Syphilitic Parkinsonism Medications

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• Syphilis

Drug List:

Zovirax 800mg Tablets

1. Name Of The Medicinal Product

Zovirax Tablets BP 800mg

2. Qualitative And Quantitative Composition

Aciclovir 800mg BP

3. Pharmaceutical Form

Dispersible film coated tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Zovirax tablets 800 mg are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections (excluding neonatal HSV and severe HSV infections in immunocompromised children).

4.2 Posology And Method Of Administration

Dosage in adults:

Treatment of varicella and herpes zoster infections: 800 mg Zovirax should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days.

In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing.

Dosing should begin as early as possible after the start of an infection: Treatment of herpes zoster yields better results if initiated as soon as possible after the onset of the rash. Treatment of chickenpox in immunocompetent patients should begin within 24 hours after the onset of the rash.

Dosage in children:

Treatment of varicella infections:

6 years and over: 800 mg Zovirax four times daily.

Treatment should continue for five days.

No specific data are available on the treatment of herpes zoster infections in immunocompetent children.

Dosage in the elderly:

The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see Dosage in renal impairment below).

Adequate hydration of elderly patients taking high oral doses of aciclovir should be maintained.

Dosage in renal impairment:

Caution is advised when administering aciclovir to patients with impaired renal function. Adequate hydration should be maintained.

In the treatment of herpes zoster infections it is recommended to adjust the dosage to 800 mg Aciclovir twice daily at approximately twelve-hourly intervals for patients with severe renal impairment (creatinine clearance less than 10 ml/minute) and to 800 mg Aciclovir three times daily at intervals of approximately eight hours for patients with moderate renal impairment (creatinine clearance in the range of 10-25 ml/minute).

Administration

Zovirax tablets are for oral administration and may be dispersed in a minimum of 50 ml of water or swallowed whole with a little water. Ensure that patients on high doses of aciclovir are adequately hydrated.

4.3 Contraindications

Zovirax tablets are contra-indicated in patients known to be hypersensitive to aciclovir or valaciclovir, or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Use in patients with renal impairment and in elderly patients:

Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see 4.2 Posology and Method of Administration). Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see 4.8 Undesirable Effects). Prolonged or repeated courses of aciclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued aciclovir treatment (see section 5.1).

Hydration status: Care should be taken to maintain adequate hydration in patients receiving high doses of aciclovir.

The data currently available from clinical studies is not sufficient to conclude that treatment with aciclovir reduces the incidence of chickenpox-associated complications in immunocompetent patients.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions have been identified.

Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations. Probenecid and cimetidine increase the AUC of aciclovir by this mechanism, and reduce aciclovir renal clearance. Similarly increases in plasma AUCs of aciclovir and of the inactive metabolite of mycophenolate mofetil, an immunosuppresant agent used in transplant patients have been shown when the drugs are coadministered. However no dosage adjustment is necessary because of the wide therapeutic index of aciclovir.

4.6 Pregnancy And Lactation

A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Zovirax. The birth defects described amongst Zovirax exposed subjects have not shown any uniqueness or consistent pattern to suggest a common cause.

Caution should however be exercised by balancing the potential benefits of treatment against any possible hazard. Findings from reproduction toxicology studies are included in Section 5.3.

Following oral administration of 200 mg Zovirax five times a day, Aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to Aciclovir dosages of up to 0.3 mg/kg/day. Caution is therefore advised if Zovirax is to be administered to a nursing woman.

Fertility:

There is no information on the effect of aciclovir on human female fertility.

In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

4.7 Effects On Ability To Drive And Use Machines

There have been no studies to investigate the effect of aciclovir on driving performance or the ability to operate machinery. A detrimental effect on such activities cannot be predicted from the pharmacology of the active substance, but the adverse event profile should be borne in mind.

4.8 Undesirable Effects

The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their incidence depending on the indication.

The following convention has been used for the classification of undesirable effects in terms of frequency:- Very common

Blood and lymphatic system disorders:

Very rare: Anaemia, leukopenia, thrombocytopenia.

Immune system disorders:

Rare: Anaphylaxis.

Psychiatric and nervous system disorders:

Common: Headache, dizziness.

Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma.

The above events are generally reversible and usually reported in patients with renal impairment or with other predisposing factors (see 4.4 Special Warnings and Precautions for Use).

Respiratory, thoracic and mediastinal disorders:

Rare: Dyspnoea.

Gastrointestinal disorders:

Common: Nausea, vomiting, diarrhoea, abdominal pains.

Hepato-biliary disorders:

Rare: Reversible rises in bilirubin and liver related enzymes.

Very rare: Hepatitis, jaundice.

Skin and subcutaneous tissue disorders:

Common: Pruritus, rashes (including photosensitivity).

Uncommon: Urticaria. Accelerated diffuse hair loss. Accelerated diffuse hair loss has been associated with a wide variety of disease processes and medicines, the relationship of the event to aciclovir therapy is uncertain.

Rare: Angioedema

Renal and urinary disorders:

Rare: Increases in blood urea and creatinine.

Very rare: Acute renal failure, renal pain.

Renal pain may be associated with renal failure and crystalluria.

General disorders and administration site conditions:

Common: Fatigue, fever.

4.9 Overdose

Aciclovir is only partly absorbed in the gastrointestinal tract.

Patients have ingested overdoses of up to 20g aciclovir on a single occasion, usually without toxic effects. Accidental, repeated overdoses of oral aciclovir over several days have been associated with gastrointestinal effects (such as nausea and vomiting) and neurological effects (headache and confusion).

Overdosage of intravenous aciclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with intravenous overdosage.

Management: patients should be observed closely for signs of toxicity. Haemodialysis significantly enhances the removal of aciclovir from the blood and may, therefore, be considered a management option in the event of symptomatic overdose.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Aciclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against human herpes viruses, including herpes simplex virus (HSV) types I and II and varicella zoster virus (VZV). The inhibitory activity of Aciclovir for HSV I and HSV II and VZV is highly selective. The enzyme thymidine kinase (TK) of normal, uninfected cells does not use Aciclovir effectively as a substrate, hence toxicity to mammalian host cells is low; however, TK encoded by HSV and VZV converts Aciclovir to Aciclovir monophosphate, a nucleoside analogue which is further converted to the diphosphate and finally to the triphosphate by cellular enzymes. Aciclovir triphosphate interferes with the viral DNA polymerase and inhibits viral DNA replication with resultant chain termination following its incorporation into the viral DNA.

Prolonged or repeated courses of Aciclovir in severely immuno-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued Aciclovir treatment. Most of the clinical isolates with reduced sensitivity have been relatively deficient in viral TK, however, strains with altered viral TK or viral DNA polymerase have also been reported. In vitro exposure of HSV isolates to Aciclovir can also lead to the emergence of less sensitive strains. The relationship between the in vitro-determined sensitivity of HSV isolates and clinical response to Aciclovir therapy is not clear.

5.2 Pharmacokinetic Properties

Aciclovir is only partially absorbed from the gut. Mean steady state peak plasma concentrations (C^ssmax) following doses of 800 mg Aciclovir administered four-hourly were 8 microMol (1.8 micrograms/ml) and equivalent trough plasma levels were 4 microMol (0.9 micrograms/ml).

In adults the terminal plasma half-life after administration of intravenous Aciclovir is about 2.9 hours. Most of the drug is excreted unchanged by the kidney. Renal clearance of Aciclovir is substantially greater than creatinine clearance, indicating that tubular secretion, in addition to glomerular filtration, contributes to the renal elimination of the drug. 9-carboxymethoxymethyl-guanine is the only significant metabolite of Aciclovir, and accounts for 10-15% of the dose excreted in the urine. When Aciclovir is given one hour after 1 gram of probenecid the terminal half-life and the area under the plasma concentration time curve is extended by 18% and 40% respectively.

In adults, mean steady state peak plasma concentrations (C^ssmax) following a one hour infusion of 2.5 mg/kg, 5 mg/kg and 10 mg/kg were 22.7 microMol (5.1 micrograms/ml), 43.6 microMol (9.8 micrograms/ml) and 92 microMol (20.7 micrograms/ml), respectively. The corresponding trough levels (C^ssmin) 7 hours later were 2.2 microMol (0.5 micrograms/ml), 3.1 microMol (0.7 micrograms/ml) and 10.2 microMol (2.3 micrograms/ml), respectively. In children over 1 year of age similar mean peak (C^ssmax) and trough (C^ssmin) levels were observed when a dose of 250 mg/m² was substituted for 5 mg/kg and a dose of 500 mg/m² was substituted for 10 mg/kg. In neonates and young infants (0 to 3 months of age) treated with doses of 10 mg/kg administered by infusion over a one-hour period every 8 hours the C^ssmax was found to be 61.2 microMol (13.8 micrograms/ml) and C^ssmin to be 10.1 microMol (2.3 micrograms/ml). The terminal plasma half-life in these patients was 3.8 hours. A separate group of neonates treated with 15 mg/kg every 8 hours showed approximate dose proportional increases, with a Cmax of 83.5 micromolar (18.8 microgram/ml) and Cmin of 14.1 micromolar (3.2 microgram/ml). In the elderly, total body clearance falls with increasing age associated with decreases in creatinine clearance although there is little change in the terminal plasma half-life.

In patients with chronic renal failure the mean terminal half-life was found to be 19.5 hours. The mean Aciclovir half-life during haemodialysis was 5.7 hours. Plasma Aciclovir levels dropped approximately 60% during dialysis.

Cerebrospinal fluid levels are approximately 50% of corresponding plasma levels. Plasma protein binding is relatively low (9 to 33%) and drug interactions involving binding site displacement are not anticipated.

5.3 Preclinical Safety Data

Mutagenicity:- The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir is unlikely to pose a genetic risk to man.

Carcinogenicity:- Aciclovir was not found to be carcinogenic in long term studies in the rat and the mouse.

Teratogenicity:- Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rats, rabbits or mice.

In a non-standard test in rats, foetal abnormalities were observed, but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.

Fertility:- Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at doses of aciclovir greatly in excess of those employed therapeutically. Two generation studies in mice did not reveal any effect of aciclovir on fertility.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline Cellulose Ph Eur

Aluminium Magnesium Silicate BP

Sodium Starch Glycollate BP

Povidone (K30) Ph Eur

Magnesium Stearate Ph Eur

Filmcoat

Hypromellose HSE

Titanium Dioxide HSE

Polyethylene glycol 400 HSE

Polish

Polyethylene Glycol 8000 NF

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 30°C

Keep dry

Protect from light

6.5 Nature And Contents Of Container

PVC/Aluminium foil blisterpack (5 tablets per blister strip)

Pack size : 35 tablets (marketed).

Polypropylene container with polyethylene snap-on lid.

Pack size : 35 and 800 tablets (non-marketed)

PVC/Aluminium foil blister sample pack.

Pack size: 5 and 2 tablets(non-marketed).

Polyethylene bag in a rigid polypropylene container with a polypropylene lid.

Pack size : 8000 tablets (non-marketed).

6.6 Special Precautions For Disposal And Other Handling

No special instructions for use.

Administrative Data

7. Marketing Authorisation Holder

The Wellcome Foundation Ltd

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex UB6 ONN

Trading as

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex UB11 1BT

8. Marketing Authorisation Number(S)

PL 00003/0299

9. Date Of First Authorisation/Renewal Of The Authorisation

16 April 1997

10. Date Of Revision Of The Text

September 2011

Glucose Chewable Tablets

Pronunciation: GLOO-kose
Generic Name: Glucose
Brand Name: BD Glucose

Glucose Chewable Tablets are used for:

Treating reactions caused by low blood glucose (sugar).

Glucose Chewable Tablets are a monosaccharide (simple sugar). It works by quickly raising the glucose level in the blood.

Do NOT use Glucose Chewable Tablets if:

• you are allergic to any ingredient in Glucose Chewable Tablets


• you are unable to swallow

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

Before using Glucose Chewable Tablets:

Some medical conditions may interact with Glucose Chewable Tablets. 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

Some MEDICINES MAY INTERACT with Glucose Chewable Tablets. However, no specific interactions with Glucose Chewable Tablets are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Glucose Chewable Tablets 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 Glucose Chewable Tablets:

Use Glucose Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Chew thoroughly before swallowing.


• If your reaction continues, you may repeat the dose in 10 minutes. You may repeat the dose as needed for low blood glucose reactions that may occur from longer acting insulin.


• If you miss a dose of Glucose Chewable Tablets, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Glucose Chewable Tablets.

Important safety information:

• Do not give Glucose Chewable Tablets to anyone who is unconscious and unable to swallow.


• If your symptoms do not improve within 20 minutes or if they become worse, check with your doctor.


• Notify your doctor about any low blood sugar reactions.


• Check the expiration date on Glucose Chewable Tablets regularly. Replace it so you always have a nonexpired product available.


• PREGNANCY and BREAST-FEEDING: Glucose Chewable Tablets has not been shown to cause harm to the fetus when taken during pregnancy. It is unknown if Glucose Chewable Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Glucose Chewable Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Glucose Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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).

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.

Proper storage of Glucose Chewable Tablets:

Store Glucose Chewable Tablets 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 Glucose Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Glucose Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Glucose Chewable Tablets 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 Glucose Chewable Tablets. 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 Glucose resources

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• Hypoglycemia

HBVAXPRO 40mcg

1. Name Of The Medicinal Product

HBVAXPRO 40 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

2. Qualitative And Quantitative Composition

One dose (1 ml) contains:

Hepatitis B virus surface antigen, recombinant (HBsAg) *.................. 40 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al⁺)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

The vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process. See sections 4.3, 4.4 and 4.8.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Suspension for injection

Slightly opaque white suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

HBVAXPRO is indicated for the active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients.

It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

4.2 Posology And Method Of Administration

Posology

Predialysis and dialysis adult patients: 1 dose (1 ml) at each injection.

Primary vaccination:

A course of vaccination should include three injections:

Schedule 0, 1, 6 months: two injections with an interval of one month; a third injection 6 months after the first administration.

Booster:

A booster dose must be considered in these vaccinees if the antibody level against hepatitis B virus surface antigen (anti-HBsAg) after primary series is less than 10 IU/l.

In accordance with standard medical practice for hepatitis B vaccine administration, regular antibody testing should be done in hemodialysis patients. A booster dose should be given when antibody levels decline below 10 IU/l.

Special dosage recommendations for known or presumed exposure to hepatitis B virus (e.g needlestick with contaminated needle):

- Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).

- The first dose of the vaccine should be given within 7 days of exposure and can be administered simultaneously with hepatitis B immunoglobulin but at a separate injection site.

- Serologic testing is also recommended, with the administration of subsequent doses of vaccine, if necessary, (i.e according to the serologic status of the patient) for short and long term protection.

- In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given as in the recommended immunisation schedule.

Method of administration

This vaccine should be administered intramuscularly.

The deltoid muscle is the preferred site for injection in adults.

Do not inject intravascularly.

Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopoenia or bleeding disorders.

Precautions to be taken before handling or administering the product: see section 6.6.

4.3 Contraindications

- History of hypersensitivity to the active substance, or to any of the excipients, or trace residuals (e.g. formaldehyde and potassium thiocyanate) (see sections 6.1 and 2)

- Vaccination should be postponed in individuals with a severe febrile illness or acute infection.

4.4 Special Warnings And Precautions For Use

As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8).

This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process. Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8).

Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.

A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These factors include older age, male gender, obesity, smoking, route of administration and some chronic underlying diseases. Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of HBVAXPRO. Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.

Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases.

The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver.

Caution should be exercised when prescribing to pregnant or breast-feeding women. (see section 4.6).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

This vaccine can be administered:

- with hepatitis B immunoglobulin, at a separate injection site.

- to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine.

- concomitantly with other vaccines, using separate sites and syringes.

4.6 Pregnancy And Lactation

Fertility:

HBVAXPRO has not been evaluated in fertility studies.

Pregnancy:

There is no clinical data on the use of HBVAXPRO on pregnant women.

The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Breast-feeding:

There is no clinical data on the use of HBVAXPRO on breast-feeding women.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. However, HBVAXPRO is expected to have no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

a. Summary of the safety profile

The most common side effects seen are injection-site reactions: transient soreness, erythema, induration.

b. Tabulated summary of adverse reactions

The following undesirable effects have been reported following the widespread use of the vaccine.

As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established.

Adverse reactions	Frequency
General disorders and administration site conditions
Local reactions (injection site): Transient soreness, Erythema, Induration	Common (
Fatigue, Fever, Malaise, Influenza-like symptoms	Very rare (<1/10,000)
Blood and the lymphatic system disorders
Thrombocytopenia, Lymphadenopathy	Very rare (<1/10,000)
Immune system disorders
Serum sickness, Anaphylaxis, Polyarteritis nodosa	Very rare (<1/10,000)
Nervous system disorders
Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope	Very rare (<1/10,000)
Vascular disorders
Hypotension, Vasculitis	Very rare (<1/10,000)
Respiratory, thoracic and mediastinal disorders
Bronchospasm-like symptoms	Very rare (<1/10,000)
Gastrointestinal disorders
Vomiting, Nausea, Diarrhoea, Abdominal pain	Very rare (<1/10,000)
Skin and subcutaneous tissue disorders
Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Eczema	Very rare (<1/10,000)
Musculoskeletal, connective tissue and bone disorders
Arthralgia, Arthritis, Myalgia, Pain in extremity	Very rare (<1/10,000)
Investigations
Elevation of liver enzymes	Very rare (<1/10,000)

4.9 Overdose

There have been reports of administration of higher than recommended doses of HBVAXPRO.

In general, the adverse event profile reported with overdose was comparable to that observed with the recommended dose of HBVAXPRO.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: anti-infectious, ATC code: J07BC01

The vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Development of an antibody titre against hepatitis B virus surface antigen (anti-HBsAg) equal to or greater than 10 IU/l measured 1 to 2 months after the last injection correlates with protection to hepatitis B virus infection.

In clinical trials, 96 % of 1,497 healthy infants, children, adolescents and adults given a 3 dose course of a previous formulation of Merck's recombinant hepatitis B vaccine developed a protective level of antibodies against hepatitis B virus surface antigen (

Although the duration of the protective effect of a previous formulation of Merck's recombinant hepatitis B vaccine in healthy vaccinees is unknown, follow-up over 5-9 years of approximately 3,000 high-risk subjects given a similar plasma-derived vaccine has revealed no cases of clinically apparent hepatitis B infection.

In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck's recombinant hepatitis B vaccine in healthy adults.

In accordance with standard medical practice for hepatitis B vaccine administration, regular antibody testing should be done in hemodialysis patients. A booster dose should be given when antibody levels decline below 10 IU/l. In subjects in whom insufficient antibody titres are achieved after boosting, the use of alternative hepatitis B vaccines should be considered.

Reduced risk of Hepatocellular Carcinoma

Hepatocellular carcinoma is a serious complication of hepatitis B virus infection. Studies have demonstrated the link between chronic hepatitis B infection and hepatocellular carcinoma and 80 % of hepatocellular carcinomas are caused by hepatitis B virus infection. Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Animal reproduction studies have not been conducted.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride

Borax

Water for injections.

6.2 Incompatibilities

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

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

6.5 Nature And Contents Of Container

1 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps. Pack size of 1.

6.6 Special Precautions For Disposal And Other Handling

The vaccine should be inspected visually in order to detect any appearance of precipitate or discolouring of the content prior to administration. If these conditions exist, the product should not be administered.

Before use, the vial should be well shaken.

Once the vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.

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

7. Marketing Authorisation Holder

SANOFI PASTEUR MSD SNC

8, rue Jonas Salk

F-69007 Lyon

France

8. Marketing Authorisation Number(S)

EU/1/01/183/015

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 27/04/2001

Date of latest renewal: 04/08/2006

10. Date Of Revision Of The Text

03/2011

Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu

Geneyes

Generic Name: tetrahydrozoline ophthalmic (TE tra hye DROZ oh leen)

Brand Names: Altazine, Geneye Extra, Geneyes, Opti-Clear, Optigene 3, Redness Relief, Redness Relief Original, Visine, Visine Maximum Redness Relief, Vision Clear

What is Geneyes (tetrahydrozoline ophthalmic)?

Tetrahydrozoline ophthalmic narrows the blood vessels (veins and arteries) in your eyes.

Tetrahydrozoline ophthalmic (for the eyes) is used to relieve redness, burning, irritation, and dryness of the eyes caused by wind, sun, and other minor irritants.

Tetrahydrozoline ophthalmic may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Geneyes (tetrahydrozoline ophthalmic)?

Do not use tetrahydrozoline ophthalmic without medical advice if you have glaucoma. Do not use this medication while wearing contact lenses. Tetrahydrozoline ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using tetrahydrozoline ophthalmic before putting your contact lenses in. Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye. Do not use tetrahydrozoline ophthalmic more often than recommended, or use it for longer than 48 to 72 hours without medical advice. Long-term use of this medication may damage the blood vessels in the eyes. Call your doctor if your symptoms do not improve or if they get worse.

What should I discuss with my healthcare provider before using Geneyes (tetrahydrozoline ophthalmic)?

Do not use tetrahydrozoline ophthalmic without medical advice if you have glaucoma.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• 
  

  heart disease or coronary artery disease;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

FDA pregnancy category C. It is not known whether tetrahydrozoline ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether tetrahydrozoline nasal 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. Do not give this medication to a child without a doctor's advice.

How should I use Geneyes (tetrahydrozoline ophthalmic)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not use tetrahydrozoline ophthalmic more often than recommended, or use it for longer than 48 to 72 hours without medical advice. Long-term use of this medication may damage the blood vessels in the eyes. Call your doctor if your symptoms do not improve or if they get worse. Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using tetrahydrozoline before putting your contact lenses in. Wash your hands before and after using the eye drops.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

  
  


• 
  

  Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

  
  

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Since tetrahydrozoline ophthalmic is used on an as needed basis, you are not likely to miss a dose.

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 Geneyes (tetrahydrozoline ophthalmic)?

Do not use other eye medications during treatment with tetrahydrozoline ophthalmic unless your doctor tells you to.

Geneyes (tetrahydrozoline ophthalmic) side effects

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

• 
  

  severe burning, stinging, swelling, or other irritation after using the eye drops;

  
  


• 
  

  fast or pounding heartbeats; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  burning, stinging, pain, or increased redness of the eye;

  
  


• 
  

  tearing or blurred vision;

  
  


• 
  

  nausea;

  
  


• 
  

  nervousness, dizziness, drowsiness;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  headache.

  
  

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 Geneyes (tetrahydrozoline ophthalmic)?

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

• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or

  
  


• 
  

  a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

  
  

This list is not complete and other drugs may interact with tetrahydrozoline ophthalmic. 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 Geneyes resources

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

• Clarinex Monograph (AHFS DI)


• Visine Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Geneyes with other medications

• Eye Dryness/Redness

Where can I get more information?

• Your pharmacist can provide more information about tetrahydrozoline ophthalmic.

See also: Geneyes side effects (in more detail)

Zofran Oral, Oromucosal

Generic Name: ondansetron (Oral route, Oromucosal route)

on-DAN-se-tron

Commonly used brand name(s)

In the U.S.

• Zofran


• Zofran ODT


• Zuplenz

Available Dosage Forms:

• Film


• Tablet, Disintegrating


• Tablet


• Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Serotonin Receptor Antagonist, 5-HT3

Uses For Zofran

Ondansetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation. It is also used to prevent nausea and vomiting that may occur after surgery. Ondansetron works in the stomach to block the signals to the brain that cause nausea and vomiting.

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

Before Using Zofran

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 ondansetron in children under 4 years of age. 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 ondansetron in the elderly.

Pregnancy

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

Breast Feeding

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

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

• Apomorphine


• Cisapride


• Dronedarone


• Fluconazole


• Mesoridazine


• Pimozide


• Posaconazole


• Sparfloxacin


• Thioridazine

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.

• Acecainide


• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Azithromycin


• Bretylium


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Enflurane


• Erythromycin


• Flecainide


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Ibutilide


• Iloperidone


• Isoflurane


• Isradipine


• Lapatinib


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Paliperidone


• Pazopanib


• Perflutren Lipid Microsphere


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Salmeterol


• Saquinavir


• Sematilide


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Tedisamil


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

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.

• Cyclophosphamide

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:

• Allergy to other selective 5-HT3 receptor antagonists (alosetron Lotronex], dolasetron [Anzemet], granisetron [Kytril], palonosetron [Aloxi])—Use with caution. It is likely you will also be allergic to ondansetron.

• Bowel blockage or


• Gastric distension (enlarged abdomen)—May cover up symptoms of these stomach or intestinal problems.

• Heart rhythm problems (e.g., prolonged QT interval)—Use with caution. May make this condition worse.

• Liver disease—May have an increased chance of side effects.

• Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse.

Proper Use of ondansetron

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

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

To use the oral disintegrating tablet:

• Make sure your hands are dry.


• Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.


• Immediately place the tablet on top of the tongue. The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

To use the oral soluble film:

• Make sure your hands are clean and dry before and after using this medicine.


• Fold the pouch along the dotted line to expose the tear notch.


• While still folded, tear the pouch carefully along the edge and remove the film out from the pouch.


• Put the soluble film immediately on top of your tongue where it will dissolve in 4 to 20 seconds. Do not chew or swallow the film whole.


• Once the film is dissolved, you may swallow with or without water.

If you vomit within 30 minutes after using this medicine, take the same amount of medicine again. If vomiting continues, check with your doctor.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

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

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

• For oral dosage forms (oral disintegrating tablets, solution, or tablets):
  
  • For prevention of moderate nausea and vomiting after treatment with cancer medicines:
    
    • Adults, teenagers, and children 12 years of age—At first, 8 milligrams (mg) taken 30 minutes before starting cancer treatment. The 8-mg dose is taken again 8 hours after the first dose. Then, the dose is 8 mg every 12 hours for 1 to 2 days.
    
    
    • Children 4 to 11 years of age—At first, 4 mg taken 30 minutes before starting cancer treatment. The 4-mg dose is taken again 4 and 8 hours after the first dose. Then, the dose is 4 mg every 8 hours for 1 to 2 days.
    
    
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of more severe nausea and vomiting after treatment with cancer medicines:
    
    • Adults, teenagers, and children 12 years of age—One 24-milligram (mg) tablet taken 30 minutes before starting cancer treatment.
    
    
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of nausea and vomiting after radiation treatment:
    
    • Adults—At first, 8 milligrams (mg) taken 1 to 2 hours before radiation treatment. Then, the dose is 8 mg every 8 hours.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of nausea and vomiting after surgery:
    
    • Adults—16 milligrams (mg) one hour before anesthesia is given.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (soluble film):
  
  • For prevention of moderate nausea and vomiting after treatment with cancer medicines:
    
    • Adults, teenagers, and children 12 years of age—At first, one 8-milligram (mg) film taken 30 minutes before starting cancer treatment. The second 8-mg film is taken 8 hours after the first dose. Then, one 8-mg film is taken two times a day (every 12 hours) for 1 to 2 days.
    
    
    • Children 4 to 11 years of age—At first, one 4-milligram (mg) film taken 30 minutes before starting cancer treatment. The second and third 4-mg films are taken 4 and 8 hours after the first dose. Then, one 4-mg film is taken three times a day (every 8 hours) for 1 to 2 days.
    
    
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of more severe nausea and vomiting after treatment with cancer medicines:
    
    • Adults—24 milligrams (mg) or three 8-mg films taken 30 minutes before starting cancer treatment. Each film should be dissolved in the tongue before taking the next film.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of nausea and vomiting after radiation treatment:
    
    • Adults—One 8-milligram (mg) film three times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of nausea and vomiting after surgery:
    
    • Adults—16 milligrams (mg) or two 8-mg films taken 1 hour before anesthesia is given. Each film should be dissolved in the tongue before taking the next film.
    
    
    • Children—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.

If you miss a dose of this medicine, and you feel nauseated or you vomit, take the missed dose as soon as possible.

Storage

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

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

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 Zofran

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

Do not use this medicine if you are receiving apomorphine (Apokyn®). Using these medicines together may increase risk for more serious problems.

This medicine may cause serious allergic reactions, including 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 while you are using this medicine.

Check with your doctor right away if you start to have pain or swelling in your stomach area. These may be signs of a serious stomach or bowel problem.

Zofran 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:

More common

• Confusion


• dizziness


• fast heartbeat


• fever


• headache


• shortness of breath


• weakness

Less common

• Decrease in the frequency of urination


• decrease in urine volume


• difficulty with passing urine (dribbling)


• painful urination

Rare

• Arm, back, or jaw pain


• chest pain or discomfort


• chest tightness or heaviness


• convulsions


• cough


• decreased urine


• difficulty with breathing


• difficulty with swallowing


• dry mouth


• fast, pounding, or irregular heartbeat or pulse


• hives


• increased thirst


• itching


• loss of appetite


• loss of bladder control


• loss of consciousness


• mood changes


• muscle pain or cramps


• nausea or vomiting


• noisy breathing


• numbness or tingling in the hands, feet, or lips


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


• skin rash


• sweating


• tightness in the chest


• total body jerking


• unusual tiredness or weakness


• wheezing

Incidence not known

• Blurred vision


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


• fixed position of the eye


• heart stops


• hoarseness


• inability to move the eyes


• increased blinking or spasms of the eyelid


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• no breathing


• no pulse or blood pressure


• noisy breathing


• pounding heartbeat


• slow or irregular breathing


• sticking out of the tongue


• sweating


• trouble with breathing, speaking, or swallowing


• unconscious


• uncontrolled twisting movements of the neck, trunk, arms, or legs


• unusual facial expressions

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

• Anxiety


• difficulty having a bowel movement (stool)


• dry mouth


• general feeling of discomfort or illness


• hyperventilation


• irritability


• restlessness


• shaking


• trouble sleeping

Rare

• Difficulty with speaking


• drooling


• loss of balance control


• muscle trembling, jerking, or stiffness


• shuffling walk


• stiffness of the limbs


• twisting movements of the body


• uncontrolled movements, especially of the face, neck, and back

Incidence not known

• Feeling of warmth


• hiccups


• hives or welts


• redness of the face, neck, arms, and occasionally, upper chest


• redness of the skin

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: Zofran Oral, Oromucosal 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 Zofran Oral, Oromucosal resources

• Zofran Oral, Oromucosal Side Effects (in more detail)
• Zofran Oral, Oromucosal Use in Pregnancy & Breastfeeding
• Drug Images
• Zofran Oral, Oromucosal Drug Interactions
• Zofran Oral, Oromucosal Support Group
• 64 Reviews for Zofran Oral, Oromucosal - Add your own review/rating

Compare Zofran Oral, Oromucosal with other medications

• Alcohol Dependence
• Gastroenteritis
• Nausea/Vomiting
• Nausea/Vomiting, Chemotherapy Induced
• Nausea/Vomiting, Postoperative
• Nausea/Vomiting, Radiation Induced
• Obsessive Compulsive Disorder
• Postanesthetic Shivering
• Pruritus

Eltrombopag

Pronunciation: el-TROM-boe-pag
Generic Name: Eltrombopag
Brand Name: Promacta

Eltrombopag may cause serious and sometimes fatal liver problems. Your doctor will perform blood tests to check your liver before you start Eltrombopag and for as along as you take it. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, stomach pain, or unusual tiredness or weakness.

Eltrombopag is used for:

Treating low blood platelets in certain patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Eltrombopag is a thrombopoietin (TPO) receptor agonist. It works by causing the bone marrow to produce more clot-forming cells (platelets).

Do NOT use Eltrombopag if:

• you are allergic to any ingredient in Eltrombopag


• you have low blood platelets caused by chemotherapy or by a condition other than chronic ITP (eg, certain bone marrow problems, such as myelodysplastic syndrome or blood cancer; chronic liver disease)

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

Before using Eltrombopag:

Some medical conditions may interact with Eltrombopag. 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 liver or kidney problems, cataracts, other bleeding problems, or bone marrow problems, or if you have had surgery to remove your spleen


• if you have a blood clot, a history of blood clots, a high number of clot-forming cells (platelets) in the blood, or a condition that may increase your risk of getting a blood clot (eg, antithrombin III deficiency, antiphospholipid syndrome)


• if you use tobacco products


• if you take a blood thinner (eg, warfarin) or an antiplatelet medicine (eg, clopidogrel)

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

• Ciprofloxacin, fluvoxamine, gemfibrozil, omeprazole, rifampin, or trimethoprim because they may increase the risk of Eltrombopag's side effects


• Acetaminophen, benzylpenicillin, doxorubicin, HMG-CoA reductase inhibitors (eg, atorvastatin, rosuvastatin), meglitinides (eg, nateglinide), methotrexate, narcotic pain medications (eg, codeine), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of their side effects may be increased by Eltrombopag

This may not be a complete list of all interactions that may occur. Ask your health care provider if Eltrombopag 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 Eltrombopag:

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

• Eltrombopag comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Eltrombopag refilled.


• Take Eltrombopag by mouth on an empty stomach at least 1 hour before or 2 hours after a meal.


• Take Eltrombopag at least 4 hours before or 4 hours after you take certain other medicines (eg, antacids), calcium-rich foods (eg, dairy products, calcium-fortified juices), or supplements that contain iron, calcium, aluminum, magnesium, selenium, or zinc.


• Do not suddenly stop taking Eltrombopag. You may have an increased risk of severe low platelets and bleeding. If you need to stop Eltrombopag, your doctor will need to monitor your condition.


• If you miss a dose of Eltrombopag, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in 1 day.

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

Important safety information:

• If you stop taking Eltrombopag, the number of clot-forming cells (platelets) in your blood may return to a similar low platelet count as before you started taking Eltrombopag. Low blood platelets may increase your risk of bleeding, especially if you are also taking certain other medicines (eg, anticoagulants such as warfarin, antiplatelet medicines such as clopidogrel). These effects are most likely to occur within 4 weeks after you stop taking Eltrombopag. Your doctor will check your blood platelet counts for at least 4 weeks after you stop taking Eltrombopag. Tell your doctor if you have unusual bruising or bleeding after you stop taking Eltrombopag. Avoid activities that may cause bruising or injury. Discuss any questions or concerns with your doctor.


• Tell your doctor or dentist that you take Eltrombopag before you receive any medical or dental care, emergency care, or surgery.


• Serious blood clots have occurred in patients taking Eltrombopag. Some serious blood clots may be fatal. The risk of developing a blood clot may be greater if you have a high number of clot-forming cells (platelets) in the blood. However, blood clots have occurred in patients with normal or low blood platelet levels. Tell your doctor immediately if you notice any signs of a blood clot (eg, pain, redness, tenderness, or swelling in the legs; chest pain; shortness of breath; coughing up blood).


• Lab tests, including liver function, complete blood cell counts, peripheral blood smears, and eye exams, may be performed while you use Eltrombopag and for at least 4 weeks after you stop Eltrombopag. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Eltrombopag with caution in East Asian patients (eg, Chinese, Japanese, Taiwanese, Korean) and in patients who have moderate to severe liver problems. They may be more sensitive to the medicine and may require a lower dose than other patients. Discuss any questions or concerns with your doctor.


• Use Eltrombopag with caution in the ELDERLY; they may be more sensitive to its effects.


• Eltrombopag should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Eltrombopag can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Eltrombopag while you are pregnant. It is not known if Eltrombopag is found in breast milk. Do not breast-feed while taking Eltrombopag.

Possible side effects of Eltrombopag:

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:

Back pain; diarrhea; indigestion; menstrual changes; mild flu-like symptoms (eg, fever, headache, tiredness, sore throat, body aches); minor muscle aches or pain; nausea; runny or stuff nose; sneezing; vomiting.

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); bleeding of the eye or eyelid; chest pain; coughing; coughing up blood; dark urine; frequent, painful, or urgent urination; new or worsening vision problems (eg, cloudy vision); pain, redness, tenderness, or swelling in the legs; severe or persistent nausea, vomiting, or stomach pain; symptoms of heart attack (eg, pain in the chest or jaw; numbness or an arm or leg; sudden, severe vomiting or headache; fainting); symptoms of stroke (eg, confusion, slurred speech, sudden vision changes, one-sided weakness); trouble breathing; unusual bruising or bleeding; unusual burning, itching, numbness, or tingling of the skin; unusual tiredness or weakness; yellowing of the skin or eyes.

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: Eltrombopag side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bleeding; chest pain; confusion; coughing; dark urine; one-sided weakness; pain, redness, tenderness, or warmth in the legs; slurred speech; trouble breathing; unusual tiredness or weakness; vision problems; yellowing of the skin or eyes.

Proper storage of Eltrombopag:

Store Eltrombopag at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Eltrombopag out of the reach of children and away from pets.

General information:

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


• Eltrombopag 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 Eltrombopag. 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 Eltrombopag resources

• Eltrombopag Side Effects (in more detail)
• Eltrombopag Dosage
• Eltrombopag Use in Pregnancy & Breastfeeding
• Eltrombopag Drug Interactions
• Eltrombopag Support Group
• 1 Review for Eltrombopag - Add your own review/rating

• Eltrombopag Professional Patient Advice (Wolters Kluwer)


• Eltrombopag Monograph (AHFS DI)


• eltrombopag Advanced Consumer (Micromedex) - Includes Dosage Information


• Promacta Prescribing Information (FDA)


• Promacta Consumer Overview

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