

Race—The effect of race on Nutropin Depot disposition is unknown due to the limited number of non‑Caucasian patients in the Nutropin Depot studies.

Growth Hormone Deficiency—Nutropin Depot has not been studied in healthy adults or children. However, reported values for clearance of rhGH formulated for daily administration in adults and children with GHD range from 138–245 mL/hr/kg and are similar to those observed in healthy adults and children. Mean terminal t1/2 values following IV and SC administration in adult and pediatric patients with GHD are also similar to those observed in healthy adult males.

Renal Insufficiency—Nutropin Depot has not been studied in patients with renal insufficiency. Children and adults with chronic renal failure (CRF) and end‑stage renal disease (ESRD) tend to have decreased clearance of rhGH formulated for daily administration compared with normals. Endogenous GH production may also increase in some individuals with ESRD. However, no GH accumulation has been reported in children with CRF or ESRD dosed with daily regimens.

Hepatic Insufficiency—Nutropin Depot has not been studied in patients with hepatic insufficiency. A reduction in clearance of rhGH formulated for daily administration has been noted in patients with severe liver dysfunction. The clinical significance of this decrease is unknown.

Pharmacodynamics

IGF‑I levels peaked between 1.5 and 3.5 days postdose and remained above baseline for approximately 16 to 20 days, confirming GH activity for an extended period. Repeated dosing of Nutropin Depot over 6 months showed no progressive accumulation of IGF‑I (as shown in Figure 2) or IGF‑binding protein 3 (IGFBP‑3).

Figure 2

Repeated‑Dose Mean (SD) IGF‑I Concentrations in Pediatric GHD Patients

Efficacy Studies

Pediatric Growth Hormone Deficiency (GHD)

In two multicenter, open‑label clinical studies in prepubertal children (mean age (± SD) 7.4±2.8) with idiopathic or organic GHD previously untreated with rhGH, 91 patients were treated with Nutropin Depot at 1.5 mg/kg once monthly or 0.75 mg/kg twice monthly by subcutaneous injection for up to six months. (See DOSAGE AND ADMINISTRATION for the number of injections required per dose.) The mean prestudy growth rate was 4.8±2.4 cm/yr (n=89). The dose‑pooled, mean 6‑month annualized growth rate on Nutropin Depot therapy was 8.4±2.2 cm/yr (n=89).

Seventy‑six patients continued treatment in an extension study. For patients who completed 12 months the mean growth rate was 7.8±1.9 cm/yr for the two dose groups combined (n=69). Mean height SD score changed from –3.0±1.0 prestudy to –2.5±0.9 at Month 12 (n=69). The mean 0 to 12 month change in bone age was 1.0±0.4 years (n=63). During the long‑term extension study, fourteen of seventy‑five (19%) patients discontinued due to dissatisfaction with growth response. Historical studies of GHD children treated with daily Protropin® (somatrem for injection) or Nutropin® [somatropin (rDNA origin) for injection] injections for 12 months at 0.3 mg/kg weekly had the following mean values: baseline growth rate 3.6 to 4.8 cm/yr; first year growth rate 10.1 to 11.3 cm/yr; first year change in bone age 1.1 to 1.5 years.

In a dose‑ranging study, 24 patients previously treated with daily GH (mean age 9.6±2.2 years; mean duration of prior GH therapy 2.8±1.6 yr, range 0.9 to 6.1 yr) were switched to Nutropin Depot therapy at the above doses. The mean growth rate on previous treatment was 8.2±3.0 cm/yr (range 3.2 to 13.1 cm/yr) and on Nutropin Depot was 5.1±2.0 cm/yr (range 2.4 to 9.6 cm/yr). During a long‑term extension study, four of ten previously treated patients discontinued due to dissatisfaction with growth response. Historical studies of GHD children (n=181) treated with daily Protropin or Nutropin at a dose of 0.3 mg/kg weekly had the following mean growth rates: first year growth rate 9.7 to 11.4 cm/yr; second year growth rate 8.1 to 8.9 cm/yr; third year growth rate 7.5 to 7.8 cm/yr; fourth year growth rate 6.6 to 7.1 cm/yr.

Indications and Usage for Nutropin Depot

Nutropin Depot® [somatropin (rDNA origin) for injectable suspension] is indicated for the long‑term treatment of growth failure due to a lack of adequate endogenous GH secretion.

Considerations for use:—As with any GH treatment, patients should be monitored closely throughout therapy for growth response to Nutropin Depot. Failure to respond adequately requires careful assessment, as described under DOSAGE AND ADMINISTRATION. Patients for whom no discernible cause is found should be considered for a course of treatment with a daily form of rhGH. Experience in patients who were treated with daily GH and switched to Nutropin Depot is limited.

Contraindications

Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure. Two placebo‑controlled clinical trials in non‑growth hormone‑deficient adult patients (n = 522) with these conditions revealed a significant increase in mortality (41.9% vs. 19.3%) among somatropin‑treated patients (doses 5.3–8 mg/day) compared to those receiving placebo (see WARNINGS).

Nutropin Depot should not be used for growth promotion in pediatric patients with closed epiphyses.

Nutropin Depot should not be used in patients with active neoplasia. GH therapy should be discontinued if evidence of neoplasia develops.

Growth hormone is contraindicated in patients with Prader‑Willi syndrome who are severely obese or have severe respiratory impairment

(see WARNINGS). Nutropin Depot is not indicated for the treatment of short stature in genetically confirmed Prader‑Willi syndrome.

Warnings

See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma, or with acute respiratory failure. The safety of continuing growth hormone treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with growth hormone in patients having acute critical illnesses should be weighed against the potential risk.

There have been reports of fatalities after initiating therapy with growth hormone in pediatric patients with Prader‑Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader‑Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with growth hormone. If during treatment with growth hormone, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader‑Willi syndrome treated with growth hormone should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively (see CONTRAINDICATIONS). Nutropin Depot is not indicated for the treatment of short stature in genetically confirmed Prader‑Willi syndrome.

Precautions

General: Nutropin Depot should be prescribed by physicians experienced in the diagnosis and management of patients with GHD.

Because GH may reduce insulin sensitivity, patients should be monitored for evidence of glucose intolerance.

For patients with diabetes mellitus, the insulin dose may require adjustment when GH therapy is instituted. Because GH may reduce insulin sensitivity, particularly in obese individuals, patients should be observed for evidence of glucose intolerance. Patients with diabetes or glucose intolerance should be monitored closely during GH therapy.

Patients with symptomatic hypoglycemia associated with GHD should be closely monitored.

Patients with a history of an intracranial lesion should be examined frequently for progression or recurrence of the lesion. In pediatric patients, clinical literature has demonstrated no relationship between GH replacement therapy and central nervous system (CNS) tumor recurrence or new extracranial tumors.

Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth.

Progression of scoliosis can occur in patients who experience rapid growth. Because GH increases growth rate, patients with a history of scoliosis who are treated with GH should be monitored for progression of scoliosis. GH has not been shown to increase the incidence of scoliosis.

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with GH products. Symptoms usually occurred within the first 8 weeks of the initiation of GH therapy. In all reported cases, IH‑associated signs and symptoms resolved after termination of therapy or a reduction of the GH dose. Funduscopic examination of patients is recommended at the initiation and periodically during the course of GH therapy.

As with any protein, local or systemic allergic reactions may occur. Parents/Patients should be informed that such reactions are possible and that prompt medical attention should be sought if allergic reactions occur (see ADVERSE REACTIONS).

Laboratory Tests: Serum levels of inorganic phosphorus, alkaline phosphatase, and parathyroid hormone (PTH) may increase with GH therapy.

Untreated hypothyroidism prevents optimal response to GH. Changes in thyroid hormone laboratory measurements may develop during GH treatment. Therefore, patients should have periodic thyroid function tests and should be treated with thyroid hormone when indicated.

Drug Interactions: Excessive glucocorticoid therapy will inhibit the growth‑promoting effect of human GH. Patients with ACTH deficiency should have their glucocorticoid‑replacement dose carefully adjusted to avoid an inhibitory effect on growth.

Limited published data indicate that GH treatment increases cytochrome P450 (CP450) mediated antipyrine clearance in humans. These data suggest that GH administration may alter the clearance of compounds known to be metabolized by CP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporin). Careful monitoring is advisable when GH is administered in combination with other drugs known to be metabolized by CP450 liver enzymes.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity, mutagenicity, and fertility studies have not been conducted with Nutropin Depot.

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

Nursing Mothers: It is not known whether GH is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nutropin Depot is administered to a nursing mother.

Information for Patients: Patients being treated with Nutropin Depot and/or their parents should be informed of the potential benefits and risks associated with treatment. If home use is determined to be desirable by the physician, instructions on appropriate use should be given, including a review of the contents of the Patient Information Insert. This information is intended to aid in the safe and effective administration of the medication. It is not a disclosure of all possible adverse or intended effects.

If home use is prescribed, a puncture‑resistant container for the disposal of used syringes and needles should be recommended to the patient. Patients and/or parents should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes (see Patient Information Insert).

Adverse Reactions

As with all protein pharmaceuticals, patients may develop antibodies to the protein. GH antibody‑binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases when binding capacity exceeds 2 mg/L, growth attenuation has been observed. In clinical studies of pediatric patients who were treated with Nutropin Depot, 0/138 patients with GHD screened for antibody production developed antibodies with binding capacities ≥ 2 mg/L at any time during a treatment period of up to 17.4 months.

In addition to an evaluation of compliance with the prescribed treatment program and thyroid status, testing for antibodies to GH should be carried out in any patient who fails to respond to therapy.

In studies involving 138 pediatric patients treated with Nutropin Depot, the most frequent adverse reactions were injection‑site reactions, which occurred in nearly all patients. On average, 2 to 3 injection‑site adverse reactions were reported per injection. These reactions included nodules (61% of injections), erythema (53%), pain post‑injection (47%), pain during injection (43%), bruising (20%), itching (13%), lipoatrophy (13%), and swelling or puffiness (8%). The intensity of these reactions was generally rated mild to moderate, with pain during injection occasionally rated as severe (7%).

Adverse reactions observed less frequently in the Nutropin Depot studies which were considered possibly, probably, or definitely related to the drug by the treating physician (usually occurring 1–3 days postdose) included: headache (13% of subjects), nausea (8%), lower extremity pain (7%), fever (7%), and vomiting (5%). These symptoms were generally self‑limited and well‑tolerated. One patient experienced a generalized body rash that was most likely an allergic reaction to Nutropin Depot.

Leukemia has been reported in a small number of GHD patients treated with GH. It is uncertain whether this increased risk is related to the pathology of GH deficiency itself, GH therapy, or other associated treatments such as radiation therapy for intracranial tumors. On the basis of current evidence, experts cannot conclude that GH therapy is responsible for these occurrences.

Other adverse drug reactions that have been reported in GH‑treated patients include the following: 1) Metabolic: mild, transient peripheral edema; 2) Musculoskeletal: arthralgia, carpal tunnel syndrome; 3) Skin: rare increased growth of pre‑existing nevi; patients should be monitored for malignant transformation; 4) Endocrine: gynecomastia; and 5) Rare pancreatitis. Of these reactions, only edema (< 1% of patients) and arthralgia (4%) were reported as related to drug in the Nutropin Depot studies.

Overdosage

The recommended dosage of Nutropin Depot should not be exceeded. Acute overdosage could lead to fluid retention, headache, nausea, vomiting, and/or hyperglycemia. Long‑term overdosage could result in signs and symptoms of gigantism and/or acromegaly, consistent with the known effects of excess GH. (See recommended dosage instructions given below.)

Nutropin Depot Dosage and Administration

The Nutropin Depot dosage and administration schedule should be individualized for each patient. Response to GH therapy in pediatric patients tends to decrease over time. However in pediatric patients, failure to increase growth rate, particularly during the first year of therapy, suggests the need for close assessment of compliance and evaluation of other causes of growth failure, such as hypothyroidism, undernutrition, and advanced bone age.

Once-Monthly Injection—It is recommended that an SC injection at a dosage of 1.5 mg/kg body weight be administered on the same day of each month. Dosages above the recommended once monthly regimen have not been studied in clinical trials. Note: subjects over 15 kg will require more than one injection per dose.

Twice-Monthly Injections—It is recommended that an SC injection at a dosage of 0.75 mg/kg body weight be administered twice each month on the same days of each month (e.g., Days 1 and 15 of each month). Dosages above the recommended twice‑monthly regimen have not been studied in clinical trials. Note: subjects over 30 kg will require more than one injection per dose.

The table below indicates the required number of injections per dose.

	Number of Injections Per Dose
Patient Weight (kg)	0.75 mg/kg twice monthly	1.5 mg/kg once monthly
* Twice‑monthly dosing recommended
≤15	1	1
>15–30	1	2
>30–45	2	3
>45–60	2	*
>60	3	*

Preparation of Dose

Nutropin Depot powder may only be suspended in Diluent for Nutropin Depot supplied in the kit and administered with the supplied needles.

1. Using the chart below, determine the volume of diluent needed to suspend Nutropin Depot. Withdraw the diluent into a 3 cc syringe using the needle supplied in the kit. Only the diluent supplied in the kit should be used for reconstitution, and any remaining diluent should be discarded.
   
   
   
   
   
   
   
   
   
   

   Vial Size (mg somatropin)	Volume of Diluent to Be Added (mL)
   Note: Since the suspension is viscous and prevents complete withdrawal of the entire vial contents, the vials are overfilled to ensure delivery of the labeled amount of somatropin. Using these diluent volumes for final suspension results in a final concentration of 19 mg/mL somatropin in each vial size.
   13.5	0.8
   18	1.0
   22.5	1.2



2. Inject the diluent into the vial against the vial wall. Swirl the vial vigorously for up to 2 minutes to disperse the powder in the diluent. Mixing is complete when the suspension appears uniform, thick, and milky, and all the powder is fully dispersed. Do not store the vial after reconstitution or the suspension may settle.


3. Withdraw the required dose. Only one vial should be used for each injection. Replace the needle with a new needle from the kit and administer the dose immediately to avoid settling of the suspension in the syringe. Deliver the dose from the syringe at a continuous rate over not more than 5 seconds. Discard unused vial contents as the product contains no preservative. An extra needle has been provided in the kit.

Stability and Storage

Before Suspension—Nutropin Depot and diluent vials must be stored at 2–8°C/36–46°F (under refrigeration). Avoid freezing the vials of Nutropin Depot and Diluent for Nutropin Depot. Do not expose the Nutropin Depot vial to temperatures above 25°C (77°F). Expiration dates are stated on the labels.

After Suspension—Because Nutropin Depot contains no preservatives, all injections must be given immediately. Do not allow the suspension to settle prior to withdrawal of the dose. Suspended solution cannot be stored or used to suspend another vial of Nutropin Depot.

How Supplied

Nutropin Depot is supplied as single‑use vials with 13.5 mg, 18 mg, or 22.5 mg sterile, preservative‑free somatropin powder per vial.

Each 13.5 mg kit contains one single‑use 13.5 mg vial of Nutropin Depot® [somatropin (rDNA origin) for injectable suspension], one 1.5 mL single‑use vial of Diluent for Nutropin Depot, and three 21‑gauge, 1/2" needles: NDC 50242‑032‑35.

Each 18 mg kit contains one single‑use 18 mg vial of Nutropin Depot® [somatropin (rDNA origin) for injectable suspension], one 1.5 mL single‑use vial of Diluent for Nutropin Depot, and three 21‑gauge, 1/2" needles: NDC 50242‑034‑41

Each 22.5 mg kit contains one single‑use 22.5 mg vial of Nutropin Depot® [somatropin (rDNA origin) for injectable suspension], one 1.5 mL single‑use vial of Diluent for Nutropin Depot, and three 21‑gauge, 1/2" needles: NDC 50242‑036‑54.

Nutropin Depot®[somatropin (rDNA origin) for injectable suspension] and

Diluent for Nutropin Depot are manufactured for:

Genentech, Inc.

1 DNA Way

South San Francisco, CA 94080-4990

©2004 Genentech, Inc

7217802

LF0535

(4819503)

FDA Approval Date December 1999

Code Revision Date January 2004

Nutropin Depot  somatropin  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50242-032

Packaging # NDC Package Description Multilevel Packaging 1 50242-032-35 1 KIT In 1 CARTON None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 VIAL   0.8 MILLILITER  in 1  Part 2 1 VIAL   1.5 MILLILITER  in 1

Part 1 of 2 Nutropin Depot  somatropin  injection, suspension

Product Information       Route of Administration SUBCUTANEOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Somatropin (Somatropin) Active 13.5 MILLIGRAM  In 0.8 MILLILITER Zinc acetate Inactive   zinc carbonate Inactive   polyactide-coglycolide microspheres Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0.8 MILLILITER In 1 VIAL None

Part 2 of 2 DILUENT  diluent  injection, suspension

Product Information       Route of Administration SUBCUTANEOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength water (water) Active 1.5 MILLILITER  In 1.5 MILLILITER carboxymethylcellulose Inactive 30 MILLIGRAM  In 1 MILLILITER polysorbate 20 Inactive 1 MILLIGRAM  In 1 MILLILITER sodium chloride Inactive 9 MILLIGRAM  In 1 MILLILITER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 1.5 MILLILITER In 1 VIAL None

Nutropin Depot  somatropin  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50242-034

Packaging # NDC Package Description Multilevel Packaging 1 50242-034-41 1 KIT In 1 CARTON None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 VIAL   1 MILLILITER  in 1  Part 2 1 VIAL   1.5 MILLILITER  in 1

Part 1 of 2 Nutropin Depot  somatropin  injection, suspension

Product Information       Route of Administration SUBCUTANEOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Somatropin (Somatropin) Active 18 MILLIGRAM  In 1 MILLILITER Zinc acetate Inactive   zinc carbonate Inactive   polyactide-coglycolide microspheres Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 1 MILLILITER In 1 VIAL None

Part 2 of 2 DILUENT  diluent  injection, suspension

Product Information       Route of Administration SUBCUTANEOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength water (water) Active 1.5 MILLILITER  In 1.5 MILLILITER carboxymethylcellulose Inactive 30 MILLIGRAM  In 1 MILLILITER polysorbate 20 Inactive 1 MILLIGRAM  In 1 MILLILITER sodium chloride Inactive 9 MILLIGRAM  In 1 MILLILITER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 1.5 MILLILITER In 1 VIAL None

Nutropin Depot  somatropin  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50242-036

Packaging # NDC Package Description Multilevel Packaging 1 50242-036-54 1 KIT In 1 CARTON None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 VIAL   1.2 MILLILITER  in 1  Part 2 1 VIAL   1.5 MILLILITER  in 1

Part 1 of 2

Hydrocot

Generic Name: hydrochlorothiazide (Oral route)

hye-droe-klor-oh-THYE-a-zide

Commonly used brand name(s)

In the U.S.

• Aquazide H


• Hydrocot


• Microzide


• Zide

Available Dosage Forms:

• Tablet


• Capsule


• Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Diuretic

Chemical Class: Thiazide

Uses For Hydrocot

Hydrochlorothiazide is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Hydrochlorothiazide is also used to treat fluid retention (edema) that is caused by congestive heart failure, severe liver disease (cirrhosis), kidney disease, or treatment with a steroid or hormone medicine.

Hydrochlorothiazide is a thiazide diuretic (water pill). It is used to help reduce the amount of water in the body by increasing the flow of urine. It may also be used for other conditions as determined by your doctor.

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

Before Using Hydrocot

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hydrochlorothiazide capsules or tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrochlorothiazide capsules in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving hydrochlorothiazide capsules.

No information is available on the relationship of age to the effects of hydrochlorothiazide tablets in geriatric patients. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving hydrochlorothiazide tablets.

Pregnancy

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

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetyldigoxin


• Arsenic Trioxide


• Deslanoside


• Digitalis


• Digitoxin


• Digoxin


• Droperidol


• Flecainide


• Ketanserin


• Levomethadyl


• Lithium


• Metildigoxin


• Ouabain


• Proscillaridin


• Sotalol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alacepril


• Apazone


• Aspirin


• Benazepril


• Bepridil


• Bromfenac


• Captopril


• Carbamazepine


• Celecoxib


• Chlorpropamide


• Cholestyramine


• Cilazapril


• Cyclophosphamide


• Delapril


• Diclofenac


• Diflunisal


• Enalaprilat


• Enalapril Maleate


• Etodolac


• Fenoprofen


• Flurbiprofen


• Fosinopril


• Ginkgo


• Glipizide


• Gossypol


• Ibuprofen


• Ibuprofen Lysine


• Imidapril


• Indomethacin


• Ketoprofen


• Ketorolac


• Licorice


• Lisinopril


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Moexipril


• Nabumetone


• Naproxen


• Nepafenac


• Oxaprozin


• Pentopril


• Perindopril


• Piroxicam


• Quinapril


• Ramipril


• Salicylic Acid


• Salsalate


• Spirapril


• Sulindac


• Temocapril


• Tolmetin


• Topiramate


• Trandolapril


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anuria (not able to urinate) or


• Sulfa drug allergy (e.g., sulfamethoxazole/trimethoprim, Bactrim®, Septra®)—Should not be used in patients with these conditions.

• Asthma or


• Diabetes or


• Electrolyte imbalance (e.g., hypercalcemia, hypokalemia, hyponatremia, hypomagnesemia) or


• Gout or


• Hypercholesterolemia (high cholesterol in the blood) or


• Hyperuricemia (high uric acid in the blood) or


• Hypoglycemia (low blood sugar) or


• Liver disease or


• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of hydrochlorothiazide

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

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt) or potassium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to receive it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For fluid retention (edema):
  
  • For oral dosage form (tablets):
    
    • Adults—The usual dose is 25 to 100 milligrams (mg) daily as a single or divided dose. Your doctor may want you to take this dose every other day or on 3 to 5 days each week.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor.
    
    
  
  


• For high blood pressure:
  
  • For oral dosage form (capsule):
    
    • Adults—At first, 12. 5 milligrams (mg) or one capsule once a day. Your doctor may want you to take this alone or together with other blood pressure medicines. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 25 milligrams (mg) once a day. Your doctor may increase your dose as needed and may be taken as a single dose or divided into two doses.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Hydrocot

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

Check with your doctor right away if you have any of the following symptoms while taking this medicine: convulsions or seizures; decreased urine; drowsiness; dry mouth; excessive thirst; increased heart rate or pulse; muscle pains or cramps; nausea or vomiting; or unusual tiredness or weakness. These may be symptoms of a condition called hypokalemia or potassium loss.

Stop using this medicine and check with your doctor immediately if you have blurred vision, difficulty in reading, eye pain, or any other change in vision during or after treatment. This could be a sign of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause some people to become dizzy. Do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Drinking alcoholic beverages may also make the dizziness worse. While you are taking this medicine, be careful to limit the amount of alcohol you drink.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests (e.g., tests for parathyroid function) may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Hydrocot Side Effects

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

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Abdominal or stomach pain


• back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the urine or stools


• bloody urine


• blue lips and fingernails


• blurred vision


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


• chest pain


• chills


• clay-colored stools


• cloudy urine


• cold sweats


• confusion


• constipation


• cough or hoarseness


• coughing that sometimes produces a pink frothy sputum


• coughing up blood


• cracks in the skin


• darkened urine


• decrease in urine output or decrease in urine-concentrating ability


• decreased frequency or amount of urine


• diarrhea


• difficult, fast, or noisy breathing, sometimes with wheezing


• difficulty with breathing


• difficulty with swallowing


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position


• dry mouth


• fast or irregular heartbeat


• fever


• flushed, dry skin


• fruit-like breath odor


• general body swelling


• general feeling of discomfort or illness


• general feeling of tiredness or weakness


• greatly decreased frequency of urination or amount of urine


• headache


• hives


• increased blood pressure


• increased hunger


• increased sweating


• increased thirst


• increased urination


• indigestion


• itching


• joint pain, stiffness, or swelling


• loss of appetite


• loss of heat from the body


• lower back or side pain


• muscle cramps or pain


• nausea or vomiting


• nosebleeds


• numbness, tingling, pain, or weakness in the hands or feet


• pain in the joints or muscles


• painful or difficult urination


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


• pinpoint red spots on the skin


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


• rash


• red, irritated eyes


• red skin lesions, often with a purple center


• red, swollen skin


• redness, soreness, or itching skin


• scaly skin


• seizures


• shortness of breath


• sore throat


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


• sores, welting, or blisters


• sugar in the urine


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


• swollen or painful glands


• tenderness of salivary glands


• thickening of bronchial secretions


• tightness in the chest


• trembling


• troubled breathing


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight loss


• vomiting of blood


• weakness and heaviness of the legs


• weight gain


• wheezing


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Cramping


• decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• feeling of constant movement of self or surroundings


• hair loss or thinning of the hair


• inability to have or keep an erection


• increased sensitivity of the skin to sunlight


• loss in sexual ability, desire, drive, or performance


• muscle spasm


• pinpoint red or purple spots on the skin


• redness or other discoloration of the skin


• restlessness


• sensation of spinning


• severe sunburn


• weakness

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

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

See also: Hydrocot side effects (in more detail)

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

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More Hydrocot resources

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

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