Go PLR Content Directory South Carolina: March 2012

Monday 26 March 2012

Plasmanate

Generic Name: Plasma Protein Fraction
Class: Blood Derivatives
ATC Class: B05AA
VA Class: BL500
CAS Number: 55963-80-9

Introduction

Protein colloid; sterile solution of selected proteins prepared from pooled human plasma.¹⁰⁴

Uses for Plasmanate

Fluid Resuscitation (Shock)

Used for plasma volume expansion in the treatment of certain types of shock, including shock resulting from burns, crushing injuries, abdominal emergencies, or any other cause where there is a predominant loss of plasma fluids and not RBCs.¹⁰⁴

Adequate replacement for human plasma in the treatment of shock and suitable means of providing human proteins for their osmotic effect;¹⁰⁴ however, albumin solutions may be preferable because they contain a greater percentage of albumin and, since they are more purified, are less likely to cause hypotensive reactions.^a (See Hypotension under Cautions.)

Initial therapy in infants and small children for shock resulting from dehydration and infection.¹⁰⁴

Emergency treatment of shock due to hemorrhage.¹⁰⁴ Following the emergency phase of therapy, transfusions of whole blood or RBCs may be indicated, depending on the severity of the blood loss.¹⁰⁴

Plasmanate Dosage and Administration

Administration

IV Administration

Administer by IV infusion, preferably at a site at some distance from any site of infection or trauma.¹⁰⁴

Swab the rubber stopper on vial with iodine tincture followed by a sterile antiseptic swab.¹⁰⁴ Insert a 16-gauge needle or dispensing pin perpendicular to the stopper in the area delineated by a raised ring.¹⁰⁴

Does not contain preservatives; discard any partially used vials.¹⁰⁴

Do not mix with protein hydrolysates or solutions containing alcohol.¹⁰⁴

To minimize administration errors, consult the manufacturer’s administration instructions for proper use.¹⁰⁴

Rate of Administration

Adjust rate of infusion according to the clinical response of the patient and changes in BP.¹⁰⁴

For hypovolemic shock in infants and young children: Infusion at a rate of up to 5–10 mL/minute has been suggested.^a

As plasma volume approaches normal, do not exceed 5–8 mL/minute.^a Rapid IV infusion (e.g., >10 mL/minute) may cause vascular overload.¹⁰⁴ ^a (See Infusion Effects under Cautions.)

Dosage

Dosage depends on the patient’s condition and response to therapy.¹⁰⁴

Pediatric Patients

Fluid Resuscitation (Shock)

Hypovolemic Shock

Infants and young children: Initially, 6.6–33 mL/kg (0.33–1.65 g/kg of protein).^a Subsequent dosage is determined by the patient’s condition.^a

Adults

Fluid Resuscitation (Shock)

Hypovolemic Shock

Usual minimum effective dosage: 250–500 mL (12.5–25 g of protein).¹⁰⁴ Subsequent dosage is determined by the patient’s condition.^a

Prescribing Limits

Adults

Fluid Resuscitation (Shock)

Hypovolemic Shock

Do not exceed 5–8 mL/minute.^a

Special Populations

No special population dosage recommendations at this time.¹⁰⁴

Cautions for Plasmanate

Contraindications

Cardiopulmonary bypass procedures.¹⁰⁴ (See Hypotension under Cautions.)

Severe anemia.¹⁰⁴

CHF.¹⁰⁴

Increased blood volume.¹⁰⁴

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Potential vehicle for transmission of human viruses, including hepatitis virus, or other infectious agents.¹⁰⁴

Despite screening for certain viruses (e.g., human immunodeficiency virus [HIV], hepatitis B virus [HBV], hepatitis C virus [HCV]) and a pasteurization procedure to reduce viral infectious potential associated with plasma protein fraction (PPF), a risk for transmission of infectious agents still remains.^a

Transmission of nonenveloped viruses, including hepatitis HAV and parvovirus B19, has been documented following administration of plasma-derived coagulation factors.¹⁰⁵

Report any suspected PPF-associated infections to the manufacturer.¹⁰⁴

Risk of Creutzfeldt-Jakob Disease

May carry a risk of transmitting the causative agent of Creutzfeldt-Jacob disease (CJD) or variant CJD (vCJD).¹⁰⁰ ¹⁰¹ ¹⁰² ¹⁰³ ¹⁰⁶ ¹⁰⁷

There have been 3 probable cases of vCJD acquired through transfusion of human RBCs,¹¹⁷ although, transmission via human plasma derivatives (including plasma-derived albumin) has not been documented to date.¹⁰⁶ ¹⁰⁷ ¹⁰⁸

Risk of West Nile Virus

Evidence exists that West Nile Virus (WNV) can be transmitted in transplanted organs (e.g., heart, liver, kidney) and blood products (e.g., whole blood, packed RBCs, fresh frozen plasma).¹¹⁰ ¹¹¹ ¹¹³ ¹¹⁴ However, WNV transmission unlikely through commercially available plasma-derived preparations since WNV is an enveloped virus, like HCV, which is known to be inactivated by the heat and solvent/detergent viral inactivation procedures used in the manufacture of these preparations.¹¹¹ ¹¹²

For further information on WNV precautions related to blood and blood products, the FDA’s guidance for industry should be consulted ().¹¹¹

General Precautions

Infusion Effects

Rapid infusion may cause vascular overload.^a

Observe all patients (especially those with normal or increased circulatory volumes) for signs of hypervolemia, including dyspnea, fluid in the lungs, pulmonary edema, cardiac failure, or abnormal increases in BP or central venous pressure.^a

Hypotension

Hypotension may occur, especially following rapid IV infusion (i.e., at rates >10 mL/minute) in patients undergoing surgery or in the pre- or postoperative period or during intra-arterial administration in patients on cardiopulmonary bypass.¹⁰⁴ Monitor BP during administration; slow or stop the infusion if sudden hypotension occurs.¹⁰⁴ BP may return to normal spontaneously following slowing or discontinuance of the infusion; vasopressors also may be used to correct hypotension.¹⁰⁴

Sodium Content

Commercially available PPF contains approximately 145 mEq of sodium per liter.¹⁰⁴

Trauma or Surgery Risk

Rapid rise in BP accompanying administration of PPF following injuries or surgery may reveal bleeding points that were not apparent at the lower BP; observe patient carefully to prevent hemorrhage and subsequent shock.^a

Hematologic Effects

Does not contain coagulation factors and, therefore, cannot be used to correct coagulation disorders.¹⁰⁴ Contains trace amounts of blood groups A and B isohemagglutins; however, these are at such low concentrations that use of PPF should have no effect on routine blood typing procedures.¹⁰⁴

Specific Populations

Pregnancy

Category C.¹⁰⁴

Pediatric Use

Manufacturer states that safety and efficacy not established in pediatric patients; however, protein colloid has been found to be very useful in infants and small children for initial treatment of shock resulting from dehydration and infection.¹⁰⁴

Hepatic Impairment

Use with caution in patients with hepatic failure because of added protein, fluid, and sodium load.^a

Renal Impairment

Use with caution in patients with renal failure because of added protein, fluid, and sodium load.^a

Common Adverse Effects

Flushing,¹⁰⁴ urticaria,¹⁰⁴ nausea,¹⁰⁴ headache,¹⁰⁴ back pain.¹⁰⁴

Plasmanate Pharmacokinetics

Absorption

Duration

Following IV administration, increased blood volume may last up to 48 hours.¹⁰⁴

Stability

Storage

Parenteral

Solution for Injection

Room temperature (not >30°C).¹⁰⁴ Do not freeze.¹⁰⁴

Do not use solutions that appear turbid.¹⁰⁴

Do not start administration if >4 hours have elapsed since the container was first entered.¹⁰⁴

Do not use solutions that have been frozen, since the container may crack and permit contamination of the contents.¹⁰⁴

ActionsActions

Pharmacologic properties of PPF are similar to those of its primary constituent, albumin.^a

Replacement for human plasma in the treatment of shock.¹⁰⁴

IV administration of PPF results in an increased blood volume.¹⁰⁴

Causes a shift of fluid from the interstitial spaces into the circulation and a slight increase in the concentration of plasma protein.^a

Advice to Patients

Potential risk of transmission of infectious agents (e.g., human viruses).¹⁰⁴

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.¹⁰⁴

Importance of women informing clinicians if they are or plan to become pregnant.¹⁰⁴

Importance of informing patients of other important precautionary information.¹⁰⁴ (See Cautions.)

Preparations

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

Plasma Protein Fraction (Human)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV infusion	50 mg/mL	Plasmanate	Talecris

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 August 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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

100. Nightingale SL. Dear doctor letter regarding withdrawal of certain plasma products. Rockville, MD: Department of Health and Human Services. Public Health Service. Food and Drug Administration; 1995 Mar 29.

101. Department of Health and Human Services, Food and Drug Administration. Precautionary measures to further reduce the possible risk of transmission of Creutzfeldt-Jakob disease by blood and blood products. 1995 Aug 8. Memorandum.

102. Department of Health and Human Services, Food and Drug Administration. Precautionary measures to further reduce the possible risk of transmission of Creutzfeldt-Jakob disease by blood and blood products. 1995 Aug 8. (Supplemental recommendations to 1987 Nov 25 memorandum on deferral of donors who have received human pituitary-derived growth hormone.)

103. Vidor A. Dear customer letter regarding withdrawal of certain lots of Buminate 25%. Lakewood, NJ: Baxter Healthcare Corp; 1997 Mar 13.

104. Talecris. Plasmanate (plasma protein fraction [human] 5%) prescribing information. Research Triangle Park, NC; 2005 Jan.

105. Medical and Scientific Advisory Council (MASAC), National Hemophilia Foundation. MASAC recommendations concerning the treatment of hemophilia and other bleeding disorders (revised October 2005). MASAC recommendation #165. From National Hemophilia Foundation website ().

106. Medical and Scientific Advisory Council (MASAC), National Hemophilia Foundation. MASAC recommendations regarding the use of recombinant clotting factor products with respect to pathogen transmission (June 3, 2006). MASAC recommendation #169. From National Hemophilia Foundation website ().

107. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). Guidance for industry. Revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jacob disease (CJD) and variant Creutzfeldt-Jacob disease (vCJD) by blood and blood products. January 2002. From FDA website ().

108. Ricketts MN, Cashman NR, Stratton EE et al. Is Creutzfeldt-Jacob disease transmitted in blood? Emerg Infectious Dis. 1997; 3:155-63.

109. Brown P, Will RG, Bradley R et al. Bovine spongiform encephalopathy and variant Creutzfeldt-Jakob disease: background, evolution, and current concerns. Emerg Infectious Dis. 2001; 7:6-16.

110. Centers for Disease Control and Prevention. West Nile virus activity—United States, October 10–16, 2002, and update on West Nile virus infections in recipients of blood transfusions. MMWR Morb Mortal Wkly Rep. 2002; 51:929-31. [PubMed 12403410]

111. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). Guidance for industry. Revised recommendations for the assessment of donor suitability and blood and blood product safety in cases of known or suspected West Nile virus infection. May 2003. From FDA website ().

112. National Hemophilia Foundation. West Nile virus fact sheet. From National Hemophilia Foundation website ().

113. Harrington T, Kuehnert MF, Kamel H et al. West Nile virus infection transmitted by blood transfusion. Transfusion. 2003; 43:1018-22. [PubMed 12869105]

114. Iwamoto M, Jernigan DB, Gausch A et al. Transmission of West Nile virus from an organ donor to four transplant recipients. N Engl J Med. 2003; 348:2196-203. [PubMed 12773646]

115. Chiron. New test developed to screen donated blood for West Nile virus by July 1 deadline. Press release. 2003 June 18.

116. Centers for Disease Control and Prevention. Questions and answers: blood transfusions and organ donations. From the CDC website ().

117. Hewitt PE, Llewelyn CA, Mackenzie J et al. Creutzfeldt-Jakob disease and blood transfusion: result of the UK transfusion medicine epidemiological review study. Vox Sang. 2006; 91:221-30. [PubMed 16958834]

a. AHFS Drug Information 2007. McEvoy GK, ed. Plasma protein fraction. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 1405–6.

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Plasmanate

Plasma protein fraction (human)

Sunday 25 March 2012

panitumumab

Generic Name: panitumumab (pan i TUE moo mab)

Brand Names: Vectibix

What is panitumumab?

Panitumumab is a cancer medication. It interferes with the growth of cancer cells and slows their growth and spread in your body.

Panitumumab is used to treat metastatic colorectal cancer that has progressed after treatment with other chemotherapy.

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

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

Before receiving this medication, tell your doctor if you have any allergies or breathing problems. You may not be able to receive panitumumab, or you may need a dosage adjustment or special tests during treatment.

Panitumumab may cause severe skin problems such as acne, itching, redness, skin rash, dryness, peeling, cracking, or oozing, and swelling or infection around your fingernails or toenails. This medication can also cause redness or irritation of your eyes or eyelids. More severe forms of skin problems can lead to widespread infection and possibly death. Seek emergency medical attention at the first sign of any skin rash.

Some people receiving a panitumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have a fever or chills during the injection.

The side effects of panitumumab may not appear when you first start using the medication. Severe skin or eye reactions may occur up to 2 weeks after the start of your treatment. These effects may not clear up for weeks or even months after you stop receiving panitumumab.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Panitumumab can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

This medication may affect a woman's fertility (ability to have children). You may also have irregular menstrual periods while receiving panitumumab.

What should I discuss with my health care provider before receiving panitumumab?

This medication may cause severe skin problems such as acne, itching, redness, skin rash, dryness, peeling, cracking, or oozing, and swelling or infection around your fingernails or toenails. More severe forms of skin problems can lead to widespread infection and possibly death. Seek emergency medical attention at the first sign of any skin rash. Do not use this medication if you are allergic to panitumumab.

Before receiving this medication, tell your doctor if you have any allergies or breathing problems. You may not be able to receive panitumumab, or you may need a dose adjustment or special tests to safely receive this medication.

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

This medication may affect a woman's fertility (ability to have children). You may also have irregular menstrual periods while receiving panitumumab.

How is panitumumab given?

Panitumumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 90 minutes to complete.

Before you receive this medication, you may need to undergo a biopsy to make sure panitumumab is the right medication to treat your cancer.

Panitumumab is usually given once every 2 weeks. Follow your doctor's instructions.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your panitumumab injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a panitumumab overdose are unknown.

What should I avoid while taking panitumumab?

Panitumumab side effects

Some of the side effects of panitumumab may not appear when you first start using the medication. Severe skin or eye reactions may occur up to 2 weeks after the start of your treatment. These effects may not clear up for weeks or even months after you stop receiving panitumumab.

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:

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

swelling of your hands or ankles;

acne, dryness, peeling, cracking, bleeding, oozing, pus, or any other sign of skin infection;

cough or wheezing, running out of breath easily;

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

drowsiness, restless feeling, confusion, muscle stiffness, fast or uneven heart rate, chest pain;

redness, swelling, or irritation of your eyes or eyelids; or

swelling or infection around your fingernails or toenails.

Less serious side effects may include:

nausea, vomiting, stomach pain;

diarrhea or constipation; or

tired feeling.

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

Panitumumab Dosing Information

Usual Adult Dose for Colorectal Cancer:

6 mg/kg administered as an intravenous infusion over 60 minutes every 14 days

What other drugs will affect panitumumab?

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

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Panitumumab Professional Patient Advice (Wolters Kluwer)

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Panitumumab Monograph (AHFS DI)

Vectibix Prescribing Information (FDA)

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Compare panitumumab with other medications

Colorectal Cancer

Where can I get more information?

Your doctor can provide more information about panitumumab.

See also: panitumumab side effects (in more detail)

Saturday 24 March 2012

Prostap SR DCS

1. Name Of The Medicinal Product

PROSTAP^® SR DCS 3.75 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe

2. Qualitative And Quantitative Composition

PROSTAP SR Powder: contains 3.75 mg leuprorelin acetate (equivalent to 3.57 mg base).

Sterile Solvent: Each ml contains carmellose sodium 5 mg, mannitol (E421) 50 mg, polysorbate 80 1 mg, glacial acetic acid up to 0.05 mg in Water for Injections.

When reconstituted with Sterile Solvent, the suspension contains 3.75 mg/ml leuprorelin acetate.

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Powder and solvent for suspension for injection in pre-filled syringe

Powder: A sterile, lyophilised, white, odourless powder.

Solvent: A clear, odourless, slightly viscous, sterile solvent.

4. Clinical Particulars

4.1 Therapeutic Indications

(i) Metastatic prostate cancer.

(ii) Locally advanced prostate cancer, as an alternative to surgical castration.

(iii) As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.

(iv) As an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression.

(v) Management of endometriosis, including pain relief and reduction of endometriotic lesions.

(vi) Endometrial preparation prior to intrauterine surgical procedures including endometrial ablation or resection.

(vii) Preoperative management of uterine fibroids to reduce their size and associated bleeding.

(See Section 5.1)

4.2 Posology And Method Of Administration

Prostate Cancer: The usual recommended dose is 3.75 mg presented as a one month depot injection and administered as a single subcutaneous or intramuscular injection every month. The majority of patients will respond to a 3.75 mg dose. PROSTAP SR therapy should not be discontinued when remission or improvement occurs. As with other drugs administered chronically by injection, the injection site should be varied periodically.

Response to PROSTAP SR therapy may be monitored by clinical parameters and by measuring serum levels of testosterone and acid phosphatase. Clinical studies with leuprorelin acetate have shown that testosterone levels increased during the first 4 days of treatment in the majority of non-orchidectomised patients. They then decreased and reached castrate levels by 2-4 weeks. Once attained, castrate levels were maintained as long as drug therapy continued. If a patient's response appears to be sub-optimal, then it would be advisable to confirm that serum testosterone levels have reached or are remaining at castrate levels. Transient increases in acid phosphatase levels sometimes occur early in the treatment period but usually return to normal or near normal values by the 4th week of treatment.

Endometriosis: The recommended dose is 3.75 mg administered as a single subcutaneous or intramuscular injection every month for a period of 6 months only. Treatment should be initiated during the first 5 days of the menstrual cycle.

In women receiving GnRH analogues for the treatment of endometriosis, the addition of hormone replacement therapy (HRT - an estrogen and progestogen) has been shown to reduce bone mineral density loss and vasomotor symptoms. Therefore if appropriate, HRT should be co-administered with PROSTAP SR taking into account the risks and benefits of each treatment.

Endometrial preparation prior to intrauterine surgery: A single 3.75 mg subcutaneous or intramuscular injection 5-6 weeks prior to surgery. Therapy should be initiated during days 3 to 5 of the menstrual cycle.

Preoperative management of uterine fibroids: The recommended dose is 3.75 mg administered as a single subcutaneous or intramuscular injection every month, usually for 3-4 months but for a maximum of six months.

Elderly: As for adults.

Children: PROSTAP SR is not recommended in children under 18 years due to insufficient data on safety and efficacy in this patient group.

Administration

The pre-filled syringe of PROSTAP SR microsphere powder should be reconstituted immediately prior to administration by subcutaneous or intramuscular injection.

To prepare for injection, screw the plunger rod into the end stopper until the end stopper begins to turn.

While holding the syringe upright, depress the plunger slowly by pushing the plunger rod until the middle stopper is at the blue line in the middle of the barrel.

NOTE: Pushing the plunger rod quickly or over the blue line will cause leakage of the suspension from the needle.

Gently tap the syringe on the palm keeping the syringe upright to thoroughly mix the particles to form a uniform suspension. The suspension will appear milky.

NOTE: Avoid hard tapping to prevent the generation of bubbles.

Remove the sheath and advance the plunger rod to expel the air from the syringe.

Inject the entire contents of the syringe subcutaneously or intramuscularly as you would for a normal injection.

4.3 Contraindications

Hypersensitivity to the active substance, any of the excipients or to synthetic gonadotrophin releasing homone (Gn-RH) or Gn-RH derivatives.

Women: PROSTAP SR is contra-indicated in women who are or may become pregnant while receiving the drug. PROSTAP SR should not be used in women who are breastfeeding or have undiagnosed abnormal vaginal bleeding.

Men: There are no known contra-indications to the use of PROSTAP SR in men.

4.4 Special Warnings And Precautions For Use

As would be expected with this class of drug, development or aggravation of diabetes may occur, therefore diabetic patients may require more frequent monitoring of blood glucose during treatment with PROSTAP SR.

Hepatic dysfunction and jaundice with elevated liver enzyme have been reported. Therefore, close observation should be made and appropriate measures taken if necessary.

Spinal fracture, paralysis, hypotension and worsening of depression have been reported.

Men: In the initial stages of therapy, a transient rise in levels of testosterone, dihydrotestosterone and acid phosphatase may occur. In some cases, this may be associated with a "flare" or exacerbation of the tumour growth resulting in temporary deterioration of the patient's condition. These symptoms usually subside on continuation of therapy. "Flare" may manifest itself as systemic or neurological symptoms in some cases.

In order to reduce the risk of “flare”, an anti-androgen may be administered beginning 3 days prior to leuprorelin acetate therapy and continuing for the first two to three weeks of treatment. This has been reported to prevent the sequelae of an initial rise in serum testosterone.

Patients at risk of ureteric obstruction or spinal cord compression should be considered carefully and closely supervised in the first few weeks of treatment. These patients should be considered for prophylactic treatment with anti-androgens. Should urological/neurological complications occur, these should be treated by appropriate specific measures.

If an anti-androgen is used over a prolonged period, due attention should be paid to the contra-indications and precautions associated with its extended use.

Whilst the development of pituitary adenomas has been noted in chronic toxicity studies at high doses in some animal species, this has not been observed in long term clinical studies with leuprorelin acetate.

Women: When considering the preoperative treatment of fibroids it is mandatory to confirm the diagnosis of fibroids and exclude an ovarian mass, either visually by laparoscopy or by ultrasonography or other investigative technique, as appropriate, before PROSTAP SR therapy is instituted.

During the early phase of therapy, sex steroids temporarily rise above baseline because of the physiological effect of the drug. Therefore, an increase in clinical signs and symptoms may be observed during the initial days of therapy, but these will dissipate with continued therapy.

The induced hypo-estrogenic state results in a small loss in bone density over the course of treatment, some of which may not be reversible. The extent of bone demineralisation due to hypo-estrogenaemia is proportional to time and, consequently, is the adverse event responsible for limiting the duration of therapy to 6 months. The generally accepted level of bone loss with LHRH analogues such as PROSTAP SR is 5%. In clinical studies with PROSTAP SR the levels varied between 2.3% and 15.7% depending on the method of measurement. During one six-month treatment period, this bone loss should not be important. In patients with major risk factors for decreased bone mineral content such as chronic alcohol and/or tobacco use, strong family history of osteoporosis, or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids, PROSTAP SR therapy may pose an additional risk. In these patients, the risks and benefits must be weighed carefully before therapy with PROSTAP SR is instituted. This is particularly important in women with uterine fibroids where age related bone loss may have already begun to occur.

Therefore, before using PROSTAP SR for the preoperative treatment of uterine fibroids, patients with major risk factors for decreased bone mineral content (see above) should have their bone density measured and where results are below the normal (5^th percentile by DEXA scan) range, PROSTAP SR therapy should not be started.

In women with submucous fibroids there have been reports of severe bleeding following the administration of PROSTAP SR as a consequence of the acute degeneration of the fibroids. Patients should be warned of the possibility of abnormal bleeding or pain in case earlier surgical intervention is required.

PROSTAP SR may cause an increase in uterine cervical resistance, which may result in difficulty in dilating the cervix for intrauterine surgical procedures.

In women receiving GnRH analogues for the treatment of endometriosis, the addition of HRT (an estrogen and progestogen) has been shown to reduce bone mineral density loss and vasomotor symptoms.

Precautions

Men: Patients with urinary obstruction and patients with metastatic vertebral lesions should begin PROSTAP SR therapy under close supervision for the first few weeks of treatment.

Women: Since menstruation should stop with effective doses of PROSTAP SR, the patient should notify her physician if regular menstruation persists.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

4.6 Pregnancy And Lactation

Safe use of leuprorelin acetate in pregnancy has not been established clinically.

Studies in animals have shown reproductive toxicity (see section 5.3). Before starting treatment with PROSTAP SR, pregnancy must be excluded. There have been reports of foetal malformation when PROSTAP SR has been given during pregnancy.

PROSTAP SR should not be used in women who are breastfeeding.

When used monthly at the recommended dose, PROSTAP SR usually inhibits ovulation and stops menstruation. Contraception is not ensured, however, by taking PROSTAP SR and therefore patients should use non-hormonal methods of contraception during treatment.

Patients should be advised that if they miss successive doses of PROSTAP SR, breakthrough bleeding or ovulation may occur with the potential for conception. Patients should be advised to see their physician if they believe they may be pregnant. If a patient becomes pregnant during treatment, the drug must be discontinued. The patient must be apprised of this evidence and the potential for an unknown risk to the foetus.

4.7 Effects On Ability To Drive And Use Machines

PROSTAP SR can influence the ability to drive and use machines due to visual disturbances and dizziness.

4.8 Undesirable Effects

Side effects seen with PROSTAP SR are due mainly to the specific pharmacological action, namely increases and decreases in certain hormone levels. Adverse events which have been reported infrequently include peripheral oedema, pulmonary embolism, hypertension, palpitations, fatigue, muscle weakness, diarrhoea, nausea, vomiting, anorexia, fever/chills, headache (occasionally severe), hot flushes, arthralgia, myalgia, dizziness, insomnia, depression, paraesthesia, visual disturbances, weight changes, hepatic dysfunction, jaundice, increases in liver function test values (usually transient) and irritation at the injection site. Changes in blood lipids and alteration of glucose tolerance have also been reported which may affect diabetic control. Thrombocytopenia and leucopenia have been reported rarely. Hypersensitivity reactions including rash, pruritus, urticaria, and rarely, wheezing or interstitial pneumonitis have also been reported. Anaphylactic reactions are rare.

Spinal fracture, paralysis, hypotension and worsening of depression have been reported (see Section 4.4).

A reduction in bone mass may occur with the use of GnRH agonists.

Very rare cases of pituitary apoplexy have been reported following initial administration in patients with pituitary adenoma.

Men: In cases where a "tumour flare" occurs after PROSTAP SR therapy, an exacerbation may occur in any symptoms or signs due to disease, for example, bone pain, urinary obstruction, weakness of the lower extremities and paraesthesia. These symptoms subside on continuation of therapy.

Impotence and decreased libido will be expected with PROSTAP SR therapy.

The administration of PROSTAP SR is often associated with hot flushes and sometimes sweating.

Orchiatrophy and gynaecomastia have been reported occasionally.

Women: Those adverse events occurring most frequently with PROSTAP SR are associated with hypo-estrogenism; the most frequently reported are hot flushes, mood swings including depression (occasionally severe), and vaginal dryness. Estrogen levels return to normal after treatment is discontinued.

The induced hypo-estrogenic state results in a small loss in bone density over the course of treatment, some of which may not be reversible (see Section 4.4).

Breast tenderness or change in breast size may occur occasionally. Hair loss has also been reported occasionally.

Vaginal haemorrhage may occur during therapy due to acute degeneration of submucous fibroids (see Section 4.4).

4.9 Overdose

No case of overdose has been reported.

In animal studies, doses of up to 500 times the recommended human dose resulted in dyspnoea, decreased activity and local irritation at the injection site. In cases of overdose, the patients should be monitored closely and management should be symptomatic and supportive.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Gonadotrophin Releasing Hormone Analogues

ATC code: L02AE 02

PROSTAP SR contains leuprorelin acetate, a synthetic nonapeptide analogue of naturally occurring GnRH which possesses greater potency than the natural hormone. Leuprorelin acetate is a peptide and therefore unrelated to the steroids. Chronic administration results in an inhibition of gonadotrophin production and subsequent suppression of ovarian and testicular steroid secretion. This effect is reversible on discontinuation of therapy.

Administration of leuprorelin acetate results in an initial increase in circulating levels of gonadotrophins which leads to a transient increase in gonadal steroid levels in both men and women. Continued administration of leuprorelin acetate results in a decrease of gonadotrophin and sex steroid levels. In men serum testosterone levels, initially raised in response to early luteinising hormone (LH) release, fall to castrate levels in about 2-4 weeks. Estradiol levels will decrease to postmenopausal levels in premenopausal women within one month of initiating treatment.

The drug is well absorbed from the subcutaneous or intramuscular route, binds to luteinising hormone releasing hormone (LHRH) receptors and is rapidly degraded. In this dose form, an initial high level of leuprorelin acetate in the plasma is achieved within 3 hours followed by a drop over 24-48 hours to maintenance levels of 0.3-0.8ng/ml and a slow decline thereafter. Effective levels persist for 30-40 days after a single dose.

Leuprorelin acetate is inactive when given orally.

A randomised, open-label, comparative multi-centre study was performed to compare the efficacy and safety of the 3.75 mg and 11.25 mg depots of leuprorelin acetate. 48% of patients included had locally advanced disease (T3N0M0), 52% of patients had metastatic disease. Mean serum testosterone level fell below the threshold for chemical castration (0.5 ng/ml) at one month of treatment, continuing to decrease thereafter and stabilising at a value below the castration threshold. The decline in serum PSA mirrored that of serum testosterone in both groups.

In an open, prospective clinical trial involving 205 patients receiving 3.75 mg leuprorelin acetate on a monthly basis as treatment for metastatic prostate cancer, the long-term efficacy and safety of leuprorelin acetate was assessed. Testosterone levels were maintained below the castrate threshold over the 63-month follow up period. Median survival time exceeded 42.5 months for those receiving monotherapy and 30.9 months for those receiving leuprorelin acetate in combination with anti-androgens (this difference relating to baseline differences between groups)

In a meta-analysis involving primarily patients with metastatic disease, no statistically significant difference in survival was found for patients treated with LHRH analogues compared with patients treated with orchidectomy.

In another randomised, open-label, multi-centre comparative trial, leuprorelin acetate in combination with flutamide has been shown to significantly improve disease-free survival and overall survival when used as an adjuvant therapy to radiotherapy in 88 patients with high-risk localised (T1-T2 and PSA of at least 10 ng/mL or a Gleason score of at least 7), or locally advanced (T3-T4) prostate cancer. The optimum duration of adjuvant therapy has not been established. This US study used a higher dose of leuprorelin acetate (7.5mg/month) which is therapeutically equivalent to the European licensed dose.

The use of a LHRH agonist may be considered after prostatectomy in selected patients considered at high risk of disease progression. There are no disease-free survival data or survival data with leuprorelin acetate in this setting.

5.2 Pharmacokinetic Properties

Studies submitted show that single intramuscular or subcutaneous doses of leuprorelin acetate over the dose range 3.75 to 15 mg results in detectable levels of leuprorelin acetate for more than 28 days, good bioavailability, a consistent and predictable pharmacokinetic profile, and biological efficacy at plasma levels of less than 0.5 ng/ml. The pharmacokinetic profile is similar to that seen in animal studies using the compound, with an initial high level of drug released from the microcapsules during reconstitution and injection followed by a plateau over a 2-3 week period before levels gradually become undetectable. There appears to be no significant difference between the routes of administration (im vs sc) in biological effectiveness or pharmacokinetics.

The metabolism, distribution and excretion of leuprorelin acetate in humans have not been fully determined.

5.3 Preclinical Safety Data

A teratogenic effect has been observed in rabbits but not in rats.

6. Pharmaceutical Particulars

6.1 List Of Excipients

PROSTAP SR Powder

Gelatin

Copoly (DL lactic acid/glycolic acid) 72:25 mol%

Mannitol (E421)

Sterile Solvent

Carmellose sodium

Mannitol (E421)

Polysorbate 80

Glacial Acetic Acid (for pH adjustment)

Water for Injections

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years unopened.

Once reconstituted with sterile solvent, the suspension should be administered immediately.

6.4 Special Precautions For Storage

Do not store above 25^oC.

Do not refrigerate or freeze.

Store in the original container in order to protect from light.

6.5 Nature And Contents Of Container

One dual chamber pre-filled syringe containing 3.75 mg leuprorelin acetate powder in the front chamber and 1 ml of Sterile Solvent in the rear chamber.

1 x 25 gauge syringe needle

1 x syringe plunger

1 x injection site swab

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Takeda UK Limited

Takeda House

Mercury Park

Wooburn Green

High Wycombe

Bucks., HP10 0HH

8. Marketing Authorisation Number(S)

16189/0012

9. Date Of First Authorisation/Renewal Of The Authorisation

28/04/2011

10. Date Of Revision Of The Text

28/04/2011

Friday 23 March 2012

TheoCap

Generic Name: theophylline (Oral route)

thee-OF-i-lin

Commonly used brand name(s)

In the U.S.

Elixophyllin

Norphyl

Phyllocontin

Quibron-T

Quibron-T/SR

Theo-24

TheoCap

Theochron

Theo-Dur

Theo-Time

Truxophyllin

Uniphyl

Available Dosage Forms:

Solution

Tablet, Extended Release, 12 HR

Tablet

Capsule, Extended Release, 24 HR

Capsule, Extended Release

Tablet, Extended Release

Capsule, Extended Release, 12 HR

Syrup

Capsule

Tablet, Extended Release, 24 HR

Elixir

Tablet, Enteric Coated

Therapeutic Class: Bronchodilator

Chemical Class: Methylxanthine

Uses For TheoCap

Theophylline is used together with other medicines to treat the symptoms of asthma, bronchitis, emphysema, and other lung diseases.

Theophylline belongs to a group of medicines known as bronchodilators. Bronchodilators are medicines that relax the muscles in the bronchial tubes (air passages) of the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

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

Before Using TheoCap

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of theophylline in children. However, children younger than 1 year of age are more likely to have serious side effects, which may require caution and an adjustment in the dose for patients receiving theophylline.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of theophylline in the elderly. However, elderly patients may be more sensitive to the effects of theophylline than younger adults, and are more likely to have kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving theophylline.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Bupropion

Cimetidine

Ciprofloxacin

Deferasirox

Desogestrel

Dienogest

Drospirenone

Enoxacin

Erythromycin

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etintidine

Etonogestrel

Fluvoxamine

Halothane

Idrocilamide

Imipenem

Levofloxacin

Levonorgestrel

Medroxyprogesterone Acetate

Mestranol

Mexiletine

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Pefloxacin

Peginterferon Alfa-2a

Rofecoxib

Thiabendazole

Troleandomycin

Vemurafenib

Zileuton

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

Adenosine

Adinazolam

Alprazolam

Aminoglutethimide

Amiodarone

Azithromycin

Bromazepam

Brotizolam

Cannabis

Carbamazepine

Chlordiazepoxide

Clobazam

Clonazepam

Clorazepate

Diazepam

Disulfiram

Estazolam

Febuxostat

Flunitrazepam

Flurazepam

Fosphenytoin

Halazepam

Interferon Alfa-2a

Ipriflavone

Isoproterenol

Ketazolam

Lorazepam

Lormetazepam

Medazepam

Methotrexate

Midazolam

Nilutamide

Nitrazepam

Oxazepam

Pancuronium

Pentoxifylline

Phenobarbital

Phenytoin

Piperine

Prazepam

Propafenone

Quazepam

Rifampin

Rifapentine

Riluzole

Ritonavir

Secobarbital

St John's Wort

Tacrine

Tacrolimus

Telithromycin

Temazepam

Ticlopidine

Triazolam

Viloxazine

Zafirlukast

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine

food

Proper Use of theophylline

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

Take this medicine exactly as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep the blood level constant, take this medicine at the same time each day and do not miss any doses.

After you or your child begin taking theophylline, it is very important that your doctor check the level of the medicine in the blood at regular intervals to decide if the dose needs to be changed. Keep all appointments for testing the blood level.

Take the extended-release capsule or tablet every morning at the same time each day. You may take your second dose 10 to 12 hours after the morning dose and before the evening meal, unless your doctor tells you otherwise.

Swallow the extended-release tablet whole. Do not break, crush, or chew it. You may take the extended-release tablet with or without food.

It is best to take the extended-release capsule one hour before a high-fat meal or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

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

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

To treat symptoms of asthma, bronchitis, and emphysema:
- For oral dosage form (elixir or tablets):
  - Adults, teenagers, and children above 1 year of age weighing more than 45 kilograms (kg)—At first, 300 milligrams (mg) per day, divided and given every 6 to 8 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
  - Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day, divided and given every 6 to 8 hours.
  - Children and teenagers 1 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day, divided and given every 4 to 6 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
  - Infants younger than 1 year of age—Dose is based on body weight and age and must be determined by your doctor.
- For oral dosage form (extended-release capsules):
  - Adults, teenagers, and children 12 years of age and older weighing more than 45 kilograms (kg)—At first, 300 to 400 milligrams (mg) as a single dose, usually in the morning, or divided and given two times per day. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
  - Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day as a single dose, usually in the morning, or divided and given two times per day.
  - Children and teenagers 12 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day as a single dose, usually in the morning, or divided and given two times per day. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
  - Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release tablets):
  - Adults, teenagers, and children 6 years of age and older weighing more than 45 kilograms (kg)—At first, 300 milligrams (mg) per day, divided and given every 12 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
  - Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day, divided and given every 12 hours.
  - Children and teenagers 6 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day, divided and given every 12 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
  - Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using TheoCap

It is very important that your doctor check the progress of you or your child at regular visits, especially for the first few weeks after you begin using this medicine. Blood tests may be needed to check for unwanted effects.

A change in your usual behavior or physical well-being may affect the way this medicine works in your body. Tell your doctor if you or your child:

Have had a fever of 102 degrees F or higher for at least 24 hours or more.

Have started or stopped smoking tobacco or marijuana in the last few weeks.

Have started or stopped taking another medicine in the last few weeks.

Have changed your diet in the last few weeks.

Stop using this medicine and check with your doctor right away if you or your child have the following symptoms while using this medicine: nausea or vomiting that continues, headaches, trouble with sleeping, seizures, or irregular heartbeats.

Do not stop or change the dose of this medicine without checking first with your doctor.

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

This medicine may add to the central nervous system (CNS) stimulant effects of caffeine-containing foods or beverages such as chocolate, cocoa, tea, coffee, and cola drinks. Avoid eating or drinking large amounts of these foods or beverages while using this medicine. If you have questions about this, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal (e.g., St. John's wort) or vitamin supplements.

TheoCap Side Effects

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

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

Incidence not known

Chest pain or discomfort

dizziness

fainting

fast, slow, or irregular heartbeat

increase in urine volume

lightheadedness

persistent vomiting

pounding or rapid pulse

seizures

shakiness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach pain

blurred vision

confusion

confusion about identity, place, and time

dark-colored urine

decrease in frequency of urination

decreased urine

diarrhea

difficulty in passing urine (dribbling)

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

dry mouth

fast, pounding, or irregular heartbeat or pulse

fever

increased thirst

irregular heartbeat

loss of appetite

mood changes

muscle cramps or spasms

muscle pain or stiffness

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

pain or discomfort in the arms, jaw, back, or neck

painful urination

shakiness in the legs, arms, hands, or feet

shortness of breath

sweating

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

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

Incidence not known

Headache

irritability

restlessness

sleeplessness

trouble sleeping

unable to sleep

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: TheoCap 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 TheoCap resources

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

TheoCap Concise Consumer Information (Cerner Multum)

TheoCap Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Theophylline Prescribing Information (FDA)

Theophylline Professional Patient Advice (Wolters Kluwer)

Elixophyllin Prescribing Information (FDA)

Elixophyllin Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

Quibron-T MedFacts Consumer Leaflet (Wolters Kluwer)

Quibron-T Prescribing Information (FDA)

Theo-24 Prescribing Information (FDA)

Theochron Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Theolair tablets Prescribing Information (FDA)

Theophyllines Monograph (AHFS DI)

Uniphyl Prescribing Information (FDA)

Compare TheoCap with other medications

Apnea of Prematurity
Asthma, acute
Asthma, Maintenance

Saturday 17 March 2012

Pilocarpine Drops

Pronunciation: pye-loe-KAR-peen
Generic Name: Pilocarpine
Brand Name: Examples include Isopto Carpine and Piloptic

Pilocarpine Drops are used for:

Treating certain types of glaucoma (increased pressure in the eye) alone or in combination with other medicines. It may also be used to reverse the effects of other medicines used during eye surgeries or examinations. It may also be used for other conditions as determined by your doctor.

Pilocarpine Drops are a direct-acting miotic. It works by lowering the fluid pressure inside the eyeball by increasing fluid drainage from the eyeball. It also causes the pupils to constrict or get smaller (miosis).

Do NOT use Pilocarpine Drops if:

you are allergic to any ingredient in Pilocarpine Drops

you have a certain type of glaucoma (eg, pupillary block glaucoma), eye inflammation, or a severe eye infection

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

Before using Pilocarpine Drops:

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

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

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

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

if you have a detached retina, an eye infection, or chronic obstructive pulmonary disease

if you have had a heart attack

Some MEDICINES MAY INTERACT with Pilocarpine Drops. However, no specific interactions with Pilocarpine Drops are known at this time.

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

How to use Pilocarpine Drops:

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

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

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

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

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

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

Important safety information:

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

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

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

Possible side effects of Pilocarpine Drops:

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

Blurred vision; change in vision; eyelid twitching; headache at the temples or around the eyes; increased tearing; nearsightedness; redness or swelling of the eye; temporary stinging or burning.

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); detachment of the retina; fast or abnormal heartbeat; increase in blood pressure; poor vision at night.

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.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include asthma; blurred vision; diarrhea; fainting; increased saliva; increased sweating; irregular heartbeat; vomiting.

Proper storage of Pilocarpine Drops:

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

General information:

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

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

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

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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Pilocarpine resources

Pilocarpine Use in Pregnancy & Breastfeeding
Pilocarpine Drug Interactions
Pilocarpine Support Group
0 Reviews for Pilocarpine - Add your own review/rating

Compare Pilocarpine with other medications

Glaucoma
Intraocular Hypertension

Thursday 15 March 2012

The 50:50 Ointment

The 50:50 Ointment

(Liquid Paraffin, White Soft Paraffin)

An emollient ointment for the symptomatic relief of dry skin conditions

500 g e

Read all of this label for full instructions.

Before you use this medicine

Do not use:

If you are allergic to any of the ingredients

You can use this medicine if you are pregnant or breastfeeding.

This ointment is greasy, and so if you apply it to your hands, be careful if you drive or use machines.

How to use

Adults and children:

Apply a thin layer of ointment to the affected area. Apply in the direction of hair growth to help prevent irritation in hair follicles.

Apply when you need to, at least twice a day or ideally three or four times a day.

If you are an adult treating a large area of your body you may use up to one tub a week.

For use on the skin only.

If anyone accidentally swallows some: Talk to a pharmacist or doctor.

Possible side effects

Most people will not have problems, but some may get some of these:

Rarely, allergic reactions (e.g. skin rash, red or itchy skin)

Irritation of hair follicles if used for a long period of time

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

How to store

Do not store above 25°C.

Store in the original container.

Stir well if the ointment starts to separate.

Keep all medicines out of the sight and reach of children.

Use by the date on the base of the tub.

Active ingredients

This ointment for cutaneous use contains Liquid Paraffin 50% w/w, White Soft Paraffin 50% w/w.

PL 00014/0622

Text prepared 1/09

Manufactured for

BCM Specials

Nottingham

NG90 2PR

by the

Marketing Authorisation holder

The Boots Company PLC

Nottingham

NG2 3AA

If you need more advice ask your pharmacist.

BTC19168 vF 12/06/09

thyroid

THYE-roid

Oral route(Tablet)

In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects .

Commonly used brand name(s)

In the U.S.

Armour Thyroid

Nature-Throid NT-1

Nature-Throid NT-1/2

Nature-Throid NT-2

Nature-Throid NT-3

Nature-Thyroid

Westhroid

Available Dosage Forms:

Tablet

Capsule

Therapeutic Class: Thyroid Supplement

Uses For thyroid

Thyroid is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. It is also used to help decrease the size of enlarged thyroid glands (known as goiter) and to treat thyroid cancer .

Thyroid is also used in some medical tests to help diagnose problems with the thyroid gland .

thyroid is available only with your doctor's prescription .

Before Using thyroid

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 thyroid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to thyroid 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 performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of thyroid in children .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of thyroid in the elderly. However, elderly patients are more likely to have age-related heart and blood vessel problems, which may require caution in patients receiving thyroid .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	A	Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

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. When you are taking thyroid, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Acenocoumarol

Anisindione

Dicumarol

Kelp

Phenindione

Phenprocoumon

Warfarin

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.

Proper Use of thyroid

thyroid usually needs to be taken for life. Do not stop taking thyroid or change your doses without first checking with your doctor. It may take several weeks before you start to notice an improvement in your symptoms .

Dosing

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

For oral dosage form (tablet):
- For the treatment of hypothyroidism:
  - Adults—At first, 30 milligrams (mg) once a day. Then, your doctor may increase your dose a little at a time up to the usual maintenance dose of 60 to 120 mg a day. A lower starting dose of 15 mg/day may be given to patients for certain conditions.
  - Children 0 to 6 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 15 to 30 mg once a day.
  - Children 6 to 12 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 30 to 45 mg once a day.
  - Children 1 to 5 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 45 to 60 mg once a day.
  - Children 6 to 12 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 60 to 90 mg once a day.
  - Children over 12 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is over 90 mg once a day .

Missed Dose

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

Storage

DRUG: GENERAL, STORAGE DRUG: GENERAL, STORAGE

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

Keep out of the reach of children.

Precautions While Using thyroid

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects .

Thyroid should not be used for the treatment of obesity or for the purpose of losing weight. thyroid is ineffective for weight reduction and when taken in larger amount, it may cause more serious medical conditions .

Hypothyroidism can sometimes cause infertility in men and women. Thyroid should not be used for the treatment of infertility unless it is caused by hypothyroidism .

Call your doctor right away if you start to have chest pain, fast, irregular, pounding, or racing heartbeat or pulse, excessive sweating, heat intolerance, nervousness, or any other unusual medical condition .

For patients with diabetes, it is very important that you keep track of your blood or urine sugar levels as instructed by your doctor. Check with your doctor immediately if you notice any changes in your sugar levels .

A temporary loss of hair may occur during the first few months of thyroid therapy. Ask your doctor about this if you have any concerns .

thyroid 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.

Get emergency help immediately if any of the following symptoms of overdose occur:

Changes in appetite

changes in menstrual periods

chest pain

diarrhea

fast or irregular heartbeat

fever

hand tremors

headache

irritability

leg cramps

nervousness

sensitivity to heat

shortness of breath

sweating

trouble sleeping

vomiting

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: thyroid side effects (in more detail)

More thyroid resources

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

Armour Thyroid Prescribing Information (FDA)

Armour Thyroid Concise Consumer Information (Cerner Multum)

Armour Thyroid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare thyroid with other medications

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Hypothyroidism, After Thyroid Removal
Thyroid Cancer
TSH Suppression
Underactive Thyroid