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Acromegaly Medications


Definition of Acromegaly: Acromegaly is a chronic metabolic disorder caused by the presence of too much growth hormone. It results in gradual enlargement of body tissues including the bones of the face, jaw, hands, feet, and skull.

Drugs associated with Acromegaly

The following drugs and medications are in some way related to, or used in the treatment of Acromegaly. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Acromegaly

Medical Encyclopedia:

Acromegaly
Drug List:/tags/parlodel/
/tags/sandostatin-lar-depot-kit/
Somavert
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Somatuline Depot


Pronunciation: lan-REE-oh-tide
Generic Name: Lanreotide
Brand Name: Somatuline Depot
Somatuline Depot is used for:

Treating certain patients with acromegaly. It may also be used for other conditions as determined by your doctor.

Somatuline Depot is a somatostatin analog. It works by reducing the levels of certain hormones (eg, growth hormone, insulin-like growth factor-1) in the blood.

Do NOT use Somatuline Depot if: you are allergic to any ingredient in Somatuline Depot you are allergic to latex or rubber

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

Before using Somatuline Depot:

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

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of gallstones or gallbladder problems, liver problems, thyroid problems, heart problems (eg, slow heartbeat, heart valve problems), high blood pressure, or pancreas problems if you have a history of kidney problems or are on dialysis if you have diabetes or use insulin or other medicine to lower your blood sugar

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

Medicines that may lower heart rate, such as beta-blockers (eg, propranolol), because the risk of slow heartbeat may be increased. Ask your doctor if you are unsure if any of your medicines might lower your heart rate Bromocriptine, quinidine, or terfenadine because the risk of their side effects may be increased by Somatuline Depot Cyclosporine because its effectiveness may be decreased by Somatuline Depot

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

How to use Somatuline Depot:

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

An extra patient leaflet is available with Somatuline Depot. Talk to your pharmacist if you have questions about this information. Somatuline Depot is usually given as an injection every 4 weeks at your doctor's office, hospital, or clinic. Do not use Somatuline Depot if it contains particles, is discolored, or if the vial is cracked or damaged. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Somatuline Depot, contact your doctor right away.

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

Important safety information: Diabetes patients - Somatuline Depot may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine. Somatuline Depot may lower your blood sugar levels. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. If these symptoms occur, tell your doctor right away. Somatuline Depot may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. Lab tests, including growth hormone levels, blood sugar levels, and thyroid function, may be performed while you use Somatuline Depot. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Somatuline Depot should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Somatuline Depot while you are pregnant. It is not known if Somatuline Depot is found in breast milk. Do not breast-feed while taking Somatuline Depot. Possible side effects of Somatuline Depot:

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

Constipation; diarrhea; gas; headache; joint pain; mild stomach pain or discomfort; minor redness, pain, or swelling at the injection site; nausea; vomiting; weight loss.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dizziness; severe or persistent headache; severe or persistent nausea, stomach pain, or vomiting; slow or irregular heartbeat; symptoms of gallstones (eg, sudden pain around the upper right stomach area, right shoulder area, or between your shoulder blades; yellowing of the skin or eyes; fever with chills); unusual tiredness or weakness.

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

See also: Somatuline Depot side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Somatuline Depot:

Somatuline Depot is usually handled and stored by a health care provider.

General information: If you have any questions about Somatuline Depot, please talk with your doctor, pharmacist, or other health care provider. Somatuline Depot is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Somatuline Depot resources Somatuline Depot Side Effects (in more detail) Somatuline Depot Use in Pregnancy & Breastfeeding Somatuline Depot Drug Interactions Somatuline Depot Support Group 0 Reviews for Somatuline Depot - Add your own review/rating Somatuline Depot Prescribing Information (FDA) Somatuline Depot Monograph (AHFS DI) Somatuline Depot Advanced Consumer (Micromedex) - Includes Dosage Information Somatuline Depot Consumer Overview Compare Somatuline Depot with other medications Acromegaly
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Gonadotropin releasing hormones


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Gonadotropin releasing hormone (GnRH) is a hormone produced in the hypothalamus and transported to the pituitary gland through the blood stream. GnRH controls the secretion of follicle stimulating hormone (FSH) and luteinizing hormone (LH) from the anterior pituitary. Secretion of GnRH is controlled by neural input from other parts of the brain and in females particularly, through negative feedback by the sex steroids.

More potent analogues of GnRH (compared to endogenous GnRH) have been synthesized and are used to treat endometriosis, fibroids, infertility and prostate cancer.

See also

Medical conditions associated with gonadotropin releasing hormones:

Amenorrhea Bleeding Disorder Breast Cancer, Adjuvant Breast Cancer, Palliative Endometriosis Gonadotropin Deficiency Hirsutism Precocious Puberty Prostate Cancer Uterine Fibroids Drug List: Lupron-Depot-11-25-Mg-Depot-Suspension Trelstar-La Lupron-Depot Lupron Lupron-Depot-Ped-Kit Lupron-Depot-3-75-Mg-Suspension Synarel Zoladex Supprelin-La-Implant Eligard Factrel Lupron-Depot-Gyn Trelstar Trelstar-Depot Vantas Viadur-Implant
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Lanreotide Acetate


Class: Other Miscellaneous Therapeutic Agents
Chemical Name: [cyclo S - S] - 3 - (2 - naphthyl) - d - alanyl - l - cysteinyl - l - tyrosyl - d - tryptophyl - l - lysyl - l - valyl - l - cysteinyl - l - threoninamide acetate (salt)
CAS Number: 127984-74-1
Brands: Somatuline Depot

Introduction

Synthetic octapeptide pharmacologically related to somatostatin.1 6 8

Uses for Lanreotide Acetate Acromegaly

Long-term treatment of acromegaly in patients who have had inadequate responses to or are not candidates for surgical resection and/or radiotherapy (designated an orphan drug by FDA for this use).1 2

Goal of therapy is to normalize concentrations of growth hormone (GH) and insulin-like growth factor 1 (IGF-1).1

Improves certain manifestations of acromegaly (asthenia, joint pain, swelling of extremities, excessive perspiration, headache).4

Lanreotide Acetate Dosage and Administration General

Individualize dosage based on patient’s response (GH and IGF-1 levels, clinical symptoms); monitor serum GH and IGF-1 concentrations and adjust dosage accordingly.1 9

Administration Sub-Q Administration

Administer by deep sub-Q injection into the upper outer quadrant of the buttock; alternate injection sites every 4 weeks between the right and left buttock.1 5

Allow product to reach room temperature by removing sealed pouch from refrigerator 30 minutes prior to administration.1 Keep pouch sealed until time of administration.1

Insert the needle rapidly to its full length at an angle perpendicular to the skin; the skin should not be folded prior to administration.1

Dosage

Available as lanreotide acetate; dosage expressed in terms of lanreotide.1

Adults Acromegaly Sub-Q

Initially, 90 mg once every 4 weeks for 3 months.1

After 3 months, adjust subsequent dosages based on response (GH and IGF-1 concentrations and clinical response) (see Table 1).1

Table 1. Adjustment of Lanreotide Dosage According to Response in Adults with Acromegaly

Response

Dosage Adjustment

GH concentration >1 to 2.5 ng/mL, normal IGF-1 concentration, and controlled clinical symptoms

Maintain dosage at 90 mg once every 4 weeks1

GH concentration ?1 ng/mL, normal IGF-1 concentration, and controlled clinical symptoms

Reduce dosage to 60 mg once every 4 weeks1

GH concentration >2.5 ng/mL, elevated IGF-1 concentration, and/or uncontrolled clinical symptoms

Increase dosage to 120 mg once every 4 weeks1

Special Populations Hepatic Impairment Acromegaly Sub-Q

In patients with moderate to severe hepatic impairment, initially, 60 mg once every 4 weeks for 3 months.1 Subsequent dosages are determined based on GH and IGF-1 concentrations and clinical response.1

Renal Impairment Acromegaly Sub-Q

In patients with moderate to severe hepatic impairment, initially, 60 mg once every 4 weeks for 3 months.1 Subsequent dosages are determined based on GH and IGF-1 concentrations and clinical response.1

Geriatric Patients

Dosage adjustments not required.1

Cautions for Lanreotide Acetate Contraindications

None.1

Warnings/Precautions Sensitivity Reactions Latex Sensitivity

The needle cover of the prefilled syringe contains dry natural rubber (latex).1

Biliary Effects

Biliary abnormalities (e.g., cholelithiasis, biliary sludge) occur commonly,1 possibly due to decreased gallbladder motility, inhibited gallbladder contractility, and decreased bile secretion.1 Incidence may be related to dose and duration of therapy.1 Perform gallbladder studies periodically.1

Endocrine Effects

Hypoglycemia or hyperglycemia can occur as a result of inhibition of insulin and glucagon secretion.1 Monitor blood glucose concentrations when lanreotide therapy is initiated or dosage adjusted in patients with diabetes mellitus.1 10 Adjust dose of antidiabetic agents as necessary.1 (See Interactions.)

Slight decreases in thyroid function possible; hypothyroidism reported rarely.1 Assess thyroid function when indicated.1

Cardiovascular Effects

Sinus bradycardia, bradycardia, and hypertension reported.1 Exercise care when initiating therapy in patients with bradycardia.1

Specific Populations Pregnancy

Category C.1

Lactation

Not known whether lanreotide is distributed into milk. 1 Discontinue nursing or the drug. 1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1

Hepatic Impairment

Clearance may be decreased; dosage adjustment recommended for patients with moderate to severe hepatic impairment.1 (See Hepatic Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Renal Impairment

Clearance may be decreased; dosage adjustment recommended for patients with moderate to severe renal impairment.1 (See Renal Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Common Adverse Effects

Diarrhea, abdominal pain, nausea, constipation, flatulence, vomiting, cholelithiasis, injection site reactions, arthralgia, headache.1

Interactions for Lanreotide Acetate Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP isoenzyymes: Potential pharmacokinetic interaction (decreased substrate clearance).1 Caution advised if used concomitantly with CYP3A4 substrates with a low therapeutic index.1

Drugs Associated with Bradycardia

Possible additive effect on heart rate reduction; dosage adjustment of the concomitantly administered drug may be necessary.1

Effects on GI Absorption of Drugs

Possible decreased absorption of concomitant drugs.1

Specific Drugs

Drug

Interaction

Comments

Antidiabetic therapy

Possible hypoglycemia or hyperglycemia1

Monitor blood glucose concentrations when lanreotide is initiated or dose altered; adjust dose of insulin and/or antidiabetic agent as necessary1

?-Adrenergic blocking agents

Possible additive bradycardia1

Dosage adjustment of ?-blocker may be necessary 1

Bromocriptine

Increased bioavailability of bromocriptine1

Cyclosporine

Possible decreased cyclosporine concentrations1

Adjust cyclosporine dosage as required1

Quinidine

Possible increased quinidine concentrations1

Use with caution1

Vitamin K

No effect on vitamin K absorption1

Lanreotide Acetate Pharmacokinetics Absorption Bioavailability

Mean bioavailability was 73.4, 69, and 78.4% following sub-Q administration of single 60-, 90-, and 100-mg dosages, respectively.1 A drug depot is formed at the injection site allowing for sustained release.1

Peak levels obtained during the first day following sub-Q administration.1

Duration

Serum concentrations slowly decline over 28 days with low peak to trough fluctuation noted at steady state.1

Distribution Extent

Not known whether lanreotide is distributed into milk. 1

Elimination Elimination Route

<5% excreted in urine; <0.5% recovered unchanged in feces, indicating some biliary excretion.1

Half-life

23–30 days following single-dose administration to healthy subjects.1

Special Populations

In healthy geriatric individuals, half-life was increased by 85%.1

End-stage renal disease requiring dialysis decreases clearance twofold and doubles half-life.1 (See Renal Impairment under Dosage and Administration.)

Moderate to severe hepatic impairment reduces clearance by 30%.1 (See Hepatic Impairment under Dosage and Administration.)

Stability Storage Parenteral Injection

2–8°C in original package; protect from light.1

ActionsActions

Decreases the concentration of GH and IGF-1.1 8

Inhibits basal secretion of several gastric enzymes (e.g., motilin, gastric inhibitory peptide, pancreatic polypeptide) and postprandial secretion of pancreatic polypeptide, gastrin, and cholecystokinin.1 8

Has high affinity for somatostatin receptors (SSTR) 2 and 5 in the anterior pituitary and pancreas.1 6 8

Advice to Patients

Provide copy of manufacturer’s patient information.1

Importance of advising patients to closely adhere to the schedule for return visits and lanreotide injections in order to maintain steady control of GH and IGF-1 levels.5

Importance of informing clinician if allergy to latex exists.5

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 5

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 5

Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

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

Lanreotide Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, extended-release

60 mg (of lanreotide)

Somatuline Depot (available in disposable prefilled syringe)

Tercica

90 mg (of lanreotide)

Somatuline Depot (available in disposable prefilled syringe)

Tercica

120 mg (of lanreotide)

Somatuline Depot (available in disposable prefilled syringe)

Tercica

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 May 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Tercica. Somatuline Depot (lanreotide) injection prescribing information. Brisbane, CA; 2007 Aug.

2. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 2007 Oct 3. From FDA web site. Accessed 2008 Jan 25

3. AACE Acromegaly Guidelines Task Force. AACE medical guidelines for clinical practice for the diagnosis and treatment of acromegaly. Endocr Pract. 2004; 10:213-25. [PubMed 15382339]

4. Chanson P, Barson-Chazott, Kuhn JM et al. Control of IGF-I levels with titrated dosing of lanreotide autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (OXF). 2008; 69:299-305. [PubMed 18248639]

5. Ipsen Pharma Biotech. Somatuline Depot (lanreotide) injection patient labeling. Signes, France; 2007 Aug.

6. Croxtall JD, Scott LJ. Lanreotide Autogel: a review of its use in management of acromegaly. Drugs. 2008; 68:711-23. [PubMed 18370450]

7. Murray RD, Melmed S. A critical analysis of clinically available somatostatin analog formulations for therapy of acromegaly. Clin Endocrinol Metab. 2008; 93:2957-68.

8. Croxtall JD, Scott LJ. Spotlight on lanreotide autogel in acromegaly. Biodrugs. 2008; 22:275-7. [PubMed 18611070]

9. Melmed S. Acromegaly. N Engl J Med. 2006; 355:2558-73. [PubMed 17167139]

10. Terica, Brisbane, CA: Personal communication.

More Lanreotide Acetate resources Lanreotide Acetate Side Effects (in more detail) Lanreotide Acetate Use in Pregnancy & Breastfeeding Lanreotide Acetate Drug Interactions Lanreotide Acetate Support Group 0 Reviews for Lanreotide Acetate - Add your own review/rating Compare Lanreotide Acetate with other medications Acromegaly
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Short Stature for Age Medications


Definition of Short Stature for Age: Short stature refers to any person who is significantly below the average height for a person of the same age and sex -- specifically, the shortest 3 - 5% of the population. More...

Drugs associated with Short Stature for Age

The following drugs and medications are in some way related to, or used in the treatment of Short Stature for Age. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Short Stature for Age

Medical Encyclopedia:

Short stature
Drug List: Accretropin Genotropin Humatrope-Cartridge Norditropin Norditropin-Flexpro Norditropin-Nordiflex Nutropin Nutropin-Aq Nutropin-Depot Omnitrope Saizen Serostim Tev-Tropin Zorbtive
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Lupron Depot Depot Suspension


Pronunciation: LOO-proe-lide
Generic Name: Leuprolide
Brand Name: Lupron Depot
Lupron Depot Depot Suspension is used for:

Treating symptoms of advanced prostate cancer. It may also be used for certain conditions as determined by your doctor.

Lupron Depot Depot Suspension is a gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. This prevents the growth of certain tumors that need these hormones to grow.

Do NOT use Lupron Depot Depot Suspension if: you are allergic to any ingredient in Lupron Depot Depot Suspension, to GnRH, or to another GnRH agonist (eg, histrelin) you are pregnant, able to become pregnant, or are breast-feeding

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

Before using Lupron Depot Depot Suspension:

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

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of diabetes or high blood sugar, urinary problems (eg, a blockage of the bladder or ureters), spinal cord problems, abnormal growths on or near the spinal cord, a certain type of irregular heartbeat (congenital long QT syndrome) or other heart problems (eg, congestive heart failure), blood vessel problems, or a stroke if you have bone problems (eg, weak bones, osteoporosis) or if a family member has had bone problems if you have blood electrolyte problems (eg, low blood magnesium or potassium levels) if you are taking medicines that can weaken the bones, such as anticonvulsants (eg, phenytoin) or corticosteroids (eg, prednisone) if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Lupron Depot Depot Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following: Antiarrhythmic medicines (eg, amiodarone, quinidine, sotalol) because they may increase the risk of a certain type of irregular heartbeat (prolonged QT interval)

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

How to use Lupron Depot Depot Suspension:

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

An extra patient leaflet is available with Lupron Depot Depot Suspension. Talk to your pharmacist if you have questions about this information. Lupron Depot Depot Suspension is usually given every 6 months (24 weeks) as an injection at your doctor's office, hospital, or clinic. If you will be using Lupron Depot Depot Suspension at home, a health care provider will teach you how to use it. Be sure you understand how to use Lupron Depot Depot Suspension. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Lupron Depot Depot Suspension if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. Do not miss any doses of Lupron Depot Depot Suspension. If you miss a dose of Lupron Depot Depot Suspension, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Lupron Depot Depot Suspension.

Important safety information: Certain hormone levels may increase during the first few weeks of treatment with Lupron Depot Depot Suspension. This may cause you to experience worsening symptoms or onset of new symptoms (eg, bone pain; blood in the urine; difficulty urinating; burning, numbness, or tingling) during the first few weeks of treatment. Patients with growths on or near the spine or spinal cord, or a blockage of the bladder or ureters may be at greater risk of developing serious and sometimes fatal complications. Contact your doctor if any new or worsened symptoms occur while you are using Lupron Depot Depot Suspension. Lupron Depot Depot Suspension lowers the amount of certain hormones in your body. This may result in certain effects, such as changes in breast size, breast soreness or tenderness, testicular changes, decreased sexual ability, hot flashes, or night sweats. Discuss any questions or concerns with your doctor. Lupron Depot Depot Suspension may cause your bones to weaken (decreased bone density) or become more prone to fractures, especially if you use it for a long time. Contact your doctor if you notice bone pain or if you have questions or concerns. A slight increase in the risk of stroke or serious and sometimes fatal heart problems has been reported with the use of GnRH agonists in men. Although the risk appears to be low, seek immediate medical attention if you experience chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache or vomiting; or vision changes. Discuss any questions or concerns with your doctor. A serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of Lupron Depot Depot Suspension. Most cases developed within 2 weeks after the first dose. Contact your doctor right away if you experience a sudden headache, vomiting, fainting, mental or mood changes, eye weakness, inability to move your eyes, or vision changes. High blood sugar and an increased risk of the development of diabetes has been reported in men who use GnRH agonists. Patients who already have diabetes may develop trouble controlling their blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. Diabetes patients - Lupron Depot Depot Suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lupron Depot Depot Suspension may interfere with certain lab tests, including certain hormone and pituitary gland function tests. Be sure your doctor and lab personnel know you are using Lupron Depot Depot Suspension. Lab tests, including blood testosterone levels, prostate-specific antigen (PSA), hemoglobin A1c, blood glucose, and bone density, may be performed while you use Lupron Depot Depot Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Lupron Depot Depot Suspension is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Lupron Depot Depot Suspension if you are pregnant. It may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Lupron Depot Depot Suspension is found in breast milk. Do not breast-feed while using Lupron Depot Depot Suspension. Possible side effects of Lupron Depot Depot Suspension:

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

Constipation; dizziness; hot flashes; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); mild joint or back pain; tiredness; trouble sleeping.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; burning, numbness, tingling, or weakness; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, nervousness); new or worsening bone pain; paralysis; seizures; severe dizziness or light-headedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of infection (eg, chills, fever); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual bruising or bleeding; urination problems (eg, trouble urinating, inability to urinate, painful urination); vision changes or blurred vision; vomit that looks like coffee grounds.

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

See also: Lupron Depot side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Lupron Depot Depot Suspension:

Store Lupron Depot Depot Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Because the product does not contain a preservative, once mixed, discard the suspension if it is not used right away. Keep Lupron Depot Depot Suspension out of the reach of children and away from pets.

General information: If you have any questions about Lupron Depot Depot Suspension, please talk with your doctor, pharmacist, or other health care provider. Lupron Depot Depot Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Lupron Depot resources Lupron Depot Side Effects (in more detail) Lupron Depot Use in Pregnancy & Breastfeeding Lupron Depot Drug Interactions Lupron Depot Support Group 24 Reviews for Lupron Depot - Add your own review/rating Compare Lupron Depot with other medications Endometriosis Hirsutism Prostate Cancer Uterine Fibroids
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Sandostatin LAR Depot injectable


Generic Name: octreotide (injectable) (ok TREE oh tide)
Brand Names: SandoSTATIN, SandoSTATIN LAR Depot

What is octreotide?

Octreotide is a man-made protein that is similar to a hormone in the body called somatostatin. Octreotide lowers many substances in the body such as insulin and glucagon (involved in regulating blood sugar), growth hormone, and chemicals that affect digestion.

Octreotide is used to treat acromegaly. Octreotide is also used to reduce flushing episodes and watery diarrhea caused by cancerous tumors (carcinoid syndrome) or tumors called vasoactive intestinal peptide tumors (VIP adenomas).

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

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

Before using octreotide, tell your doctor if you have diabetes, gallbladder disease, heart disease, thyroid problems, pancreatitis, kidney disease, or liver disease.

Octreotide is given as an injection under the skin or into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. Be sure to follow the instructions for the exact type of octreotide your doctor has prescribed for you.

While using octreotide, call your doctor if you have severe stomach pain, fever, bloating, nausea and vomiting, or jaundice (yellowing of the skin or eyes). These may be signs of serious side effects

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

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using octreotide, tell your doctor if you have:

diabetes;

gallbladder disease;

heart disease;

thyroid problems;

pancreatitis;

kidney disease; liver disease. FDA pregnancy category B. Octreotide is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Using octreotide can affect certain hormones that may make it easier for you to get pregnant, even if you were unable to get pregnant before. Talk to your doctor about using birth control to avoid unwanted pregnancy. It is not known whether octreotide passes into breast milk. Do not use octreotide without telling your doctor if you are breast-feeding a baby. How should I use octreotide?

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.

Octreotide is given as an injection under the skin or into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. Be sure to follow the instructions for the exact type of octreotide your doctor has prescribed for you.

Do not draw your octreotide dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your blood or urine will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Store this medication in the refrigerator, protected from light. Do not allow the medication to freeze.

To reduce discomfort from your injection, take the medicine bottle out of the refrigerator about 30 minutes before using the medication. Allow the medicine to reach room temperature before using, but never warm the medicine in hot water or a microwave.

Throw away any medicine left in the bottle after 14 days of use. Then start a new bottle.

The Sandostatin LAR Depot kit should be kept at room temperature for 30 to 60 minutes before mixing the medicine. Give the injection right away after mixing your dose.

What happens if I miss a dose?

Contact your doctor if you miss a dose of octreotide.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of octreotide is not expected to produce life-threatening side effects.

What should I avoid while using octreotide?

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

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

slow or irregular heartbeats;

gallbladder problems (stomach pain);

pancreatitis (pain in the upper stomach or back, nausea, vomiting, fever, bloating, yellowing of the skin or eyes);

thyroid problems (may be detected by blood tests);

low blood sugar (headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, nausea); or

high blood sugar (increased thirst and urination; flushed or dry skin; drowsiness).

Less serious side effects may include:

nausea or vomiting;

diarrhea;

mild stomach pain or gas;

constipation; or

pain or irritation where you injected the medication.

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.

What other drugs will affect octreotide?

Before using octreotide, tell your doctor if you are taking any of the following medicines:

bromocriptine (Parlodel);

cyclosporine (Neoral, Sandimmune, Gengraf);

a diuretic (water pill);

diabetes medication such as insulin, glipizide (Glucotrol), glyburide (Diabeta, Micronase), tolbutamide (Orinase), metformin (Glucophage), pioglitazone (Actos), rosiglitazone (Avandia), and others; or

medicine for heart disease or high blood pressure.

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

More Sandostatin LAR Depot resources Sandostatin LAR Depot Side Effects (in more detail) Sandostatin LAR Depot Use in Pregnancy & Breastfeeding Sandostatin LAR Depot Drug Interactions Sandostatin LAR Depot Support Group 1 Review for Sandostatin LAR Depot - Add your own review/rating Compare Sandostatin LAR Depot with other medications Acromegaly Carcinoid Tumor Diabetes, Type 1 Diarrhea Gastrinoma Glucagonoma Insulinoma Pituitary Adenoma Small Bowel or Pancreatic Fistula Vasoactive Intestinal Peptide Tumor Where can I get more information? Your pharmacist can provide more information about octreotide.

See also: Sandostatin LAR Depot side effects (in more detail)


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Lupron Depot Suspension


Pronunciation: LOO-proe-lide
Generic Name: Leuprolide
Brand Name: Lupron Depot
Lupron Depot Suspension is used for:

Treating symptoms of advanced prostate cancer. It may also be used for certain conditions as determined by your doctor.

Lupron Depot Suspension is a gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. This prevents the growth of certain tumors that need these hormones to grow.

Do NOT use Lupron Depot Suspension if: you are allergic to any ingredient in Lupron Depot Suspension, to GnRH, or to another GnRH agonist (eg, histrelin) you are pregnant, able to become pregnant, or are breast-feeding

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

Before using Lupron Depot Suspension:

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

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of diabetes or high blood sugar, urinary problems (eg, a blockage of the bladder or ureters), spinal cord problems, abnormal growths on or near the spinal cord, a certain type of irregular heartbeat (congenital long QT syndrome) or other heart problems (eg, congestive heart failure), blood vessel problems, or a stroke if you have bone problems (eg, weak bones, osteoporosis) or if a family member has had bone problems if you have blood electrolyte problems (eg, low blood magnesium or potassium levels) if you are taking medicines that can weaken the bones, such as anticonvulsants (eg, phenytoin) or corticosteroids (eg, prednisone) if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Lupron Depot Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following: Antiarrhythmic medicines (eg, amiodarone, quinidine, sotalol) because they may increase the risk of a certain type of irregular heartbeat (prolonged QT interval)

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

How to use Lupron Depot Suspension:

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

An extra patient leaflet is available with Lupron Depot Suspension. Talk to your pharmacist if you have questions about this information. Lupron Depot Suspension is usually given every 3 months (12 weeks) as an injection at your doctor's office, hospital, or clinic. If you will be using Lupron Depot Suspension at home, a health care provider will teach you how to use it. Be sure you understand how to use Lupron Depot Suspension. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Lupron Depot Suspension if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. Do not miss any doses of Lupron Depot Suspension. If you miss a dose of Lupron Depot Suspension, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Lupron Depot Suspension.

Important safety information: Certain hormone levels may increase during the first few weeks of treatment with Lupron Depot Suspension. This may cause you to experience worsening symptoms or onset of new symptoms (eg, bone pain; blood in the urine; difficulty urinating; burning, numbness, or tingling) during the first few weeks of treatment. Patients with growths on or near the spine or spinal cord, or a blockage of the bladder or ureters may be at greater risk of developing serious and sometimes fatal complications. Contact your doctor if any new or worsened symptoms occur while using Lupron Depot Suspension. Lupron Depot Suspension lowers the amount of certain hormones in your body. This may result in certain effects, such as changes in breast size, breast soreness or tenderness, testicular changes, decreased sexual ability, hot flashes, or night sweats. Discuss any questions or concerns with your doctor. Lupron Depot Suspension may cause your bones to weaken (decreased bone density) or become more prone to fractures, especially if you use it for a long time. Contact your doctor if you notice bone pain or if you have questions or concerns. A slight increase in the risk of stroke or serious and sometimes fatal heart problems has been reported with the use of GnRH agonists in men. Although the risk appears to be low, seek immediate medical attention if you experience chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache or vomiting; or vision changes. Discuss any questions or concerns with your doctor. A serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of Lupron Depot Suspension. Most cases developed within 2 weeks after the first dose. Contact your doctor right away if you experience a sudden headache, vomiting, fainting, mental or mood changes, eye weakness, inability to move your eyes, or vision changes. High blood sugar and an increased risk of the development of diabetes has been reported in men who use GnRH agonists. Patients who already have diabetes may develop trouble controlling their blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. Diabetes patients - Lupron Depot Suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lupron Depot Suspension may interfere with certain lab tests, including certain hormone and pituitary gland function tests. Be sure your doctor and lab personnel know you are using Lupron Depot Suspension. Lab tests, including blood testosterone levels, prostate-specific antigen (PSA), hemoglobin A1c, blood glucose, and bone density, may be performed while you use Lupron Depot Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Lupron Depot Suspension should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Lupron Depot Suspension if you are pregnant. It may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Lupron Depot Suspension is found in breast milk. Do not breast-feed while using Lupron Depot Suspension. Possible side effects of Lupron Depot Suspension:

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

Dizziness; general body pain; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); tiredness; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; burning, numbness, tingling, or weakness; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, nervousness); new or worsening bone pain; paralysis; seizures; severe dizziness or light-headedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of infection (eg, chills, fever); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual bruising or bleeding; urination problems (eg, trouble urinating, inability to urinate, painful urination); vision changes or blurred vision; vomit that looks like coffee grounds.

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

See also: Lupron Depot side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Lupron Depot Suspension:

Store Lupron Depot Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Because the product does not contain a preservative, once mixed, discard the suspension if not used right away. Keep Lupron Depot Suspension out of the reach of children and away from pets.

General information: If you have any questions about Lupron Depot Suspension, please talk with your doctor, pharmacist, or other health care provider. Lupron Depot Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Lupron Depot resources Lupron Depot Side Effects (in more detail) Lupron Depot Use in Pregnancy & Breastfeeding Lupron Depot Drug Interactions Lupron Depot Support Group 24 Reviews for Lupron Depot - Add your own review/rating Compare Lupron Depot with other medications Endometriosis Hirsutism Prostate Cancer Uterine Fibroids
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Trelstar LA Mixject


Generic Name: triptorelin (TRIP toe REL in)
Brand Names: Trelstar Depot, Trelstar Depot Mixject, Trelstar LA, Trelstar LA Mixject

What is Trelstar LA Mixject (triptorelin)?

Triptorelin is a man-made form of a hormone that regulates many processes in the body. Triptorelin overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily.

Triptorelin is used to treat the symptoms of prostate cancer. Triptorelin treats only the symptoms of prostate cancer and does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.

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

What is the most important information I should know about Trelstar LA Mixject (triptorelin)? You should not use this medication if you are allergic to triptorelin or similar drugs such as leuprolide (Lupron, Viadur, Eligard) or goserelin (Zoladex).

Before using triptorelin, tell your doctor if you have any type of cancer that has spread to your spine, a bladder obstruction or problems with urination, diabetes, heart disease, high blood pressure, high cholesterol, a history of stroke or heart attack, or if you smoke.

After your injection, your prostate cancer symptoms may get worse for a short time because triptorelin raises your testosterone levels. These side effects should get better within 3 or 4 weeks. Call your doctor if your symptoms do not improve, or if they get worse while using triptorelin. Some of the side effects of triptorelin are symptoms of prostate cancer that may occur because the medicine raises your testosterone levels. Call your doctor at once if you have pain or burning when you urinate, blood in your urine, bone pain, numbness, tingling, muscle weakness, or loss of movement in any part of your body. Although triptorelin is not for use by women, this medication can cause birth defects and should not be used by a woman who is pregnant or who may become pregnant. What should I discuss with my healthcare provider before using Trelstar LA Mixject (triptorelin)? You should not use this medication if you are allergic to triptorelin or similar drugs such as leuprolide (Lupron, Viadur, Eligard) or goserelin (Zoladex).

If you have any of these other conditions, you may need a triptorelin dose adjustment or special tests:

any type of cancer that has spread to your spine;

a bladder obstruction or problems with urination;

diabetes, heart disease, high blood pressure, recent weight gain, high cholesterol (especially in men);

heart disease, high blood pressure, high cholesterol;

a history of heart attack or stroke; or

if you smoke.

FDA pregnancy category X. Although triptorelin is not for use by women, this medication can harm an unborn baby or cause birth defects. Triptorelin should not be used by a woman who is pregnant or who may become pregnant. It is not known whether triptorelin passes into breast milk or if it could harm a nursing baby. Although triptorelin is not for use by women, this medication should not be used while breast-feeding a baby. How should I use Trelstar LA Mixject (triptorelin)?

Triptorelin is injected into a muscle. 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 patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

This medication comes with a vial (bottle) of powder medicine and a prefilled syringe of sterile water. The powder must be mixed with the sterile water before using the medicine. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not save the mixture for later use. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Triptorelin is usually given once every 4, 12, or 24 weeks. Your dose schedule will depend on the strength of triptorelin you are using. Follow your doctor's dosing instructions very carefully.

After your injection, your prostate cancer symptoms may get worse for a short time because triptorelin raises your testosterone levels. These side effects should get better within 3 or 4 weeks. Call your doctor if your symptoms do not improve, or if they get worse while using triptorelin.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store vials and prefilled syringes at room temperature away from moisture, heat, and light. Do not freeze. What happens if I miss a dose?

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

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 Trelstar LA Mixject (triptorelin)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Trelstar LA Mixject (triptorelin) 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. Call your doctor at once if you have a serious side effect. Some of these side effects are symptoms of prostate cancer that may occur because the medicine raises your testosterone levels:

painful or difficult urination, burning when you urinate, blood in the urine;

bone pain;

numbness, tingling, or muscle weakness (especially in your legs and feet);

loss of movement in any part of your body;

fever, chills, body aches, flu symptoms;

sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech; or

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

hot flashes;

back pain, pain or swelling in your legs;

headache, dizziness, tired feeling;

decreased interest in sex, impotence, trouble having an orgasm;

nausea, vomiting, diarrhea, upset stomach;

sleep problems (insomnia);

breast pain or swelling; or

pain where the medicine was injected.

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.

What other drugs will affect Trelstar LA Mixject (triptorelin)?

There may be other drugs that can interact with triptorelin. 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.

More Trelstar LA Mixject resources Trelstar LA Mixject Side Effects (in more detail) Trelstar LA Mixject Use in Pregnancy & Breastfeeding Trelstar LA Mixject Drug Interactions Trelstar LA Mixject Support Group 1 Review for Trelstar LA Mixject - Add your own review/rating Trelstar Depot Prescribing Information (FDA) Trelstar Depot MedFacts Consumer Leaflet (Wolters Kluwer) Trelstar Depot Advanced Consumer (Micromedex) - Includes Dosage Information Trelstar LA Prescribing Information (FDA) Triptorelin Pamoate Monograph (AHFS DI) Compare Trelstar LA Mixject with other medications Prostate Cancer Where can I get more information? Your doctor or pharmacist can provide more information about triptorelin.

See also: Trelstar LA Mixject side effects (in more detail)


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Synacthen Ampoules 250mcg


1. Name Of The Medicinal Product

Synacthen® Ampoules 250mcg

2. Qualitative And Quantitative Composition

Tetracosactide acetate PhEur 250micrograms per ampoule.

3. Pharmaceutical Form

A clear colourless sterile solution in a clear glass ampoule.

4. Clinical Particulars 4.1 Therapeutic Indications

Diagnostic test for the investigation of adrenocortical insufficiency.

4.2 Posology And Method Of Administration

Adults: This preparation of Synacthen is intended for administration for diagnostic purposes only as a single intramuscular or intravenous dose; it is not to be used for repeated therapeutic administration.

The 30-minute Synacthen diagnostic test: This test is based on measurement of the plasma cortisol concentration immediately before and exactly 30 minutes after an intramuscular or intravenous injection of 250micrograms (1ml) Synacthen. Adrenocortical function can be regarded as normal if the post-injection rise in plasma cortisol concentration amounts to at least 200nmol/litre (70micrograms/litre).

Where the 30-minute test has yielded inconclusive results, or where it is desired to determine the functional reserve of the adrenal cortex, a 5-hour test can be performed with Synacthen Depot (see separate Summary of Product Characteristics). Furthermore, a 3-day test with Synacthen Depot may be used to differentiate between primary and secondary adrenocortical insufficiency.

Children: An intravenous dose of 250micrograms/1.73m? body surface area has been suggested. Thus for children aged 5 to 7 years, approximately half the adult dose will be adequate. For more accurate dosing of other ages, standard body surface area tables should be consulted.

Elderly: There is no evidence to suggest that dosage should be different in the elderly.

4.3 Contraindications

History of hypersensitivity to ACTH, Synacthen or Synacthen Depot. Synacthen is contra-indicated in patients with allergic disorders (e.g. asthma).

4.4 Special Warnings And Precautions For Use

Before using Synacthen, the doctor should make every effort to find out whether the patient is suffering from, or has a history of, allergic disorders (see Section 4.3 “Contra-indications”). In particular, he should enquire whether the patient has previously experienced adverse reactions to ACTH, Synacthen or other drugs.

Synacthen should only be administered under the supervision of appropriate senior hospital medical staff (e.g. consultants).

If local or systemic hypersensitivity reactions occur after the injection (for example, marked redness and pain at the injection site, urticaria, pruritus, flushing, faintness or dyspnoea), Synacthen or other ACTH preparations should be avoided in the future. Hypersensitivity reactions tend to occur within 30 minutes of an injection. The patient should therefore be kept under observation during this time.

Preparation should be made in advance to combat any anaphylactic reaction that may occur after an injection of Synacthen. In the event of a serious anaphylactic reaction occurring, the following measures must be taken immediately: administer adrenaline (0.4 to 1ml of a 0.1% solution intramuscularly or 0.1 to 0.2ml of a 0.1% solution in 10ml physiological saline slowly intravenously) as well as a large intravenous dose of a corticosteroid (for example 100mg to 500mg hydrocortisone, three or four times in 24 hours), repeating the dose if necessary.

The hydrocortisone product information prepared by the manufacturer should also be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

The Synacthen test should not be utilised during pregnancy and lactation unless there are compelling reasons for doing so.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness.

4.8 Undesirable Effects

Hypersensitivity reactions:

Synacthen may provoke hypersensitivity reactions. In patients suffering from, or susceptible to, allergic disorders (especially asthma) this may take the form of anaphylactic shock (see Section 4.3 “Contra-indications”).

Hypersensitivity may be manifested as skin reactions at the injection site, dizziness, nausea, vomiting, urticaria, pruritus, flushing, malaise, dyspnoea, angioneurotic oedema and Quinke's oedema.

Other side effects are unlikely to be observed with short-term use of Synacthen as a diagnostic tool. Should information be required on the side effects reported with therapeutic use of tetracosactide acetate, see Synacthen Depot Summary of Product Characteristics.

4.9 Overdose

Overdosage is unlikely to be a problem when the product is used as a single dose for diagnostic purposes.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Tetracosactide acetate consists of the first 24 amino acids occurring in the natural corticotropic hormone (ACTH) sequence and displays the same physiological properties as ACTH. In the adrenal cortex, it stimulates the biosynthesis of glucocorticoids, mineralocorticoids, and, to a lesser extent androgens.

The site of action of ACTH is the plasma membrane of the adrenocortical cells, where it binds to a specific receptor. The hormone-receptor complex activates adenylate cyclase, stimulating the production of cyclic AMP (adenosine monophosphate) and so promoting the synthesis of pregnenolone from cholesterol. From pregnenolone the various corticosteroids are produced via different enzymatic pathways.

5.2 Pharmacokinetic Properties

Following an intravenous injection, elimination of tetracosactide acetate from the plasma consists of 3 phases. The half-lives of these phases are approximately 7 minutes (0 to 1 hour), 37 minutes (1 to 2 hours) and 3 hours thereafter.

Tetracosactide acetate has an apparent volume of distribution of approximately 0.4L/kg.

In the serum, tetracosactide acetate is broken down by serum endopeptidases into inactive oligopeptides and then by aminopeptidases into free amino acids. The rapid elimination from plasma is probably not attributable to this relatively slow cleavage process, but rather to the rapid concentration of the active substance in the adrenal glands and kidneys.

Following an iv dose of 131I-labelled tetracosactide acetate, 95 to 100% of the radioactivity is excreted in the urine within 24 hours.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber, which are additional to those already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Acetic acid, sodium acetate, sodium chloride and water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Synacthen should be protected from light and stored in a refrigerator (2 - 8°C).

6.5 Nature And Contents Of Container

The ampoules are colourless glass PhEur type I. Five ampoules are packed in a cardboard box.

6.6 Special Precautions For Disposal And Other Handling

Shake well before use.

Administrative Data 7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

8. Marketing Authorisation Number(S)

PL 16853/0017

9. Date Of First Authorisation/Renewal Of The Authorisation

25 June 1998

10. Date Of Revision Of The Text

February 2005

11. Legal Status

POM

Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks of Alliance Pharmaceuticals Ltd.


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Trelstar Depot


Generic Name: triptorelin (Intramuscular route)

trip-toe-REL-in

Commonly used brand name(s)

In the U.S.

Trelstar Trelstar Depot Trelstar LA

Available Dosage Forms:

Powder for Suspension

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

Uses For Trelstar Depot

Triptorelin is used to treat advanced prostate cancer in men. It is a hormone that is similar to the one normally released from the hypothalamus gland in the brain. When given on a regular basis to men, triptorelin decreases testosterone levels which helps treat prostate cancer.

This medicine is to be given only by or under the supervision of a doctor.

Before Using Trelstar Depot

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 triptorelin 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 triptorelin in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

Bladder blockage or Diabetes or Heart or blood vessel disease or Hyperglycemia (high blood sugar) or Spinal cord problems—Use with caution. May make these conditions worse. Kidney disease or Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of triptorelin

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

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into your muscle (usually in the buttocks). This medicine needs to be given on a fixed schedule. Make sure you keep all of your appointments.

Precautions While Using Trelstar Depot

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

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

When you first start using this medicine, some of your symptoms might get worse or you might have new symptoms for a short time. Tell your doctor right away if you have bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating.

This medicine may cause changes in your blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

This medicine may increase your risk of having a heart attack or stroke. Call your doctor right away if you have chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; nausea; sweating; or vomiting.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Trelstar Depot 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 or nurse immediately if any of the following side effects occur:

Less common Bladder pain bloating or swelling of the face, arms, hands, lower legs, or feet bloody or cloudy urine blurred vision burning while urinating chest pain cough producing mucus decrease in urine volume or frequency of urination difficult or labored breathing difficult, burning, or painful urination difficulty in passing urine dizziness dry mouth flushed, dry skin frequent urge to urinate fruit-like breath odor headache high blood pressure increased hunger increased thirst increased urination loss of consciousness lower back or side pain nausea nervousness pale skin pounding in the ears rapid weight gain shortness of breath slow or fast heartbeat stomachache sweating tightness in the chest tingling of the hands or feet troubled breathing troubled breathing with exertion unexplained weight loss unusual bleeding or bruising unusual tiredness or weakness unusual weight gain or loss vomiting wheezing Incidence not known Anxiety changes in skin color changes in vision chest discomfort cold, clammy, or pale skin confusion dizziness or lightheadedness fainting inability to speak irregular heartbeats numbness or tingling in the face, arms, or legs pain pain or discomfort in the arms, jaw, back, or neck pain, redness, or swelling in the arm or leg seizures severe or sudden headache slow heart rate slurred speech sudden shortness of breath or troubled breathing temporary blindness tenderness trouble speaking, thinking, or walking weakness in the arm or leg on one side of the body, sudden and severe

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:

More common Bone pain chills decrease in testicle size diarrhea fever decreased interest in sexual intercourse feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest general feeling of discomfort or illness inability to have or keep an erection joint pain leg pain loss in sexual ability, desire, drive, or performance loss of appetite muscle aches and pains redness of the face, neck, arms, and occasionally, upper chest runny nose shivering sore throat sudden sweating trouble sleeping Less common Acid or sour stomach back pain belching body aches or pain breast pain burning, dry, or itching eyes congestion crying depersonalization difficulty having a bowel movement (stool) difficulty with moving discharge or excessive tearing dysphoria euphoria eye pain heartburn hoarseness indigestion injection site pain itching lack or loss of strength leg cramps loss of appetite mental depression muscle aching or cramping muscle pains or stiffness pain paranoia quick to react or overreact emotionally rapidly changing moods rash redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid runny nose sleeplessness stomach discomfort, upset, or pain swelling of the breasts or breast soreness in both females and males swollen joints tender, swollen glands in the neck trouble with swallowing voice changes weight loss

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: Trelstar Depot side effects (in more detail)

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

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Trelstar Depot resources Trelstar Depot Side Effects (in more detail) Trelstar Depot Use in Pregnancy & Breastfeeding Trelstar Depot Drug Interactions Trelstar Depot Support Group 0 Reviews for Trelstar Depot - Add your own review/rating Trelstar Depot Prescribing Information (FDA) Trelstar Depot MedFacts Consumer Leaflet (Wolters Kluwer) Trelstar Depot Concise Consumer Information (Cerner Multum) Trelstar LA Prescribing Information (FDA) Triptorelin Pamoate Monograph (AHFS DI) Compare Trelstar Depot with other medications Prostate Cancer
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Gonapeptyl Depot 3.75 mg


1. Name Of The Medicinal Product

GONAPEPTYL DEPOT

3.75 mg

Powder and solvent for suspension for injection.

2. Qualitative And Quantitative Composition

One pre-filled syringe contains 3.75 mg triptorelin (as acetate) to be suspended in one ml suspension agent.

For excipients, see 6.1.

3. Pharmaceutical Form

Powder and solvent for suspension for injection

prolonged release in pre-filled syringes.

4. Clinical Particulars 4.1 Therapeutic Indications

Men:

Treatment of advanced, hormone-dependent prostate carcinoma.

Women:

Preoperative reduction of myoma size to reduce the symptoms of bleeding and pain in women with symptomatic uterine myomas.

Symptomatic endometriosis confirmed by laparoscopy when suppression of the ovarian hormonogenesis is indicated to the extent that surgical therapy is not primarily indicated.

Children:

Treatment of confirmed central precocious puberty (girls under 9 years, boys under 10 years).

4.2 Posology And Method Of Administration

The product should only be used under the supervision of an appropriate specialist having requisite facilities for regular monitoring of response.

It is important that the injection of the sustained release form be performed strictly in accordance with the instructions given in section 6.6.

Following reconstitution, the suspension has to be injected immediately.

Dosage and method of administration

The dosage of one syringe, equivalent to 3.75 mg triptorelin, is injected every 28 days either subcutaneously (e.g. into the skin of the abdomen, the buttock or thigh) or deep intramuscularly. The injection site should be changed each time.

Men:

Once every four weeks an injection with one syringe, equivalent to 3.75 mg triptorelin. In order to continually suppress testosterone levels, it is important to comply with a 4-weekly administration.

Women:

? Uterine myomas and endometriosis:

Once every four weeks an injection with one syringe, equivalent to 3.75 mg triptorelin. The treatment must be initiated in the first 5 days of the cycle.

Children:

At the beginning of treatment one injection with one syringe, equivalent to 3.75 mg triptorelin, on days 0, 14, and 28. Thereafter one injection every 4 weeks. Should the effect be insufficient, the injections may be given every 3 weeks. Dosing should be based on body weight. Children weighing less than 20 kg are injected with 1.875 mg (half dose), children between 20 and 30 kg receive 2.5 mg (2/3 dose), and children with more than 30 kg body weight are injected with 3.75 mg triptorelin (full dose).

Note for specific patient groups:

? There is no need to adjust the dose for the elderly.

? According to current data, dose reduction or prolongation of the dosage interval in patients with impaired renal function is not necessary.

Duration of administration

? Prostate carcinoma:

Treatment with Gonapeptyl Depot is usually a long-term therapy.

- Uterine myomas and endometriosis:

The duration of treatment depends on the initial degree of severity of endometriosis and on the evolution of its clinical manifestations (functional and anatomical) and on the evolution of the volume of the uterine myomas, determined by ultrasonography during treatment. Normally, the maximum attainable result is achieved after 3 to 4 injections.

In view of the possible effect on bone density, therapy should not exceed a duration of 6 months (see 4.4).

- Central precocious puberty (CPP):

Treatment should be stopped if a bone maturation of older than 12 years in girls and older than 13 years in boys has been achieved.

4.3 Contraindications

General:

Known hypersensitivity to triptorelin, poly-(d,l lactide coglycolide), dextran, or to any of the excipients.

In men:

? Hormone independent prostate carcinoma

? As sole treatment in prostate cancer patients with spinal cord compression or evidence of spinal metastases (see also section 4.4)

? After orchiectomy (in case of surgical castration Gonapeptyl Depot does not cause further decrease of serum testosterone)

In women:

? Pregnancy

? Clinically manifest osteoporosis

? Lactation period

In children:

? Progressive brain tumours

4.4 Special Warnings And Precautions For Use

Men:

The initial transient increase of serum testosterone has, in few patients, been associated with a temporary aggravation of symptoms of the disease (see 4.8). The patient should be advised to consult the physician, if any of these symptoms aggravates. For that reason, the use of Gonapeptyl Depot has to be carefully evaluated in patients with premonitory signs of medullary compression and the medical surveillance has to be closer in the first weeks of treatment, particularly in patients with urinary tract obstructions due to metastases and/or in patients with spinal metastases.

In order to prevent accentuation of the clinical symptoms, supplementary administration of an appropriate antiandrogen agent should be considered in the initial phase of the treatment.

In order to control the therapeutic effect, the prostate-specific antigen (PSA) and the testosterone plasma levels should be regularly monitored during treatment. Testosterone levels should not exceed 1 ng/ml.

Women:

Gonapeptyl Depot should only be prescribed after careful diagnosis (e.g. laparoscopy). Pregnancy should be precluded prior to treatment.

- Uterine myomas and endometriosis:

Menstruation does not occur during treatment. A supervening metrorrhagia in the course of treatment is abnormal (apart from the first month), and should lead to verification of plasma oestrogen level. Should this level be less than 50 pg/ml, possible associated organic lesions should be sought. After withdrawal of treatment, ovarian function resumes, e.g. menstrual bleeding will resume after 7-12 weeks after the final injection.

Non-hormonal contraception should be used during the initial month of treatment as ovulation may be triggered by the initial release of gonadotrophins. It should also be used from 4 weeks after the last injection until resumption of menstruation or until another contraceptive method has been established.

During treatment of uterine myomas the size of uterus and myoma should be determined regularly, e.g. by means of ultrasonography. Disproportionally fast reduction of uterus size in comparison with the reduction of myoma tissue has in isolated cases led to bleeding and sepsis.

Treatment with Gonapeptyl Depot over several months can lead to a decrease of bone density (see 4.8). For this reason, therapy should not exceed a duration of 6 months. After withdrawal of treatment, the bone loss is generally reversible within 6 - 9 months.

Particular caution is therefore advised in patients with additional risk factors in view of osteoporosis.

Children:

The chronological age at the beginning of therapy should be under 9 years in girls and under 10 years in boys.

After finalising the therapy, development of puberty characteristics will occur. Information with regards to future fertility is still limited. In most girls menses will start on average one year after ending the therapy, which in most cases is regular.

Pseudo-precocious puberty (gonadal or adrenal tumour or hyperplasia) and gonadotropin-independent precocious puberty (testicular toxicosis, familial Leydig cell hyperplasia) should be precluded.

Allergic and anaphylactic reactions have been reported in adults and children. These include both local site reactions and systemic symptoms. The pathogenesis could not be elucidated. A higher reporting rate was seen in children.

General:

When triptorelin is co-administered with drugs affecting pituitary secretion of gonadotrophins caution should be given and the patient's hormonal status should be supervised.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Oestrogen containing medicinal products should not be used during treatment with Gonapeptyl Depot.

4.6 Pregnancy And Lactation

Very limited data on the use of triptorelin during pregnancy do not indicate an increased risk of congenital malformations. However, long-term follow-up studies on development are far too limited. Animal data do not indicate direct or indirect harmful effects with respect to pregnancies or postnatal developments, but there are indications for foetotoxicity and delayed parturition. Based on the pharmacological effects disadvantageous influence on the pregnancy and the offspring cannot be excluded and Gonapeptyl Depot should not be used during pregnancy. Women of childbearing potential should use effective non-hormonal contraception. It is not known whether triptorelin is excreted in human milk. Because of the potential for adverse reactions from triptorelin in nursing infants, breastfeeding should be discontinued prior to and throughout administration.

4.7 Effects On Ability To Drive And Use Machines

Gonapeptyl Depot has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

Adverse experiences reported among patients treated with triptorelin during clinical trials and from post-marketing surveillance are shown below. As a consequence of decreased testosterone or oestrogen levels, most patients are expected to experience adverse reactions, with hot flushes being the most frequently reported (30% in men and 75-100% in women). Additionally, impotence and decreased libido should be expected in 30-40% of male patients, while bleeding/spotting, sweating, vaginal dryness and/or dyspareunia, decrease in libido and mood changes are expected in more than 10% of women.

Due to the fact that the testosterone levels normally increase during the first week of treatment, worsening of symptoms and complaints may occur (e.g. urinary obstruction, skeletal pain due to metastases, compression of the spinal cord, muscular fatigue and lymphatic oedema of the legs). In some cases urinary tract obstruction decreases the kidney function. Neurological compression with asthenia and paraesthesia in the legs has been observed.

Organ class

Common Adverse Reactions ( > 1/100, < 1/10)

Uncommon Adverse Reactions ( > 1/1000, < 1/100)

 

Men and women

 

   

Endocrine

 

Depressive mood; irritation

 

Metabolic and nutritional

 

Elevated enzyme levels (LDH, ?GT, SGOT, SGPT)

Gastrointestinal

 

Nausea

 

Musculo-skeletal system

 

Myalgia; arthralgia

 

Body as a whole – general:

Tiredness; sleep disturbances; hypersensitivity reactions (itching; skin rash; fever)

Anaphylaxis

Application site disorders

Temporary pain at injection site

Foreign body reaction at injection site

 

Men

 

   

Platelet, bleeding and clotting disorders

 

 

Thrombo-embolic disorder

Endocrine

Gynecomastia; headache; perspiration

Testicular atrophy; reduced growth of beard; hair loss on chest, arms and legs

Cardiovascular

 

Hypertension

Gastro-intestinal

 

Loss of appetite; gastralgia; dry mouth

Respiratory system disorders

 

Recurrence of asthma

General

 

 

Weight changes

 

Women

   

Metabolic and nutritional

 

Slight rise in serum cholesterol

Central and peripheral nervous system

 

Visual disturbances; paraesthesia

General

 

 

Aching of back

Children

 

   

Endocrine

 

Vaginal bleeding and discharge

Gastrointestinal

 

 

Vomiting; nausea

Body as a whole – general

 

Anaphylaxis

Slight trabecular bone loss may occur. This is generally reversible within 6-9 months after treatment discontinuation (see section 4.4).

 

Two cases of epiphysiolysis capitis femoris have been reported during use with triptorelin. Whether or not a causal relationship exists is unknown.

4.9 Overdose

There is insufficient experience of overdosing with triptorelin to draw conclusions on possible adverse effects. Considering the package form and the pharmaceutical form, overdosing is not expected.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Gonadorelinanaloga

ATC code: L02AE04

Triptorelin is a synthetic decapeptide analogue of the natural gonadotrophin-releasing hormone (GnRH). GnRH is a decapeptide, which is synthesised in the hypothalamus and regulates the biosynthesis and release of the gonadotrophins LH (luteinising hormone) and FSH (follicle stimulating hormone) by the pituitary. Triptorelin stimulates the pituitary more strongly to secretion of LH and FSH than a comparable dose of gonadorelin, whereas the duration of action is longer. The increase of LH and FSH levels will initially lead to an increase of serum testosterone concentrations in men or serum oestrogen concentrations in women. Chronic administration of a GnRH agonist results in an inhibition of pituitary LH- and FSH-secretion. This inhibition leads to a reduction in steroidogenesis, by which the serum estradiol concentration in women and the serum testosterone concentration in men fall to within the postmenopausal or castrate range, respectively, i.e. a hypogonadotrophic hypogonadal state. In children with precocious puberty, the concentration of estradiol or testosterone will decrease to within the prepubertal range. Plasma DHEAS (dihydroepiandrostenedion sulphate) levels are not influenced. Therapeutically, this leads to a decrease in growth of testosterone-sensitive prostate tumours in men, and to reduction of endometriosis foci and oestrogen-dependent uterus myomas in women. Regarding uterine myoma, maximal benefit of treatment is observed in women with anaemia (haemoglobin inferior or equal to 8 g/dl). In children suffering from CPP triptorelin treatment leads to a suppression of the secretion of gonadotropins, estradiol, and testosterone to prepubertal levels. This results in arrest or even regression of pubertal signs and an increase in adult height prediction in CPP patients.

5.2 Pharmacokinetic Properties

After intramuscular administration of Gonapeptyl Depot, the plasma concentrations of triptorelin are determined by the (slow) degradation of the poly-(d,l lactide coglycolide) polymer. The mechanism inherent to this administration form enables this slow release of triptorelin from the polymer.

After I.M. or S.C. application of a triptorelin depot-formulation (sustained-release microcapsules), a rapid increase in the concentration of triptorelin in plasma is recorded, with a maximum in the first hours. Then the triptorelin concentration declines notably within 24 hours. On day 4 the value reaches a second maximum, falling below the detection limit in a biexponential course after 44 days. After S.C. injections the triptorelin increase is more gradual and in a somewhat lower concentration than after I.M. injections. After S.C. injection, the decline in the triptorelin concentration takes longer, with values falling below the detection limit after 65 days.

During treatment over a period of 6 months and an administration every 28 days, there was no evidence of triptorelin accumulation in both modes of administration. Plasma triptorelin values decreased to approx. 100 pg/ml before the next application after I.M. or S.C. application (median values). It is to be assumed that the non-systemically available proportion of triptorelin is metabolized at the injection site, e.g. by macrophages.

In the pituitary, the systemically available triptorelin is inactivated by N-terminal cleavage via pyroglutamyl-peptidase and a neutral endopeptidase. In the liver and the kidneys, triptorelin is degraded to biologically inactive peptides and amino acids.

40 minutes after the end of an infusion of 100 ?g triptorelin (over 1 hour) 3-14% of the administered dose has already been eliminated by the kidney.

For patients with an impaired renal function, adaptation and individualization of therapy with the triptorelin depot-formulation seems to be unnecessary, on account of the subordinate significance of the renal elimination route and the broad therapeutic range of triptorelin as an active component.

Bioavailability:

Men:

The systemic bioavailability of the active component triptorelin from the intramuscular depot is 38.3% in the first 13 days. Further release is linear at 0.92% of the dose per day on average. Bioavailability after S.C. application is 69% of I.M. availability.

Women:

After 27 test days, 35.7% of the applied dose can be detected on average, with 25.5% being released in the first 13 days and further release being linear at 0.73% of the dose per day on average.

General:

Calculation of the model-depending kinetic parameters (t?, Kel, etc.) is inapplicable in presentations with a strongly protracted release of the active component.

5.3 Preclinical Safety Data

In rats, but not in mice treated over a long period of time with triptorelin, an increase in pituitary tumors has been detected. The influence of triptorelin on pituitary abnormalities in humans is unknown. The observation is considered not to be relevant to humans. Pituitary tumors in rodents in connection with other LHRH analogues have also been known to occur. Triptorelin has been shown to be embryo-/foetotoxic and to cause a delay in embryo-/foetal development as well as delay in parturition in rats. Preclinical data reveal no special hazard to humans based on repeat dose toxicity and genotoxicity studies. Single I.M. or S.C. injection of Gonapeptyl Depot or its suspension agent produced delayed foreign body reactions at the injection site. Within 8 weeks, these late reactions were nearly reversed after I.M. injection but only slightly reversed after S.C. injection. Local tolerance of Gonapeptyl Depot after I.V. injection was limited

6. Pharmaceutical Particulars 6.1 List Of Excipients

One pre-filledsyringe with powder contains:

Poly-(d,l lactide coglycolide)

Propyleneglycol octanoate decanoate

One pre-filledsyringe with one ml suspension agent contains:

Dextran 70

Polysorbate 80

Sodium chloride

Sodium hydrogen phosphate dihydrate

Sodium hydroxide

Water for injection

6.2 Incompatibilities

In the absence of compatibility studies this medicinal product should not be mixed with other medicinal products.

6.3 Shelf Life

3 years

Reconstituted suspension: 3 minutes

6.4 Special Precautions For Storage

Store at 2°C - 8°C (in a refrigerator). Keep the container in the outer carton.

6.5 Nature And Contents Of Container

Powder: Pre-filled syringe

Solvent: Pre-filled syringe

Pre-filled syringes (borosilicate glass type I, clear) with a connector (polypropylene), black chlorobutyl rubber stopper (plunger stopper, type I) and injection needle.

Pack sizes:

1 pre-filled syringe (powder) plus

1 pre-filled syringe (solvent)

3 pre-filled syringes (powder) plus

3 pre-filled syringes (solvent)

6.6 Special Precautions For Disposal And Other Handling

GonapeptylDepot is for single use only and any unused suspension should be discarded.

1. Preparation

Instructions for the physician how to prepare the suspension.

Since successful treatment depends upon correct preparation of the suspension, the following instructions must be strictly followed.

- Take the package of Gonapeptyl Depot from the refrigerator.

- Remove the cap from the disposable syringe containing the powder. Keep upright to prevent spilling.

- Open the package with the connector without removing the connector.

- Screw the syringe containing the sustained release microparticles on the connector in the package, then remove it.

Screw the syringe containing the suspension agent tightly on the free end of the connector and ensure that it fits tightly.

2. Reconstitution of a suspension

Empty the liquid into the syringe with the powder, then shoot it back and forth into the first syringe – the first two or three times without pushing the injection rod all the way in. Repeat this about 10 times or until you have a homogeneous milky-like suspension. While preparing the suspension, you might possibly create some foam. It is important that the foam be dissolved or removed from the syringe before giving the injection.

Mixing

Mix approximately 10 times

3. Injection

- Remove the connector together with the empty syringe.

- Mount the injection needle on the syringe with the ready-to-use suspension.

- Inject subcutaneously or deep into the muscle immediately.

7. Marketing Authorisation Holder

Ferring Pharmaceuticals Ltd.

The Courtyard

Waterside Drive

Langley

Berkshire SL3 6EZ

United Kingdom

8. Marketing Authorisation Number(S)

PL 03194/0085

9. Date Of First Authorisation/Renewal Of The Authorisation

14th May 2003

10. Date Of Revision Of The Text
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Synovitis Medications


Definition of Synovitis:

Inflammation of a synovial membrane. It is usually painful, particularly on motion and is characterised by a fluctuating swelling due to effusion within a synovial sac.

Synovitis is qualified as fibrinous, gonorrhoeal, hyperplastic, lipomatous, metritic, puerperal, rheumatic, scarlatinal, syphilitic, tuberculous, urethral, etc.

Drugs associated with Synovitis

The following drugs and medications are in some way related to, or used in the treatment of Synovitis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Aristocort Baycadron Clinacort-Injection Clinalog-Injection De-Sone-La-Injection Decadron Deltasone Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Ken-Jec-40-Injection Kenalog-10-Suspension Kenalog-40-Suspension Meticorten Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Tac-3-Injection Triam-Forte Triamcot-Injection Triamonide-40-Injection U-Tri-Lone-Injection Zema-Pak-10-Day
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Meningitis, Listeriosis Medications


Drugs associated with Meningitis, Listeriosis

The following drugs and medications are in some way related to, or used in the treatment of Meningitis, Listeriosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Baycadron De-Sone-La-Injection Decadron Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Solurex-Injection Solurex-La-Injection Zema-Pak-10-Day
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Adrenocortical Insufficiency Medications


Definition of Adrenocortical Insufficiency:

Loss, to varying degrees, of adrenocortical function.

Synonym: hypocorticoidism.

Drugs associated with Adrenocortical Insufficiency

The following drugs and medications are in some way related to, or used in the treatment of Adrenocortical Insufficiency. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Adrenocortical Insufficiency

Micromedex Care Notes:

Addison's DiseaseSecondary Adrenal Insufficiency

Medical Encyclopedia:

Exogenous adrenal insufficiency
Drug List:/tags/a-hydrocort/
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Lichen Simplex Chronicus Medications


Definition of Lichen Simplex Chronicus: Lichen simplex chronicus is a skin disorder characterized by chronicitching and scratching. The persistent scratching causes formation of thick, leathery hyperpigmented skin.

Drugs associated with Lichen Simplex Chronicus

The following drugs and medications are in some way related to, or used in the treatment of Lichen Simplex Chronicus. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Lichen Simplex Chronicus

Medical Encyclopedia:

Lichen simplex chronicus
Drug List: Aloquin-Gel Aristocort-Forte Aristospan-Suspension Clinacort-Injection Clinalog-Injection Ken-Jec-40-Injection Kenalog-10-Suspension Kenalog-40-Suspension Prudoxin-Topical Tac-3-Injection Triam-Forte Triamcot-Injection Triamonide-40-Injection U-Tri-Lone-Injection Zonalon-Cream
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Hemolytic Anemia Medications


Definition of Hemolytic Anemia: Hemolytic anemia is a condition of an inadequate number of circulating red blood cells (anemia), caused by premature destruction of red blood cells. There are a number of specific types of hemolytic anemia which are described individually.

Drugs associated with Hemolytic Anemia

The following drugs and medications are in some way related to, or used in the treatment of Hemolytic Anemia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Hemolytic AnemiaAutoimmune Hemolytic Anemia (4 drugs) G-6-PD Deficiency (0 drugs) Learn more about Hemolytic Anemia

Micromedex Care Notes:

Erythroblastosis FetalisHemolytic AnemiaJaundice In NewbornsRh Factor Incompatibility

Medical Encyclopedia:

Congenital spherocytic anemiaDrug-induced immune hemolytic anemiaHemolytic anemiaHemolytic anemia caused by chemicals and toxinsIron deficiency anemiaNewborn jaundiceRh incompatibility

Harvard Health Guide:

Symptoms and treatment for Hemolytic Anemia
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Opiate Adjunct Medications


Drugs associated with Opiate Adjunct

The following drugs and medications are in some way related to, or used in the treatment of Opiate Adjunct. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Adgan-Injection Anergan-50-Injection Antinaus-50-Injection Phenadoz-Rectal Phenergan Promethegan-Rectal
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Uveitis, Posterior Medications


Drugs associated with Uveitis, Posterior

The following drugs and medications are in some way related to, or used in the treatment of Uveitis, Posterior. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Uveitis, Posterior Infectious Posterior Uveitis (0 drugs) Learn more about Uveitis, Posterior

Medical Encyclopedia:

Uveitis
Drug List: Baycadron De-Sone-La-Injection Decadron Deltasone Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Meticorten Ozurdex Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Zema-Pak-10-Day
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Meningitis, Haemophilus influenzae Medications


Drugs associated with Meningitis, Haemophilus influenzae

The following drugs and medications are in some way related to, or used in the treatment of Meningitis, Haemophilus influenzae. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Meningitis, Haemophilus influenzaeHaemophilus influenzae Prophylaxis (12 drugs)
Drug List:/tags/baycadron/
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Zema-Pak-10-Day
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